DNIB UNWIND, INC. - FORM 10-K

DNIB UNWIND, INC. - FORM 10-K - March 11, 2015

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

x	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2014

¨	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File No. 001-36072

BIND Therapeutics, Inc.

(Exact name of registrant as specified in its charter)


Delaware		56-2596148
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

325 Vassar Street Cambridge, MA		02139
(Address of principal executive offices)		(Zip Code)

617-491-3400

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		The NASDAQ Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act:

None

(Title of Class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No x

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. x

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x

The aggregate market value of the registrant’s outstanding common stock held by non-affiliates of the registrant, based upon the closing price of the registrant’s common stock on The NASDAQ Global Select Market on June 30, 2014, was $151,947,159

As of February 28, 2015, there were 20,392,918 of the Registrant’s common shares, no par value, issued and outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Registrant’s Definitive Proxy Statement for the Registrant’s 2015 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission are incorporated by reference in answer to Part III of this Annual Report on Form 10-K.

BIND Therapeutics, Inc.

FORM 10-K

YEAR ENDED DECEMBER 31, 2014

TABLE OF CONTENTS


Item No.		Page No.
PART I			1
Item 1.	Business		1
Item 1A.	Risk Factors		40
Item 1B.	Unresolved Staff Comments		72
Item 2.	Properties		72
Item 3.	Legal Proceedings		72
Item 4.	Mine Safety Disclosures		72

PART II			74
Item 5.	Market for Registrant’s Common Shares, Related Stockholder Matters and Issuer Purchases of Equity Securities		74
Item 6.	Selected Financial Data		76
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		77
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk		90
Item 8.	Financial Statements and Supplementary Data		91
Item 9.	Changes In and Disagreements with Accountants on Accounting and Financial Disclosure		117
Item 9A.	Controls and Procedures		117
Item 9B.	Other Information		117

PART III			117
Item 10.	Directors, Executive Officers and Corporate Governance		118
Item 11.	Executive Compensation		118
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters		118
Item 13.	Certain Relationships and Related Transactions, and Director Independence		118
Item 14.	Principal Accountant Fees and Services		118

PART IV			118
Item 15.	Exhibits and Financial Statement Schedules		118

As used in this report, the terms “we,” “us,” “our,” “BIND”, and the “Company” mean BIND Therapeutics, Inc. and its subsidiaries, unless the context indicates another meaning.

Unless otherwise noted, all dollar amounts in this report are expressed in United States dollars.

PART I

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, the matters discussed in this Annual Report on Form 10-K are forward looking statements that involve risks, uncertainties and assumptions that, if they never materialize or if they prove incorrect, could cause our consolidated results to differ materially from those expressed or implied by such forward-looking statements. We make such forward-looking statements under the provision of the “Safe Harbor” section of the Private Securities Litigation Reform Act of 1995. Actual future results may vary materially from those projected, anticipated, or indicated in any forward-looking statements as a result of various factors, including those set forth in Item 1A of this Annual Report on Form 10-K under the heading “Risk Factors.” Readers should also carefully review the risk factors described in the other documents that we file from time to time with the SEC. In this Annual Report on Form 10-K, the words “anticipates,” “believes,” “expects,” “intends,” “future,” “could,” “estimates,” “plans,” “would,” “should,” “potential,” “continues” and similar words or expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements. Forward-looking statements also include the assumptions underlying or relating to any of the foregoing statements. The forward-looking statements contained in this Annual Report include, but are not limited to, statements related to: anticipated financial performance; expected liquidity and capitalization; management’s plans and objectives for future operations, expenditures and product development, and investments in research and development; business prospects; potential of future product releases; our ability to protect our intellectual property from third-party claims; anticipated sales performance; industry trends; market conditions; changes in accounting principles; changes in actual or assumed tax liabilities; expectations regarding tax exposures; anticipated reinvestment of future earnings; anticipated expenditures in regard to our benefit plans; ability to repay our indebtedness; and our intentions regarding the use of cash. All forward-looking statements included in this document are based on information available to us on the date hereof. We will not undertake and specifically decline any obligation to update any forward looking statements.

Item 1.

Business

Overview

We are a clinical-stage nanomedicine platform company developing a pipeline of Accurins, our novel targeted therapeutics designed to result in superior patient outcomes by increasing the concentration and duration of therapeutic payloads at disease sites while reducing exposure to healthy tissue. We are leveraging our Medicinal Nanoengineering platform to develop a pipeline of Accurins in oncology and have a number of strategic collaborations with biopharmaceutical companies to develop Accurins based on their proprietary payloads. We are leveraging strategic collaborations to expand Accurin development beyond oncology. Our wholly owned, lead drug candidate, BIND-014, is a prostate-specific membrane antigen (PSMA) -targeted Accurin that contains docetaxel, a clinically-validated and widely-used cancer chemotherapy drug, as the therapeutic payload. PSMA is a clinically-validated tumor marker expressed on prostate cancer cells and the blood vessels of many types of non-prostate solid tumors, including non-small cell lung cancer, or NSCLC. BIND-014 is currently in development for the treatment of NSCLC patients with KRAS mutations or squamous histology. In addition, we plan to initiate clinical trials with BIND-014 in cervical, bladder, head and neck and cholangio cancers in 2015. We are also advancing BIND-510, a PSMA-targeted Accurin drug candidate containing the potent microtubule inhibitor vincristine, through pre-clinical studies to position it for an investigational new drug, or IND, filing in 2016. Lastly, we are developing Accurins designed to inhibit polo-like kinase 1 (PLK1) and kinesin spindle protein (KSP), both of which we believe are promising anti-mitotic targets that have been limited in the clinic due to dose-limiting toxicities prior to achieving therapeutic dose levels. We have ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd. and Merck & Co., or Merck (known as Merck Sharp & Dohme outside the United States and Canada), to develop Accurins based on their proprietary therapeutic payloads and targeting ligands.

A major challenge in developing drugs is to ensure that therapeutic agents focus their activity at sites of disease and minimize their activity on healthy tissue. This is especially difficult with drugs used to treat cancer,

where the goal is to destroy or inhibit growth of cancer cells without damaging similar healthy cells. First generation cancer drugs were cytotoxic chemotherapies, such as Taxotere, which target the mechanisms responsible for cell proliferation, a key characteristic of cancer cells. However, these drugs have limited selectivity and since the mechanisms responsible for cell proliferation are also a property of certain healthy cells, this leads to significant adverse effects when healthy cells are destroyed. Biopharmaceutical companies have more recently developed more selective drugs, which are commonly referred to as targeted therapies, such as Herceptin™ and Gleevec™, by targeting proteins found at higher levels on the surface of cancer cells or by inhibiting dysregulated biochemical pathways inside cancer cells. More recently, drugs such as Kadcyla™ have increased efficacy by linking toxins and antibodies to deliver targeted cytotoxicity. While these newer drugs are an improvement in targeting cancer cells relative to normal tissue, as we learn more about cancer biology there continues to be a need to develop drugs with increased selectivity.

We believe Accurins represent the next stage in the evolution of drug therapy. Accurins are nanoparticles designed to concentrate high levels of therapeutic payload at sites of disease while limiting exposure to healthy tissue. In order to accomplish this, Accurins are designed with three important properties: 1) long circulating half-life so that the particles can reach the target tissue; 2) targeting mechanisms so that the particles can accumulate at the site of disease; and 3) controlled release of the therapeutic payload so that when the particles accumulate at the target tissue the majority of the therapeutic payload can be released at the disease site and not in healthy tissue. Accurins have the potential to significantly increase the selectivity of a therapeutic payload and result in efficacy and safety not currently achievable with conventional treatment standards.

Product Pipeline and Platform

We are leveraging our Medicinal Nanoengineering platform to develop a pipeline of Accurins targeting hematological and solid tumors. We also have a number of strategic collaborations with biopharmaceutical companies to develop Accurins in areas of high unmet need using our collaborator’s proprietary payloads. The following table depicts our proprietary and collaboration products and their various stages of development:

LOGO

Evolution of Targeted Therapies

The challenge for all drugs is to maximize the net clinical benefit by increasing the desired therapeutic effect and reducing adverse effects. This is especially difficult with drugs used to treat cancer, where the goal is to destroy or inhibit growth of cancer cells without damaging similar healthy cells. First generation cancer drugs were cytotoxic chemotherapies, such as Taxotere, which target the mechanisms responsible for cell proliferation, a key characteristic of cancer cells, with limited selectivity. The mechanisms responsible for cell proliferation are also a property of healthy cells, which can lead to significant adverse events when healthy cells are destroyed. Biopharmaceutical companies developed more selective drugs, such as Herceptin and Gleevec, that target proteins found at higher levels on the surface of cancer cells or inhibit dysregulated biochemical pathways inside cancer cells.

A further step in the evolution of targeted therapies is antibody drug conjugates, or ADCs. ADCs consist of an antibody or antibody fragment and a chemically linked toxin. ADCs are designed to target antigens that are exclusively or preferentially expressed on the surface of cancer cells. The antibody causes the ADC to bind to the target cancer cells, where the ADC is required to be internalized by the cell in order to break the chemical link and release the toxin to kill the target cell. Because of the targeting, ADCs are expected to produce lower side effects and a greater net clinical benefit as compared to the toxin alone. Examples of ADCs include Adcetris™, which is approved to treat relapsed and refractory Hodgkins lymphoma, and Kadcyla, which is approved to treat metastatic breast cancer.

The advent of targeted therapies has represented a major advance in the fight against important diseases including cancer. In some instances targeted therapies have displaced cytotoxic agents in standard cancer regimens, and in others targeted therapies are now used in combination with cytotoxics. However, many targeted therapies are subject to the same limitations as cytotoxic agents, and despite the commercial and clinical success of targeted therapies, we believe the industry is increasingly recognizing potential limitations associated with these therapies, including:

•

Many molecularly-targeted therapies are directed toward cellular processes that are essential for cancer cell survival and proliferation, but also play important roles in normal cells. Because targeted drugs distribute throughout the body in much the same way as cytotoxic drugs, their clinical utility is often limited by toxicity.

•

The limited payload capacity of a monoclonal antibody requires that ADCs carry highly toxic payloads, restricting the universe of payloads that can be delivered. Most current ADCs in clinical development or on the market use one of a few highly toxic molecules such as maytansine, calicheamicin or aurastatin.

•

Since ADCs require the internalization of the antibody and the cleavage of the link between the antibody scaffold and the payload, ADCs must be targeted to antigens that are internalized by cancer cells at a rate sufficient to result in an effective intracellular concentration of the toxin.

As a result of these limitations and as we learn more about cancer biology, we believe there continues to be a need to develop targeted therapies with increased net clinical benefit.

The Emergence of Nanomedicine

Recently, there has been a growing interest in the development of therapeutics using nanotechnology. Nanotechnology is the science and engineering of manipulating matter at the nanometer scale and involves systems on the order of one-thousandth the thickness of a human hair. Nanomedicine is the medical application of nanotechnology to develop therapeutics with clinically useful chemical, physical and biological properties. There are several nanomedicine platforms at various stages of development or commercialization, many of which have limitations. Notable platforms include albumin nanoparticles, liposomes and polymeric nanoparticles.

•

Albumin nanoparticles utilize the plasma protein albumin to formulate therapeutic agents. Abraxane™ is an albumin nanoparticle paclitaxel that does not contain Cremophor, an excipient used in

conventional solvent-based formulations of paclitaxel, such as Taxol. Abraxane has been effective at improving the net clinical benefit compared to conventional paclitaxel formulations by eliminating the side effects associated with the Cremophor and enabling higher dosing of paclitaxel. However, Abraxane has not been clinically shown to target any specific cellular target. The albumin nanoparticles separate from the paclitaxel upon administration, which then distributes widely throughout all tissues.

•

Liposomes encapsulate a therapeutic payload within a lipid shell. Liposomes can cross the walls of new or defective blood vessels and accumulate at the site of the disease. For example, Doxil, liposomal doxorubicin, has been approved for the treatment of multiple types of cancer and has been effective at improving the net clinical benefit by reducing cumulative cardiotoxicity and enabling a longer treatment period. Despite the success of Doxil, the widespread adoption of liposomal technologies has been limited by the difficulty in encapsulating different therapeutic payloads within the lipid shell and controlling their release. Liposomes have also proven difficult to manufacture at commercial scale.

•

Polymeric nanoparticles utilize synthetic polymers to attempt to create therapeutics that concentrate at the site of disease while minimizing exposure to healthy tissue, thereby increasing net clinical benefit. Polymeric nanoparticles vary with respect to whether they physically entrap or chemically attach the therapeutic payload to the polymer, the presence or absence of targeting ligands and the type of synthetic polymer used. Accurins are a member of this class of targeted therapies.

We believe nanomedicine holds the promise of combining the targeting specificity of monoclonal antibodies and ADCs with the breadth of applicability of traditional small molecule drugs and other therapeutics, thereby increasing the net clinical benefit for the treatment of cancer and other diseases.

Accurins

We believe Accurins represent the next stage in the evolution of targeted therapies and nanomedicine.

LOGO

Accurins are polymeric nanoparticles that incorporate a therapeutic payload and have prolonged circulation within the bloodstream, enable targeting of the diseased tissue or cells, and provide for the controlled and timely release of the therapeutic payload.

Prolonged circulation. We design Accurins with a stealth and protective layer that enables them to circulate within the bloodstream for a prolonged period of time, and accumulate at the disease site before being cleared from the circulatory system.

Targeting. We design Accurins with specific pharmaceutical properties intended to target tumors at three levels: tissue, cellular and molecular. Tissue targeting is achieved by engineering the physical and chemical properties—size, shape and surface properties—of the Accurin to allow it to escape through gaps in the blood vessels surrounding tumors and other disease sites. Cellular targeting is achieved using proprietary targeting ligands on the surface of the Accurin that binds to specific cell surfaces or tissue markers. The specific characteristics of the therapeutic payload may enable molecular targeting within the diseased cells. The following diagram depicts the mechanisms of tissue targeting and cellular targeting.

LOGO

Tissue Targeting (Passive/Biophyiscal Targeting): We engineer biophysical properties of the nanoparticles to avoid immune surveillance and escape through gaps in blood vessels surrounding tumors and other disease sites.

Cellular Targeting (Active/Ligand-Directed, Receptor-Mediated Binding): We attach a targeting ligand on the surface of the nanoparticle to bind to specific cell-surface or tissue markers.

Controlled and timely release. We design Accurins with specific polymers that provide for the controlled and timely release of the therapeutic payload. Upon administration, the therapeutic payload begins to diffuse through the polymeric matrix. Subsequently, the polymer breaks down to lactic acid, a compound naturally found in the body. If the therapeutic payload releases before the Accurins accumulate at the disease site, the Accurins will be unable to effectively increase drug concentration in the diseased tissue and the anticipated therapeutic impact will be minimized or lost. Similarly, if the therapeutic payload is not released, or releases too slowly, the anticipated therapeutic impact will be lost or minimized and new toxicities may be created.

By combining prolonged circulation, triple targeting and controlled and timely release of the therapeutic payload, Accurins have the potential to significantly increase the net clinical benefit associated with the therapeutic payload and result in efficacy and safety currently not achievable with conventional treatment standards.

These diagrams depict an Accurin and its key components:

LOGO

• Controlled-release polymer matrix

• Unmodified therapeutic payload

• Stealth and protective layer

• Targeting ligands

LOGO

• Controlled-release polymer matrix—We physically entrap the therapeutic payload in a matrix of clinically-validated, biodegradable and biocompatible FDA approved polymers that mediate the release of the therapeutic payload at the disease site. The matrix is engineered, or programmed, to control the release of the therapeutic payload at a predetermined rate for the specific therapeutic payload and disease application.

LOGO

• Unmodified therapeutic payload—Our Accurins are designed to use a broad range of therapeutic payloads, including small molecules, peptides, proteins and nucleic acids, such as siRNA and mRNA.

• Stealth and protective layer—We have designed a stealth and protective layer for the Accurin using polyethylene glycol, or PEG, which is engineered to protect the Accurin from the body’s immune detection and clearance mechanisms by creating a hydration shell. PEG also provides attachment sites for the targeting ligand through linking chemistries.

• Targeting ligands—To facilitate cellular targeting, we utilize a targeting ligand on the surface of the Accurin that binds to specific cell-surface or tissue markers, enabling the Accurins to preferentially accumulate at their intended site of action. Targeting ligands may include small molecules, peptides, antibodies and antibody fragments.

The PEG and polymers used in our Accurins have been used in other medical products that have been approved by the FDA and other regulatory agencies.

Medicinal nanoengineering

We develop Accurins utilizing our Medicinal Nanoengineering platform. We engineer combinatorial libraries of targeted nanoparticles with systematically varied physical and chemical properties, such as particle size, surface properties, ligand density, therapeutic payload amount and release profile, using a self-assembly nanoparticle fabrication process. We design the Accurin to balance circulation time and payload release rate with effective targeting and binding for a particular cell or tissue target.

Manufacturing of Accurins

Accurins are manufactured using a readily-scalable, self-assembly nanoemulsion process with well-defined, robust unit operations. This highly specialized and precisely controlled manufacturing process enables us to reproducibly manufacture Accurins across many scales, from gram-scale at the laboratory bench to hundreds of grams for IND- enabling toxicology studies complying with the FDA’s good laboratory practice, or GLP, regulations to the multi-kilogram scale for clinical batches complying with FDA’s current good manufacturing practice, or cGMP, regulations. In addition, our well-controlled, self-assembly manufacturing process is the backbone of our Medicinal Nanoengineering platform, allowing us to take a combinatorial approach varying key nanoparticle parameters, such as drug load and release profiles, nanoparticle size/distribution and targeting ligand content, to identify Accurins for lead candidate selection. Our approach differs from common approaches to the preparation of nanoparticles that often employ multiple steps for drug incorporation and, separately, for the attachment of ligands to preformed nanoparticles, which create several challenges for reproducibility, yield and scalability. We have more than five issued U.S. patents relating to Accurin manufacturing processes.

We believe the design and manufacture of our Accurins allows us to create a targeted nanomedicine that achieves concentrations of therapeutic payload at disease sites unachievable through alternative therapeutic modalities to maximize therapeutic benefits.

Therapeutic Payloads

We have engineered Accurins that incorporate therapeutic payloads with a range of physicochemical properties. We have demonstrated in preclinical studies that these Accurins can improve tumor growth suppression, achieve higher concentrations of the payload in tumors compared to the payload administered in conventional form, and have pharmacokinetics and tolerability differentiated from their therapeutic payloads.

For example, we have incorporated vincristine, the highly potent vinca alkaloid that works as a microtubule inhibitor, into a PSMA-targeted Accurin nanoparticle. Evidence of meaningfully greater efficacy and an improved toxicity profile compared to vincristine in conventional form has been demonstrated across a broad range of in vivo tumor models. In normal rats, the plasma concentration was more than 100 times higher in animals receiving the Accurin form of vincristine compared to conventional vincristine. In cynomolgus monkeys, Accurin vincristine was well tolerated with minimal side effects at a vincristine dose that caused moribundity when administered in conventional form. In a mouse tumor model of human breast cancer, we observed an approximately 10-fold increase in tumor vincristine concentration and an approximately two-fold increase in the maximum tolerated dose with Accurin vincristine compared to conventional vincristine. At its maximum tolerated dose, a single dose of Accurin vincristine resulted in complete inhibition of tumor growth for the duration of the experiment, approximately 50 days after treatment, while conventional vincristine administered at its maximum tolerated dose inhibited tumor growth for approximately two weeks.

In addition, as part of our research and development work with collaborators, we have incorporated multiple kinase inhibitors into Accurins and observed differentiated pharmacokinetics and improved net clinical benefit in preclinical models compared to the parent forms of the therapeutic payloads. In normal rats, the plasma concentrations were more than 100 times higher in animals receiving Accurins compared to the payloads. In rodent models, these Accurins were well tolerated with reduced side effects. In rodent tumor models of human cancers, we observed up to 10-fold increases in tumor concentrations for the Accurin over the parent payloads and significantly prolonged activity. The Accurins resulted in complete inhibition of tumor growth at the termination point of the studies through the preferential targeting of payload to tumors and avoidance/reduction of toxicity in off-target healthy cells.

BIND-014

Our lead drug candidate, BIND-014, is a PSMA -targeted Accurin that contains docetaxel, a clinically-validated and widely-used cancer chemotherapy drug. PSMA is a clinically-validated tumor marker expressed on prostate cancer cells and the blood vessels of many types of non-prostate solid tumors, including NSCLC. In 2013, we initiated two Phase 2 clinical trials to evaluate the level of clinical activity of BIND-014, one in NSCLC, where we evaluated two dose schedules (60mg/m² on day one of a 21 day cycle, or Q3W, and 40 mg/m² on day 1, 8 and 15 of a 28 day cycle, or Q1W), and one in metastatic castrate resistant prostate cancer (mCRPC), where we evaluated only the Q3W schedule. In November 2014, we announced positive topline data for BIND-014 in the NSCLC patient population with promising signals of efficacy in two subpopulations of NSCLC with high unmet need: KRAS mutant tumors and tumors with squamous histology. We are currently advancing BIND-014 for the treatment of NSCLC patients with KRAS mutations or squamous histology. In January 2015, we also announced positive topline data from the ongoing Phase 2 trial in mCRPC; however, given the rapidly emerging treatment landscape in mCRPC we have decided not to move forward with the development of BIND-014 in mCRPC and focus our resources on more promising opportunities. We plan to initiate clinical trials with BIND-014 in cervical, bladder, head and neck and cholangio cancers in 2015.

PSMA Targeting

PSMA is a transmembrane glycoprotein also known as glutamate carboxypeptidase II (GCPII) and N-acetyl-L-aspartyl-L-glutamate peptidase I (NAALADase I). Published preclinical and clinical data have shown PSMA to be preferentially expressed on prostate cancer cells and vasculature of non-prostate solid tumors as demonstrated in the table below. PSMA has not been found in normal vasculature, which makes it an attractive target for the treatment of solid tumors.


	Patients expressing PSMA								Number of U.S. patients
Tumor	Tumor Cells				Tumor Vasculature				Incidence		Mortality
Prostate		184/184	(100	%)		2/12	(17	%)		238,590		29,720
Breast		0/6	(0	%)		5/6	(83	%)		232,340		39,620
Colorectal		0/130	(0	%)		110/130	(85	%)		142,820		50,830
Renal cell		0/75	(0	%)		67/75	(89	%)		65,150		13,680
Bladder		8/167	(5	%)		166/167	(99	%)		72,570		15,210
Gastric		0/119	(0	%)		79/119	(66	%)		21,600		10,990
Neuroendocrine		0/5	(0	%)		5/5	(100	%)		1,000		420
Melanoma		0/5	(0	%)		5/5	(100	%)		76,690		9,480
Pancreatic duct		0/4	(0	%)		4/4	(100	%)		45,220		38,460
NSCLC		0/5	(0	%)		5/5	(100	%)		193,961		135,558
Soft tissue sarcoma		0/6	(0	%)		5/6	(83	%)		11,410		4,390

PSMA is a clinically-validated target in prostate cancer and is the target of an FDA-approved imaging agent, ProstaScint, and ADCs currently in clinical development.

Docetaxel

Docetaxel, marketed as Taxotere, is one of the most commonly used cancer chemotherapy drugs and was first approved by the FDA in 1996. It is approved for the treatment of breast cancer, NSCLC, mCRPC, head and neck cancer, and gastric cancer. Taxotere achieved global sales of approximately $3 billion in 2009, the year prior to its loss of marketing exclusivity in the United States, and generic docetaxel continues to be a mainstay in the oncology practice.

Docetaxel, the therapeutic payload in BIND-014, is more effective in some cancers compared to other cancers. For example, in metastatic breast cancer, single-agent docetaxel has a 30-60% response rate and six-month progression-free survival. On the other hand, in second-line NSCLC, where it is one of the most

commonly used chemotherapy agents, the response rate is only 5-9% with a progression-free survival of approximately three months. In clinical trials with docetaxel in KRAS mutant NSCLC, no responses were seen with docetaxel as a single agent. The following table indicates the single-agent efficacy of docetaxel in various solid tumors based on several published clinical studies.


Indication	Response Rate (%)(1)			Progression-Free Survival (Months)
NSCLC (2^nd Line)		5-9	%		3
NSCLC KRAS mutant		0	%		—
mCRPC		45-65	%		6-8
Breast (1^st Line Metastatic)		30-60	%		6
Bladder (2^nd Line)		13	%		5
Cervix (2^nd Line)		0-21	%		2-3
Ovary (2^nd Line)		20-25	%		5
Biliary (1^st-2^nd Line)		0-20	%		4-6
Gastric (2^nd Line)		14	%		2.6
Head and Neck (2^nd Line)		27-43	%		5-6.5

(1)	Response rate is a reduction in tumor volume or, with respect to mCRPC, prostate-specific antigen, or PSA, levels.

Docetaxel is associated with significant toxicities and side effects. These include neutropenia, anemia, infection, fluid retention and edema, neuropathy, rash, mucositis, fatigue, muscle weakness, nail loss, and hair loss. Market research suggests that many cancer patients, especially lung and prostate, who are elderly or have poor performance that are potentially eligible for docetaxel do not receive it because of concerns related to its toxicity.

BIND-014 Market Opportunity

Our development plan seeks to advance BIND-014 in NSCLC patients with KRAS mutant tumors or squamous histology. Together, KRAS mutant and squamous histology represent approximately 45% of the locally advanced or metastatic NSCLC population, and both indications offer the opportunity to develop an improved standard of care as well as a substantive commercial opportunity. In addition, we plan to initiate clinical trials with BIND-014 in cervical, bladder, head and neck and cholangio cancers in 2015.

NSCLC

NSCLC remains an area of high unmet medical need. According to the World Health Organization, lung cancer is the number one cause of cancer related morbidity and mortality worldwide, with an estimated 1.8 million new diagnoses and 1.6 million deaths annually. Approximately 80-90% of lung cancer diagnoses are of the non-small cell type, of which squamous cell and adenocarcinoma subtypes make up 26% and 50% of these cases, respectively. Despite the availability of numerous active therapies, the prognosis remains poor, with average five-year survival as low as 16% for all patients diagnosed with NSCLC, and less than 5% for patients with locally-advanced or metastatic disease at diagnosis.

While surgical resection and radiation and/or chemotherapy can affect cures in early-stage lung cancer, current therapy for locally-advanced or metastatic NSCLC primarily focuses on palliative pharmacotherapy. Of the more than 450,000 estimated patients who will be diagnosed with non-small cell lung cancer in the United States and EU-28 in 2015, more than 60% will have locally-advanced or metastatic disease at diagnosis and thus be eligible for therapeutic treatment. Of the remainder, one-third to one-half will develop relapsed or metastatic disease following treatment for localized disease.

The treatment for patients with locally-advanced or metastatic NSCLC in the key global markets of the United States, Western Europe, and Japan focuses on extending survival and ameliorating cancer symptoms while maintaining the best possible quality of life. Treatment includes various chemotherapy regimens as well as a handful of therapies that target specific oncogenic drivers such as the epithelial growth factor receptor (EGFR) and anaplastic lymphoma-kinase (ALK). Less than one third of patients with NSCLC adenocarcinomas are reported to have tumors that express these molecular markers (EGFR and ALK). The single most common genetic mutation identified thus far in lung adenocarcinoma, known as Kirsten rat sarcoma viral oncogene or KRAS, accounts for one-quarter of diagnoses. Presence of KRAS mutations, independent of treatment, is prognostic of poor survival compared to the absence of KRAS mutations. There is currently no approved targeted therapy specific to the KRAS mutation.

For patients who lack sensitizing EGFR mutations and ALK rearrangements, chemotherapy remains the mainstay of NSCLC therapy for both squamous and non-squamous carcinoma sub-types. Current first-line therapy for advanced or metastatic NSCLC consists of platinum-based combination chemotherapy. The most effective combination chemotherapy approach for initial treatment of patients with advanced or metastatic squamous lung cancer, cisplatin/gemcitabine, provides a median survival of only 10.8 months, while median survival in patients with non-squamous histologies of 12.6 months have been reported with cisplatin/pemetrexed. Whether or not KRAS mutations are prognostic for response to therapy remains controversial, with one recent retrospective study showing no difference in progression-free survival or responsiveness to chemotherapy or EGFR tyrosine-kinase inhibitors between KRAS-mutant and KRAS-wild type patients.

Second-line therapy for patients with advanced or metastatic NSCLC is typically monotherapy with agents such as docetaxel, pemetrexed (non squamous only), gemcitabine or erlotinib, if these agents have not already been given. Taxanes are used extensively to treat NSCLC in the United States, EU-28, and Japan, with a large percentage of these patients receiving docetaxel, predominantly in second or subsequent lines of treatment. Notwithstanding its widespread use in the second-line treatment for NSCLC, docetaxel has modest efficacy in this setting. In the definitive docetaxel trial in NSCLC, patients previously treated with platinum-based chemotherapy, partial responses were observed in only 5.5% of patients and median overall survival surpassed best supportive care by only 2.9 months (7.5 months vs. 4.6 months, P=0.003). By concentrating docetaxel at the tumor site, we believe that BIND-014 will be able to achieve superior efficacy to docetaxel in this setting without worsening treatment tolerability.

Cervical Cancer

Cervical cancer is a malignant neoplasm arising from cells originating in the cervix. One of the most common symptoms of cervical cancer is abnormal vaginal bleeding, but in some cases there may be no obvious symptoms until the cancer has progressed to an advanced stage. Human papillomavirus (HPV) infection appears to be involved in the development of more than 90% of cases. Most cervical cancers are squamous cell carcinomas, arising in the squamous (flattened) epithelial cells that line the cervix. Adenocarcinoma, arising in glandular epithelial cells is the second most common type. Very rarely, cancer can arise in other types of cells.

Worldwide, cervical cancer is the second most common and the fifth deadliest cancer in women. There were expected to be approximately 12,000 new patients with invasive cervical cancer diagnosed in the United States in 2014 with approximately 4,000 deaths from this disease. In developed countries, the widespread use of cervical screening programs has dramatically reduced the incidence of invasive cervical cancer and incidence is expected to further decline with the recent adoption of HPV vaccines. However, worldwide cervical cancer is a major public health issue with approximately 500,000 new cases and 250,000 deaths per year. India and China account for almost half of these cases where screening programs and the use of HPV vaccines are less common.

The prognosis of advanced cervical cancer is discouraging. Recurrent, persistent or advanced cervical cancer responds poorly to current treatment modalities. Five-year survival rates have been approximately 57.4% and 16.1% for patients with regional and distant disease, respectively.

Cisplatin combinations have been the first-line standard of care for advanced disease for decades, with cisplatin/paclitaxel preferred. Recently Avastin in combination with chemotherapy received FDA approval for the treatment of persistent, recurrent or metastatic disease based on a four-month survival advantage compared to chemotherapy alone in a Phase 3 study of 452 patients. Despite many studies of cytotoxics and targeted agents given as single agents or in combination regimens, no Phase 3 studies have demonstrated efficacy in the second-line setting, and there is no standard of care for patients once they progress on their first-line regimen. Docetaxel had a response rate of 0-9% in this patient population. The vascular nature of cervical cancer may be a good rationale for BIND-014 targeting PSMA as a result of the convincing data on the presence of PSMA in cervical cancer.

Bladder Cancer

Urothelial bladder cancer (UBC) is the most common cancer of the urinary system worldwide with transitional cell carcinoma (TCC) being the predominant histologic type. It was estimated that in 2014, there would be approximately 75,000 new cases of bladder cancer and 16,000 deaths in the United States. Similar worldwide data estimate that there were 123,000 bladder cancer deaths in men and 42,000 in females in 2012.

The overall 5-year survival rate for metastatic UBC in the United States is 5.5%. Poor prognostic factors for survival in patients with metastatic UBC include advanced stage of disease at the time of initial diagnosis, Karnofsky Performance Status (KPS) <80%, visceral metastasis (i.e., lung, liver, or bone). The presence of these unfavorable features was associated with a median survival of 4 months compared with 18 months in patients without these features.

The majority of urothelial tumors arise in the bladder with the remainder originating in the renal pelvis, urethra, or ureter. TCC is the most common histologic subtype associated with bladder cancer and accounts for greater than 90% of all urothelial bladder cancer cases in the industrialized world, whereas non-urothelial subtypes, including squamous cell, adenocarcinoma, and small cell carcinoma, are more frequent in other areas of the world.

Despite the use of cisplatin-based therapies in first-line metastatic disease, the prognosis for patients with advanced UBC remains dismal, with a median OS of approximately 15 months. 30% to 50% of patients are not appropriate candidates for combination chemotherapy with cisplatin, the standard of care, because of comorbidities or impaired functional status. For cisplatin-ineligible patients, the prognosis is even more limited, with a median overall survival of approximately nine months. Nearly all patients who receive first-line treatment will experience disease progression and require second-line treatment. There are currently no approved second-line therapies for UBC in the United States and only one approved agent (vinflunine) in the EU. Patients who receive second-line treatment for their disease, typically a single agent taxane or gemcitabine, have a median survival duration of approximately seven to eight months with significant toxicities, e.g., neuropathy, febrile neutropenia, myelosuppression, and alopecia, which negatively impact quality of life. Therefore, there is a continuing need for more efficacious and better-tolerated treatments for patients with advanced UBC.

Head & Neck Cancer –

Globally, there are approximately 120,000 new cases of head and neck cancer annually. Squamous cell carcinomas of the head and neck (SCCHN) are a diverse range of cancers, grouped by anatomic site, that together represent 90% of all head and neck cancer cases. SCCHN typically affects older (>60 yrs.) male patients with five-year survival rates of 60-70%. Alcohol, tobacco use and HPV infection are the primary risk factors. For patients with metastatic disease, five-year survival rates drop to 35-40%.

Treatment is complex for patients with SCCHN. The specific site of disease, stage and pathologic findings guide treatment. Single-modality treatment with surgery or radiation therapy is generally recommended for the 30-40% of patients who present with early-stage disease. In contrast, combined modality therapy is generally

recommended for the approximately 60% of patients with locally or regionally advanced disease. Cisplatin is the systemic therapy of choice for advanced disease. Carboplatin/5-FU or Erbitux (cetuximab) are also used first-line and significantly improve overall survival. There is no standard of care for patients who progress on first-line therapy. Single agents such as docetaxel, paclitaxel or carboplatin are commonly used. Combination regimens are also used, when tolerated, and have generally demonstrated double the response rates of single agents, but no survival advantage. Enrollment in clinical trials is recommended, suggesting a significant unmet medical need.

Cholangiocarcinoma

Cholangiocarcinoma (CC) is the second most common primary liver tumor behind hepatocellular carcinoma. CC accounts for 3% of all gastrointestinal tumors and, assuming that CC comprises about 20% of the combined categories of “liver and intrahepatic bile duct” and “gallbladder and other biliary cancers,” it was estimated that in 2014 there would be around 8,000-9,000 new cases in the United States and approximately 5,500 deaths. Worldwide data do not break down liver cancer/gallbladder cancer into CC and other types, therefore obtaining accurate estimates is problematic (GLOBOCAN 2012).

CCs are adenocarcinomas, and can be intrahepatic, perihilar or extrahepatic/distal. Location of the primary tumor determines the surgical treatment, which is the only curative approach and is limited to resectable disease. There is no evidence that the location of advanced disease determines the outcome of systemic treatment, which is generally abysmal. The overall survival for Stage III-IV disease is approximately six months and five-year survival is approximately 10%.

Cisplatin-gemcitabine combination chemotherapy is the first-line global standard of care for patients with unresectable or recurrent CC; however, neither therapy has a specific label for use in CC. Despite the recent move to the use of cisplatin-gemcitabine in first-line metastatic disease, the prognosis for patients with advanced CC remains dismal, with a median OS of barely one year. Therapy is also associated with significant toxicities, namely between one and two-thirds of patients with G3-4 hematological toxicity, 18% with G3-4 infections, one-fifth with G3-4 fatigue and overall 71% experiencing a grade 3-4 toxicity, which is likely to negatively impact quality of life.

In second-line CC there is no accepted standard of care. Several chemotherapeutic agents have been studied as single agents over the last two decades with low overall response rates, generally below 10%. Guidelines generally recommend inclusion in a clinical trial and there is a continuing need for more efficacious and better-tolerated treatments for patients with advanced CC.

BIND-014 Development

NSCLC

Positive results from our ongoing Phase 2 study of BIND-014 in NSCLC were presented at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain in November 2014. The trial met the primary objective in the Q3W arm (60 mg/m² of BIND-014 on Day 1 of a 21-day cycle) as measured by overall response rate. These data from our ongoing Phase 2 study demonstrated substantial clinical activity as monotherapy in advanced second line NSCLC patients, with 15% partial response rate (n= 40; 5 confirmed, 1 unconfirmed), progression free survival of 2.7 months, and mediation duration response of 5.2 months. In addition, BIND-014 demonstrated prolonged disease control, with 63% of patients (25) achieving stable disease or partial response for more than 6 weeks and 48% (19) for more than 12 weeks, and meaningful reductions of docetaxel-related toxicities. Based on the promising results of the Q3W arm and the more patient-friendly once every three week dosing schedule, combined with the absence of a confirmed partial response in the first 22 patients enrolled on the once weekly dosing schedule, we chose not to continue evaluating the weekly dosing schedule. We believe that the increased anti-tumor activity at a lower dose than conventional docetaxel provides important validation of our Accurin platform. We expect to report final overall survival data from our ongoing Phase 2 trial with BIND-014 in the NSCLC broad patient population in the first half of 2015.

LOGO

In the Phase 2 study, BIND-014 also demonstrated promising anti-tumor activity in NSCLC patients with KRAS mutant tumors, with two out of nine patients (22%) with KRAS mutations enrolled in the trial experiencing an objective response. One KRAS mutant NSCLC objective response was also seen in the Phase 1 trial with BIND-014, yielding a combined total confirmed response rate of 30% across both studies. Additionally, in the Phase 2 study, BIND-014 demonstrated prolonged disease control in NSCLC patients with KRAS mutations, with 66% of patients (6) achieving stable disease or partial response for more than six weeks and 44% (4) for more than 12 weeks. KRAS mutations in NSCLC account for approximately 20% of all NSCLC and are generally associated with poor response to currently available drug therapy regimens, including docetaxel.

LOGO

An additional signal was observed in NSCLC patients with squamous histology, with interim overall survival of 11.1 months as of October 23, 2014. Although no confirmed objective responses were seen in this subset of patients, BIND-014 demonstrated prolonged disease control in NSCLC patients with squamous histology (n=9), with 66% of patients (6) achieving stable disease for more than six weeks and 55% (5) for more than 12 weeks. Squamous histology is a major NSCLC subtype accounting for approximately 25% of all NSCLC and there are limited treatment options available.

LOGO

Importantly, and consistent with previous results with BIND-014, neutropenia, anemia, neuropathy, and alopecia, adverse events commonly observed with docetaxel, were significantly reduced with BIND-014 and dose reductions or discontinuations in the study due to toxicity were less than 10%. In addition, 21 of 40 patients received four or more cycles of therapy, attesting to the tolerability of BIND-014.

BIND-014: Phase 2 data in NSCLC


Treatment Emergent Adverse Events	BIND-014
Hematologic (%)
Anemia
Any Grade		20
Grade 3/4		0
Neutropenia
Any Grade		10
Grade 3/4		5
Infection
Any Grade		10
Grade 3/4		0
Febrile Neutropenia
Any Grade		3
Leukopenia
Any Grade		3
Grade 3/4		0
Non-hematologic (%)
Nausea
Any Grade		25
Grade 3/4		3
Hypersensitivity
Any Grade		18
Grade 3/4		3
Alopecia
Any Grade		15
Edema Peripheral
Any Grade		15
Grade 3/4		0
Peripheral Neuropathy
Any Grade		13
Grade 3/4		3

In January 2015, we enrolled the first patient expressing a KRAS mutation in the iNSITE 1 (BIND-014 Nanoparticle Study In Patients with Advanced KRAS Mutant or Squamous NSCLC to Determine Tolerability and Efficacy) trial, a two-tier Phase 2 trial with BIND-014 in NSCLC patients with KRAS mutant or squamous histology. We anticipate enrolling the first NSCLC patient with squamous histology in this trial in the first quarter of 2015. Total enrollment in each tier of the trial is expected to be 40 patients, with preliminary data anticipated as early as the second half of 2015. There were approximately 1.4 million new cases of NSCLC worldwide in 2012 and NSCLC patients with KRAS mutant tumors or squamous histology account for approximately 650,000 of these cases.

mCRPC

Our Phase 2 trial of BIND-014 in mCRPC enrolled 42 patients, 31 of whom had been treated with androgen inhibitors prior to enrolling in the study. In January 2015, we announced topline data from this ongoing study showing that BIND-014 demonstrated promising efficacy profile, with radiographic progression-free survival, or rPFS, of 8.1 months as of December 15, 2014. Two patients remained on treatment as of December 15, 2014. Twenty-four patients continue to be followed for overall survival and 60% of the patients enrolled attained an rPFS of six months or greater. Safety and tolerability were also promising, with notable reductions in adverse

effects that often limit dosing of conventional docetaxel, including hematologic and non-hematologic toxicities. Given the rapidly evolving prostate cancer treatment landscape, we believe that there are more promising opportunities for the Accurin platform within our development portfolio rather than for the treatment of mCRPC. We plan to present complete results of the mCRPC trial at an upcoming medical meeting.

Other Indications

We plan to initiate the iNSITE 2 (BIND-014 Nanoparticle Study In Patients with Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer, and Squamous Cell Carcinoma of the Head and Neck to Determine Tolerability and Efficacy) trial, a Phase 2 multi-tumor trial with BIND-014 in patients with cholangiocarcinoma, cervical cancer, bladder cancer, and head and neck cancers, in the second quarter of 2015. Each of these indications were selected based on three criteria: signals of efficacy in our Phase 1 clinical trial with BIND-014, evidence that these tumors are sensitive to docetaxel, and significant level of unmet need for these patients. This trial will be conducted as a single arm, open-label, multi-center, Phase 2 efficacy and safety study of BIND-014 in patients with either advanced urothelial carcinoma (transitional cell carcinoma), cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck. A Fleming two-stage design for Phase 2 oncology studies will be employed with starting and stopping rules established. Up to a total of 160 patients will be enrolled in the trial.

This trial’s primary objective is to determine the objective response rate (ORR), with secondary objectives of determining progression-free survival (PFS), overall survival (OS), best overall response rate (BOR), duration of response (DOR), time to response (TTR), disease control rate (DCR), and assessing the safety and tolerability of BIND-014.

Additional exploratory objectives are added to potentially identify patients likely to benefit from BIND-014. These include the use of Fe-MRI as a predictive biomarker for measuring tumor deposition of circulating nanoparticles, the use of expression of prostate-specific membrane antigen (PSMA) and microvessel density (MVD) found on archival tumor tissue blocks and fresh tumor biopsies using immunohistochemistry (IHC) and the use of detecting genetic alterations seen by next generation sequencing (NGS).

Phase 1 Clinical Development

We have completed a Phase 1 clinical trial evaluating BIND-014 in patients with advanced and metastatic solid tumors at Q3W and Q1W dosing schedules.

The trial was designed to enroll individual cohorts of one to three patients at a starting dose and, if no dose limiting toxicities, or DLTs, were observed, the dose was increased to the next pre-specified dose level for the next cohort of patients until a maximum tolerated dose was identified. As long as there was no disease progression, patients were allowed to stay on drug; however, since the starting dose was typically sub-therapeutic we expected patients’ tumors in the early cohorts to continue to grow.

Q3W Schedule Results

In the Q3W portion of the trial, we evaluated dose levels ranging from 3.5 mg/m² to 75 mg/m² and we determined the maximum tolerated dose to be 60 mg/m² given as a 60-minute infusion on the Q3W schedule based on the observed toxicity profile. The Q3W portion of the trial enrolled 30 patients with a variety of advanced malignancies. Of those 30, 28 patients were evaluable for toxicities at six different dose levels. The other two patients had disease progression before their first dose of BIND-014. All of the patients in the trial previously failed standard therapies for their disease. The trial included patients with NSCLC, head and neck cancer, mCRPC and a variety of gastrointestinal and other malignancies.

Q1W Schedule Summary

In the Q1W portion of the trial, BIND-014 was evaluated on a weekly schedule in which it was administered on days 1, 8, and 15 of a 28-day cycle. During the Q1W portion of the trial, we evaluated dose levels ranging from 15 mg/m² to 45 mg/m² and we determined the maximum tolerated dose to be 40 mg/m² given as a 60-minute infusion on the Q1W schedule based on the observed toxicity profile. The Q1W portion of the trial enrolled 28 patients with a variety of advanced malignancies. Of the 28 enrolled into the trial, 27 patients were evaluable for toxicities over six different dose levels. One was patient was enrolled and not treated with BIND-014 due to rapid disease progression prior their first scheduled dose of BIND-014. All of the patients enrolled into the trial previously failed standard therapies for their disease. The trial included patients with NSCLC, breast cancer, gastric cancer, a variety of hepatobiliary cancers and uterine cancers in addition to other advanced malignancies.

Preclinical Development

Prior to entering clinical development, we completed preclinical studies in mice, rats and nonhuman primates to evaluate the accumulation of BIND-014 at the targeted disease site, the effects of prolonged circulation of BIND-014 and the impact of BIND-014 on tumor size and growth. The performance of BIND-014 in these preclinical studies suggests that BIND-014 is highly differentiated from, and superior to, Taxotere.

We compared the pharmacokinetics of BIND-014 and Taxotere in cynomolgus monkeys. In the study, equal doses of BIND-014 or Taxotere were administered to animals and blood samples collected at various times over a 70-hour period were analyzed to measure the total docetaxel concentration. The docetaxel concentration was approximately 10 to 100 times higher with BIND-014 than Taxotere for the entire duration of the experiment. These data suggest that BIND-014 prolongs the retention of docetaxel in the circulation, making it available to disseminate into tumor sites. Similar findings have been obtained in other animal species, including mice and rats. The following graph depicts the levels of docetaxel concentration in studied cynomolgus monkeys over the 70-hour study period administered at the same dose. The first measurement of docetaxel shown below is lower due to the rapid diffusion upon administration.

LOGO

We also studied the levels of accumulation of docetaxel in a mouse model of human prostate cancer when treated with BIND-014 or Taxotere. Prostate tumor-derived cells were implanted in mice and allowed to form tumors. The mice were then treated with equal doses of either BIND-014 or Taxotere. Tumors were harvested at two and 12 hours after docetaxel administration and analyzed for total docetaxel concentration. After two hours, the docetaxel concentration in tumors was higher in animals that received BIND-014, but not statistically different from docetaxel. After 12 hours, the docetaxel concentration was more than seven times higher in the animals treated with BIND-014 (p<0.01). Between two and 12 hours, the concentration of docetaxel in tumors increased in animals treated with BIND-014, but decreased in the animals treated with Taxotere. The following graph depicts the results of this study.

LOGO

We believe that the increase in the concentration of docetaxel in tumors in mice treated with BIND-014 is due to the combined effects of prolonged circulation time of BIND-014, extravasation of BIND-014 into tumors through defects in the tumor blood vessels, binding of the particles to PSMA and controlled release of docetaxel.

We also compared the efficacy of BIND-014, a version of BIND-014 without targeting ligand, which we refer to as PTNP, and docetaxel in mouse models using the LNCaP human prostate cancer cell line and the MX-1 human breast cancer cell line. Tumor cells were implanted in mice and allowed to form tumors. Different groups of mice were then treated every four days with equal doses of either BIND-014, PTNP, docetaxel, or a solution containing no docetaxel, which we refer to as vehicle. In the prostate cancer model, mice received four doses over 16 days. In the breast cancer model, three doses were administered over 12 days. The size of the tumors was periodically measured to determine the effect of treatment on the rate of tumor growth or shrinkage. In both tumor models, while Taxotere slowed down the rate of tumor growth compared to vehicle, the tumors still increased in size, particularly after treatment was discontinued. BIND-014 treatment resulted in significantly increased shrinkage of the tumors when compared to docetaxel, which persisted even after treatment was stopped (p<0.05 in prostate cancer model, p<0.01 in the breast cancer model). BIND-014 was also significantly more effective than PTNP in the prostate cancer model, which expresses PSMA (p<0.05). BIND-014 and PTNP docetaxel nanoparticles were equally effective in the breast tumor model, which does not express PSMA. We attribute the improved efficacy of BIND-014 to the increased docetaxel concentration in tumors resulting from accumulation of BIND-014 particles via tissue and cell targeting. The following graphs provide the results of the prostate and breast cancer tumor studies.

LOGO

BIND-510

In November 2014, we selected our second proprietary product candidate, BIND-510, based on its promising characteristics as a PSMA-targeted Accurin containing vincristine, a potent vinca alkaloid microtubule disrupting agent. The clinical utility of vincristine in conventional form is limited by toxicity, which limits the dose and duration of treatment. By applying our Accurin technology, BIND-510 is designed to concentrate high levels of vincristine in tumors while limiting exposure to healthy tissue. Evidence of meaningfully greater efficacy and an improved toxicity profile compared to vincristine in its conventional form has been demonstrated across a broad range of in vivo tumor models with Accurin formulations of vincristine. In particular, in preclinical models, doses of Accurin formulations of vincristine have shown anti-tumor activity without evidence of overt toxicity. We believe that BIND-510 has the potential to overcome vincristine’s dose-limiting toxicity profile—specifically, its cumulative and irreversible neuropathy—the major limitation of vincristine. Based on these encouraging preclinical results, we plan to advance BIND-510 through important preclinical studies in 2015 to position it for an IND filing with the U.S. Food and Drug Administration in 2016.

Collaborations

In addition to our internal development programs, we also consider opportunities to collaborate with recognized biopharmaceutical companies to develop Accurins incorporating therapeutic payloads and targeting ligands from their proprietary product portfolios. We have established a number of ongoing collaborations with biopharmaceutical companies, including announced agreements with Pfizer, Inc., AstraZeneca AB, Roche and

Merck (known as MSD outside the United States and Canada) to develop Accurins based on their therapeutic payloads. Our collaboration agreements generally require the collaborator to pay all the development costs associated with the Accurin, including those incurred by us. In addition, the upfront and potential milestone payments received under these agreements provide us with additional capital resources to develop our own proprietary pipeline of Accurins.

We generally consider each of the following criteria when evaluating a potential collaborator and its proposed therapeutic payload:

•

The physical and chemical properties of the proposed therapeutic payload are well suited for encapsulation and release in an Accurin;

•

The therapeutic payload has high therapeutic potential for addressing an important unmet medical need;

•

The therapeutic payload is highly validated in its original, untargeted form;

•

The collaborator possesses substantial resources and capabilities for contributing to the development and commercialization of our collaboration product;

•

The collaborator places strategic importance on our collaboration product in their portfolio;

•

The collaborator is committed to our project as demonstrated by the sponsorship of their executive management; and

•

The collaborator values our relationship and ongoing input in the development of the collaboration product.

Amgen

We entered into the collaboration agreement with Amgen in January 2013, with the goal of developing a nanomedicine for treating solid cancer tumors based on our platform for targeted and programmable nanomedicines and Amgen’s undisclosed proprietary cancer compound. Under the agreement, Amgen had an option to select a novel Accurin candidate for further development, and if Amgen failed to exercise its option, then we had the right to exercise an exclusive option to obtain a license from Amgen to develop, manufacture and commercialize Accurins containing the Amgen therapeutic payload. In June 2014, Amgen notified us that it would not exercise its option, and we notified Amgen that we would not exercise our option.

Pfizer

We and Pfizer are each responsible for using commercially reasonable efforts to develop licensed products under a development plan. Pfizer is required to pay for all of our development costs. If Pfizer exercises any option, it will be solely responsible for all further development and commercialization activities with respect to the licensed products covered by the option, and Pfizer is also solely responsible for obtaining all regulatory approvals for the applicable licensed products and conducting all communications with regulatory authorities. Pfizer must use commercially reasonable efforts to develop and seek regulatory approval for at least one licensed product in at least one indication in at least one major market country, and to commercialize each licensed

product in each major market country where Pfizer receives regulatory approval. If Pfizer exercises its option with respect to any compound family, we may not develop or commercialize, or license a third party to develop or commercialize, any nanotherapeutic incorporating any compound in such compound family.

We are responsible for manufacturing licensed products through early clinical trials. Thereafter, we will negotiate with Pfizer the manufacture of licensed products by us for further development and commercialization, but under some circumstances, Pfizer assumes responsibility for all further manufacturing of licensed products.

Under the agreement, we received an upfront payment of $4.0 million in 2013 with the potential to receive contingent payments totaling up to $89.5 million in the aggregate under each option upon exercise of the option and achievement by Pfizer of specified development and regulatory events, plus additional contingent payments totaling up to $110.0 million in the aggregate under each option upon achievement by Pfizer of specified commercial events. We achieved a development milestone in December 2014. We will also receive royalties in the low-single digit to the high-single digit percentages of aggregate worldwide net sales of each licensed product, if any. We receive royalties on a country-by-country and licensed product-by-licensed product basis until the later of the expiration of the Pfizer patents covering such licensed product or twelve years after the first commercial sale of such licensed product in such country.

The agreement will remain in effect, on a country-by-country and licensed product-by-licensed product basis, until Pfizer’s obligation to pay us royalties ends, unless Pfizer fails to exercise either option before both options expire or Pfizer fails to timely pay any option exercise fee, in which case the agreement will terminate immediately. Either Pfizer or we may terminate the agreement for the other party’s uncured material breach or insolvency, and Pfizer may terminate the agreement for convenience upon 60 days’ prior notice.

AstraZeneca

We and AstraZeneca are each responsible for using commercially reasonable efforts to develop licensed products under a development plan that extends a previously completed feasibility study we conducted for AstraZeneca. AstraZeneca is required to pay for all of our development costs. AstraZeneca is also solely responsible for, and must use commercially reasonable efforts in, obtaining all regulatory approvals for licensed products. We are responsible for manufacturing licensed product for use in preclinical and some clinical trials. AstraZeneca is responsible for manufacturing other supplies of licensed products. For a specified number of years after entering into this agreement, we may not develop or commercialize a compound against the same target as AstraZeneca’s Aurora B kinase inhibitor, Barasertib (AZD1152).

Under the agreement, we received an upfront payment of $4.0 million in 2013 and have the potential to receive contingent payments totaling up to $193 million in the aggregate upon achievement by AstraZeneca of specified clinical, regulatory and commercial events. We will also receive tiered royalties in the low-single digit to the low-double digit percentages of aggregate worldwide net sales of licensed product, if any. We will receive royalties on a country-by-country and licensed product-by-licensed product basis generally until the AstraZeneca patents and any regulatory exclusivity relating to such licensed product expire.

The agreement will remain in effect, on a country-by-country and licensed product-by-licensed product basis, until AstraZeneca’s obligation to pay us royalties ends. Either AstraZeneca or we may terminate the agreement for the other party’s uncured material breach or insolvency, AstraZeneca may terminate the agreement

for convenience upon three or six months’ prior notice, depending on the development stage at which such notice is given, or if we undergo a change of control and AstraZeneca does not receive adequate assurances that our acquirer will commit sufficient resources to our development obligations, and we may terminate the agreement if AstraZeneca challenges any of the patents licensed by us to AstraZeneca under the agreement.

Our collaboration with AstraZeneca has achieved positive preclinical results to date with the Accurin nanoparticle AZD2811, demonstrating improved efficacy and enhanced trafficking to tumor sites in multiple preclinical models while displaying minimal bone marrow toxicity. AZD2811 is an Accurin containing AZD1152-hQPA, the active metabolite of the prodrug barasertib (AZD1152), a potent and selective inhibitor of Aurora B kinase. We and AstraZeneca are working toward an IND application with the U.S. FDA for AZD2811 in mid-2015.

Roche

In June 2014, we entered into a research agreement with Roche to discover novel nanomedicines using Accurins for the treatment of diseases in therapeutic areas outside of oncology. The collaboration will focus on combining BIND’s Accurin technology with Roche’s proprietary therapeutic payloads and targeting ligands.

Merck

We entered into a research and development agreement with Merck in November 2014 that leverages our Medicinal Nanoengineering platform to create targeted Accurins that utilize compounds provided from Merck’s oncology pipeline for the treatment of cancer. The first two payloads provided from Merck, a kinesin spindle protein (KSP) inhibitor and a polo-like kinase 1 (PLK1) inhibitor, will be incorporated into Accurins and developed as potential internal product candidates at BIND. This collaboration represents a new type of agreement that provides us with another valuable path forward to expand our internal pipeline by providing access to promising proprietary therapeutic payloads well-suited to our Accurin platform.

Under terms of the agreement, we lead all aspects of product development prior to the end of Phase 1 and can choose to advance or terminate programs at our sole discretion. At end of Phase 1, we and Merck can choose to take products forward under a defined picking mechanism; we will choose first, except in situations where Merck makes additional monetary or compound contributions to the collaboration. The party taking a product forward has worldwide development and commercial rights. If Merck does not exercise its option, we can choose to take all the products forward globally. If we opt in at the end of phase 1, we make no payments to Merck beyond a royalty on future product sales. If Merck opts in, it will pay us a fee based on a multiple of our research and development expenses and a royalty on future product sales, if any. There are incentives in the contract for Merck to offer additional compounds from its oncology pipeline in the future; however, we are under no obligation to accept additional compounds.

Manufacturing

We have a pilot manufacturing facility at our Cambridge location where we conduct process development, scale-up activities and assemble the manufacturing equipment in a non-GMP environment. We do not own or operate GMP manufacturing facilities for the production of any of our drug candidates, and we do not have plans to develop our own manufacturing operations in the foreseeable future. We currently rely on third-party contract manufacturers for all of our required raw materials, therapeutic payload and finished product for our preclinical research and clinical trials. We do not currently have arrangements in place for redundant supply or a second source for required raw materials used in the manufacture of our drug candidates, including the polymers used in our Accurins, or for the manufacture of finished BIND-014 product. We also do not have any current contractual relationship for the manufacture of commercial supplies of any of our drug candidates if they are approved. If any of our products are approved by any regulatory agency, we intend to enter into agreements with a third-party contract manufacturer and one or more backup manufacturers for the commercial production of those products.

Development and commercial quantities of any products that we develop will need to be manufactured in facilities, and by processes, that comply with the requirements of the FDA and the regulatory agencies of other jurisdictions in which we are seeking approval. We currently employ internal resources to manage our manufacturing contractors.

Intellectual Property

Patents and Proprietary Rights

We actively seek to protect our medicinal nanoengineering platform technology, which we consider important to our business, including by pursuing patents relating to our products and compositions, their methods of use and the processes for their manufacture, as well as any other relevant inventions and improvements that are commercially important to the development of our business and are eligible for patent protection. We attempt a layered approach by seeking multiple different patents or patent applications on different aspects of Accurins. We also rely on trade secrets that may be important to the development of our business.

Our success will depend significantly on our ability to obtain and maintain patent and other proprietary protection for the technology, inventions and improvements we consider important to our business; defend our patents; preserve the confidentiality of our trade secrets; and operate without infringing the patents and proprietary rights of third parties. We also rely on know-how, continuing technological innovation and in-licensing opportunities to develop and maintain our proprietary position.

Medicinal Nanoengineering Platform Patent Portfolio

As of December 31, 2014, we owned more than 20 issued U.S. patents, more than 40 pending U.S. provisional and non-provisional patent applications that relate to our medicinal nanoengineering platform, as well as issued and pending foreign counterparts to many of these patents and patent applications. As of December 31, 2014, we had licenses to more than 10 U.S. patents and six pending patent applications, as well as several pending foreign counterparts to many of these patents and patent applications that also relate to our medicinal nanoengineering platform. Of these licensed patents and patent applications, we license the majority on an exclusive basis, with the rest licensed non-exclusively to us. The exclusive licenses are, in some cases, limited to certain technical fields, for example for medical and diagnostic purposes. Our owned and licensed patents and patent applications relate to our nanoparticles, nanoparticle compositions, nanoparticles with specific drugs, targeting ligands, methods of making nanoparticles, methods of making targeting ligands and methods of treating breast and prostate cancer using our nanoparticles. We believe these patents and patent applications relate to advances in the nanoparticle field that are important for the development of a therapeutic nanoparticle. The issued patents generally are expected to expire between 2025 and 2030, and applications are pending which would expire, if issued, between 2032 and 2035.

BIND-014 Patent Portfolio

We also strive to protect BIND-014 with multiple layers of patents. As of December 31, 2014, of the owned medicinal nanoengineering platform patents and patent applications described above, more than 10 issued U.S. patents, more than 10 pending U.S. provisional and various non-provisional patent applications and pending foreign counterparts relate to our BIND-014 Accurin. As of December 31, 2014, of the licensed medicinal nanoengineering platform patents and patent applications described above, more than five U.S. patents and patent applications, as well as several foreign counterparts to these patents and patent applications, relate to our BIND-014 Accurin. Our BIND-014 patent portfolio consists of patents directed to BIND-14 nanoparticles, compositions of BIND-014 nanoparticles, methods of making BIND-014, and methods of using BIND-014. The issued patents directed to BIND-014 generally are expected to expire between 2025 and 2030, and applications are pending which would expire, if issued, between 2032 and 2035.

The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file, the patent term is 20 years from the date of filing the non-provisional application or Patent Cooperation Treaty application.

In the United States, a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the U.S. Patent and Trademark Office in granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier-filed patent. The patent term of a patent that covers an approved drug may also be eligible for patent term extension, which permits patent term restoration as compensation for the patent term lost during the development and regulatory review process. To obtain a patent extension in the United States, the term of the relevant patent must not have expired before the extension application, the patent cannot have been extended previously under this law, an application for extension must be submitted, the product must be subject to regulatory review prior to its commercialization, and the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product. The active ingredient in BIND-014, docetaxel, has been previously approved and commercially marketed and, as such, we do not expect to be eligible for a patent term extension in the United States. If our future products contain active ingredients that have not been previously approved, we may be eligible for a patent term extension in the United States. If patent extensions are available to us outside of the United States, we would expect to file for a patent term extension in applicable jurisdictions.

Trade Secrets

We endeavor to maintain trade secret protection for certain aspects of our technology. In some situations, maintaining information as a trade secret is more appropriate than filing a patent application. Specifically, we have a number of trade secrets relating to identifying new Accurins and to our Accurin manufacturing process. With regard to manufacturing Accurins, we believe that small changes in processing Accurins can result in Accurins with different properties. As a result, we expect the FDA and other regulatory bodies to require additional clinical data for approval of a generic Accurin. As such, we believe that maintaining our manufacturing process as a trade secret will be helpful to maintaining our product exclusivity.

Third-Party Rights

Many pharmaceutical companies, biotechnology companies and academic institutions are competing with us in the field of nanotechnology and filing patent applications potentially relevant to our business. In order to contend with the strong possibility of third-party intellectual property conflicts, we periodically conduct freedom-to-operate studies, but such studies may not uncover all patents relevant to our business. With respect to BIND-014, we are aware of a third-party U.S. patent application that contains claims related to a formulation of a nanoparticle composition. We have an issued U.S. patent and pending non-U.S. patent applications claiming similar subject matter, which we believe have earlier priority filing dates than the third party application. Most countries award patents to the first party to file their patent application, however, these U.S. patents and patent applications are subject to U.S. laws that award patents to the first party to invent the claimed invention, rather than the first party to file a patent application. The possibility therefore exists for an interference proceeding between our issued patent and this third-party patent application to determine the earliest party to invent the composition. While we believe we are in a strong position to win any potential interference proceeding, although we believe it unlikely, the possibility exists that this third-party patent application could win such an interference proceeding and obtain claims that cover a formulation of a composition of BIND-014. We believe the potential exists, if necessary, to find and use an alternative formulation which would be outside of any valid and issued claims that could be obtained from this third-party patent application, but we may need to overcome certain technical challenges in order to do so, and this process may cause us to incur additional costs and delays.

From time to time, we find it necessary or prudent to obtain licenses from third-party intellectual property holders. Where licenses are readily available at reasonable cost, such licenses are considered a normal cost of doing business. In other instances, however, we may use the results of freedom-to-operate studies to guide our

early-stage research away from areas where we are likely to encounter obstacles in the form of third-party intellectual property. For example, where a third party holds relevant intellectual property and is a direct competitor, a license might not be available on commercially reasonable terms or available at all. We strive to identify potential third-party intellectual property issues in the early stages of research of our research programs, in order to minimize the cost and disruption of resolving such issues.

In spite of these efforts to avoid obstacles and disruptions arising from third-party intellectual property, it is impossible to establish with certainty that our technology platform or our product programs will be free of claims by third-party intellectual property holders. Even with modern databases and on-line search engines, freedom-to-operate searches are imperfect and may fail to identify relevant patents and published applications. Even when a third-party patent is identified, we may conclude upon a thorough analysis, that we do not infringe the patent or that the patent is invalid. If the third-party patent owner disagrees with our conclusion and we continue with the business activity in question, we might have patent litigation thrust upon us. Alternatively, we might decide to initiate litigation in an attempt to have a court declare the third-party patent invalid or non-infringed by our activity. In either scenario, patent litigation typically is costly and time-consuming, and the outcome is uncertain. The outcome of patent litigation is subject to uncertainties that cannot be quantified in advance, for example, the credibility of expert witnesses who may disagree on technical interpretation of scientific data. Ultimately, in the case of an adverse outcome in litigation, we could be prevented from commercializing a product or using certain aspects of our technology platform as a result of patent infringement claims asserted against us. This could have a material adverse effect on our business. For further discussion of the risks relating to our intellectual property see “Risk Factors—Risks Related to Our Intellectual Property.”

In-Licensed Intellectual Property

Massachusetts Institute of Technology

In June 2007, we entered into a license agreement with the Massachusetts Institute of Technology, or MIT, which was amended in November 2008 and April 2013. Pursuant to this agreement, MIT granted us a worldwide license under certain periods and patent applications generally relating to targeted nanoparticles and methods of making targeted nanoparticles to develop and commercialize licensed products and processes for all therapeutic and diagnostic uses and as research reagents, except in connection with therapeutic or prophylactic vaccines with a limited-term option to license certain improvements. Certain licensed MIT patents and patent applications relate to BIND-014. This license is exclusive with respect to certain of MIT’s patent rights and non-exclusive with respect to other of MIT’s patent rights.

We are obligated to use diligent efforts to develop and commercialize one or more licensed products, and thereafter make licensed products reasonably available to the public. We must also achieve specified milestone events by specified dates. Failure to achieve such milestone events may be treated by MIT as a material breach, which could allow MIT to terminate the agreement.

We must also make contingent payments to MIT totaling up to $1.5 million in the aggregate upon achievement by us or our collaboration partners of specified clinical, regulatory and commercial events. We must also pay MIT royalties in the low-single digit percentages on aggregate worldwide net sales of licensed products, including sales by our collaboration partners. We must also reimburse MIT for all reasonable costs related to the prosecution and maintenance of the licensed patents rights. Under the agreement, we must pay MIT a percentage, ranging from the high-single digits to the low-mid double digits, of any consideration we receive from sublicensees, including our collaboration partners, and a specified percentage, in the mid-single digits, of all payments we receive in excess of a specified amount in the aggregate for the practice of the licensed patents on behalf of non-sublicensee third parties. Finally, in connection with the agreement we issued to MIT and some other parties shares of our common stock representing a low-single digit percentage of our then-outstanding common stock.

The agreement remains in effect until expiration or abandonment of all issued patents and filed patent applications within the rights licensed to us under the agreement. The agreement will terminate automatically if

we assign the agreement or any of our rights or obligations thereunder in connection with a change of control and the proposed assignee fails to agree in writing to be bound by the terms and conditions of the agreement. MIT may terminate the agreement if we cease to carry on our business related to the agreement, if we fail to maintain the insurance coverage required under the agreement or if we materially breach the agreement and fail to cure such breach. We may terminate the agreement for convenience upon six months’ prior notice.

The Johns Hopkins University

In February 2009, we entered into a license agreement with The Johns Hopkins University, or JHU, which was amended in January 2013. Pursuant to the agreement, JHU granted us an exclusive, worldwide license under some of its intellectual property rights relating to nanoparticles targeting PSMA in all fields of use. Certain licensed JHU patent applications relate to BIND-014. Under this agreement, we are obligated to use commercially reasonable efforts to develop and commercialize licensed products as soon as practicable, and after commercialization we must endeavor to keep licensed products reasonably available to the public.

We are responsible for costs relating to the prosecution and maintenance of the licensed patents incurred after the date of the agreement. We must make contingent payments to JHU totaling up to $1.0 million in the aggregate upon achievement by us or our collaborators of specified patent prosecution, clinical, regulatory and commercial events and pay JHU royalties in the low-single digit percentages on aggregate worldwide net sales of licensed products, including sales by our collaborators, subject to a minimum annual royalty. Finally, we must pay JHU 30% of any consideration we receive from sublicensees who solely sublicense the intellectual property we have licensed from JHU.

The agreement remains in effect on a country-by-country basis until the date of expiration of the last to expire licensed patent in such country. Either we or JHU may terminate the agreement for the other party’s uncured material breach, and we may terminate the agreement for convenience upon 90 days’ prior notice.

Yale University

In January 2013, we entered into a license agreement with Yale University, or Yale, pursuant to which Yale granted us an exclusive, worldwide license under specified intellectual property rights relating to targeted and high density drug-loaded polymeric materials to develop and commercialize licensed products and to practice licensed methods for the treatment of cancer. The rights granted to us under the agreement specifically exclude the use of licensed products for the treatment of brain cancer and for specified types of vaccines. We have the option to expand the rights granted to us under the agreement to include the treatment of cardiovascular disease, inflammation and/or autoimmune disorders, after we initiate specified studies in the respective field, subject to any then-existing third-party rights and upon the payment by us to Yale of a specified amount for each such field so added. Certain of the Yale licensed intellectual property relates to BIND-014.

We are obligated to use commercially reasonable efforts to develop and commercialize one or more licensed products or licensed methods. Our agreement with Yale requires us to achieve specified milestone events. Failure to achieve such milestone events or to use commercially reasonable efforts to develop and commercialize one or more licensed products or licensed methods may result in termination of the agreement by Yale. Both Yale and we must use commercially reasonable efforts, when possible under good business practice, to facilitate the availability of licensed products in low and lower-middle income countries at locally affordable prices, under reasonable terms and circumstances to improve access to such licensed products in such countries.

While the agreement remains in effect, we must pay Yale royalties below 1% on aggregate worldwide net sales of licensed products and licensed methods, including sales by our collaborators. Under the agreement, in addition to the royalties described in the previous sentence, we must pay Yale 40% of any consideration we receive from sublicensees who solely sublicense the intellectual property we have licensed from Yale. Finally, we are also responsible for costs relating to the prosecution and maintenance of the licensed patents.

The agreement remains in effect until the date on which the last claim of the licensed patents expires. Either we or Yale may terminate the agreement for the other party’s uncured material breach, we may terminate the agreement for convenience upon 60 days’ prior notice, and Yale may terminate the agreement if we fail to make a payment when due, fail to obtain or maintain adequate insurance coverage, become insolvent, challenge or assist others in challenging the licensed patents, or fail to terminate a sublicense if the applicable sublicensee challenges or assists others in challenging the licensed patents.

Other

We may license intellectual property from certain other parties that we believe to be necessary or useful for the conduct of our business, and may enter additional license agreements in the future.

Intellectual Property in Collaborations

We have entered into research and development collaboration agreements with Pfizer, AstraZeneca, and Merck. In each collaboration, we provide our collaborator with exclusive rights to inventions relating to the collaborator’s molecules that arise out of the collaboration. These agreements provide for us to own general improvements to our medicinal nanoengineering platform technology that arise out of the collaborations. We did not provide any of our collaborators with the right to enforce our medicinal nanoengineering platform patent portfolio, with the exception of patents relating to the applicable drug candidates.

Competition

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. While we believe that our medicinal nanoengineering technologies, integrated research, clinical and manufacturing capabilities, development experience and scientific knowledge provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions. Any drug candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

Many of our competitors may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

The key competitive factors affecting the success of BIND-014 and any other drug candidates that we develop, if approved, are likely to be their efficacy, safety, convenience, price, the level of generic competition and the availability of reimbursement from government and other third-party payors.

indications that we are pursuing, and additional products are expected to become available on a generic basis over the coming years. If our drug candidates achieve marketing approval, we expect that they will be priced at a significant premium over competitive generic products.

The most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy and targeted drug therapy. There are a variety of available drug therapies marketed for solid tumors. In many cases, these drugs are administered in combination to enhance efficacy. Some of these drugs are branded and subject to patent protection, and others are available on a generic basis, including docetaxel, the therapeutic payload contained in BIND-014. Many of these approved drugs are well-established therapies and are widely accepted by physicians, patients and third-party payors. In general, although there has been considerable progress over the past few decades in the treatment of solid tumors and the currently marketed therapies provide benefits to many patients, these therapies all are limited to some extent in their efficacy and frequency of adverse events, and none of them are successful in treating all patients. As a result, the level of morbidity and mortality from solid tumor cancers remains high.

There are also a number of products in late stage clinical development to treat solid tumors. The products in development may provide efficacy, safety, convenience and other benefits that are not provided by currently marketed therapies. As a result, they may provide significant competition for BIND-014 or any other drug candidate for which we obtain marketing approval.

Current second-line treatments for advanced or metastatic NSCLC include docetaxel, alone or in combination with VEGFR inhibitor ramucirumab or other chemotherapy agents such as pemetrexed (indicated only for non squamous carcinoma), gemcitabine and vinorelbine. There are also a few molecularly-targeted therapies including erlotinib, gefitinib, and afatinib, which are used to treat patients with mutations in the EGFR, and crizotinib and ceritinib, which are used in the small subset of patients with an ALK mutation. No targeted therapies are approved for patients with KRAS mutations at this point, although AstraZeneca’s selumitinib is in Phase 3 clinical trials in combination with docetaxel for KRAS mutant NSCLC.

We perceive that our most significant competition comes from a new form of immunotherapies based on inhibition of programmed death-1 (PD-1) receptors and programmed death-ligand 1 (PD-L1). There are a number of trials underway to evaluate PD-1 and PD-L1 inhibitors in NSCLC and one PD-1 inhibitor was recently approved (March 2015) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

We also face competition from other nanomedicine platforms developing targeted therapies, including platforms focused on albumin nanoparticles, liposomes and polymeric nanoparticles.

Government Regulation

Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug products such as those we are developing. BIND-014 and any other drug candidates that we develop must be approved by the FDA before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in foreign countries.

United States Drug Development Process

In the United States, the FDA regulates drugs under the FDCA and FDA’s implementing regulations. Drugs are also subject to other federal, state and local statutes and regulations. The process of obtaining regulatory approvals and subsequent compliance with appropriate federal, state and local statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval may subject an applicant to administrative or judicial sanctions. FDA sanctions may include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. The process required by the FDA before a drug may be marketed in the United States generally involves the following:

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Completion of extensive preclinical laboratory tests, preclinical animal studies and formulation studies in accordance with applicable regulations, including the FDA’s GLP regulations;

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Submission to the FDA of an IND, which must become effective before human clinical trials may begin;

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Performance of adequate and well-controlled human clinical trials in accordance with applicable regulations, including the FDA’s current good clinical practice, or GCP, regulations to establish the safety and efficacy of the proposed drug for its proposed indication;

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Submission to the FDA of a NDA, for a new drug product;

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A determination by the FDA within 60 days of its receipt of an NDA to accept the NDA for filing and review;

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Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug is produced to assess compliance with the FDA’s cGMP regulations to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

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Potential FDA audit of the preclinical and/or clinical trial sites that generated the data in support of the NDA; and

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FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States.

Before testing any compounds with potential therapeutic value in humans, the drug candidate enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the drug candidate. The conduct of the preclinical tests must comply with federal regulations and requirements including the FDA’s GLP regulations. The sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. An IND is a request for authorization from the FDA to administer an investigational drug product to humans. The central focus of an IND submission is on the general investigational plan and the protocols for human studies. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and places the IND on clinical hold within that 30-day time period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA may also impose a clinical hold on a drug candidate at any time before or during clinical trials due to safety concerns or noncompliance. Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate such trial.

Clinical trials involve the administration of the drug candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control,

in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety and assess efficacy. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Further, each clinical trial must be reviewed and approved by an independent institutional review board, or IRB, at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers issues such as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries.

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

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Phase 1. The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion, the side effects associated with increasing doses, and if possible, to gain early evidence of effectiveness. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

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Phase 2. The drug is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases or conditions and to determine dosage tolerance, optimal dosage and dosing schedule.

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Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall benefit/risk ratio of the product and provide an adequate basis for product approval. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA. Phase 3 clinical trials usually involve several hundred to several thousand participants.

Post-approval studies, or Phase 4 clinical trials, may be conducted after initial marketing approval. These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, FDA may mandate the performance of Phase 4 studies.

The FDCA permits the FDA and an IND sponsor to agree in writing on the design and size of clinical studies intended to form the primary basis of a claim of effectiveness in an NDA. This process is known as a Special Protocol Assessment, or SPA. An SPA agreement may not be changed by the sponsor or the FDA after the trial begins except with the written agreement of the sponsor and the FDA, or if the FDA determines that a substantial scientific issue essential to determining the safety or effectiveness of the drug was identified after the testing began. For certain types of protocols, including carcinogenicity protocols, stability protocols, and Phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim, the FDA has agreed under its performance goals associated with the Prescription Drug User Fee Act, or PDUFA, to provide a written response on most protocols within 45 days of receipt. However, the FDA does not always meet its PDUFA goals, and additional FDA questions and resolution of issues leading up to an SPA agreement may result in the overall SPA process being much longer, if an agreement is reached at all.

Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects. Phase 1, Phase 2 and Phase 3 clinical trials may fail to be completed successfully within any specified period, if at all. The FDA, the IRB or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients. Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee. This group provides authorization for whether or not a trial may move forward at designated checkpoints based on access to certain data from the study. We may also suspend or terminate a clinical trial based on evolving business objectives and/or competitive climate.

Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the drug candidate and, among other things, must include developed methods for testing the identity, strength, quality and purity of the final drug. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf life.

FDA Review and Approval Processes

The results of product development, preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product. The application must include negative or ambiguous results of preclinical and clinical trials as well as positive findings. Data may come from company-sponsored clinical trials intended to test the safety and effectiveness of a use of a product, or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and effectiveness of the investigational drug product to the satisfaction of the FDA. The submission of an NDA is subject to the payment of substantial user fees; a waiver of such fees may be obtained under certain limited circumstances, such as when the product candidate has received orphan drug designation.

In addition, under the Pediatric Research Equity Act, or PREA, an NDA or supplement to an NDA must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has been granted. However, if only one indication for a product has orphan designation, a pediatric assessment may still be required for any applications to market that same product for the non-orphan indication(s).

The FDA reviews all NDAs submitted before it accepts them for filing and may request additional information rather than accepting an NDA for filing. The FDA must make a decision on accepting an NDA for filing within 60 days of receipt. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under the goals and policies agreed to by the FDA under PDUFA, for drugs that do not contain new molecular entities, such as BIND-014, the FDA has ten months from the date of receipt in which to complete its initial review of a standard NDA and respond to the applicant, and six months for a priority NDA. Priority review is available for NDAs for drugs that treat a serious condition that, if approved, would provide a significant improvement in safety or effectiveness. The FDA does not always meet its PDUFA goal dates for standard and priority NDAs, and the review process is often significantly extended by FDA requests for additional information or clarification.

The FDA reviews each NDA to determine, among other things, whether the proposed product is safe and effective for its intended use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality and purity. The FDA may refer applications for novel drug

products or drug products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical sites to assure compliance with GCP requirements. After the FDA evaluates the application, manufacturing process and manufacturing facilities, it may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the application is not ready for approval. A Complete Response Letter usually describes all of the specific deficiencies in the NDA identified by the FDA. A Complete Response Letter may require additional clinical data, including an additional pivotal Phase 3 clinical trial, and/or other significant and time-consuming requirements related to clinical trials, preclinical studies or manufacturing. If a Complete Response Letter is issued, the applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data and information is submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we do.

If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling or may condition the approval of the NDA on other changes to the proposed labeling, development of adequate controls and specifications, or a commitment to conduct one or more post-market studies or clinical trials. For example, the FDA may require Phase 4 testing which involves clinical trials designed to further assess a drug’s safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized. The FDA may also determine that a risk evaluation and mitigation strategy, or REMS, is necessary to ensure that the benefits of the drug outweigh its risks. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS, and the FDA will not approve the NDA without an approved REMS. Depending on FDA’s evaluation of a drug’s risks, a REMS may include medication guides, physician communication plans, or elements to assure safe use, such as limitations on who may prescribe or dispense the drug, requirements that patients enroll in a registry or undergo certain health evaluations, and other risk minimization tools. Following approval of an NDA with a REMS, the sponsor is responsible for marketing the drug in compliance with the REMS and must submit periodic REMS assessments to the FDA.

Section 505(b)(2) Regulatory Pathway

New drugs must obtain FDA approval through an NDA prior to marketing in the United States. Most NDAs are submitted under Section 505(b)(1) of the FDCA, where all clinical investigations supporting the safety and effectiveness of the drug product are conducted by or for the applicant. However, an NDA may also be submitted under Section 505(b)(2) of the FDCA, which enables the applicant to rely, in part, on the FDA’s findings of safety and efficacy for an existing product, or published literature, in support of its application. We plan to seek approval for BIND-014 under Section 505(b)(2) of the FDCA.

Section 505(b)(2) NDAs often provide an alternate regulatory pathway to FDA approval for new or improved formulations or new uses of previously approved products. Specifically, Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. In a 505(b)(2) NDA, the

applicant may rely upon the FDA’s findings from preclinical or clinical studies conducted for an approved product. The FDA may also require Section 505(b)(2) applicants to perform additional studies or measurements to support the change from the approved product. The FDA may then approve the new drug candidate for all or some of the label indications for which the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant.

In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent with claims that cover the applicant’s product. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential competitors in support of approval of a generic drug or a new drug submitted for approval under a Section 505(b)(2) NDA. To the extent that the Section 505(b)(2) applicant is relying on findings of safety or efficacy for an already approved product, the applicant is subject to existing exclusivity for the reference product and is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that a generic applicant would. Specifically, applicants must certify to the FDA concerning any patents listed for the approved product in the Orange Book that: (1) the required patent information has not been filed; (2) the listed patent has expired; (3) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or (4) the listed patent is invalid or will not be infringed by the new product. A certification that the new product will not infringe the already approved product’s listed patents or that such patents are invalid is called a Paragraph IV certification. If an applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the application has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification prevents the FDA from approving the application until the earlier of 30 months from the date of the lawsuit, expiration of the patent, settlement of the lawsuit or a decision in the infringement case that is favorable to the applicant. Thus approval of a Section 505(b)(2) NDA can be stalled until all the listed patents claiming the referenced product have expired, until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired, and, in the case of a Paragraph IV certification and subsequent patent infringement suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case that is favorable to the Section 505(b)(2) applicant.

Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States, there is no reasonable expectation that sales of the drug in the United States will be sufficient to offset the cost of developing and making the drug available in the United States for the disease or condition will be recovered from sales of the drug. Orphan drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process, though companies with orphan-designated drugs are eligible for certain incentives, including opportunities for grant funding toward clinical trial costs, tax credits for qualified clinical testing and waiver of application user fees.

If the FDA approves a sponsor’s marketing application for a designated orphan drug for use in the rare disease or condition for which it was designated, the sponsor is eligible for a seven-year period of marketing exclusivity, during which the FDA may not approve another sponsor’s marketing application for a drug with the same active moiety and intended for the same use or indication as the approved orphan drug, except in limited circumstances, such as if a subsequent sponsor demonstrates its product is clinically superior. During a sponsor’s orphan drug exclusivity period, competitors, however, may receive approval for drugs with different active

moieties for the same indication as the approved orphan drug, or for drugs with the same active moiety as the approved orphan drug, but for different indications. Orphan drug exclusivity could block the approval of one of our products for seven years if a competitor obtains approval for a drug with the same active moiety intended for the same indication before we do, unless we are able to demonstrate that grounds for withdrawal of the orphan drug exclusivity exist, or that our product is clinically superior. Further, if a designated orphan drug receives marketing approval for an indication broader than the rare disease or condition for which it received orphan drug designation, it may not be entitled to exclusivity. Orphan drug status in the EU has similar but not identical benefits in that jurisdiction.

We may seek orphan drug designation for one or more of our product candidates, but the FDA may disagree with our analysis of the prevalence of the particular disease or condition or other criteria for designation and refuse to grant orphan status. Even if we do obtain orphan drug designation for a product candidate, we cannot guarantee that the FDA will later grant approval for the drug, or that we will be able to secure orphan drug exclusivity if we do obtain approval.

Expedited Development and Review Programs

The FDA has a Fast Track program that is intended to expedite or facilitate the process for reviewing new drug products that meet certain criteria. Specifically, new drugs are eligible for Fast Track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. Unique to a Fast Track product, the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.

Any product submitted to the FDA for approval, including a product with a Fast Track designation, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. A product is eligible for priority review if it is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA will attempt to direct additional resources to the evaluation of an NDA designated for priority review and, under PDUFA, the FDA’s goal is to act on such NDAs within six months. Additionally, a product may be eligible for accelerated approval. Drug products studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require that a sponsor of a drug product receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

The FDA may also accelerate the approval of a designated breakthrough therapy, which is a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The sponsor of a breakthrough therapy may request the FDA to designate the drug as a breakthrough therapy at the time of, or any time after, the submission of an IND for the drug. If the FDA designates a drug as a breakthrough therapy, it must take actions appropriate to expedite the development and review of the application, which may include holding meetings with the sponsor and the review team

throughout the development of the drug; providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable; involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; and taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment.

Fast Track designation, priority review, accelerated approval and breakthrough therapy designation do not change the standards for approval but may expedite the development or approval process. We plan to explore these opportunities for BIND-014 as appropriate for our targeted indications.

Post-Approval Requirements

Any drug products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among other requirements, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling (known as “off-label use”), limitations on industry sponsored scientific and educational activities, and requirements for promotional activities involving the Internet. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such off-label uses.

In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval. We rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of our products in accordance with cGMP regulations. cGMP regulations require, among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in restrictions on a product, manufacturer or holder of an approved NDA, including, among other things, recall or withdrawal of the product from the market. In addition, changes to the manufacturing process are strictly regulated, and depending on the significance of the change, may require prior FDA approval before being implemented. Other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

The FDA also may require Phase 4 testing and surveillance to monitor the effects of an approved product or place conditions on an approval that could restrict the distribution or use of the product. Discovery of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties, among others. Newly discovered or developed safety or effectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures, such as a REMS. Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under development. For example, in June 2014, the FDA issued guidance reflecting FDA’s current thinking on certain issues related to the use of nanotechnology in FDA-regulated products. The guidance provides that the FDA will address issues such as the safety, effectiveness,

public health impact, and regulatory status of nanotechnology products on a case-by-case basis using the FDA’s existing review processes; however, the guidance represents only the FDA’s current thinking, which may change in the future. While the FDA has not issued any regulations or drug-specific guidance to date, it is possible that the FDA and other regulatory authorities could issue regulations or additional guidance in the future regarding nanotechnology-based therapeutics that could adversely affect our drug candidates.

United States Patent Term Restoration, Generic Nanomedicine Pathway and Marketing Exclusivity

Depending upon the timing, duration and specifics of the FDA approval of the use of our drug candidates, if any, some of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of an NDA plus the time between the submission date of an NDA and the approval of that application. Only one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. However, to obtain a patent extension in the United States, the permission for the commercial marketing or use of the product after the applicable regulatory review period must be the first permitted commercial marketing or use of the product. As the active ingredient in BIND-014, docetaxel, has been previously approved and commercially marketed, we do not expect to be eligible for a patent term extension in the United States. If a future product contains an active ingredient which has not been previously approved, we may intend to apply for restoration of patent term for one of the U.S. patents relating to such product, depending on the expected length of the clinical trials, other factors involved in the filing of the relevant NDA, and the eligibility for patent term extension.

Market exclusivity provisions under the FDCA can also delay the submission or the approval of certain competing marketing applications. The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to obtain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as the original innovative drug or for another indication, where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one of the patents listed with the FDA by the innovator NDA holder. The FDCA also provides three years of marketing exclusivity for an NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, clinical investigations to support new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the modification for which the drug received approval on the basis of the new clinical investigations and does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for drugs containing the active agent for the original indication or condition of use. Five-year and three-year exclusivity will not delay the submission or approval of any full NDA. However, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the preclinical and clinical trials necessary to demonstrate safety and effectiveness.

Other types of non-patent marketing exclusivity include orphan drug exclusivity under the Orphan Drug Act, which may offer a seven-year period of marketing exclusivity as described above, and pediatric exclusivity under the Best Pharmaceuticals for Children Act, which may add six months to existing exclusivity periods and patent terms. This six-month pediatric exclusivity may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial.

In addition, regulatory authorities have established heightened requirements for the demonstration of equivalence between proposed generic drugs and therapeutics using certain nanomedicine platforms, such as liposomes and other nanoparticulate suspensions. We expect these requirements will apply to the development of generic Accurins as well. We believe these additional regulatory requirements will strengthen the protection afforded by our intellectual property portfolio and present significant barriers to entry for potential generics.

Coverage and Reimbursement

Sales of our products will depend, in part, on the extent to which our products will be covered by third-party payors, such as government health care programs, commercial insurance and managed healthcare organizations. These third-party payors are increasingly limiting coverage and reimbursement for medical products and services. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. Decreases in third-party reimbursement for our drug candidates or a decision by a third-party payor to not cover our drug candidates could reduce physician usage of our products once approved and have a material adverse effect on our sales, results of operations and financial condition.

Fraud and Abuse Laws

We will also be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments in which we will conduct our business once our products are approved. The laws that may affect our ability to operate include: the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; the federal healthcare programs’ Anti-Kickback Law, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent; federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; and state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.

Research and Development

We have invested $28.9 million, $24.4 million and $13.1 million in research and development for the years ended December 31, 2014, 2013, and 2012, respectively.

Financial Information

See Note 2 to the Consolidated Financial Statements for financial information about geographic areas, Notes 2 and 4 to the Consolidated Financial Statements for information about our revenues, and the Consolidated Financial Statements for our net loss and total assets.

Employees

As of December 31, 2014, we had 89 full-time employees, 70 of whom were primarily engaged in research and development activities. A total of 28 employees have an M.D. or Ph.D. degree. None of our employees is represented by a labor union and we consider our employee relations to be good.

Other Information

We were incorporated under the laws of the state of Delaware on May 19, 2006 under the name BIND Biosciences, Inc., and changed our name to BIND Therapeutics, Inc. in April 2013. On September 25, 2013, we completed an initial public offering of our common stock. We maintain a website with the address www.bindtherapeutics.com. We are not including the information contained in our website as part of, or incorporating it by reference into, this Annual Report on Form 10-K. We make available, free of charge through our website, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to these reports as soon as reasonably practicable after we electronically file these materials with, or otherwise furnish them to, the Securities and Exchange Commission (“SEC”).

Item 1A.

Risk Factors

Our business faces significant risks and uncertainties. Certain important factors may have a material adverse effect on our business prospects, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to consider the following discussion of risk factors, in its entirety, in addition to other information contained in or incorporated by reference into this Annual Report on Form 10-K and our other public filings with the SEC. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.

Risks Related to Our Financial Position and Need for Additional Capital

We have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.

Since inception, we have incurred significant operating losses. Our net loss was $32.5 million for the fiscal year ended December 31, 2014. As of December 31, 2014, we had an accumulated deficit of $137.3 million. Through December 31, 2014, we have financed our operations primarily through our initial public offering, private placements of our preferred stock and convertible debt securities, borrowings under our credit facility with Hercules Technology III, L.P., or Hercules, collaborations and government grants. Since December 31, 2014, we completed an underwritten public offering of common stock and warrants, receiving net proceeds of approximately $20 million, and entered into an amendment to our credit facility with Hercules, receiving net proceeds of approximately $12 million. All of our revenue to date has been collaboration revenue and government grants. We have devoted substantially all of our financial resources and efforts to developing our medicinal nanoengineering platform, identifying potential drug candidates, and conducting preclinical studies and clinical trials. We are conducting Phase 2 clinical trials of BIND-014, our preclinical pipeline and collaborations are in early stages of development, and we have not completed development of any Accurins or other drugs. We expect to continue to incur significant expenses and operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:

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conduct our Phase 2 clinical trials of BIND-014, our lead Accurin drug candidate, a prostate-specific membrane antigen, or PSMA, targeted Accurin that contains docetaxel, and potentially conduct pivotal clinical trials of BIND-014;

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continue the research and development of our other drug candidates, including BIND-510 and any in-licensed technologies and therapeutic payloads, but excluding research and development costs of our drug candidates being developed in collaboration with Pfizer Inc., AstraZeneca AB, and F. Hoffmann-La Roche Ltd. as these collaborators generally are required to pay all such development costs, including those incurred by us;

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seek to enhance our Medicinal Nanoengineering^® platform and discover and develop additional drug candidates;

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seek regulatory approvals for any drug candidates that successfully complete clinical trials;

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potentially establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;

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maintain, expand and protect our intellectual property portfolio; and

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add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts and to support our transition to a public company.

To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our drug candidates, discovering additional drug candidates, obtaining regulatory approval for these drug candidates and manufacturing, marketing and selling any products for which we may obtain regulatory approval, and establishing and managing our collaborations at various stages of each candidate’s development. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.

Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. If we are required by the U.S. Food and Drug Administration, or FDA, or the European Medicines Agency, or EMA, to perform studies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our drug candidates, our expenses could increase and revenue could be further delayed.

Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

We will need additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

We expect our expenses to increase as we expand development of our internal pipeline and collaborations. In addition, if we obtain regulatory approval for any of our drug candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.

We expect that our cash, cash equivalents, and short-term investments as of December 31, 2014, combined with the net proceeds of approximately $12.0 million from the January 2015 amended term loan with Hercules and the net proceeds of approximately $20.0 million from the February 2015 common stock and warrant offering, will fund our operating expenses and capital expenditure requirements into mid-2016. This expectation is based on our current operating plans and research and development funding that we expect to receive under our existing collaborations, but excludes any potential milestone payments. In October 2014, we entered into an ATM facility pursuant to which we may, at our option, offer and sell shares of our common stock from time to time for an aggregate offering price of up to $40.0 million. As of the date of this 10-K filing, we have not sold any shares of common stock under the ATM facility. We do not know whether and to what extent we will seek to

sell shares pursuant to the ATM facility and, when and if we decide to sell shares, we do not know if we will be able to do so and on what terms. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

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our collaboration agreements remaining in effect, our collaborators exercising their options under these agreements, our ability to achieve milestones under these agreements and our entering into additional collaboration agreements;

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the progress and results of our clinical trials of BIND-014;

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the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other drug candidates, including BIND-510;

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the costs, timing and outcome of regulatory review of our drug candidates;

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the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our drug candidates for which we receive marketing approval;

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the revenue, if any, received from commercial sales of our drug candidates for which we receive marketing approval;

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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and

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the extent to which we acquire or in-license other products and technologies.

Identifying potential drug candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, our drug candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings and license and collaboration agreements. We do not have any committed external source of funds other than research and development funding under our existing collaborations and government grants. We have conducted a public equity offering since our initial public offering, which has caused the ownership interest of each of our existing stockholders to be diluted. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of each of our existing stockholders will be further diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

The state of the economy and the financial and credit markets at the time or times we seek additional financing may make it more difficult and more expensive to obtain.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or grant licenses on terms that may not be favorable to us and/or that may reduce the value of our common stock.

Our limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.

We commenced active operations in 2007, and our operations to date have been limited to organizing and staffing our company, business planning, raising capital, developing our medicinal nanoengineering platform, identifying potential drug candidates, and conducting preclinical studies and clinical trials. All but one of our drug candidates, BIND-014, are still in preclinical development. We are in Phase 2 clinical trials for BIND-014, our leading drug candidate. We have not yet demonstrated our ability to successfully complete any pivotal clinical trials, obtain regulatory approvals, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history.

In addition, as a young business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

We expect our financial condition and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, the results of any quarterly or annual periods should not be relied on as indications of future operating performance.

The terms of our credit facility place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.

We have an amended credit facility with an outstanding principal balance of $15 million with Hercules that is secured by a lien covering substantially all of our personal property, excluding intellectual property. The credit facility contains customary affirmative and negative covenants and events of default applicable to us and our subsidiaries. The affirmative covenants include, among others, covenants requiring us (and us to cause our subsidiaries) to maintain our legal existence and governmental approvals, deliver certain financial reports and maintain insurance coverage. The negative covenants include, among others, restrictions on us and our subsidiaries transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets, and suffering a change in control, in each case subject to certain exceptions. If we default under the facility, the lender may accelerate all of our repayment obligations and take control of our pledged assets, potentially requiring us to renegotiate our agreement on terms less favorable to us or to immediately cease operations. Further, if we are liquidated, the lender’s right to repayment would be senior to the rights of the holders of our common stock to receive any proceeds from the liquidation. The lender could declare a default upon the occurrence of any event that it interprets as a material adverse effect as defined under the credit facility, thereby requiring us to repay the loan immediately or to attempt to reverse the declaration of default through negotiation or litigation. Any declaration by the lender of an event of default could significantly harm our business and prospects and could cause the price of our common stock to decline. If we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.

Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

Under Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a

three year period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income may be limited. Taking into account our initial public offering and other transactions, including our February 2015 common stock and warrant offering, we may have triggered an “ownership change” limitation. In addition, we may experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which are outside our control. As a result, our ability to use our pre-change net operating loss carryforwards and other pre-change tax attributes to offset U.S. federal taxable income may be subject to limitations, which could result in increased tax liability to us.

Risks Related to the Discovery and Development of Our Drug Candidates

We may not be successful in our efforts to use and expand our medicinal nanoengineering platform to build a pipeline of drug candidates and develop marketable drugs.

We are using our proprietary medicinal nanoengineering platform to develop BIND-014 and additional Accurins, with an initial focus on the treatment of various types of cancer. We are at an early stage of development and our platform has not yet, and may never lead to, approvable or marketable drugs. Even if we are successful in continuing to build our pipeline, the potential drug candidates that we identify may not be suitable for clinical development, including as a result of their harmful side effects, limited efficacy or other characteristics that indicate that they are unlikely to be products that will receive marketing approval and achieve market acceptance. If we do not successfully develop and commercialize drug candidates based upon our technological approach, we will not be able to obtain product or collaboration revenues in future periods, which likely would result in significant harm to our financial position and adversely affect our stock price.

We are early in our development efforts and have only one drug candidate in clinical development. All of our other drug candidates are still in preclinical development. If we or our collaborators are unable to successfully develop and commercialize drug candidates or experience significant delays in doing so, our business will be materially harmed.

We are early in our development efforts and have only one drug candidate, BIND-014, in clinical development. All of our other drug candidates are still in preclinical development. We have invested substantially all of our efforts and financial resources in developing our medicinal nanoengineering platform, identifying potential drug candidates, and conducting preclinical studies and clinical trials. Our ability to generate product revenues, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our drug candidates. The success of our drug candidates will depend on several factors, including the following:

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completion of preclinical studies and clinical trials with positive results;

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receipt of marketing approvals from applicable regulatory authorities;

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obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our drug candidates;

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making arrangements with third-party manufacturers for, or establishing, commercial manufacturing capabilities;

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launching commercial sales of our products, if and when approved, whether alone or in collaboration with others;

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successfully maintaining existing collaborations and entering into new ones throughout the development process as appropriate, from preclinical studies through to commercialization;

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acceptance of the products, if and when approved, by patients, the medical community and third-party payors;

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effectively competing with other therapies;

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obtaining and maintaining coverage and adequate reimbursement by third-party payors, including government payors, for our drug candidates;

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protecting our rights in our intellectual property portfolio;

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maintaining a continued acceptable safety profile of the products following approval; and

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maintaining and growing an organization of scientists and business people who can develop and commercialize our products and technology.

If we or our collaborators do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully develop and commercialize our drug candidates, which would materially harm our business.

Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug candidates.

All but one of our drug candidates are in preclinical development, with one, BIND-014, in Phase 2 clinical development, and their risk of failure is high. It is impossible to predict when or if any of our drug candidates will prove effective and safe in humans or will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the sale of any drug candidate, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our drug candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failed clinical trial can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. For example, preliminary efficacy signals in our clinical trials of BIND-014 were observed in only a small number of patients in a single-arm, open-label setting and might not be achieved by any other patients treated with BIND-014 in future trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their drug candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products.

We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our drug candidates, including:

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regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

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we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

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clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

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the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;

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our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

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we may have to suspend or terminate clinical trials of our drug candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks;

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regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

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the cost of clinical trials of our drug candidates may be greater than we anticipate;

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the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate;

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our drug candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials;

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regulators may revise the requirements for approving our drug candidates, or such requirements may not be as we anticipate; and

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regarding trials managed by our existing or any future collaborators, our collaborators may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but potentially suboptimal for us.

If we are required to conduct additional clinical trials or other testing of our drug candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our drug candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:

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be delayed in obtaining marketing approval for our drug candidates;

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lose the support of collaborators, requiring us to bear more of the burden of development of certain compounds;

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not obtain marketing approval at all;

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obtain marketing approval in some countries and not in others;

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obtain approval for indications or patient populations that are not as broad as we intend or desire;

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obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;

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be subject to additional post-marketing testing requirements; or

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have the product removed from the market after obtaining marketing approval.

We are currently in Phase 2 clinical development for BIND-014. However, we cannot provide any assurance that we will successfully complete Phase 2 clinical development and be able to initiate pivotal clinical trials for BIND-014. The results of our Phase 2 clinical trials could yield negative or ambiguous results. Since this is our most advanced drug candidate, such results could adversely affect future development plans, collaborations and our stock price.

Our product development costs will increase if we experience delays in clinical testing or marketing approvals. We do not know whether any of our preclinical studies or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our drug candidates or allow our competitors to bring products to market before we do, potentially impairing our ability to successfully commercialize our drug candidates and harming our business and results of operations.

If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate or continue clinical trials for our drug candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States. In addition, some of our competitors have ongoing clinical trials for drug candidates that treat the same indications as our drug candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ drug candidates.

Patient enrollment is affected by other factors including:

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the severity of the disease under investigation;

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the patient eligibility criteria for the study in question;

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the perceived risks and benefits of the drug candidate under study;

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the efforts to facilitate timely enrollment in clinical trials;

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our payments for conducting clinical trials;

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the patient referral practices of physicians;

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the ability to monitor patients adequately during and after treatment; and

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the proximity and availability of clinical trial sites for prospective patients.

Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our drug candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing.

If serious adverse or unacceptable side effects are identified during the development of our drug candidates or we observe limited efficacy, we may need to abandon or limit our development of some of our drug candidates.

If our drug candidates are associated with undesirable side effects in clinical trials, have limited efficacy or have characteristics that are unexpected, we may need to abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

For example, of the more than 160 patients dosed in our clinical trials of BIND-014, almost all have experienced at least one adverse event, with one treatment-related adverse event resulting in death. A number of patients have discontinued treatment as a result of treatment-related adverse events. The most common adverse events experienced by patients in clinical trials are fatigue, nausea, diarrhea, anemia, anorexia, dyspnea, alopecia, and neutropenia (a low number of white blood cells), all of which are toxicities that are frequently associated with docetaxel as well as many other cancer drugs. The treatment-related death in the Phase 1 clinical trial involved an elderly patient with advanced biliary cancer with a biliary stent who was treated with BIND-014 at 75 mg/m² once every three weeks and developed sepsis as a consequence of neutropenia, which has previously been observed in clinical studies of patients receiving docetaxel. The adverse events observed in clinical trials are qualitatively similar to those associated with docetaxel. In light of the similarity with other FDA-approved cancer therapeutics, we believe our results to date suggest an acceptable safety profile at this stage of development. However, many compounds that initially showed promise in early stage testing for treating cancer have later been found to cause side effects that prevented further development of the compound.

Risks Related to Our Dependence on Third Parties

Our existing collaborations are important to our business, and future collaborations may also be important to us. If we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected.

We have entered into collaborations with other biopharmaceutical companies to develop Accurins based on therapeutic payloads from their product pipelines, and such collaborations currently represent a significant portion of our product pipeline. Our ongoing collaboration and license agreements include those we have announced with AstraZeneca, Pfizer, and Roche, and others that we have not announced. These collaborations also have provided us with important funding for our development programs and we expect to receive additional funding under these collaborations in the future. Our existing collaborations, and any future collaborations we enter into, may pose a number of risks, including the following:

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collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;

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collaborators may not perform their obligations as expected;

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collaborators may not pursue development and commercialization of any drug candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

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collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing;

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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or drug candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours, which may cause collaborators to cease to devote resources to the commercialization of our drug candidates;

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a collaborator with marketing and distribution rights to one or more of our drug candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products;

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disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of drug candidates, might lead to additional responsibilities for us with respect to drug candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

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collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

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collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

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collaborations may be terminated for the convenience of the collaborator and, if terminated, we would potentially lose the right to pursue further development or commercialization of the applicable drug candidates;

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collaborators may learn about our technology and use this knowledge to compete with us in the future;

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results of collaborators’ preclinical or clinical studies could produce results that harm or impair other products using our technology;

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there may be conflicts between different collaborators that could negatively affect those collaborations and potentially others; and

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the number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers.

If our collaborations do not result in the successful development and commercialization of products or if one of our collaborators terminates its agreement with us, or in the case of Pfizer, elects not to exercise its option under the collaboration agreement, we may not receive any future research and development funding or milestone or royalty payments under the collaboration. For example, in June 2014, Amgen and we notified each other that both parties would not exercise the respective options to develop an Accurin incorporating the Amgen therapeutic payload. If we do not receive the funding we expect under these agreements, our continued development of our medicinal nanoengineering platform and drug candidates could be delayed and we may need additional resources to develop additional drug candidates. All of the risks relating to product development, regulatory approval and commercialization described in this report also apply to the activities of our collaborators and there can be no assurance that our collaborations will produce positive results or successful products on a timely basis or at all.

In addition, for a specified period of time following the execution of our collaboration agreement with AstraZeneca, we may not develop or commercialize a compound against the same molecular target as AstraZeneca’s drug candidate. Also, for a limited time while the Roche research agreement is in effect, we are required to work exclusively with Roche with respect to the use of BIND technology targeting therapeutic molecules to specified organs. As a result, our ability to enter into collaboration agreements for additional drug candidates against these targets are significantly limited until the end of the period specified in our collaboration agreements. These restrictions may have the effect of preventing us from undertaking development and other efforts that may appear to be attractive to us.

Additionally, subject to its contractual obligations to us, if a collaborator of ours is involved in a business combination or otherwise changes its business priorities, the collaborator might deemphasize or terminate the development or commercialization of any drug candidate licensed to it by us. If any of our collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our perception in the business and financial communities and our stock price could be adversely affected.

We may in the future determine to collaborate with additional pharmaceutical and biotechnology companies for development and potential commercialization of therapeutic products. We face significant competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may not be able to access therapeutic payloads that would be suitable to development with our platform, have to curtail the development of a drug candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms or at all. If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our drug candidates or bring them to market or continue to develop our product platform and our business may be materially and adversely affected.

We rely, and expect to continue to rely, on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.

We currently rely on third-party clinical research organizations, or CROs, to conduct Phase 2 development of BIND-014 and do not plan to independently conduct clinical trials of our other drug candidates. We expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to conduct and manage our clinical trials. These agreements might terminate for a variety of reasons, including a failure to perform by the third parties. If we need to enter into alternative arrangements, that would delay our product development activities.

Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with regulatory standards, commonly referred to as good clinical practices, or GCPs, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Other countries’ regulatory agencies also have requirements for clinical trials with which we must comply. We also are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within specified timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our drug candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our drug candidates.

We also expect to rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development or marketing approval of our drug candidates or commercialization of our products, producing additional losses and depriving us of potential product revenue. We contract with third parties for the manufacture of our drug candidates for preclinical and clinical testing and expect to continue to do so for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We have a pilot manufacturing facility at our Cambridge, Massachusetts location where we conduct process development, scale-up activities and assemble the manufacturing equipment for use in the manufacture of Accurins. However, we do not have any manufacturing facilities that meet the FDA’s current good manufacturing practices, or cGMP, requirements for the production of any drug candidates used in humans. We rely, and expect to continue to rely, on third parties for the manufacture of our drug candidates for clinical testing, as well as for commercial manufacture if any of our drug candidates receive marketing approval. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates on a timely basis or at all or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.

We may be unable to establish any agreements with third-party manufacturers or to do so on acceptable terms. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

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failure of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;

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breach of the manufacturing agreement by the third party;

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failure to manufacture our product according to our specifications;

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failure to manufacture our product according to our schedule or at all;

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misappropriation of our proprietary information, including our trade secrets and know-how; and

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termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of drug candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.

Our drug candidates and any products that we may develop may compete with other drug candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval. We do not currently have arrangements in place for redundant supply or a second source for required raw materials used in the manufacture of our drug candidates, including the polymers

used in our Accurins, or for the manufacture of finished BIND-014 product. If our current contract manufacturers cannot perform as agreed, we may be required to replace such manufacturers and we may be unable to replace them on a timely basis or at all. In particular, there are a very few manufacturers capable of supplying the polymers used in our Accurins.

Our current and anticipated future dependence upon others for the manufacture of our drug candidates or products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.

Risks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters

If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our drug candidates or will not be able to do so as soon as anticipated, and our ability to generate revenue will be materially impaired.

Our drug candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by the EMA and similar regulatory authorities outside the United States. Failure to obtain marketing approval for a drug candidate will prevent us from commercializing the drug candidate. We have not received approval to market any of our drug candidates from regulatory authorities in any jurisdiction. We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third parties to assist us in this process. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the drug candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Our drug candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use. For example, new cancer drugs frequently are indicated only for patient populations that have not responded to an existing therapy or have relapsed. If any of our drug candidates with a cancer indication receives marketing approval, the accompanying label may limit the approved use of our drug in this way, which could limit sales of the product and thereby have a negative effect on our results of operations and financial condition.

The process of obtaining marketing approvals, both in the United States and abroad, is expensive and may take many years. If additional clinical trials are required for certain jurisdictions, these trials can vary substantially based upon a variety of factors, including the type, complexity and novelty of the drug candidates involved, and may ultimately be unsuccessful. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in the regulatory review process for each submitted product application, may cause delays in the review and approval of an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept a marketing application as deficient or may decide that our data is insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a drug candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

The FDA and other regulatory authorities are monitoring whether nanotechnology-based therapeutics pose any specific health and human safety risks. In June 2014, the FDA issued guidance providing that it will address issues such as safety, effectiveness, public heath impact, and regulatory status of nanotechnology products on a case-by-case basis using the FDA’s existing review processes. It is possible that the FDA or other regulatory authorities could issue additional guidance or regulations in the future regarding nanotechnology-based therapeutics that could adversely affect our drug candidates.

If we experience delays in obtaining approval or if we fail to obtain approval of our drug candidates, the commercial prospects for our drug candidates may be harmed and our ability to generate revenues will be materially impaired.

If the FDA does not conclude that BIND-014 satisfies the requirements for approval under the Section 505(b)(2) regulatory approval pathway, or if the requirements for approval of BIND-014 under Section 505(b)(2) are not as we expect, the approval pathway for BIND-014 will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in any case may not be successful.

We intend to seek FDA approval for BIND-014 through the Section 505(b)(2) regulatory pathway. Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FDCA, would allow a new drug application, or NDA, we submit to the FDA to rely in part on data in the public domain or the FDA’s prior conclusions regarding the safety and effectiveness of an approved drug product, which could expedite the development program for BIND-014 by potentially decreasing the amount of clinical data that we would need to generate in order to obtain FDA approval. If the FDA does not allow us to pursue the Section 505(b)(2) regulatory pathway as anticipated, we may need to conduct additional clinical trials, provide additional data and information, and meet additional standards for product approval. If this were to occur, the time and financial resources required to obtain FDA approval for BIND-014, and complications and risks associated with regulatory approval of BIND-014, would likely substantially increase. Moreover, inability to pursue the Section 505(b)(2) regulatory pathway may result in new competitive products reaching the market more quickly than BIND-014, which would likely materially adversely impact our competitive position and prospects. Even if we are able to utilize the Section 505(b)(2) regulatory pathway, there is no guarantee this will ultimately lead to accelerated product development or earlier approval.

In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to special requirements designed to protect the patent rights of sponsors of previously approved drugs that may be referenced in a Section 505(b)(2) NDA. These requirements may give rise to patent litigation and mandatory delays in approval of our NDA for up to 30 months or longer depending on the outcome of any litigation. Further, it is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such petitions can significantly delay, or even prevent, the approval of a new product. Even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition.

Moreover, even if BIND-014 is approved under Section 505(b)(2), the approval may be subject to limitations on the indicated uses for which the products may be marketed or to other conditions of approval, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the products.

In the European Economic Area, or EEA (composed of the 27 European Union, or EU, Member States plus Iceland, Liechtenstein and Norway), we intend to seek approval for BIND-014 under the hybrid application pathway of the EU Centralized Procedure.

The hybrid pathway is available for (i) products that do not fall under the strict definition of a generic medicinal product, (ii) whose bioequivalence to the reference product cannot be demonstrated through bioavailability studies, or (iii) whose active substances, therapeutic indications, strength, pharmaceutical form or route of administration, differs from that of the reference product. Hybrid applications may rely in part on the results of preclinical tests and clinical trials contained in the authorization dossier of the reference product, which will however need to be supplemented with additional data. We have not engaged in pre-submission discussions with the EMA to determine the eligibility of the centralized hybrid process for BIND-014. If the EMA does not

allow us to pursue the centralized hybrid pathway as anticipated, we may need to conduct additional clinical trials, provide additional data and information, and meet additional standards to have BIND-014 authorized in the EEA.

A fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process.

We may seek fast track designation for some of our drug candidates. If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA fast track designation. The FDA has broad discretion whether or not to grant this designation, and even if we believe a particular drug candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even if we do receive fast track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

We may not be able to obtain orphan drug exclusivity for our drug candidates.

Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States.

Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the EMA or the FDA from approving another marketing application for the same drug for that time period. The applicable period is 7 years in the United States and ten years in Europe. The European exclusivity period can be reduced to nine years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

A breakthrough therapy designation by the FDA for our drug candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our drug candidates will receive marketing approval.

We may seek a breakthrough therapy designation for some of our drug candidates. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. For drugs that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as breakthrough therapies by the FDA are also eligible for accelerated approval.

Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our drug candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. The availability of breakthrough therapy designation was established recently with the passage of the Food and Drug Administration Safety and Innovation Act of 2012, and the FDA only recently released guidance on its implementation of the breakthrough therapy framework in May 2014. As a result, we cannot be sure that our evaluation of our drugs as qualifying for breakthrough therapy designation will meet the FDA’s expectations. In any event, the receipt of a breakthrough therapy designation for a drug candidate may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of our drug candidates qualify as breakthrough therapies, the FDA may later decide that the products no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Failure to obtain marketing approval in international jurisdictions would prevent our drug candidates from being marketed abroad.

In order to market and sell our products in the European Union and many other jurisdictions, we or our collaborators must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval in foreign countries may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country. We or our collaborators may not obtain approvals for our drug candidates from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any market.

Any drug candidate for which we obtain marketing approval could be subject to post-marketing restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

Any drug candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping. Even if marketing approval of a drug candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, including the requirement to implement a risk evaluation and mitigation strategy, or REMS, which could include requirements for a restricted distribution system. If any of our drug candidates receives marketing approval, the accompanying label may limit the approved use of our drug, which could limit sales of the product.

The FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of our approved products. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we market our products outside of their approved

indications, we may be subject to enforcement action for off-label marketing. Violations of the FDCA relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

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litigation involving patients taking our drug;

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restrictions on such products, manufacturers or manufacturing processes;

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restrictions on the labeling or marketing of a product;

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restrictions on product distribution or use;

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requirements to conduct post-marketing studies or clinical trials;

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warning letters;

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withdrawal of the products from the market;

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refusal to approve pending applications or supplements to approved applications that we submit;

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recall of products;

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fines, restitution or disgorgement of profits or revenues;

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suspension or withdrawal of marketing approvals;

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damage to relationships with existing and potential collaborators;

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unfavorable press coverage and damage to our reputation;

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refusal to permit the import or export of our products;

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product seizure; or

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injunctions or the imposition of civil or criminal penalties.

Noncompliance with similar European Union requirements regarding safety monitoring or pharmacovigilance can also result in significant financial penalties. Similarly, failure to comply with U.S. and foreign regulatory requirements regarding the development of products for pediatric populations and the protection of personal health information can also lead to significant penalties and sanctions.

Our relationships with customers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, including the Foreign Corrupt Practices Act, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any drug candidates for which we obtain marketing approval. Our future arrangements with third-party payors, physicians and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any products for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations include the following:

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the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;

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the federal False Claims Act imposes criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the false claims statutes;

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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

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federal law requires applicable manufacturers of covered drugs to report payments and other transfers of value to physicians and teaching hospitals, as well as the ownership and investment interests held by such physicians and their immediate family members, by the 90th day of each calendar year; and

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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.

Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. State and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and affect the prices we may obtain.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our drug candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any drug candidates for which we obtain marketing approval.

In the United States, in 2010, President Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the PPACA, a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.

Among the provisions of the PPACA of importance to our potential drug candidates are the following:

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an annual, nondeductible fee payable by any entity that manufactures or imports specified branded prescription drugs and biologic agents;

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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;

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expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance;

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a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices;

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extension of manufacturers’ Medicaid rebate liability;

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expansion of eligibility criteria for Medicaid programs;

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expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

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new requirements to report financial arrangements with physicians and teaching hospitals;

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a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and

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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.

In addition, other legislative changes have been proposed and adopted since the PPACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments, will remain through 2024 unless additional Congressional action is taken. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain.

We expect that the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our drug candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.

In some countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our drug candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

The workers’ compensation insurance we maintain may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Risks Related to the Commercialization of Our Drug Candidates

Even if any of our drug candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

If any of our drug candidates receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. For example, current cancer treatments like chemotherapy and radiation therapy are well established in the medical community, and physicians may continue to rely on these treatments. In addition, many new drugs have been recently approved and many more are in the pipeline for the same diseases for which we are developing our drug candidates. If our drug candidates do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of our drug candidates, if approved for commercial sale, will depend on a number of factors, including:

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their efficacy, safety and other potential advantages compared to alternative treatments;

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our ability to offer them for sale at competitive prices;

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their convenience and ease of administration compared to alternative treatments;

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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

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the strength of marketing and distribution support;

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the availability of third-party coverage and adequate reimbursement for our drug candidates;

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the prevalence and severity of their side effects;

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any restrictions on the use of our products together with other medications;

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interactions of our products with other medicines patients are taking; and

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inability of certain types of patients to take our product.

If we are unable to establish effective sales, marketing and distribution capabilities or enter into agreements with third parties with such capabilities, we may not be successful in commercializing our drug candidates if and when they are approved.

We do not have a sales or marketing infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any product for which we obtain marketing approval, we will need to establish a sales and marketing organization or make arrangements with third parties to perform sales and marketing functions.

In the future, we expect to build a focused oncology sales and marketing infrastructure to market or co-promote some of our drug candidates in the United States and potentially elsewhere, if and when they are approved. There are risks involved with establishing our own sales, marketing and distribution capabilities. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a drug candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our products on our own include:

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our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

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the inability of sales personnel to obtain access to or educate physicians on the benefits of our products;

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the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;

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unforeseen costs and expenses associated with creating an independent sales and marketing organization; and

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inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies.

Outside the United States, we expect to rely on third parties to sell, market and distribute our drug candidates. We may not be successful in entering into arrangements with such third parties or may be unable to do so on terms that are favorable to us. In addition, our product revenues and our profitability, if any, may be lower if we rely on third parties for these functions than if we were to market, sell and distribute any products that we develop ourselves. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our drug candidates.

We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.

The development and commercialization of new drug products is highly competitive. We face competition with respect to our current drug candidates, and will face competition with respect to any drug candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for which we are developing our drug candidates. Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to our approach, and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Many of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources, market presence and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific, sales and marketing and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products. Generic products are currently on the market, including the therapeutic payload in BIND-014, for the indications that we are pursuing, and additional products are expected to become available on a generic basis over the coming years. If our drug candidates achieve marketing approval, we expect that they will be priced at a significant premium over competitive generic products.

The most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy and targeted drug therapy. There are a variety of available drug therapies marketed for solid tumors. In many cases, these drugs are administered in combination to enhance efficacy. Some of these drugs are branded and subject to patent protection, and others are available on a generic basis, including the therapeutic payload contained in BIND-014. Many of these approved drugs are well established therapies and are widely accepted by physicians, patients and third-party payors. There are also a number of products in late stage clinical development to treat solid tumors. These products in development may provide efficacy, safety, convenience and other benefits that are not provided by currently marketed therapies. As a result, they may provide significant competition for BIND-014 or any other drug candidate for which we obtain marketing approval.

Even if we are able to commercialize any drug candidates, the products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business.

The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drug products vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control, including possible price reductions, even after initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more drug candidates, even if our drug candidates obtain marketing approval.

Our ability to commercialize any drug candidates successfully also will depend in part on the extent to which coverage and reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for drugs. Coverage and reimbursement may not be available for any product that we commercialize and, even if these are available, the level of reimbursement may not be sufficient to generate a profit. Reimbursement may affect the demand for, or the price of, any drug candidate for which we obtain marketing approval. Obtaining and maintaining adequate reimbursement for our products may be difficult. We may be required to conduct expensive pharmacoeconomic studies to justify coverage and reimbursement or the level of reimbursement relative to other therapies. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not be able to successfully commercialize any drug candidate for which we obtain marketing approval.

There may be significant delays in obtaining reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or similar regulatory authorities outside the United States. Moreover, eligibility for reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related to the testing of our drug candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop. If we cannot successfully defend ourselves against claims that our drug candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

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decreased demand for any drug candidates or products that we may develop;

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injury to our reputation and significant negative media attention;

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withdrawal of clinical trial participants;

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significant costs to defend the related litigation;

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substantial monetary awards to trial participants or patients;

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loss of revenue;

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reduced resources of our management to pursue our business strategy; and

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the inability to commercialize any products that we may develop.

We currently hold product liability insurance coverage, which may not be adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of our drug candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Risks Related to Employee Matters and Managing Growth and Other Risks Related to Our Business

Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on the principal members of our management, scientific and clinical team. Although we have entered into employment letter agreements with our executive officers, each of them may terminate their employment with us at any time. We do not maintain “key person” insurance for any of our executives or other employees.

Recruiting and retaining qualified scientific, clinical, manufacturing and sales and marketing personnel will also be critical to our success. The loss of the services of our executive officers or other key employees could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.

We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

We expect to experience growth in the number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs, manufacturing and, if any of our drug candidates receives marketing approval, sales, marketing and distribution. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

A variety of risks associated with operating internationally could materially adversely affect our business.

In addition to our U.S. operations, we have operations in Russia through our wholly-owned subsidiary, BIND (RUS) LLC, and may have other such international operations in the future. We face risks associated with our operations in Russia, including possible unfavorable regulatory, pricing and reimbursement, legal, political, tax and labor conditions, which could harm our business. We are also conducting and in the future plan to continue to conduct clinical trials of drug candidates in Russia. We are subject to numerous risks associated with international business activities in Russia and elsewhere, including:

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compliance with differing or unexpected regulatory requirements for our products;

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compliance with Russian laws with respect to our BIND (RUS) LLC subsidiary;

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difficulties in staffing and managing foreign operations;

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foreign government taxes, regulations and permit requirements;

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U.S. and foreign government tariffs, trade restrictions, price and exchange controls and other regulatory requirements;

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economic weakness, including inflation, natural disasters, war, events of terrorism or political instability in particular foreign countries;

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fluctuations in currency exchange rates, which could result in increased operating expenses and reduced revenues;

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compliance with tax, employment, immigration and labor laws, regulations and restrictions for employees living or traveling abroad;

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changes in diplomatic and trade relationships; and

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challenges in enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States.

These and other risks associated with our international operations in Russia and elsewhere may materially adversely affect our business, financial condition and results of operations.

Sanctions against Russia, and Russia’s response to those sanctions, could adversely affect our business.

Due to Russia’s intervention in Ukraine and annexation of Crimea, the United States and the European Union have imposed sanctions on certain individuals and entities in Russia and Ukraine, including economic sanctions restricting certain entities’ access to U.S. securities markets. In response, Russia has imposed entry

bans on certain U.S. lawmakers and officials. We have a wholly owned subsidiary, BIND (RUS) LLC, in Russia, which holds $2.2 million in cash, $2.1 million of which was denominated in U.S. dollars, and $1.0 million in restricted cash in Russian banks as of December 31, 2014. Our subsidiary conducts research and development activities for our product pipeline, including clinical trials for BIND-014. Our success is dependent upon our ability to successfully complete clinical development of and obtain regulatory approval of our drug candidates. If the United States and Europe were to impose sanctions on additional Russian businesses, or if Russia were to take retaliatory action against U.S. companies operating in Russia, our research and development activities and our business could be affected.

Our business and operations would suffer in the event of system failures or security breaches.

Our internal computer systems and those of our current and future contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Any system failure or security breach by employees or others may pose a risk that sensitive data, including clinical trial data, intellectual property, trade secrets or personal information belonging to us, our patients or our collaborators may be exposed to unauthorized persons or to the public. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on third parties to manufacture our drug candidates and conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability, the further development and commercialization of our drug candidates could be delayed, and the trading price of our common stock could be adversely affected.

Risks Related to Our Intellectual Property

If we or our licensors are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.

Our success depends in large part on our ability to obtain and maintain patent and other intellectual property protection in the United States and other countries with respect to our proprietary technology and products. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and drug candidates.

The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost, in a timely manner, or in all jurisdictions. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, in some circumstances, we do not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties. We may also require the cooperation of our licensors in order to enforce the licensed patent rights, and such cooperation may not be provided. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States and we may fail to seek or obtain patent protection in all major markets. For example, European patent law restricts the patentability of methods of treatment of the human body more than United States law does. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the

United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned patents or pending patent applications, or that we were the first to file for patent protection of such inventions, nor can we know whether those from whom we license patents were the first to make the inventions claimed or were the first to file. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.

Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications are prosecuted and may also affect patent litigation. The U.S. Patent and Trademark Office, or U.S. PTO, recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, only became effective on March 16, 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.

Moreover, we may be subject to a third-party preissuance submission of prior art to the U.S. PTO, or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future drug candidates.

Even if our owned and licensed patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and ultimately unsuccessful.

Competitors may infringe our issued patents or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming.

Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly, which could adversely affect us and our collaborators.

Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Our commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our drug candidates and use our proprietary technologies without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology and pharmaceutical industries. We cannot guarantee that our technology, products or use of our products do not infringe third-party patents. It is also possible that we have failed to identify relevant third-party patents or applications. For example, applications filed before November 29, 2000 and certain applications filed after that date that will not be filed outside the United States remain confidential until patents issue. Patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing, which is referred to as the priority date. Therefore, patent applications covering our products or technology could have been filed by others without our knowledge. Additionally, pending patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover our technologies, our products or the use of our products.

We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference or derivation proceedings before the U.S. PTO and similar bodies in other countries. Third parties may assert infringement claims against us based on existing intellectual property rights and intellectual property rights that may be granted in the future. With respect to BIND-014, we are aware of a third-party U.S. patent application that contains claims related to a formulation of a nanoparticle composition. We have an issued U.S. patent and pending non-U.S. patent applications claiming similar subject matter, and we believe our patents and patent applications have an earlier priority filing date. However, these patents and applications are subject to U.S. laws that awards patents to the first party to invent the claimed invention, rather than the first party to file a patent application. The possibility exists for an interference proceeding between our issued patent and this third-party patent application to determine the earliest party to invent the composition and that this third-party patent application could win such an interference proceeding and obtain claims covering this formulation of a nanoparticle composition.

If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our drug candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.

Periodic maintenance fees on any issued patent are due to be paid to the U.S. PTO and foreign patent agencies in several stages over the lifetime of the patent. The U.S. PTO and various foreign governmental patent

agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.

If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.

We are party to multiple license agreements that impose, and we may enter into additional licensing and funding arrangements with third parties that may impose, diligence, development and commercialization timelines, milestone payment, royalty, insurance and other obligations on us. Under our existing licensing agreements, we are obligated to pay royalties on net product sales of drug candidates or related technologies to the extent they are covered by the agreement. If we fail to comply with our obligations under current or future license agreements, our counterparties may have the right to terminate these agreements, in which event we might not be able to develop, manufacture or market any product that is covered by these agreements or may face other penalties under the agreements. Such an occurrence could materially adversely affect the value of drug candidates being developed using rights licensed to us under any such agreement. Termination of these agreements or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology.

We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.

Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that these employees or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. Litigation may be necessary to defend against these claims.

In addition, while it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. Our and their assignment agreements may not be self-executing or may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to management.

Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be

negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patents for some of our technology and drug candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also seek to enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Our trade secrets may also be obtained by third parties by other means, such as breaches of our physical or computer security systems. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

Risks Related to Our Common Stock

Our executive officers, directors and principal stockholders, if they choose to act together, will have the ability to control or significantly influence all matters submitted to stockholders for approval.

As of December 31, 2014, our executive officers, directors and stockholders who own more than 5% of our outstanding common stock and their respective affiliates, in the aggregate, hold shares representing approximately 55% of our outstanding voting stock. As a result, if these stockholders were to choose to act together, they would be able to control or significantly influence all matters submitted to our stockholders for approval, as well as our management and affairs. For example, these persons, if they choose to act together, would control or significantly influence the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets. This concentration of ownership control may:

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delay, defer or prevent a change in control;

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entrench our management and the board of directors; or

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impede a merger, consolidation, takeover or other business combination involving us that other stockholders may desire.

The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for our stockholders.

Our stock price is likely to be volatile. The stock market in general and the market for smaller biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price for our common stock may be influenced by many factors, including:

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the success of competitive products or technologies;

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results of clinical trials of our drug candidates or those of our competitors;

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developments related to our existing or any future collaborations;

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regulatory or legal developments in the United States and other countries;

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developments or disputes concerning patent applications, issued patents or other proprietary rights;

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the recruitment or departure of key personnel;

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the level of expenses related to any of our drug candidates or clinical development programs;

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the results of our efforts to discover, develop, acquire or in-license additional drug candidates or products;

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actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

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variations in our financial results or those of companies that are perceived to be similar to us;

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changes in the structure of healthcare payment systems;

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market conditions in the pharmaceutical and biotechnology sectors;

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general economic, industry and market conditions; and

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the other factors described in this “Risk Factors” section.

Sales of a substantial number of shares of our common stock in the public market could cause the market price of our common stock to drop significantly, even if our business is doing well.

Sales of a substantial number of shares of our common stock in the public market, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock. As of February 28, 2015, we had approximately 20.3 million shares of common stock outstanding, of which approximately 4.7 million shares are currently subject to lock-up agreements executed in connection with our February 2015 common stock and warrant offering. In addition, approximately 2.2 million shares of our common stock issuable upon the exercise of the warrants issued in the February 2015 offering will be freely tradable without restriction or further registration under the Securities Act. Because these outstanding warrants are exercisable into our common stock, volatility or a reduction in the market price of our common stock could have an adverse effect on the market price of these warrants. We have also registered all shares of common stock that we may issue under our equity compensation plans, which can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates.

We are an emerging growth company, and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and may remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the completion of the initial public offering of our common stock. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.0 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

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not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;

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not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;

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reduced disclosure obligations regarding executive compensation; and

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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.

We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be reduced or more volatile. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this exemption and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

We have incurred and will continue to incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.

As a public reporting company, we have incurred and will continue to incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act of 2002 and rules subsequently implemented by the SEC and NASDAQ have imposed various requirements on public companies, including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. In particular, pursuant to Section 404 of the Sarbanes-Oxley Act, our management is required to annually assess the effectiveness of our internal control over financial reporting. Once we cease to be an emerging growth company, our independent registered public accounting firm will be required to furnish an annual attestation report on our internal control over financial reporting. These requirements have increased and will continue to increase our legal and financial compliance costs and will make some activities more time consuming and costly.

If we are unable to maintain effective internal controls, we may not have adequate, accurate or timely financial information, and we may be unable to meet our reporting obligations as a public company or comply with the requirements of the SEC or Section 404. This could result in a restatement of our financial statements, the imposition of sanctions, including the inability of registered broker dealers to make a market in our common stock, or investigation by regulatory authorities. Any such action or other negative results caused by our inability to meet our reporting requirements or comply with legal and regulatory requirements or by disclosure of an accounting, reporting or control issue could adversely affect the trading price of our securities and our business. Material weaknesses in our internal control over financial reporting could also reduce our ability to obtain financing or could increase the cost of any financing we obtain. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

If securities or industry analysts issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.

The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business. If any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance, or if our target animal studies and operating results fail to meet the expectations of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

Provisions in our restated certificate of incorporation and amended and restated bylaws and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our restated certificate of incorporation and our amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control of our company that stockholders may consider

favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Among other things, these provisions include those establishing:

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a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;

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no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

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the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from filling vacancies on our board of directors;

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the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer;

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the ability of our board of directors to alter our bylaws without obtaining stockholder approval;

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the required approval of the holders of at least two-thirds of the shares entitled to vote at an election of directors to adopt, amend or repeal our bylaws or repeal the provisions of our restated certificate of incorporation regarding the election and removal of directors;

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a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

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the requirement that a special meeting of stockholders may be called only by the chairman of the board of directors, the chief executive officer, the president or the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and

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advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of us.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General Corporation Law of the State of Delaware, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner. Furthermore, our restated certificate of incorporation specifies that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for most legal actions involving actions brought against us by stockholders. This provision may have the effect of discouraging lawsuits against our directors and officers. The enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against us, a court could find the choice of forum provisions contained in our restated certificate of incorporation to be inapplicable or unenforceable in such action.

We do not anticipate paying any cash dividends on our capital stock and, consequently, a stockholder’s ability to achieve a return on investment will depend on appreciation in the price of our common stock.

We have never declared or paid cash dividends on our capital stock. We currently intend to retain all of our future earnings, if any, to finance the growth and development of our business. In addition, our Hercules credit

facility currently prohibits us from paying dividends on our equity securities, and any future debt agreements may likewise preclude us from paying dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

We could be subject to securities class action litigation.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because pharmaceutical companies have experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

Item 1B.

Unresolved Staff Comments

None.

Item 2.

Properties

Our headquarters are located in Cambridge, Massachusetts, where we occupy approximately 51,000 square feet of office and laboratory space. The term of the lease expires on April 30, 2017. We also lease office and laboratory space in Moscow, Russia.

Item 3.

Legal Proceedings

We are not currently party to any material legal proceedings.

Item 4.

Mine Safety Disclosures

Not applicable.

Executive Officers of the Registrant

Andrew Hirsch, age 44, has served as our President and Chief Executive Officer since March 10, 2015. Prior to that, Mr. Hirsch served as our Chief Operating Officer since February 15, 2014, and as our Chief Financial Officer since July 2012. From June 2011 to May 2012, he was Vice President of Finance and Chief Financial Officer at Avila Therapeutics, Inc., a biotechnology company, until its acquisition by Celgene Corporation. From 2002 to 2011, Mr. Hirsch served in roles of increasing responsibility at Biogen Idec, a biotechnology company, including the most recent role from 2010 to 2011 as Vice President, Corporate Strategy and M&A. While at Biogen Idec, Mr. Hirsch also served as Program Executive for the Tecfidera development team, leading the successful transition from phase 2 to phase 3 clinical trials, as well as the Avonex and Tysabri programs. Additionally, Mr. Hirsch held various positions in the finance organization at Biogen Idec including leading the company’s Business Planning and Investor Relations functions. He received his M.B.A. from the Tuck School at Dartmouth College and a B.A. in Economics from the University of Pennsylvania.

Hagop Youssoufian, M.Sc., M.D., age 58, has served as our Chief Medical Officer since November 2014. Prior to joining BIND, Dr. Youssoufian served as Executive Vice President of Research and Development at Progenics Pharmaceuticals, Inc., a biopharmaceutical company. Prior to that, from June 2011 to April 2013, he and was President and Chief Medical Officer at Ziopharm Oncology, a biopharmaceutical company. Dr. Youssoufian also served as Senior Vice President and Chief Medical Officer at ImClone Systems, a biopharmaceutical company, from April 2005 to June 2011. In addition, Dr. Youssoufian has held other senior roles in clinical and translational science at ImClone Systems, Sanofi Aventis and Bristol-Myers Squibb. Dr. Youssoufian has served on the faculties at Baylor College of Medicine and Harvard Medical School and received his M.Sc. and M.D. from the University of Massachusetts Medical School and a B.S. from Boston College.

Dan Koerwer, age 47, has served as our Chief Business Officer since March 10, 2015. Prior to that, he served as our Senior Vice President, Business Development and Commercial since June 2013. From August 2010 to June 2013, Mr. Koerwer served as our Head of Market and Business Development. From 2007 to July 2010, Mr. Koerwer was President and Managing Director of Eidetica Biopharma, GmbH, a subsidiary of Biogen Idec focused on developing a portfolio of protein therapeutics. From 1998 to 2007, he held various management roles at Biogen Idec. Mr. Koerwer led Research Operations across Biogen Idec’s North American research sites. Subsequently, he led global New Product Commercialization then assumed the role of Chief of Staff, Biogen Idec International in Zug, Switzerland. Mr. Koerwer has worked as a management consultant with Booz, Allen & Hamilton and began his career in sales at the Rohm and Haas Company. He received his M.B.A. from Harvard Business School and B.S. in Biochemistry from Boston College.

Christopher Lindblom, age 43, has served as our Senior Vice President, Finance and Administration, Treasurer and Secretary since March 10, 2015. Prior to that, he served as our Vice President, Finance since March 2014. From May 2013 to March 2014, Mr. Lindblom was the Vice President of Finance and Treasurer of OvaScience, Inc., a life sciences company. From October 2006 to May 2013, he served in various financial roles of increasing responsibility at Infinity Pharmaceuticals, Inc., a biotechnology company, including as Vice President, Accounting and Finance from July 2010. Mr. Lindblom previously served as Assistant Controller and in other finance roles at Millennium Pharmaceuticals, Inc. from April 2002 to October 2006, including during the VELCADE product launch. Mr. Lindblom began his career at PricewaterhouseCoopers. He is a certified public accountant. He received his M.B.A. from Boston College and B.S. in Accounting from Syracuse University.

PART II

Item 5.

Market for Registrant’s Common Shares, Related Stockholder Matters and Issuer Purchases of Equity Securities

Market Information

Our common stock has been listed on The NASDAQ Global Select Market under the symbol “BIND” since September 19, 2013. The following table sets forth on a per share basis, for the periods indicated, the low and high sale prices of our common stock as reported by The NASDAQ Global Select Market.


	Common Stock Price
	High		Low
Fiscal year ended December 31, 2014:
Fourth quarter	$	10.75	$	5.32
Third quarter	$	13.72	$	8.55
Second quarter	$	13.23	$	8.00
First quarter	$	15.21	$	10.68
Fiscal year ended December 31, 2013:
Fourth quarter	$	15.89	$	8.36
Third quarter (from September 20, 2013)	$	15.10	$	13.99

Holders

As of the close of business on March 10, 2015, there were approximately 48 holders of record of our common shares. Since many of the common shares are registered in “nominee” or “street” names, we believe that the total number of beneficial owners is considerably higher.

Dividend Policy

We have never declared or paid cash dividends on our common shares. We currently intend to retain any current and future earnings to finance the growth and development of our business and, therefore, does not anticipate paying any cash dividends in the foreseeable future. Our amended and restated credit facility contains restrictions on our ability to pay dividends.

Purchases of Equity Securities by the Issuer and Affiliated Purchaser

None.

Use of Proceeds from our Initial Public Offering

On September 19, 2013, the Securities and Exchange Commission (the “SEC”) declared effective our Registration Statement on Form S-1 (File No. 333-190566), as amended, filed in connection with the initial public offering of our common stock. Pursuant to the Registration Statement, we issued and sold an aggregate of 5,070,499 shares of our common stock at a price to the public of $15.00 per share. There has been no material change in the expected use of the net proceeds from our initial public offering as described in our final prospectus, dated September 19, 2013, filed with the SEC pursuant to Rule 424(b) relating to our Registration Statement on Form S-1.

Performance Graph

This performance graph shall not be deemed “soliciting material” or to be “filed” with the SEC for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities under that section, and shall not be deemed to be incorporated by reference into any filing of we under the Securities Act of 1933, as amended, or the Exchange Act.

The following graph compares the cumulative total return to stockholders for our common shares for the period from September 19, 2013 through December 31, 2014 with The NASDAQ Composite Index and the NASDAQ Biotechnology index (NBI). The comparison assumes an investment of $100 is made on September 19, 2013 in our common shares and in each of the indices and in the case of the indices it also assumes reinvestment of all dividends. The performance shown is not necessarily indicative of future performance.

LOGO

Item 6.

Selected Financial Data

The following tables set forth, for the periods and as of the dates indicated, our selected consolidated financial data. The consolidated statements of operations data for the years ended December 31, 2014, 2013, and 2012 and the consolidated balance sheet data as of December 31, 2014 and 2013 are derived from our audited consolidated financial statements included in this Annual Report on Form 10-K. The consolidated statements of operations data for the year ended December 31, 2011, and consolidated balance sheet data as of December 31, 2012 and 2011 are derived from our audited consolidated financial statements that are not included in this Annual Report on Form 10-K. You should read the following information together with the more detailed information contained in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the related notes included elsewhere in this Annual Report on Form 10-K. Our historical results are not indicative of the results to be expected in the future.


	Years Ended December 31,
	2014			2013			2012			2011
				(in thousands, except share and per share data)
Consolidated Statements of Operations:
Revenue	$	10,426		$	10,901		$	1,047		$	905

Operating expenses:
Research and development		28,874			24,370			13,052			11,440
General and administrative		15,060			13,394			6,625			4,787

Total operating expenses		43,934			37,764			19,677			16,227

Loss from operations		(33,508	)		(26,863	)		(18,630	)		(15,322	)
Other income (expense)
Interest expense, net		(312	)		(698	)		(641	)		(1,671	)
other income (expense), net		1,283			(102	)		31			138

Total other income (expense)		971			(800	)		(610	)		(1,533	)

Net loss		(32,537	)		(27,663	)		(19,240	)		(16,855	)
Accretion of redeemable convertible preferred stock		—			(3,704	)		(4,967	)		(2,967	)

Net loss attributable to common stock holders	$	(32,537	)	$	(31,367	)	$	(24,207	)	$	(19,822	)

Net loss per share attributable to common stockholders:
Basic and diluted	$	(1.97	)	$	(5.19	)	$	(11.70	)	$	(10.50	)
Weighted average common shares outstanding:
Basic and diluted		16,495,648			6,049,385			2,069,071			1,887,082

	2014			2013			2012			2011
Consolidated Balance Sheet Data:
Cash and cash equivalents		19,348			51,612			4,886			22,440
Short & long-term investments		21,582			25,771			—			3,249
Working capital		32,028			52,736			613			22,263
Total assets		54,068			88,408			12,670			30,048
Long-term debt (including current portion)		3,274			4,685			3,335			5,131
Preferred stock warrant liability		—			—			404			744
Redeemable convertible preferred stock		—			—			79,286			74,319
Additional paid in capital		177,269			174,468			—			—
Accumulated deficit		(137,279	)		(104,742	)		(75,205	)		(51,695	)
Total stockholders’ equity (deficit)		37,164			69,314			(75,923	)		(52,882	)

Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes and other financial information included elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” section of this Annual Report on Form 10-K for a discussion of important factors that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a clinical-stage nanomedicine platform company developing a pipeline of Accurins, our novel targeted therapeutics, by leveraging our Medicinal Nanoengineering platform. Our initial therapeutic priority is in oncology, and we have entered into a number of strategic collaborations with biopharmaceutical companies to develop Accurins that focus on creating important new targeted therapeutics in areas of high unmet need. Our lead drug candidate, BIND-014, is a prostate-specific membrane antigen (PSMA) -targeted Accurin that contains docetaxel, a clinically-validated and widely-used cancer chemotherapy drug. On January 7 2015, we announced the enrollment of the first patient expressing a KRAS mutation in the iNSITE 1 (BIND-014 Nanoparticle Study In Patients with Advanced KRAS Mutant or Squamous NSCLC to Determine Tolerability and Efficacy) trial, a two-tier phase 2 trial with BIND-014 in NSCLC patients with KRAS mutant or squamous histology. The trial was driven by positive results from the Phase 2 trial in NSCLC presented at the EORTC-NCI-AACR Annual Symposium in Barcelona on November 19, 2014.

We have ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd. and Merck & Co., or Merck (known as Merck Sharp & Dohme outside the United States and Canada), to develop Accurins based on their proprietary therapeutic payloads and targeting ligands.

We were incorporated in May 2006 and commenced active operations in early 2007. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, developing our technology, identifying potential drug candidates, undertaking preclinical studies and, beginning in 2011, conducting clinical trials. To date, we have financed our operations primarily through private placements of our preferred stock and convertible debt securities, funding received from collaboration and license agreements, government grants, our credit facility and public offerings of our common stock and warrants. We have no products approved for sale, and all of our revenue to date has been collaboration revenue or government grant revenue. As of December 31, 2014, our cash and cash equivalents and marketable securities totaled $40.9 million, of which $2.2 million was held by our Russian subsidiary designated solely for use in its operations.

Since inception, we have incurred significant operating losses. Our net loss was $32.5 million for the year ended December 31, 2014, compared to $27.7 million for the year ended December 31, 2013. As of December 31, 2014, we had an accumulated deficit of $137.3 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future.

Our financial results have been, and will continue to be, impacted by several significant trends, which are described below. While these trends are important to understanding and evaluating our financial results, this discussion should be read in conjunction with our consolidated financial statements and the notes thereto in Item 8, Part I of this annual report, and the other transactions, events, and trends discussed in “Risk Factors” in Item 1A, Part I of this annual report.

The consolidated financial statements and following information include the accounts of BIND Therapeutics, Inc. and our wholly owned subsidiaries, BIND (RUS), LLC, a Russian limited liability company, and BIND Biosciences Security Corporation, a Massachusetts securities corporation. All intercompany accounts and transactions have been eliminated.

In addition to our internal development programs, we actively seek opportunities to collaborate with recognized biopharmaceutical companies to develop Accurins incorporating therapeutic payloads from their proprietary product portfolios. Our collaboration agreements, with the exception of our agreement with Merck, require the collaborator to pay all the research and development costs associated with the Accurin, including those incurred by us. In addition, the upfront and potential milestone payments received under these agreements provide us with additional capital resources to develop our own proprietary pipeline of Accurins.

Merck

In November 2014, we entered into a joint research and development agreement with Merck to discover and develop novel nanomedicines for oncology. This collaboration will leverage our proprietary nanomedicine technology to create targeted Accurins based on novel, potent payloads from Merck’s preclinical oncology portfolio. The first two Merck compounds include a kinesin spindle protein (KSP) inhibitor and a polo-like kinase 1 (PLK1) inhibitor. Both KSP and PLK1 are regulators of cellular mitosis and are considered essential to the proliferation of cancer cells. These pathways have proven difficult to target effectively using conventional agents due to therapeutic index limitations. Under the terms of the agreement, we agreed to apply our Medicinal Nanoengineering platform to develop targeted Accurins based initially on Merck-supplied investigational KSP and PLK1 inhibitors. The agreement also includes the option to incorporate additional Merck compounds in the future. We agreed to fund and conduct research and development activities to advance Accurin product candidates based on these agents through first-in-human clinical studies, after which Merck and we will alternate in choosing whether or not to further develop and commercialize the Accurin products. If we opt in, in most scenarios there will be no payments made to Merck beyond a royalty on future product sales, if any. If Merck opts in, it agreed to pay us a fee based on a multiple of our research and development expenses, plus a royalty on future product sales, if any.

Roche

In June 2014, we entered into a research agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc., or Roche, to discover novel nanomedicines using Accurins for the treatment of diseases in therapeutic areas outside of oncology. The research agreement focuses on combining BIND’s Accurin technology with Roche’s proprietary therapeutic payloads and targeting ligands. Under the agreement, Roche paid us an immaterial, non-refundable upfront fee and, additionally, will compensate us for our research and development services up to a specified amount. The upfront fee will be creditable against an upfront fee negotiated in a future Roche agreement, if any.

AstraZeneca

In April 2013, we entered into a license agreement with AstraZeneca, pursuant to which we granted to AstraZeneca a worldwide license to research, develop, manufacture and commercialize Accurins incorporating barasertib (AZD1152), a potent selective inhibitor of the Aurora B kinase for any therapeutic use in humans or animals. AstraZeneca is required to pay for all of our development costs. We are responsible for manufacturing licensed product for use in preclinical and some clinical trials. Under the agreement, we received an upfront payment of $4.0 million and have the potential to receive contingent payments totaling up to $193.0 million in the aggregate upon achievement by AstraZeneca of specified clinical, regulatory and commercial events. We will also receive tiered royalties in the low-single digit to the low-double digit percentages of aggregate worldwide net sales of licensed product, if any.

We and AstraZeneca are working toward a mid-2015 IND application with the FDA for AZD2811. AZD2811 is an Accurin containing AZD1152-hQPA, the active metabolite of the prodrug barasertib (AZD1152), a potent and selective inhibitor of aurora B kinase.

Pfizer

In March 2013, we entered into a research, option and license agreement with Pfizer, pursuant to which we granted to Pfizer two options to obtain an exclusive worldwide license to use, develop, manufacture and commercialize Accurins incorporating specified Pfizer drug candidates, for the treatment, prevention and/or diagnosis of any disease or medical condition in humans, except that the licensed rights exclude some vaccine products and products for the treatment of brain cancer. Pfizer may exercise either one or both of its options to acquire the exclusive license for the specified drug candidate until September 2015, and subject to certain adjustments, by paying us a specified option exercise fee. Pfizer is required to pay for all of our development costs. We are responsible for manufacturing licensed products through early clinical trials. In December 2014, we achieved a development milestone. Under the agreement, we received an upfront payment of $4.0 million in 2013 and have the potential to receive contingent payments up to $89.5 million upon the achievement of specified development and regulatory events, including the milestone we have already achieved. We may also receive additional payments up to $110.0 million for specified commercial events as well as royalties in the low-single to high-single digit percentages on potential future sales of each Accurin commercialized, if any.

Amgen

In January 2013, we entered into a license agreement with Amgen, Inc. which was amended in December 2013. Pursuant to the agreement, we granted to Amgen an option to obtain an exclusive worldwide license to develop, manufacture and commercialize an Accurin incorporating a specified Amgen kinase inhibitor for all uses except for some vaccine applications. Under the agreement, we received an upfront payment of $5.0 million as well as potential development and regulatory milestone payments contingent upon Amgen exercising its option. In June 2014, Amgen notified us that it would not exercise its option; therefore, we had no further performance obligations to Amgen. As a result, we recognized the remaining portion of the upfront license fee of $0.8 million as revenue during the year ended December 31, 2014. In June 2014, we also notified Amgen that we would not exercise our option to develop an Accurin incorporating the Amgen therapeutic payload.

Financial Overview

Revenue

Our revenue consists of collaboration revenue, which may include amounts recognized related to upfront payments for licenses or options to obtain licenses in the future, research and development funding and milestone payments earned under collaboration and license agreements with our collaboration partners. In addition, we earn revenue under the terms of government contracts which require the performance of certain research and development activities. We expect that any revenue we generate will fluctuate from quarter to quarter as a result of the timing and amount of license fees, research and development reimbursements, payments for manufacturing services, and milestone and other payments from collaborations. We do not expect to generate revenue from product sales for at least the next several years. If we or our collaborators fail to complete the development of our drug candidates in a timely manner or obtain regulatory approval for them, our ability to generate future revenue, and our results of operations and financial position, would be materially adversely affected.

Research and Development

Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, clinical trial and related clinical manufacturing expenses, fees paid to clinical research organizations, or CROs, and investigative sites, payments to universities under our license agreements and other outside expenses. In the early phases of development, our research and development costs are often devoted to expanding our product platform and are not necessarily allocable to a specific target.

We expense research and development costs as incurred. Conducting a significant amount of research and development is central to our business model. Drug candidates in late stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of late stage clinical trials. We plan to increase our research and development expenses for the foreseeable future as we seek to complete development of BIND-014, and to further advance our preclinical and earlier stage research and development projects. The successful development of our clinical and preclinical drug candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of BIND-014 or any of our preclinical programs or the period, if any, in which material net cash inflows from these drug candidates may commence. Clinical development timelines, the probability of success and development costs can differ materially from expectations. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those which we currently anticipate will be required for the completion of clinical development of a drug candidate or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

General and Administrative

General and administrative expense primarily consists of compensation of personnel in executive, finance, accounting, legal, corporate communications, corporate development, human resources and early commercial functions. Other costs include facilities costs not otherwise included in research and development expense, and professional fees for legal and accounting services. General and administrative expense also consists of the costs of maintaining our intellectual property portfolio.

Interest Expense, net

Interest expense consists of interest expense on our amounts borrowed under our credit facility. Interest income consists of interest income earned on our cash and cash equivalents and short-term investments and income from loans to our founders and chief executive officer. The loans to our founders and chief executive officer were fully repaid in August 2013.

Other Income (Expense), net

The functional currency of our Russian subsidiary is the ruble. Accordingly, the amounts denominated in U.S. dollars are subject to transaction gains and losses, which are reported in the accompanying Consolidated Statements of Operations. Changes to the fair value of preferred stock warrants were included in other income (expense). The preferred stock warrants were automatically adjusted on the date of the closing of the IPO, September 25, 2013, to provide for the issuance of shares of common stock upon their exercise, and are no longer measured at fair value.

Critical Accounting Policies and Use of Estimates

The following discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make judgments, estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates, including those related to revenue recognition, accrued expenses, and assumptions in the valuation of stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates. Differences between actual and estimated results have not been material and are adjusted in the period they become known. We believe that the following accounting policies and estimates are most critical

to understanding and evaluating our reported financial results. Please refer to note 2 to our consolidated financial statements for a description of our significant accounting policies.

Revenue Recognition

Collaborative Research and Development and Multiple-Deliverable Arrangements

We enter into collaborative arrangements for the development and commercialization of drug candidates utilizing our technology. The terms of these agreements have typically included multiple deliverables by us (for example, license rights, research and development services and manufacturing of clinical materials) in exchange for consideration to us of some combination of non-refundable license fees, research and development funding, payments based upon achievement of clinical development or other milestones and royalties in the form of a designated percentage of product sales or profits.

Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collection is reasonably assured. Multiple-deliverable arrangements, such as license and development agreements, are analyzed to determine whether the deliverables can be separated or whether they must be accounted for as a single unit of accounting. When deliverables are separable, consideration received is allocated to the separate units of accounting based on the relative selling price method and the appropriate revenue recognition principles are applied to each unit. When we determine that an arrangement should be accounted for as a single unit of accounting, we must determine the period over which the performance obligations will be performed and revenue will be recognized.

The assessment of multiple-deliverable arrangements requires judgment in order to determine the appropriate unit of accounting, the estimated selling price of each unit of accounting and the point in time that, or period over which, revenue should be recognized.

Accrued Expenses

As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing contracts and purchase orders, reviewing the terms of our vendor agreements, communicating with our applicable personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. The majority of our service providers invoice us monthly in arrears for services performed. We make estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include:

•

fees payable to CROs and investigative sites in connection with clinical studies;

•

fees payable to vendors in connection with preclinical development activities; and

•

fees payable to vendors related to clinical manufacturing, development and distribution of clinical supplies.

We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical studies on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows and expense recognition. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual accordingly. Our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in our reporting changes in estimates in any particular period. We have not experienced any significant adjustments to our estimates to date.

Stock-Based Compensation

We expense the fair value of employee stock options and other equity compensation. We use our judgment in determining the fair value of our equity instruments, including in selecting the inputs we use for the Black-Scholes valuation model. Equity instrument valuation models are by their nature highly subjective. Any significant changes in any of our judgments, including those used to select the inputs for the Black-Scholes valuation model, could have a significant impact on the fair value of the equity instruments granted and the associated compensation charge we record in our financial statements.

Results of Operations

The following table summarizes our results of operations for the years ended December 31, 2014, 2013 and 2012, in thousands, together with the change in each item as a percentage.


	Years Ended December 31,
	2014			% change			2013			% change			2012
Revenue	$	10,426			(4	)%	$	10,901			941	%	$	1,047

Operating expenses:
Research and development		28,874			18	%		24,370			87	%		13,052
General and administrative		15,060			12	%		13,394			102	%		6,625

Total operating expenses		43,934			16	%		37,764			92	%		19,677

Loss from operations		(33,508	)		25	%		(26,863	)		44	%		(18,630	)
Other income (expense)
Interest expense, net		(312	)		(55	)%		(698	)		9	%		(641	)
Other income (expense), net		1,283			(1,358	)%		(102	)		(429	)%		31

Total other income (expense)		971			(221	)%		(800	)		31	%		(610	)

Net loss	$	(32,537	)		18	%	$	(27,663	)		44	%	$	(19,240	)

Revenue


	Years Ended December 31,
(in thousands)	2014		% change			2013		% change			2012
Revenue	$	10,426		(4	)%	$	10,901		941	%	$	1,047

The decrease in revenue for the year ended December 31, 2014 compared to the year ended December 31, 2013 was primarily due to a $3.1 million reduction in up-front license fee revenue recognized under the proportional performance method under our collaboration agreements with AstraZeneca, Amgen and Pfizer, compared to the prior year, and a $0.2 million reduction in research and development service revenue recognized under our government grants, compared to the prior year. These decreases were partially offset by a $2.8 million increase in reimbursable research and development services we performed under our collaboration agreements primarily with AstraZeneca, Pfizer and Roche, compared to the prior year.

The increase in revenue for the year ended December 31, 2013 compared to the year ended December 31, 2012 was primarily due to $6.7 million related to up-front license fee revenue recognized under the proportionate performance method under our 2013 collaboration agreements primarily from Amgen, AstraZeneca and Pfizer, as well as $3.3 million related to reimbursement research and development services we performed primarily for AstraZeneca and Pfizer.

Research and Development Expense


	Years Ended December 31,
(in thousands)	2014		% change			2013		% change			2012
Research and development	$	28,874		18	%	$	24,370		87	%	$	13,052

Research and development expenses represented approximately 66%, 65%, and 66% of our total operating expenses for the years ended December 31, 2014, 2013, and 2012, respectively.

The increase in research and development expense for the year ended December 31, 2014 compared to the year ended December 31, 2013 was primarily driven by headcount growth to support the development of BIND’s internal pipeline and collaborations which led to an increase in salaries and benefits of $2.7 million and associated laboratory supplies of $1.0 million for our research and development personnel.

The increase in research and development expense for the year ended December 31, 2013 compared to the year ended December 31, 2012 was primarily due to costs associated with the expansion of BIND-014 clinical development, work under our collaboration agreements and stock compensation expense as a result of our initial public offering.

External research and development spending focused on the advancement of BIND-014, with expenses increasing for the year ended December 31, 2013 as compared to the year ended December 31, 2012 principally due to an increase in the number of patients enrolled in our Phase 1 clinical trial as well as the related costs associated with initiating work and patient enrollment in two Phase 2 clinical trials for BIND-014. Our internal research and development expenses increased in 2013 as compared to 2012 primarily due to the increase in headcount in the United States as a result of work under our collaboration agreements and stock compensation expense associated with our initial public offering.

We began to track and accumulate both external and internal costs by major program starting on January 1, 2013. These expenses primarily relate to payroll and related expenses for personnel working on the programs, process development and manufacturing, preclinical toxicology studies, clinical trial costs and allocated costs of facilities. The following table illustrates our research and development expenses by major program during the periods indicated (in thousands, except percentages):


	Year Ended December 31,				January 1, 2013 to December 31, 2014
(in thousands)	2014		2013		January 1, 2013 to December 31, 2014
Research and development expenses:
BIND-014	$	14,771	$	13,479	$	28,250
Collaborations		6,459		4,738		11,197
Discovery and preclinical stage product programs, collectively		7,644		6,153		13,797

Total research and development expenses	$	28,874	$	24,370	$	53,244

We expect expenses related to our BIND-014 program to increase as we continue clinical development. We do not believe that the historical costs of any of our programs are indicative of the future costs associated with these programs or represent what any other future drug development program we initiate may cost. Due to the variability in the length of time and scope of activities necessary to develop a product candidate and uncertainties related to cost estimates and our ability to obtain marketing approval for our product candidates, accurate and meaningful estimates of the total costs required to bring our product candidates to market are not available.

Because of the risks inherent in drug discovery and development, we cannot reasonably estimate or know:

•

the nature, timing and estimated costs of the efforts necessary to complete the development of our programs;

•

the completion dates of these programs; or

•

the period in which material net cash inflows are expected to commence, if at all, from the programs described above and any potential future product candidates.

There is significant uncertainty regarding our ability to successfully develop any product candidates, including:

•

the scope, rate of progress and cost of our clinical trials that we are currently running or may commence in the future;

•

the scope and rate of progress of our preclinical studies and other research and development activities;

•

clinical trial results;

•

the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights relating to our programs under development;

•

the terms and timing of any strategic alliance, licensing and other arrangements that we have or may establish in the future relating to our programs under development;

•

the cost and timing of regulatory approvals;

•

the cost of establishing clinical supplies of any product candidates; and

•

the effect of competing technological and market developments.

General and Administrative Expense


	Years Ended December 31,
(in thousands)	2014		% change			2013		% change			2012
General and administrative	$	15,060		12	%	$	13,394		102	%	$	6,625

For the year ended December 31, 2014, our general and administrative expenses increased by $1.7 million, or 12%, compared to the same period in 2013. The increase was primarily driven by $1.6 million in higher salaries and benefits for our general and administrative personnel, $1.3 million in higher external consulting expenses (including early commercial) as well as higher insurance and other expenses principally related to operating as a public company since September 2013. The increase was partially offset by $2.8 million in lower stock-compensation expense as certain performance-based stock option awards granted to two executives vested upon the closing of our IPO.

For the year ended December 31, 2013, our general and administrative expenses increased by $6.8 million, or 102%, compared to the same period in 2012. The increase in these expenses was primarily due to stock-based compensation expense, the majority of which was due to vesting of stock options for two executives upon the closing of our IPO. The balance was due to consulting services in preparation for our IPO and expenses related to operating as a public company.

Interest Expense, net


	Years Ended December 31,
(in thousands)	2014			% change			2013			% change			2012
Interest expense, net	$	(312	)		(55	)%	$	(698	)		9	%	$	(641	)

For the year ended December 31, 2014, our interest expense, net decreased primarily due to $0.3 million in additional interest expense related to the June 2013 amended and restated credit facility recorded during the year ended December 31, 2013.

Other Income (Expense), net


	Years Ended December 31,
(in thousands)	2014		% change			2013			% change			2012
Other income (expense), net	$	1,283		(1,358	)%	$	(102	)		(429	)%	$	31

Our Russian subsidiary’s functional currency is the ruble, and the majority of its cash is held in U.S. dollars. Therefore, the U.S. dollar denominated cash held in Russia is subject to transaction gains and losses. We recorded $1.3 million of gains, $0.2 million of gains and $0.3 million of losses for the years ended December 31, 2014, 2013, and 2012, respectively.

Liquidity and Capital Resources

Since our inception and through December 31, 2014, our capital resources have included gross proceeds from the sale of common stock in our IPO, proceeds from the sale of preferred stock and convertible debt securities, collaborations and license agreements, government grants, and borrowings under our credit facility.

In addition to our existing cash, cash equivalents, and short-term investments, we receive research and development funding and are eligible to earn a significant amount of milestone payments under our collaboration agreements. Our ability to earn these milestone payments and the timing of achieving these milestones is dependent upon the outcome of our research and development and regulatory activities and is uncertain at this time. Our rights to receive research and development funding and the payment of certain milestones under our collaboration agreements are our only committed external source of funds.

Our significant capital resources are as follows (amounts in thousands):


	Years Ended December 31,
	2014		2013		2012
Consolidated Balance Sheet Data:
Cash, cash equivalents, and short & long-term investments	$	40,930	$	77,383	$	4,886
Working capital		32,028		52,736		613
Total assets		54,068		88,408		12,670

Cash Flows

The following is a summary of cash flows for the years ended December 31, 2014, 2013 and 2012 (in thousands):


	Years Ended December 31,
	2014			2013			2012
	(In thousands, except percentages)
Net cash provided by (used in) operating activities	$	(29,886	)	$	(13,037	)	$	(17,238	)
Net cash provided by (used in) investing activities		409			(27,823	)		1,311
Capital expenditures (included in investing activities above)		(3,358	)		(2,588	)		(793	)
Net cash provided by (used in) financing activities		(1,293	)		87,833			(1,967	)

Operating Cash Flows

Net cash used in operating activities was $29.9 million during the year ended December 31, 2014, compared to $13.0 million in 2013. The increase in cash used in operating activities in the year ended December 31, 2014 was primarily driven by a decrease in upfront payments received from collaboration agreements compared to the same period in 2013. We did not enter into any collaboration agreements with material upfront payments in the year ended December 31, 2014. In addition, we funded a larger net loss during the year ended December 31, 2014 compared to the same period in 2013.

Net cash used in operating activities was $13.0 million during the year ended December 31, 2013 compared to $17.2 million in 2012. The decrease in cash used in operating activities in 2013 compared to 2012 was primarily driven by an increase in cash received under the collaboration agreements with Amgen, Pfizer and AstraZeneca, partially offset by increased operating expenses.

Investing Cash Flows

Net cash provided by investing activities was $0.4 million for the year ended December 31, 2014, compared to net cash used in investing activities of $27.8 million in 2013. The increase in cash provided by investing activities during the year ended December 31, 2014 compared to 2013 was primarily due to an increase of $30.5 million in maturities of investments and $11.8 million in proceeds from sales of investments partially offset by an increase of $12.5 million purchase of investments and an increase of $0.8 million of purchases of property and equipment principally related to laboratory equipment.

Net cash used in investing activities was $27.8 million for the year ended December 31, 2013, compared to net cash provided by investing activities of $1.3 million in 2012. The increase in cash used in investing activities during 2013 compared to 2012 was primarily due to investment of proceeds from our initial public offering partially offset by property and equipment purchases related to equipment for the manufacture of our clinical product in Russia and laboratory equipment.

Financing Cash Flows

Net cash used in financing activities of $1.3 million during the year ended December 31, 2014 was primarily due to $1.2 million in debt repayments under our credit facility.

Net cash provided by financing activities of $87.8 million during the year ended December 31, 2013 is primarily due to the proceeds, net of expenses, from our initial public offering of $67.7 million, cash received related to the sale of Series D preferred stock to investors for net proceeds of $17.3 million, cash received related to the sale of Series BRN preferred stock to investors for net proceeds of $1.5 million as well as the net increase in debt of $1.2 million associated with the amended and restated credit facility.

Net cash used in financing activities was $2.0 million during the year ended December 31, 2012 and is primarily related to the $1.7 million repayment of amounts outstanding under credit agreements entered into in the previous year.

We have not generated any revenue from the sale of drugs to date, and we do not expect to generate any such revenue for the next several years, if at all. We have instead relied on the proceeds from sales of equity securities, interest on investments, up-front license fees, expense reimbursement, milestones and cost sharing under our collaborations and debt to fund our operations. Because our product candidates are in various stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability.

At-the-Market Facility

In October 2014, we entered into an at-the-market sales agreement (“Sales Agreement”) with Cowen & Company, LLC (“Cowen”) pursuant to which we may from time to time, at our option, offer and sell shares of our common stock having an aggregate offering price of up to $40 million through Cowen, acting as our sales agent. Upon delivery of a placement notice by us and subject to the terms and conditions of the Sales Agreement, Cowen will use its commercially reasonable efforts to sell shares of our common stock, based upon our instructions. We have provided Cowen with customary indemnification rights, and Cowen will be entitled to a commission of up to 3.0% of the gross proceeds from sales of shares of our common stock under the Sales Agreement. Sales of shares of our common stock, if any, under the Sales Agreement may be made by any method permitted by law that is deemed an “at the market” offering as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made through the Nasdaq Global Select Market, on any other existing trading market for our common stock or to or through a market maker. We may also authorize Cowen to sell shares in negotiated transactions. We have no obligation to sell shares of our common stock and cannot provide any assurances that we will issue any shares pursuant to the Sales Agreement. We may also suspend the offering of shares of our common stock upon notice and subject to other conditions under the Sales Agreement or may at any time upon notice terminate the Sales Agreement. As of December 31, 2014, we have not sold any shares of common stock under the Sales Agreement.

Equity Raise

On February 10, 2015, we completed an underwritten public offering of 3,739,130 units at the public offering price of $5.75 per unit. Each unit consisted of one share of our common stock and six-tenths (0.6) of a warrant to purchase one share of our common stock with an exercise price of $6.60 per share. We received net proceeds of approximately $20 million after deducting underwriting discounts and commissions and estimated offering expenses payable by us and not including any future proceeds from the exercise of the warrants.

Indebtedness

In June 2013, we entered into an amended and restated credit facility with Hercules Technology III, L.P. (“Hercules”) as lender, pursuant to which we borrowed an aggregate principal amount of $4.5 million in term loans. The credit facility is secured by substantially all of our personal property other than our intellectual property. The loan under the credit facility bears interest at a floating per annum rate equal to 10.25% plus the prime rate less 3.25% (with a minimum rate of 10.25%). At December 31, 2014, our interest rate was the minimum rate of 10.25%. We were required to make interest payments on any loans funded under the credit facility through February 28, 2014, or the interest-only period. All outstanding loans under the credit facility began amortizing at the end of the interest-only period, with monthly payments of principal and interest being made by us to Hercules in 30 consecutive monthly installments. All loans mature on the first day of the 30th month following the end of the interest-only period. The credit facility includes affirmative and negative covenants applicable to us and our subsidiaries. The affirmative covenants include, among others, covenants requiring us (and us to cause our subsidiaries) to maintain our legal existence and governmental approvals, deliver certain financial reports and maintain insurance coverage. The negative covenants include, among others, restrictions on us and our subsidiaries transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets, and suffering a change in control, in each case subject to certain exceptions. Additionally, the credit facility restricts us from investing in our wholly-owned domestic subsidiary, BIND Biosciences Security Corporation, unless we hold cash and other liquid investments equal to $25.0 million, less any payments of principal that we have made to Hercules under the credit facility.

due under the credit facility, a breach of covenants under the credit facility, our insolvency and the insolvency of our subsidiaries, the occurrence of a material adverse effect, the occurrence of any default under certain other indebtedness, and a final judgment against us in an amount greater than $500,000.

In January 2015, we entered into an amendment to the amended and restated credit facility (“New Term Loan”) with Hercules as lender. The amendment provides us with a term loan in an amount equal to $15.0 million, a portion of which was used to repay our existing term loan with Hercules in the aggregate amount of $3.1 million, and the remainder of which will be used for general corporate purposes.

The principal balance of the New Term Loan bears interest at a floating per annum rate equal to 8.35% plus the prime rate less 3.25% (with a minimum rate of 8.35%). The New Term Loan matures on July 2, 2018 (the “Maturity Date”) and we are required to make interest-only payments on the New Term Loan beginning on February 2, 2015 and continuing through December 31, 2015. Beginning on January 1, 2016, we will repay the New Term Loan in equal monthly installments of principal and interest, with the entire remaining principal balance and all accrued and unpaid interest due on the Maturity Date.

Plan of Operations and Future Funding Requirements

Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research and development services, laboratory and related supplies, clinical costs, legal and other regulatory expenses and general overhead costs.

We expect that our cash, cash equivalents, and short-term investments as of December 31, 2014, combined with the net proceeds of approximately $12 million from the January 2015 amended term loan with Hercules and the net proceeds of approximately $20 million from the February 2015 common stock and warrant offering, will fund our operating expenses and capital expenditure requirements into mid-2016. This expectation is based on our current operating plans and research and development funding that we expect to receive under our existing collaborations, but excludes any potential milestone payments. We have based these estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Additionally, the process of testing drug candidates in clinical trials is costly, and the timing of progress in these trials is uncertain. Because our drug candidates are in various stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our drug candidates or whether, or when, we may achieve profitability. Our future capital requirements will depend on many factors, including:

•

our collaboration agreements remaining in effect and our ability to achieve milestones under these agreements;

•

the progress and results of our clinical trials of BIND-014;

•

the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other drug candidates;

•

the number and development requirements of other drug candidates that we pursue;

•

the costs, timing and outcome of regulatory review of our drug candidates;

•

the revenue, if any, received from commercial sales of our drug candidates for which we receive marketing approval;

•

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and

•

the extent to which we acquire or in-license other products and technologies.

We have not generated any revenue from the sale of drugs to date, and we do not expect to generate any such revenue for the next several years, if at all. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings and revenue from license and collaboration arrangements. Except for any obligations of our collaborators to reimburse us for research and development expenses or to make milestone payments under our agreements with them, we do not have any committed external source of liquidity. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or drug candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

Contractual Obligations and Contingent Liabilities

The following summarizes our significant contractual obligations as of December 31, 2014, (in thousands):


Contractual Obligations	Total		Less than 1 Year		1 to 3 Years		3 to 5 Years		More than 5 Years
Operating leases	$	6,002	$	2,496	$	3,468	$	38	$	—
Research and development contract obligations		1,495		65		280		370		780
Debt		3,274		1,792		1,482		—		—

Total obligations	$	10,771	$	4,353	$	5,230	$	408	$	780

Operating Leases. Represents future minimum lease payments under non-cancelable operating leases in effect as of December 31, 2014, including the remaining lease payments for our current facilities in Cambridge, Massachusetts. The minimum lease payments above do not include common area maintenance charges or real estate taxes.

Research and development contract obligations. Represents minimum annual license fees payable to universities under our license agreements.

Debt. Represents obligations by us to make payments under long-term equipment lease and loan agreements. These amounts include interest.

The contractual obligations table does not include any potential contingent payments upon the achievement by us specified patent prosecution, clinical, regulatory and commercial events, as applicable, or royalty payments we may be required to make under license agreements we have entered into with various universities pursuant to which we have in-licensed certain intellectual property, including our license agreement with the MIT. See “Business—Intellectual Property—In-Licensed Intellectual Property” for additional information. The table also excludes potential payments we may be required to make under manufacturing and CRO agreements as the timing of when these payments will actually be made is uncertain and the payments are contingent upon the initiation and completion of future activities.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under Securities and Exchange Commission rules.

Item 7A. Quantitative and Qualitative Disclosures about Market Risk

The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates. As of December 31, 2014, we had cash equivalents of $19.3 million, consisting of interest-bearing money market accounts and certificates of deposit. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Due to the short-term maturities of our cash equivalents and the low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents or investments. As of December 31, 2014, we were also subject to interest rate risk from the loans under the credit facility that bear interest at an annual rate equal to (a) 10.25% plus (b) the prime rate (as reported in the Wall Street Journal) minus (c) 3.25% subject to a floor of 10.25%. A 100 basis point increase in interest rates at December 31, 2014, would not have a material effect on our annual pre-tax interest expense.

In addition, we are subject to currency risk for balances held in rubles in our foreign subsidiary. We work to maintain all balances in U.S. dollars until payment in rubles is required to minimize this currency risk. Fluctuations in the exchange rate over the past 18 months have been approximately 100%. As of December 31, 2014, we maintained $2.2 million in cash, $2.1 million of which was denominated in U.S. dollars, and $1.0 million in restricted cash in Russian banks. We do not hedge against foreign currency risks.

Item 8.

Financial Statements and Supplementary Data

BIND THERAPEUTICS, INC.

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS


Report of Independent Registered Public Accounting Firm			92
Consolidated Balance Sheet as of December 31, 2014 and 2013			93
Consolidated Statements of Operations for the years ended December 31, 2014, 2013 and 2012			94
Consolidated Statements of Comprehensive Loss for the years ended December 31, 2014, 2013 and 2012			95
Consolidated Statements of Cash Flows for the years ended December 31, 2014, 2013 and 2012			96
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the years ended December 31, 2014, 2013 and 2012			97
Notes to Consolidated Financial Statements			98

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of

BIND Therapeutics, Inc.

Cambridge, Massachusetts

We have audited the accompanying consolidated balance sheets of BIND Therapeutics, Inc. and subsidiaries (the “Company”) as of December 31, 2014 and 2013, and the related consolidated statements of operations, comprehensive loss, redeemable convertible preferred stock and stockholders’ equity (deficit), and cash flows for each of the three years in the period ended December 31, 2014. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of BIND Therapeutics, Inc. and subsidiaries as of December 31, 2014 and 2013, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2014, in conformity with accounting principles generally accepted in the United States of America.

/s/ Deloitte & Touche LLP

Boston, Massachusetts

March 11, 2015

BIND THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS (In thousands, except share data and par value)


	December 31,
	2014			2013
ASSETS
Current assets:
Cash and cash equivalents	$	19,348		$	51,612
Short-term investments		21,582			10,384
Amounts due under collaboration agreements		2,892			1,269
Prepaid expenses and other current assets		2,141			1,532

Total current assets		45,963			64,797
Property and equipment, net		6,567			6,079
Long-term investments		—			15,387
Restricted cash		1,526			2,084
Other assets		12			61

Total	$	54,068		$	88,408

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current portion of long-term debt	$	1,792		$	1,411
Accounts payable		1,796			2,643
Accrued expenses		5,260			2,921
Current portion of deferred revenue		5,087			5,086

Total current liabilities		13,935			12,061

Long-term liabilities:
Long-term debt, less current		1,482			3,274
Deferred revenue, less current		481			2,384
Other long-term liabilities		1,006			1,375

Total long-term liabilities		2,969			7,033

Total liabilities		16,904			19,094

Commitments (Note 14)
Stockholders’ equity:
Preferred stock, $0.0001 par value—10,000,000 shares authorized, no shares issued and outstanding at December 31, 2014 and December 31, 2013		—			—
Common stock, $0.0001 par value—200,000,000 shares authorized, 16,548,681 shares issued and outstanding at December 31, 2014, 16,438,706 shares issued and 16,410,840 shares outstanding at December 31, 2013		2			2
Additional paid in capital		177,269			174,468
Accumulated deficit		(137,279	)		(104,742	)
Accumulated other comprehensive loss		(2,828	)		(414	)

Total stockholders’ equity		37,164			69,314

Total	$	54,068		$	88,408

See notes to consolidated financial statements.

BIND THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data)


	Years Ended December 31,
	2014			2013			2012
Revenue	$	10,426		$	10,901		$	1,047

Operating expenses:
Research and development		28,874			24,370			13,052
General and administrative		15,060			13,394			6,625

Total operating expenses		43,934			37,764			19,677

Loss from operations		(33,508	)		(26,863	)		(18,630	)
Other income (expense)
Interest expense, net		(312	)		(698	)		(641	)
Other income (expense), net		1,283			(102	)		31

Total other income (expense)		971			(800	)		(610	)

Net loss		(32,537	)		(27,663	)		(19,240	)
Accretion of redeemable convertible preferred stock		—			(3,704	)		(4,967	)

Net loss attributable to common stockholders	$	(32,537	)	$	(31,367	)	$	(24,207	)

Net loss per share attributable to common stockholders:
Basic and diluted	$	(1.97	)	$	(5.19	)	$	(11.70	)
Weighted average common shares outstanding:
Basic and diluted		16,495,648			6,049,385			2,069,071

See notes to consolidated financial statements.

BIND THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (in thousands)


	Years Ended December 31,
	2014			2013			2012
Net loss	$	(32,537	)	$	(27,663	)	$	(19,240	)
Other comprehensive loss:
Foreign currency translation adjustments		(2,411	)		(399	)		388
Unrealized losses on investments		(3	)		—			—

Comprehensive loss	$	(34,951	)	$	(28,062	)	$	(18,852	)

See notes to the consolidated financial statements

BIND THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands)


	Years Ended December 31,
	2014			2013			2012
Cash flows from operating activities:
Net loss	$	(32,537	)	$	(27,663	)	$	(19,240	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		1,732			1,413			1,167
Stock-based compensation		2,566			6,016			693
Change in fair value of warrant liability		—			273			(340	)
Other non-cash operating activities, net		45			56			(28	)
Increase (decrease) in cash and cash equivalents from:
Amounts due under collaboration agreements		(1,624	)		(1,213	)		234
Prepaid expenses and other current assets		(707	)		(164	)		(857	)
Accounts payable and accrued expenses		2,114			1,368			613
Deferred revenue		(1,475	)		6,877			520

Net cash used in operating activities		(29,886	)		(13,037	)		(17,238	)

Cash flows from investing activities:
Purchases of property and equipment		(3,358	)		(2,588	)		(793	)
Proceeds from repayment of stockholder loans		—			712			94
Increase in restricted cash and other assets		(99	)		(118	)		(1,257	)
Proceeds from sales of investments		11,759			—			—
Proceeds from maturities of investments		31,271			800			4,499
Purchases of investments		(39,164	)		(26,629	)		(1,250	)
Other investing activities		—			—			18

Net cash provided by (used in) investing activities		409			(27,823	)		1,311

Cash flows from financing activities:
Proceeds from issuance of Series D redeemable convertible preferred stock—net		—			17,284			—
Proceeds from issuance of Series BRN redeemable convertible preferred stock—net		—			1,500			—
Proceeds from exercise of stock options		235			236			4
Proceeds from initial public offering, net of commissions and offering costs		(265	)		67,693			—
Payments under capital lease		(38	)		(53	)		(297	)
Borrowings under credit facility		—			4,500			—
Repayments of credit facility		(1,225	)		(3,327	)		(1,674	)

Net cash (used in) provided by financing activities		(1,293	)		87,833			(1,967	)

Effect of exchange rate on cash		(1,494	)		(247	)		340

(Decrease) increase in cash and cash equivalents		(32,264	)		46,726			(17,554	)
Cash and cash equivalents—Beginning of year		51,612			4,886			22,440

Cash and cash equivalents—End of year	$	19,348		$	51,612		$	4,886

Noncash investing activities:
Property and equipment purchases included in accounts payable	$	310		$	870		$	7

Noncash financing activities:
Fair value of warrants allocated to deferred finance fees	$	—		$	168		$	—

Accretion of redeemable convertible preferred stock	$	—		$	3,704		$	4,967

Conversion of redeemable convertible preferred stock into common stock	$	—		$	101,774		$	—

Initial public offering costs incurred but unpaid at period end	$	—		$	265		$	—

Supplementary cash flow information—Interest paid	$	598		$	369		$	485

See notes to consolidated financial statements.

BIND THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (in thousands, except share data and par value)


	Redeemable Convertible Preferred Stock, $0.0001 Par Value						Common Stock, $0.0001 Par Value				Loans Due from Stockholders			Additional Paid-In Capital			Total Accumulated Deficit			Accumulated Other Comprehensive Loss			Total
	Shares			Amount			Shares		Amount		Loans Due from Stockholders			Additional Paid-In Capital			Total Accumulated Deficit			Accumulated Other Comprehensive Loss			Total
BALANCE—January 1, 2012		19,994,583		$	74,319			1,988,575	$	1	$	(785	)	$	—		$	(51,695	)	$	(403	)	$	(52,882	)
Vesting of common stock								159,641																—
Stock-based compensation															693									693
Accrued interest on stockholder note												(19	)											(19	)
Payments of stockholder notes												100												100
Exercise of stock options								3,523							4									4
Accretion of issuance costs to redemption value					472										(472	)								(472	)
Accrued dividends on redeemable convertible preferred stock					4,495										(225	)		(4,270	)					(4,495	)
Other comprehensive income																					388			388
Net loss																		(19,240	)					(19,240	)

BALANCE—December 31, 2012		19,994,583			79,286			2,151,739		1		(704	)		—			(75,205	)		(15	)		(75,923	)
Vesting of common stock								159,651																—
Issuance of Series D redeemable convertible preferred stock in 2013—net of issuance costs of $113		2,899,228			17,284
Issuance of Series BRN redeemable convertible preferred stock in 2013		250,000			1,500
Accrued interest on stockholder note												(8	)											(8	)
Payments of stockholder notes												712												712
Accretion of issuance costs to redemption value					308										(308	)								(308	)
Accrued dividends on redeemable convertible preferred stock					3,396										(1,522	)		(1,874	)					(3,396	)
Preferred shares converted to common Stock		(23,143,811	)		(101,774	)		8,833,504		1					101,773									101,774
Reclassification of warrants to purchase shares of redeemable convertible preferred stock into a warrant to purchase common stock															845									845
Issuance of Common Stock from initial public offering, net of underwriting fees and issuance costs of $8,629								5,070,499							67,428									67,428
Exercise of stock options								195,447							236									236
Stock-based compensation															6,016									6,016
Other comprehensive loss																					(399	)		(399	)
Net loss																		(27,663	)					(27,663	)

BALANCE—December 31, 2013		—			—			16,410,840		2		—			174,468			(104,742	)		(414	)		69,314
Vesting of common stock								27,847																—
Exercise of stock options								109,994							235									235
Stock-based compensation															2,566									2,566
Other comprehensive loss																					(2,414	)		(2,414	)
Net loss																		(32,537	)					(32,537	)

BALANCE—December 31, 2014		—		$	—			16,548,681	$	2	$	—		$	177,269		$	(137,279	)	$	(2,828	)	$	37,164

See notes to consolidated financial statements.

BIND THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. NATURE OF BUSINESS

BIND Therapeutics, Inc. is a clinical-stage nanomedicine platform company developing Accurins™, which are targeted and programmable therapeutics. As used throughout these consolidated financial statements, the terms “BIND,” “we,” “us,” and “our” refer to the business of BIND Therapeutics, Inc. including our wholly-owned subsidiaries, BIND (RUS) LLC and BIND Biosciences Security Corporation. Our strategy is to leverage our Medicinal Nanoengineering^® platform to develop our own pipeline of Accurins, initially in oncology, as well as to develop Accurins in collaboration with biopharmaceutical companies.

Our success is dependent upon our ability to successfully complete clinical development and obtain regulatory approval of our drug candidates; successfully commercialize any approved products; generate revenue; meet our obligations; maintain adequate financing; and, ultimately, attain profitable operations.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Initial Public Offering—On September 25, 2013, we completed an initial public offering (“IPO”) of our common stock, which resulted in the sale of 4,700,000 shares, at a price of $15.00 per share. On October 23, 2013, we closed a portion of the underwriters’ over-allotment option, and we sold an additional 370,499 shares at a price to the public of $15.00 per share. We received net proceeds before expenses from the IPO of $67.4 million after deducting underwriting discounts and commissions paid. In connection with the closing of the IPO, all of our outstanding redeemable convertible preferred stock automatically converted to common stock at a 1:2.62 ratio on September 25, 2013, resulting in an additional 8,515,439 shares of our common stock becoming outstanding.

Principles of Consolidation—The consolidated financial statements include our accounts and our wholly-owned subsidiaries, BIND (RUS), LLC, a Russian limited liability corporation, and BIND Biosciences Security Corporation, a Massachusetts securities corporation. All intercompany accounts and transactions have been eliminated.

Use of Estimates—The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities (including clinical trial accruals), and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. We base estimates and assumptions on historical experience when available and on various factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Foreign Currency Translation—The functional currency of our Russian subsidiary is the Russian ruble (RUB). All assets and liabilities of our Russian subsidiary are translated at year-end exchange rates and revenues and expenses are translated at average exchange rates for the year. Translation adjustments are reflected in the accumulated other comprehensive (loss) income component of stockholders’ equity. At December 31, 2014, we maintained $2.2 million of cash, $2.1 million of which was denominated in U.S. dollars, and $1.0 million of restricted cash in Russian banks. At December 31, 2013, we maintained $4.4 million of cash, $2.2 million of which was denominated in U.S. dollars, and $1.5 million of restricted cash in Russian banks. Accordingly, the amounts denominated in U.S. dollars are subject to transaction gains and losses, which are reported in the accompanying consolidated statements of operations.

Cash and Cash Equivalents—Cash equivalents are stated at fair value and include short-term, highly liquid investments with remaining maturities of 90 days or less at the date of purchase. Cash equivalents consist of money market funds recorded at fair value and certificates of deposit and US government agency notes recorded at amortized cost.

Short-term and Long-term Investments— Short-term and long-term investments represent holdings of available-for-sale marketable securities in accordance with our investment policy and cash management strategy. Short-term investments mature within 12 months from the balance sheet date, and long-term investments represent investments with maturity dates greater than one year from the balance sheet date. At the time that the maturity dates of these investments become one year or less, the securities are reclassified as short-term investments. Our investments in marketable securities are recorded at fair value, with any unrealized gains and losses, net of taxes, reported as a component of stockholders’ equity until realized or until a determination is made that an other-than-temporary decline in market value has occurred. The cost of marketable securities sold is determined based on the specific identification method and any realized gains or losses on the sale of investments are reflected as a component of interest expense, net.

Restricted Cash—Restricted cash represents cash deposits held in connection with obligations under facility leases (see Note 14) or as performance collateral under our grant from the Ministry for Industry and Trade of the Russian Federation (see Note 4). Amounts are reported as non-current unless restrictions are expected to be released in the next twelve months.

Concentration of Credit Risk—Financial instruments that subject us to significant concentrations of credit risk consist primarily of cash. Substantially all of our cash is held at financial institutions that management believes to be of high-credit quality. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits; however, these deposits may be redeemed upon demand and, therefore, bear minimal risk.

As of December 31, 2014, two customers accounted for 55% and 41% of our amounts due under collaboration agreements. As of December 31, 2013, three customers accounted for 45%, 28%, and 18% of our amounts due under collaboration agreements.

During the year ended December 31, 2014, we had two customers representing 68% and 13% of total revenue. During the year ended December 31, 2013, we had three customers representing 38%, 25% and 23% of total revenue. During the year ended December 31, 2012, we had four customers representing 38%, 31%, 16% and 15% of total revenue.

Property and Equipment—Property and equipment are recorded at cost. Costs associated with maintenance and repairs are expensed as incurred. Depreciation and amortization are provided using the straight-line method over the estimated useful lives:


Asset Category		Useful Lives
Equipment		3–7 years
Furniture and fixtures		3–7 years
Leasehold improvements		3–10 years or the remaining term of respective lease, if shorter

Impairment of Long-Lived Assets—Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, we compare the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying value, an impairment loss is recorded for the difference between the carrying value and fair value of the asset. To date, no such impairment has occurred.

Segment and Geographic Information—Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) about which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. Our chief operating decision maker is the Chief Executive Officer. Our chief operating decision maker reviews consolidated operating results to make decisions about allocating resources and assessing performance for the entire company. We view our operations and manage our business as one operating segment; however, we operate in two geographic regions: United States (Cambridge, MA) and Russia (Moscow). Information about our operations in different geographic regions is presented in the tables below (in thousands):


	Years Ended December 31,
	2014		2013		2012
Revenues:
United States	$	9,703	$	9,955	$	724
Russia		723		946		323

Total Revenues	$	10,426	$	10,901	$	1,047



	As of December 31,
	2014		2013		2012
Long-Lived Assets:
United States	$	5,759	$	4,730	$	3,973
Russia		808		1,349		103

Total Long-Lived Assets	$	6,567	$	6,079	$	4,076

Revenue Recognition

Collaborative Research and Development and Multiple-Deliverable Arrangements

We have entered into collaborative arrangements with strategic partners for the development and commercialization of product candidates utilizing our technologies. The terms of these agreements have typically included multiple deliverables by us (for example, license rights, research and development services and manufacturing of clinical materials) in exchange for consideration to us of some combination of non-refundable license fees, research and development funding, payments based upon achievement of clinical development or other milestones and royalties in the form of a designated percentage of product sales or profits.

Royalty Revenues and Sales-Based Milestones

Under certain of our agreements, we may be entitled to royalty revenues and/or milestone payments based on net sales. We will recognize royalty revenues and sales-based milestone payments in the period that sales are reported to us, assuming all other revenue recognition criteria are met.

Grant Revenue

Revenues from government grants are recognized in the period we perform the service.

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Deferred Revenue

Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized within one year following the balance sheet date are classified as non-current deferred revenue.

Research and Development Costs—Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, clinical trial and related clinical manufacturing expenses, fees paid to clinical research organizations and investigator sites, payments to universities under our license agreements and other outside expenses. Research and development costs are expensed as incurred. Research and development costs that are paid in advance of performance are capitalized as a prepaid expense until incurred.

Stock-Based Compensation—We account for all share-based payment awards granted to employees and nonemployees using a fair value method. Our share-based payments include stock options and grants of common stock, including common stock subject to vesting. The measurement date for employee awards is the date of grant, and share-based compensation costs are recognized as expense over the employees’ requisite service period, which is the vesting period, on a straight-line basis. We issued performance based grants where the vesting of the grant is tied to certain milestone performance and in these cases, the compensation is recognized as expense when achievement of the milestone is probable. The measurement date for nonemployee awards is the date the services are completed, resulting in periodic adjustments to stock-based compensation during the vesting period for changes in the fair value of the awards. Stock-based compensation costs for nonemployees are recognized as expense over the vesting period on a straight-line basis.

Net Loss Per Share Attributable to Common Stockholders—Basic net loss attributable to common stockholders per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss attributable to common stockholders per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period, determined using the treasury-stock method and the as-if-converted method, for convertible securities, if inclusion of these is dilutive.

Income Taxes—Deferred tax assets and liabilities are recognized for the expected future tax consequences of events that have been included in our consolidated financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the consolidated financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized.

We assessed our income tax positions and recorded tax benefits based upon management’s evaluation of the facts, circumstances, and information available at the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, we record the largest amount of tax benefit with a greater than 50% likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, no tax benefit is recognized in the financial statements. We classify interest and penalties associated with material uncertain tax positions as a component of income tax expense. As of December 31, 2014, we have not identified any material uncertain tax positions.

Guarantees and Indemnifications—As permitted under Delaware law, we indemnify our officers, directors, and employees for certain events or occurrences while the officer or director is, or was, serving at our

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request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime. We lease laboratory and office space in Cambridge, Massachusetts, under a noncancelable operating lease. We have standard indemnification arrangements under these leases that require us to indemnify the landlord against any liability for injury, loss, accident, or damage from any claims, actions, proceedings, or costs resulting from certain acts, breaches, violations, or nonperformance under our lease.

Through December 31, 2014, we had not experienced any losses related to these indemnification obligations and no material claims were outstanding. We do not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.

Recent Accounting Pronouncements— On August 27, 2014, the Financial Accounting Standards Board (“FASB”) issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-15”), which provides guidance on determining when and how to disclose going-concern uncertainties in the financial statements. The new standard requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date the financial statements are issued. An entity must provide certain disclosures if “conditions or events raise substantial doubt about the entity’s ability to continue as a going concern.” ASU 2014-15 is effective for us on January 1, 2017. We are currently assessing the potential impact of the adoption of ASU 2014-15 on our consolidated financial statements.

On May 28, 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”), its final standard on revenue from contracts with customers. ASU 2014-09 outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. The core principle of the revenue model is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In applying the revenue model to contracts within its scope, an entity identifies the contract(s) with a customer, identifies the performance obligations in the contract, determines the transaction price, allocates the transaction price to the performance obligations in the contract and recognizes revenue when (or as) the entity satisfies a performance obligation. ASU 2014-09 also requires significantly expanded disclosures about revenue recognition. ASU 2014-09 is effective for us on January 1, 2017. We are currently assessing the potential impact of the adoption of ASU 2014-09 on our consolidated financial statements.

3. NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS

The following table summarizes the computation of basic and diluted net loss per share attributable to our common stockholders (in thousands, except share and per share data):


	Years Ended December 31,
	2014			2013			2012
Net loss	$	(32,537	)	$	(27,663	)	$	(19,240	)
Accretion of preferred stock issuance costs to redemption value		—			(308	)		(472	)
Accrued dividends on redeemable convertible preferred stock		—			(3,396	)		(4,495	)

Net loss attributable to common stockholders—basic and diluted	$	(32,537	)	$	(31,367	)	$	(24,207	)

Weighted-average number of common shares—basic and diluted		16,495,648			6,049,385			2,069,071
Net loss per share attributable to common stockholders—basic and diluted	$	(1.97	)	$	(5.19	)	$	(11.70	)

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Because we have reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share.

The following potentially dilutive securities outstanding, prior to the use of the treasury stock method or as-if-converted method, have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact due to the losses reported:


	As of December 31,
	2014		2013		2012
Options to purchase common stock		2,769,307		2,212,298		2,081,609
Warrants to purchase common stock		74,412		74,412		—
Warrants to purchase redeemable convertible preferred stock		—		—		60,305
Redeemable convertible preferred stock		—		—		7,631,520
Unvested common stock		—		27,866		187,517

4. REVENUE

Our revenue for the periods presented consists of the following (in thousands):


	Years Ended December 31,
	2014		2013		2012
Government grants	$	723	$	946	$	479
Research and development and collaboration agreements		9,703		9,955		568

Total	$	10,426	$	10,901	$	1,047

Government Grants—Government grants consist primarily of a research grant from the Ministry for Industry and Trade of the Russian Federation (the “MPT Grant”) that was awarded in October 2012 in the amount of RUB 147.9 million ($4.9 million). Advance funding under the contract of RUB 40.0 million ($1.0 million), RUB 39.0 million ($1.2 million), and RUB 29.5 million ($1.0 million), was received during the years ended December 31, 2014, 2013, and 2012, respectively. Revenue recognized for this contract for the years ended December 31, 2014, 2013 and 2012, was $0.7 million, $0.9 million and $0.3 million, respectively. Cash received from the MPT Grant that exceeds revenue recognized has been recorded in deferred revenue.

Research and Development and Collaboration Agreements—Revenue recognized for research and development agreements related principally to our 2013 agreements with AstraZeneca AB, Pfizer Inc., and Amgen, Inc. and our 2014 agreement with F. Hoffmann-La Roche Ltd. Under these agreements, we performed research and/or studies to assess the feasibility of developing Accurins incorporating therapeutic payloads from such pharmaceutical and biotechnology companies’ proprietary product portfolios and provided the resulting data from such work to the pharmaceutical and biotechnology companies in exchange for reimbursement for research and development services and upfront fees for which revenue was initially deferred and recognized over the performance period.

F. Hoffmann-La Roche Ltd.—In June 2014, we entered into a research agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc., or Roche, to discover novel nanomedicines using Accurins for the treatment of diseases in therapeutic areas outside of oncology. The research agreement focuses on combining BIND’s Accurin technology with Roche’s proprietary therapeutic payloads and targeting ligands. Under the agreement, Roche paid us an immaterial, non-refundable upfront fee and, additionally, will compensate us for our research and development services up to a specified amount. The upfront fee, which was received by us in July 2014, will be creditable against any such fee negotiated in a future Roche agreement, if any. Therefore, we

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will not recognize revenue related to the upfront fee during the term of the research agreement. During the year ended December 31, 2014, we recognized revenue of $0.4 million for reimbursed research and development activities related to the Roche research agreement.

AstraZeneca AB—In April 2013, we entered into a license agreement with AstraZeneca. Under the agreement, we granted to AstraZeneca a worldwide license to research, develop, manufacture and commercialize Accurins incorporating a specified AstraZeneca product candidate for any therapeutic use in humans or animals. This license is exclusive with respect to our intellectual property rights that arise under this agreement or the feasibility study that preceded it, and non-exclusive with respect to all of our other intellectual property rights. We and AstraZeneca are each responsible for using commercially reasonable efforts to develop licensed products under a development plan that extends a previously completed feasibility study we conducted for AstraZeneca. AstraZeneca is required to pay for all of our development costs. AstraZeneca is also solely responsible for, and must use commercially reasonable efforts in, obtaining all regulatory approvals for licensed products. AstraZeneca may terminate the agreement effective upon six months’ prior written notice to us.

Under the agreement, we received an upfront payment of $4.0 million and have the potential to receive contingent payments totaling up to $193 million in the aggregate upon achievement by AstraZeneca of specified clinical, regulatory and commercial events. We will also receive tiered royalties in the low-single digit to the low-double digit percentages of aggregate worldwide net sales of licensed product, if any. We will receive royalties on a country-by-country and licensed product-by-licensed product basis generally until the AstraZeneca patents and any regulatory exclusivity relating to such licensed product expire.

We determined that the deliverables under the agreement include the license, the research and development services and participation in the Joint Steering Committee (“JSC”). The JSC deliverable ends at the same time as the research and development services. Our obligations related to the research and development services are to use commercially reasonable efforts to perform the research as set forth in the design/preclinical collaboration plan. We also determined that, pursuant to the accounting guidance governing revenue recognition on multiple element arrangements, the license and undelivered research and development services and participation in the JSC do not have standalone value due to the specialized nature of the research services to be provided by us. In addition, while AstraZeneca has the ability to grant sublicenses, it cannot sublicense all or substantially all of its rights under the agreement. The uniqueness of the Company’s research services and the limited sublicense right are indicators that standalone value is not present in the arrangement. Therefore the deliverables are not separable and, accordingly, the license and undelivered research and development and JSC services are being treated as a single unit of accounting. When multiple deliverables are accounted for as a single unit of accounting, we base our revenue recognition model on the final deliverable, since multiple deliverables are accounted for as a single unit of accounting. Under the agreement, the last deliverable to be completed is our research and development services and our participation in the JSC which is expected to be completed in 2015. We are utilizing a proportional performance model to recognize revenue related to the upfront payment and our other research and development services (both our internal effort as well as external costs). During the years ended December 31, 2014 and 2013, we recognized revenue of $7.1 million and $2.5 million, respectively, related to the AstraZeneca license agreement.

Pfizer Inc.—In March 2013, we entered into a research, option and license agreement with Pfizer Inc. pursuant to which we granted to Pfizer two options to obtain an exclusive worldwide license to use, develop, manufacture and commercialize Accurins incorporating specified Pfizer drug candidates, for the treatment, prevention and/or diagnosis of any disease or medical condition in humans, except that the licensed rights exclude some vaccine products and products for the treatment of brain cancer. Pfizer may exercise either one or both of its options to acquire the exclusive license for the specified drug candidate until September 2015, subject to certain adjustments, by paying us a specified option exercise fee. If Pfizer exercises any option, it will be solely responsible for all further development and commercialization activities with respect to the licensed products covered by the option, and Pfizer is also solely responsible for obtaining all regulatory approvals for the applicable licensed products and conducting all communications with regulatory authorities. Pfizer may terminate this agreement without cause for any or no reason effective upon 60 days’ prior written notice to us.

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Under the agreement, we received an upfront payment of $4.0 million and have the potential to receive contingent payments totaling up to $89.5 million in the aggregate under each option upon exercise of the option and achievement by Pfizer of specified development and regulatory events plus additional contingent payments totaling up to $110 million in the aggregate under each option upon achievement by Pfizer of specified commercial events. In December 2014, we achieved a development milestone which was paid by Pfizer in February 2015. We will also receive royalties in the low-single digit to the high-single digit percentages of aggregate worldwide net sales of each licensed product, if any. We will receive royalties on a country-by-country and licensed product-by-licensed product basis generally until the expiration of the Pfizer patents covering such licensed product.

Our deliverables under the agreement include the research and development services and participation on a Joint Research Committee (“JRC”). The JRC deliverable ends at the same time as the research and development services. Our obligations related to the research and development services are to use commercially reasonable efforts to perform the research as set forth in the design/preclinical collaboration plan. We determined that the JRC does not have standalone value apart from the research and development services, and we considered these deliverables a single unit of accounting. We concluded that the Pfizer options are not deliverables of the agreement because they are substantive options and are not priced at a significant and incremental discount. The performance period is the expected period over which the services of the combined unit are performed, which we expect will span through 2015. We are utilizing a proportional performance model to recognize the upfront payment, the achieved milestone and our other research and development services (both our internal effort as well as external costs). During the years ended December 31, 2014 and 2013, we recognized revenue of $1.4 million and $2.7 million, respectively, related to the Pfizer research, option and license agreement.

Amgen, Inc.—In January 2013, we entered into a license agreement with Amgen, Inc. (“Amgen”), pursuant to which we granted to Amgen an option to obtain an exclusive worldwide license to develop, manufacture and commercialize an Accurin incorporating a specified Amgen drug candidate for all uses except for some vaccine applications (“Amgen Option”). Under the agreement, we received an upfront payment of $5.0 million as well as potential development and regulatory milestone payments contingent upon Amgen exercising its option.

Our deliverables under the agreement included conducting the research and development program and participation on a JRC. The JRC deliverable ended at the same time as the research and development services. Our obligations related to the research and development services were to use commercially reasonable efforts to perform the research as set forth in the design/preclinical collaboration plan. Having determined that the JRC did not have standalone value apart from the research and development program, we considered these deliverables as a single unit of accounting. We concluded that the Amgen Option was not a deliverable of the agreement because it was a substantive option and was not priced at a significant and incremental discount. The performance period was the expected period over which the services of the combined unit were performed, which we expected would span through the middle of 2014. The upfront payment was being recognized over the performance period on a proportional performance basis.

In December 2013, we and Amgen amended the license agreement to extend the period during which Amgen could exercise its option by nine months, to July 2014. In June 2014, Amgen notified us that it would not exercise its option; therefore, we had no further performance obligations to Amgen. As a result, we recognized the remaining portion of the upfront license fee of $0.8 million as revenue during the year ended December 31, 2014. In June 2014, we also notified Amgen that we would not exercise our option to develop an Accurin incorporating the Amgen therapeutic payload.

During the years ended December 31, 2014 and 2013, we recognized revenue of $0.8 million and $4.2 million, respectively, related to the Amgen license agreement.

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5. SHORT-TERM AND LONG-TERM INVESTMENTS

The following is a summary of marketable securities (included in short and long-term investments in the Consolidated Balance Sheets) as of December 31, 2014 and 2013 (in thousands):


	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
December 31, 2014
Certificates of deposit	$	9,225	$	—	$	(4	)	$	9,221
U.S. government agency notes		12,360		1		—			12,361

Total	$	21,585	$	1	$	(4	)	$	21,582

December 31, 2013
Certificates of deposit	$	1,784	$	—	$	(1	)	$	1,783
U.S. government agency notes		23,987		3		(2	)		23,988

Total	$	25,771	$	3	$	(3	)	$	25,771

The contractual maturities of our investments as of December 31, 2014 are all due within one year. We had $10,000 and zero of realized gains on our short-term investments for the years ended December 31, 2014 and 2013, respectively. Our certificates of deposit are each under $250,000 and are subject to insurance by the Federal Deposit Insurance Corporation. There were no other-than-temporary impairments recognized for the years ended December 31, 2014 and 2013.

6. FAIR VALUE MEASUREMENTS

Financial instruments, including cash equivalents, restricted cash, amounts due under collaboration agreements, accounts payable, and accrued expenses are carried in the consolidated financial statements at amounts that approximate fair value at December 31, 2014 and 2013. Fair values are based on market prices and assumptions concerning the amount and timing of estimated future cash flows and assumed discount rates, reflecting varying degrees of perceived risk.

We believe that our debt obligations bear interest at rates which approximate prevailing market rates for instruments with similar characteristics and, accordingly, the carrying values for these instruments approximate fair value. The debt fair value measurements are considered level 2 in the fair value hierarchy.

Included in cash and cash equivalents as of December 31, 2014 and 2013, are money market fund investments of $9.7 million and $45.3 million, U.S. government agency notes of $3.3 million and zero, and certificates of deposit of $1.7 million and $0.5 million, respectively.

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, which are the following:

Level 1—Quoted prices in active markets that are accessible at the market date for identical unrestricted assets or liabilities.

Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs for which all significant inputs are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

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Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Fair value of marketable securities is determined utilizing third party pricing services. The pricing services use many observable market inputs to determine value, including benchmark yields, reportable trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers, reference data, new issue data, monthly payment information and collateral performance. We validate the prices provided by our third party pricing services by understanding the models used, obtaining market values from other pricing sources, and confirming that those securities trade in active markets.

There have been no changes to the valuation methods during the years ended December 31, 2014 and 2013. We evaluate transfers between levels at the end of each reporting period. There were no transfers of assets or liabilities between Level 1 and Level 2 during the years ended December 31, 2014 and 2013. We had no short-term or long-term investments that were classified as Level 3 at any point during years ended December 31, 2014 and 2013. A summary of our assets and liabilities that are measured at fair value as of December 31, 2014 and 2013 is as follows (in thousands):


			Fair Value Measurements Using
	Carrying Value		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
December 31, 2014
Money market funds(1)	$	10,268	$	10,268	$	—	$	—
Certificates of deposit(2)		9,221		—		9,221		—
U.S. government agency notes(2)		12,361		—		12,361		—

Total	$	31,850	$	10,268	$	21,582	$	—

December 31, 2013
Money market funds(1)	$	45,268	$	45,268	$	—	$	—
Certificates of deposit(2)		1,783		—		1,783		—
U.S. government agency notes(2)		23,988		—		23,988		—

Total	$	71,039	$	45,268	$	25,771	$	—

(1)	Money market funds are included within cash and cash equivalents and restricted cash in the accompanying consolidated balance sheets.

(2)	Certificates of deposit and U.S. government agency notes are included within short-term investments and long-term investments in the accompanying consolidated balance sheets.

7. PREPAID EXPENSES AND OTHER CURRENT ASSETS

Prepaid expenses as of December 31, 2014 and 2013 consisted of the following (in thousands):


	As of December 31,
	2014		2013
Prepaid service agreements	$	249	$	345
Prepaid insurance expenses		628		532
Prepaid clinical expenses		426		313
Other prepaid expenses and other current assets		838		342

Total prepaid expenses and other current assets	$	2,141	$	1,532

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8. PROPERTY AND EQUIPMENT, NET

Property and equipment as of December 31, 2014 and 2013 consisted of the following (in thousands):


	As of December 31,
	2014			2013
Equipment	$	9,081		$	7,216
Leasehold improvements		3,301			3,119
Furniture and fixtures		142			97

Total property and equipment		12,524			10,432
Less accumulated depreciation and amortization		(5,957	)		(4,353	)

Property and equipment—net	$	6,567		$	6,079

Depreciation and amortization expense for the years ended December 31, 2014, 2013, and 2012 was $1.7 million, $1.4 million, and $1.2 million, respectively.

9. ACCRUED EXPENSES AND OTHER LONG-TERM LIABILITIES

Accrued expenses as of December 31, 2014 and 2013 consisted of the following (in thousands):


	As of December 31,
	2014		2013
Accrued compensation and benefits	$	1,687	$	612
Accrued clinical trial costs		700		709
Deferred rent, current portion		606		513
Other accrued expenses		2,267		1,087

Total accrued expenses	$	5,260	$	2,921

Other long-term liabilities as of December 31, 2014 and 2013 consisted of the following (in thousands):


	As of December 31,
	2014		2013
Deferred rent, less current portion	$	925	$	1,375
Other long-term liabilities		81		—

Total other long-term liabilities	$	1,006	$	1,375

10. LONG-TERM DEBT

Debt—In June 2013, we entered into an amended and restated credit facility with Hercules Technology III, L.P. (“Hercules”) as lender, pursuant to which we borrowed an aggregate principal amount of $4.5 million in term loans. The credit facility is secured by substantially all of our personal property other than our intellectual property. The loan under the credit facility bear interest at a floating per annum rate equal to 10.25% plus the prime rate less 3.25% (with a minimum rate of 10.25%). At December 31, 2014, our interest rate was the minimum rate of 10.25%. We were required to make interest payments on any loans funded under the credit facility through February 28, 2014, or the interest-only period. All outstanding loans under the credit facility began amortizing at the end of the interest-only period, with monthly payments of principal and interest being made by us to Hercules in 30 consecutive monthly installments. All loans mature on the first day of the 30th month following the end of the interest-only period.

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The credit facility includes affirmative and negative covenants applicable to us and our subsidiaries. The affirmative covenants include, among others, covenants requiring us (and us to cause our subsidiaries) to maintain our legal existence and governmental approvals, deliver certain financial reports and maintain insurance coverage. The negative covenants include, among others, restrictions on us and our subsidiaries transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets, and suffering a change in control, in each case subject to certain exceptions. Additionally, the credit facility restricts us from investing in our wholly-owned domestic subsidiary, BIND Biosciences Security Corporation, unless we hold cash and other liquid investments equal to $25.0 million, less any payments of principal that we have made to Hercules under the credit facility.

The credit facility also includes events of default, the occurrence and continuation of which provide Hercules with the right to exercise remedies against us and the collateral securing the loans under the credit facility, including our cash. These events of default include, among other things, our failure to pay any amounts due under the credit facility, a breach of covenants under the credit facility, our insolvency and the insolvency of our subsidiaries, the occurrence of a material adverse effect, the occurrence of any default under certain other indebtedness, and a final judgment against us in an amount greater than $500,000.

As of December 31, 2014, there are a total of 74,412 warrants to purchase common stock outstanding that were primarily issued in connection with the Hercules credit facility and the credit facility amendment.

Future principal payments under our debt agreements as of December 31, 2014, are as follows (in thousands):


2015	$	1,792
2016		1,482

	$	3,274

Interest expense for the years ended December 31, 2014, 2013, and 2012 was $0.5 million, $0.9 million, and $0.7 million, respectively.

In January 2015, we entered into an amendment to the amended and restated credit facility (“New Term Loan”) with Hercules as lender. The January 2015 amendment provides us with a term loan in an amount equal to $15.0 million, a portion of which was used to repay our existing term loan with the Lender in the aggregate amount of $3.1 million, and the remainder of which will be used for general corporate purposes.

In connection with the closing of the amendment in January 2015, we also paid Hercules a facility charge of approximately $0.2 million. Furthermore, on the earliest to occur of (i) the Maturity Date, (ii) the date that we prepay the New Term Loan, or (iii) the date that the New Term Loan becomes due and payable, we agreed to pay Hercules an end of term charge of approximately $0.8 million.

In connection with the closing of the amendment in January 2015, we and Hercules entered into a Warrant Agreement (the “Warrant”), pursuant to which Hercules, as warrantholder, has the right to purchase 81,227 shares of our common stock at an exercise price of $5.54. The Warrant is exercisable beginning on the date of issuance and expires five years from that date.

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11. REDEEMABLE CONVERTIBLE PREFERRED STOCK

In connection with the closing of the IPO, all of our outstanding redeemable convertible preferred stock automatically converted to common stock at a 1:2.62 ratio on September 25, 2013, resulting in an additional 8,515,439 shares of our common stock becoming outstanding.

12. STOCKHOLDERS’ EQUITY

At-the-Market Facility—In October 2014, we entered into an at-the-market sales agreement (“Sales Agreement”) with Cowen & Company, LLC (“Cowen”) pursuant to which we may from time to time, at our option, offer and sell shares of our common stock having an aggregate offering price of up to $40 million through Cowen, acting as our sales agent. Upon delivery of a placement notice by us and subject to the terms and conditions of the Sales Agreement, Cowen will use its commercially reasonable efforts to sell shares of our common stock, based upon our instructions. We have provided Cowen with customary indemnification rights, and Cowen will be entitled to a commission of up to 3.0% of the gross proceeds from sales of shares of our common stock under the Sales Agreement. Sales of shares of our common stock, if any, under the Sales Agreement may be made by any method permitted by law that is deemed an “at the market” offering as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made through the Nasdaq Global Select Market, on any other existing trading market for our common stock or to or through a market maker. We may also authorize Cowen to sell shares in negotiated transactions. We have no obligation to sell shares of our common stock and cannot provide any assurances that we will issue any shares pursuant to the Sales Agreement. We may also suspend the offering of shares of our common stock upon notice and subject to other conditions under the Sales Agreement or may at any time upon notice terminate the Sales Agreement. As of December 31, 2014, we have not sold any shares of common stock under the Sales Agreement.

2013 Incentive Award Plan—Our 2013 Incentive Award Plan (the “2013 Plan”) provides for the issuance of common stock and stock options to employees, officers, directors, consultants, and advisors. Under the 2013 Plan, the Board determines the number of shares of common stock to be granted and the terms pursuant to the awards. The exercise price of incentive stock options cannot be less than the fair value of the common stock on the date of grant. Stock options awarded under the 2013 Plan expire 10 years after the grant date, unless the Board sets a shorter term. In September 2013, the Board authorized the number of shares authorized to be issued under the 2013 Plan to 1,335,877. The 2013 Plan provides an annual increase on the first day of each calendar year beginning January 1, 2014 and ending on and including January 1, 2023, equal to the lesser of (A) 1,335,877 Shares, (B) 4% of the Shares outstanding (on an as-converted basis) on the final day of the immediately preceding calendar year and (C) such smaller number of Shares as determined by the Board; provided, however, no more than 10,000,000 Shares may be issued upon the exercise of Incentive Stock Options. As of December 31, 2014, there were 1,385,244 shares of common stock available for future grant under the 2013 Plan.

2006 Stock Incentive Plan—Our 2006 Stock Incentive Plan (the “2006 Plan”) provided for the issuance of common stock and stock options to employees, officers, directors, consultants, and advisors. Under the 2006 Plan, the Board determined the number of shares of common stock to be granted pursuant to the awards, as well as the exercise price and terms of such awards. The exercise price of incentive stock options cannot be less than the fair value of the common stock on the date of grant. Stock options awarded under the 2006 Plan expire 10 years after the grant date, unless the Board sets a shorter term. In June 2013, the Board increased the number of shares authorized to be issued under the 2006 Plan to 3,157,394. As of December 31, 2014, there were no shares of common stock available for future grant under the 2006 Plan.

Prior to September 19, 2013, in determining the exercise prices for options granted, the Board has considered the fair value of the common stock as of the measurement date. The fair value of the common stock was determined by the Board based on a variety of different factors, including our financial position, the status of development efforts within we, the composition and ability of the current scientific and management teams, the current climate in the market place, the illiquid nature of our common stock, arm’s-length sale of our preferred stock, the effect of the rights and preferences of the preferred stockholders, and the prospects of a liquidity event, among others.

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Certain of our unvested stock options will vest upon the sale of all or substantially all of our stock or assets.

A summary of option activity under the 2013 Plan and 2006 Plan as of December 31, 2014, and changes during the year then ended is as follows (in thousands, except share and per share data):


	Number of Shares			Weighted- Average Exercise Price Per Share		Weighted- Average Remaining Contractual Term (in Years)		Aggregate Intrinsic Value
Outstanding—January 1, 2014		2,212,298		$	2.81		7.90	$	27,176
Granted		837,480			10.65
Exercised		(109,994	)		2.14
Forfeited		(170,477	)		6.25

Outstanding—December 31, 2014		2,769,307		$	4.99		7.55	$	5,901

Exercisable—December 31, 2014		1,570,728		$	2.76		6.56	$	4,787

Options vested and expected to vest—December 31, 2014		2,586,375		$	4.82		7.46	$	5,719

During the years ended December 31, 2014, 2013, and 2012, we used the Black-Scholes option-pricing model to estimate the fair value of stock option grants. The assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimates. The assumptions used in determining fair value of our employee stock options granted for the years ended December 31, 2014, 2013, and 2012, are as follows:


	For the Years Ended December 31,
	2014			2013			2012
Expected volatility		85	%		67	%		66	%
Weighted-average risk-free interest rate		1.84	%		1.26	%		1.15	%
Expected dividend yield		0	%		0	%		0	%
Expected term (years)		5.89			6.03			7.04

We derived the risk-free interest rate assumption from the U.S. Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the awards being valued. We based the assumed dividend yield on our expectation of not paying dividends in the foreseeable future. The expected term of the awards represented the period of time that the awards were expected to be outstanding. We calculated the expected term of options using historical grant, exercise and cancellation data. The estimated volatility is based upon a weighted calculation of our historical price volatility and the historical volatility of comparable companies with publicly available share prices. The accounting guidance for stock-based compensation requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

The weighted-average grant-date fair value of options granted in 2014, 2013 and 2012 was $7.78, $6.05, and $0.80 per share, respectively. The fair value is being expensed over the vesting period of the options, generally four years, on a straight-line basis as the services are being provided.

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During the years ended December 31, 2014, 2013 and 2012, we issued nonemployee stock options to purchase 50,000, 30,000 and 165,970 shares of common stock, respectively, at a weighted-average exercise price of $8.45, $9.33 and $2.52 per share, respectively, with primarily a four-year vesting period. The shares were estimated to have a fair value at the grant date of approximately $357,000, $221,000 and $532,000, respectively, using the Black-Scholes option-pricing model using the fair value of the common stock and the following assumptions:


	For the Years Ended December 31,
	2014			2013			2012
Expected volatility		85	%		74	%		66	%
Weighted-average risk-free interest rate		2.50	%		3.00	%		1.68	%
Expected dividend yield		0	%		0	%		0	%
Expected term (years)		10			10			10

The related stock-based compensation is subject to remeasurement and is being expensed on a straight-line method over the vesting term.

As of December 31, 2014, there was $5.6 million (includes $0.4 million of compensation for options containing performance conditions) of unrecognized compensation cost related to the stock options granted under the 2006 Plan and 2013 Plan. As of December 31, 2014, $5.2 million of compensation with only service conditions is expected to be recognized over the remaining requisite service period of 3.1 years.

We have recorded aggregate stock-based compensation expense related to the issuance of stock option awards in the following line items in the accompanying consolidated statement of operations (in thousands):


	Year Ended December 31,
	2014		2013		2012
Research and development	$	1,079	$	1,695	$	469
General and administrative		1,487		4,321		224

Total	$	2,566	$	6,016	$	693

In September 2013, certain performance based stock option awards, granted to two executives, vested upon the closing of our IPO resulting in stock-based compensation expense of $3.6 million.

Reserved Shares—As of December 31, 2014 and 2013, we have reserved the following shares of common stock for warrants and exercise of stock options:


	December 31, 2014		December 31, 2013
Warrants to purchase common stock		74,412		74,412
2013 and 2006 stock option plans		4,293,307		3,544,291

Total		4,367,719		3,618,703

13. INCOME TAXES

We have no current or deferred income tax expense for the years ended December 31, 2014, 2013, and 2012, due to our net operating loss position. We did not record a federal or state income tax provision or benefit for the year ended December 31, 2014, due to the losses incurred in the in the corresponding periods as well as our continued maintenance of a full valuation allowance against our net deferred tax assets.

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The reconciliation between income taxes computed at the federal statutory income tax rate and the provision for (benefit from) income taxes is as follows:


	Years ended December 31,
	2014			2013			2012
Federal statutory rate		34.0	%		34.0	%		34.0	%
Effect of:
State taxes, net of federal tax benefit		5.9			0.0			0.0
Change in valuation allowance		(43.0	)		(32.9	)		(33.3	)
Research and development tax credit		1.8			1.7			2.3
Stock-based compensation		—			(4.6	)		(0.4	)
Return to provision		2.4			1.7			—
Other		(1.1	)		0.1			(2.6	)

Total		0.0	%		0.0	%		0.0	%

The significant components of our deferred tax assets as of December 31, 2014 and 2013, are as follows (in thousands):


	2014			2013
Net operating loss carryforwards	$	31,538		$	12,161
Capitalized expenses		15,409			23,187
Research and development credits		4,259			3,230
Stock based compensation		3,195			1,419
Deferred revenue		1,635			—
Accrued expenses		757			1,118
Property and equipment		486			326
Other—net		—			129

Deferred tax assets		57,279			41,570
Deferred tax liability		(1,236	)		(658	)
Valuation allowance		(56,043	)		(40,912	)

Net deferred tax asset and liability	$	—		$	—

Because of our limited operating history, management has concluded that it is more likely than not that the benefits of losses to date which result in deferred tax assets will not be realized and, accordingly, we provided a full valuation allowance against the net deferred tax assets. As such, there is no income tax benefit recorded in the accompanying consolidated statements of operations for all periods presented. The valuation allowance increased by approximately $15.1 million and $11.8 million in 2014 and 2013, respectively, due to the increase in the deferred tax assets (primarily due to the net operating loss carryforwards and capitalization of certain expenses for tax purposes).

At December 31, 2014, we had federal, foreign, and state net operating loss carryforward of approximately $74.7 million, $4.6 million, and $78.6 million, respectively, available to reduce future taxable income, if any. The federal net operating loss carryforwards expire beginning in 2027 and ending in 2034. The state net operating loss carryforwards began expiring in 2012 and may continue to expire through 2034. At December 31, 2014, we had available federal and state income tax credits of approximately $2.6 million and $1.7 million, respectively, which are available to reduce future income taxes, if any, through 2029 (state) and 2034 (federal).

Realization of the future tax benefits is dependent on many factors, including our ability to generate taxable income within the net operating loss carryforward period. Under the provisions of the Internal Revenue Code,

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certain substantial changes in our ownership, including a sale of the company or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss carryforwards, which could be used annually to offset future taxable income.

We file tax returns in the United States, Massachusetts, and Russia. In the United States and Massachusetts, the tax years 2006 through 2013 remain open to examination by the Internal Revenue Service and in Russia, the tax year 2013 remains open to examination by taxing jurisdictions in Russia. As a result, carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service or other state tax authorities if they have or will be used in a future period. We are not currently under examination by the Internal Revenue Service or any other jurisdiction for any tax years. We do not believe material uncertain tax positions have arisen to date. We have not recorded any interest or penalties on any unrecognized tax benefits since our inception.

14. COMMITMENTS

Leases—Our Cambridge headquarters is under a five-year operating lease beginning in April 2012 and expiring in 2017. In June 2014, we amended our primary office and laboratory lease to include space in the same building that we had been previously subleasing from a third party. Total rent expense for all operating leases for the years ended December 31, 2014, 2013 and 2012 was $2.0 million, $1.2 million, and $1.2 million, respectively.

In connection with the lease agreement, we issued a letter of credit to the landlord for $0.5 million in 2011. We secured the letter of credit using restricted cash for the full amount of the letter.

Future minimum commitments due under all leases at December 31, 2014, are as follows (in thousands):


Year Ending December 31,
2015	$	2,496
2016		2,571
2017		897
2018		38

Total minimum lease payments	$	6,002

License Agreements—We have a license agreement to a portfolio of approximately 15 patent families from a university that was entered into in 2007. We will pay royalties in the low single digit percentages on the commercial sale of such licensed product. We may also make contingent payments to the university totaling up to $1.5 million in aggregate upon achievement of specified clinical, regulatory and commercial events. We are also required to pay the university a percentage, ranging from the high-single digits to the low-mid double digits, of any consideration we receive from sublicensees, including our collaboration partners, and a specified percentage, in the mid-single digits, of all payments we receive in excess of a specified amount in the aggregate for the practice of the licensed patents on behalf of non-sublicensee third parties. Contingent payments totaling $1.4 million have been made to the university through December 31, 2014.

We have a license agreement with a second university that was entered into in 2009. Under this agreement, we may be required to make payments totaling $1 million based on the achievement of certain milestones and will pay royalties in the low single digit percentages on commercial sales of licensed products, subject to a minimum annual royalty. We are required to pay the university 30% of consideration received from sublicensees who solely sublicense the intellectual property we have licensed from the university. No contingent payments have been made to the university through December 31, 2014.

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In January 2013, we entered into a license agreement with a third university. We may also pay royalties at a rate of less than 1% on commercial sales of such licensed products. We must also pay the university 40% of any consideration received from sublicensees who solely sublicense the intellectual property we have licensed from the university. No contingent payments have been made to the university through December 31.

We recorded research and development expenses, exclusive of sublicense consideration, relating to these agreements of $0.2 million, $0.2 million and less than $0.1 million for the years ended December 31, 2014, 2013, and 2012, respectively.

15. 401(k) PLAN

We have a 401(k) defined contribution plan (the “401(k) Plan”) for substantially all of our employees. Eligible employees may make pretax contributions to the 401(k) Plan up to statutory limits. At the election of our Board, we may elect to match employee contributions, but have not done so through December 31, 2014.

16. QUARTERLY FINANCIAL DATA (unaudited)

The following table summarizes the unaudited quarterly financial data for the last two fiscal years:

CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data)


	Three-months ended
	March 31, 2014			June 30, 2014			September 30, 2014			December 31, 2014
Revenue	$	1,565		$	2,459		$	3,365		$	3,037

Operating expenses:
Research and development		6,823			6,901			7,131			8,019
General and administrative		3,261			3,774			3,827			4,198

Total operating expenses		10,084			10,675			10,958			12,217

Loss from operations		(8,519	)		(8,216	)		(7,593	)		(9,180	)
Other income (expense)		197			(228	)		316			686

Net loss		(8,322	)		(8,444	)		(7,277	)		(8,494	)
Accretion of redeemable convertible preferred stock		—			—			—			—

Net loss attributable to common stock holders	$	(8,322	)	$	(8,444	)	$	(7,277	)	$	(8,494	)

Net loss per share attributable to common stockholders:
Basic and diluted	$	(0.51	)	$	(0.51	)	$	(0.44	)	$	(0.51	)
Weighted average common shares outstanding:
Basic and diluted		16,423,795			16,464,410			16,544,402			16,548,092

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CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data)


	Three-months ended
	March 31, 2013			June 30, 2013			September 30, 2013			December 31, 2013
Revenue	$	1,488		$	2,777		$	4,566		$	2,070

Operating expenses:
Research and development		5,657			5,960			5,348			7,405
General and administrative		1,967			2,449			6,280			2,698

Total operating expenses		7,624			8,409			11,628			10,103

Loss from operations		(6,136	)		(5,632	)		(7,062	)		(8,033	)
Other income (expense)		(153	)		(287	)		(316	)		(44	)

Net loss		(6,289	)		(5,919	)		(7,378	)		(8,077	)
Accretion of redeemable convertible preferred stock		(1,335	)		(1,412	)		(957	)		—

Net loss attributable to common stock holders	$	(7,624	)	$	(7,331	)	$	(8,335	)	$	(8,077	)

Net loss per share attributable to common stockholders:
Basic and diluted	$	(3.51	)	$	(3.32	)	$	(2.46	)	$	(0.50	)
Weighted average common shares outstanding:
Basic and diluted		2,170,827			2,210,766			3,391,239			16,298,668

17. SUBSEQUENT EVENTS

Debt—As noted in Note 10, in January 2015, we entered into a New Term Loan with Hercules as lender. The New Term Loan provides us with a term loan of $15.0 million, a portion of which was used to repay our existing term loan with the Lender in the aggregate amount of $3.1 million, and the remainder of which will be used for general corporate purposes.

Equity Raise—In February 2015, we completed an underwritten public offering of 3,739,130 units at the public offering price of $5.75 per unit. Each unit consisted of one share of our common stock and six-tenths (0.6) of a warrant to purchase one share of our common stock with an exercise price of $6.60 per share. We received net proceeds of approximately $20 million after deducting underwriting discounts and commissions and estimated offering expenses payable by us and not including any future proceeds from the exercise of the warrants.

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Item 9.

Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

None.

Item 9A.

Controls and Procedures

Limitations on Effectiveness of Controls and Procedures

In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated, as of the end of the period covered by this Annual Report on Form 10-K, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)). Based on that evaluation, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2014.

Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting during the quarter ended December 31, 2014, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Management’s Annual Report on Internal Control Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Securities Exchange Act of 1934, as amended.

Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in “Internal Control-Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management concluded that, as of December 31, 2014, our internal control over financial reporting was effective.

This annual report does not include an attestation report of our registered public accounting firm on internal control over financial reporting due to an exemption established by the JOBS Act for “emerging growth companies”.

Item 9B.

Other Information

None.

PART III

Certain information required by Part III is omitted from this Annual Report on Form 10-K and is incorporated herein by reference to the Registrant’s Definitive Proxy Statement for the Annual Meeting of Stockholders scheduled to be held on June 9, 2015 to be filed with the Securities and Exchange Commission.

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Item 10.

Directors, Executive Officers and Corporate Governance

Our board of directors has adopted a Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available on our website at http://ir.bindtherapeutics.com/governance.cfm in the “Investors & Media” section. We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of our Code of Business Conduct and Ethics, as well as Nasdaq’s requirement to disclose waivers with respect to directors and executive officers, by posting such information on our website at the address and location specified above.

The information in response to this item is contained in part under the caption “Executive Officers of the Registrant” at the end of Part I of this Annual Report on Form 10-K. The remainder of the response to this item is contained in the Proxy Statement for our Annual Meeting of Stockholders scheduled to be held on June 9, 2015 and is incorporated herein by reference.

Item 11.

Executive Compensation

The information required to be disclosed by this item is contained in the Proxy Statement for our Annual Meeting of Stockholders scheduled to be held on June 9, 2015 and is incorporated herein by reference.

Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 13.

Certain Relationships and Related Transactions, and Director Independence

Item 14.

Principal Accountant Fees and Services

PART IV

Item 15.

Exhibits and Financial Statement Schedules

(a) Documents filed as part of this report:

1.	List of Financial Statements

The financial statements required by this item are listed in Item 8, “Financial Statements and Supplementary Data” herein.

2.	List of Financial Statement Schedules

All schedules are omitted because they are not applicable, not required or the required information is shown in the consolidated financial statements or notes thereto.

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3.	List of Exhibits

Incorporated by Reference

Exhibit
Number

Exhibit Description

Form

File No.

Exhibit

Filing
Date

Filed/
Furnished
Herewith

3.1

Restated Certificate of Incorporation of BIND Therapeutics, Inc.

8-K

001-36072

3.1

9/25/13

3.2

Amended and Restated By-laws of BIND Therapeutics, Inc.

8-K

001-36072

3.2

9/25/13

4.1

Specimen Stock Certificate evidencing the shares of common stock

S-1/A

333-190566

4.1

9/5/13

4.2

Fourth Amended and Restated Investors’ Rights Agreement, dated as of November 7, 2011, as amended.

S-1

333-190566

4.2

8/12/13

4.3

Warrant dated June 27, 2008 issued by the Registrant to GE Capital Equity Investments, Inc.

S-1

333-190566

4.3

8/12/13

4.4

Warrant dated January 10, 2011 issued by the Registrant to Hercules Technology III, L.P.

S-1

333-190566

4.4

8/12/13

4.5

Warrant dated June 12, 2013 issued by the Registrant to Hercules Technology Growth Capital, Inc.

S-1

333-190566

4.5

8/12/13

4.6

Form of Indenture.

S-3

333-199105

4.2

10/01/14

10.1#

2006 Stock Incentive Plan, as amended, and form of option agreements thereunder

S-1

333-190566

10.1

8/12/13

10.2#

2013 Incentive Award Plan and forms of option agreement, restricted stock agreement and restricted stock unit agreement thereunder

S-1/A

333-190566

10.2

9/5/13

10.3#

Non-Employee Director Compensation Program, as amended on September 24, 2014

10-Q

001-36072

10.1

11/06/14

10.4#

Form of Indemnification Agreement for Directors and Officers

S-1/A

333-190566

10.4

8/20/13

10.5#

Consulting Agreement, dated as of October 31, 2006, by and between the Registrant and Robert S. Langer, Jr., as amended on June 11, 2010 and August 28, 2013

S-1/A

333-190566

10.5

9/5/13

10.6#

Amended and Restated Consulting Agreement, dated as of July 12, 2007, by and between the Registrant and Omid Farokhzad, as amended on June 11, 2010 and August 28, 2013

S-1/A

333-190566

10.6

9/5/13

119

Incorporated by Reference

Exhibit
Number

Exhibit Description

Form

File No.

Exhibit

Filing
Date

Filed/
Furnished
Herewith

10.7#

Offer Letter, dated as of January 11, 2010, between the Registrant and Scott Minick and the letter agreement dated as of August 28, 2013 related thereto

S-1/A

333-190566

10.7

9/5/13

10.8#

Consulting Agreement, dated as of January 15, 2014, between the Registrant and Greg Berk, M.D.

8-K

001-36072

10.1

1/17/14

10.9#

Offer Letter, dated as of March 20, 2013, between the Registrant and Greg Berk, M.D. and letter agreements dated as of March 13, 2013, March 20, 2013 and August 28, 2013 related thereto

S-1/A

333-190566

10.9

9/5/13

10.10#

Amended and Restated Employment Agreement, dated as of June 28, 2013, between the Registrant and Daniel Lynch, as superseded by the Consulting Agreement, dated as of August 28, 2013

S-1/A

333-190566

10.10

9/5/13

10.11#

Offer Letter, dated as of June 3, 2007, between the Registrant and Jeff Hrkach and letter agreements dated as of April 10, 2013 and August 28, 2013 related thereto

S-1/A

333-190566

10.11

9/5/13

10.12†

Exclusive Patent License Agreement, dated as of June 30, 2007, as amended on November 24, 2008 and March 18, 2013, by and between the Registrant and Massachusetts Institute of Technology

S-1/A

333-190566

10.12

9/5/13

10.13†

Exclusive License Agreement, dated as of February 17, 2009, as amended on January 1, 2013, by and between the Registrant and The Johns Hopkins University

S-1/A

333-190566

10.13

8/28/13

10.14†

Exclusive License Agreement, dated as of January 31, 2013, by and between the Registrant and Yale University

S-1/A

333-190566

10.14

8/28/13

10.15†

Amended and Restated License Agreement, effective as of January 7, 2013, by and between the Registrant and Amgen, Inc.

S-1/A

333-190566

10.15

8/28/13

10.16

Amendment No. 1, effective as of December 6, 2013, to Amended and Restated License Agreement, effective as of January 7, 2013, by and between the Registrant and Amgen Inc.

8-K

001-36072

10.1

12/12/13

120

Incorporated by Reference

Exhibit
Number

Exhibit Description

Form

File No.

Exhibit

Filing
Date

Filed/
Furnished
Herewith

10.17†

Amended and Restated Research, Option and License Agreement, effective as of March 25, 2013, by and between the Registrant and Pfizer, Inc.

S-1/A

333-190566

10.16

8/28/13

10.18†

Amended and Restated License Agreement, effective as of April 19, 2013, by and between the Registrant and AstraZeneca AB (publ)

S-1/A

333-190566

10.17

8/28/13

10.19

Amended and Restated Loan and Security Agreement, dated as of June 12, 2013, between the Registrant and Hercules Technology III, L.P.

S-1

333-190566

10.18

8/12/13

10.20

Lease, dated as of July 20, 2011, by and between the Registrant and BMR-325 Vassar Street LLC

S-1

333-190566

10.19

8/12/13

10.21

First Amendment to Lease, dated June 26, 2014, by and between the Registrant and BMR-325 Vassar Street LLC

10-Q

001-36072

10.2

8/7/14

10.22#

Omnibus Amendment to Stock Option Agreements under 2006 Stock Incentive Plan, dated as of January 13, 2014, between the Registrant and Greg Berk, M.D.

8-K

001-36072

10.2

1/17/14

10.23#

Letter Agreement waiving director compensation, dated October 24, 2013, by and between the Registrant and Yurii Udaltsov, Cand. Sc.

10-Q

001-36072

10.1

8/7/2014

21.1

Subsidiaries of the Registrant

23.1

Consent of Deloitte & Touche LLP

31.1

Rule 13a-14(a) / 15d-14(a) Certification of Chief Executive Officer

31.2

Rule 13a-14(a) / 15d-14(a) Certification of Chief Financial Officer

32.1

Section 1350 Certification of Chief Executive Officer

32.2

Section 1350 Certification of Chief Financial Officer

101.INS

XBRL Instance Document

101.SCH

XBRL Taxonomy Extension Schema Document

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document

121

Incorporated by Reference

Exhibit
Number

Exhibit Description

Form

File No.

Exhibit

Filing
Date

Filed/
Furnished
Herewith

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

XBRL Taxonomy Extension Label Linkbase Document

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document

*	Filed herewith.

**	Furnished herewith.

#	Indicates management contract or compensatory plan.

†	Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934.

122

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


BIND Therapeutics, Inc.

By:		/s/ Andrew Hirsch
		Andrew Hirsch President and Chief Executive Officer

March 11, 2015

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.


Signature	Title	Date

/s/ Andrew Hirsch Andrew Hirsch	President and Chief Executive Officer (principal executive officer)	March 11, 2015

/s/ Christopher Lindblom Christopher Lindblom	Senior Vice President, Finance and Administration (principal financial and accounting officer)	March 11, 2015

/s/ Daniel Lynch Daniel Lynch	Chairman of the Board of Directors	March 11, 2015

/s/ Peter Barton Hutt Peter Barton Hutt	Director	March 11, 2015

/s/ Robert Langer, Sc.D. Robert Langer, Sc.D.	Director	March 11, 2015

/s/ Scott Minick Scott Minick	Director	March 11, 2015

/s/ Amir Nashat, Sc.D. Amir Nashat, Sc.D.	Director	March 11, 2015

/s/ Eric K. Rowinsky, M.D. Eric K. Rowinsky, M.D.	Director	March 11, 2015

/s/ Charles A. Rowland, Jr. Charles A. Rowland, Jr.	Director	March 11, 2015

/s/ Amy W. Schulman Amy W. Schulman	Director	March 11, 2015

/s/ Yurii Udaltsov, Cand. Sc. Yurii Udaltsov, Cand. Sc.	Director	March 11, 2015

Large accelerated filer

Accelerated filer

Non-accelerated filer

¨ (Do not check if a smaller reporting company)

Smaller reporting company