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EX-32 - RULE 1350 CERTIFICATION OF CHIEF FINANCIAL OFFICER - TYME TECHNOLOGIES, INC.ex_32-2.htm
EX-32 - RULE 1350 CERTIFICATION OF CHIEF EXECUTIVE OFFICER - TYME TECHNOLOGIES, INC.ex_32-1.htm
EX-31 - RULE 13(A)-14(A)/15(D)-14(A) CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER - TYME TECHNOLOGIES, INC.ex_31-2.htm
EX-31 - RULE 13(A)-14(A)/15(D)-14(A) CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER - TYME TECHNOLOGIES, INC.ex_31-1.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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:  December 31, 2016

OR


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


For the transition period:


Commission file number:  333-179311


TYME TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)


Delaware

45-3864597

(State or other jurisdiction of incorporation or organization)

(IRS Employer Identification No.)


44 Wall Street - 12th Floor

New York, New York 10005

(Address of principal executive offices)

(Zip Code)


(646) 205-1603

(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 [_]


(Note: The registrant is a voluntary filer of reports and has filed during the preceding 12 months all reports it would have been required to file by Section 13 or 15(d) of the Securities Exchange Act if the registrant had been subject to one of such Sections.)


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 the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer [_]

 

Accelerated filer [X]

Non-accelerated filer [_]

 

Smaller reporting company [_]

(Do not check if a smaller reporting company)

 

 


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


As of January 31, 2017, there were 88,162,844 shares of the registrant’s common stock, par value $0.0001 per share, issued and outstanding. (Includes 3,500,000 shares which have been placed into escrow and are subject to surrender for cancellation. See Part II, Item 1 of this report.)




TABLE OF CONTENTS


 

Page

PART I - FINANCIAL INFORMATION

 

 

 

Item 1.

Financial Statements

1

 

 

 

 

Condensed Consolidated Balance Sheets as of December 31, 2016 (unaudited) and March 31, 2016 (audited)

1

 

 

 

 

Condensed Consolidated Statements of Operations (unaudited) for the three and nine months ended December 31, 2016 and 2015

2

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the nine months ended December 31 , 2016

3

 

 

 

 

Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended December 31, 2016 and 2015

4

 

 

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

5

 

 

 

Item 2.

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

15

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

19

 

 

 

Item 4.

Controls and Procedures

19

 

PART II - OTHER INFORMATION

 

 

 

Item 1.

Legal Proceedings

21

 

 

 

Item 1A.

Risk Factors

22

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

22

 

 

 

Item 3.

Defaults Upon Senior Securities

22

 

 

 

Item 4.

Mine Safety Disclosures

22

 

 

 

Item 5.

Other Information

22

 

 

 

Item 6.

Exhibits

22

 

 

 

SIGNATURES

24




PART I – FINANCIAL INFORMATION


Item 1. Financial Statements


Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets


 

December 31,

 

March 31,

 

 

2016

 

2016

 

 

(Unaudited)

 

(Audited)

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

$

2,985,450

 

$

6,105,309

 

Prepaid and other assets

 

60,131

 

 

226,098

 

Total current assets

 

3,045,581

 

 

6,331,407

 

Property and equipment, net

 

8,606

 

 

11,816

 

Total assets

$

3,054,187

 

$

6,343,223

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable and other current liabilities

$

2,562,728

 

$

1,676,918

 

Insurance note payable

 

40,635

 

 

232,100

 

Total current liabilities

 

2,603,363

 

 

1,909,018

 

Total liabilities

 

2,603,363

 

 

1,909,018

 

 

 

 

 

 

 

 

Commitments and contingencies (See Note 8.)

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, $0.0001 par value, 10,000,000 shares authorized at December 31, 2016 and March 31, 2016, -0- shares issued and outstanding at December 31, 2016 and March 31, 2016

 

 

 

 

Common stock, $0.0001 par value, 300,000,000 shares authorized, 88,130,152 issued and outstanding at December 31, 2016, and 87,611,370 issued and outstanding at March 31, 2016

 

8,815

 

 

8,763

 

Additional paid in capital

 

31,220,530

 

 

23,080,749

 

Accumulated deficit

 

(30,778,521

)

 

(18,655,307

)

Total stockholders’ equity

 

450,824

 

 

4,434,205

 

Total liabilities and stockholders’ equity

$

3,054,187

 

$

6,343,223

 


The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.


- 1 -



Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)


 

 

Three Months Ended
December 31,

 

Nine Months ended
December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

 

$

 

$

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

1,745,681

 

 

1,136,563

 

 

4,461,689

 

 

3,234,649

 

General and administrative

 

 

1,245,268

 

 

1,298,470

 

 

7,661,525

 

 

3,266,986

 

Total operating expenses

 

 

2,990,949

 

 

2,435,033

 

 

12,123,214

 

 

6,501,635

 

Loss from operations

 

 

(2,990,949

)

 

(2,435,033

)

 

(12,123,214

)

 

(6,501,635

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

 

 

 

(376,255

)

 

 

 

(376,255

)

Net loss

 

$

(2,990,949

)

$

(2,058,778

)

$

(12,123,214

)

$

(6,125,380

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per common share

 

$

(0.04

)

$

(0.03

)

$

(0.14

)

$

(0.08

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted weighted average shares outstanding

 

 

84,517,074

 

 

82,189,523

 

 

84,272,099

 

 

80,139,356

 


The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.


- 2 -



Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ Equity

For the Nine Months ended December 31, 2016

(Unaudited)


 

 

Common Stock

 

Additional
Paid-in

 

Accumulated

 

Total
Stockholders’

 

 

 

Shares

 

Amount

 

Capital

 

deficit

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, April 1, 2016

 

87,611,370

 

$

8,763

 

$

23,080,749

 

$

(18,655,307

)

$

4,434,205

 

Issuance of common stock in private placement offering for cash, net of associated expense

 

452,314

 

 

45

 

 

1,469,960

 

 

 

 

1,470,005

 

Stock-based compensation for employees, directors and consultants

 

 

 

 

 

6,369,828

 

 

 

 

6,369,828

 

Issuance of common stock for services

 

50,000

 

 

5

 

 

199,995

 

 

 

 

200,000

 

Issuance of common stock to Scientific Advisory Board members

 

16,468

 

 

2

 

 

99,998

 

 

 

 

100,000

 

Net loss

 

 

 

 

 

 

 

(12,123,214

)

 

(12,123,214

)

Balance, December 31, 2016

 

88,130,152

 

$

8,815

 

$

31,220,530

 

$

(30,778,521

)

$

450,824

 


The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.


- 3 -



Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(Unaudited)


 

 

Nine Months ended
December 31,

 

 

 

2016

 

2015

 

 

 

 

 

 

 

 

 

Cash flows from operating activities:

 

 

 

 

 

 

 

Net loss

 

$

(12,123,214

)

$

(6,125,380

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

Depreciation

 

 

3,210

 

 

3,218

 

Issuance of common stock for services

 

 

200,000

 

 

200,000

 

Issuance of common stock to Scientific Advisory Board

 

 

100,000

 

 

125,000

 

Stock-based compensation for employees, directors and consultants

 

 

6,369,828

 

 

635,859

 

Gain on remeasurement of derivative liability

 

 

 

 

(376,300

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Prepaid and other assets

 

 

165,967

 

 

353,441

 

Accounts payable and other current liabilities

 

 

885,810

 

 

855,689

 

Net cash used in operating activities

 

 

(4,398,399

)

 

(4,328,473

)

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

Net cash used in investing activities

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

Change in due from officer

 

 

 

 

(17,623)

 

Insurance note payments

 

 

(191,465

)

 

 

Proceeds from private placement offering , net

 

 

1,470,005

 

 

2,966,000

 

Proceeds from the collection of stock subscription receivable

 

 

 

 

2,500,000

 

Net cash provided by financing activities

 

 

1,278,540

 

 

5,448,377

 

 

 

 

 

 

 

 

 

Net (decrease) increase in cash

 

 

(3,119,859

)

 

1,119,904

 

Cash and cash equivalents - beginning of period

 

 

6,105,309

 

 

3,326,380

 

Cash and cash equivalents - end of period

 

$

2,985,450

 

$

4,446,284

 


The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.


- 4 -



Tyme Technologies, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

December 31, 2016

(Unaudited)

 

Note 1. Nature of Business and Basis of Presentation.

 

The accompanying consolidated financial statements include the results of operations of Tyme Technologies, Inc. (“Tyme Tech”) and its wholly owned subsidiaries, Tyme Inc. (“Tyme”) and Luminant Biosciences, LLC (“Luminant”) (collectively, the “Company”).  Luminant conducted the initial research and development of the Company’s therapeutic platform.  Since January 1, 2014, the majority of the Company’s research and development activities and other business efforts have been conducted by Tyme.

 

On October 27, 2016, the Board of Directors of Tyme Tech approved a change in fiscal year end from December 31 to March 31 of each year. As a result of the change in fiscal year, Tyme Tech prepared and filed a transition report on Form 10-QT (the “Transition Report”).  The accompanying balance sheet as of March 31, 2016, was derived from the Company’s audited financial statements included in Form 10-QT filed with the SEC on November 8, 2016.  The accompanying consolidated statements of operations and the consolidated statements of cash flows and footnote disclosures for the nine months ended December 31, 2016 and 2015 are unaudited.


Tyme Tech was incorporated in the State of Florida on November 22, 2011, to engage in the business of producing, marketing and selling an ultra-premium vodka product to retailers. Management determined to cease the ultra-premium vodka business and attempt to acquire other assets or business operations that would maximize shareholder value. Effective as of September 18, 2014, the Company (then constituting a Florida corporation with the name Global Group Enterprises Corp.) reincorporated in the State of Delaware by merging into its wholly-owned Delaware subsidiary, Tyme Technologies, Inc., which was formed on August 22, 2014 specifically for this purpose (the “Reincorporation”). Tyme Technologies, Inc. was the surviving corporation in such merger.

 

On March 5, 2015, Tyme Tech consummated a reverse triangular merger with Tyme (the “Merger”). The Merger resulted in Tyme becoming a wholly-owned subsidiary of Tyme Tech. Tyme is a clinical-stage biopharmaceutical company focused on the development and commercialization of highly targeted cancer therapeutics with a broad range of oncology indications for humans. Tyme was incorporated in Delaware in 2013 and its operations to date have been directed primarily toward developing business strategies, research and development activities and preparing for clinical trials for human oncologic product candidates.


During the fourth quarter of calendar 2015, the Company’s Investigational New Drug Application for its SM-88 drug candidate for breast cancer patients (the “IND”) was accepted by the United States Food and Drug Administration (the “FDA”).  Subsequent to the FDA’s acceptance of our IND for SM-88 and approval of our clinical trial for breast cancer, we made a determination, based on input from various sources and the strong interest of several clinical sites, to prioritize our clinical trial objectives by initiating a study in prostate cancer. On June 13, 2016, we announced that we have begun recruiting for a phase Ib/II clinical trial, using our proprietary compound, SM-88, to use in human prostate cancer. We are also evaluating protocols for clinical studies of SM-88 in pancreatic cancer.

 

Going Concern

 

The Company has incurred losses and negative cash flows from operations since inception (July 26, 2013) and has an accumulated deficit of $30,778,521 as of December 31, 2016.  The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its products currently in development.  The Company’s primary sources of liquidity to date have been the issuance of common stock, convertible promissory notes and contributed capital by its founders.  Substantial additional financing will be needed by the Company to fund its operations and to seek applicable FDA and foreign governmental authorization to commercially market its product candidates.  There is no assurance that such financing will be available when needed or on acceptable terms.  These factors raise substantial doubt about the Company’s ability to continue as a going concern.

 

The consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded assets amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

 

Management is evaluating different strategies to obtain the required additional funding for future operations. These strategies may include, but are not limited to, additional funding from current or new investors, officers and directors; borrowings of debt; public or private offerings of the Company’s equity or debt securities; partnerships and/or collaborations. There can be no assurance that any of these future-funding efforts will be successful.


- 5 -



The Company is subject to those risks associated with any specialty pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants, as well as third party contractors.

 

Note 2. Summary of Significant Accounting Policies.

 

Basis of Presentation

 

The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

 

Unaudited Interim Financial Information

 

The accompanying balance sheet as of March 31, 2016, was derived from the Company’s audited financial statements included in the Form 10-QT filed with the SEC on November 8, 2016.  The interim unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and the notes thereto included in the Form 10-QT.


The accompanying condensed consolidated balance sheet as of December 31, 2016, the condensed consolidated statements of operations for the three and nine months ended December 31, 2016 and 2015, the condensed consolidated statement of stockholders’ equity for the nine months ended December 31, 2016 and the condensed consolidated statements of cash flows for the nine months ended December 31, 2016 and 2015 are unaudited.

 


The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of December 31, 2016  and the results of its operations for the three and nine months ended December 31, 2016 and 2015 as well as its cash flows for the nine months ended December 31, 2016 and 2015.  

 

The interim unaudited condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”).  The results of operations for the interim periods presented are not necessarily indicative of the results to be expected for any subsequent quarter or for the year ending March 31, 2017.  Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading.

 

Significant Accounting Policies

 

The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended March 31, 2016 included in the Company’s Transition Report on Form 10-QT filed with the SEC on November 8, 2016.  Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies.

 

Recent Accounting Pronouncements

 

In August 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update or ASU, 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), which amended the existing accounting standards for the statement of cash flows. The amendments provide guidance on eight classification issues related to the statement of cash flows. The Company is required to adopt the guidance in the first quarter of fiscal 2019 and early adoption is permitted. The amendments should be applied retrospectively to all periods presented. For issues that are impracticable to apply retrospectively, the amendments may be applied prospectively as of the earliest date practicable. The Company is currently in the process of assessing the impact of ASU 2016-15 on its statement of cash flows.

 

- 6 -



In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (“ASU 2016-13”), which introduces a new model for recognizing credit losses on financial instruments based on an estimate of current expected credit losses. ASU 2016-13 will apply to (1) loans, accounts receivable, trade receivables, and other financial assets measured at amortized cost, (2) loan commitments and other off-balance sheet credit exposures, (3) debt securities and other financial assets measured at fair value through other comprehensive income, and (4) beneficial interests in securitized financial assets. ASU 2016-13 will be effective in fiscal years beginning after December 15, 2019 including interim periods within those fiscal years. The Company is currently in the process of assessing the impact of ASU 2016-13 on the Company’s financial statements and related disclosures.

 

In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”), which provides for simplification of certain aspects of employee share-based payment accounting including income taxes, classification of awards as either equity or liabilities, accounting for forfeitures and classification on the statement of cash flows. ASU 2016-09 will be effective for the Company in the first quarter of 2017 and will be applied either prospectively, retrospectively or using a modified retrospective transition approach depending on the area covered in this update. The Company is currently in the process of assessing the impact of ASU 2016-09 on the Company’s consolidated financial statements and disclosures.

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual periods beginning after December 15, 2019, and for interim periods within fiscal years beginning after December 15, 2020, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact that the standard will have on its consolidated financial statements.

 

In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments - Overall (Subtopic 825-10), Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-1”), which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. ASU 2016-01 will be effective for the Company for annual periods and interim periods within those annual periods beginning after December 15, 2018 and early adoption is not permitted. The Company does not anticipate that the adoption of this standard will have a material impact on its consolidated financial statements.

 

In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740). The amendments in this update require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The Company did not retrospectively adjust the prior periods within the Balance Sheet. The early adoption ASU 2015-17 did not have a material impact on the Company’s financial position, results of operations or liquidity. The reason for the change is to simplify the presentation of deferred income taxes.

 

In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which provides guidance on determining when and how reporting entities must disclose going-concern uncertainties in their 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 of issuance of the entity’s financial statements (or within one year after the date on which the financial statements are available to be issued, when applicable). Further, an entity must provide certain disclosures if there is “substantial doubt about the entity’s ability to continue as a going concern.” This guidance is effective for annual reporting periods ending after December 15, 2016, and for annual periods and interim periods thereafter, with early adoption permitted. The Company does not anticipate that the adoption of this standard will have a material impact on its consolidated financial statements, other than potentially on the footnote disclosures.

 

- 7 -



Note 3. Net Loss Per Common Share

 

The following table sets forth the computation of basic and diluted net loss per common share for the periods indicated:

 

 

 

Three Months Ended
December 31,

 

Nine Months ended
December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share calculation:

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(2,990,949

)

$

(2,058,778

)

$

(12,123,214

)

$

(6,125,380

)

Weighted average common shares outstanding — basic and diluted

 

 

84,517,074

 

 

82,189,523

 

 

84,272,099

 

 

80,139,356

 

Net loss per share of common stock — basic and diluted

 

$

(0.04

)

$

(0.03

)

$

(0.14

)

$

(0.08

)

 

There are 3,500,000 shares in escrow, subject to cancellation, that have not been included in basic weighted average common shares outstanding for the three and nine months ended December 31, 2016 and 2015. (See Note 7. Stockholders’ Equity.)

 

The following outstanding securities at December 31, 2016 and 2015 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive:

 

 

 

2016

 

2015

 

 

 

 

 

 

 

Stock options

 

 

2,520,000

 

 

150,000

 

Warrants

 

 

967,418

 

 

476,267

 

Total

 

 

3,487,418

 

 

626,267

 

 

Note 4. Property and Equipment, Net.

 

Property and equipment, net consisted of the following:

 

 

 

December 31, 2016

 

March 31, 2016

 

 

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

Machinery and equipment

 

$

21,463

 

$

21,463

 

Less: accumulated depreciation

 

 

(12,857

)

 

(9,647

)

 

 

$

8,606

 

$

11,816

 

 

Depreciation expense was $3,210 and $3,218 for the nine months ended December 31, 2016 and 2015, respectively.

 

Note 5. Accounts Payable and Other Current Liabilities.

 

Accounts payable and other current liabilities consisted of the following:

 

 

 

December 31, 2016

 

March 31, 2016

 

 

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

Legal

 

$

1,169,056

 

$

795,478

 

Consulting

 

 

80,908

 

 

44,056

 

Accounting and auditing

 

 

59,332

 

 

143,357

 

Research and development

 

 

749,838

 

 

324,787

 

Board of Directors and Scientific Advisory Board compensation

 

 

450,000

 

 

337,500

 

Other

 

 

53,594

 

 

31,740

 

 

 

$

2,562,728

 

$

1,676,918

 


- 8 -



Note 6. Debt.

 

Insurance Note Payable

 

The Company entered into an agreement to finance director and officer insurance premiums totaling $232,100 for the policy year ending in March 2017.  The Company made a payment of $65,000 in April 2016 and, thereafter, payments will be made in eight equal installments of $21,274, inclusive of interest accruing at 3.99%.  

 

As of December 31, 2016, the Company has a prepaid asset associated with the financing of insurance premiums of $60,131 included as part of current assets for the policy year ending in March 2017. This amount is equal to the total premiums of $232,100 offset by expense recognized through December 31, 2016 of approximately $170,000.

 

Note 7. Stockholders’ Equity.

 

Preferred Stock

 

The Company is authorized to issue up to 10,000,000 shares of preferred stock, each with a par value of $0.0001.  Shares of Company preferred stock may be issued from time to time in one or more series and/or classes, each of which will have such distinctive designation or title as shall be determined by the Company’s board of directors prior to the issuance of any shares of such series or class.  The Company preferred stock will have such voting powers, full or limited or no voting powers and such preferences and relative, participating, optional or other special rights and such qualifications, limitations or restrictions thereof, as shall be stated in such resolution or resolutions providing for the issue of such series or class of Company preferred stock as may be adopted from time to time by the Company’s board of directors prior to the issuance of any shares thereof.  No shares of Company preferred stock are currently issued or outstanding and the Company’s board of directors has not designated any class or series of Company preferred stock for use in the future.  

 

Common Stock

 

Authorized, Issued and Outstanding

 

The Company is authorized to issue 300,000,000 shares of common stock, each with a par value of $0.0001, of which 88,130,152 shares were issued and outstanding at December 31, 2016 and 87,611,370 shares were issued and outstanding at March 31, 2016.

 

Voting

 

Each holder of Company common stock is entitled to one vote for each share thereof held by such holder at all meetings of stockholders (and written action in lieu of meetings). The number of authorized shares of Company common stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of majority of the combined number of issued and outstanding shares of the Company.

 

Dividends

 

Dividends may be declared and paid on the Company common stock from funds lawfully available therefore, as and when determined by the board of directors. At December 31, 2016 no dividends have been declared by the company.

 

Liquidation

 

In the event of the liquidation, dissolution, or winding-up of the Company, holders of Company common stock will be entitled to receive all assets of the Company available for distribution to its stockholders.

 

- 9 -



Escrow shares

 

Pursuant to the March 5, 2015 Agreement and Plan of Merger and Reorganization between Tyme, Inc and Tyme Tech that resulted in the Merger, (” Merger Agreement”), the Pre-Merger Company stockholders would have had the opportunity to receive 1,333,333 shares of Company common stock in the event that the Company conducted an offering of at least $20,000,000 at a pre-money Company valuation between $200,000,000 and $400,000,000 with such offering proceeds placed in escrow on or before the date which was five months following the consummation of the Merger. As this offering did not occur, these 1,333,333 shares were not issued by the Company.  The Merger Agreement further provided that, if the pre-money valuation on which the raised funds were placed into escrow was less than $200,000,000, or if no money was raised within such five month period, up to 3,500,000 shares of Company common stock were required to be surrendered for cancellation.  Such 3,500,000 shares were placed into escrow pursuant to an Adjustment Shares Escrow Agreement entered into at the time of Merger Closing (the “Adjustment Shares Escrow Agreement”).  The date on which the offering funds were required to be placed into escrow was extended under the terms of the Second Omnibus Amendment to November 5, 2015.  No offering was consummated, nor were any offering funds placed into escrow.  On November 10, 2015, the Company advised the escrow agent of such facts and demanded the surrender for cancellation of the 3,500,000 shares placed into escrow under the Adjustment Shares Escrow Agreement.  Under the Adjustment Shares Escrow Agreement, the depositor of such escrowed shares had until November 18, 2015 to challenge the Company’s demand for surrender of the Escrowed Shares.

 

On November 17, 2015, the Company received notice from the depositor of such 3,500,000 shares disputing the grounds for the surrender for cancellation of those shares. Until resolved by court order or otherwise, the 3,500,000 shares shall remain in escrow.


On January 19, 2016, the Company filed a complaint against the depositor with the Commercial Division of the Supreme Court of New York, New York and on April 1, 2016, the Company filed an amended complaint, which asserts causes of actions for (i) a declaratory judgment declaring that the relevant contracts require the 3,500,000 escrowed Adjustment Shares to be released to the Company; (ii) breach of contract for failure to deliver the 3,500,000 escrowed Adjustment Shares to the Company; (iii) conversion for the depositors willful and malicious interference with the Company’s rights to the Adjustment Shares; and (iv) replevin for the escrow agent’s refusal to surrender the escrowed Adjustment Shares to the Company.

 

On June 20, 2016, the depositor filed their answer and asserted two counterclaims. The first counterclaim alleges that the Company purportedly breached its obligation to allow the depositor to provide additional financing by refusing to allow the depositor to purchase 17,200,000 shares at a price of $1.1626 per share. The depositor alleges that it was damaged by at least $144,000,000 based upon the differential between the depositor’s proposed share purchase price and the then-current market value of the Company’s Common stock. The depositor’s second counterclaim alleges that the Company purportedly breached its fiduciary duties to the depositor as a stockholder of the Company, by rejecting the depositor’s proposed financing described above. The Company believes the depositor’s counterclaims are without merit and intends to vigorously defend these claims and seek the return of the 3,500,000 escrowed Adjustment Shares in accordance with the terms set out in the Merger Agreement and the Adjustment Shares Escrow Agreement. The Company moved to dismiss the counterclaims on August 10, 2016, the depositor filed its opposition on September 21, 2016 and the Company filed its reply memorandum of law on October 28, 2016.

 

Private Placement Offering


During the quarter ended December 31, 2016, the Company raised $1,470,005 through a private placement of 452,314 shares of its common stock.

 

Securities Issued for Services


On July 1, 2016, pursuant to a Securities Acquisition Agreement, dated as of June 29, 2016, the Company issued to a law firm, in satisfaction of $200,000 of payables due such law firm, an aggregate of (i) 50,000 shares of the Company’s common stock, par value $0.0001 per share, and (ii) 29,767 Warrants.  Each Warrant entitles its holder to purchase one share of common stock at an initial exercise price of $5.00 at any time during the period commencing on June 29, 2016 and terminating on the tenth anniversary of such date.  No registration rights were granted related to these shares or warrants.  The warrants are included within additional paid-in capital on the statement of stockholders’ equity and will not be subject to remeasurement.


- 10 -



Derivative Liability

 

Contemporaneous with the closing of the Merger, among other matters, the Company completed a private placement offering (the “PPO”). In addition, a Tyme convertible promissory note was converted into shares (“Bridge Note conversion Shares”) of the Company common stock. The investor in the PPO and the Bridge Note holder have been granted anti-dilution protection with respect to the PPO Shares and Bridge Note Conversion Shares such that, if within two years after the closing of the Merger, the Company shall issue additional shares of Company common stock or common stock equivalents, for a consideration per share less than $0.50 per share (the “Lower Price”), each such investor and holder will be entitled to receive from the Company additional shares (“Lower Price Shares”) of Company common stock in an amount such that, when added to the number of shares initially purchased by such investor or received upon conversion of the Bridge Note, will equal the number of shares that such investor’s PPO subscription amount would have purchased or the Bridge Note holder would have received upon conversion of the Bridge Note at the Lower Price.  GEM Global Yield Fund LLC SCS (“GEM”) was the sole investor in the PPO and designee of the Bridge Note holder who received the Bridge Note Conversion Shares.


The Company has determined that this anti-dilution protection is a freestanding financial instrument that will be carried as a liability at fair value.  At the time of the merger, in the quarter ended March 31, 2015, management measured this derivative at fair value and recognized a derivative liability of $376,300 on the consolidated balance sheet, with the offset recorded against additional paid-in capital.  The derivative is valued primarily using models based on unobservable inputs that represent management’s best estimate of what market participants would use in pricing the liability at the measurement date and thus are classified as Level 3.  The model incorporates various assumptions related to the Company’s stock price and ascribes a probability based on management’s expectation that such assumptions would occur.  Changes in the fair values of the derivative are recognized in earnings in the current period.  As of December 31, 2015, the Company determined that the likelihood of the anti-dilution provisions being met was remote based on the Company’s current stock price and the length of time remaining until maturity, and therefore, the anti-dilution protection had no value.  There have been no changes in the assumptions used at December 31, 2015 and therefore the derivative liability continues to have no value as of December 31, 2016.

 

Note 8. Commitments and Contingencies.

 

Contract Service Providers

 

In the course of the Company’s normal business operations, it enters into agreements and arrangements with contract service providers to assist in the performance of its research and development and clinical research activities. Substantially all of these agreements and arrangements are on an as needed basis.

 

Employment Agreement

 

On March 5, 2015, the Company entered into employment agreements with its Chief Executive Officer and Chief Operating Officer.  Under these agreements, each of such two executive officers will be entitled to an annual base salary of $450,000 and such performance bonuses as the Company’s board of directors may determine, from time to time, in its sole discretion.  The base salaries will be reviewed annually (commencing in 2016) by the Company’s board of directors; provided that the base salaries may not be decreased from their then current levels due to any board review.  The employment agreements each have a term of five years; provided, however, that, commencing on the first anniversary of the dates of the agreements and on each anniversary thereafter, the term shall automatically be extended by one year, such that, at any time during the term of the agreement, the remaining employment term shall never be less than four years and one day.  If employment is terminated by the Company without Cause or by the executive for Good Reason, the executive will be entitled to receive (i) base salary as in effect at the time of such termination to the extent such amount has accrued through the termination date and remains unpaid, (ii) any fully earned and declared but unpaid performance bonus as of the termination date, (iii) an amount equal to the sum of base salary the executive would have received from the date of such termination through the then applicable expiration date, which shall be payable in the same amounts and at the same intervals as if the employment period had not ended and (iv) any unpaid expenses as of the termination date. If the employment is terminated for “Cause,” or in the case of the executive’s death or disability, the executive will only be entitled to his base salary through the termination date, plus any accrued and unpaid performance bonus as of the termination date.  On May 9, 2016, each of the Chief Executive Officer and the Chief Operating Officer received an option to purchase 500,000 shares vesting monthly over a 36-month period. The exercise price of this option was set at $8.75 per share.

 

- 11 -



The Company entered into an employment arrangement, set forth in a letter agreement dated as of January 27, 2016, with its then-Chief Financial Officer the (“Former Chief Financial Officer”).  The new employment arrangement superseded the prior letter agreement with the Former Chief Financial Officer which was dated as of May 15, 2015.  As part of the new employment agreement, as of March 31, 2016, the officer was granted a five year option to purchase up to 200,000 shares of the Company’s common stock at a per share purchase price of $11.00, the closing price of the common stock on the date of the new agreement. One-half of the shares subject to such option vested immediately upon grant and the remaining 100,000 shares subject to the option vested on July 27, 2016. The options granted on January 27, 2016 were cancelled on May 9, 2016 upon the issuance of a new award on that date. The May 9, 2016 award to the Former Chief Financial Officer provided for an option to purchase 500,000 shares, with the option for 300,000 shares fully vested as of the date of grant and the option for 200,000 shares vesting monthly over a 36-month period. The exercise price of this option was set at $8.75 per share.

 

Pursuant to a prior agreement, the Former Chief Financial Officer also was granted a five-year option to purchase 150,000 shares of Company common stock at $7.75 per share. The option vested with respect to 75,000 shares on November 15, 2015 and the remaining 75,000 shares vested on May 15, 2016.


On January 16, 2017, the Former Chief Financial Officer resigned from the Company.  Pursuant to the terms of the Company’s 2015 Equity Incentive Plan (the “2015 Plan”), the Former Chief Financial Officer’s option awards are exercisable to the extent vested, until three months after the date of his termination.

 

On May 9, 2016, the board of directors of the Company approved an employment agreement with its Chief Medical Officer.  The approved agreement provides for an annual salary of $400,000 and severance benefits payable in certain circumstances.  The Board also approved a grant to the Chief Medical Officer of an option to purchase 500,000 shares of common stock vesting over a four-year term on a monthly basis.  The exercise price of this option was set at $8.75 per share.


Legal Proceedings

 

Other than discussed in Note 7, the Company is not involved in any legal proceeding that it expects to have a material effect on its business, financial condition, results of operations or cash flows.

 

Note 9. Equity Incentive Plan.

 

On March 5, 2015, the Company’s Board of Directors adopted and the Company’s stockholders approved, the 2015 Plan.  A reserve of 10,000,000 shares of Company common stock has been established for issuance under the 2015 Plan.  No more than an aggregate of 3,333,333 shares of common stock may be awarded during the twelve months following the 2015 Plan adoption.  Awards under the 2015 Plan may include, but need not be limited to, one or more of the following: options, stock appreciation rights, restricted stock, performance grants, stock bonuses, and any other type of award deemed by the administrator to be consistent with the purposes of the 2015 Plan.  The exercise price of all options awarded under the 2015 Plan must be no less than 100% of the fair market value of the Company common stock on the date of the grant and have a term of no greater than ten years from the date of grant.  As of December 31, 2016, there were 7,427,162 shares available for grant under the 2015 Plan.

 

Stock Options

 

As of December 31, 2016, there was $10,068,092 of total unrecognized compensation related to non-vested stock options.  The cost is expected to be recognized over the remaining period of the options which are expected to vest through 2020. In addition to the grants to members of management, the Company has also granted options to certain of its employees as well as consultants working in an advisory capacity and the independent directors on its Board.

 

The Company uses the Black-Scholes option pricing model to determine the fair value of stock options granted.  In accordance with ASC 718 for employees, the compensation expense is amortized on a straight-line basis over the requisite service period, which approximates the vesting period. Compensation expense for stock options granted to consultants is recognized on a straight-line basis over the term of the service contract.

 

The expected volatility of options granted has been determined using the method described under ASC 718 using the expected volatility of similar companies.  The expected term of options granted to employees in the current fiscal period has been based on the contractual term of the agreement as prescribed by ASC 718 Share-Based Payment.

 

- 12 -



The assumptions utilized to determine such values are presented in the following table:

 

 

December 31, 2016

 

December 31, 2015

 

(Unaudited)

 

(Unaudited)

 

 

 

 

Risk free interest rate

1.77%

 

1.65%

Expected volatility

88.45%

 

82.90%

Expected term

10 years

 

5 years

Dividend yield

0%

 

0%


The following is a summary of the status of the Company’s stock options as of December 31, 2016:

 

 

 

Number of
Options

 

Weighted Average
Exercise Price

 

 

 

 

 

 

 

 

 

Outstanding at March 31, 2016

 

 

350,000

 

$

9.61

 

Granted

 

 

2,370,00

 

 

8.44

 

Exercised

 

 

 

 

 

Forfeited/Cancelled

 

 

(200,000

)

 

11.00

 

Outstanding at December 31, 2016

 

 

2,520,000

 

 

8.40

 

Grant date fair value of options granted during the nine months ended December 31, 2016

 

$

7.20

 

 

 

 


 

 

Stock Options Outstanding

 

Stock Options Vested

Range of
Exercise
Price

 

Number
Outstanding at
December 31,
2016

 

Weighted
Average
Exercise
Price

 

Weighted
Average
Remaining
Life (Years)

 

Aggregate
Intrinsic
Value

 

Number
Vested at
December 31,
2016

 

Weighted
Average
Exercise
Price

 

Aggregate
Intrinsic
Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$3.50-$8.75

 

2,520,000

 

$8.40

 

9.02

 

$6,250

 

1,072,083

 

$8.03

 

$694


The intrinsic value is calculated as the excess of the market value of December 31, 2016 over the exercise price of the options.


Share-based compensation expense recognized was as follows:


 

 

 

Three Months Ended
December 31,

 

 

Nine Months ended
December 31,

 

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

617,609

 

$

 

$

1,856,213

 

$

 

General and administrative

 

 

497,982

 

 

193,504

 

 

4,513,615

 

 

485,859

 

 

 

$

1,115,591

 

$

193,504

 

$

6,369,828

 

$

485,859

 


Stock Grants

 

On March 10, 2015, the Company adopted an independent director compensation policy and also adopted a compensation policy with respect to a special advisor to the Company’s board of directors. Under such independent director compensation policy, each of those directors meeting the NASDAQ stock market definition of independent director is entitled to receive annual compensation in the amount of $100,000, one-half to be paid in cash on a quarterly basis, in arrears, and the remaining one-half of the compensation to be paid in the form of Company common stock on a quarterly basis, in arrears, with the shares valued at the closing sale price of the Company common stock on the last trading day of the applicable quarterly period. The special advisor was compensated in the same manner as the independent directors through the date the special advisor joined the Company’s board of directors (May 9, 2016). Additionally, effective as of September 30, 2015, the Company established a Scientific and Medical Advisory Board, and five individuals were appointed as members of such advisory board and a compensation policy for the advisory board’s members, substantially identical to the compensation policy for the Company’s independent directors, was adopted. At the end of calendar 2015, one member of the Scientific and Medical Advisory Board became a full time employee of the Company and is no longer compensated as a member of the advisory board.


- 13 -



The Company issued to its three independent directors and special advisor and their five scientific advisory board members an aggregate of 29,122 shares of Company common stock as compensation during the nine months ended December 31, 2015.  The shares were valued using the $8.50 closing sale price of the Company common stock on the last trading day of the quarter ended June 30, 2015 and September 30, 2015 and $11.25 for the last trading day of the quarter ending December 31,2015.  Total stock compensation expense related to these stock grants were $112,500 and $275,000 for the three and nine months ended December 31, 2015, respectively.

 

On May 9, 2016, the Company amended the independent director compensation policy. The independent directors will continue to receive $50,000 in cash annually. Pursuant to the amended compensation policy, the independent directors received an immediate stock option grant of 25,000 shares with an exercise price per share at fair market value ($8.75). Beginning with the Company’s 2017 annual meeting, members who are reelected as members of the Board will receive an annual stock option grant of 10,000 shares at fair market value. Each of these stock option awards will vest 50% on the date of grant and 50% on the first anniversary of the date of grant. These stock option awards are in addition to the annual payment of $50,000 in cash fees for the independent directors.

 

The Company issued 16,468 shares of Company common stock as compensation to its scientific advisory board members during the nine months ended December 31, 2016.  The shares were valued using the $6.05 and $6.10 closing sale price of the Company common stock on the last trading day of the quarters ended June 30, 2016, and September 30, 2016, respectively.  Total compensation expense related to these stock grants was $50,000 and $150,000 for the three and nine months ended December 31, 2016. At December 31, 2016 the company has accrued $100,000 for the cash value of the stock compensation related to the quarters ended September 30, 2016 and December 31, 2016.


Note 10.  Income Taxes


A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized.  The Company weighed all available positive and negative evidence and concluded that a full valuation allowance should continue to be maintained on its net deferred tax assets that predominantly consists of cumulative net operating losses.


The Company is required to evaluate uncertain tax positions taken or expected to be taken in the course of preparing the Company’s consolidated financial statements to determine whether the tax positions are more likely than not of being sustained by the applicable tax authority.  Tax positions with respect to tax at the Company level deemed not to meet the “more-likely-than-not” threshold would be recorded as a tax expense in the current year.  As of December 31, 2016 the Company had $331,545 of unrecognized tax benefits, which were offset with the net operating loss and valuation allowance on the consolidated balance sheet.  None of the gross unrecognized tax benefits would affect the effective tax rate at December 31, 2016, if recognized.


The Company had no income tax related penalties or interest for periods presented in these consolidated financial statements related to uncertain tax positions, which would be recorded as tax expense should the Company accrue for such items.

 

Note 11.  Subsequent Events.

 

The Company evaluates events or transactions that occur after the balance sheet date but prior to the issuance of consolidated financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. For its interim financial statements as of December 31, 2016 and for the three and nine months then ended, management of the Company determined that there were no reportable subsequent event to be disclosed, other than the resignation of the Former Chief Financial Officer effective January 16, 2017.  The Company’s chief operating officer will serve as interim chief financial officer while a permanent replacement search is conducted.

 

- 14 -



Item 2. 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 related notes appearing in our Quarterly Report on Form 10-Q.  Some of the information contained in this discussion and analysis or set forth elsewhere in our Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties.  As a result of many factors, including those factors set forth in the “Risk Factors” section of our Annual Report on Form 10-K filed on March 30, 2016, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.  As used in this report, unless the context suggests otherwise, “we,” “us,” “our,” “the Company” or “Tyme Technologies” refer to Tyme Technologies, Inc.

 

Overview

 

We were originally formed in Florida on November 22, 2011, to produce, market and sell an ultra-premium vodka product to retailers. We were not successful in our efforts and we turned our efforts towards seeking, investigating and, if such investigation warranted, engaging in a business combination with a private entity whose business presented an opportunity for our stockholders.

 

Effective as of September 18, 2014, we (then constituting a Florida corporation with the name Global Group Enterprises Corp.) reincorporated in the State of Delaware by merging into our wholly-owned Delaware subsidiary, Tyme Technologies, Inc., which was formed on August 22, 2014 specifically for this purpose (the “Reincorporation”).  Tyme Technologies, Inc. was the surviving corporation in such merger.  As a result of the Reincorporation, among other things, (i) we changed our name to Tyme Technologies, Inc., (ii) we changed our jurisdiction of incorporation from Florida to Delaware, (iii) we increased our authorized capital stock from 250,000,000 shares of common stock, $0.0001 par value per share, to 300,000,000 shares of common stock, $0.0001 par value per share, and 10,000,000 shares of preferred stock, $0.0001 par value per share, (iv) each share of Global Group Enterprises Corp.’s common stock outstanding at the time of the Reincorporation was automatically converted into 4.3334 shares of Tyme Technologies, Inc.’s common stock, with the result that the 12,000,000 shares of common stock outstanding immediately prior to the Reincorporation were converted into 52,000,800 shares of common stock outstanding immediately thereafter.


In November 2016 the Company filed for 10-QT effectively changing the Company’s calendar year end to a fiscal year ending March 31 of each calendar year.

 

We are in the process of evaluating our short- and long-term financing requirements in order to effectuate our business plan. We anticipate that we will seek to raise required capital by the issuance of equity or debt securities, through private or public offerings or by other means. Our inability to raise necessary funds to conduct our planned operations could have a severe adverse effect on our ability to become a viable company. In addition, no assurance can be given that we will be able to obtain funds on favorable terms, if at all.

 

Recent Developments

 

In September 2015, we filed an Investigational New Drug Application (“IND”) with the FDA for our SM-88 drug candidate. In October 2015, the FDA accepted the IND and concluded that we may proceed with a clinical investigation of SM-88 for breast cancer. Subsequently, we made a determination, based on input from various sources and the strong interest of several clinical sites, to prioritize our clinical trial objectives by initiating a study in prostate cancer. On June 13, 2016, we announced that we have begun recruiting for a phase Ib/II clinical trial, using SM-88 to treat prostate cancer.

 

The trial will be a single-arm, open-label trial and up to five clinical sites will be involved. Prospective enrollees will have prostate cancer, rising PSA levels, without metastatic disease, and have failed androgen deprivation therapy. We will report results on PSA levels and novel biomarker components, as well as progression free survival data at the conclusion of the study, or earlier, if appropriate milestones are met. The Company is also evaluating the expansion of its phase II program to other types of cancer, including pancreatic cancer.

 

- 15 -



Critical Accounting Policies and Significant Judgments and Estimates

 

This 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 GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, revenue recognition, deferred revenue and stock-based compensation. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no significant changes in our critical accounting policies and significant judgments and estimates as discussed in our Form 10-QT filed on November 8, 2016 with the SEC.

 

Results of Operations

 

Three and Nine Months Ended December 31, 2016 Compared to Three and Nine Months Ended December 31, 2015

 

Net loss for the three months ended December 31, 2016 was $2,990,949 compared to $2,058,778 for the three months ended December 31, 2015.  Net loss for the nine months ended December 31, 2016 was $12,123,214 compared to $6,125,380 for the nine months ended December 31, 2015.

 

Revenues and Other Income

 

During the three and nine month periods ended December 31, 2016 and 2015, we did not realize any revenues from operations. We do not anticipate recognizing any revenues until such time as one of our products has been approved for marketing by appropriate regulatory authorities or we enter into collaboration or licensing arrangement, none of which is anticipated to occur in the near future.

 

Operating Costs and Expenses

 

For the three months ended December 31, 2016, operating costs and expenses totaled $2,990,949 compared to $2,435,033 for the three months ended December 31, 2015, representing an increase of $555,916. Operating costs and expenses were comprised of the following:

 

Research and development expenses were $1,745,681 for the three months ended December 31, 2016, compared to $1,136,563 for the three months ended December 31, 2015, representing an increase of $609,118. All research and development expenditures have been incurred in respect of our lead drug candidate, SM-88, and its technology platform. Research and development activities primarily consist of the following:

 

 

Salary expense for research and development personnel was $225,500 for the three months ended December 31, 2016, compared to $130,288 for the three months ended December 31, 2015, an increase of $95,212 between the comparable periods. This increase in 2016 expense is primarily attributable to a new hire.

 

 

 

 

Consulting and study expenses were $572,191 for the three months ended December 31, 2016, compared to $671,231 for the three months ended December 31, 2015, representing a decrease of $99,040 between the comparable periods. These types of expenses are anticipated to vary between future accounting periods as we continue to develop our drug candidates and seek governmental approval of such drug candidates.

 

 

 

 

Cash and stock compensation expense totaling $100,000 related to the Scientific Advisory Board compared to $125,000 for the three months ended December 31, 2015. This decrease is due to fewer Scientific Advisory Board members in the quarter ended December 31, 2016.

 

 

 

 

Stock based compensation expense related to stock options granted to research and development personnel was $617,609 for the three months ended December 31, 2016.  No stock options were granted during or prior to the three months ended December 31, 2015 to research and development personnel.

 

General and administrative expenses were $1,245,268 for the three months ended December 31, 2016, compared to $1,298,470 for the three months ended December 31, 2015, representing a decrease of $53,202. The general and administrative expenses for the respective periods include:

 

- 16 -



 

Salary expense for non-research and development personnel was $247,365 for the three months ended December 31, 2016, compared to $215,284 for the three months ended December 31, 2015, representing a $32,081 increase between the comparable periods. The increase is due to a new hired employee during the quarter ending March 31, 2016.

 

 

 

 

Stock based compensation expense related to stock options granted was $497,982 for the three months ended December 31, 2016 compared to $193,504 for the three months ended December 31, 2015, representing an increase of $304,478 between the comparable periods. Stock options were granted to a larger population of executives and employees during the three months ended December 31, 2016 compared to only one non-research and development personnel stock option grant prior to the three months ending December 31, 2015.

 

 

 

 

Accounting and legal fees were $327,466 for the three months ended December 31, 2016 compared to $721,936 for the three months ended December 31, 2015, representing a decrease of $394,470. The 2016 decrease is due to decrease in legal activity in the current period.


For the nine months ended December 31, 2016, operating costs and expenses totaled $12,123,214 compared to $6,501,635 for the nine months ended December 31, 2015, representing an increase of $5,621,579. Operating costs and expenses were comprised of the following:


Research and development expenses were $4,461,689 for the nine months ended December 31, 2016, compared to $3,234,649 for the nine months ended December 31, 2015, representing an increase of $1,227,040. All research and development expenditures have been incurred in respect of our lead drug candidate, SM-88, and its technology platform. Research and development activities primarily consist of the following:


 

Salary expense for research and development personnel was $656,474 for the nine months ended December 31, 2016, compared to $385,561 for the nine months ended December 31, 2015, an increase of $270,913 between the comparable periods. The 2016 increase is primarily attributable to head count changes during the year compared to the prior year.

 

 

 

 

Consulting and study expenses were $1,098,706 for the nine months ended December 31, 2016, compared to $1,768,592 for the nine months ended December 31, 2015, representing a decrease of $669,886 between the comparable periods. These types of expenses are anticipated to vary between future accounting periods as we continue to develop our drug candidates and seek governmental approval of such drug candidates.

 

 

 

 

Cash and stock compensation expense totaling $300,000 related to the Scientific Advisory Board for the nine months ended December 31, 2016 compared to $250,000 for the nine months ended December 31, 2015. This increase is due to a change in Scientific Advisory Board compensation structure in September 2015.

 

 

 

 

Stock based compensation expense related to stock options granted to research and development personnel was $1,856,213 for the nine months ended December 31, 2016. No stock options were granted during or prior to the nine months ended December 31, 2015 to research and development personnel.

 

General and administrative expenses were $7,661,525 for the nine months ended December 31, 2016, compared to $3,266,986 for the nine months ended December 31, 2015, representing an increase of $4,394,539. The general and administrative expenses for the respective periods include:

 

 

Salary expense for non-research and development personnel was $771,784 for the nine months ended December 31, 2016, compared to $630,438 for the nine months ended December 31, 2015, representing a $141,346 increase between the comparable periods. The increase is due to a new hire during the quarter ending March 31, 2016.

 

 

 

 

Stock based compensation expense related to stock options granted was $4,513,615 for the nine months ended December 31, 2016 compared to $485,859 for the nine months ended December 31, 2015, representing an increase of $4,027,756 between the comparable periods. Stock options were granted to a larger population of executives and employees during the nine months ended December 31, 2016 compared to only one non-research and development personnel stock option grant prior to the nine months ended December 31, 2015.

 

 

 

 

Legal and accounting fees were $1,714,162 for the nine months ended December 31, 2016 compared to $1,430,989 for the nine months ended December 31, 2015, representing an increase of $283,173 mainly attributable to a change from calendar year-end to a fiscal  year ending March 31 and an audit which was conducted for the interim quarter ended March 31, 2016.

 

- 17 -



Other income (expense)

 

There were no interest charges for the three and nine months ended December 31, 2016 and 2015.  There was no other income or expense for the three and nine months ended December 31, 2016, compared to $376,255 of other income for the three and nine months ended December 31, 2015, respectively.  Other expense recorded for the three and nine months ended December 31, 2015 related to the gain on the remeasurement of the derivative liability.

 

Liquidity and Capital Resources

 

At December 31, 2016, we had cash of $2,985,450, working capital of $442,218 and stockholders’ equity of $450,824.

 

Net cash used in or provided by operating, investing and financing activities from continuing operations were as follows:

 

 

 

Nine Months ended

December 31,

 

 

 

2016

 

2015

 

 

 

 

 

 

 

 

 

Net cash used in operating activities

 

$

4,398,399

 

$

4,328,473

 

Net cash used in investing activities

 

 

 

 

 

Net cash provided by financing activities

 

 

1,278,540

 

 

5,448,377

 

 

Operating Activities

 

Our cash used in operating activities in the nine months ended December 31, 2016 totaled $4,398,399 which is the sum of (i) our net loss of $12,123,214 less non-cash expenses totaling $6,673,038 (principally stock-based compensation), and (ii) changes in operating assets and liabilities of $1,051,777.

 

Our cash used in operating activities in the nine months ended December 31, 2015 totaled $4,328,473, which is the sum of (i) our net loss of $6,125,380 less non-cash expenses totaling $587,777 (principally the issuance of common stock for services) , and (ii) changes in operating assets and liabilities of $1,209,130.

 

Investing Activities

 

We had no net cash used in investing activities for the nine months ended December 31, 2016 and 2015.

 

Financing Activities

 

During the nine months ended December 31, 2016, our financing activities consisted of the following:

 

In October 2016, pursuant to a securities purchase agreement, the Company received $1,470,005 in a private placement of securities. The Company sold and issued 452,314 shares of the company stock.

 

 

Insurance notes payments were made totaling $191,465.

 

During the nine months ended December 31, 2015, our financing activities consisted of the following:

 

We received $2,500,000 from the collection of the stock subscription receivable representing the principal amount of the Private Placement Offering Note.

 

 

We received proceeds of $2,966,000 from the private placement offering of common stock.

 

Liquidity and Capital Requirements Outlook

 

Liquidity

 

We anticipate requiring additional capital in order to fund the development of our product candidates, as well as to engage in strategic transactions. The most significant funding needs are anticipated to be in connection with preparing for and conducting one or more phase II clinical trials of our SM-88 drug candidate and related studies and investigations.

 

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To meet our short and long-term liquidity needs, we currently expect to use existing cash balances and a variety of other means, including potential issuances of debt or equity securities in public or private financings, option exercises, and partnerships and/or collaborations. The demand for the equity and debt of biopharmaceutical companies like ours is dependent upon many factors, including the general state of the financial markets. During times of extreme market volatility, capital may not be available on favorable terms, if at all. Our inability to obtain such additional capital could materially and adversely affect our business operations. In addition, we expect to seek as appropriate grants for scientific and clinical studies. There can be no assurance that we will be successful in qualifying for or obtaining such grants.

 

We believe that our cash balances as of December 31, 2016 will be sufficient to fund the business through the next five to seven months.

 

While we will continue to seek capital through a number of means, there can be no assurance that additional financing will be available on acceptable terms, if at all, and our negotiating position in capital generating efforts may worsen as existing resources are used.

 

Additional equity financing may be dilutive to our stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict our ability to operate as a business; and our stock price may not reach levels necessary to induce option exercises. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the development of our drug candidates or raise funds on terms that we currently consider unfavorable. These factors raise substantial doubt about our ability to continue as a going concern.

 

Seasonality

 

The Company does not believe that its operations are seasonal in nature.

 

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 SEC rules.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risks.

 

The primary objective of our investment activities is to preserve capital while at the same time maximizing yields without significantly increasing risk. Our cash balance as of December 31, 2016 was held in insured depository accounts, of which approximately $2,735,450 exceeded insurance limits.

 

Item 4. Controls and Procedures.

 

Our management, with the participation of our Chief Executive Officer and Interim Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2016 as required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act.  The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

 

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officer to allow timely decisions regarding required disclosure.  Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

Based on the evaluation of our disclosure controls and procedures as of December 31, 2016, our Chief Executive Officer and Interim Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were not effective for the reasons set forth below.

 

- 19 -



The matters involving internal controls and procedures that our management considered to be material weaknesses under the standards of the Public Company Accounting Oversight Board were:

 

inadequate segregation of duties consistent with control objectives;

 

 

ineffective controls over period end financial disclosure and reporting processes; and

 

 

lack of a senior financial reporting executive.

 

The aforementioned material weaknesses were identified by Mr. Hoffman and Michael Demurjian, the Company’s Chief Operating Officer and Interim Chief Financial Officer, in connection with their review of our financial statements as of December 31, 2016.  In addition, our management noted further control and procedures deficiencies, including those relating to segregation of duties over cash disbursements and the prompt analysis of the financial impact of all transactions to which we are a party.

 

Our management believes that the material weaknesses set forth above did not have an effect on our financial results.

 

Management’s Remediation Initiatives

 

In an effort to remediate the identified material weaknesses and other deficiencies and enhance our internal controls, we have initiated, or plan to initiate, the following series of measures:

 

Assuming we are able to secure additional working capital, we will create additional positions in order to segregate duties consistent with control objectives and will increase our personnel resources and technical accounting expertise within the accounting function. Since our fiscal quarter ended September 30, 2015, we have retained accounting and financial reporting advisory firms with significant experience with publicly held companies to assist management in the accounting function and in implementing and enhancing our internal controls over financial reporting.

 

 

We intend to design and implement centralized and automated enhancements to the processing of invoices to assure standardized supplier setup and proper entry by invoice type into our accounts payable system. These enhancements will also incorporate adherence to signing authorities as part of payment processing and ensure the completion of timely month end reconciliation procedures for accounts payable and accrued expenses.

 

 

We intend to hire a new Chief Financial Officer.

 

Changes in Internal Control over Financial Reporting

 

We recently formed an audit committee. We anticipate that such audit committee will discuss with management, including our Interim Chief Financial Officer, and our independent registered public accounting firm, the status of our financial controls and procedures and determine what changes are necessary to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with US GAAP.  We anticipate that a number of changes in our financial controls and procedures will be made in the ensuing periods.

 

- 20 -



PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

Except as set forth below, we are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on us, our business, operating results or financial condition.

 

On March 5, 2015, we, our wholly-owned subsidiary formed for the purposes of completing the merger (which we refer to as “Acquisition Sub”), Tyme Inc. (“Tyme”) and certain other parties entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”).  Simultaneous with the execution of the Merger Agreement, we and the other parties to the Merger Agreement consummated the transactions contemplated by the Merger Agreement (the “Merger”).  We refer to the date that the transactions contemplated by the Merger Agreement, including the Merger, were consummated as the “Closing Date.”  Pursuant to the terms of the Merger Agreement, Acquisition Sub merged with and into Tyme.  Tyme was the surviving corporation in the Merger and thus became our wholly-owned subsidiary.

 

The Merger Agreement provided that, in the event we raised additional capital in a public or private offering (in one or more closings) for gross proceeds of at least $20 million (a “Qualified Offering”), based on a pre-money valuation of our Company of at least $200 million, within five months of the earlier two dates specified in the Merger Agreement, as amended and subject to certain conditions (with such date being referred to as the “Qualified Offering Trigger Termination Date”), the holders of record of our Common Stock as of the Closing Date (the “Pre-Merger Company Stockholders”) would have the opportunity to receive, pro rata, 1,333,333 additional restricted shares of our Common Stock (the “Qualified Offering Shares”).

 

The Merger Agreement further provided that:

 

if the pre-money valuation of our Company upon a Qualified Offering is $150 million or more but less than $200 million, the Pre-Merger Company Stockholders will surrender to us for cancellation without consideration 1 million shares of our Common Stock;

 

 

if the pre-money valuation of our Company upon a Qualified Offering is $100 million or more but less than $150 million, the Pre-Merger Company Stockholders will surrender to us for cancellation without consideration 2 million shares of our Common Stock; and

 

 

if the pre-money valuation of the Company upon a Qualified Offering is less than $100 million (which Qualified Offering may be rejected in the Company’s sole and absolute discretion) or if no Qualified Offering occurs within five months of the Qualified Offering Trigger Termination Date, the Pre-Merger Company Stockholders would be obligated to surrender to us for cancellation without consideration 3.5 million shares of our Common Stock.

 

The Pre-Merger Company Stockholders previously placed into escrow pursuant to an escrow agreement (the “Adjustment Shares Escrow Agreement”) 3.5 million shares of our Common Stock (the “Adjustment Shares”) to secure such surrender obligations described above.

 

We had the sole authority to determine all matters relating to the Qualified Offering, including the subscription price, pre-money valuation and whether or not to accept any subscriber’s subscription offer.  No Qualified Offering occurred by the Qualified Offering Trigger Termination Date and we have sought a return of the Adjustment Shares from the escrow under the Adjustment Shares Escrow Agreement.

 

On November 10, 2015, we made demand of the escrow agent holding the Adjustment Shares for their surrender for cancellation. On November 17, 2015, GEM Global Yield Fund LLC SCS (“GEM”), as depositor and on behalf of the Pre-Merger Company Stockholders, challenged such demand.

 

On January 19, 2016, we filed a complaint against GEM with the Commercial Division of the Supreme Court of New York, New York, captioned Tyme Technologies, Inc. v. GEM Global Yield Fund LLC SCS and CKR Law LLP, Index No. 650250/2016.  On April 1, 2016, we filed an Amended Complaint.  The Amended Complaint asserts causes of actions for (i) a declaratory judgment declaring that the relevant contracts require the 3.5 million escrowed Adjustment Shares to be released to us; (ii) breach of contract for failure to deliver the 3.5 million escrowed Adjustment Shares to us; (iii) conversion for GEM’s willful and malicious interference with Tyme Technologies’ rights to the Adjustment Shares; and (iv) replevin for CKR Law’s refusal to surrender the escrowed Adjustment Shares to us.

 

- 21 -



On June 20, 2016, the depositor filed their answer and asserted two counterclaims.  The first counterclaim alleges that the Company purportedly breached its obligation to allow the depositor to provide additional financing by refusing to allow the depositor to purchase 17,200,000 shares at a price of $1.1626 per share.  The depositor alleges that it was damaged by at least $144,000,000 based upon the differential between the depositor’s proposed share purchase price and the then-current market value of the Company’s Common stock.  The depositor’s second counterclaim alleges that the Company purportedly breached its fiduciary duties to the depositor as a stockholder of the Company, by rejecting the depositor’s proposed financing described above.  The Company believes the depositor’s counterclaims are without merit and intends to vigorously defend these claims and seek the return of the 3,500,000 escrowed Adjustment Shares in accordance with the terms set out in the Merger Agreement and the Adjustment Shares Escrow Agreement.  The Company moved to dismiss the counterclaims on August 10, 2016, the depositor filed its opposition on September 21, 2016 and the Company filed its reply memorandum of law on October 28, 2016.

 

Item 1A. Risk Factors.

 

There have been no material changes to the risk factors disclosed in Part 1, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on March 30, 2016.  Such risk factors are relevant in evaluating our business, financial position, future results and prospects.  The risks described in our Annual Report on Form 10-K are not the only risks we face.  Additional risks that we do not presently know or that we currently believe are immaterial could also materially and adversely affect any of our business, financial position, future results or prospects.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

During the quarter ended December 31, 2016, the Company raised $1,470,005 through a private placement of 452,314 shares of its common stock.  The shares were offered and issued in reliance upon an exemption from registration pursuant to Section 4(a)(2) of the Securities Act.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not applicable.

 

Item 5. Other Information.

 

None.

 

Item 6. Exhibits.

 

In reviewing the agreements included or incorporated by reference as exhibits to our Quarterly Report on Form 10-Q, please remember that they are included to provide the reader with information regarding their terms and are not intended to provide any other factual or disclosure information about our Company or the other parties to the agreements.  The agreements may contain representations and warranties by each of the parties to the applicable agreement.  These representations and warranties have been made solely for the benefit of the parties to the applicable agreement and:

 

should not in all instances be treated as categorical statements of fact, but rather as a way of allocating the risk to one of the parties if those statements prove to be inaccurate;

 

 

have been qualified by disclosures that were made to the other party in connection with the negotiation of the applicable agreement, which disclosures are not necessarily reflected in the body of the as-filed agreement;

 

 

may apply standards of materiality in a way that is different from what may be viewed as material to readers of this Form 10-Q or other investors; and

 

 

were made only as of the date of the applicable agreement or such other date or dates as may be specified in the agreement and are subject to more recent developments.

 

- 22 -



Accordingly, such representations and warranties may not describe the actual state of affairs as of the date they were made or at any other time. Additional information about our Company may be found elsewhere in this Form 10-Q and our other public filings, which are available without charge through the SEC’s website at http://www.sec.gov.

 

Exhibit
Number

Description

31.1*

Rule 13(a)-14(a)/15(d)-14(a) Certification of Principal Executive Officer.

31.2*

Rule 13(a)-14(a)/15(d)-14(a) Certification of Principal Financial Officer.

32.1*

Rule 1350 Certification of Chief Executive Officer.

32.2*

Rule 1350 Certification of Chief Financial Officer.

101.INS*

XBRL Instance Document.

101.SCH*

XBRL Schema Document.

101.CAL*

XBRL Calculation Linkbase Document.

101.DEF*

XBRL Definition Linkbase Document.

101.LAB*

XBRL Label Linkbase Document.

101.PRE*

XBRL Presentation Linkbase Document.

__________

* Filed Herewith.


- 23 -



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.

 

Dated: February 14, 2017

 

 

TYME TECHNOLOGIES, INC.

 

 

 

 

 

 

 

 

 

 

By:

/s/ Steve Hoffman

 

 

 

Steve Hoffman

 

 

 

President and

 

 

 

Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

/s/ Michael Demurjian

 

 

 

Michael Demurjian

 

 

 

Chief Operating Officer and

 

 

 

Interim Chief Financial Officer

 

 

 

(Principal Financial Officer

 

 

 

and Principal Accounting Officer)

 


- 24 -