UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

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

 

For the quarterly period ended June 30, 2015

 

OR

 

¨

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

 

For the transition period from              to  

           

Commission File Number: 001-35112

Medgenics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware	98-0217544
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
435 Devon Park Drive, Building 700 Wayne, Pennsylvania	19087
(Address of Principal Executive Offices)	(Zip Code)

 

(610) 254-4201

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)  

 

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

 

Large accelerated filer	¨	Accelerated filer	x
Non-accelerated filer	¨  (Do not check if a smaller reporting company)	Smaller reporting company	¨

 

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

 

As of August 5, 2015, the registrant had 24,930,443 shares of common stock, $0.0001 par value, outstanding.

 

 

MEDGENICS, INC.

 

CONTENTS

 

		Page
PART I	FINANCIAL INFORMATION	1
ITEM 1.	Financial Statements	1
ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk	20
ITEM 4.	Controls and Procedures	21
PART II	OTHER INFORMATION	21
ITEM 1.	Legal Proceedings	21
ITEM 1A.	Risk Factors	21
ITEM 2.	Unregistered Sales of Equity Securities and Use of Proceeds	21
ITEM 3.	Defaults Upon Senior Securities	22
ITEM 4.	Mine Safety Disclosures	22
ITEM 5.	Other Information	22
ITEM 6.	Exhibits	23
Signatures		24

 

Unless the context otherwise requires, all references in this Quarterly Report on Form 10-Q to the “Company”, “Medgenics”, “we,” “us” and “our” refer to Medgenics, Inc., a Delaware corporation organized on January 27, 2000, and its wholly-owned subsidiary, Medgenics Medical (Israel) Ltd., a company organized under the laws of the State of Israel. We use TARGT^TM and TARGT_EPO^TM as trademarks in the United States and elsewhere. All other trademarks or trade names referred to in this document are the property of their respective owners.

 

 

`PART I — FINANCIAL INFORMATION

ITEM 1 — Financial Statements

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

As of June 30, 2015

 

IN U.S. DOLLARS IN THOUSANDS

 

(Unaudited)

  

INDEX

 

		Page
Consolidated Balance Sheets		2 - 3
Consolidated Statements of Operations		4
Statements of Changes in Stockholders' Equity		5
Consolidated Statements of Cash Flows		6 - 7
Notes to the Interim Consolidated Financial Statements		8 - 14

  

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands (except share and per share data)

 

 

		June 30,				December 31,
		2015				2014
		Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	22,012			$	33,288
Accounts receivable and prepaid expenses			2,104				315
Total current assets			24,116				33,603
LONG-TERM ASSETS:
Restricted lease deposits			87				83
Severance pay fund			99				99
Property and equipment, net			454				495
Total long-term assets			640				677
Total assets		$	24,756			$	34,280

 

 

 

 

The accompanying notes are an integral part of the interim consolidated financial statements

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands (except share and per share data)

 

		June 30,				December 31,
		2015				2014
		Unaudited
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables		$	742			$	1,076
Other accounts payable and accrued expenses			1,844				2,562
Total current liabilities			2,586				3,638
LONG-TERM LIABILITIES:
Accrued severance pay			354				368
Liability in respect of warrants			826				612
Total long-term liabilities			1,180				980
Total liabilities			3,766				4,618
STOCKHOLDERS' EQUITY:
Common stock - $0.0001 par value; 100,000,000 shares authorized;  24,937,443 shares issued and 24,928,943 shares outstanding at June 30, 2015; 24,851,075 shares issued and 24,818,075 shares outstanding at December 31, 2014			3				3
Additional paid-in capital			136,133				129,797
Accumulated deficit			(115,146	)			(100,138	)
Total stockholders' equity			20,990				29,662
Total liabilities and stockholders' equity		$	24,756			$	34,280

 

 

The accompanying notes are an integral part of the interim consolidated financial statements.

 

 MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands (except share and per share data)

 

 

		Six months ended June 30,								Three months ended June 30,
		2015				2014				2015				2014
		Unaudited
Research and development expenses		$	8,359			$	4,097			$	4,458			$	1,955
Less:
Participation by the Office of the Chief Scientist			(1,430	)			(1,182	)			(1,430	)			(1,182	)
Research and development expenses, net			6,929				2,915				3,028				773
General and administrative expenses			7,836				5,957				3,889				2,864
Operating loss			(14,765	)			(8,872	)			(6,917	)			(3,637	)
Financial expenses			(262	)			(337	)			(8	)			(217	)
Financial income			24				18				843				15
Loss before taxes on income			(15,003	)			(9,191	)			(6,082	)			(3,839	)
Taxes on income			5				6				4				1
Loss		$	(15,008	)		$	(9,197	)		$	(6,086	)		$	(3,840	)
Basic loss per share		$	(0.60	)		$	(0.49	)		$	(0.24	)		$	(0.21	)
Diluted loss per share		$	(0.63	)		$	(0.49	)		$	(0.28	)		$	(0.21	)
Weight average number of common     stock used in computing basic loss per share			24,875,344				18,664,544				24,906,823				18,715,541
Weight average number of common stock used in computing diluted loss per share			24,969,314				18,664,544				25,094,763				18,715,541

 

 

The accompanying notes are an integral part of the interim consolidated financial statements.

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

U.S. dollars in thousands (except share and per share data)

 

 

		Common stock								Additional paid-in capital				Accumulated deficit				Total stockholders' equity
		Shares				Amount
Balance as of  December 31, 2013			18,497,307			$	2			$	100,126			$	(81,705	)		$	18,423
Stock-based compensation related to the  issuance and vesting of restricted common stock to directors and an employee			28,000				(*)				331				-				331
Stock-based compensation related to options and warrants granted to consultants, directors and employees			-				-				3,191				-				3,191
Exercise of  warrants and options			255,458				(*)				951				-				951
Loss			-				-				-				(9,197	)			(9,197	)
Balance as of  June 30, 2014 (unaudited)			18,780,765			$	2			$	104,599			$	(90,902	)		$	13,699
Balance as of December 31, 2014			24,818,075			$	3			$	129,797			$	(100,138	)		$	29,662
Stock-based compensation related to vesting of restricted common stock to directors			24,500				(*)				-				-				-
Stock-based compensation related to options and warrants granted to consultants, directors and employees			-				-				5,840				-				5,840
Exercise of  warrants and options			86,368				(*)				496				-				496
Loss			-				-				-				(15,008	)			(15,008	)
Balance as of  June 30, 2015 (unaudited)			24,928,943			$	3			$	136,133			$	(115,146	)		$	20,990

 

(* ) Represents an amount lower than $ 1.

 

 

 

The accompanying notes are an integral part of the interim consolidated financial statements.

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

  

 

		Six months ended  June 30,
		2015				2014
		Unaudited
CASH FLOWS FROM OPERATING ACTIVITIES:
Loss		$	(15,008	)		$	(9,197	)
Adjustments to reconcile loss to net cash used in operating activities:
Depreciation			124				98
Loss from disposal of property and equipment			17				-
Stock-based compensation related to options, warrants and restricted shares granted to employees, directors and consultants			5,840				3,522
Change in fair value of warrants classified as a liability			250				306
Accrued severance pay, net			(14	)			(325	)
Changes in operating assets and liabilities:
Accounts receivable and prepaid expenses			(1,789	)			(795	)
Trade payables			(334	)			(74	)
Other accounts payable and accrued expenses			(718	)			(225	)
Restricted lease deposits			(4	)			11
Net cash used in operating activities			(11,636	)			(6,679	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment			(100	)			(233	)
Cash used in investing activities		$	(100	)		$	(233	)

  

 

 

 

The accompanying notes are an integral part of the interim consolidated financial statements.

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 

		Six months ended  June 30,
		2015				2014
		Unaudited
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of options and warrants		$	460			$	951
Cash provided by financing activities			460				951
Decrease in cash and cash equivalents			(11,276	)			(5,961	)
Balance of cash and cash equivalents at the beginning of the period			33,288				22,390
Balance of cash and cash equivalents at the end of the period		$	22,012			$	16,429
Supplemental disclosure of cash flow information:
Cash paid during the period for taxes		$	5			$	6
Classification of liability in respect of warrants into equity due to the exercise of warrants		$	36			$	-

 

 

 

The accompanying notes are an integral part of the interim consolidated financial statements.

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)

 

 

NOTE 1:-

GENERAL

 

a.

Medgenics, Inc. (the "Company") was incorporated in January 2000 in Delaware. The Company has a wholly-owned subsidiary, Medgenics Medical Israel Ltd. (the "Subsidiary"), which was incorporated in Israel in March 2000. The Company and the Subsidiary are engaged in the research and development of products in the field of biotechnology and associated medical equipment.

 

The Company's common stock is traded on the NYSE MKT.

  

b.

As reflected in the accompanying financial statements, the Company incurred a loss for the six month period ended June 30, 2015 of $15,008 and had a negative cash flow from operating activities of $11,636 during the six month period ended June 30, 2015. The accumulated deficit as of June 30, 2015 is $115,146. The Company and the Subsidiary have not yet generated revenues from product sale. Management's plans also include seeking additional investments and commercial agreements to continue the operations of the Company and the Subsidiary.

 

The Company believes that its existing cash and cash equivalents should be sufficient to meet its operating and capital requirements through the third quarter of 2016.

 

 

NOTE 2:-

SIGNIFICANT ACCOUNTING POLICIES

 

The accompanying unaudited interim financial statements of the Company, have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and the rules of the Securities and Exchange Commission ("SEC") and should be read in conjunction with the audited financial statements and notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2014 ("2014 Form 10-K") as filed with the SEC. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim periods presented have been reflected herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that would substantially duplicate the disclosure contained in the audited financial statements for the most recent fiscal year as reported in the 2014 Form 10-K have been omitted.

 

 

 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)

 

 

NOTE 3:-

STOCKHOLDERS' EQUITY

 

a.

Issuance of stock options, warrants and restricted shares to employees and directors:

 

1.

A summary of the Company's activity for restricted shares granted to employees and directors is as follows:

 

Restricted shares		Six months ended June 30, 2015
Number of restricted shares as of December 31, 2014			24,500
Vested			(24,500	)
Number of restricted shares as of  June 30, 2015			-

 

2.

A summary of the Company's activity for options and warrants granted to employees and directors is as follows:

 

		Six months ended  June 30, 2015
		Number of options and warrants				Weighted Average exercise price				Weighted average remaining contractual terms (years)				Aggregate intrinsic value
Outstanding at December 31, 2014			8,211,124			$	5.48				6.79			$	5,490
Granted			1,642,837				6.87
Exercised			(10,500	)			4.48
Outstanding at June 30, 2015			9,843,461			$	5.71				6.85			$	11,186
Vested and expected to vest at June  30, 2015			9,583,932			$	5.71				6.80			$	10,999
Exercisable at June 30, 2015			4,955,686			$	5.62				5.03			$	7,479

 

Calculation of aggregate intrinsic value is based on the closing share price of the Company's common stock as reported on the NYSE MKT on June 30, 2015 ($6.13 per share).

 

As of June 30, 2015, there was $11,072 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted to employees and directors. That cost is expected to be recognized over a weighted-average period of 1.8 years.

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)

 

 

NOTE 3:-

STOCKHOLDERS' EQUITY (Cont.)

 

b.

Issuance of shares, stock options and warrants to consultants:

 

A summary of the Company's activity for warrants and options granted to consultants is as follows:

 

		Six months ended  June 30, 2015
		Number of options and warrants				Weighted average exercise price				Weighted average remaining contractual terms (years)				Aggregate intrinsic value
Outstanding at December 31, 2014			473,826			$	6.53				3.29			$	207
Exercised			(1,558	)			4.99
Outstanding at June 30, 2015			472,268			$	6.54				2.80			$	448
Exercisable at  June 30, 2015			435,601			$	6.62				2.53			$	426

Calculation of aggregate intrinsic value is based on the closing share price of the Company's common stock as reported on the NYSE MKT on June 30, 2015 ($6.13 per share).

 

As of June 30, 2015, there was $134 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted to consultants. That cost is expected to be recognized over a weighted-average period of 1.3 years. 

 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)

 

 

NOTE 3:-

STOCKHOLDERS' EQUITY (Cont.)

 

c.

Compensation expenses:

 

Compensation expenses related to restricted shares, warrants and options granted to employees, directors and consultants was recorded in the Consolidated Statement of Operations in the following line items:

 

		Six months ended June 30,								Three months ended June 30,
		2015				2014				2015				2014
		Unaudited								Unaudited
Research and development expenses		$	981			$	493			$	524			$	224
General and administrative expenses			4,859				3,029				2,199				1,534
		$	5,840			$	3,522			$	2,723			$	1,758

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)

 

 

NOTE 3:-

STOCKHOLDERS' EQUITY (Cont.)

 

d.

Summary of shares to be issued upon exercise of options and warrants:

 

A summary of shares to be issued upon exercise of all the options and warrants, segregated into ranges, as of June 30, 2015 is presented in the following table:

 

						As of June 30, 2015
						Shares to be				Shares to be
						Issued upon				Issued upon				Weighted Average
						Exercise of				Exercise of				Remaining
		Exercise				Options and				Options and				Contractual Terms
		Price per				Warrants				Warrants				of Options and
Options / Warrants		Share ($)				Outstanding				Exercisable				Warrants (in years)
Options:
Granted to Employees and Directors
			2.66-3.14				196,000				173,000				6.5
			3.86-4.99				3,618,429				1,960,579				7.7
			5.13-7.25				3,737,477				797,950				8.5
			8.19-10.80				1,386,365				1,118,967				3.9
							8,938,271				4,050,496
Granted to Consultants			5.02-6.65				79,348				42,681				6.3
Total Shares to be Issued upon Exercise of Options							9,017,619				4,093,177
Warrants:
Granted to Employees and Directors			2.49				905,190				905,190				0.8
Granted to Consultants			3.19-4.99				191,447				191,447				2.2
			9.17-11.16				201,473				201,473				2.0
							392,920				392,920
Granted to Investors			4.10-6.00				3,191,806				3,191,806				0.7
			6.78-8.34				4,614,921				4,614,921				2.5
							7,806,727				7,806,727
Total Shares to be Issued upon Exercise of Warrants							9,104,837				9,104,837
Total Shares to be Issued upon Exercise of Options and Warrants							18,122,456				13,198,014

 

 

 

 MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)

 

 

NOTE 4:-

FAIR VALUE MEASUREMENTS

 

The Company classified certain warrants with down-round protection issued to the purchasers of convertible debentures in 2010 as a liability at their fair value according to ASC 815-40-15-7I. The liability in respect of these warrants is remeasured at each reporting period until exercised or expired. Changes in the fair value of these warrants are reported in the Consolidated Statement of Operations as financial income or expense.

 

The fair value of these warrants was estimated at June 30, 2015 and December 31, 2014 using the Binomial pricing model with the following assumptions:

 

		June 30, 2015				December 31, 2014
Dividend yield			0	%			0	%
Expected volatility			51.6	%			53.3	%
Risk-free interest rate			0.01	%			0.2	%
Contractual life (in years)			0.2				0.7

 

The changes in level 3 liabilities measured at fair value on a recurring basis:

 

		Fair value  of liability  in respect  of warrants
Balance as of December 31, 2013		$	1,211
Change in the liability in respect of warrants			306
Balance as of June 30, 2014 (unaudited)		$	1,517
Balance as of December 31, 2014		$	612
Classification of liability in respect of warrants into equity due to the exercise of warrants			(36	)
Change in the liability in respect of warrants			250
Balance as of June 30, 2015 (unaudited)		$	826

  

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)

 

 

NOTE 6:-

LOSS PER SHARE

 

Details in the computation of diluted loss per share:

 

		Six months ended June 30,
		2015								2014
		Weighted average number of shares				Loss				Weighted average number of shares				Loss
		Unaudited
For the computation of basic loss			24,875,344			$	15,008				18,664,544			$	9,197
Effect of potential dilutive common shares issuable upon exercise of warrants classified as liability			93,970				824	(**)			-	(*)		$	-	(*)
For the computation of diluted loss			24,969,314			$	15,832				18,664,544			$	9,197

 

		Three months ended June 30,
		2015								2014
		Weighted average number of shares				Loss				Weighted average number of Shares				Loss
		Unaudited
For the computation of basic loss			24,906,823			$	6,086				18,715,541			$	3,840
Effect of potential dilutive common shares issuable upon exercise of warrants classified as liability			187,940				824	(**)			-	(*)		$	-	(*)
For the computation of diluted loss			25,094,763			$	6,910				18,715,541			$	3,840

 

	(*)	Anti-dilutive.
	(**)	Financial income resulted from changes in fair value of warrants classified as liability.

 

The total weighted average number of shares related to the outstanding options, warrants and restricted shares excluded from the calculations of diluted loss per share due to their anti-dilutive effect was 17,950,345 and 16,275,584 for the six months ended June 30, 2015 and 2014, respectively.

- - - - -

 

ITEM 2 — Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q.

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements are often identified by the use of words such as, but not limited to, “can,” “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “continues,” “anticipates,” “intends,” “seeks,” “targets,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to them. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2014, and any updates to those risk factors included in Part II, Item 1A of this Quarterly Report on Form 10-Q. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

 

Overview

 

We are a clinical stage rare and orphan disease company developing an innovative and proprietary ex vivo gene therapy platform, offering what we believe to be a novel therapeutic approach for use in the $50 billion orphan and rare disease therapeutics markets. Our TARGT^TM (Transduced Autologous Restorative Gene Therapy) platform is designed to provide sustained protein and peptide therapies to treat a range of chronic diseases and conditions. We are currently studying our lead product MDGN-201, which we refer to as TARGT_EPO^TM, in three Phase 1/2 clinical trials in patients with End Stage Renal Disease (ESRD). We are currently studying TARGT_EPO in identified sub-populations of unmet need including patients who are treated chronically with hemodialysis or peritoneal dialysis, all of whom are also renal transplant eligible patients. We are planning to further examine the impact of TARGT_EPO on blood pressure and other markers of cardiovascular risk in these ESRD patients. Future studies will also examine patients who may be hypo-responsive to recombinant humanized erythropoietin (rHuEPO), patients with myelodysplastic syndrome (MDS), and patients with Beta thalassemia intermedia – whose conditions may qualify for orphan drug designation. We have initiated in vivo proof of concept pre-clinical studies with several other orphan or rare disease candidates, and have initiated discussions with regulatory agencies for some of those programs in 2015.

 

In June 2014, the first patient was enrolled in our Phase 1/2 clinical trial of MDGN-201 (TARGT_EPO). The aim of the ongoing trial is to validate the potential of our TARGT platform using a second-generation expression cassette of the HDAd viral vector, which was developed to enhance durability of the proposed therapeutic effect. The ongoing study is evaluating the potential of the updated platform to offer sustained production and delivery of endogenous erythropoietin (eEPO) to treat anemia in dialysis patients with ESRD. This open-label trial is expected to enroll up to 18 patients with ESRD who require rHuEPO treatment for anemia. We expect that each patient will receive one or more TARGT_EPO microorgans and will be followed for at least one year. The trial endpoints include plasma eEPO levels, blood counts and safety assessment.

 

We have now completed enrollment in the low-dose cohort of the Phase 1/2 clinical trial of MDGN-201. All six patients who received TARGT_EPO microorgans have shown positive initial response to therapy at approximately 100x lower Cmax than rHuEPO (e.g., EPREX). Five of six patients maintained hemoglobin levels within their targeted range due to red blood cell production stimulated by eEPO for at least five months following implantation without receiving any injections of rHuEPO or blood transfusions, and one patient continues to remain stable without receiving any injections of rHuEPO or blood transfusions for 13 months since implantation. The low-dose was well-tolerated in all six patients and there have been no treatment-related serious adverse events (SAEs). Enrollment in the mid-dose cohort of the Phase 1/2 trial began in the first quarter of 2015 and three patients have been enrolled. Implanted TARGTs produced eEPO in all three patients. One patient in this cohort was not able to maintain his hemoglobin levels within the targeted range and required injections of rHuEPO and exited the study. The other two mid-dose patients are stable and have not received any injections of rHuEPO or blood transfusions. We also enrolled two patients in our first trial studying TARGT_EPO in patients with ESRD who are undergoing peritoneal dialysis. These patients remain stable and have not received any injections of rHuEPO or blood transfusions. In the second quarter we received clearance to proceed from FDA for our investigational new drug application with the United States Food and Drug Administration, and we have started a Phase 1/2 clinical trial in the United States studying TARGT_EPO in ESRD patients who are undergoing peritoneal dialysis. The first patient in this study was enrolled at the end of the second quarter, and represents the first patient that the Company is studying in a clinical trial in the United States.

 

 

In June 2015, our wholly-owned subsidiary, Medgenics Medical (Israel) Ltd., which we refer to as MMI, was awarded a government grant of up to NIS 13.3 million (approximately $3.4 million) from the Israeli Office of the Chief Scientist (OCS) at the Ministry of Economy of Israel. The grant will be used to cover research and development expenses for the 13-month period from December 2014 through December 2015 to support further research and clinical development of our TARGT system with respect to the treatment of rare and orphan diseases. Under the terms of the OCS grant, MMI will be required to repay the grant in full, plus interest, through royalties on revenue received from commercializing the developed technology. The payment of royalties is contingent on such revenues and, in the absence of such revenues, no royalty payments to the OCS will be required.

 

We have generated significant losses to date, and we expect to continue to generate losses as we progress towards the commercialization of our product candidates.  We incurred net losses of approximately $15.01 million for the six month period ended June 30, 2015. As of June 30, 2015, we had stockholders’ equity of approximately $20.99 million.  We are unable to predict the extent of any future losses or when we will become profitable, if at all.

 

Financial Operations Overview

 

Research and Development Expense

 

Research and development expense consists of: (i) internal costs associated with our development activities; (ii) payments we make to third party contract research organizations, contract manufacturers, clinical trial sites and consultants; (iii) technology and intellectual property license costs; (iv) manufacturing development costs; (v) personnel related expenses, including salaries and other related costs, including stock-based compensation expense, for the personnel involved in product development; (vi) activities related to regulatory filings and the advancement of our product candidates through preclinical studies and clinical trials; and (vii) facilities and other allocated expenses, which include direct and allocated expenses for rent, facility maintenance, as well as laboratory and other supplies. All research and development costs are expensed as incurred.

 

Conducting a significant amount of development is central to our business model. Product candidates in later-stage clinical development generally have higher development costs than those in earlier stages of development, primarily due to the significantly increased size and duration of the clinical trials. We plan to increase our research and development expenses for the foreseeable future in order to complete the proof of concept of our TARGT_EPO microorgans with a second generation expression cassette of the HDAd viral vector and implantation protocol, and our earlier-stage research and development projects including in targeted rare and orphan disease indications.

 

The process of conducting pre-clinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among others, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of these uncertainties, together with the uncertainty associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. We are concurrently focusing on proceeding with the approved TARGT_EPO trial to obtain proof of concept with the second generation expression cassette of the HDAd viral vector and new implantation protocol and pursuing pre-clinical research and development in targeted orphan and rare disease.

 

 

Research and development expenses are shown net of participation by third parties.

 

General and Administrative Expense

 

General and administrative expense consists primarily of salaries and other related costs, including stock-based compensation expense, for persons serving as our directors and in our executive, finance and accounting functions. Other general and administrative expense includes facility-related costs not otherwise included in research and development expense, costs associated with industry and trade shows, and professional fees including legal services and accounting services. We expect that our general and administrative expenses will increase as we add personnel.

 

Financial Expense and Income

 

Financial expense consists primarily of warrant valuations and foreign currency exchange differences.

 

Financial income consists primarily of warrant valuations.

 

Results of Operations for the Six Months Ended June 30, 2015 and 2014

 

Research and Development Expenses

 

Gross research and development expenses for the six months ended June 30, 2015 were $8.36 million, increasing from $4.10 million for the same period in 2014 due mainly to increased materials and sub-contractor costs and increased stock-based compensation expenses related to options granted to research and development personnel. Net research and development expenses for the six months ended June 30, 2015 increased to $6.93 million from $2.92 million for the same period in 2014. The increase in net research and development expenses was due to the increase in gross research and development expenses offset in part by an increase of $0.25 million in the participation by the OCS.

 

General and Administrative Expenses

 

General and administrative expenses for the six months ended June 30, 2015 were $7.84 million, increasing from $5.96 million for the same period in 2014 primarily due to increased stock-based compensation expenses related to options granted to directors and general and administrative personnel, offset in part by a decrease in professional fees.

 

Financial Expenses and Income

 

Financial expenses for the six months ended June 30, 2015 were $0.26 million, decreasing from $0.34 million for the same period in 2014. This decrease was mainly due to the change in valuation of the warrant liability.

 

Financial income for the six months ended June 30, 2015 and 2014 was approximately $0.02 million, mainly comprised of foreign currency exchange differences.

 

 

Results of Operations for the Three Months Ended June 30, 2015 and 2014

 

Research and Development Expenses

 

Gross research and development expenses for the three months ended June 30, 2015 were $4.46 million, increasing from $1.96 million for the same period in 2014 due mainly to increased sub-contractor costs and increased stock-based compensation expenses related to options granted to research and development personnel. Net research and development expenses for the three months ended June 30, 2015 increased to $3.03 million from $0.77 million for the same period in 2014. The increase in net research and development expenses was due to the increase in gross research and development expenses offset in part by an increase of $0.25 million in the participation by the OCS.

 

General and Administrative Expenses

 

General and administrative expenses for the three months ended June 30, 2015 were $3.89 million, increasing from $2.86 million for the same period in 2014 primarily due to increased stock-based compensation expenses related to options granted to directors and general and administrative personnel, offset in part by a decrease in professional fees.

 

Financial Expenses and Income

 

Financial expenses for the three months ended June 30, 2015 were de minimis, decreasing from $0.22 million for the same period in 2014. This decrease was mainly due to the change in valuation of the warrant liability.

 

Financial income for the three months ended June 30, 2015 was $0.84 million, increasing from $0.02 million for the same period in 2014. This increase was mainly due to the change in valuation of the warrant liability.

 

Liquidity and Capital Resources

 

Sources of Liquidity

 

We have financed our operations primarily through a combination of equity issues, debt issues and grants from the Israeli Office of the Chief Scientist (OCS) and other third parties.

 

We received $12.27 million from inception through June 30, 2015 from the OCS in development grants, of which $1.51 was received during the six months ended June 30, 2015.

 

In December 2014, we completed a registered public offering of 5,893,750 shares of common stock, including 768,750 shares sold pursuant to the full exercise of the underwriters’ over-allotment option, at a price to the public of $4.10 per share. The net proceeds from this offering to us were approximately $22.21 million, after deducting underwriting discounts and commissions and offering expenses payable by us.

 

Cash Flows

 

We had cash and cash equivalents of $22.01 million at June 30, 2015 and $33.29 million at December 31, 2014. The decrease in our cash balance during the six months ended June 30, 2015 was primarily the result of operating activities during the period.

 

Net cash used in operating activities of $11.64 million for the six months ended June 30, 2015 and $6.68 million for the six months ended June 30, 2014 reflect an increase of $4.96 million in cash expenses for our operations.

 

 

Our cash used in investing activities relates to our purchases of property and equipment.

 

Net cash provided by financing activities was $0.46 million for the six months ended June 30, 2015 and $0.95 million for the six months ended June 30, 2014. Our cash flows from financing activities during each of these periods were the result of the exercise of options and warrants.

 

Funding Requirements

 

Our future capital requirements will depend on a number of factors, including our success in targeting rare and orphan disease candidates, the timing and outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims and other intellectual property rights, the acquisition of licenses to new products or compounds, the status of competitive products, the availability of financing, and our success in developing markets for our product candidates.

 

Without taking into account any revenue we may receive as a result of licensing or other commercialization agreements, we believe that cash on hand, including the net proceeds we received from our public offering of common stock in 2014, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through the third quarter of 2016. We have based this estimate on assumptions that may prove to be wrong and we could use our available resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials.

 

We do not anticipate that we will generate revenue from the sale of products for at least three years; we do, however, intend to seek licensing or other commercialization agreements for existing and new TARGT applications. In the absence of additional funding or adequate funding from commercialization agreements, we expect our continuing operating losses to result in decreases in our cash balances over the next several quarters.

 

Absent significant corporate collaboration and licensing arrangements, we will need to finance our future cash needs through public or private equity offerings or debt financings. We do not currently have any commitments for future external funding. We may need to raise additional funds more quickly if one or more of our assumptions prove to be incorrect or if we choose to expand our product development efforts more rapidly than we presently anticipate, and we may decide to raise additional funds even before we need them if the conditions for raising capital are favorable. We may seek to encourage holders of our warrants to exercise, sell additional equity or debt securities or obtain a bank credit facility. The sale of additional equity or debt securities, if convertible, could result in dilution to our stockholders. The incurrence of indebtedness would result in increased fixed obligations and could also result in covenants that would restrict our operations.

 

Our plans include seeking additional investments and commercial agreements to continue our operations. However, there is no assurance that we will be successful in our efforts to raise the necessary capital and/or reach such commercial agreements to continue our planned research and development activities.

 

Critical Accounting Policies

 

Our management’s 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 estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.

 

While our significant accounting policies are more fully described in Note 2 to our financial statements included elsewhere in this Quarterly Report on Form 10-Q, we believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating our reported financial results and affect the more significant judgments and estimates that we use in the preparation of our financial statements.

 

 

Liability in Respect of Warrants

 

In the past, we issued warrants whose exercise price is subject to downward adjustment. In accordance with Accounting Standards Codification No. 815-40-15-7I, we classified these warrants as a liability at their fair value. The warrants liability will be re-measured at each reporting period until exercised or expired. The increase in the fair value of the warrants during the six months ended June 30, 2015 of $0.25 million, and the increase in the fair value of the warrants during the six months ended June 30, 2014 of $0.31 million are reported in the Statements of Operations as financial expense.

 

We estimate the fair value of these warrants at the respective balance sheet dates using the Binomial option pricing model. We use a number of assumptions to estimate the fair value, including the remaining contractual terms of the warrants, risk-free interest rates, expected dividend yield and expected volatility of the price of the underlying common stock. These assumptions could differ significantly in the future, thus resulting in variability of the fair value which would impact the results of operations in the future.

 

Stock-Based Compensation

 

We account for stock options according to the Accounting Standards Codification No. 718 (ASC 718) “Compensation - Stock Compensation.” Under ASC 718, stock-based compensation cost is measured at grant date, based on the estimated fair value of the award, and is recognized as an expense over the employee’s requisite service period on a straight-line basis.

 

We account for stock options granted to non-employees on a fair value basis using an option pricing method in accordance with ASC 718. The initial non-cash charge to operations for non-employee options with vesting are revalued at the end of each reporting period based upon the change in the fair value of the options and amortized to consulting expense over the related vesting period.

 

For the purpose of valuing options and warrants granted to our employees, non-employees and directors during the six months ended June 30, 2015 and 2014, we used the Binomial options pricing model. To determine the risk-free interest rate, we utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of our awards. We estimated the expected life of the options granted based on anticipated exercises in the future periods assuming the success of our business model as currently forecast. The expected dividend yield reflects our current and expected future policy for dividends on our common stock. The expected stock price volatility for our stock options was calculated by examining historical volatilities for publicly traded industry peers as we do not have sufficient trading history for our common stock. We will continue to analyze the expected stock price volatility and expected term assumptions as more historical data for our common stock becomes available. We currently estimate that we will experience 5% to 8% forfeitures for those options currently outstanding.

 

Off-Balance Sheet Arrangements

 

There have been no material changes to the discussion of off-balance sheet arrangements included in our Annual Report on Form 10-K for the year ended December 31, 2014.

 

ITEM 3 — Quantitative and Qualitative Disclosures about Market Risk

 

There has been no significant change in our exposure to market risk during the six months ended June 30, 2015. For a discussion of our exposure to market risk, refer to Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” contained in our Annual Report on Form 10-K for the year ended December 31, 2014.

 

 

ITEM 4 — Controls and Procedures

 

Evaluation of disclosure controls and procedures

 

As required by Exchange Act Rule 13a-15(b), in connection with the filing of this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of June 30, 2015, the end of the period covered by this report.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) during the quarter ended June 30, 2015 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II — OTHER INFORMATION

 

ITEM 1 — Legal Proceedings

 

We are not currently a party, as plaintiff or defendant, to any legal proceedings which, individually or in the aggregate, are expected by us to have a material effect on our business, financial condition or results of operation if determined adversely to us.

 

ITEM 1A — Risk Factors

 

There are no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2014.

 

ITEM 2 — Unregistered Sales of Equity Securities and Use of Proceeds

 

Recent Sales of Unregistered Securities

 

In the three months ended June 30, 2015, the following securities were sold by us without registration under the Securities Act. The securities described below were exempt from registration under the Securities Act in reliance upon Section 4(a)(2) of the Securities Act. There were no underwriters employed in connection with any of these transactions.

 

Common Stock Issued Upon Exercise of Outstanding Warrants and Options

 

In April 2015, an investor exercised warrants to purchase 1,607 shares of common stock at an exercise price of $4.10 per share using the cashless exercise method. Using this cashless exercise method, the investor was issued 878 shares.

 

In April 2015, an investor exercised warrants to purchase 51,331 shares of common stock at an exercise price of $6.78 per share, or an aggregate exercise price of approximately $348 thousand.

 

In May 2015, an investor exercised warrants to purchase 21,885 shares of common stock at an exercise price of $4.99 per share using the cashless exercise method. Using this cashless exercise method, the investor was issued 8,568 shares.

 

In June 2015, an investor exercised warrants to purchase 8,036 shares of common stock at an exercise price of $4.10 per share, or an aggregate exercise price of approximately $33 thousand.

 

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

 

None.

 

 

ITEM 3 — Defaults Upon Senior Securities

 

None.

 

ITEM 4 — Mine Safety Disclosures

 

Not applicable.

 

ITEM 5 — Other Information

 

None.

 

 

ITEM 6 — Exhibits

 

Exhibit No.	Description
3.1	Amended and Restated Certificate of Incorporation (previously filed as Exhibit 3.1 to the Company’s Registration Statement on Form S-1 filed November 5, 2010 (File No. 333-170425) and incorporated herein by reference).
3.2	Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as Exhibit 3.2 to the Company’s Registration Statement on Form S-1 filed November 5, 2010 (File No. 333-170425) and incorporated herein by reference).
3.3	Certificate of Amendment to Amended and Restated Certificate of Incorporation dated as of February 14, 2011 (previously filed as Exhibit 4.3 to the Company’s Post-Effective Amendment No. 1 to Form S-1 on Form S-3 filed July 16, 2012 (File No. 333-170425) and incorporated herein by reference).
3.4	Second Amended and Restated By-Laws (previously filed as Exhibit 3.3 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011 (File No. 001-35112) and incorporated herein by reference).
10.1	Non-Executive Director Appointment Letter, dated as of May 21, 2015, between the Company and Barbara G. Duncan (previously filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed June 10, 2015 (File No. 001-35112) and incorporated herein by reference).
31.1	Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
31.2	Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
32.1	Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
101	Interactive Data File (filed herewith).

 

 

SIGNATURES

 

Pursuant to the requirements 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.

 

	MEDGENICS, INC.
Date: August 10, 2015	By:	/s/ Michael F. Cola
		Michael F. Cola
		President and Chief Executive Officer
		(Principal Executive Officer)
Date: August 10, 2015	By:	/s/ John H. Leaman
		John H. Leaman
		Chief Financial Officer
		(Principal Financial Officer)