Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended:

December 31, 2020

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: 001-38169

 

TYME TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

45-3864597

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

1 Pluckemin Way – Suite 103

Bedminster, New Jersey 07921

(Address of principal executive offices)

(Zip Code)

(212) 461-2315

(Registrant’s telephone number, including area code)

 

Not Applicable

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

 

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value

TYME

Nasdaq Capital Market

 

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      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files).    Yes      No  

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

 

Large accelerated filer

 

 

Accelerated filer

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

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

The number of shares outstanding of the registrant’s common stock on January 27, 2021 was 130,427,089.

 


Table of Contents

TABLE OF CONTENTS

 

 

 

 

 

Page

 

 

 

Special Note Regarding Forward-Looking Statements

 

1

 

 

 

 

 

 

 

PART I- FINANCIAL INFORMATION

 

 

Item 1.

 

Financial Statements.

 

2

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of December 31, 2020 (unaudited) and March 31, 2020.

 

2

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations (unaudited) for the three and nine months ended December 31, 2020 and 2019.

 

3

 

 

 

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the three and nine months ended December 31, 2020 and 2019.

 

4

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended December 31, 2020 and 2019.

 

5

 

 

 

 

 

 

 

Notes to Unaudited Condensed Consolidated Financial Statements.

 

6

 

 

 

 

 

Item 2.

 

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

 

17

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk.

 

26

 

 

 

 

 

Item 4.

 

Controls and Procedures.

 

26

 

 

 

 

 

 

 

PART II- OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings.

 

27

 

 

 

 

 

Item 1A.

 

Risk Factors.

 

27

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds.

 

27

 

 

 

 

 

Item 3.

 

Defaults Upon Senior Securities.

 

27

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures.

 

27

 

 

 

 

 

Item 5.

 

Other Information.

 

27

 

 

 

 

 

Item 6.

 

Exhibits.

 

28

 

 

 

 

 

SIGNATURES

 

 

 

29

 

 

 


Table of Contents

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS


Certain statements in this Quarterly Report on Form 10-Q are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. All statements contained in this Quarterly Report on Form 10-Q other than statements of historical facts, including statements regarding our future results of operations and financial position, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements within this report include, without limitation, statements regarding our drug candidates (including SM-88 and TYME- 18) and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned preclinical or clinical trials, including the proposed TYME-19 proof-of-concept study, preliminary data results and the therapeutic design and mechanisms of our drug candidates. The words “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” “anticipates,” and similar expressions (including their use in the negative) are intended to identify forward-looking statements. Forward-looking statements can also be identified by discussions of future matters such as: the effect of the novel coronavirus (COVID-19) pandemic and the associated economic downturn and impacts on the Company's ongoing clinical trials and ability to analyze data from those trials; the cost of development and potential commercialization of our lead drug candidate and of other new products; expected releases of interim or final data from our clinical trials; possible collaborations; and the timing, scope, status, objectives and strategy of our ongoing and planned trials; the success of management transitions; and other statements that are not historical. The forward-looking statements contained in this report are based on management’s current expectations and projections which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include but are not limited to: the severity, duration, and economic and operational impact of the COVID-19 pandemic; that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply, and in the ability to achieve adequate start and completion dates, as well as uncertainties in clinical trial design and patient enrollment, dropout or discontinuation rates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trials may differ from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; and the factors described in the section captioned “Risk Factors” in this report and in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended March 31, 2020, filed with the U.S. Securities and Exchange Commission on May 22, 2020, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission (available at www.sec.gov).

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, achievements or events and circumstances reflected in the forward-looking statements will occur. Moreover, we operate in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from any forward-looking statements we make. We cannot assure you that forward-looking statements in this report or therein will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us to any other person that we will achieve our objectives and plans in any specified time frame, or at all. We disclaim any intent or duty to update any of these forward-looking statements after completion of this Quarterly Report on Form 10-Q to conform these statements to actual results or revised expectations.

The cautionary statements made in this report are intended to be applicable to all related forward-looking statements wherever they may appear in this report. We urge you not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Except as required by law, we assume no obligation to update our forward-looking statements, even if new information becomes available in the future.

 

1


Table of Contents

PART I – FINANCIAL INFORMATION

Item 1.

Financial Statements.

Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

 

 

 

December 31, 2020

 

 

March 31, 2020

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

13,487,688

 

 

$

26,700,416

 

Prepaid clinical costs

 

 

1,433,758

 

 

 

396,962

 

Prepaid expenses and other current assets

 

 

270,560

 

 

 

981,949

 

Total current assets

 

 

15,192,006

 

 

 

28,079,327

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

1,295

 

 

 

5,181

 

Prepaid clinical costs, net of current portion

 

 

530,989

 

 

 

1,266,025

 

Operating lease right-of-use asset

 

 

84,242

 

 

 

150,301

 

 

 

 

 

 

 

 

 

 

Total assets

 

$

15,808,532

 

 

$

29,500,834

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable and other current liabilities (including $84,000 and

   $73,000 of related party accounts payable, respectively)

 

$

3,002,531

 

 

$

2,827,302

 

Severance payable

 

 

398,200

 

 

 

380,722

 

Accrued bonuses

 

 

1,177,512

 

 

 

1,800,979

 

Insurance note payable

 

 

 

 

 

518,124

 

Operating lease liability

 

 

33,868

 

 

 

54,661

 

Total current liabilities

 

 

4,612,111

 

 

 

5,581,788

 

Long-term liabilities

 

 

 

 

 

 

 

 

   Severance payable

 

 

960,135

 

 

 

1,254,910

 

Operating lease liability, net of current portion

 

 

51,807

 

 

 

 

Warrant liability

 

 

1,018,977

 

 

 

3,639,000

 

Total liabilities

 

 

6,643,030

 

 

 

10,475,698

 

Commitments and contingencies (see Note 9)

 

 

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 0

   shares issued and outstanding

 

 

 

 

 

 

Common stock, $0.0001 par value, 300,000,000 shares authorized,

130,172,441 issued and outstanding at December 31, 2020, 300,000,000 authorized, 123,312,252 issued and outstanding at March 31, 2020

 

 

13,019

 

 

 

12,333

 

Additional paid in capital

 

 

138,764,795

 

 

 

126,828,055

 

Accumulated deficit

 

 

(129,612,312

)

 

 

(107,815,252

)

Total stockholders' equity

 

 

9,165,502

 

 

 

19,025,136

 

Total liabilities and stockholders' equity

 

$

15,808,532

 

 

$

29,500,834

 

 

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

 

2


Table of Contents

Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

 

 

Three Months Ended

December 31,

 

 

Nine Months Ended                   December 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenues

$

 

 

$

 

 

$

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

3,548,992

 

 

 

3,458,886

 

 

 

12,971,735

 

 

 

9,368,640

 

General and administrative (including $109,000, $58,500, $450,000 and $307,000 of related party legal expenses, respectively)

 

2,321,974

 

 

 

3,084,796

 

 

 

7,992,735

 

 

 

9,597,780

 

Total operating expenses

 

5,870,966

 

 

 

6,543,682

 

 

 

20,964,470

 

 

 

18,966,420

 

Loss from operations

 

(5,870,966

)

 

 

(6,543,682

)

 

 

(20,964,470

)

 

 

(18,966,420

)

Other income (expenses):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of warrant liability

 

(228,750

)

 

 

(425,795

)

 

 

(3,002,449

)

 

 

2,593,601

 

Gain on warrant exchange

 

 

 

 

 

 

 

2,228,697

 

 

 

 

Interest income

 

1,544

 

 

 

38,257

 

 

 

19,057

 

 

 

185,753

 

Interest expense

 

(22,539

)

 

 

(26,310

)

 

 

(77,895

)

 

 

(88,530

)

Total other income (expenses)

 

(249,745

)

 

 

(413,848

)

 

 

(832,590

)

 

 

2,690,824

 

Net loss

$

(6,120,711

)

 

$

(6,957,530

)

 

$

(21,797,060

)

 

$

(16,275,596

)

Basic and diluted loss per common share

$

(0.05

)

 

$

(0.06

)

 

$

(0.17

)

 

$

(0.15

)

Basic and diluted weighted average shares outstanding

 

130,172,441

 

 

 

112,071,354

 

 

 

127,611,426

 

 

 

111,961,971

 

 

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

 

3


Table of Contents

Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ Equity

For the Three and Nine Months Ended December 31, 2020 and 2019

(Unaudited)

 

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

Paid-in

Capital

 

 

Accumulated Deficit

 

 

Stockholders'

Equity

 

Balance, April 1, 2020

 

 

123,312,252

 

 

$

12,333

 

 

$

126,828,055

 

 

$

(107,815,252

)

 

$

19,025,136

 

Issuance of common stock from at-the-market financing facility, net of associated expenses of $120,790

 

 

891,944

 

 

 

89

 

 

 

1,171,497

 

 

 

 

 

 

1,171,586

 

Warrant to share exchange

 

 

2,406,250

 

 

 

241

 

 

 

3,393,534

 

 

 

 

 

 

3,393,775

 

Stock based compensation

 

 

 

 

 

 

 

 

1,068,696

 

 

 

 

 

 

1,068,696

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(8,825,815

)

 

 

(8,825,815

)

Balance, June 30, 2020

 

 

126,610,446

 

 

$

12,663

 

 

$

132,461,782

 

 

$

(116,641,067

)

 

$

15,833,378

 

Issuance of common stock from at-the-market financing facility, net of associated expenses of $166,918

 

 

3,561,995

 

 

 

356

 

 

 

4,634,192

 

 

 

 

 

 

4,634,548

 

Stock based compensation

 

 

 

 

 

 

 

 

883,929

 

 

 

 

 

 

883,929

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,850,534

)

 

 

(6,850,534

)

Balance, September 30, 2020

 

 

130,172,441

 

 

$

13,019

 

 

$

137,979,903

 

 

$

(123,491,601

)

 

$

14,501,321

 

Stock based compensation

 

 

 

 

 

 

 

 

784,892

 

 

 

 

 

 

784,892

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,120,711

)

 

 

(6,120,711

)

Balance, December 31, 2020

 

 

130,172,441

 

 

$

13,019

 

 

$

138,764,795

 

 

$

(129,612,312

)

 

$

9,165,502

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, April 1, 2019

 

 

103,946,048

 

 

$

10,397

 

 

$

95,472,181

 

 

$

(85,814,696

)

 

$

9,667,882

 

Issuance of common stock from underwritten registered offering, net of associated expenses of $111,227

 

 

8,000,000

 

 

 

800

 

 

 

3,884,372

 

 

 

 

 

 

3,885,172

 

Cashless exercise of warrants

 

 

4,889

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock based compensation

 

 

 

 

 

 

 

 

1,624,961

 

 

 

 

 

 

1,624,961

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(3,191,986

)

 

 

(3,191,986

)

Balance, June 30, 2019

 

 

111,950,937

 

 

$

11,197

 

 

$

100,981,514

 

 

$

(89,006,682

)

 

$

11,986,029

 

Stock based compensation

 

 

 

 

 

 

 

 

1,446,062

 

 

 

 

 

 

1,446,062

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,126,080

)

 

 

(6,126,080

)

Balance, September 30, 2019

 

 

111,950,937

 

 

$

11,197

 

 

$

102,427,576

 

 

$

(95,132,762

)

 

$

7,306,011

 

Issuance of common stock from at-the-market financing facility, net of associated expenses of $165,157

 

 

582,968

 

 

 

58

 

 

 

452,494

 

 

 

 

 

 

452,552

 

Stock based compensation

 

 

 

 

 

 

 

 

1,602,116

 

 

 

 

 

 

1,602,116

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,957,530

)

 

 

(6,957,530

)

Balance, December 31, 2019

 

 

112,533,905

 

 

$

11,255

 

 

$

104,482,186

 

 

$

(102,090,292

)

 

$

2,403,149

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

4


Table of Contents

Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

Nine Months Ended                   December 31,

 

 

 

2020

 

 

2019

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(21,797,060

)

 

$

(16,275,596

)

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

 

 

 

 

 

 

 

 

Depreciation

 

 

3,886

 

 

 

3,886

 

Amortization of employees, directors and consultants stock options

 

 

2,737,518

 

 

 

4,673,140

 

Change in fair value of warrant liability

 

 

3,002,449

 

 

 

(2,593,601

)

Gain on warrant exchange

 

 

(2,228,697

)

 

 

 

Change in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid clinical costs

 

 

(301,760

)

 

 

121,298

 

Prepaid expenses and other assets

 

 

711,389

 

 

 

708,099

 

Operating lease right-of-use asset

 

 

141,498

 

 

 

218,419

 

Accounts payable and other current liabilities

 

 

175,229

 

 

 

(157,045

)

Severance payable

 

 

(277,297

)

 

 

(330,474

)

Accrued bonuses

 

 

(623,467

)

 

 

(193,889

)

Operating lease liability

 

 

(44,425

)

 

 

(34,938

)

Net cash used in operating activities

 

 

(18,500,737

)

 

 

(13,860,701

)

 

 

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

 

 

Net cash used in investing activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

 

 

Insurance note payments

 

 

(518,124

)

 

 

(597,339

)

Proceeds from registered offerings, net of issuance costs

 

 

5,806,133

 

 

 

11,621,325

 

Net cash provided by financing activities

 

 

5,288,009

 

 

 

11,023,986

 

 

 

 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

 

(13,212,728

)

 

 

(2,836,715

)

 

 

 

 

 

 

 

 

 

Cash and cash equivalents – beginning

 

 

26,700,416

 

 

 

14,302,328

 

Cash and cash equivalents – ending

 

$

13,487,688

 

 

$

11,465,613

 

 

 

 

 

 

 

 

 

 

Supplemental Cash Flow Information:

 

 

 

 

 

 

 

 

Interest

 

$

77,895

 

 

$

88,530

 

Income taxes

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

Noncash operating activities:

 

 

 

 

 

 

 

 

Operating lease right-of-use asset obtained in exchange for lease liabilities.

 

$

75,439

 

 

$

 

Noncash investing and financing activities:

 

 

 

 

 

 

 

 

Cashless exchange of April 2019 Warrants to purchase 5,833,333 shares of common stock for 2,406,250 shares in May 2020.

 

$

 

 

$

 

Cashless exchange of April 2019 Warrants to purchase 2,166,667 shares of common stock for May 2020 Warrant to purchase the same number of shares common stock.

 

$

 

 

$

 

Cashless exercise of 78,431 warrants for 4,889 shares in 2019.

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

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Table of Contents

 

Tyme Technologies, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

December 31, 2020

(Unaudited)

Note 1. Nature of Business

Tyme Technologies, Inc. is a Delaware corporation headquartered in Bedminster, New Jersey, with a wholly-owned subsidiary, Tyme Inc. (together, “TYME” or the “Company”). The majority of the Company’s research, development and other business activities are conducted by Tyme Inc., which was incorporated in Delaware in 2013.

TYME is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTsTM) that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific pathways within cancer, TYME’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic requirements to cause cancer cell death. With the development of TYME-18 and TYME-19 (discussed below), the Company believes it is also emerging as a leader in the development of bile acids as potential therapies for cancer and viruses such as COVID-19.

 

The Company’s lead clinical CMBT compound, SM-88, is an oral investigational modified proprietary tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has achieved confirmed tumor responses across 15 different cancers, both solid and liquid tumors, including pancreatic, lung, breast, prostate, sarcoma and lymphoma cancers with minimal serious Grade 3 or higher adverse events, which the Company believes is rare for investigational compounds. In fiscal year 2020, TYME launched its pivotal study for SM-88 in the third-line treatment of pancreatic cancer through an amendment to its ongoing TYME-88-Panc trial (“Part 2”), with the first patient dosed in the third quarter of the fiscal year. Primarily as a result of unpredictable pandemic-related delays, the Company does not anticipate the trial to be fully enrolled before calendar year 2022. The Company has also partnered with Pancreatic Cancer Action Network (“PanCAN”) to study SM-88 in an adaptive randomized Phase II/III trial with registration intent known as Precision PromiseSM. In Precision Promise, SM-88 is initially being studied as second-line monotherapy and the study of SM-88 could expand to first-line combination therapy with standard of care. In addition, patient enrollment has advanced in an investigator-initiated Phase II study evaluating SM-88 in high-risk sarcomas. In calendar year 2019, the Company presented final SM-88 prostate Phase II clinical data showing encouraging clinical benefit in patients with bio-marker recurrent prostate cancer, with the final results published in the peer-reviewed journal, Investigational New Drugs, on September 13, 2020. The Company continues to evaluate the expansion of its SM-88 clinical program to other tumor types.

TYME-18 is a CMBT compound under development that is delivered intratumorally. TYME-18 leverages a member of the bile acid family to create a potential treatment for inoperable tumors. Preliminary observations of the local administration of TYME-18, a combination of a proprietary surfactant system and natural sulfonic acid, suggested its potential as an important regulator of energy metabolism that may impede the ability of tumors to increase in size, which, in addition to its lytic functionality, could prove useful in difficult-to-treat cancers. In initial preclinical xenograft mouse studies, TYME-18 was able to completely resolve over 90 percent (11/12 mice) of established colorectal tumors within 12 days versus an average of over 600 percent growth in the control animals.

TYME-19 is an oral synthetic member of the bile acid family, a family that the Company also leverages in its anticancer compound, TYME-18. Because of its expertise in metabolic therapies, the Company was able to identify TYME-19 as a potent, well characterized antiviral bile acid and has performed preclinical experiments establishing effectiveness against COVID-19. Bile acids have primarily been used for liver disease; however, like all steroids, they are messenger molecules that modulate a number of diverse critical cellular regulators. Bile acids modulate lipid and glucose metabolism and can remediate dysregulated protein folding, with potentially therapeutic effects on cardiovascular, neurologic, immune, and other metabolic systems. Some agents in this class also have antiviral properties. In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity to the treated cells. Previous preclinical research has also shown select bile acids like TYME-19 have had broad antiviral activity. TYME has partnered with physicians from Massachusetts General Hospital and the Weill Cornell Medical Center to design a proof-of-concept trial for recently diagnosed, symptomatic patients. The trial is expected to start as soon as customary trial site and regulatory approvals are completed.

The accompanying condensed consolidated financial statements include the results of operations of Tyme Technologies, Inc. and its wholly-owned subsidiaries.

 

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Liquidity

 

The condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has historically funded its operations primarily through equity offerings.

 

In April 2019, the Company raised net proceeds of approximately $11.3 million after underwriting discounts and before expenses through an underwritten registered offering.

 

On October 18, 2019, TYME entered into an Open Market Sale AgreementSM (as amended, the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as sales agent, pursuant to which the Company may, from time to time, sell shares of common stock through Jefferies having an aggregate offering price of up to $30.0 million (the “Jefferies ATM”). In the nine months ended December 31, 2020, the Company raised approximately $6.1 million in aggregate gross proceeds through the Sale Agreement and paid commissions and expenses of $0.3 million. At December 31, 2020, there remained approximately $22.2 million of availability to sell shares through the Jefferies ATM.

 

On January 7, 2020, the Company entered into a Securities Purchase Agreement with Eagle Pharmaceuticals, Inc. (“Eagle”), pursuant to which the Company raised $20.0 million through the issuance and sale to Eagle of 10,000,000 shares of common stock, at a price of $2.00 per share (the “Eagle SPA”). The Eagle SPA provides that Eagle will, subject to certain conditions, make an additional payment of $20 million upon the occurrence of a milestone event, which is defined as the earlier of (i) achievement of the primary endpoint of overall survival in the TYME-88-Panc pivotal trial; (ii) achievement of the primary endpoint of overall survival in the PanCAN Precision Promise SM-88 registration arm; or (iii) FDA approval of SM-88 in any cancer indication. This payment would be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement. The proceeds of the aforementioned offerings are being used by the Company for continued clinical studies, drug commercialization and development activities and other general corporate and operating expenses.

       

For the nine months ended December 31, 2020, the Company had negative cash flow from operations of $18.5 million and net loss of $21.8 million, which included non-cash expenses of $3.0 million related to change in fair value of warrant liability and $2.7 million non-cash equity compensation, partially offset by a non-cash gain on warrant exchange of $2.2 million. As of December 31, 2020, the Company had working capital of approximately $10.6 million.

Management has concluded that substantial doubt does not exist regarding the Company’s ability to satisfy its obligations as they come due during the twelve-month period following the issuance of these financial statements. This conclusion is based on the Company’s assessment of qualitative and quantitative conditions and events, considered in aggregate as of the date of issuance of these financial statements that are known and reasonably knowable. Among other relevant conditions and events, the Company has considered its operational plans, liquidity sources, obligations due or expected, funds necessary to maintain the Company’s operations, and potential adverse conditions or events as of the issuance date of these financial statements.

Note 2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements and related notes should be read in conjunction with the consolidated financial statements and related notes contained in the Company’s Annual Report on Form 10-K for the year ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 22, 2020 (the “2020 10-K”). The condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the SEC related to interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The financial information contained herein is unaudited; however, management believes all adjustments have been made that are necessary to present fairly the results for the interim periods. All such adjustments are of a normal and recurring nature. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the full year.

The Company’s condensed consolidated financial statements include the accounts of Tyme Technologies, Inc. and its subsidiary, Tyme Inc. All intercompany transactions and balances have been eliminated in consolidation. 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”).

 

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Significant Accounting Policies

 

The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended March 31, 2020 included in the Company’s 2020 10-K.

Reclassifications

The Company has reclassified certain prior period amounts to conform to the current period presentation. These reclassifications have no effect on the previously reported net loss or cash flows.

Fair Value of Financial Instruments

The carrying amounts reported in the Company’s condensed consolidated financial statements for cash, accounts payable, and other current liabilities approximate their respective fair values because of the short-term nature of these accounts. The fair value of the severance payable approximates the carrying value, which represents the present value of future severance payments. The fair value of the derivative liability is discussed in Note 6.

Derivative Warrant Liability

Certain freestanding common stock warrants that are related to the issuance of common stock are classified as liabilities and recorded at fair value due to characteristics that require liability accounting, primarily the obligation to issue registered shares of common stock upon notification of exercise or certain price protection provisions. Warrants of this type are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of other income (expense) in the condensed consolidated statement of operations. As noted in Note 8, Stockholders’ Equity, the Company classifies a warrant to purchase shares of its common stock as a liability on its condensed consolidated balance sheet if the warrant is a free-standing financial instrument that contains certain price protection features that cause the warrants to be treated as derivatives or requires the issuance of registered common shares upon exercise. Each warrant of this type is initially recorded at fair value on date of grant using the Monte Carlo simulation model or the Black-Sholes model, and is subsequently re-measured to fair value at each subsequent balance sheet date. Changes in fair value of the warrant are recognized as a component of other income (expense) in the consolidated statement of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrant. The Company utilizes Level 3 fair value criteria to measure the fair value of the warrants (see Note 6).

 

Risks and Uncertainties

The Company is subject to those risks associated with any biotechnology 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.

Current Economic Conditions

In March 2020, the World Health Organization categorized the novel coronavirus (COVID-19) as a pandemic and the United States declared the COVID-19 outbreak a national emergency. The COVID-19 pandemic, and actions taken by governments and others to reduce its spread, including travel restrictions, shutdowns of businesses deemed non-essential, and stay-at-home or similar orders, has negatively impacted the global economy, financial markets, and the Company’s industry and has disrupted day-to-day life and business operations. Even as certain restrictions have been lifted, new processes implemented and vaccines begin to be distributed and administered, the Company believes that the current economic conditions are likely to continue to have a negative impact for the foreseeable future, and the extent to which they may impact the Company’s operations, liquidity and financial condition remains uncertain and may be significant.

Recent Accounting Pronouncements

 

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which modifies the disclosure requirements on fair value in Topic 820. Under this ASU, certain disclosure requirements for fair value measurements are eliminated, amended or added. The guidance is effective for the Company fiscal year and interim periods within those fiscal years beginning after December 15, 2019.  The Company has adopted ASU 2018-13 using a prospective method effective April 1, 2020. The adoption of this ASU did not have a material effect on the Company’s financial statements and related disclosures. See Note 6.

 

 

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In August 2020, the FASB issued ASU No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40). ASU No. 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, the new guidance modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted earnings per share (“EPS”) computation.

 

The amendments in ASU No. 2020-06 are effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after

December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. FASB also specified that an entity should adopt the guidance as of the beginning of its annual fiscal year and is not permitted to adopt the guidance in an interim period. The Company is assessing the impact on its consolidated financial statements and disclosures.

 

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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Basic and diluted net loss per common share calculation:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(6,120,711

)

 

$

(6,957,530

)

 

$

(21,797,060

)

 

$

(16,275,596

)

Weighted average common shares outstanding — basic and diluted:

 

 

130,172,441

 

 

 

112,071,354

 

 

 

127,611,426

 

 

 

111,961,971

 

Net loss per share of common stock — basic and diluted

 

$

(0.05

)

 

$

(0.06

)

 

$

(0.17

)

 

$

(0.15

)

 

The Company calculates net loss per share in accordance with ASC Topic 260, “Earnings per Share”. Basic net loss per share is computed by dividing net loss attributable to the Company by the weighted average number of shares of Company Common Stock outstanding for the period, and diluted earnings per share is computed by including common stock equivalents outstanding for the period. During the periods presented, the calculation excludes any potential dilutive common shares and any equivalents as they would have been anti-dilutive.

 

Warrants issued in April 2019, discussed further in Note 8, participated on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the Board of Directors (the “Board”) on the Company’s common stock. For purposes of computing EPS, these warrants were, when outstanding, considered to participate with common stock in the earnings of the Company and, therefore, the Company calculates basic and diluted EPS using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders and participating securities according to dividends declared and participation rights in undistributed earnings. No income was allocated to the warrants for the three and nine months ended December 31, 2020 and 2019 as results of operations was a loss for these periods.

 

The following outstanding securities at December 31, 2020 and 2019 have been excluded from the computation of diluted weighted average shares outstanding, as they are anti-dilutive:

 

 

 

December 31,

 

 

 

2020

 

 

2019

 

Stock options

 

 

15,456,522

 

 

 

11,808,482

 

Warrants

 

 

3,104,318

 

 

 

8,937,651

 

Total

 

 

18,560,840

 

 

 

20,746,133

 

 

 

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Note 4. Accounts Payable and Other Current Liabilities

Accounts payable (including accounts payable to a related party – see Note 11) and other current liabilities consisted of the following:

 

 

 

December 31,

2020

 

 

March 31,

2020

 

Legal

 

$

190,456

 

 

$

199,671

 

Consultant and professional services

 

 

74,546

 

 

 

109,504

 

Accounting and auditing

 

 

62,897

 

 

 

118,837

 

Research and development

 

 

2,151,135

 

 

 

1,863,355

 

Board of Directors and Medical Advisory Board Compensation

 

 

482,781

 

 

 

484,750

 

Other

 

 

40,716

 

 

 

51,185

 

Total

 

$

3,002,531

 

 

$

2,827,302

 

 

Note 5. Severance Payable

 

On March 15, 2019, the Company entered into a Release Agreement related to the separation of employment of its then-Chief Operating Officer. The agreement provides for salary continuance for five years, reimbursement of health benefits for three years and a modification to his outstanding stock options to extend the post-termination exercise period for his vested options from three months to five years. The Company recorded severance expense at its present value of $2.5 million (using a discount rate of 6%) for the year ended March 31, 2019, including $0.4 million relating to the stock option modification. The severance liability payable as of December 31, 2020 and March 31, 2020 was $1.4 million and $1.6 million, respectively.

 

6. Fair Value Measurements

 

The carrying amounts reported in the Company’s condensed consolidated financial statements for cash, accounts payable, and other current liabilities approximate their respective fair values because of the short-term nature of these accounts. The fair value of the severance payable approximates the carrying value, which represents the present value of future severance payments. The fair value of the derivative liability is discussed below.

Fair value is defined as the price that would be received if selling an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

The fair value hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets (Level 1), and the lowest priority to unobservable inputs (Level 3). The Company’s financial assets are classified within the fair value hierarchy based on the lowest level of inputs that is significant to the fair value measurement. The three levels of the fair value hierarchy, and their applicability to the Company’s financial assets, are described below.

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date of identical, unrestricted assets.

Level 2: Quoted prices for similar assets, or inputs that are observable, either directly or indirectly, for substantially the full term through corroboration with observable market data. Level 2 includes investments valued at quoted prices adjusted for legal or contractual restrictions specific to the security.

Level 3: Pricing inputs are unobservable for the assets. Level 3 assets include private investments that are supported by little or no market activity. Level 3 valuations are for instruments that are not traded in active markets or are subject to transfer restrictions and may be adjusted to reflect illiquidity and/or non-transferability, with such adjustment generally based on available market evidence. In the absence of such evidence, management’s best estimate is used.

An adjustment to the pricing method used within either Level 1 or Level 2 inputs could generate a fair value measurement that effectively falls in a lower level in the hierarchy. The Company had no material re-measurements of fair value with respect to financial assets and liabilities, during the periods presented, other than those assets and liabilities that are measured at fair value on a recurring basis.


The Company has segregated all financial assets and liabilities that are measured at fair value on a recurring basis into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement date in the table below. The fair value measurement for the warrants issued in connection with the registered offering that closed on April 2, 2019 (the “April 2019 Warrants”) and the warrant issued in conjunction with the Exchange Agreements (see Note 8 for transaction details)

 

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(the May 2020 Warrant”) are based on significant inputs not observable in the market and are classified as Level 3 liability as of March 31, 2020 and December 31, 2020, respectively. 

 

The fair value of the April 2019 Warrants was determined using a Monte Carlo simulation model and included significant unobservable inputs including volatility and the probability of fundamental transactions occurring (see Note 8 for further discussion of the issuance of common stock from an underwritten registered offering). The fair value of the May 2020 Warrant was determined using the Black Scholes model and included significant unobservable inputs such as volatility. Both models incorporated several observable assumptions at each valuation date including: the price of the Company’s common stock on the date of valuation, the remaining contractual term of the warrant and the risk free interest rate over the term. Transfers are calculated on values as of the transfer date. There were no transfers between Levels 1, 2 and 3 during the nine months ended December 31, 2020.

 

The following table details key inputs and assumptions used to estimate the fair value of the May 2020 Warrant as of December 31, 2020 using a Black Scholes model and April 2019 Warrants liability as of March 31, 2020 using the Monte Carlo simulation models:

 

 

 

May 2020 Warrant

 

 

April 2019 Warrants

 

 

 

December 31, 2020

 

 

March 31, 2020

 

Stock price

 

$

1.22

 

 

$

1.10

 

Volatility

 

 

72

%

 

 

60

%

Remaining term (years)

 

3.25

 

 

 

4.01

 

Expected dividend yield

 

 

 

 

 

 

Risk-free rate

 

 

0.19

%

 

 

0.33

%

 

The Company’s financial instruments measured at fair value on a recurring basis are as follows:

 

Description

 

Total

 

 

Quoted

prices in

active

markets

 

 

Significant

other

observable

inputs

 

 

Significant

unobservable

inputs

 

 

 

 

 

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

December 31, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liability

 

$

1,018,977

 

 

 

 

 

 

 

 

$

1,018,977

 

March 31, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liability

 

$

3,639,000

 

 

 

 

 

 

 

 

$

3,639,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The following table summarizes activity for liabilities measured at fair value using Level 3 significant unobservable inputs:

 

 

 

December 31, 2020

 

Beginning balance, March 31, 2020

 

$

3,639,000

 

Change in fair value of April 2019 Warrants liability before May 20, 2020 Warrant Exchange

 

 

3,661,000

 

Less: fair value of April 2019 Warrants as of May 20, 2020

 

 

(7,300,000

)

Plus: fair value of May 2020 Warrant as of May 20, 2020

 

 

1,677,528

 

Change in fair value of May 2020 Warrant liability from May 20, 2020 to December 31, 2020

 

 

(658,551

)

Ending balance, December 31, 2020

 

$

1,018,977

 

 

Note 7. Debt

Insurance Note Payable

 

During the year ended March 31, 2020, the Company entered into a short-term financing arrangement with its insurance carrier related to payment of premium for its Director and Officer liability insurance coverage totaling $0.5 million for the policy year ending on March 18, 2021. As of December 31, 2020 and March 31, 2020, there remained a balance of $0 million and $0.5 million, respectively, recorded to insurance note payable on the accompanying consolidated balance sheets.

 

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Note 8. Stockholders’ Equity

 

The following summarizes the common stock warrant activity for the nine months ended December 31, 2020:

 

 

 

Warrant

Shares of

Common Stock

 

 

Weighted Average Exercise Price

 

Outstanding at March 31, 2020

 

 

8,937,651

 

 

$

2.31

 

Granted

 

 

2,166,667

 

 

 

1.80

 

Exchanged

 

 

(8,000,000

)

 

 

2.00

 

Outstanding at December 31, 2020

 

 

3,104,318

 

 

$

2.77

 

 

At each of December 31, 2020 and March 31, 2020, 3,074,551 and 8,907,884, respectively, of common stock purchase warrants relating to securities purchase agreements were outstanding and exercisable.

 

Warrants

 

The Company has warrants to purchase its common stock outstanding as of December 31, 2020, as follows:

 

Issued

 

Classification

 

Warrants

Outstanding

 

 

Exercise

Price

 

 

Expiration

December 2015

 

Equity

 

 

446,500

 

 

$

5.00

 

 

December 2025

February 2016

 

Equity

 

 

461,384

 

 

$

5.00

 

 

February 2026

July 2016

 

Equity

 

 

29,767

 

 

$

5.00

 

 

June 2026

May 2020

 

Liability

 

 

2,166,667

 

 

$

1.80

 

 

April 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

At-the-Market Financing Facility

 

On October 18, 2019, the Company entered into the Sale Agreement with Jefferies, which was amended on August 12, 2020, pursuant to which the Company may, from time to time, sell shares of common stock, having an aggregate offering price of up to $30.0 million through Jefferies, as the Company’s sales agent. As indicated in the amendment, the shares will be offered and sold by the Company pursuant to its currently effective Registration Statement on Form S-3, as amended (Reg. No. 333-245033). Any sales of common stock pursuant to the Sales Agreement will be made by methods deemed to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. Jefferies will use commercially reasonable efforts to sell the shares from time to time, based on the instructions of the Company. The Company will pay Jefferies a commission rate of three percent (3%) of the gross proceeds from the sales of shares of Common Stock sold pursuant to the Sale Agreement. Under the Sale Agreement, the Company is not required to use the full available amount authorized and it may, by giving notice as specified in the Sale Agreement, terminate the Sale Agreement at any time.

 

During the nine months ended December 31, 2020, the Company raised approximately $6.1 million in gross proceeds via sale of 4,453,939 shares of Common Stock. The Company incurred $0.3 million of related costs that partially offset the proceeds. At December 31, 2020, there remained approximately $22.2 million of availability to sell shares through the Jefferies ATM.   

 

Securities Purchase Agreement

 

On January 7, 2020, the Company and Eagle entered into the Eagle SPA, pursuant to which the Company issued and sold to Eagle 10,000,000 shares of common stock, at a price of $2.00 per share. The Eagle SPA provides that Eagle will, subject to certain conditions, make an additional payment of $20 million upon the occurrence of a milestone event, which is defined as the earlier of (i) achievement of the primary endpoint of overall survival in the TYME-88-Panc pivotal trial; (ii) achievement of the primary endpoint of overall survival in the PanCAN Precision Promise SM-88 registration arm; or (iii) FDA approval of SM-88 in any cancer indication. This payment would be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement.

 

 

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April 2019 - Registered Offering

 

In April 2019, the Company completed an underwritten registered offering (the “Offering”) of 8,000,000 shares of its common stock at a price of $1.50 per share. The total net proceeds of the Offering were $11.3 million after deducting underwriter’s discounts and before expenses related to the Offering.

 

As part of the Offering, the investors received warrants to purchase up to 8,000,000 shares of the Company’s Common Stock at an exercise price of $2.00 per share (the “April 2019 Warrants”). 

 

The April 2019 Warrants, prior to their exchange, discussed below, participated with common stock on a one-for-one basis for distribution dividends or other assets of the Company.

 

Exchange Agreements

 

On May 20, 2020, the Company entered into exchange agreements with holders (the “Holders”) of the April 2019 Warrants. The April 2019 Warrants were offered and issued pursuant to the Company’s previous shelf registration statement on Form S-3 (File No. 333-211489).

 

Pursuant to exchange agreements (the “Share Exchange Agreements”) with Holders of the April 2019 Warrants to purchase 5,833,333 shares of Common Stock in the aggregate, the Company issued an aggregate of 2,406,250 shares of common stock (the “Exchange Shares”) in exchange for such April 2019 Warrants. Concurrently therewith, each such Holder executed and delivered to the Company a leak-out agreement (a “Share Leak-Out Agreement”) that contained trading restrictions with respect to the Exchange Shares, which (i) for the first 90 days, prohibit any sales of Exchange Shares, (ii) for the subsequent 90 days, limit sales of Exchange Shares on any day to 2.5% of that day’s trading volume of Common Stock, and (iii) prohibit new short positions or short sales on Common Stock for the combined 180 day period.

 

The Company also entered into an exchange agreement (the “Warrant Exchange Agreement”) with another Holder of April 2019 Warrants to purchase 2,166,667 shares of Common Stock in the aggregate. Pursuant to the Warrant Exchange Agreement, the Company issued such Holder a new warrant (the “May 2020 Warrant”) to purchase the same number of shares of Common Stock. The May 2020 Warrant has the same expiration date, April 2, 2024, as the April 2019 Warrants, but has an exercise price of $1.80 and does not include the price protection, anti-dilution provisions or other restrictions on Company action from the April 2019 Warrants. Concurrently therewith, such Holder executed and delivered to the Company a leak-out agreement that contained trading restrictions on sales of Common Stock issued upon exercise of the May 2020 Warrant that are substantially similar to the restrictions on Exchange Shares in the Share Leak-Out Agreement, provided that the leak-out restrictions will only apply to the first 893,750 shares of Common Stock issued pursuant to the May 2020 Warrant.

 

The April 2019 Warrants were remeasured as of May 20, 2020, before the exchange, using the Monte Carlo pricing simulation resulting in a fair value of approximately $7.3 million, and the change in fair value from March 31, 2020 to the fair value before the exchange of approximately $3.7 million was recorded as an expense component of other income (expense) within the condensed consolidated statement of operations. The key assumptions in applying the Monte Carlo simulation model were as follows: $1.70 stock price, 73% volatility, 3.87 years remaining term, 0.28% risk free rate and the probability of fundamental transactions occurring. The change in fair value of the April 2019 Warrants for the nine months ended December 31, 2019 was $2.6 million and recorded as a component of other income (expense) within the condensed consolidated statement of operations.

 

At May 20, 2020, the fair value of the 2,406,250 shares issued under the Share Exchange Agreements was approximately $3.4 million and resulted in a gain on exchange of approximately $1.9 million.

 

The exercise price of the May 2020 Warrant is subject to adjustment upon the occurrence of specific events, including stock dividends, stock splits, combinations and reclassifications of the Company’s Common Stock.

 

The Company determined that the May 2020 Warrant should be recorded as a derivative liability on the condensed consolidated balance sheet due to the May 2020 Warrant’s contractual provisions requiring issuance of registered common shares upon exercise. At May 20, 2020, the May 2020 Warrant was recorded at the fair value of $1.7 million as determined using the Black Scholes model and the change in fair value before and after the exchange of $0.3 million was recorded as a gain on warrant exchange as a component of other income (expense) within the condensed consolidated statement of operations. The key assumptions in applying the Black Scholes model were as follows: $1.64 stock price, 73% volatility, 3.87 years remaining term, 0.27% risk free rate and 7% discount for lack of marketability. The change in fair value of the May 2020 Warrant from May 20, 2020 through December 31, 2020 of $0.7 million income was recorded as a component of other income (expense) within the condensed consolidated statement of operations.

 

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Note 9. 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.

 

On April 1, 2020, the Company amended the Clinical Research Funding and Drug Supply Agreement dated October 9, 2018, with PanCAN, to enroll individuals diagnosed with pancreatic cancer in a platform style clinical research study. Stage 1 of the study was initiated in the fourth quarter of fiscal year 2020. As of December 31, 2020, after taking into consideration amounts already incurred, the remaining expense to the Company is approximately $5.3 million, subject to enrollment adjustments, and is expected to be incurred over one year and nine months.

Purchase Commitments

 

The Company has entered into contracts with manufacturers to supply SM-88 and certain related conditioning agents, in order to achieve favorable pricing on supplied products. These contracts have non-cancellable elements related to the scheduled deliveries of these products in future periods. Payments are made by us to the manufacturer when the products are delivered and of acceptable quality. The outstanding future contract obligations structured to match clinical supply needs for the Company’s ongoing trials and registration activity are approximately $0.6 million and $3.5 million, respectively, at December 31, 2020. The Company expects the timing of associated payments to predominately occur through fiscal year 2022.

 

Legal Proceedings

 

The Company is not currently a party to any material legal proceedings and is not aware of any pending or threatened legal proceeding against it that it believes could have a material adverse effect on the Company, its business, operating results or financial condition. From time to time, the Company may be involved in litigation, claims or other contingencies arising in the ordinary course of business. The Company would accrue a liability when a loss is considered probable and the amount can be reasonably estimated. When a material loss contingency is reasonably possible but not probable, the Company would not record a liability, but instead would disclose the nature and the amount of the claim, and an estimate of the loss or range of loss, if such estimate can be made. Legal fees are expensed as incurred.

 

Note 10. Leases

 

The Company has a lease for office space in New Jersey, which expires in February 2023.  

 

Total Company rent expense, including short term rentals, was approximately $14,000 and $155,000 for the three and nine months ended December 31, 2020 and $79,000 and $235,000 for the three and nine months ended December 31, 2019.  

 

Operating lease right-of-use (“ROU”) assets and liabilities on the condensed consolidated balance sheet represents the present value of the remaining lease payments over the remaining lease terms. ROU assets also include any initial direct costs incurred and any lease payments made at or before the lease commencement date, less lease incentives received. Payments for additional monthly fees to cover the Company's share of certain facility expenses are not included in operating lease right-of-use assets and liabilities. The Company uses its incremental borrowing rate of 11.0% to calculate the present value of its lease payments, as the implicit rates in the leases are not readily determinable.

 

As of December 31, 2020, the future minimum lease payments under non-cancellable operating lease agreements for which the Company has recognized operating lease right-of-use assets and lease liabilities were as follows:

 

 

 

December 31, 2020

 

Fiscal year 2021

 

$

9,974

 

Fiscal year 2022

 

 

43,164

 

Fiscal year 2023

 

 

43,164

 

Total remaining lease payments

 

 

96,302

 

Less: present value adjustment

 

 

(10,627

)

Total operating lease liabilities

 

 

85,675

 

Less: current portion

 

 

(33,868

)

Operating lease liabilities, net of current portion

 

$

51,807

 

 

 

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Note 11. Related Party Transactions

 

Legal

 

Faegre Drinker Biddle & Reath (“Faegre Drinker”), formerly Drinker Biddle & Reath LLP (“DBR”) has provided legal services to the Company. The Company’s Chief Legal Officer and Corporate Secretary holds the consulting role “Senior Counsel” with the Faegre Drinker. Before joining the Company as Chief Legal Officer and Corporate Secretary, he was a partner at DBR and a non-employee director of the Company. In that capacity he received equity compensation payable to non-employee directors generally under the Company’s Amended and Restated 2016 Stock Option Plan for Non-Employee Directors (the “2016 Director Plan”) (see Note 12, Equity Incentive Plan) as well as cash compensation payable to non-employee directors generally. Legal fees incurred associated with Faegre Drinker were approximately $127,000 and $523,000 for the three and nine months ended December 31, 2020, respectively, and $170,000 and $620,000 for the three and nine months ended December 31, 2019. At December 31, 2020 and March 31, 2020, the Company had approximately $84,000 and $73,000, respectively, in accounts payable and accrued expenses payable to Faegre Drinker.

Note 12. Equity Incentive Plan

Stock Options

 

As of December 31, 2020, there was approximately $4.8 million of total unrecognized compensation expense related to non-vested stock options. The cost is expected to be recognized over the remaining weighted average service period of 2.73 years.

 

As of December 31, 2020, there were 2,534,633 shares available for grant under the Company’s 2015 Equity Incentive Plan and 2016 Director Plan.

 

Stock based compensation expense was recognized as follows:

 

 

 

Three Months Ended

December 31,

 

 

Nine Months Ended                   December 31,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

General and administrative

 

$

490,000

 

 

$

959,000

 

 

$

1,589,000

 

 

$

2,748,000

 

Research and development

 

 

295,000

 

 

 

643,000

 

 

 

1,149,000

 

 

 

1,925,000

 

Total

 

$

785,000

 

 

$

1,602,000

 

 

$

2,738,000

 

 

$

4,673,000

 

 

The Company uses the Black-Scholes option pricing model to determine the fair value of stock options granted. For employees and non-employees, the compensation expense is amortized on a straight-line basis over the requisite service period, which approximates the vesting period. The Company accounts for forfeitures as they occur, rather than estimating forfeitures as of an award’s grant date.

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, non-employees and consultants in the current fiscal period has been based on the term by using the simplified method as allowed under SAB No. 110 and ASU 2018-7.

 

The weighted average assumptions used to determine such values are presented in the following table:

 

 

 

December 31,

2020

 

 

December 31,

2019

 

Risk free interest rate

 

0.17% - 0.53%

 

 

1.39% - 2.38%

 

Expected volatility

 

88.02% - 101.67%

 

 

71.65% - 76.22%

 

Expected term (in years)

 

2.8 - 6.1

 

 

2.5 - 6

 

Dividend yield

 

 

0

%

 

 

0

%

 

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Table of Contents

 

The following is a summary of the status of the Company’s stock options for the nine months ended December 31, 2020:

 

 

 

Number of

Options

 

 

Weighted

Average

Exercise

Price

 

Outstanding at March 31, 2020

 

 

11,815,982

 

 

$

3.43

 

Granted

 

 

5,568,000

 

 

$

1.24

 

Cancelled/Forfeited

 

 

(1,927,460

)

 

$

1.75

 

Outstanding at December 31, 2020

 

 

15,456,522

 

 

$

2.85

 

Options exercisable at December 31, 2020

 

 

9,853,275

 

 

$

3.70

 

 

 

 

 

 

 

 

Stock Options Outstanding

 

 

Stock Options Vested

 

Range of

Exercise

Price

 

Number Outstanding at December 31, 2020

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Life

(Years)

 

 

Aggregate

Intrinsic

Value

 

 

Number

Vested at December 31, 2020

 

 

Weighted

Average

Exercise

Price

 

 

Aggregate

Intrinsic

Value

 

$0.95 - $8.75

 

 

15,456,522

 

 

$

2.85

 

 

 

7.5

 

 

$

438,795

 

 

 

9,853,275

 

 

$

3.70

 

 

$

39,000

 

 

The intrinsic value calculated as the excess of the market value as of December 31, 2020 over the exercise price of the options, is $438,795. The market value per share as of December 31, 2020 was $1.22 as reported by the NASDAQ Capital Market.

Note 13. 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 available positive and negative evidence and concluded that a full valuation allowance should continue to be maintained on its net deferred tax assets.

The Company is required to evaluate uncertain tax positions taken or expected to be taken in the course of preparing the Company’s condensed consolidated financial statements to determine whether the tax positions are more likely than not of being sustained by the applicable tax authority. As of December 31, 2020, the Company’s uncertain tax positions remain unchanged. Due to the full valuation allowance, none of the gross unrecognized tax benefits, if recognized, would affect the effective tax rate at December 31, 2020.

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

 

                     

\

\\

 

 

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Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The disclosures in this Quarterly Report are complementary to those made in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 22, 2020 (the “2020 10-K”). 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 this Quarterly Report as well as our audited financial statements, notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our 2020 Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, 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 this report and of our 2020 Form 10-K, 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,” “TYME” or “Tyme Technologies” refer to Tyme Technologies, Inc. together with its subsidiaries. All amounts in Management’s Discussion and Analysis of Financial Condition and Results of Operations are approximate.

Overview

 

TYME is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTsTM) that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific pathways within cancer, TYME’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic requirements to cause cancer cell death. Our first-in-class CMBT compounds include SM-88 and TYME-18. These compounds are structurally and mechanistically different, and we believe they offer the potential for better and safer medicines. Early clinical results demonstrated by SM-88 in multiple advanced cancers, including pancreatic, prostate, sarcomas and breast, reinforce the potential of our emerging CMBT pipeline. Moreover, we believe our pipeline offers hope to patients for a new future in long-term management of advanced cancers. With the development of TYME-18 and TYME-19 (discussed below), we believe we are also emerging as a leader in the development of bile acids as potential therapies for cancer and viruses such as COVID-19.

 

Our lead clinical CMBT compound, SM-88, is an oral investigational modified proprietary tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. To date, clinical trial data have shown that SM-88 has achieved confirmed tumor responses across 15 different cancers, both solid and liquid tumors, including pancreatic, lung, breast, prostate, sarcoma and lymphoma cancers, with minimal serious Grade 3 or higher adverse events, which we believe is rare for investigational compounds. In fiscal year 2020, we launched our pivotal study for SM-88 in the third-line treatment of pancreatic cancer through an amendment to our ongoing TYME-88-Panc trial (Part 2), with the first patient dosed in the third quarter of the fiscal year. While all trials for SM-88 are still actively enrolling patients, the COVID-19 pandemic has significantly impacted enrollment of our TYME-88-Panc pivotal trial, and, as such, we do not anticipate the trial to be fully enrolled before calendar year 2022. (See “COVID-19 Update” below.) We estimate the remaining cost of the TYME-88-Panc trial (Part 2) to be approximately $6.0 million through calendar year 2022. We have also partnered with the Pancreatic Cancer Action Network (“PanCAN”) to study SM-88 in an adaptive randomized Phase II/III trial with registration intent known as Precision PromiseSM. In Precision Promise, SM-88 is initially being studied as second-line monotherapy and the study of SM-88 could expand to first-line combination therapy with standard of care. At December 31, 2020, the remaining estimated cost for Precision Promise Stage 1 is approximately $6.8 million. In addition, patient enrollment has advanced in an investigator-initiated Phase II study evaluating SM-88 in high-risk sarcomas with data readout expected in calendar year 2021. We presented final SM-88 prostate Phase II clinical data at the European Society for Medical Oncology’s ESMO 2019 conference showing encouraging clinical benefit in patients with bio-marker recurrent prostate cancer and the final results were published in the peer-reviewed journal, Investigational New Drugs, on September 13, 2020. The Company continues to evaluate the expansion of our SM-88 clinical program to other tumor types.

 

TYME-18 is a CMBT compound under development that is delivered intratumorally. TYME-18 leverages a member of the bile acid family to create a potential treatment for inoperable tumors. Preliminary observations of the local administration of TYME-18, a combination of a proprietary surfactant system and natural sulfonic acid, suggested its potential as an important regulator of energy metabolism that may impede the ability of tumors to increase in size which, in addition to its lytic functionality, could prove useful in difficult-to-treat cancers. In initial preclinical xenograft mouse studies, TYME-18 was able to completely resolve over 90 percent (11/12 mice) of established colorectal tumors within 12 days versus an average of over 600 percent growth in the control animals.

 

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TYME-19 is an oral synthetic member of the bile acid family, a family that the Company also leverages in its anticancer compound, TYME-18. Because of its expertise in metabolic therapies, the Company was able to identify TYME-19 as a potent, well characterized antiviral bile acid and has performed preclinical experiments establishing effectiveness against COVID-19. Bile acids have primarily been used for liver disease; however, like all steroids, they are messenger molecules that modulate a number of diverse critical cellular regulators. Bile acids modulate lipid and glucose metabolism and can remediate dysregulated protein folding, with potentially therapeutic effects on cardiovascular, neurologic, immune, and other metabolic systems. Some agents in this class also have antiviral properties.

 

In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity to the treated cells. Previous preclinical research has also shown select bile acids like TYME-19 have had broad antiviral activity.

 

TYME has partnered with physicians from Massachusetts General Hospital and the Weill Cornell Medical Center to design a proof-of-concept trial for recently diagnosed, symptomatic patients. The trial is expected to start as soon as customary trial site and regulatory approvals are completed.

COVID-19 Update

In March 2020, the World Health Organization categorized the novel coronavirus (COVID-19) as a pandemic and the President of the United States declared the COVID-19 outbreak a national emergency. The COVID-19 pandemic, and actions taken by governments and others to reduce its spread, including travel restrictions, shutdowns of businesses deemed non-essential, and stay-at-home or similar orders, has negatively impacted the global economy, financial markets, and our industry and has disrupted day-to-day life and business operations. We are closely monitoring the impact of COVID-19 on all aspects of our business, our clinical trials, and the safety of patients, including as cities and states ease certain restrictions and begin to reopen or consider doing so and also as they re-impose certain restrictions. We continue to work closely with our clinical trial sites during the pandemic. While all trials for SM-88 are still actively enrolling patients and we believe we have sufficient clinical supply to complete all of our trials, the COVID-19 pandemic has significantly impacted enrollment of our TYME-88-Panc pivotal trial. Enrollment has slowed primarily due to various reasons related to the pandemic, including but not limited to an overall decrease in cancer diagnoses, changes in patient treatment practices, changes in hospital or university policies, federal, state or local regulations, and prioritization of hospital resources toward pandemic efforts. These pandemic-related effects have had a greater impact on our enrollment rates than originally anticipated, and, as such, we do not expect full enrollment for the TYME-88-Panc pivotal trial before calendar year 2022.

 

We are committed to working with the clinical trial sites to assure appropriate access for patients who are seeking clinical trial options for these advanced cancers for which the patients have limited or no other treatment options. We have also taken important steps to protect the health and welfare of our employees, consultants and board members, primarily by adapting to a fully “work-from-home” model since March 2020. The extent to which COVID-19 impacts our product candidates and business, including patients’ willingness to participate and remain in clinical trials, the timing of meeting enrollment expectations, the ability of our third-party partners to remain operational and our access to capital markets and financing sources, however, depends on numerous evolving factors that are highly uncertain and cannot be accurately predicted, including those identified under “Risk Factors” in this report and in the 2020 10-K, many of which are beyond our control. Management continues to monitor the situation closely and intends to continue to adapt and implement process adjustments as needed.

Recent Developments

 

Consistent with our overall corporate mission of developing effective cancer therapies that aim to extend patients’ lives while not compromising on their quality of life and developing bile acids as potential therapies for cancer and viruses such as COVID-19, during the three months ended December 31, 2020 and subsequently, we note the following activities:

 

TYME Announces Patent Issuance


On February 3, 2021, TYME announced that it received notification that the United States Patent and Trademark Office had granted additional patent claims related to the Company’s metabolic technology platform. The patent, U.S. Patent No. 10,905,698, is directed to methods for treating COVID-19.

 

As discussed above in the “Overview” section, the Company is developing and studying TYME-19 in the fight against COVID-19. TYME-19 is an investigational compound that is not approved in the U.S. for any disease indication. TYME intends to initiate the appropriate clinical trials to substantiate the safety and efficacy of TYME-19.

 

 

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TYME Presents SM-88 Abstract at the American Society of Clinical Oncology 2021 Gastrointestinal Cancers Symposium

 

An abstract highlighting clinical data for TYME's lead candidate, oral SM-88 (racemetyrosine), in patients with metastatic pancreatic cancer, was presented at the American Society of Clinical Oncology (ASCO) Virtual 2021 Gastrointestinal Cancers Symposium’s  session titled Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer held on January 17, 2021. The new data presented demonstrates the potential role of SM-88 in advanced pancreatic cancer through the analysis of circulating tumor cells (CTCs) and passively acquired biometrics data from a wearable device.

 

Leadership Changes

 

On November 23, 2020, the Board of Directors of the Company (the “Board”) appointed Richard Cunningham as the new Chief Executive Officer of the Company, effective November 24, 2020. The Board also appointed Mr. Cunningham to serve on the Board to fill a vacancy as a Class II director, effective November 24, 2020. Mr. Cunningham brings over 20 years of leadership experience in the healthcare and biopharmaceutical industry.

 

In conjunction with Mr. Cunningham’s appointment as the new Chief Executive Officer, Steve Hoffman agreed to step down as Chief Executive Officer and continue in his role of Chief Science Officer of the Company, effective November 24, 2020, and will remain a Class I director and Chairman of the Board.

 

In connection with the resignation of the Company’s former President and Chief Financial Officer on September 15, 2020, Barbara Galaini, the Company’s Principal Accounting Officer and Corporate Controller, has been the acting Principal Financial Officer since September 30, 2020.

 

Evaluation of Development Strategy and Product Candidate Portfolio

 

Our new Chief Executive Officer joined the Company during the quarter and initiated a strategic review of the Company’s development strategy and product candidate portfolio with the goal of maximizing opportunities, improving operational efficiencies and minimizing risk as we focus on creating value for all stakeholders and seeking to deliver disruptive science and disease-altering medicines for patients in need. 

 

This process may result in us deciding to modify or discontinue current or planned studies, in reallocating time and resources among existing product candidates, in exploring new product candidates or in making other operational changes, including to our reliance on internal and external resources. It could also result in changes to the timing of our studies and expected research and development costs. Any decisions on advancing, reprioritizing or eliminating any of our programs will be based on evaluation of a number of factors, including our assessment of internal and external resources, the design of or results from our preclinical and clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for pipeline candidates, the costs and complexities of manufacturing to ensure a safe and sustainable supply of investigational compounds can be delivered to patients, the potential of competing products, the likelihood of any challenges to our intellectual property, regardless of merit, the ongoing and potential effects of the COVID-19 or any future pandemics, and industry and market conditions generally. The Company intends to provide updates as management reviews and finalizes its assessment.

 

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 accounting principles generally accepted in the United States (“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, warrant liability, 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 2020 10-K.

 

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Derivative Warrant Liability

Certain freestanding common stock warrants that are related to the issuance of common stock are classified as liabilities and recorded at fair value due to characteristics that require liability accounting, primarily the obligation to issue registered shares of common stock upon notification of exercise or certain price protection provisions. Warrants of this type are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of other income (expense) in the consolidated statement of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrant. The Company utilizes Level 3 fair value criteria to measure the fair value of the warrants.

As noted in Item 1. Note 8, Stockholders’ Equity, the Company classifies a warrant to purchase shares of its common stock as a liability on its condensed consolidated balance sheet if the warrant is a free-standing financial instrument that contains certain price protection features or requires issuance of registered common shares upon exercise which cause the warrants to be treated as derivatives. Each warrant of this type is initially recorded at fair value on date of grant using the Monte Carlo simulation model or the Black Scholes model, and is subsequently re-measured to fair value at each subsequent balance sheet date. Changes in fair value of the warrant are recognized as a component of other income (expense) in the consolidated statement of operations. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrant.

Results of Operations

Three and Nine Months Ended December 31, 2020 Compared to Three and Nine Months Ended December 31, 2019

Net loss for the three months ended December 31, 2020 was $6,121,000 compared to $6,958,000 for the three months ended December 31, 2019 and the net loss for the nine months ended December 31, 2020 was $21,797,000 compared to $16,276,000 for the nine months ended December 31, 2019. The decrease in losses for the current three-month period is due to decreased general and administrative costs and other expenses . The increase in losses for the current nine-month period is due to the non-cash expense variance of $5,596,000 in the fair value of the warrant liability, partially offset by the non-cash gain of $2,229,000 on the warrant exchange, and to increased operating costs. The increase in operating costs for the current nine-month period of $1,998,000 related to increased research and development costs of $3,603,000, partially offset by a $1,605,000 decrease in general and administrative costs.

Cash used in operating activities for the nine months ended December 31, 2020 was $18,501,000 compared to $13,861,000 for the nine months ended December 31, 2019. See Cash Flows section below for further details.

Revenues

During the three and nine months ended December 31, 2020 and 2019, the Company did not realize any revenues from operations. We do not anticipate any revenues until such time as one of our product candidates has been approved for commercialization by appropriate regulatory authorities, or we enter into certain types of collaboration or licensing arrangements, none of which is anticipated to occur in the near future.

Operating Costs and Expenses

For the three months ended December 31, 2020, operating costs and expenses totaled $5,871,000 compared to $6,544,000 for the three months ended December 31, 2019, a decrease of $673,000. Operating costs and expenses were comprised of the following:

 

Research and development expenses were $3,549,000 for the three months ended December 31, 2020, comparable to $3,459,000 for the three months ended December 31, 2019, a decrease of $90,000. Substantially 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:

 

o

Study and consulting expenses were $2,479,000 for the three months ended December 31, 2020, compared to $2,134,000 for the three months ended December 31, 2019, an increase of $345,000 between the comparable periods. The increase is mainly attributable to increased activity, related to Part 2 of our TYME-88-Panc trial and the Precision Promise Phase II/III trial.

 

o

Salary and salary related expenses for research and development personnel were $775,000 for the three months ended December 31, 2020, compared to $682,000 for the three months ended December 31, 2019, an increase of $93,000 primarily due to shift in resources to research and development.

 

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o

Included in research and development expense for the three months ended December 31, 2020 is $295,000 of stock based compensation expense related to stock options granted to research and development personnel compared to $643,000 for the three months ended December 31, 2019, a decrease of $348,000 primarily attributable to fully vested grants.

 

General and administrative expenses were $2,322,000 for the three months ended December 31, 2020, compared to $3,085,000 for the three months ended December 31, 2019, a decrease of $763,000. The general and administrative expenses for the respective periods include:

 

o

Other general and administrative expenses were $1,833,000 during the three months ended December 31, 2020, compared to $2,126,000 for the three months ended December 31, 2019, a decrease of $293,000, reflecting lower employee related and business travel costs.

 

o

Stock based compensation expense related to stock options was $490,000 for the three months ended December 31, 2020 compared to $959,000 for the three months ended December 31, 2019, a decrease of $469,000, primarily attributable to fully vested grants and cancellation of options.

For the nine months ended December 31, 2020, operating costs and expenses totaled $20,965,000 compared to $18,967,000 for the nine months ended December 31, 2019, an increase of $1,998,000. Operating costs and expenses were comprised of the following:

 

Research and development expenses were $12,972,000 for the nine months ended December 31, 2020, compared to $9,369,000 for the nine months ended December 31, 2019, an increase of $3,603,000. Substantially 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:

 

o

Study and consulting expenses were $9,628,000 for the nine months ended December 31, 2020, compared to $5,427,000 for the nine months ended December 31, 2019, an increase of $4,201,000 between the comparable periods. The increase is mainly attributable to increased activity, including supply costs, related to Part 2 of our TYME-88-Panc trial and the Precision Promise Phase II/III trial.

 

o

Salary and salary related expenses for research and development personnel were $2,194,000 for the nine months ended December 31, 2020, compared to $2,008,000 for the nine months ended December 31, 2019 an increase of $186,000 primarily due to a shift in resources to research and development.

 

o

Included in research and development expense for the nine months ended December 31, 2020 is $1,149,000 of stock based compensation expense related to stock options granted to research and development personnel compared to $1,925,000 for the nine months ended December 31, 2019, a decrease of $776,000 primarily attributable to fully vested grants.

 

General and administrative expenses were $7,993,000 for the nine months ended December 31, 2020, compared to $9,598,000 for the nine months ended December 31, 2019, a decrease of $1,605,000. The general and administrative expenses for the respective periods include:

 

o

Other general and administrative expenses were $6,404,000 during the nine months ended December 31, 2020, compared to $6,850,000 for the nine months ended December 31, 2019, a decrease of $446,000, reflecting lower office expenses, employee related and business travel costs.

 

o

Stock based compensation expense related to stock options was $1,589,000 for the nine months ended December 31, 2020 compared to $2,748,000 for the nine months ended December 31, 2019, a decrease of $1,159,000, primarily attributable to fully vested grants.

Other income (expense)

For the three months ended December 31, 2020, the Company had $229,000 non-cash expense relating to the change in fair value of the warrant liability during the period, compared to $426,000 for the three months ended December 31, 2019. For the nine months ended December 31, 2020, the Company had $3,002,000 non-cash expense relating to the change in fair value of the warrant liability during the period compared to $2,594,000 of non-cash income for the nine months ended December 31, 2019, resulting in a $5,596,000 variance between the periods. See Item 1, Note 8 for details regarding changes in the fair value of the warrant liability.

For the nine months ended December 31, 2020, the Company had a non-cash gain on warrant exchanges of $2,229,000 pursuant to the Share Exchange Agreements and the Warrant Exchange Agreement. See Item 1, Note 8 for additional details.

 

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Table of Contents

For the three and nine months ended December 31, 2020 the Company earned interest income on cash accounts of $2,000 and $19,000 compared to $38,000 and $186,000 for the three and nine months ended December 31, 2019. For the three and nine months ended December 31, 2020, the Company had interest expense primarily related to the amortization of the severance payable discount of $23,000 and $78,000 compared to $26,000 and $89,000 for the three and nine months ended December 31, 2019.

Adjusted Net Loss and Adjusted Net Loss per Share

 

After adjusting for change in fair value of warrant liability, amortization of employees, directors and consultants stock options and gain on warrant exchange, adjusted net loss for the three months ended December 31, 2020 was $5,107,000 or $0.04 per share compared to $4,930,000 or $0.05 per share for the three months ended December 31, 2019. Adjusted net loss for the nine-month period ended December 31, 2020 was $18,286,000 or $0.15 per share compared to $14,197,000 or $0.13 per share for the same period in the prior year. Adjusted net loss and adjusted net loss per share are non-GAAP measures. See “Use of Non-GAAP Measures” below for a reconciliation to the comparable GAAP measures.

Use of Non-GAAP Measures

 

Adjusted net loss and adjusted net loss per share as presented in this report are non-GAAP measures. The adjustments relate to the change in fair value of warrant liabilities, amortization of employees, directors and consultants stock based compensation and gain on warrant exchange. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles ("Non-GAAP Measures"). In the reconciliation tables that follow, we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures, net loss and net loss per share. These items are adjusted because they are not operational or because they are significant non-cash charges and management believes these adjustments are meaningful to understanding the Company's performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP. Our definitions of adjusted net loss and adjusted loss per share may not be comparable to similar measures reported by other companies.

 

Reconciliation of Net Loss to Adjusted Net Loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

December 31,

 

 

Nine Months Ended                   December 31,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net loss (GAAP)

 

$

(6,121,000

)

 

$

(6,958,000

)

 

$

(21,797,000

)

 

$

(16,276,000

)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of warrant liability

 

 

229,000

 

 

 

426,000

 

 

 

3,002,000

 

 

 

(2,594,000

)

Amortization of employees, directors and consultants stock options

 

 

785,000

 

 

 

1,602,000

 

 

 

2,738,000

 

 

 

4,673,000

 

Gain on warrant exchange

 

 

 

 

 

 

 

 

(2,229,000

)

 

 

 

Adjusted net loss (non-GAAP)

 

$

(5,107,000

)

 

$

(4,930,000

)

 

$

(18,286,000

)

 

$

(14,197,000

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of Net Loss Per Share to Adjusted Net Loss Per Share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

December 31,

 

 

Nine Months Ended                   December 31,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net loss per share (GAAP)

 

$

(0.05

)

 

$

(0.06

)

 

$

(0.17

)

 

$

(0.15

)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of warrant liability

 

*

 

 

*

 

 

 

0.02

 

 

 

(0.02

)

Amortization of employees, directors and consultants stock options

 

 

0.01

 

 

 

0.01

 

 

 

0.02

 

 

 

0.04

 

Gain on warrant exchange

 

 

 

 

 

 

 

 

(0.02

)

 

 

 

Adjusted net loss per share (non-GAAP)

 

$

(0.04

)

 

$

(0.05

)

 

$

(0.15

)

 

$

(0.13

)

* The effect of the change in fair value of the warrant liability was negligible to the adjusted net loss per share.

 

 

The Non-GAAP Measures for the three and nine months ended December 31, 2020 and 2019 provide management with additional insight into the Company’s results of operations from period to period by excluding certain non-operational and non-cash charges, and are calculated using the following adjustments to net loss:

 

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a)

The warrants issued as part of an equity offering on April 2, 2019 were measured at fair value using a Monte Carlo model which takes into account, as of the valuation date, factors including the current exercise price, the remaining contractual term of the warrant, the current price of the underlying stock, its expected volatility, the risk-free interest rate for the term of the warrant and the estimates of the probability of fundamental transactions occurring.

The May 2020 Warrant issued as part of the warrant exchange as described under the subheading “Historical Financings” below was measured at fair value using a Black-Scholes model which takes into account, as of the valuation date, factors including the current exercise price, the remaining contractual term of the warrant, the current price of the underlying stock, its expected volatility and the risk-free interest rate for the term of the warrant.

 

The warrant liability is revalued at each reporting period or upon exercise. Changes in fair value are recognized in the consolidated statements of operations and are excluded from adjusted net loss and adjusted net loss per share.

 

 

b)

The Company uses the Black-Scholes option pricing model to determine fair value of stock options granted. For employees and non-employees, the compensation expense is amortized over the requisite service period which approximates the vesting period. The expense is excluded from adjusted net loss and adjusted net loss per share.

 

 

c)

Gain on warrant exchange resulted from the difference in fair value of the warrants issued as part of the equity offering on April 2, 2019 before their exchange (as described under the subheading “Historical Financings” below) and the fair value of the common stock exchange shares and the May 2020 warrant granted pursuant to the Share Exchange Agreements and the Warrant Exchange Agreement, respectively.

 

Adjusted basic net loss per share is computed by dividing adjusted net loss by the weighted average number of shares of Company common stock outstanding for the period, and adjusted diluted loss per share is computed by also including common stock equivalents outstanding for the period. During the periods presented, the calculation excludes any potential dilutive common shares and any equivalents as they would have been anti-dilutive as the Company incurred losses for the periods then ended.

Liquidity and Capital Resources

Liquidity and Capital Requirements Outlook


We anticipate requiring additional capital to further fund the development of our product candidates, as well as to engage in potential partnerships or collaborations. The most significant funding needs are in connection with (i) conducting Part 2 of TYME-88-Panc, our pivotal trial, and participating in Precision Promise, an adaptive randomized Phase II/III trial with registration intent, which examine our lead compound SM-88 for patients with second- and third-line pancreatic cancer, (ii) participating in an investigator-initiated clinical trial of SM-88 in sarcoma, and (iii) conducting additional or related studies and investigations, including small-scale preclinical studies related to the mechanism of action of our lead clinical program SM-88 and other potential drug candidates, including TYME-18 and TYME-19. The greater scale of these trials is expected to lead to increased costs, including providing SM-88 for patient use. If we determine to move beyond the preclinical stage for any of our preclinical trials or if we pursue studies in other cancer types, our liquidity requirements will be increased. As discussed in the 2020 10-K and as part of the strategic review process discussed in the “Recent Developments” section above, we continue to evaluate the expansion of our clinical program to hematological, breast, prostate and other cancers.

 

Primarily as a result of its active clinical trials, including timing of enrollment, as well as other business developments, the Company currently anticipates that its quarterly cash operating expense will average approximately $6.0 to $6.5 million during fiscal year 2021. Management expects that the Company’s net cash usage or net “cash burn” will be less than its operating costs.

 

As of December 31, 2020, the Company had cash on hand of approximately $13.5 million and a working capital of approximately $10.6 million.

 

Management has concluded that substantial doubt does not exist regarding the Company’s ability to satisfy its obligations as they come due during the twelve-month period following the issuance of these financial statements. This conclusion is based on the Company’s assessment of qualitative and quantitative conditions and events, considered in aggregate as of the date of issuance of these financial statements that are known and reasonably knowable. Among other relevant conditions and events, including the ongoing COVID-19 pandemic and related government and economic responses, the Company has considered its operational plans, liquidity sources, obligations due or expected, funds necessary to maintain the Company’s operations, and potential adverse conditions or events as of the issuance date of these financial statements.

 

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The Company has historically funded its operations primarily through equity offerings of its common stock. As a clinical-stage entity, without product revenues and ongoing needs to fund our clinical development activities and general operations, we regularly evaluate opportunities to raise capital and obtain necessary, as well as opportunistic financing. 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 and biotechnology 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.

 

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, which we expect to raise, 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 certain or all of our drug candidates or raise funds on terms that we currently consider unfavorable.

 

From time to time, we may also restructure our outstanding securities or seek to repurchase or redeem them if we

believe doing so would provide us with additional flexibility to raise capital or is otherwise in the best interests of the Company.

 

Historical Financings

 

On January 7, 2020, the Company and Eagle Pharmaceuticals, Inc. (“Eagle”) entered into a Securities Purchase Agreement (the “Eagle SPA”), pursuant to which the Company issued and sold to Eagle 10,000,000 shares of common stock, at a price of $2.00 per share. The Eagle SPA provides that Eagle will, subject to certain conditions, make an additional payment of $20 million upon the occurrence of a milestone event, which is defined as the earlier of (i) achievement of the primary endpoint of overall survival in the TYME-88-Panc pivotal trial; (ii) achievement of the primary endpoint of overall survival in the PanCAN Precision PromiseSM SM-88 registration arm; or (iii) U.S. Food and Drug Administration (“FDA”) approval of SM-88 in any cancer indication. This payment would be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement.

 

On October 18, 2019, the Company entered into an Open Market Sale AgreementSM , which was amended on August 12, 2020 (the “Sale Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company may, from time to time, sell shares of Common Stock, having an aggregate offering price of up to $30.0 million through Jefferies, as the Company’s sales agent (the “Jefferies ATM”). As indicated in the amendment, the shares will be offered and sold by the Company pursuant to its currently effective Registration Statement on Form S-3, as amended (Reg. No. 333-245033). Any sales of Common Stock pursuant to the Sales Agreement will be made by methods deemed to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. Jefferies will use commercially reasonable efforts to sell the shares from time to time, based on the instructions of the Company. The Company will pay Jefferies a commission rate of three percent (3%) of the gross proceeds from the sales of shares of Common Stock sold pursuant to the Sale Agreement. Under the Sale Agreement, the Company is not required to use the full available amount authorized and it may, by giving notice as specified in the Sale Agreement, terminate the Sale Agreement at any time. During the nine months ended December 31, 2020, the Company raised approximately $6.1 million in gross proceeds via the sale of 4,453,939 shares of common stock under the Jefferies ATM. The Company incurred $0.3 million of related costs which partially offset such proceeds. As of December 31, 2020, there remained approximately $22.2 million of availability in the Jefferies ATM.

 

Prior to the Jefferies ATM, the Company had a similar facility with Canaccord Genuity Inc. (“Canaccord”) that was closed shortly before the opening of the Jefferies ATM. There was no activity in the Canaccord facility for the three and nine month period ended December 31, 2019.

 

On April 2, 2019, the Company closed on an underwritten registered offering of 8,000,000 shares of its common stock, par value $0.0001 per share (“Common Stock”), and warrants to purchase up to 8,000,000 shares of its common stock with an exercise price of $2.00 per share (the “April 2019 Warrants”) at a combined purchase price of $1.50 per share of common stock and accompanying warrant. The net proceeds to the Company, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, were approximately $11 million. The proceeds of the offering are being used for continued and new clinical

 

24

 


Table of Contents

trials, continued development of compounds, and other general corporate purposes. On May 20, 2020, the Company entered into exchange agreements with holders (the “Holders”) of the April 2019 Warrants. The April 2019 Warrants were offered and issued pursuant to the Company’s Registration Statement on Form S-3 (Registration No. 333-211489), which was declared effective by the SEC on August 16, 2017, a base prospectus dated August 16, 2017 and a prospectus supplement dated March 28, 2019.

 

Pursuant to exchange agreements (the “Share Exchange Agreements”) with Holders of the April 2019 Warrants to purchase 5,833,333 shares of Common Stock in the aggregate, the Company issued an aggregate of 2,406,250 shares of Common stock (the “Exchange Shares”) in exchange for such April 2019 Warrants. Concurrently therewith, each such Holder executed and delivered to the Company a leak-out agreement (a “Share Leak-Out Agreement”) that contained trading restrictions with respect to the Exchange Shares, which (i) for the first 90 days, prohibit any sales of Exchange Shares, (ii) for the subsequent 90 days, limit sales of Exchange Shares on any day to 2.5% of that day’s trading volume of Common Stock, and (iii) prohibit new short positions or short sales on Common Stock for the combined 180 day period.

 

The Company also entered into an exchange agreement (the “Warrant Exchange Agreement”) with another Holder of April 2019 Warrants to purchase 2,166,667 shares of Common Stock in the aggregate. Pursuant to the Warrant Exchange Agreement, the Company issued such Holder a new warrant (the “May 2020 Warrant”) to purchase the same number of shares of Common Stock. The May 2020 Warrant has the same expiration date, April 2, 2024, as the April 2019 Warrants, but has an exercise price of $1.80 and does not include the price protection, anti-dilution provisions or other restrictions on Company action from the 2019 April Warrants. Concurrently therewith, such Holder executed and delivered to the Company a leak-out agreement that contained trading restrictions on sales of Common Stock issued upon exercise of the May 2020 Warrant that are substantially similar to the restrictions on Exchange Shares in the Share Leak-Out Agreement, provided that the leak-out restrictions will only apply to the first 893,750 shares of Common Stock issued pursuant to the May 2020 Warrant.

 

After such exchanges, the April 2019 Warrants no longer remained outstanding.

 

Cash Flows

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

 

 

 

Nine Months Ended December 31,

 

 

 

2020

 

 

2019

 

Net cash (used in) provided by operating activities

 

$

(18,501,000

)

 

$

(13,861,000

)

Net cash (used in) provided by investing activities

 

 

 

 

 

 

Net cash (used in) provided by financing activities

 

 

5,288,000

 

 

 

11,024,000

 

Operating Activities

Our cash used in operating activities in the nine months ended December 31, 2020 totaled $18.5 million, which is the sum of (i) our net loss of $21.8 million, adjusted for non-cash expenses of $3.0 million related to change in fair value of warrant liability and $2.7 million expense amortization of stock-based compensation, partially offset by $2.2 million non-cash gain on warrant exchange and (ii) changes in operating assets and liabilities of $0.2 million.

Our cash used in operating activities in the nine months ended December 31, 2019 totaled $13.9 million, which is the sum of (i) our net loss of $16.3 million, adjusted for non-cash income of $2.6 million (related to change in fair value of warrant liability) and non-cash expenses totaling $4.7 million (principally amortization of stock-based compensation), and (ii) changes in operating assets and liabilities of $0.3 million.

 

Investing Activities

No cash was used in investing activities for the nine months ended December 31, 2020 and December 31, 2019.

Financing Activities

 

During the nine months ended December 31, 2020, our financing consisted of the following:

 

 

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Table of Contents

 

The Company raised approximately $6.1 million in gross proceeds via the sale of 4,453,939 shares of common stock under the Jefferies ATM. The Company incurred $0.3 million of related costs which partially offset such proceeds.

  

 

The Company made payments of $518,000 on the insurance note payable related to premiums for its Director and Officer liability insurance coverage.  

During the nine months ended December 31, 2019, our financing consisted of the following:

 

 

In April 2019, the Company raised $11.3 million after underwriting discounts and before offering expenses of $0.1 million through an underwritten registered offering of 8,000,000 shares of our common stock and 8,000,000 common stock purchase warrants.

 

 

For the nine months ended December 31, 2019, the Company raised approximately $0.6 million in gross proceeds via sale of 582,968 shares of common stock under the Jefferies ATM. The Company incurred $0.2 million of related costs which partially offset the proceeds.

 

 

During the nine months ended December 31, 2019, the Company made payments of $597,000 on the insurance note payable related to premiums for its Director and Officer liability insurance coverage.

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 Risk.  

Not required for smaller reporting companies.

Item 4.

Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

Under the supervision of and with the participation of management, including our principal executive officer and acting principal financial officer, we evaluated the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities and Exchange Act of 1934, as amended, as of December 31, 2020. Based on such evaluation, our principal executive officer and acting principal financial officer concluded that our disclosure controls and procedures were effective.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2020, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

26

 


Table of Contents

PART II – OTHER INFORMATION

Item 1.

Legal Proceedings.

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.

Item 1A.

Risk Factors.

Our Annual Report on Form 10-K for the year ended March 31, 2020 includes a detailed discussion of our risk factors. Except as set forth below, at the time of this filing, there have been no material changes to the risk factors that were included in the Form 10-K.

We are currently evaluating the Company’s development strategy and product candidate portfolio, which may result in significant changes and have a material impact on our business, results of operations and financial condition.

In connection with our new CEO recently joining the Company, we are currently undertaking a strategic review of our development strategy and product candidate portfolio. As a result of this review, we may elect to discontinue, delay or modify preclinical or clinical trials of some product candidates or focus on others, and we may implement other operational changes, including to our reliance on internal and external resources. Any decision to make such changes will be based on an evaluation of a number of factors, including our assessment of internal and external resources, the design of or results from our preclinical and clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for pipeline candidates, the costs and complexities of manufacturing to ensure a safe and sustainable supply of investigational compounds can be delivered to patients, the potential of competing products, the likelihood of any challenges to our intellectual property, regardless of merit, the ongoing and potential effects of the COVID-19 or any future pandemics, and industry and market conditions generally. Any resulting changes could mean a significant change in the costs and timing associated with the development of our product candidates and could therefore materially impact our business, results of operations and financial condition. There can be no assurance that this review process will lead to the completion of any particular course of action.

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3.

Defaults Upon Senior Securities.

None.

Item 4.

Mine Safety Disclosures.

Not applicable.

 

Item 5.    Other Information.

None.

  

    

 

 

27

 


Table of Contents

Item 6.

Exhibits.

 

Exhibit

  

 

Number

  

Description

 

 

    3.1

 

Amended and Restated Certificate of Incorporation of Tyme Technologies, Inc. (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed with the SEC on September 19, 2014.)

 

 

 

    3.2

 

Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Tyme Technologies, Inc., effective April 2, 2018. (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed with the SEC on April 2, 2018.)

 

    3.3

 

Certificate of Designation of Series A Convertible Stock, dated January 7, 2020. (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed with the SEC on January 8, 2020.)

 

    3.4

 

Amended and Restated By-Laws of Tyme Technologies, Inc., effective April 2, 2018. (Incorporated by reference to Exhibit 3.2 to our Current Report on Form 8-K, filed with the SEC on April 2, 2018.)

 

  10.1 *

 

Letter Agreement, dated November 24, 2020, by and between Richard Cunningham and Tyme Technologies, Inc.***

 

  10.2 *

 

Letter Agreement, dated November 24, 2020, by and between Steve Hoffman and Tyme Technologies, Inc.***

 

 

  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 **

  

Section 1350 Certification of Principal Executive Officer and Principal 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.

**

Furnished herewith.

***

Mr. Cunningham’s and Mr. Hoffman’s personal addresses have respectively been redacted from these exhibits.

 

28

 


Table of Contents

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 3, 2021

 

TYME TECHNOLOGIES, INC.

 

 

By:

 

/s/ Richard Cunningham

 

 

Richard Cunningham

 

 

Chief Executive Officer

(Principal Executive Officer)

 

By:

 

/s/ Barbara Galaini

 

 

Barbara Galaini

 

 

Corporate Controller

(Principal Financial Officer and Principal Accounting Officer)

 

 

 

29

 

Execution Version

EXHIBIT 10.1

TYME TECHNOLOGIES, INC.
1 PLUCKEMIN WAY - SUITE 103
BEDMINSTER NJ 07921

November 24, 2020

Mr. Richard Cunningham

[REDACTED]

[REDACTED]

 

Dear Richard:

This letter sets forth our agreement with respect to your employment (hereinafter “letter agreement”) with Tyme Technologies, Inc., a Delaware corporation (the “Company”).

1.Employment.  Your employment with the Company will be upon the terms and conditions set forth in this letter agreement beginning on the date that you sign this letter agreement (the “Effective Date”) and ending as provided in Section 4 (the “Employment Period”).  

2.Position and Duties.  During the Employment Period, you will serve as Chief Executive Officer of the Company and will have the usual and customary duties, responsibilities and authorities of a person in such position and such other duties assigned to you by the Board of Directors of the Company (the “Board”) which are consistent with your position.  You will report directly to the Board. You will devote your full working time, efforts and attention to, and diligently and conscientiously perform the duties of, such position.  In addition to performing such duties for the Company, you may be required to perform similar duties for the Company’s existing subsidiaries or affiliates, and/or any subsidiaries and/or affiliates which may be formed or acquired from time to time in the future, including without limitation Tyme Inc., a Delaware corporation, and Luminant Biosciences, LLC (collectively, all such subsidiaries and/or affiliates, including subsidiaries formed after the date hereof, shall be referred to as the “Company Affiliates”).  Except for travel for business purposes, you will be employed and your primary offices will be located at the Company office located at 1 Pluckemin Way, Suite 103, Bedminster, New Jersey (the “Company Office”). You will be appointed as a member of the Board effective as of the Effective Date, and the Company shall cause you to be nominated as a member of the Board at each annual meeting of stockholders of the Company during the Employment Period at which your Board seat is up for re-election. You represent to the Company that you are not subject to or a party to any employment agreement, non-competition covenant, or other agreement that would be breached by, or prohibit you from executing, this Agreement and performing fully your duties and responsibilities hereunder.

3.Compensation.

(a)Base Salary. During the Employment Period, your base salary will be $550,000 per annum (your “Base Salary”).  Your Base Salary will be payable in regular installments in accordance with the Company’s general payroll practices and subject to withholding and other payroll taxes.  Your Base Salary may be reviewed annually (consistent with

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the Company’s past practice and timing) by the Board and may be increased by the Board in its sole discretion, it being understood that any increase in calendar year 2021 shall be prorated for the partial year of service (for the avoidance of doubt, such increased amount shall be considered your “Base Salary” for all purposes of this letter agreement).  Unless agreed by you in writing, your Base Salary may not be decreased below your then current Base Salary by the Board or otherwise.

(b)Sign-On Bonus. As an inducement for you to join the Company in the role of Chief Executive Officer and to compensate you for certain costs associated with transitioning your prior business activities, the Company shall pay you a sign-on bonus in the amount of $75,000 (the “Sign-On Bonus”). The Sign-On Bonus shall be paid in a lump sum within 30 days following the Effective Date. You shall be required to repay the full amount of the Sign-On Bonus if, prior to the first anniversary of the Effective Date, your employment terminates either (1) by the Company for Cause (as defined below) or (2) by you for any reason other than Good Reason (as defined below), and to the fullest extent permitted by applicable law you authorize the Company to deduct the repayment amount, or a portion thereof, from any monies owed to you. For the avoidance of doubt, you shall not be required to repay any portion of the Sign-On Bonus by reason of termination of employment for any other reason (including, without limitation, death or Disability).

(c)Cash Incentive Plan. With respect to each fiscal year of the Company ending during the Employment Period, you shall be eligible to earn an incentive award (an “Annual Target Incentive Award”) under the Company’s Cash Incentive Plan, or any successor plan (the “Cash Incentive Plan”) pursuant to the terms and conditions of the Cash Incentive Plan. Your incentive award shall be paid at such times and in such manner as set forth in the Cash Incentive Plan. Prior to or at the beginning of each fiscal year of the Company, the independent directors of the Board (upon the recommendation of the Compensation Committee) shall determine your Annual Target Incentive Award, taking into consideration such factors as the independent directors deem appropriate. Your Annual Target Incentive Award under the Cash Incentive Plan for fiscal year 2021 (i.e., the year ending March 31, 2021) shall be 50% of Base Salary, provided, however, the Annual Target Incentive Award for the 2021 fiscal year, to the extent earned under the Cash Incentive Plan, shall be prorated (based on the ratio of the number of days from the Effective Date to the last day of the fiscal year to 365). For the avoidance of doubt, in the event of any conflict between term definitions in this Section 3(c) and the Cash Incentive Plan, the definitions in this Agreement shall control.

(d)Sign-On Option Grant. In connection with your entering into this letter agreement, we shall grant to you on November 25, 2020 (the “Grant Date”), under the Company’s 2015 Equity Incentive Plan, as amended, or any successor plan (the “Equity Plan”), an option (the “Option”) to purchase up to 2,000,000 shares (each, an “Option Share”) of the common stock, par value $0.0001 per share (the “Common Stock”), of the Company, at a per Option Share purchase (exercise) price equal to the Fair Market Value of the Common Stock on the Grant Date (as Fair Market Value is defined in the Equity Plan). The Option shall have a term of ten years and, except as provided in Section 5(a)(iii) and Section 5(b)(iv) below, shall vest in equal quarterly installments over the four year period following the Grant Date (each, a “Vesting Date”), provided that you are employed by the Company on the relevant Vesting Date, and otherwise subject to the provisions of the Equity Plan.  For the avoidance of doubt, except as provided in Section 5(a)(iii)

 

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and Section 5(b)(iv) below, in the event you terminate employment with the Company prior to full vesting of the Option, the unvested portion of the Option will expire and terminate in full as of such termination and you will not have any right to exercise the unvested portion of the Option.  The vested portion of the Option will be exercisable for the period and under the terms provided in the Equity Plan. The number of Option Shares and purchase price shall be adjusted in the event of any stock splits, mergers, consolidations or similar transactions.  The Option shall be evidenced by a Stock Option Agreement in the form attached as Exhibit A to this letter agreement (the “Option Agreement”).  The Option granted pursuant to this letter agreement, Common Stock delivered pursuant to this Option, and any gains or profits on the sale of such Common Stock shall be subject to any “clawback” or recoupment policy adopted by the Company. In the event of any conflict between the provisions of this paragraph 3(d) and the provisions of the Equity Plan, the provisions of the Equity Plan shall govern. In the event of any conflict between the provisions of this paragraph 3(d) and the provisions of the Option Agreement, the provisions of this Agreement shall govern.

(e)Target Compensation after Fiscal Year 2021. Your awards under the Cash Incentive Plan and the Equity Plan shall be reviewed annually by the independent directors pursuant to the normal performance review policies for the CEO, with such targets established by the independent directors in their sole discretion, following a recommendation by the Compensation Committee. For the avoidance of doubt, any future award granted under the Equity Plan that relates to fiscal year 2021 (other than the Option granted in Section 3(d) above) shall be prorated (based on the ratio of the number of days from the Effective Date to the last day of the fiscal year to 365).

(f)During the Employment Period, you will be entitled to participate in all employee benefit programs, including without limitation health/medical insurance, for which senior executive employees of the Company are generally eligible, subject to applicable plans and policies as may be amended from time to time, in the sole discretion of the Board.  During the Employment Period, you will be entitled to four weeks paid vacation during each calendar year, with such vacation time pro-rated for any partial calendar years during the Employment Period; provided, however, that no carry-over of unused vacation time shall be permitted and no compensation shall be paid for any such unused vacation time.

(g)The Company shall reimburse you for all reasonable out-of-pocket business expenses incurred by you on behalf of the Company during the Employment Period, in accordance with applicable policies of the Company; provided that you properly account to the Company for all such expenses in accordance with the policies of the Company and the rules, regulations and interpretations of the U.S. Internal Revenue Service relating to reimbursement of business expenses (“Expenses).

(h)During the Employment Period, the Company will maintain Directors and Officers Liability Insurance coverage that includes coverage of you, subject to the terms and conditions of such policy and with limits customary for similarly situated companies.

4.Termination.  

 

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(a)The Employment Period will end on the date which is 48 months (i.e., four years) following the Effective Date, unless it is sooner terminated or is extended as provided below.   Notwithstanding the foregoing, the Employment Period (i) will terminate upon your death, (ii) may be terminated by the Company upon Notice of Termination (as defined in Section 5(f) below) delivered to you as a result of your Disability (as defined in Section 5(h) below), (iii) may be terminated by the Company at any time for Cause (as defined in Section 5(g) below), (iv) may be terminated by you for Good Reason (as defined in Section 5 (h) below) and (v) may be terminated by the Company without Cause.

(b)Effective as of the date of any Termination Date, you shall be deemed, without any further action on your part, to have automatically resigned from all Company-related positions, including as an officer and director of the Company and Company Affiliates.

5.Severance.

(a)If the Employment Period is terminated by the Company without Cause or by you for Good Reason, you will be entitled to receive:

(i)your Base Salary as in effect at the time of such termination to the extent such amount has accrued through the Termination Date (as defined in Section 5(f) below) and remains unpaid, any fully earned and declared but unpaid Target Incentive Bonus as of the Termination Date, and any unpaid Expenses that have not been reimbursed by the Company as of the Termination Date that were incurred prior to the Termination Date (the sum of these amounts, the “Accrued Obligations”);

(ii)an amount equal to one year of your Base Salary, less applicable withholdings, which shall be payable in the same amounts and at the same intervals as if the Employment Period had not ended;

(iii)immediate vesting of the portion of all your time-vesting equity awards under the Equity Plan that would have vested in the 12-month period following the Termination Date; and

(iv)if you timely elect continued coverage pursuant to COBRA, payment of your share of the premium cost at the same rate as for active employees of the Company for the 12-month period following the Termination Date.

 

The Company’s obligation to make the payments to you described in clauses (ii), (iii) and (iv) of this Section 5(a) is conditioned upon your executing and delivering, no later than 45 days following the Termination Date (and not revoking), a release relating to your employment by the Company in favor of the Company, the Company Affiliates and their respective stockholders, officers, members, managers, directors, employees, subsidiaries and affiliates substantially in the form attached as Exhibit B (a “Release”); provided, further, that until the period to revoke such Release has expired, the Company shall retain any Base Salary installment payment that would otherwise be made pursuant to clause (ii) of this Section 5(a), with such payment being made on the next regularly scheduled payroll date after such revocation period expires.

 

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(b)Change in Control Termination. If the Employment Period is terminated by the Company without Cause or by you for Good Reason, in each case, upon or within 12 months following the consummation of a Change in Control (as defined below), then, subject to your execution and non-revocation of a Release in the manner provided in Section 5(a) above, (except for the payments described in clause (i) of this Section 5(b), which shall not be subject to such Release requirement), you will be entitled to receive:

(i)the Accrued Obligations;

(ii)an amount equal to one-and-a-half times (1.5x) one year of your Base Salary, less applicable withholdings, which shall be payable in the same amounts (taking the 1.5x multiple into account) and at the same intervals as if the Employment Period had not ended;

(iii)an amount equal to one-and-a-half times (1.5x) your Annual Target Incentive Award either (i) for the year in which the Termination Date occurs (or if it has not yet been established, the Annual Target Incentive Award established for the immediately preceding year), which amount shall be paid in the same manner and at the same time that the Company pays other Company executive incentive awards under the Incentive Plan after the Termination Date;

 

(iv)immediate vesting of all your time-based equity awards under  the Equity Plan; and

(v)if you timely elect continued coverage pursuant to COBRA, payment of your share of the premium cost at the same rate as for active employees of the Company for the 18-month period following the Termination Date.

 

For purposes of this Agreement, a “Change in Control” shall be deemed to occur when and only when any of the following events first occurs: (A) any person becomes the beneficial owner, directly or indirectly, of securities of the Company representing 50% or more of the combined voting power of the Company’s then outstanding voting securities; (B) members of the Incumbent Board (as defined in the Company’s 2015 Equity Incentive Plan) cease to constitute a majority of the Board without the approval of the remaining members of the Incumbent Board; or (C) any merger (other than a merger where the Company is the survivor and there is no accompanying Change in Control under clauses (A) or (B), consolidation, liquidation or dissolution of the Company, or the sale of all or substantially all of the assets of the Company. Notwithstanding the foregoing, a Change in Control shall not be deemed to occur pursuant to clause (A) solely because 50% or more of the combined voting power of the Company’s outstanding securities is acquired by one or more employee benefit plans maintained by the Company or by any other employer, the majority interest in which is held, directly or indirectly, by the Company.  For purposes of this paragraph, the terms “person” and “beneficial owner” shall have the meaning set forth in Sections 3(a) and 13(d) of the Exchange Act, and in the regulations promulgated thereunder.

(c)Termination For Cause. If the Employment Period is terminated by the Company for Cause or by you other than for Good Reason, the Company will pay you the Accrued Obligations as of the Termination Date. Except as set forth in Section 5(e), upon delivery of the

 

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payments described in this Section 5(c), the Company will have no further obligation to you under this letter agreement with respect to your employment with the Company.

(d)Termination Due to Death or Disability. If the Employment Period is terminated due to your Disability (as defined in Section 5(h) below) or death, the Company will pay you or your estate, whichever is applicable, the Accrued Obligations as of the Termination Date. Except as set forth in Section 5(e), upon delivery of the payments described in this Section 5(d), the Company will have no further obligation to you under this letter agreement or otherwise with respect to your employment with the Company.

(e)Except as otherwise required by law or as specifically provided herein, all of your rights to salary, severance, fringe benefits, bonuses and any other amounts hereunder (if any) accruing after the termination of the Employment Period will cease upon the earlier of the Termination Date or your last day of active service.  In the event the Employment Period is terminated, your sole remedy, and the sole remedy of your successors, assigns, heirs, representatives and estate, will be to receive the payments described in this letter agreement.  Notwithstanding the foregoing, the following rights will survive any termination of the Employment Period:  (i) your rights to accrued and vested benefits under any benefit plan of the Company or any of the Company Affiliates, or as set forth in any other agreement between you and the Company or any of the Company Affiliates, (ii) your right to continued participation in the Company’s health and welfare plans, except as otherwise provided in Section 5(a)(v), at your own expense pursuant to COBRA, (iii) your right to indemnification in respect of your service as a director or officer of the Company or any of the Company Affiliates, to the maximum extent provided under the Company’s Certificate of Incorporation and By-laws (each, as they may be amended from time-to-time), the Company’s Directors and Officers Liability Insurance coverage, and any other agreement between you and the Company, (iv) your rights in respect of shares of Common Stock that you hold and (v) your rights in respect of any equity-based awards that remain outstanding following the Employment Period (subject to the provisions of this Agreement and any equity plan or award agreement that governs the terms of such equity-based awards).  

(f)Any termination of the Employment Period by the Company (other than termination upon your death) or by you must be communicated by written notice (in either case, a “Notice of Termination”) to you, if the Company is the terminating party, or to the Company, if you are the terminating party.  For purposes of this letter agreement, “Termination Date” means (i) if the Employment Period is terminated due to your death, the date of your death and (ii) if the Employment Period is terminated due to your Disability, by the Company (for Cause or without Cause) or by you (for Good Reason or without Good Reason), the date specified in the Notice of Termination (which may not be earlier than the date of such Notice of Termination).  Notwithstanding anything contained herein to the contrary, any termination of the Employment Period by you must be communicated to the Company no less than 30 days prior to the intended Termination Date; provided, however, that the Company’s decision to shorten or eliminate the notice period shall not constitute a termination by the Company and provided further that you may provide Notice of Termination to the Company at any time within 30 days after the Effective Date and, unless otherwise specified, the Termination Date shall be the date of such Notice of Termination.  

 

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(g)For purposes of this letter agreement, Cause means any one of the following: (i) a material breach by you of this letter agreement, (ii) your conviction of, guilty plea to, or confession of guilt of, a felony, (iii) materially fraudulent, dishonest or illegal conduct by you in the performance of services for or on behalf of the Company or any of the Company Affiliates, (iv) any repeated conduct by you in material violation of Company written policy, (v) any conduct by you that is materially detrimental to the reputation of the Company or any of the Company Affiliates, (vi) your misappropriation of funds of the Company or any of the Company Affiliates, (vii) your gross negligence or willful misconduct or willful failure to comply with written directions of the Board which directions are within the scope of your duties hereunder, or (viii) your engaging in discrimination, sexual or other harassment, retaliation, or any conduct involving an act of moral turpitude. A purported termination of your employment for Cause shall not be effective unless (A) the Company provides written notice to you of the facts alleged by the Company to constitute Cause and such notice is delivered to you no more than 90 days after the Company has actual knowledge of such facts and (B) you have been given an opportunity of no less than ten days after receipt of such notice to cure the circumstances alleged to give rise to Cause and the Company has cooperated in good faith with your efforts to cure such condition or circumstance, but only to the extent that such circumstances are reasonably curable.

(h)For purposes of this letter agreement “Disability” means any accident, sickness, incapacity or other physical or mental disability which prevents you from performing, with or without reasonable accommodation, the essential functions of your position pursuant to this letter agreement for either (i) 90 consecutive days or (ii) 180 days during any period of 365 consecutive days, in each case as determined in good faith by the Board. During the time periods specified above, the Company will continue to provide you with the compensation stated in Section 3 above.

(i)For purposes of this letter agreement, “Good Reason” means (i) a material diminution in your authority, title, duties or responsibilities, (ii) the failure of the Company to make all payments due to you under this letter agreement or otherwise or (iii) the relocation of your primary office to a location more than 50 miles from the Company Office.  A purported termination of your employment for Good Reason shall not be effective unless (A) you provide written notice to the Company of the facts alleged by you to constitute Good Reason and such notice is delivered to the Board no more than 60 days after the occurrence of such event, (B) the Company has been given an opportunity of no less than 30 days after receipt of such notice to cure the circumstances alleged to give rise to Good Reason and you have cooperated in good faith with the Company’s efforts to cure such condition or circumstance (which cooperation will not require you to waive or diminish any of your rights hereunder), but only to the extent that such circumstances are reasonably curable, and (c) you elect to terminate the Employment Period within 30 days following the end of the Company’s cure period due to the Company’s failure to cure.

6.Notwithstanding any other provision of this letter agreement:

(a)In the event it is determined by an independent nationally recognized public accounting firm that is reasonably acceptable to you, which is engaged and paid for by the Company prior to the consummation of any transaction constituting a 280G Change of Control (which for purposes of this Section 6 shall mean a change in ownership or control as determined in accordance with the regulations promulgated under Section 280G of the Internal Revenue Code

 

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of 1986, as amended (the “Code”), which accounting firm shall in no event be the accounting firm for the entity seeking to effectuate the 280G Change of Control (the “Accountant”), which determination shall be certified by the Accountant and set forth in a certificate delivered to you not less than ten Business Days prior to the 280G Change of Control setting forth in reasonable detail the basis of the Accountant’s calculations (including any assumptions that the Accountant made in performing the calculations), that part or all of the consideration, compensation or benefits to be paid to you under this letter agreement constitute “parachute payments” under Section 280G(b)(2) of the Code, then, if the aggregate present value of such parachute payments, singularly or together with the aggregate present value of any consideration, compensation or benefits to be paid to you under any other plan, arrangement or agreement which constitute “parachute payments” (collectively, the “Parachute Amount”) exceeds the maximum amount that would not give rise to any liability under Section 4999 of the Code, the amounts constituting “parachute payments” which would otherwise be payable to you or for your benefit shall be reduced to the maximum amount that would not give rise to any liability under Section 4999 of the Code (the “Reduced Amount”); provided that such amounts shall not be so reduced if the Accountant determines that without such reduction you would be entitled to receive and retain, on a net after-tax basis (including, without limitation, any excise taxes payable under Section 4999 of the Code), an amount which is greater than the amount, on a net after-tax basis, that you would be entitled to retain upon receipt of the Reduced Amount.  In connection with making determinations under this Section 6, the Accountant shall take into account any positions to mitigate any excise taxes payable under Section 4999 of the Code, such as the value of any reasonable compensation for services to be rendered by you before or after the 280G Change of Control.

(b)If the determination made pursuant to Section 6(a) results in a reduction of the payments that would otherwise be paid to you except for the application of this Section 6, the Company shall promptly give you notice of such determination.  Such reduction in payments shall be first applied to reduce any cash payments that you would otherwise be entitled to receive (whether pursuant to this letter agreement or otherwise) and shall thereafter be applied to reduce other payments and benefits, in each case, in reverse order beginning with the payments or benefits that are to be paid the furthest in time from the date of such determination, unless, to the extent permitted by Section 409A (as defined in Section 13(h)), you elect to have the reduction in payments applied in a different order; provided that, in no event may such payments be reduced in a manner that would result in subjecting you to additional taxation under Section 409A.  Within ten Business Days following such determination, the Company shall pay or distribute to you or for your benefit such amounts as are then due to you under this letter agreement and shall promptly pay or distribute to you or for your benefit in the future such amounts as become due to you under this letter agreement.

(c)As a result of the uncertainty in the application of Sections 280G and 4999 of the Code at the time of a determination hereunder, it is possible that amounts will have been paid or distributed by the Company to or for your benefit pursuant to this letter agreement which should not have been so paid or distributed (each, an “Overpayment”) or that additional amounts which will have not been paid or distributed by the Company to or for your benefit pursuant to this letter agreement could have been so paid or distributed (each, an “Underpayment”), in each case, consistent with the calculation of the Reduced Amount hereunder.  In the event that the Accountant, based upon the assertion of a deficiency by the Internal Revenue Service against either the Company or you which the Accountant believes has a high probability of success, determines

 

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that an Overpayment has been made, any such Overpayment paid or distributed by the Company to or for your benefit shall promptly be repaid by you to the Company together with interest at the applicable federal rate provided for in Section 7872(f)(2)(A) of the Code; provided, however, that no such repayment shall be required if and to the extent such deemed repayment would not either reduce the amount on which you are subject to tax under Sections 1 and 4999 of the Code or generate a refund of such taxes.  In the event that the Accountant, based on controlling precedent or substantial authority, determines that an Underpayment has occurred, any such Underpayment shall be promptly paid by the Company to or for your benefit together with interest at the applicable federal rate provided for in Section 7872(f)(2)(A) of the Code.

(d)In the event of any dispute with the Internal Revenue Service (or other taxing authority) with respect to the application of this Section 6, you shall control the issues involved in such dispute and make all final determinations with regard to such issues.  The Company will bear all fees and expenses of any audit, suit or proceeding by the IRS or any other taxing authority against the Company or against you, or of any claim for refund, appellate procedure, or suit brought by the Company or you against the IRS or any other taxing authority, in each case relating to the excise tax imposed by Section 4999 of the Code.

7.Confidential Information.

(a)You will not disclose or use at any time any Confidential Information (as defined below in Section 7(c)), whether or not such information is developed by you, except to the extent that such disclosure or use is required in the performance or exercise by you in good faith of (i) duties assigned to you under this letter agreement or otherwise by the Board, (ii) rights as an employee, officer, director or shareholder of the Company or any of the Company Affiliates or (iii) rights under any agreement with the Company or any of the Company Affiliates.

(b)You will deliver to the Company at the termination of the Employment Period, or at any time the Company may request, all memoranda, notes, plans, designs, records, reports, computer files and software and other documents and data (and copies thereof) that are Confidential Information or Work Product (as defined below) or information relating to the business of the Company or the Company Affiliates which you may then possess or have under your control.  Upon request, you will also make available to the Company any smartphones or other devices on which you store Company information, so that the Company may remove such information.

(c)As used in this letter agreement, the term “Confidential Information” means information that is not generally known or available to the public and that is used, developed or obtained by the Company or any of the Company Affiliates in connection with its or their businesses, including without limitation (i) information, observations and data concerning its and their business and affairs, (ii) products or services, (iii) fees, costs and pricing structures, (iv) designs, (v) analyses, (vi) drawings, designs, photographs, artwork and reports, (vii) computer software, including operating systems, applications and program listings, (viii) flow charts, manuals and documentation, (ix) databases, (x) accounting and business methods, (xi) inventions, devices, new developments, methods and processes, whether patentable or unpatentable and whether or not reduced to practice, (xii) other copyrightable works, (xiii) all production methods, processes, technology and trade secrets, (xiv) product and product candidate formulae and any

 

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trade secrets with respect to such products and product candidates and (xv) all similar and related information in whatever form.

(d)Notwithstanding the provisions of this letter agreement to the contrary, you will have no liability to the Company for disclosure of Confidential Information if the Confidential Information:

(i)is in the public domain or becomes publicly known in the industry in which the Company or any of the Company Affiliates operates or is disclosed by the Company or any of the Company Affiliates other than as the result of a breach of this letter agreement or any other agreement by you; or

(ii)is required to be disclosed by law, court order, or similar compulsion or in connection with any legal proceeding; provided, however, that such disclosure will be limited to the extent so required and, subject to the requirements of law, you will give the Company notice of your intent to so disclose such Confidential Information and will cooperate with the Company in seeking confidentiality protections.

(e)Notwithstanding the foregoing, nothing in or about this letter agreement prohibits you from (i) filing and, as provided for under Section 21F of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), maintaining the confidentiality of a claim with the Securities and Exchange Commission (the “SEC”); (ii) providing Confidential Information to the SEC, or providing the SEC with information that would otherwise violate this Section 7, to the extent permitted by Section 21F of the Exchange Act; (iii) cooperating, participating or assisting in an SEC investigation or proceeding concerning the Company without notifying the Company; or (iv) receiving a monetary award as set forth in Section 21F of the Exchange Act.  Furthermore, you are advised that you shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of any Confidential Information that constitutes a trade secret to which the Defend Trade Secrets Act (18 U.S.C. Section 1833(b)) applies that is made (A) in confidence to a federal, state or local government official, either directly or indirectly, or to an attorney, in each case, solely for the purpose of reporting or investigating a suspected violation of law or (B) in a complaint or other document filed in a lawsuit or proceeding, if such filings are made under seal.

8.Inventions and Patents.  You agree that all inventions, innovations, improvements, technical information, trade secrets, systems, software developments, ideas, results, methods, designs, artwork, analyses, drawings, reports, copyrights, service marks, trademarks, trade names, logos and all similar or related information (whether patentable or unpatentable) which relate to the Company’s or any of the Company Affiliates’ businesses, research and development or existing products (or products under development) or services and which are conceived, developed or made by you (whether or not during usual business hours and whether or not alone or in conjunction with any other person) during your employment with the Company, together with all intellectual property rights therein, including without limitation any patent applications, letters patent, trademark, trade name and service mark applications or registrations, copyrights and reissues thereof that may be granted for or upon any of the foregoing (collectively referred to herein as “Work Product”), is the exclusive property of the Company and/or the Company

 

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Affiliates.  For the avoidance of doubt and without limiting the foregoing, (x) the Company or any of the Company Affiliates shall be the sole owner of all right, title and interest in such Work Product, including without limitation all intellectual property rights relating to such Work Product, without you retaining any license or other residual right whatsoever, and (y) any rights to any new or an existing Work Product are automatically conveyed, assigned and transferred to the Company pursuant to this letter agreement.  You hereby waive and renounce to all moral rights related, directly or indirectly, to any such existing or new Work Product.  You will take reasonable steps to promptly disclose such Work Product to the Board and perform all actions reasonably requested by the Board (whether during or after the Employment Period) to establish and confirm such ownership (including without limitation the execution and delivery of assignments, consents, powers of attorney and other instruments) and to provide reasonable assistance to the Company and the Company Affiliates in connection with the prosecution of any applications for patents, trademarks, trade names, service marks or reissues thereof or in the prosecution or defense of interferences relating to any Work Product.

9.Non-Competition; Non-Solicitation; Non-Disparagement.

(a)You acknowledge that, in the course of your employment with the Company, you will become familiar with the Company’s and the Company Affiliates’ trade secrets and other Confidential Information as well as the Company’s customer information and goodwill, and that your services will be of special, unique and extraordinary value to the Company and the Company Affiliates.  Therefore, you agree that, during the Employment Period and any other period during which you are employed by the Company or any of its Affiliates, whether pursuant to this Agreement or otherwise plus twelve (12) months (the “Restriction Period”) (regardless of the reason for your separation from the Company and whether caused by you or the Company), you will not (x) anywhere the Company or any of the Company Affiliates conducts business or (y) anywhere the Company or any of the Company Affiliates has spent time and resources in connection with expanding its business, directly or indirectly, either on your own behalf or on behalf of any other person, firm or entity: own, manage, operate, work as an employee for, consult with, provide services or financing to, or join, control or participate in the ownership, management, operation or control of, any business (whether in corporate, proprietorship or partnership form or otherwise) that is engaged in the business of manufacturing, marketing, sale, research or development of pharmaceuticals for cancer utilizing a methodology or mechanism that is similar to methodologies or mechanisms used or actively being developed by the Company (collectively, “Specified Therapies”).

(b)Nothing in Section 9(a) will prohibit you from being a passive owner of not more than 2% of the outstanding stock of a publicly-traded corporation, so long as you have no active participation in the business of such corporation.

(c)During the Restriction Period, you also will not:

(i)induce or attempt to induce any customer, supplier or other business relation of the Company or any of the Company Affiliates to cease doing business with the Company or any of the Company Affiliates, or in any way interfere with the relationship between any such customer, supplier or business relation, on the one hand, and the Company or any of the Company Affiliates, on the other hand;

 

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(ii)engage, employ, solicit or contact with a view to the engagement or employment of, any employee, officer or manager of, or full-time consultant to, the Company or any of the Company Affiliates or any person who has been an employee, officer or manager of, or consultant to, the Company or any of the Company Affiliates, if he or she has been in such a role at any time within the immediately prior three months; or

(iii)assist any individual or entity to engage in the conduct referenced in clauses (i) and (ii) immediately above.

(d)Notwithstanding anything herein to the contrary, Section 9(a) shall not apply if this Agreement is terminated within 30 days after the Effective Date by the Company without cause or by you with or without Good Reason.

10.Enforcement.

(a)Because the employment relationship between you and the Company is unique and because you have access to Confidential Information, Work Product and Company goodwill, you agree that money damages would be an inadequate remedy for any breach of Section 7, 8 or 9.  Therefore, in the event of a breach or threatened breach of Section 7, 8 or 9, the Company may, in addition to its other rights and remedies, apply to any court of competent jurisdiction for specific performance and/or injunctive or other relief in order to enforce, or prevent any violations of, such provisions (without posting a bond or other security).

(b)Sections 5, 6, 7, 8 and 9 will expressly survive termination of this letter agreement.  The existence of any claim or cause of action by you against the Company and/or any of the Company Affiliates shall not constitute a defense to the enforcement by the Company of the covenants contained in Section 6(b), 7, 8 or 9, but such claim or cause of action shall be litigated separately.

11.Notices.  All notices, requests, demands, claims, and other communications hereunder will be in writing.  Any notice, request, demand, claim or other communication hereunder will be deemed duly given (a) upon delivery, if delivered personally to the recipient, against written receipt therefor, or (b) upon the first Business Day after the date sent, if sent priority next Business Day delivery to the intended recipient by a reputable express courier service (charges prepaid) and addressed to the intended recipient as set forth below:

 

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If to the Company, to:

Attention: Chief Legal Officer

Tyme Technologies, Inc.

1 Pluckemin Way, Suite 103,
Bedminster, NJ 07921

 

If to you, to the address appearing in the Company’s records.

 

Any party hereto may send any notice, request, demand, claim or other communication hereunder to the intended recipient at the address set forth above using any other means, but no such notice, request, demand, claim or other communication will be deemed to have been duly given unless and until it actually is received and acknowledged by the intended recipient.  Any party hereto may change the address (or add new parties and their addresses) to which notices, requests, demands, claims, and other communications hereunder are to be delivered by giving the other parties hereto notice in the manner set forth in this Section 11.

12.Representations and Warranties. You hereby represent and warrant to the Company that (a) the execution, delivery and performance of this letter agreement by you does not and will not conflict with, breach, violate or cause a default under any agreement, contract or instrument to which you are a party or any judgment, order or decree to which you are subject, (b) you are not a party to or bound by any employment agreement, consulting agreement, non-compete agreement, confidentiality agreement or similar agreement with any other person or entity that is inconsistent with the provisions of this letter agreement or that would limit you in your duties hereunder, (c) upon the execution and delivery of this letter agreement by the Company and you, this letter agreement will be a valid and binding obligation of you and (d) you are able to perform the services described in this letter agreement.  The Company hereby represents and warrants to you that (i) the execution, delivery and performance of this letter agreement does not and will not conflict with, breach, violate or cause a default under any agreement, contract or instrument to which it is a party or any judgment, order or decree to which it is subject and (ii) upon the execution and delivery of this letter agreement by the Company and you, such agreements will be valid and binding obligations of the Company.

13.Lock-Up Agreement.  In connection with a registration with the United States Securities and Exchange Commission under the Securities Act of the public sale of shares of Common Stock, you shall not to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any securities of the Company (other than those included in the registration) without the prior written consent of the Company or such underwriters, as the case may be, for such period of time prior to the effective date of such registration and continuing through and following the effective date of such registration (not to exceed 180 days) as the Company or the underwriters, as the case may be, shall specify.  You agree that the Company may instruct its transfer agent to place stop-transfer notations in its records to enforce the provisions of this Section.  You shall execute a form of agreement reflecting the foregoing restrictions as requested by the underwriters managing such offering.

 

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14.General Provisions.

(a)Severability.  It is the desire and intent of the parties hereto that the provisions of this letter agreement be enforced to the fullest extent permissible under the laws and public policies applied in each jurisdiction in which enforcement is sought.  Accordingly, if any particular provision of this letter agreement will be adjudicated by a court of competent jurisdiction to be invalid, prohibited or unenforceable for any reason, such provision, as to such jurisdiction, will be ineffective, without invalidating the remaining provisions of this letter agreement or affecting the validity or enforceability of this letter agreement or affecting the validity or enforceability of such provision in any other jurisdiction.  Notwithstanding the foregoing, if such provision could be more narrowly drawn so as not to be invalid, prohibited or unenforceable in such jurisdiction, it will, as to such jurisdiction, be so narrowly drawn, without invalidating the remaining provisions of this letter agreement or affecting the validity or enforceability of such provision in any other jurisdiction.

(b)Complete Agreement.  This letter agreement and any schedules or exhibits expressly constitute the entire agreement among the parties hereto with respect to the subject matter hereof and supersedes and pre-empts any prior understandings, agreements or representations by or among the parties, written or oral, which may have related to the subject matter hereof in any way.

(c)Successors and Assigns.  The Company may freely assign this letter agreement, including to any Affiliate or in connection with any merger or sale of equity or assets, and upon such assignment the references herein to the Company shall be deemed to include the assignee.  You may not assign your rights and obligations under this letter agreement without the prior written consent of the Company.  Except as otherwise provided herein, this letter agreement will be binding upon and inure to the benefit of you and the Company and our respective successors, permitted assigns, personal representatives, heirs and estates, as the case may be.

(d)Governing Law.  This letter agreement will be governed by and construed in accordance with the domestic laws of New Jersey, without giving effect to the choice of law provisions thereof.  The parties agree that the exclusive venue for all disputes under this letter agreement shall be the federal and state courts sitting in Newark, New Jersey.

(e)Amendment and Waiver.  The provisions of this letter agreement may be amended and waived only with the prior written consent of the Company (with the approval of the Board) and you, and no course of conduct or failure or delay in enforcing the provisions of this letter agreement will affect the validity, binding effect or enforceability of this letter agreement or any provision hereof.

(f)Headings.  The section headings contained in this letter agreement are inserted for convenience only and will not affect in any way the meaning or interpretation of this letter agreement.

(g)Counterparts.  This letter agreement may be executed in counterparts, each of which will be deemed an original and all of which together will constitute one and the same instrument.  The signatures of any of the persons executing this letter agreement may be

 

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transmitted via facsimile or other electronic means and shall be sufficient evidence of the execution of this letter agreement.

(h)409A Provision.  

(i)For purposes of this letter agreement the term “termination of employment” and similar terms relating to your termination of employment mean a “separation from service” as that term is defined under Section 409A of the Internal Revenue Code of 1986, as amended, and the final regulations issued thereunder (“Section 409A”).  The Company and you intend that this letter agreement comply in form and operation with the requirements of Section 409A, and all provisions of this letter agreement shall be construed and interpreted in a manner consistent with the requirements for avoiding taxes or penalties under Section 409A.  To the extent permitted by applicable Department of Treasury/Internal Revenue Service guidance, or law or regulation, the Company and you will take reasonable actions to reform this letter agreement or any actions taken pursuant to their operation of this letter agreement in order to comply with Section 409A.

 

(ii)For purposes of Section 409A, each of the payments that may be made hereunder is designated as a separate payment.  To the extent that the Company determines that any payment or benefit pursuant to this letter agreement constitutes deferred compensation (within the meaning of Section 409A), such payment or benefit shall be made at such times and in such forms as the Company determines are required to comply with Section 409A and the Treasury Regulations and any applicable guidance thereunder.  If, as of the date of your termination of employment, you are a “specified employee” within the meaning of Section 409A, then to the extent necessary to comply with Section 409A and to avoid the imposition of taxes and/or penalties under Section 409A, payment to you of any amount or benefit under this letter agreement or any other Company plan, program or agreement that constitutes “nonqualified deferred compensation” under Section 409A and which under the terms of this letter agreement or any other Company plan, program or arrangement would otherwise be payable as a result of and within six (6) months following such termination shall be delayed, as provided under current regulatory requirements under Section 409A, until the earlier of (i) five (5) calendar days after the Company receives notification of your death or (ii) the first Business Day of the seventh month following the date of your termination of employment.

 

(iii)Except as otherwise permitted by Section 409A, the benefits and reimbursements provided to you under this letter agreement and any Company plan or policy during any calendar year shall not affect the benefits and reimbursements to be provided to you under the relevant section of this letter agreement or any Company plan or policy in any other calendar year, and the right to such benefits and reimbursements cannot be liquidated or exchanged for any other benefit and shall be provided in accordance with Treas. Reg. Section 1.409A-3(i)(1)(iv) or any successor thereto.  Further, in the case of reimbursement payments, reimbursement

 

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payments shall be made to you as soon as practicable following the date that the applicable expense is incurred and proper documentation is provided to the Company, but in no event later than the last day of the calendar year following the calendar year in which the underlying expense is incurred.

(i)“Business Day” Defined.  For purposes of this letter agreement, the capitalized term “Business Day” shall mean any calendar day other than a Saturday, Sunday or other day on which banks in New York, New York are authorized or required to be closed.

[THE REMAINDER OF THIS PAGE HAS INTENTIONALLY BEEN LEFT BLANK]

 

 

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If this letter agreement correctly expresses our mutual understanding, please sign and date a copy of this letter agreement and return it to the Company.

Very truly yours,

Tyme Technologies, Inc.

 

 

 

By: /s/ James Biehl

Name: James Biehl

Title:    Chief Legal Officer

 

 

The terms of this letter agreement are accepted
and agreed to as of the date set forth below by:

 

 

 

/s/ Richard Cunningham

Richard Cunningham

 

 

11/24/2020

Date

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EXHIBIT A

 

Tyme Technologies, Inc.

 

Nonqualified Stock Option Agreement

 

 

Tyme Technologies, Inc., a Delaware corporation (the “Company”), pursuant to the Tyme Technologies, Inc. 2015 Equity Incentive Plan (the “Plan”), has granted to ____________ (the “Optionee”) a nonqualified stock option (the “Option”) to purchase a total of _______ shares (each, a “Share”) of the common stock (the “Common Stock”) of the Company, at an exercise price equal to $______ (the “Exercise Price”), on the terms and conditions set forth in this Option Agreement (this “Agreement”) and, in all respects, subject to the terms and conditions of the Plan.  The effective date of grant of the Option is ________ (the “Date of Grant”). Unless otherwise defined herein, the capitalized terms defined in the Plan shall have the same defined meanings in this Agreement.

 

1.Duration.  Subject to the earlier termination as provided in this Agreement or under the Plan, the Option shall expire and shall no longer be exercisable as of the close of business on ___________ (the “Expiration Date”) [[_____] years from the Date of Grant].

 

2.Written Notice of Exercise.  The Option may be exercised only by delivering to the President or Secretary of the Company, at the Company’s principal executive offices, of a written notice of exercise substantially in the form described in paragraph 8(b) of this Agreement, accompanied by this Agreement.

 

3.Anti-Dilution Provisions.

 

(a)In the event that the number of outstanding shares of Common Stock is changed by a stock dividend, recapitalization, stock split, reverse stock split, subdivision, combination, reclassification or similar change in the capital structure of the Company without consideration, then the Exercise Price and number of shares subject to the Option shall be proportionately and appropriately adjusted as determined by the Committee, whose determination shall be final, conclusive and binding upon Optionee and the Company.

 

(b)If there is any other change in the Common Stock, including a reorganization, sale or exchange of assets, exchange of shares, offering of subscription rights, or a merger or consolidation in which the Company is the surviving corporation, an adjustment, if any, shall be made in the Shares then subject to the Option as the Board of Directors or Committee may deem equitable, and whose determination shall be final, conclusive and binding upon Optionee and the Company. Failure of the Board of Directors or the Committee to provide for an adjustment pursuant to this paragraph 3(b) prior to the effective date of any Company action referred to in this paragraph 3(b) shall be conclusive evidence that no adjustment is required in consequence of such action.

 

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(c)If the Company is merged into or consolidated with any other corporation and the Company is not the surviving corporation, or if the Company sells all or substantially all of the Company’s assets to any other corporation, then either:

(i)        the Company shall cause provisions to be made for the continuance of the Option after such event or for the substitution for the Option of an option covering the number and class of securities which the Optionee would have been entitled to receive in such merger, consolidation or if the Optionee had been the holder of record of a number of shares of Common Stock equal to the number of Shares covered by the unexercised portion of the Option immediately prior to such merger, consolidation or sale; or

(ii)      the Company shall give to Optionee written notice of the Company’s election not to cause any provision to be made under the preceding clause (i) and, then only in such event the Option shall become exercisable in full (or, at the election of the Optionee, in part) at any time during a period to be designated by the Company, ending not more than one business day prior to the effective date of the merger, consolidation or sale, in which case the Option shall not be exercisable to any extent after the expiration of such period.

Notwithstanding the provisions of this paragraph 3(c), in no event shall the Option be exercisable after the Expiration Date.

 

4.Investment Representation and Legend of Certificates.  The Company shall have the right to place upon the face and/or reverse side of any stock certificate or certificates evidencing the Shares such legend as the Committee may prescribe for the purpose of preventing disposition of such Shares in violation of the Securities Act.

 

5.Non Transferability.  The Option shall not be transferable by Optionee, other than by will, the laws of descent and distribution or pursuant to a domestic relations order, and is exercisable during the lifetime of Optionee only by Optionee, except as otherwise specifically provided in this Agreement or the Plan. The terms of this Agreement shall be binding upon the executors, administrators, heirs, successors and assigns of Optionee.

 

6.Certain Rights Not Conferred by Option.  Optionee shall not, by virtue of holding the Option, be entitled to any rights of a stockholder in the Company.

 

7.Expenses.  The Company shall pay all original issue and transfer taxes with respect to the issuance of the Shares pursuant hereto and all other fees and expenses necessarily incurred by the Company in connection therewith.

 

8.Exercise of Options.

 

(a)Except as otherwise provided herein, the Option shall become exercisable according to the following schedule, provided that the Optionee is employed by the Company on such dates:

 

Date

Number of Shares

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(b)The Option shall be exercisable, in whole or part and from time to time, but subject to the exercise schedule set forth in paragraph 8(a) of this Agreement, by written notice of such exercise, delivered to the President or Secretary of the Company, at the Company’s principal office by personal delivery, against written receipt therefor, or by pre-paid, certified or registered mail, return receipt requested. Such notice shall specify the number of Shares for which the Option is being exercised (which number, if less than all of the Shares then subject to exercise, shall be 100 or an integral multiple thereof) and shall be accompanied by:

(i)payment of the full exercise price for the Shares for which the Option is being exercised; and

 

(ii)this Agreement.

 

(c)The form of payment of the Exercise Price for Shares purchased pursuant to each exercise of the Option shall be paid in full at the time of each purchase in one or a combination of the following methods:

(i)cash;

 

(ii)check (subject to collection);

 

(iii)in the discretion of the Committee, surrender to the Company of other shares of Common Stock owned by the Optionee which:

(A)have a Fair Market Value on the date of surrender equal to the aggregate exercise price of the Shares as to which the Option is being exercised; and

 

(B)have been owned of record by Optionee for at least six months;

(iv)in the discretion of the Committee, commencing upon the date on which all of the Shares subject to the Option are exercisable in accordance with the exercise schedule set forth in paragraph 8(a) of this Agreement, by “cashless exercise,” by means of exercising the Option in full and receiving such number of Shares having a Fair Market Value on the date of such cashless exercise equal to the difference between:

 

(A)the Fair Market Value of the Shares issuable upon exercise of the Option in full on the date of such cashless exercise; and

 

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(B)the exercise price of the Option multiplied by the number of Shares issuable upon exercise of the Option in full; or

(v)in the discretion of the Committee, but, in all cases, subject to applicable law, by:

 

(A)delivery to the Company of a promissory note containing such terms and conditions determined by the Committee, in the Committee’s sole discretion, but at a rate of interest at least equal to the imputed interest specified under Section 483 or Section 1274, whichever is applicable, of the Code, and secured by the Shares issuable upon exercise of the Option for which the promissory note is being delivered and otherwise in compliance with applicable law (including, without limitation, state corporate law and federal margin requirements);

 

(B)assignment to the Company of the net proceeds (to the extent necessary to pay such exercise price) to be received from a registered broker upon the sale of the Shares or assignment of the net proceeds (to the extent necessary to pay such exercise price) of a loan from such broker in such amount; or

 

(C)such other consideration and method of payment for the issuance of stock to the extent permitted under the Plan and applicable law and satisfying the requirements of Rule 16b-3 promulgated pursuant to the Exchange Act.

 

(d)No Shares shall be delivered upon exercise of the Option until all laws, rules and regulations that the Committee may, in its sole discretion, deem applicable have been complied with. If a registration statement under the Securities Act is not then in effect with respect to the Shares issuable upon such exercise, the Company may require as a condition precedent that Optionee, upon exercising the Option, deliver to the Company a written representation and undertaking, satisfactory in form and substance to the Committee, that, among other things, Optionee is acquiring the Shares for Optionee’s own account for investment purposes only and not with a view to the distribution thereof.

 

(e)Optionee shall not be considered a record holder of the Shares so purchased for any purpose until the date on which Optionee is actually recorded as the holder of such Shares in the records of the Company.

 

(f) If the Optionee is Terminated for any reason except death or Disability, then the Optionee may exercise the Option (i) only to the extent that the Option would have been exercisable on the Termination Date and (ii) no later than three months after the Termination Date (or such longer time period not exceeding five years as may be determined by the Administrator), but in any event, no later than the Expiration Date.

 

(g)If the Optionee is Terminated because of Optionee’s death or Disability (or the Optionee dies within three months after a Termination other than for Cause or because of Optionee’s Disability), then the Option (i) may be exercised only to the extent that the Option

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would have been exercisable by Optionee on the Termination Date and (ii) must be exercised by Optionee (or Optionee’s legal representative or authorized assignee) no later than twelve months after the Termination Date (or such longer time period not exceeding five years as may be determined by the Administrator, but in any event no later than the Expiration Date.

 

(h)Notwithstanding subsections (f) and (g) above, if Optionee is terminated for Cause, neither the Optionee, the Optionee’s estate nor such other person who may then hold the Option shall be entitled to exercise the Option whatsoever.

 

9.Continued Employment.  Nothing herein shall be deemed to create any employment or consultancy or guaranty of continued employment or consultancy or limit in any way the Company’s right to terminate Optionee’s employment or consultancy at any time.

 

10.Clawback or Recoupment Policy. This Option, Common Stock delivered pursuant to this Option, and any gains or profits on the sale of such Common Stock shall be subject to any “clawback” or recoupment policy adopted by the Company.

 

11.Withholding.  Any tax consequences arising from the grant of this Option shall be borne solely by the Optionee.  The Company shall withhold taxes according to requirements under the applicable laws, rules and regulations, including withholding taxes at source.  The Optionee will not be entitled to receive from the Company any Common Stock hereunder prior to the full payment of the Optionee’s tax liabilities relating to this Option.  The Administrator may, in its discretion, permit the Optionee to elect to pay a portion or all of the required tax withholding at such time and in such manner as the Administrator shall deem to be appropriate.  

 

12.Applicable Law.  This Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of Delaware without regard to principles of conflict of laws.

 

13. Limitations Applicable to Section 16 Persons.  To the extent the Optionee is subject to Section 16 of the Exchange Act, the grant of the Option pursuant to this Agreement is intended to qualify for an exemption from Section 16 thereof pursuant to Rule 16b-3(d)(1) promulgated thereunder.  To the extent such exemption is not available, notwithstanding any other provision of the Plan or this Agreement, the Option and this Agreement shall be subject to any additional limitations set forth in any applicable exemptive rule under Section 16 of the Exchange Act (including any amendment to Rule 16b-3 of the Exchange Act) that are requirements for the application of such exemption. To the extent permitted by applicable law, this Agreement shall be deemed amended to the extent necessary to conform to such applicable exemptive rule.

 

[Signature page follows]

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We look forward to your continuing contribution to the growth of the Company.  Please acknowledge your receipt of the Plan and this Award.

 

Very truly yours,

 

Tyme Technologies, Inc.

 

 

By:

 

 

 

 


 

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OPTIONEE ACKNOWLEDGEMENT

 

OPTIONEE ACKNOWLEDGES AND AGREES THAT THE EXERCISABILITY OF THE SHARES SUBJECT TO THIS AGREEMENT AND THE OPTION IS EARNED ONLY BY CONTINUING EMPLOYMENT OR CONSULTANCY AT THE WILL OF THE COMPANY (NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED THE OPTION OR ACQUIRING SHARES HEREUNDER). OPTIONEE FURTHER ACKNOWLEDGES AND CONFIRMS THAT NOTHING IN THIS AGREEMENT, NOR IN THE PLAN WHICH IS INCORPORATED HEREIN BY REFERENCE, SHALL CONFER UPON OPTIONEE ANY RIGHT WITH RESPECT TO CONTINUATION OF EMPLOYMENT OR CONSULTANCY BY THE COMPANY, NOR SHALL IT INTERFERE IN ANY WAY WITH OPTIONEE’S OR THE COMPANY’S RIGHT, SUBJECT TO OPTIONEE’S AND THE COMPANY’S RIGHTS UNDER OTHER AGREEMENTS, IF ANY, WITH THE COMPANY, TO TERMINATE EMPLOYMENT OR CONSULTANCY AT ANY TIME, WITH OR WITHOUT CAUSE.

 

Optionee acknowledges receipt of a copy of the Plan and certain information related to this Plan and Company and represents that Optionee is familiar with the terms and provisions of the Plan, and hereby accepts the Option subject to all of the terms and provisions of the Plan. Optionee has reviewed the Plan and this Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Agreement and fully understands all of the terms and provisions of the Option and this Agreement. Optionee hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the Committee upon any questions rising under the Plan. Optionee further agrees to notify the Company upon any change in the residence address indicated below.

 

Accepted and agreed as of the Date

of Grant as first set forth above:

 

 

 

Name:

Address:

 

 

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EXHIBIT B

 

Form of Release

 

RELEASE

 

This Release (“Release”) is delivered by Richard Cunningham on this __ day of _________, 20__.

DEFINITIONS

 

A.As used herein, unless otherwise specified, the term “Employer” shall mean Tyme Technologies, Inc.; all of its affiliates, successors, predecessors, assigns, parents, subsidiaries, and divisions (whether incorporated or unincorporated); and all of its and their past and present owners, directors, officers, trustees, shareholders, managers, employees and agents (in their individual and representative capacities).

B.As used herein, unless otherwise specified, the term “Employee” shall mean Richard Cunningham and all of his heirs, family members, executors, accountants, administrators, attorneys, agents, assigns, successors and representatives.

RECITALS

WHEREAS, Employee’s employment ended on

, 20__; and

WHEREAS, it is a condition to Employee’s receipt of certain post-employment benefits (“Conditional Benefits”) under Sections 5(a)(ii), (iii) and (iv) or 5(b) (ii), (iii), (iv) and (v) of the letter agreement, dated [_________], 2020 (the “Employment Agreement”), between Employee and Employer that Employee execute this Release.

NOW THEREFORE, in consideration of the promises, representations and mutual covenants contained in this Release, and for other good and valuable consideration, the sufficiency of which is hereby acknowledged, it is agreed as follows:

1.Consideration.  Employee acknowledges that the Conditional Benefits are in excess of any earned wages or benefits due and owing to Employee, and would not be paid or provided unless Employee executed this Release.  Employee acknowledges and agrees that the Conditional Benefits are adequate and independent consideration for Employee executing this Release and releasing any and all claims against Employer.

2.Release of All Claims.  In consideration of the above, and the other promises set forth in this Release, Employee fully and forever waives, releases, acquits and discharges Employer from and for all manner of claims, actions, suits, charges, demands, grievances and/or causes of action, in law or in equity, existing by reason of and/or based upon any fact or set of facts, known or unknown, existing from the beginning of time through the date of Employee’s execution of this Release relating to and/or arising out of the Employment Agreement, Employee’s employment with Employer and/or the cessation of Employee’s employment with Employer

 

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(collectively, the “Released Claims”), including, but not limited to, all claims, actions, suits, charges, demands, grievances and/or causes of action (x) for wages, compensation, liquidated damages, commissions, bonuses, benefits, sums of money, damages of every type, costs, attorney fees, judgments, and executions, (y) alleging wrongful discharge, breach of contract, breach of implied contract, breach of the covenant of good faith and fair dealing, tortious interference with contract or business relationships, assault, battery, invasion of privacy, misappropriation of trade secrets, promissory estoppel, unjust enrichment, loss of consortium, violation of the penal statutes, negligent or intentional infliction of emotional distress, negligence, defamation, retaliation and/or discrimination and/or harassment on account of age, sex, sexual orientation, creed, religion, race, color, national origin, sensory disability, mental disability, physical disability, veteran or military status, marital status, or any other classification recognized under all applicable discrimination laws, or (z) brought under common law or civil rights or other statutes, including Title VII of the Civil Rights Act of 1964 (“Title VII”), the Age Discrimination in Employment Act (“ADEA”) (as amended by the Older Workers Benefits Protection Act (“OWBPA”)), the Family and Medical Leave Act (“FMLA”), the Employee Retirement Income Security Act (“ERISA”), the Rehabilitation Act of 1973, the Americans with Disabilities Act (“ADA”), the Consolidated Omnibus Budget Reconciliation Act (“COBRA”), the Workers Adjustment Retraining Notification Act (“WARN”), the Equal Pay Act (“EPA”), the Uniformed Services Employment and Reemployment Rights Act (“USERRA”), the National Labor Relations Act (“NLRA”), the New York State Human Rights Law, the New York City Human Rights Law, the New York Labor Law, the New Jersey Law Against Discrimination (“NJLAD”), the New Jersey Conscientious Employee Protection Act (“CEPA”), and any and all other federal, state, local statutes, ordinances, and laws, and every type of relief (legal, equitable and otherwise), available to Employee.  Employee covenants and agrees that he will not pursue or allege any claim, matter or cause of action in violation of, and/or released under, this Release.  Notwithstanding the foregoing or anything contained below, nothing in this Release shall be construed as releasing Employer from, and the Released Claims shall not include:  (a) any obligation to pay those amounts due to Employee under Section 5(a) or 5(b) of the Employment Agreement, subject to the terms and conditions thereof; (b) Employee’s rights to enforce the terms of the Employment Agreement that survive the termination of the Employment Period (as defined in the Employment Agreement) or Employment Agreement; (c) Employee’s rights described in Section 5(e) of the Employment Agreement; (d) Employee’s non-forfeitable rights to accrued benefits (within the meaning of Sections 203 and 204 of ERISA), (e) Employee’s right to indemnification or exculpation under the Employment Agreement, Employer’s policies or law with respect to Employee’s service as a director or officer of Employer (including without limitation any such rights under Employer’s Certificate of Incorporation, By-laws and Directors and Officers Liability Insurance coverage); (f) any claims that by law cannot be waived by private agreement without judicial or governmental supervision; or (g) Employee’s right to file a charge with or participate in any investigation or proceeding conducted by the U.S. Equal Employment Opportunity Commission (“EEOC”) or other government agency; provided that even though Employee can file a charge or participate in an investigation or proceeding conducted by the EEOC or other government agency, by executing this Release, Employee is waiving his ability to obtain relief of any kind from Employer to the extent permitted by law.  

3.Covenant Not to Sue.  Employee represents that he has not filed any action, charge, suit, or claim against Employer with any federal, state or local agency or court relating to any Released Claim.  Employee further agrees that should any claims, charges, complaints, suits or other actions be filed hereafter on his behalf by any federal, state or local agency or by any other

 

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person or entity with respect to a Released Claim, he will immediately withdraw with prejudice, or cause to be withdrawn with prejudice, and/or dismiss with prejudice, or cause to be dismissed with prejudice, any such claims, charges, complaints, suits or other actions filed against Employer.  Employee further agrees that, to the fullest extent permitted by law, Employee shall receive no relief of any type (monetary, equitable, or otherwise) from Employer with respect to, relating to and/or on account of any such claims, matters or actions.  Employee agrees to opt-out of any class action or collective action filed against Employer to the extent related to a Released Claim.  

4.Confidentiality.  To the fullest extent permitted by law, Employee agrees to keep confidential all facts, opinions, and information which relate in any way to Employee’s employment and/or cessation of employment with Employer, as well as the terms of this Release; provided however, Employee may discuss the terms of this Release with his spouse, legal representative, and/or tax preparer, each of whom must also agree to maintain confidentiality and comply with this Section 4.  Notwithstanding anything herein to the contrary, Section 7(e) of the Employment Agreement will apply to this Release and nothing contained herein shall prevent Employee from making truthful statements to any government authority or agency.  

5.Return of Employer’s Property.  Employee represents that he has returned to Employer any and all property, records, papers, documents and writings, in whatever form, of Employer in Employee’s possession and/or control, and that he has not retained any copies thereof, in whatever form.

6.Non-Disparagement.Employee  agrees not to disparage the Employer or the Employer’s officers, directors, employees, shareholders, parents, subsidiaries, affiliates, and agents, in any manner likely to be harmful to them or their business, business reputation, or personal reputation, and the Employer agrees to direct its officers and directors not to disparage Employee in any manner likely to be harmful to Employee in any manner including Employee’s business reputation or personal reputation; provided that Employee and the Employer may respond accurately and fully to any question, inquiry, or request for information when required by legal process or in connection with a government investigation. In addition, nothing in this provision or this Agreement is intended to prohibit or restrain Employee in any manner from making disclosures that are protected under the whistleblower provisions of federal or law or regulation.

7.Cooperation.

(a)To the fullest extent permitted by law, Employee will not cooperate with, or assist in, any claim, charge, lawsuit, or arbitration against Employer with respect to a Released Claim, unless required to do so by a lawfully issued subpoena, by court order or as expressly provided by regulation or statute. In the event Employee is served with a subpoena or is required by court order or otherwise to testify in any type of proceeding involving Employer and related to a Released Claim, Employee shall immediately advise Employer in writing of same.

8.Employee agrees to cooperate with Employer in any internal investigation, administrative, regulatory, or judicial proceeding or any dispute with a third party.  Employee’s cooperation may include being available to Employer upon reasonable notice for interviews and factual investigations, appearing at Employer’s request to give testimony without requiring service of a subpoena or other legal process, volunteering to Employer pertinent information, and turning

 

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over to Employer all relevant documents which are or may come into Employee’s possession.  Employee understands that in the event Employer asks for Employee’s cooperation in accordance with this provision, Employer will reimburse his for reasonable travel expenses (including lodging and meals) upon submission of receipts acceptable to Employer.

9.ADEA Notice and Acknowledgement.  Employee acknowledges that he has carefully read this Release and fully understands its contents.  Prior to signing this Release, Employee has been advised in writing hereby and has had an opportunity to consult with his attorney of choice concerning the terms and conditions of this Release with regard to any claim or right Employee may have under the ADEA or otherwise.  Employee has been offered at least [21/45] days to review and consider this Release.  Employee may voluntarily and knowingly waive this [21/45]-day period, or any part thereof, if he signs this Release prior to the expiration of [21/45] days.  After signing this Release, Employee shall have seven days from the signing date to revoke this Release.  This Release shall not be effective (including for purposes under the Employment Agreement) until after the seven-day revocation period has expired.  Any revocation must be made in writing and delivered to the Chief Legal Officer of Employer.  Until all applicable periods set forth in this Section 7 have expired, Employer shall not be required to make any payment to Employee which payment is, under Sections 5(a) or 5(b) of the Employment Agreement, contingent upon the signing and delivery to the Company of this Release.  By signing this Release, Employee agrees and understands that he is waiving and releasing any and all rights he may have to pursue the Released Claims against Employer, from the beginning of time up to the effective date of this Release, including, without limitation, all ADEA claims.

10.Governing Law.  New Jersey law shall govern this Release, without giving effect to any choice of law or conflict of law provision or rule (whether of the State of New Jersey or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of New Jersey.  

11.Successors and Assigns.  This Release shall inure to the benefit of the successors and assigns of Employer.

12.Severability.  If any portion of this Release is ruled unenforceable, all remaining portions of this Release shall remain valid.

13.No Reliance; No Waiver.  Employee represents that he is not relying on any representation, statement, or promise of Employer or any other party in giving this Release.  This Release may not be amended, modified, waived, or terminated except in a writing signed by Employee and an authorized representative of Employer.

14.Headings.  The paragraph and section headings in this Release are inserted merely for the convenience of reference only and shall not be used to construe, affect or modify the terms of any paragraph or provision of this Release.

EMPLOYEE WITHOUT ANY DURESS OR COERCION FREELY, KNOWINGLY AND VOLUNTARILY ENTERS INTO, AND GIVES THIS RELEASE.  EMPLOYEE UNDERSTANDS AND AGREES WITH ALL OF THE PROVISIONS AND THE TERMS STATED IN THIS RELEASE AND HAS BEEN AFFORDED SUFFICIENT AND

 

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REASONABLE TIME TO CONSIDER WHETHER TO ENTER INTO THIS RELEASE.  EMPLOYER ADVISES EMPLOYEE TO CONSULT WITH AN ATTORNEY OF EMPLOYEE’S CHOOSING PRIOR TO EXECUTING THIS RELEASE WHICH CONTAINS A RELEASE AND WAIVER.

 

Dated:

 

 

 

 

 

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Execution Version

EXHIBIT 10.2

TYME TECHNOLOGIES, INC.

1 PLUCKEMIN WAY - SUITE 103
BEDMINSTER NJ 07921

 

November 24, 2020

 

Mr. Steven Hoffman

[REDACTED]

[REDACTED]

 

Dear Steven:

 

This amended and restated letter (this “letter agreement”) sets forth our agreement with respect to your employment with Tyme Technologies, Inc., a Delaware corporation (the “Company”).

 

RECITALS:

 

WHEREAS, you previously entered into a letter agreement, dated March 5, 2015, detailing the terms of your employment with the Company (the “Prior Agreement”); and

 

WHEREAS, you and the Company desire to enter into this Agreement to amend, restate and supersede the terms and conditions of the Prior Agreement in its entirety as of the date of this letter agreement (the “Effective Date”) on the terms and conditions set forth in this Agreement.

 

1. Employment. You will be employed by the Company upon the terms and conditions set forth in this letter agreement for the period effective as of the date of this letter agreement and ending as provided in Section 4 (the “Employment Period”).

 

2. Position and Duties.

 

(a) During the Employment Period, you will serve as Chief Science Officer of the Company (the “CSO”) and will have the usual and customary duties, responsibilities and authority of a person in such position and such other duties assigned to you by the Chief Executive Officer of the Company (the “CEO”) which are consistent with your position as CSO as you have performed in such position in the past and to the Effective Date. You will report directly to the CEO. You will devote your full working time, efforts and attention to, and diligently and conscientiously perform the duties of, such position. In addition to performing such duties for the Company, you may be required to perform similar duties for the Company’s existing subsidiaries or affiliates, and/or any subsidiaries and/or affiliates which may be formed or acquired from time to time including, but not limited to, Tyme Inc., a Delaware corporation (such subsidiaries and/or affiliates, including subsidiaries formed after the date hereof, shall be referred to as the “Affiliates”). You will be free to work on a remote basis. For the avoidance of doubt, you will remain as a member of the Board of Directors (the “Board”) and Chairman of the Board effective as of the Effective Date, and the Company shall cause you to be nominated as a member of the Board at each annual meeting of stockholders of the Company during the Employment Period at which your Board seat is up for re-election (and, to the extent the Company solicits proxies for an annual meeting at which you are up for election, to solicit proxies for your election to the Board at such meeting) and shall use all reasonable efforts to have you appointed as the Chairman of the Board throughout the Employment Period.  Notwithstanding the above, the principal place that you will perform your services for the Company shall be consistent with your past practices.

 

(b) In connection with the COVID-19 pandemic, as part of your duties you will be the project manager of the Company’s TYME-19 proof-of-concept trial (RESPOnD) until the initiation of a Phase II clinical trial studying TYME-19.

 

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3. Compensation.

 

(a) Base Salary. During the Employment Period, your base salary will be as follows: for the remainder of fiscal year 2021 (i.e., the year ending March 31, 2021), $569,250 per annum; for fiscal year 2022, $500,000 per annum; for fiscal year 2023, $450,000 per annum (such amounts, your “Base Salary”). Your Base Salary will be payable in regular installments in accordance with the Company’s general payroll practices and subject to withholding and other payroll taxes. After fiscal year 2023, your Base Salary may be reviewed annually by the Board in its sole discretion. Notwithstanding the foregoing, unless agreed by you in writing, your Base Salary shall not be decreased below your then current Base Salary by the Board or otherwise.

 

(b) Cash Incentive Plan. With respect to each fiscal year of the Company ending during the Employment Period, you shall be eligible to earn an incentive award (an “Annual Target Incentive Award”) under the Company’s Cash Incentive Plan, or any successor plan (the “Cash Incentive Plan”) pursuant to the terms and conditions of the Cash Incentive Plan. Your incentive award shall be paid at such times and in such manner as set forth in the Cash Incentive Plan. Prior to or at the beginning of each fiscal year of the Company, the independent directors of the Board (upon the recommendation of the Compensation Committee) shall determine your Annual Target Incentive Award, taking into consideration such factors as the independent directors deem appropriate. For the avoidance of doubt, in the event of any conflict between term definitions in this Section 3(b) and the Cash Incentive Plan, the definitions in this Agreement shall control.

 

(c) Target Compensation after Fiscal Year 2021. Your Annual Target Incentive Award under the Cash Incentive Plan for fiscal year 2021 shall remain at 60% of Base Salary. For fiscal year 2022, your Annual Target Incentive Award for fiscal year 2022 shall be 50% of Base Salary. For fiscal year 2023, your Annual Target Incentive Award shall be 40% of Base Salary. Thereafter, your awards under the Cash Incentive Plan shall be reviewed annually by the independent directors pursuant to the normal performance review policies for the CSO, with such targets established by the independent directors in their sole discretion, following a recommendation by the Compensation Committee. Notwithstanding the foregoing, unless agreed by you in writing, your Annual Target Incentive Award shall not be decreased below 40% of your then current Base Salary by the Board or otherwise.

 

(d) During the Employment Period, you will be entitled to participate in all employee benefit programs, including without limitation health/medical insurance, for which senior executive employees of the Company are generally eligible, subject to applicable plans and policies as may be amended from time to time, in the sole discretion of the Board. During the Employment Period, you will be entitled to four weeks paid vacation during each calendar year, with such vacation time pro-rated for any partial years during the Employment Period; provided, however, that no carry-over of unused vacation time shall be permitted and no compensation shall be paid for any such unused vacation time.

 

(e) The Company agrees to reimburse you for all reasonable out-of-pocket business expenses incurred by you on behalf of the Company during the Employment Period, provided that you properly account to the Company for all such expenses in accordance with the policies of the Company and the rules, regulations and interpretations of the U.S. Internal Revenue Service relating to reimbursement of business expenses (“Expenses”).

 

(f) During the Employment Period, the Company will maintain Directors and Officers Liability Insurance coverage that includes coverage of you, subject to the terms and conditions of such policy and with limits customary for similarly situated companies.

 

4. Termination. The Employment Period will end on the fifth anniversary of the date hereof (the “Expiration Date”), unless sooner terminated as provided below. Unless the Employment Period has been terminated in accordance with the following sentence of this Article 4, commencing with the one-year anniversary hereof, and on each subsequent annual anniversary thereafter, the Expiration Date shall automatically be extended by one additional year, such that, on any given day during the Employment Period, the remaining Employment Period shall never be less than four years and one day. Notwithstanding the foregoing, the Employment Period (i) will terminate upon your death, (ii) may be terminated by the Company upon Notice of Termination (as defined in Section 5(e) below) delivered to you as a result of your Disability (as defined in Section 5(g) below), (iii) may be terminated by the Company at any time for Cause (as defined in Section 5(f) below) or without Cause and (iv) may be terminated by you for Good Reason.

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5. Severance.

 

(a) If the Employment Period is terminated by the Company without Cause or by you for Good Reason (as defined in Section 5(h) below), you will be entitled to receive (i) your Base Salary as in effect at the time of such termination to the extent such amount has accrued through the Termination Date (as defined in Section 5(e) below) and remains unpaid, (ii) any fully earned and declared but unpaid Annual Target Incentive Award as of the Termination Date, (iii) an amount equal to the sum of Base Salary you 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. Upon delivery of the payments and benefits described in this Section 5(a), the Company shall have no further obligation to you under this letter agreement or otherwise with respect to your employment with the Company. The Company’s obligation to make the payments to you described in clause (iii) of this Section 5(a) is conditioned upon your executing and delivering, no later than 14 days following the Termination Date, a release relating to your employment by the Company in favor of the Company, its Affiliates and their respective stockholders, officers, members, managers, directors, employees, subsidiaries and affiliates substantially in the form attached as Exhibit A.

 

(b) If the Employment Period is terminated by the Company for Cause or by you other than for Good Reason, the Company will pay you (i) your 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 Annual Target Incentive Award as of the Termination Date, and (iii) any unpaid Expenses as of the Termination Date. Upon delivery of the payment described in this Section 5(b), the Company will have no further obligation to you under this letter agreement or otherwise with respect to your employment with the Company.

 

(c) If the Employment Period is terminated upon your Disability (as defined in Section 5(g) below) or death, the Company will pay you or your estate or succession, whichever is applicable, (i) your 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 Annual Target Incentive Award as of the Termination Date, and (iii) any unpaid Expenses as of the Termination Date.

 

(d) Except as otherwise required by law or as specifically provided herein, all of your rights to salary, severance, fringe benefits, bonuses and any other amounts hereunder (if any) accruing after the termination of the Employment Period will cease upon the earlier of the date of such termination and your last day of active service. In the event the Employment Period is terminated, your sole remedy, and the sole remedy of your successors, assigns, heirs, representatives and estate, will be to receive the payments described in this letter agreement.

 

(e) Any termination of the Employment Period by the Company (other than termination upon your death) or by you must be communicated by written notice (in either case, a “Notice of Termination”) to you. For purposes of this letter agreement, “Termination Date” means (i) if the Employment Period is terminated by your death, the date of your death, (ii) if the Employment Period is terminated upon your Disability, by the Company or by you, the date specified in the Notice of Termination (which may not be earlier than the date of such Notice). Notwithstanding anything contained herein to the contrary, any termination of the Employment Period by you must be communicated to the Company no less than 30 days prior to the intended Termination Date.

 

(f) For purposes of this letter agreement, “Cause” means any one of the following: (i) a material breach by you of this letter agreement, (ii) your conviction of, guilty plea to, or confession of guilt of, a felony involving the Company, (iii) materially fraudulent, dishonest or illegal conduct by you in the performance of services for or on behalf of the Company or any of its Affiliates, (iv) any actual disparagement by you of the Company, (v) your misappropriation of funds of the Company or any of its Affiliates, (vi) your gross negligence or willful misconduct or willful failure to comply with written directions of the Board which directions are within the scope of your duties hereunder, or (vii) a breach of your duty of loyalty to the Company or its Affiliates with respect to its current lines of business (i.e., the treatment of cancer in humans and COVID-19). A purported termination of your employment for Cause shall not be effective unless (A) the Company provides written notice to you of the facts alleged by the Company to constitute Cause and such notice is delivered to you no more than 90 days after the Company has actual knowledge of such facts and (B) you have been given an opportunity of no less than ten days after receipt of such notice to cure the circumstances alleged to give rise to Cause and the Company has cooperated

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in good faith with your efforts to cure such condition or circumstance, but only to the extent that such circumstances are reasonably curable.

 

(g) For purposes of this letter agreement “Disability” means any accident, sickness, incapacity or other physical or mental disability which prevents you from performing substantially all of the duties you have been assigned by the Company or any of its subsidiaries for either (i) 90 consecutive days or (ii) 120 days during any period of 365 consecutive days, in each case as determined in good faith by a physician selected by the Board. During the time periods specified above, the Company will continue to provide you with the compensation stated in Section 3 above.

 

(h) For purposes of this letter agreement, “Good Reason” means the failure of the Company to make all payments due you under this letter agreement and the continuation thereof for more than five calendar days after notice to the Company of such failure and demand for such outstanding payment(s).

 

6. Confidential Information.

 

(a) You will not disclose or use at any time any Confidential Information (as defined below in Section 6(c)), whether or not such information is developed by you, except to the extent that such disclosure or use is required in the performance or exercise by you in good faith of (i) duties assigned to you under this letter agreement or otherwise by the Board, (ii) rights as an employee, officer, director or shareholder of the Company or any of its Affiliates or (iii) rights under any agreement with the Company or any Affiliates.

 

(b) You will deliver to the Company at the termination of the Employment Period, or at any time the Company may request, all memoranda, notes, plans, designs, records, reports, computer files and software and other documents and data (and copies thereof) that are Confidential Information or Work Product (as defined below) or information relating to the business of the Company or its Affiliates which you may then possess or have under your control.

 

(c) As used in this letter agreement, the term “Confidential Information” means information that is not generally known or available to the public and that is used, developed or obtained by the Company or any Affiliate in connection with its or their businesses, including but not limited to (i) information, observations and data concerning the business or affairs of the Company or its affiliates, (ii) products or services, (iii) fees, costs and pricing structures, (iv) designs, (v) analyses, (vi) drawings, designs, photographs, artwork and reports, (vii) computer software, including operating systems, applications and program listings, (viii) flow charts, manuals and documentation, (ix) data bases, (x) accounting and business methods, (xi) inventions, devices, new developments, methods and processes, whether patentable or unpatentable and whether or not reduced to practice, (xii) other copyrightable works, (xiii) all production methods, processes, technology and trade secrets, (xiv) Company product and product candidate formulae and any trade secrets with respect to such products and product candidates and (xv) all similar and related information in whatever form.

 

(d) Notwithstanding the provisions of this letter agreement to the contrary, you will have no liability to the Company for disclosure of Confidential Information if the Confidential Information:

 

(A) is in the public domain or becomes publicly known in the industry in which the Company operates or is disclosed by the Company other than as the result of a breach of this letter agreement or any other agreement by you;

 

(B) is required to be disclosed by law, court order, or similar compulsion or in connection with any legal proceeding; provided however, that such disclosure will be limited to the extent so required and, subject to the requirements of law, you will give the Company notice of your intent to so disclose such Confidential Information and will cooperate with the Company in seeking confidentiality protections; or

 

(C) is information you created or developed and does not constitute Work Product.  

 

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7. Inventions and Patents. You agree that all inventions, innovations, improvements, technical information, trade secrets, systems, software developments, ideas, results, methods, designs, artwork, analyses, drawings, reports, copyrights, service marks, trademarks, trade names, logos and all similar or related information (whether patentable or unpatentable) which relate to the Company’s or any of its Affiliates’ businesses, research and development or existing products (or products under development) or services and which are conceived, developed or made by you (whether or not during usual business hours and whether or not alone or in conjunction with any other person) during your employment with the Company, together with all intellectual property rights therein, including, but not limited to, any patent applications, letters patent, trademark, trade name and service mark applications or registrations, copyrights and reissues thereof that may be granted for or upon any of the foregoing, but only with respect to the treatment of cancer in humans and COVID-19 (collectively referred to herein as “Work Product”), is the exclusive property of the Company and/or its Affiliates. For the avoidance of doubt and without limiting the foregoing, (x) the Company or any of its Affiliates shall be the sole owner of all right, title and interest in such Work Product, including all intellectual property rights relating to such Work Product, without you retaining any license or other residual right whatsoever, (y) any rights to any new or an existing Work Product are automatically conveyed, assigned and transferred to the Company pursuant to this agreement, and (z) Work Product, for purposes of this Agreement, shall only consist of Work Product as defined by the foregoing definition but solely limited to that business, research and development or existing products (or products under development) or services and which are conceived, developed or made by you (whether or not during usual business hours and whether or not alone or in conjunction with any other person) during your employment with the Company, together with all intellectual property rights therein, relating to cancer in humans and COVID-19, and no other applications; with all other applications belonging to you. You hereby waive and renounce to all moral rights related, directly or indirectly, to any such existing or new Work Product. You will take reasonable steps to promptly disclose such Work Product to the Board and perform all actions reasonably requested by the Board (whether during or after the Employment Period) to establish and confirm such ownership (including the execution and delivery of assignments, consents, powers of attorney and other instruments) and to provide reasonable assistance to the Company and its Affiliates in connection with the prosecution of any applications for patents, trademarks, trade names, service marks or reissues thereof or in the prosecution or defense of interferences relating to any Work Product.

 

8. Non-Compete; Non-Solicitation; Non-Disparagement.

 

(a) You acknowledge that, in the course of your employment with the Company, you will become familiar with the Company’s and its Affiliates’ trade secrets and with other Confidential Information concerning the Company and its Affiliates and that your services will be of special, unique and extraordinary value to the Company and its Affiliates. Therefore, you agree that, during the Restriction Period (as defined in Section 8(b) below), you will not (x) anywhere the Company or any of its Affiliates conducts business or (y) anywhere the Company or any of its Affiliates has spent time and resources in connection with expanding its business, directly or indirectly, either on your own behalf or on behalf of any other person, firm or entity:

 

(A) own, manage, operate, consult with, provide financing to, or join, control or participate in the ownership, management, operation or control of, or the provision of financing to, any business wherever located (whether in corporate, proprietorship or partnership form or otherwise), if such business is competitive with the business of the Company; or

 

(B) say anything which is harmful to the reputation of the Company or any of its Affiliates or which could be reasonably expected to lead any person to cease to deal with the Company or any of its Affiliates on substantially equivalent terms to those previously offered or at all.

 

(b) For purposes of this letter agreement, “Restriction Period” means (i) during the Employment Period, and for a period of two years following your receipt of the final payment described in Article 5, as applicable.

 

(c) Nothing in Section 8(a) will prohibit you from being a passive owner of not more than 2% of the outstanding stock of a publicly-traded corporation, so long as you have no active participation in the business of such corporation.  In addition, nothing in Section 8(a) will prohibit you from owning a 2% or greater equity interest in the Company or any successor-in-interest to the Company.

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(d) During the Restriction Period, you will not:

 

(A) induce or attempt to induce any customer, supplier or other business relation of the Company or any of its affiliates to cease doing business with the Company or any of its Affiliates, or in any way interfere with the relationship between any such customer, supplier or business relation, on the one hand, and the Company or any Affiliates, on the other hand; or

 

(B) engage, employ, solicit or contact with a view to the engagement or employment of, any employee, officer or manager of, or full-time consultant to, the Company or any Affiliates or any person who has been an employee, officer or manager of, or consultant to, the Company or any Affiliates at any time during the two-year period ending on the date of such determination, other than John Rothman,.

 

(e) The Company, on behalf of itself and all Affiliates, agrees that during the Restriction Period they and their executive officers (or other persons acting on their behalf) will not say anything which is harmful to your reputation or which could be reasonably expected to lead any person to cease to deal with you or engage you in any consulting or employment position.

 

9. Enforcement.

 

(a) Because the employment relationship between you and the Company is unique and because you have access to Confidential Information and Work Product, you agree that money damages would be an inadequate remedy for any breach of Section 6, 7 or 8 of this letter agreement. Therefore, in the event of a breach or threatened breach of Section 6, 7 or 8 of this letter agreement, the Company may, in addition to its other rights and remedies, apply to any court of competent jurisdiction for specific performance and/or injunctive or other relief in order to enforce, or prevent any violations of, such provisions (without posting a bond or other security).

 

(b) Sections 6, 7, 8 and 9 of this letter agreement will expressly survive termination of this agreement. The existence of any claim or cause of action by you against the Company and/or any of its Affiliates shall not constitute a defense to the enforcement by the Company of the covenants contained in this Articles 6, 7 or 8, but such claim or cause of action shall be litigated separately.

 

10. Notices. All notices, requests, demands, claims, and other communications hereunder will be in writing. Any notice, request, demand, claim or other communication hereunder will be deemed duly given (i) upon delivery, if delivered personally to the recipient, against written receipt therefor, or (ii) upon the first business day after the date sent, if sent priority next-day delivery to the intended recipient by reputable express courier service (charges prepaid) and addressed to the intended recipient as set forth below:

 

If to the Company, to:

 

Attention: Chief Legal Officer

Tyme Technologies, Inc.

1 Pluckemin Way - Suite 103

Bedminster, NJ 07921

 

If to you, to the address shown on the first page, with a copy to

 

Moritt Hock & Hamroff LLP
450 Seventh Avenue, 15th Floor

New York, New York 10123

Attention: Keith S. Braun, Esq.

Any party hereto may send any notice, request, demand, claim or other communication hereunder to the intended recipient at the address set forth above using any other means, but no such notice, request, demand, claim or other communication will be deemed to have been duly given unless and until it actually is received and acknowledged by the intended recipient. Any party hereto may change the address (or add new parties and their

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addresses) to which notices, requests, demands, claims, and other communications hereunder are to be delivered by giving the other parties hereto notice in the manner set forth in this Section 10.

 

11. Representations and Warranties. You hereby represent and warrant to the Company that (a) the execution, delivery and performance of this letter agreement by you does not and will not conflict with, breach, violate or cause a default under any agreement, contract or instrument to which you are a party or any judgment, order or decree to which you are subject, (b) you are not a party to or bound by any employment agreement, consulting agreement, non-compete agreement, confidentiality agreement or similar agreement with any other person or entity that is inconsistent with the provisions of this letter agreement, (c) upon the execution and delivery of this letter agreement by the Company and you, this letter agreement will be a valid and binding obligation of you and (d) you are in good health and are not suffering from, and have never suffered from, any serious illness, disease or other physical or mental condition that has prevented or materially interfered with, or might reasonably be expected in the future to prevent or materially interfere with, your ability to perform those services described in this letter agreement. The Company hereby represents and warrants to you that (i) the execution, delivery and performance of this letter agreement by the Company does not and will not conflict with, breach, violate or cause a default under any agreement, contract or instrument to which it is a party or any judgment, order or decree to which it is subject and (ii) upon the execution and delivery of this letter agreement by the Company and you, this agreement will be a valid and binding obligation of the Company.

 

12. General Provisions.

 

(a) Severability. It is the desire and intent of the parties hereto that the provisions of this letter agreement be enforced to the fullest extent permissible under the laws and public policies applied in each jurisdiction in which enforcement is sought. Accordingly, if any particular provision of this letter agreement will be adjudicated by a court of competent jurisdiction to be invalid, prohibited or unenforceable for any reason, such provision, as to such jurisdiction, will be ineffective, without invalidating the remaining provisions of this agreement or affecting the validity or enforceability of this letter agreement or affecting the validity or enforceability of such provision in any other jurisdiction. Notwithstanding the foregoing, if such provision could be more narrowly drawn so as not to be invalid, prohibited or unenforceable in such jurisdiction, it will, as to such jurisdiction, be so narrowly drawn, without invalidating the remaining provisions of this letter agreement or affecting the validity or enforceability of such provision in any other jurisdiction.

 

(b) Complete Agreement. This letter agreement supersedes the Prior Agreement in its entirety as of the Effective Date.  This letter agreement and any schedules or exhibits expressly constitute the entire agreement among the parties hereto with respect to the subject matter hereof and supersedes and preempts any prior understandings, agreements or representations by or among the parties, written or oral, which may have related to the subject matter hereof in any way.

 

(c) Successors and Assigns. Except as otherwise provided herein, this letter agreement will be binding upon and inure to the benefit of you and the Company and our respective successors, permitted assigns, personal representatives, heirs and estates, as the case may be; provided, however, that your rights and obligations under this letter agreement will not be assigned without the prior written consent of the Company.

 

(d) Governing Law. This letter agreement will be governed by and construed in accordance with the domestic laws of New Jersey, without giving effect to the choice of law provisions thereof. The parties agree that the exclusive venue for all disputes under this agreement shall be the federal and state courts sitting in New Jersey.

 

(e) Amendment and Waiver. The provisions of this letter agreement may be amended and waived only with the prior written consent of the Company (with the approval of the Board) and you, and no course of conduct or failure or delay in enforcing the provisions of this letter agreement will affect the validity, binding effect or enforceability of this letter agreement or any provision hereof.

 

(f) Headings. The section headings contained in this agreement are inserted for convenience only and will not affect in any way the meaning or interpretation of this agreement.

 

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(g) Counterparts. This letter agreement may be executed in counterparts, each of which will be deemed an original and all of which together will constitute one and the same instrument.

 

(h) 409A Provision. For purposes of this letter agreement the term “termination of employment” and similar terms relating to your termination of employment mean a “separation from service” as that term is defined under Section 409A of the Internal Revenue Code of 1986, as amended, and the final regulations issued thereunder (“Section 409A”). The Company and you intend that this letter agreement comply in form and operation with the requirements of Section 409A. To the extent permitted by applicable Department of Treasury/Internal Revenue Service guidance, or law or regulation, the Company and you will take reasonable actions to reform this letter agreement or any actions taken pursuant to their operation of this letter agreement in order to comply with Section 409A.

 

[signature page follows]

 

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If this letter agreement correctly expresses our mutual understanding, please sign and date a copy of this letter agreement and return it to us.

 

Very truly yours,

 

Tyme Technologies, Inc.

 

 

 

By: /s/ James Biehl

Name: James Biehl

Title: Chief Legal Officer

 

The terms of this letter agreement are accepted and agreed to

 

on November 24, 2020 by:

 

 

 

/s/ Steven Hoffman

Steven Hoffman

 

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EXHIBIT A

 

Form of Release

 

RELEASE

 

This Release (“Release”) is delivered by Steven Hoffman on this ___ day of _________, 20__.

DEFINITIONS

 

A.As used herein, unless otherwise specified, the term “Employer” shall mean Tyme Technologies, Inc.; all of its affiliates, successors, predecessors, assigns, parents, subsidiaries, and divisions (whether incorporated or unincorporated); and all of its and their past and present owners, directors, officers, trustees, shareholders, managers, employees and agents (in their individual and representative capacities).

B.As used herein, unless otherwise specified, the term “Employee” shall mean Steven Hoffman and all of his heirs, family members, executors, accountants, administrators, attorneys, agents, assigns, successors and representatives.

RECITALS

WHEREAS, Employee’s employment ended on

, 20__; and

WHEREAS, it is a condition to Employee’s receipt of certain post-employment benefits (“Conditional Benefits”) under Sections 5(a) of the amended and restated letter agreement, dated [_________], 2020 (the “Employment Agreement”), between Employee and Employer that Employee execute this Release.

NOW THEREFORE, in consideration of the promises, representations and mutual covenants contained in this Release, and for other good and valuable consideration, the sufficiency of which is hereby acknowledged, it is agreed as follows:

1.Consideration.  Employee acknowledges that the Conditional Benefits are in excess of any earned wages or benefits due and owing to Employee, and would not be paid or provided unless Employee executed this Release.  Employee acknowledges and agrees that the Conditional Benefits are adequate and independent consideration for Employee executing this Release and releasing any and all claims against Employer.

2.Release of All Claims.  In consideration of the above, and the other promises set forth in this Release, Employee fully and forever waives, releases, acquits and discharges Employer from and for all manner of claims, actions, suits, charges, demands, grievances and/or causes of action, in law or in equity, existing by reason of and/or based upon any fact or set of facts, known or unknown, existing from the beginning of time through the date of Employee’s execution of this Release relating to and/or arising out of the Employment Agreement, Employee’s employment with Employer and/or the cessation of Employee’s employment with Employer (collectively, the “Released Claims”), including, but not limited to, all claims, actions, suits, charges, demands, grievances and/or causes of action (x) for wages, compensation, liquidated damages, commissions, bonuses, benefits, sums of money, damages of every type, costs, attorney fees, judgments, and executions, (y) alleging wrongful discharge, breach of contract, breach of implied contract, breach of the covenant of good faith and fair dealing, tortious interference with contract or business relationships, assault, battery, invasion of privacy, misappropriation of trade secrets, promissory estoppel, unjust enrichment, loss of consortium, violation of the penal statutes, negligent or intentional infliction of emotional distress, negligence, defamation, retaliation and/or discrimination and/or harassment on account of age, sex, sexual orientation, creed, religion, race, color, national origin, sensory disability, mental disability, physical disability, veteran or military status, marital status, or any other classification recognized under all applicable discrimination laws, or (z) brought under common law or civil rights or other statutes, including Title VII of the Civil Rights Act of 1964 (“Title VII”), the Age Discrimination in Employment Act (“ADEA”) (as amended by the Older Workers Benefits Protection Act (“OWBPA”)), the Family and Medical Leave Act (“FMLA”), the Employee Retirement Income Security Act (“ERISA”), the Rehabilitation Act of 1973, the Americans with Disabilities Act (“ADA”), the Consolidated Omnibus Budget Reconciliation Act (“COBRA”), the Workers Adjustment Retraining Notification Act (“WARN”), the

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Equal Pay Act (“EPA”), the Uniformed Services Employment and Reemployment Rights Act (“USERRA”), the National Labor Relations Act (“NLRA”), the New York State Human Rights Law, the New York City Human Rights Law, the New York Labor Law, the New Jersey Law Against Discrimination (“NJLAD”), the New Jersey Conscientious Employee Protection Act (“CEPA”), and any and all other federal, state, local statutes, ordinances, and laws, and every type of relief (legal, equitable and otherwise), available to Employee.  Employee covenants and agrees that he will not pursue or allege any claim, matter or cause of action in violation of, and/or released under, this Release.  Notwithstanding the foregoing or anything contained below, nothing in this Release shall be construed as releasing Employer from, and the Released Claims shall not include:  (a) any obligation to pay those amounts due to Employee under Section 5(a) of the Employment Agreement, subject to the terms and conditions thereof; (b) Employee’s rights to enforce the terms of the Employment Agreement that survive the termination of the Employment Period (as defined in the Employment Agreement) or Employment Agreement; (c) Employee’s rights described in Section 5(d) of the Employment Agreement; (d) Employee’s non-forfeitable rights to accrued benefits (within the meaning of Sections 203 and 204 of ERISA), (e) Employee’s right to indemnification or exculpation under the Employment Agreement, Employer’s policies or law with respect to Employee’s service as a director or officer of Employer (including without limitation any such rights under Employer’s Certificate of Incorporation, By-laws and Directors and Officers Liability Insurance coverage); (f) any claims that by law cannot be waived by private agreement without judicial or governmental supervision; or (g) Employee’s right to file a charge with or participate in any investigation or proceeding conducted by the U.S. Equal Employment Opportunity Commission (“EEOC”) or other government agency; provided that even though Employee can file a charge or participate in an investigation or proceeding conducted by the EEOC or other government agency, by executing this Release, Employee is waiving his ability to obtain relief of any kind from Employer to the extent permitted by law.  

3.Covenant Not to Sue.  Employee represents that he has not filed any action, charge, suit, or claim against Employer with any federal, state or local agency or court relating to any Released Claim.  Employee further agrees that should any claims, charges, complaints, suits or other actions be filed hereafter on his behalf by any federal, state or local agency or by any other person or entity with respect to a Released Claim, he will immediately withdraw with prejudice, or cause to be withdrawn with prejudice, and/or dismiss with prejudice, or cause to be dismissed with prejudice, any such claims, charges, complaints, suits or other actions filed against Employer.  Employee further agrees that, to the fullest extent permitted by law, Employee shall receive no relief of any type (monetary, equitable, or otherwise) from Employer with respect to, relating to and/or on account of any such claims, matters or actions.  Employee agrees to opt-out of any class action or collective action filed against Employer to the extent related to a Released Claim.  

4.Confidentiality.  To the fullest extent permitted by law, Employee agrees to keep confidential all facts, opinions, and information which relate in any way to Employee’s employment and/or cessation of employment with Employer, as well as the terms of this Release; provided however, Employee may discuss the terms of this Release with his spouse, legal representative, and/or tax preparer, each of whom must also agree to maintain confidentiality and comply with this Section 4.  Notwithstanding anything herein to the contrary, nothing contained herein shall prevent Employee from making truthful statements to any government authority or agency.  

5.Return of Employer’s Property.  Employee represents that he has returned to Employer any and all property, records, papers, documents and writings, in whatever form, of Employer in Employee’s possession and/or control, and that he has not retained any copies thereof, in whatever form.

6.Cooperation.

(a)To the fullest extent permitted by law, Employee will not cooperate with, or assist in, any claim, charge, lawsuit, or arbitration against Employer with respect to a Released Claim, unless required to do so by a lawfully issued subpoena, by court order or as expressly provided by regulation or statute. In the event Employee is served with a subpoena or is required by court order or otherwise to testify in any type of proceeding involving Employer and related to a Released Claim, Employee shall immediately advise Employer in writing of same.

7.Employee agrees to cooperate with Employer in any internal investigation, administrative, regulatory, or judicial proceeding or any dispute with a third party.  Employee’s cooperation may include being available to Employer upon reasonable notice for interviews and factual investigations, appearing at Employer’s

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request to give testimony without requiring service of a subpoena or other legal process, volunteering to Employer pertinent information, and turning over to Employer all relevant documents which are or may come into Employee’s possession.  Employee understands that in the event Employer asks for Employee’s cooperation in accordance with this provision, Employer will reimburse his for reasonable travel expenses (including lodging and meals) upon submission of receipts acceptable to Employer.

8.ADEA Notice and Acknowledgement.  Employee acknowledges that he has carefully read this Release and fully understands its contents.  Prior to signing this Release, Employee has been advised in writing hereby and has had an opportunity to consult with his attorney of choice concerning the terms and conditions of this Release with regard to any claim or right Employee may have under the ADEA or otherwise.  Employee has been offered at least [21/45] days to review and consider this Release.  Employee may voluntarily and knowingly waive this [21/45]-day period, or any part thereof, if he signs this Release prior to the expiration of [21/45] days.  After signing this Release, Employee shall have seven days from the signing date to revoke this Release.  This Release shall not be effective (including for purposes under the Employment Agreement) until after the seven-day revocation period has expired.  Any revocation must be made in writing and delivered to the Chief Legal Officer of Employer.  Until all applicable periods set forth in this Section 8 have expired, Employer shall not be required to make any payment to Employee which payment is, under Sections 5(a) of the Employment Agreement, contingent upon the signing and delivery to the Company of this Release.  By signing this Release, Employee agrees and understands that he is waiving and releasing any and all rights he may have to pursue the Released Claims against Employer, from the beginning of time up to the effective date of this Release, including, without limitation, all ADEA claims.

9.Governing Law.  New Jersey law shall govern this Release, without giving effect to any choice of law or conflict of law provision or rule (whether of the State of New Jersey or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of New Jersey.  

10.Successors and Assigns.  This Release shall inure to the benefit of the successors and assigns of Employer.

11.Severability.  If any portion of this Release is ruled unenforceable, all remaining portions of this Release shall remain valid.

12.No Reliance; No Waiver.  Employee represents that he is not relying on any representation, statement, or promise of Employer or any other party in giving this Release.  This Release may not be amended, modified, waived, or terminated except in a writing signed by Employee and an authorized representative of Employer.

13.Headings.  The paragraph and section headings in this Release are inserted merely for the convenience of reference only and shall not be used to construe, affect or modify the terms of any paragraph or provision of this Release.

EMPLOYEE WITHOUT ANY DURESS OR COERCION FREELY, KNOWINGLY AND VOLUNTARILY ENTERS INTO, AND GIVES THIS RELEASE.  EMPLOYEE UNDERSTANDS AND AGREES WITH ALL OF THE PROVISIONS AND THE TERMS STATED IN THIS RELEASE AND HAS BEEN AFFORDED SUFFICIENT AND REASONABLE TIME TO CONSIDER WHETHER TO ENTER INTO THIS RELEASE.  EMPLOYER ADVISES EMPLOYEE TO CONSULT WITH AN ATTORNEY OF EMPLOYEE’S CHOOSING PRIOR TO EXECUTING THIS RELEASE WHICH CONTAINS A RELEASE AND WAIVER.

 

Dated:

 

 

 

 

 

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EXHIBIT 31.1

RULE 13a-14(a)/15d-14(a) CERTIFICATION

I, Richard Cunningham, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of Tyme Technologies, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: February 3, 2021

 

/s/ Richard Cunningham

 

 

Richard Cunningham

 

 

Chief Executive Officer

 

 

(Principal Executive Officer)

 

EXHIBIT 31.2

RULE 13a-14(a)/15d-14(a) CERTIFICATION

I, Barbara Galaini, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of Tyme Technologies, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: February 3, 2021

 

/s/ Barbara Galaini

 

 

Barbara Galaini

 

 

Corporate Controller

 

 

(Principal Financial Officer and Principal Accounting Officer)

 

EXHIBIT 32.1

CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

(18 U.S.C. SECTION 1350)

In connection with the Quarterly Report on Form 10-Q of Tyme Technologies, Inc. (the “Company”) for the quarter ended December 31, 2020, to which this certification is being filed as of the date hereof as an exhibit thereto (the “Report”), I, Richard Cunningham, Chief Executive Officer of the Company, and I, Barbara Galaini, Corporate Controller of the Company, each certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(a)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C 78m or 78 o (d)); and

(b)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: February 3, 2021

 

 

/s/ Richard Cunningham

Richard Cunningham

Chief Executive Officer

(Principal Executive Officer)

 

 

/s/ Barbara Galaini

Barbara Galaini

Corporate Controller

(Principal Financial Officer and Principal Accounting Officer)

THIS CERTIFICATION WILL NOT BE DEEMED “FILED” FOR PURPOSES OF SECTION 18 OF THE EXCHANGE ACT OR OTHERWISE SUBJECT TO THE LIABILITY OF THAT SECTION. SUCH CERTIFICATION WILL NOT BE DEEMED TO BE INCORPORATED BY REFERENCE INTO ANY FILING UNDER THE SECURITIES ACT OR THE EXCHANGE ACT, EXCEPT TO THE EXTENT THAT OUR COMPANY SPECIFICALLY INCORPORATES IT BY REFERENCE. A SIGNED ORIGINAL OF THIS CERTIFICATION HAS BEEN PROVIDED TO THE COMPANY AND WILL BE RETAINED BY THE COMPANY AND FURNISHED TO THE SECURITIES AND EXCHANGE COMMISSION OR ITS STAFF UPON REQUEST.