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, 2018September 30, 2019

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.)

 

17 State Street – 7th Floor

New York, New York 10004

(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  

AsThe number of February 7, 2019, there were 103,342,036 shares outstanding of the registrant’s common stock par value $0.0001 per share, issued and outstanding.on October 29, 2019 was 111,950,937.


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, 2018September 30, 2019 (unaudited) and March 31, 20182019

 

2

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations (unaudited) for the three and ninesix months ended December 31,September 30, 2019 and 2018 and 2017

 

3

 

 

 

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the ninethree and six months ended December 31,September 30, 2019 and 2018 (unaudited)

 

4

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows (unaudited) for the ninesix months ended December 31,September 30, 2019 and 2018 and 2017 (unaudited)

 

5

 

 

 

 

 

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

 

6

 

 

 

 

 

Item 2.

 

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

 

1416

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk.

 

2024

 

 

 

 

 

Item 4.

 

Controls and Procedures.Procedures.

 

2024

 

 

 

 

 

 

 

PART II- OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings.

 

2225

 

 

 

 

 

Item 1A.

 

Risk Factors.

 

2225

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds.

 

2326

 

 

 

 

 

Item 3.

 

Defaults Upon Senior Securities.

 

2326

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures.

 

2326

 

 

 

 

 

Item 5.

 

Other Information.

 

2326

 

 

 

 

 

Item 6.

 

Exhibits.

 

2427

 

 

 

 

 

SIGNATURES

 

 

 

2528

 

 

 


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. 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 development and potential commercialization of our lead drug candidatecandidates (including SM-88 and Tyme-18) and of other new products, technology enhancements, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials and other statements that are not historical. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those but not limited to, that the information is of a preliminary nature and may be subject to change; uncertainties inherent in research and development, including the cost and availability of acceptable quality clinical supply and the ability to achieve adequate clinical study design and start and completion dates; 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; competitive developments; and the factors described in our Form 10-K for the year ended March 31, 20182019 and in this report under “Risk Factors,” and in any subsequent filings with the United States Securities and Exchange Commission and many of which are beyond our control. Moreover, we operate in a very 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 those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this report and our Annual Report on Form 10-K for the year ended March 31, 20182019 and subsequent reports we file from time to time may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

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. 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, 2018

 

 

March 31, 2018

 

 

September 30,  2019

 

 

March 31, 2019

 

 

(unaudited)

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

16,733,139

 

 

$

28,975,822

 

 

$

15,308,068

 

 

$

14,302,328

 

Prepaid rent

 

 

242,755

 

 

 

 

 

 

 

 

 

242,755

 

Prepaid clinical costs

 

 

510,346

 

 

 

 

 

 

296,682

 

 

 

592,134

 

Prepaid expenses and other current assets

 

 

286,723

 

 

 

732,555

 

 

 

406,185

 

 

 

1,001,898

 

Total current assets

 

 

17,772,963

 

 

 

29,708,377

 

 

 

16,010,935

 

 

 

16,139,115

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation

 

 

11,675

 

 

 

3,239

 

Prepaid clinical costs

 

 

1,266,025

 

 

 

1,306,225

 

Property and equipment, net

 

 

7,772

 

 

 

10,363

 

Prepaid rent, net of current portion

 

 

161,836

 

 

 

 

 

 

 

 

 

101,148

 

Prepaid clinical costs, net of current portion

 

 

1,266,025

 

 

 

1,266,025

 

Operating lease right-of-use asset

 

 

300,682

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total assets

 

$

19,212,499

 

 

$

31,017,841

 

 

$

17,585,414

 

 

$

17,516,651

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable and other current liabilities (including $181,000 and

$384,000 of related party accounts payable, respectively)

 

$

2,295,250

 

 

$

2,817,090

 

Accounts payable and other current liabilities (including $104,000 and

$325,000 of related party accounts payable, respectively)

 

$

3,248,696

 

 

$

3,692,308

 

Severance payable

 

 

369,497

 

 

 

428,240

 

Accrued bonuses

 

 

1,167,789

 

 

 

1,248,690

 

 

 

858,610

 

 

 

1,495,248

 

Insurance note payable

 

 

39,015

 

 

 

480,094

 

 

 

 

 

 

597,339

 

Operating lease liability

 

 

60,008

 

 

 

 

Total current liabilities

 

 

3,502,054

 

 

 

4,545,874

 

 

 

4,536,811

 

 

 

6,213,135

 

Long-term liabilities

 

 

 

 

 

 

 

 

Severance payable

 

 

1,451,726

 

 

 

1,635,634

 

Operating lease liability, net of current portion

 

 

26,661

 

 

 

 

Warrant liability

 

 

4,264,205

 

 

 

 

Total liabilities

 

 

3,502,054

 

 

 

4,545,874

 

 

 

10,279,403

 

 

 

7,848,769

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (see Note 8)

 

 

 

 

 

 

 

 

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,

103,190,385 and 101,226,479 issued and outstanding at

December 31, 2018 and March 31, 2018, respectively

 

 

10,322

 

 

 

10,125

 

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

111,950,937 issued and outstanding at September 30, 2019, 300,000,000 authorized, 103,946,048 issued and outstanding at March 31, 2019

 

 

11,197

 

 

 

10,397

 

Additional paid in capital

 

 

90,317,576

 

 

 

79,293,423

 

 

 

102,427,576

 

 

 

95,472,181

 

Accumulated deficit

 

 

(74,617,453

)

 

 

(52,831,581

)

 

 

(95,132,762

)

 

 

(85,814,696

)

Total stockholders' equity

 

 

15,710,445

 

 

 

26,471,967

 

 

 

7,306,011

 

 

 

9,667,882

 

Total liabilities and stockholders' equity

 

$

19,212,499

 

 

$

31,017,841

 

 

$

17,585,414

 

 

$

17,516,651

 

 

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,

 

Three Months Ended

September 30,

 

 

Six Months Ended                   September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

Revenues

 

$

 

 

$

 

 

$

 

 

$

 

$

 

 

$

 

 

$

 

 

$

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,525,228

 

 

 

2,585,991

 

 

 

10,979,432

 

 

 

6,402,270

 

 

3,117,798

 

 

 

3,443,516

 

 

 

5,838,560

 

 

 

6,454,203

 

 

General and administrative (including $132,000, $588,000,

$794,000 and $1,559,000 of related party legal expenses,

respectively)

 

 

3,550,223

 

 

 

2,975,274

 

 

 

10,827,879

 

 

 

7,644,476

 

General and administrative (including $97,000, $251,000, $249,000 and $651,000 of related party legal expenses, respectively)

 

3,127,454

 

 

 

3,569,174

 

 

 

6,584,178

 

 

 

7,277,656

 

 

Total operating expenses

 

 

8,075,451

 

 

 

5,561,265

 

 

 

21,807,311

 

 

 

14,046,746

 

 

6,245,252

 

 

 

7,012,690

 

 

 

12,422,738

 

 

 

13,731,859

 

 

Loss from operations

 

 

(8,075,451

)

 

 

(5,561,265

)

 

 

(21,807,311

)

 

 

(14,046,746

)

 

(6,245,252

)

 

 

(7,012,690

)

 

 

(12,422,738

)

 

 

(13,731,859

)

 

Other income

 

 

28,718

 

 

 

 

 

 

28,718

 

 

 

390,385

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of warrant liability

 

81,154

 

 

 

 

 

 

3,019,396

 

 

 

 

 

Interest income

 

67,259

 

 

 

 

 

 

147,496

 

 

 

 

 

Interest expense

 

 

(1,221

)

 

 

 

 

 

(7,279

)

 

 

 

 

(29,241

)

 

 

(2,430

)

 

 

(62,220

)

 

 

(6,057

)

 

Total other income (expenses)

 

119,172

 

 

 

(2,430

)

 

 

3,104,672

 

 

 

(6,057

)

 

Net loss

 

$

(8,047,954

)

 

$

(5,561,265

)

 

$

(21,785,872

)

 

$

(13,656,361

)

$

(6,126,080

)

 

$

(7,015,120

)

 

$

(9,318,066

)

 

$

(13,737,916

)

 

Basic and diluted loss per common share

 

$

(0.08

)

 

$

(0.06

)

 

$

(0.21

)

 

$

(0.15

)

$

(0.05

)

 

$

(0.07

)

 

$

(0.08

)

 

$

(0.14

)

 

Basic and diluted weighted average shares outstanding

 

 

103,009,449

 

 

 

89,929,161

 

 

 

101,963,833

 

 

 

89,499,882

 

 

111,950,937

 

 

 

101,647,555

 

 

 

111,906,981

 

 

 

101,438,168

 

 

 

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 NineThree and Six Months Ended December 31,September 30, 2019 and 2018

(Unaudited)

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

Total

 

 

Shares

 

 

Amount

 

 

Paid-in

Capital

 

 

Accumulated Deficit

 

 

Stockholders'

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Paid-in

Capital

 

 

Accumulated Deficit

 

 

Stockholders'

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, April 1, 2018

 

 

101,226,479

 

 

$

10,125

 

 

$

79,293,423

 

 

$

(52,831,581

)

 

$

26,471,967

 

 

 

101,226,479

 

 

$

10,125

 

 

$

79,293,423

 

 

$

(52,831,581

)

 

$

26,471,967

 

Issuance of common stock from at-the-market

financing facility, net of associated expenses

of $125,327

 

 

1,779,872

 

 

 

179

 

 

 

4,052,086

 

 

 

 

 

 

 

4,052,265

 

Exercise of options

 

 

100,000

 

 

 

10

 

 

 

269,990

 

 

 

 

 

 

 

270,000

 

Cashless exercise of warrants

 

 

84,034

 

 

 

8

 

 

 

(8

)

 

 

 

 

 

 

-

 

Stock based compensation

 

 

 

 

 

 

 

 

 

 

6,702,085

 

 

 

 

 

 

 

6,702,085

 

 

 

 

 

 

 

2,519,269

 

 

 

 

 

2,519,269

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,785,872

)

 

 

(21,785,872

)

 

 

 

 

 

 

 

 

(6,722,796

)

 

 

(6,722,796

)

Balance, December 31, 2018

 

 

103,190,385

 

 

$

10,322

 

 

$

90,317,576

 

 

$

(74,617,453

)

 

$

15,710,445

 

Balance, June 30, 2018

 

 

101,226,479

 

 

$

10,125

 

 

$

81,812,692

 

 

$

(59,554,377

)

 

$

22,268,440

 

Issuance of common stock from at-the-market financing facility, net of associated expenses of $103,237

 

 

1,497,317

 

 

 

150

 

 

 

3,337,840

 

 

 

 

 

3,337,990

 

Stock based compensation

 

 

 

 

 

 

2,183,157

 

 

 

 

 

2,183,157

 

Net loss

 

 

 

 

 

 

 

 

(7,015,120

)

 

 

(7,015,120

)

Balance, September 30, 2018

 

 

102,723,796

 

 

$

10,275

 

 

$

87,333,689

 

 

$

(66,569,497

)

 

$

20,774,467

 

 

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,

 

 

Six Months Ended                   September 30,

 

 

2018

 

 

2017

 

 

2019

 

 

2018

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(21,785,872

)

 

$

(13,656,361

)

 

$

(9,318,066

)

 

$

(13,737,916

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation

 

 

7,108

 

 

 

3,222

 

 

 

2,591

 

 

 

4,739

 

Amortization of employees, directors and consultants stock options

 

 

6,702,085

 

 

 

6,642,428

 

 

 

3,071,023

 

 

 

4,702,426

 

Gain on remeasurement of derivative liability

 

 

 

 

 

(390,385

)

Change in fair value of warrant liability

 

 

(3,019,396

)

 

 

 

Change in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prepaid rent

 

 

(404,591

)

 

 

 

 

 

 

 

 

(465,280

)

Prepaid clinical costs

 

 

295,452

 

 

 

(634,467

)

Prepaid expenses and other assets

 

 

445,832

 

 

 

(1,566,505

)

 

 

595,713

 

 

 

200,430

 

Prepaid clinical costs

 

 

(470,146

)

 

 

 

Operating lease right-of-use asset

 

 

147,215

 

 

 

 

Accounts payable and other current liabilities

 

 

(521,841

)

 

 

765,367

 

 

 

(443,612

)

 

 

(416,287

)

Severance payable

 

 

(242,651

)

 

 

 

Accrued bonuses

 

 

(80,901

)

 

 

 

 

 

(636,638

)

 

 

(557,322

)

Net cash used in operating expenses

 

 

(16,108,326

)

 

 

(8,202,234

)

Operating lease liability

 

 

(17,325

)

 

 

 

Net cash used in operating activities

 

 

(9,565,694

)

 

 

(10,903,677

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property & equipment

 

 

(15,544

)

 

 

 

 

 

 

 

 

(15,544

)

Net cash used in investing activities

 

 

(15,544

)

 

 

 

 

 

 

 

 

(15,544

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Insurance note payments

 

 

(441,078

)

 

 

 

 

 

(597,339

)

 

 

(324,847

)

Proceeds from private placement offering of common stock and warrants,

net of issuance costs

 

 

 

 

 

2,597,100

 

Issuance of common stock from at-the-market financing

 

 

4,052,265

 

 

 

5,752,936

 

Proceeds from collection of stock subscription receivable

 

 

 

 

 

174,998

 

Proceeds from exercise of stock options

 

 

270,000

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from underwritten registered offering, net of issuance costs

 

 

11,168,773

 

 

 

3,337,990

 

Net cash provided by financing activities

 

 

3,881,187

 

 

 

8,525,034

 

 

 

10,571,434

 

 

 

3,013,143

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net (decrease)increase in cash and cash equivalents

 

 

(12,242,683

)

 

 

322,800

 

Net increase (decrease) in cash and cash equivalents

 

 

1,005,740

 

 

 

(7,906,078

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents - beginning

 

 

28,975,822

 

 

 

10,482,977

 

 

 

14,302,328

 

 

 

28,975,822

 

Cash and cash equivalents - ending

 

$

16,733,139

 

 

$

10,805,777

 

 

$

15,308,068

 

 

$

21,069,744

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental Cash Flow Information:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest

 

$

7,279

 

 

$

 

 

$

62,220

 

 

$

6,057

 

Income taxes

 

$

 

 

$

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Noncash investing and financing activities:

 

 

 

 

 

 

 

 

Cashless exercise of 301,959 warrants for 84,034 shares of common stock in 2018

 

$

 

 

$

 

Derivative liability associated with the price protection feature of shares

of common stock issued

 

$

 

 

$

11,785

 

 

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

 

 

 

5


Table of Contents

 

Tyme Technologies, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

December 31, 2018September 30, 2019

(Unaudited)

Note 1. Nature of Business

Tyme Technologies, Inc. (“TYME”) is a Delaware corporation headquartered in New York, NY, with wholly-owned subsidiaries, Tyme Inc. and Luminant Biosciences, LLC (“Luminant”) (collectively, “TYME” or the “Company”). Prior to 2014, Luminant conducted the initial research and development of the Company’s therapeutic platform. Since January 1, 2014, the majority of the Company’s research, development and other business activities have been conducted by Tyme Inc., which was incorporated in Delaware in 2013. On October 27, 2016, the Board of Directors of

TYME approved a change in fiscal year end from December 31 to March 31 of each year.

The Company is a clinical stagean emerging biotechnology company developing cancer therapeuticsmetabolism-based therapies (CMBTsTM) that are intended to be broadly effective across many tumor typesa broad range of solid tumors and havehematologic cancers, while maintaining patients’ quality of life with relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutationspathways within cancer, the Company’sTYME’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknessesrequirements to compromise its defenses, leading tocause cancer cell death through oxidative stressdeath.

The Company’s lead clinical CMBT program, SM-88 (racemetyrosine), is a novel, oral, monotherapy investigational agent that has been studied in approximately 180 patients over five years, including Phase I and exposure to the body’s natural immune system.  The Company has ongoing IND-enabled Phase II clinical trials for pancreatic, prostate and other cancers. TYME recently launched its pivotal study for SM-88 in metastaticthird-line treatment of pancreatic cancer and biomarker recurrent prostate cancer.  In September 2018, the Company announcedthrough an investigator-initiated Phase IIamendment to its ongoing TYME-88-Panc trial of SM-88 in patients with previously treated metastatic sarcoma. In addition, on October 9, 2018, the Company entered into a Clinical Research Funding and Drug Supply Agreement(Part 2). TYME also partnered with the Pancreatic Cancer Action Network Inc., a non-profit tax exempt organization (“PanCAN”) to study SM-88 in an adaptive Phase II/III trial known as Precision PromiseSM, whereby SM-88 will be includedwhich the Company believes can serve as an experimental arm in thea pivotal trial. In Precision Promise, adaptive pivotalSM-88 is starting as second-line monotherapy and could expand to first-line combination therapy with standard of care. A Phase II investigator-initiated trial platform sponsored by PanCAN.evaluating SM-88 monotherapy in late-stage sarcomas was also launched in May 2019, under the direction of principal investigator Dr. Sant Chawla and in collaboration with The Joseph Ahmed Foundation. Enrollment is expected to start the third quarter of fiscal year 2020. The Company has also recently completed and presented final data from its Phase II clinical trial for prostate cancer. All of SM-88’s current clinical programs, as well as its recently completed Phase II prostate cancer trial, study SM-88 in use with three low-dose conditioning agents: methoxsalen, phenytoin, and sirolimus. The Company is actively evaluating the expansion of its clinical programsprogram to other typescancers as SM-88 has demonstrated complete or partial responses in 15 different forms of cancer and continues to pursue the development of oncology drug candidates in addition to SM-88, its lead clinical program.with a well-tolerated safety profile.

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

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. During fiscal year 2018,In April 2019, the Company raised grossnet proceeds of approximately $32.1$11.3 million through the issuance of its common stock, par value $0.0001 per share (“Common Stock”). Most recently in March 2018, the Company raised aggregate gross proceeds of $23.3 million beforeafter underwriting discounts and commissions andbefore expenses of the offering through an underwritten publicregistered offering. Previously on November 2, 2017, the Company entered into an equity distribution agreement (“Equity(the “Equity Distribution Agreement”) with Canaccord Genuity Inc. (“Canaccord”), with respect to commence an at-the-market (“ATM”) offering (the “ATM Financing Facility”) pursuant to which the Company, may, from time to time, subject to certain rules and regulations, sellsold shares of the Company’s common stock, par value $0.0001 per share (“Common StockStock”), having an aggregate offering price up to $30.0 million, through Canaccord, as the Company’s sales agent.agent (the “Canaccord ATM”). In the year ended March 31, 2018,2019, the Company raised approximately $6.2$5.8 million in aggregate gross proceeds before commissions and expenses through the Canaccord ATM Financing Facility and paid Canaccord aggregate commissions of $0.3$0.2 million. ForThe Company did not sell any shares through the nineCanaccord ATM during the six months ended December 31, 2018, the Company raised approximately $4.2 million in aggregate gross proceeds before commissionsSeptember 30, 2019 and expenses through the ATM Financing Facility and paid Canaccord aggregate commissions of $0.1 million.  At December 31, 2018,at September 30, 2019, there remained approximately $19.6$17.9 million of availability to sell shares through the facility.Canaccord ATM. On October 25, 2018,2, 2019, TYME sent notice to Canaccord that it was terminating the Equity Distribution Agreement, effective October 12, 2019. On October 18, 2019, TYME entered into an Open Market Sale AgreementSM (the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as sales agent, pursuant to which the Company decidedmay, from time to discontinue usetime, sell shares of Common Stock through Jefferies having an aggregate offering price of up to $30.0 million (the “Jefferies ATM”) (see Note 14 - Subsequent Events). The proceeds of the ATM Financing Facilityaforementioned offerings are being used by the Company for the remainder of calendar year 2018, to be reassessed in calendar year 2019. The Company has concluded it intends to reopen the ATM Financing Facility for potential use shortly after the filing of this Form 10-Q (see Part 2. Item 5. Other Information).continued clinical studies, drug commercialization and development activities and other general corporate and operating expenses.  

For the ninesix months ended December 31, 2018,September 30, 2019, the Company had negative cash flow from operations of $16.1$9.6 million and net loss of $21.8$9.3 million, which included $6.7non-cash income of $3.0 million (related to change in fair value of non-cash expenses, primarily non-cash equity compensation expense. For the three months ended December 31, 2018, the Company had negative cash flow from operations of $5.2 millionwarrant liability) and net loss of $8.0 million, which included $2.0$3.1 million of non-cash expenses, primarily non-cash equity compensation expense. As of December 31, 2018,September 30, 2019, the Company had working capital of approximately $14.3$11.5 million.

 

6


Table of Contents

 

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.statements. This conclusion is based on the Company’s assessment of qualitative and quantitative conditions and events, considered in the 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. The Company has developed an operational plan that manages expenses and delays initiation of certain operational initiatives to focus on core programs if appropriate funding is not available.

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 our condensed consolidated financial statements and related notes contained in our Annual Report on Form 10-K for the year ended March 31, 20182019 filed with the SECSecurities and Exchange Commission (the “SEC”) on June 13, 201812, 2019 (the “2018“2019 10-K”). The condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”)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 TYMETyme Technologies, Inc. and its subsidiaries, Tyme Inc. and Luminant. 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”).

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended March 31, 20182019 included in the Company’s 20182019 10-K.

Reclassifications

The Company has reclassified certain prior period amounts to conform to the current period presentation relating to prepaid clinical costs for $1,306,225.presentation. These reclassifications have no effect on the previously reported net loss or cash flows.

Recent Accounting PronouncementsFair Value of Financial Instruments

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. In July 2018, the FASB issued both ASU 2018-10, Codification Improvements to Topic 842, Leases (“ASU 2018-10”) and ASU 2018-11, Leases (Topic 842)—Targeted Improvements (“ASU 2018-11”), which provide additional guidance or clarifications affecting certain aspects of ASU 2016-02 and certain practical expedients. Further, the updated guidance allows an additional transition method to apply the new leases standard at the adoption date, as compared to the beginning of the earliest period presented, and to recognize a cumulative-effect adjustment to the beginning balance of retained earningscarrying amounts reported in the period of adoption.  Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02, ASU 2018-10 and ASU 2018-11 are effective for annual periods beginning after December 15, 2018, and for interim periods therein, with early adoption permitted. The Company is currently evaluating the impact that the standards will have on its consolidated financial statements.  Due to the small number of lease transactions, the Company does not expect the adoption of ASU 2016-02, ASU 2018-10 and ASU 2018-11 to have a material impact on itsCompany’s consolidated financial statements for cash, accounts payable, and disclosures.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 and 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 warrants. The Company utilizes Level 3 fair value criteria to measure the fair value of the warrants.

 

7


Table of Contents

 

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 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, 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.

Recent Accounting Pronouncements

The Company adopted ASU 2016‑02, Leases (Topic 842) on April 1, 2019. For its long-term operating leases, the Company recognized an operating lease right-of-use asset and an operating lease liability on its condensed consolidated balance sheets. The lease liability is determined as the present value of future lease payments using an estimated rate of interest that the Company would pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The right-of-use asset is based on the liability adjusted for any prepaid or deferred rent. The Company determines the lease term at the commencement date by considering whether renewal options and termination options are reasonably assured of exercise.

Fixed rent expense for the Company's operating leases is recognized on a straight-line basis over the term of a lease and is included in operating expenses on the condensed consolidated statements of operations. Variable lease payments including lease operating expenses are recorded as incurred.

The Company elected the optional practical expedients to forgo applying guidance in Topic 842 to short-term leases (leases 12 or fewer months at commencement and no purchase option). The package of expedients allows an entity to forgo reassessing (1) whether a contract contains a lease, (2) classification of leases, and (3) whether capitalized costs associated with a lease meet the definition of “initial direct costs” in Topic 842.

The Company elected to use the optional transition method and therefore prior period amounts continue to be reported in accordance with the historic accounting under the previous lease guidance, ASC 840, Leases (Topic 840).

Upon adoption, the Company recognized an operating right-of use asset and operating lease liability in its condensed consolidated balance sheet of approximately $0.4 million and $0.1 million, respectively. The Company also classified prepaid rent of $0.3 million as an operating right-of-use asset upon adoption. There were no adjustments to the Company’s opening accumulated deficit upon adoption.

The impact of the adoption of Topic 842 on the condensed consolidated balance sheets as of April 1, 2019 was as follows:

 

 

April 1, 2019

 

 

 

 

 

April 1, 2019

 

 

 

Prior to Adoption

of ASC Topic 842

 

 

ASC Topic 842

Adjustment

 

 

As Adjusted

 

Prepaid rent

 

$

343,903

 

 

$

(343,903

)

 

$

 

Deferred rent

 

$

 

 

$

 

 

$

 

Operating right-of-use assets

 

$

 

 

$

447,897

 

 

$

447,897

 

Operating lease liability

 

$

 

 

$

103,994

 

 

$

103,994

 

In June 2018,July 2017, the FASB issued ASU 2018-07 which simplifiesNo. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features. These amendments simplify the accounting for share-based payments madecertain financial instruments with down round features. The amendments require companies to nonemployees so thatdisregard the accountingdown round feature when assessing whether the instrument is indexed to its own stock, for such payments is substantially the same as those made to employees, with certain exceptions. Under thispurposes of determining liability or equity classification. This ASU equity-classified share based awards to nonemployees will be measured at fair value on the grant date of the awards, entities will need to assess the probability of satisfying performance conditions if any are present, and awards will continue to be classified according to ASC 718 upon vesting which eliminates the need to reassess classification upon vesting, consistent with awards granted to employees, unless the award is modified after the service has been rendered, any other conditions necessary to earn the right to benefit from the instruments have been satisfied, and the nonemployee is no longer providing services. The guidance is effective for fiscal yearsthe Company beginning after December 15, 2018, including interim periods within those fiscal years, and early adoption is permitted.with the quarter ending June 30, 2020. The Company elected to early adopthas adopted this ASU 2018-07 effective JulyApril 1, 2018.  2019 and there was no impact on the consolidated financial statements.

8


Table of Contents

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,

 

 

Three Months Ended

September 30,

 

 

Six Months Ended                   September 30,

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Basic and diluted net loss per common share calculation:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(8,047,954

)

 

$

(5,561,265

)

 

$

(21,785,872

)

 

$

(13,656,361

)

 

$

(6,126,080

)

 

$

(7,015,120

)

 

$

(9,318,066

)

 

$

(13,737,916

)

Weighted average common shares outstanding — basic and diluted:

 

 

103,009,449

 

 

 

89,929,161

 

 

 

101,963,833

 

 

 

89,499,882

 

 

 

111,950,937

 

 

 

101,647,555

 

 

 

111,906,981

 

 

 

101,438,168

 

Net loss per share of common stock — basic and diluted

 

$

(0.08

)

 

$

(0.06

)

 

$

(0.21

)

 

$

(0.15

)

 

$

(0.05

)

 

$

(0.07

)

 

$

(0.08

)

 

$

(0.14

)

 

The Company calculates net loss per share in accordance with ASC Topic 260, “Earnings per Share.”Share” (“EPS”). 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 stockCommon 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 asanti-dilutive.

   Warrants issued in April 2019, discussed further in Note 8, participate 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 are considered to participate with common stock in the earnings of the Company incurred lossesand, therefore, the Company calculates basic and diluted EPS using the two-class method. Under the two-class method, net income for the periods then ended.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 six months ended September 30, 2019 as results of operations was a loss for both periods.

 

The following outstanding securities at December 31,September 30, 2019 and 2018 and 2017 have been excluded from the computation of diluted weighted average shares outstanding, as they are anti-dilutive:

 

 

December 31 ,

 

 

September 30,

 

 

2018

 

 

2017

 

 

2019

 

 

2018

 

Stock options

 

 

8,931,305

 

 

 

5,240,120

 

 

 

12,010,807

 

 

 

8,105,472

 

Warrants

 

 

5,283,915

 

 

 

5,625,641

 

 

 

8,937,651

 

 

 

5,615,641

 

Total

 

 

14,215,220

 

 

 

10,865,761

 

 

 

20,948,458

 

 

 

13,721,113

 

 

Note 4. Accounts Payable and Other Current Liabilities

Accounts payable (including accounts payable to a related party – see Note 9)11) and other current liabilities consisted of the following:

 

 

December 31,

2018

 

 

March 31,

2018

 

 

September 30,

2019

 

 

March 31,

2019

 

Legal

 

 

280,546

 

 

$

421,128

 

 

$

247,094

 

 

$

602,129

 

Consulting

 

 

7,996

 

 

 

37,071

 

Consultant and professional services

 

 

199,757

 

 

 

170,257

 

Accounting and auditing

 

 

181,258

 

 

 

81,652

 

 

 

210,599

 

 

 

331,119

 

Research and development

 

 

1,159,310

 

 

 

1,678,675

 

 

 

1,935,831

 

 

 

1,907,787

 

Board of Directors and Scientific Advisory

 

 

462,736

 

 

 

442,610

 

Board of Directors and Scientific Advisory Board Compensation

 

 

490,125

 

 

 

489,393

 

Other

 

 

203,404

 

 

 

155,954

 

 

 

165,290

 

 

 

191,623

 

Total

 

$

2,295,250

 

 

$

2,817,090

 

 

$

3,248,696

 

 

$

3,692,308

 

 

Note 5. Severance Payable

8On 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 September 30, 2019 and March 31, 2019 was $1.8 million and $2.1 million, respectively.

9


Table of Contents

 

Note 5.6. Fair Value of Financial InstrumentsMeasurements

ThereThe carrying amounts reported in the Company’s 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 as of December 31, 2018 and March 31, 2018.

The changes ininto 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. Other than the warrants issued in connection with the issuance of Common Stock from the underwritten registered offering that closed on April 2, 2019, the Company had no assets or liabilities classified as Level 3 as of March 31, 2019 or September 30, 2019. Transfers are calculated on values as of the derivative liability fortransfer date. There were no transfers between Levels 1, 2 and 3 during the ninesix months ended December 31, 2017 are as follows:

Fair value at March 31, 2017

 

$

378,600

 

Fair value of liability-classified anti-dilution feature

 

$

11,785

 

Change in fair value of derivative liability

 

 

(390,385

)

Fair value at December 31, 2017

 

$

 

September 30, 2019.

The fair value of the derivative liabilitywarrants is considered a Level 3 valuation and was written down to zero asdetermined using a Monte Carlo simulation model. This model incorporated several assumptions at each valuation date including: the price of September 30, 2017, as the anti-dilution provisions associated with a private placement in March 2017 expired on September 10, 2017 and the anti-dilution provisionCompany’s Common Stock on the April 2017 Private Placement (defined indate of valuation, its expected volatility, the remaining contractual term of the warrant, the risk free interest rate over the term and estimates of the probability of fundamental transactions occurring (See Note 7) expired8 for further discussion of the issuance of Common Stock from an underwritten registered offering).

The Company’s financial instruments measured at fair value on October 7, 2017, in each case with no shares issued pursuant to such provisions.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)

 

September 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liability

 

$

4,264,205

 

 

 

 

 

 

 

 

$

4,264,205

 

March 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liability

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

September 30, 2019

 

Beginning balance, March 31, 2019

 

$

 

Fair value of liability-classified warrants issued with common stock

 

 

7,283,601

 

Change in fair value of warrant liability

 

 

(3,019,396

)

Ending balance

 

$

4,264,205

 

 

Note 6.7. Debt

Insurance Note Payable

During the year ended March 31, 2018,2019, 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 $480,000$0.6 million for the policy year ending on March 31, 2019.18, 2020. As of December 31, 2018September 30, 2019 and March 31, 2018,2019, there remained a balance of $39,000$0 million and $480,000,$0.6 million, respectively, recorded to Insuranceinsurance note payable on the accompanying consolidated balance sheets.

Note 7.8. Stockholders’ Equity

Securities Purchase Agreements

In April 2017,The following summarizes the Company raised $2.7 million in gross proceeds through a private placement (“April 2017 Private Placement”) of 1,069,603 shares of Common Stock and 1,069,603 common stock purchase warrants (each, a “Warrant”). Each Warrant entitles its holder to purchase one share of common stock (each, a “Warrant Share”) at an exercise price of $3.00 per Warrant Share. The Warrants expire two years fromwarrant activity for the date of issuance and vest immediately. The warrants are included within additional paid-in capital on the statement of stockholders’ equity and will not be subject to remeasurement.six months ended September 30, 2019:

 

 

Warrant

Shares of

Common Stock

 

 

Weighted Average Exercise Price

 

Outstanding at March 31, 2019

 

 

4,499,603

 

 

$

3.42

 

Granted

 

 

8,000,000

 

 

 

2.00

 

Exercised

 

 

(78,431

)

 

 

3.00

 

Expired

 

 

(3,483,521

)

 

 

3.00

 

Outstanding at September 30, 2019

 

 

8,937,651

 

 

$

2.31

 

At December 31, 2018each of September 30, 2019 and March 31, 2018, 5,254,1482019, 8,907,884 and 5,556,107,4,469,836, respectively, of common stock purchase warrants relating to securities purchase agreements were outstanding and exercisable.

Warrants

The following summarizes theCompany has warrants to purchase its common stock warrant activity for the nine months ended December 31, 2018:outstanding as of September 30, 2019, as follows:

 

 

Warrant

Shares of

Common Stock

 

 

Weighted Average Exercise Price

 

Outstanding at March 31, 2018

 

 

5,585,874

 

 

$

3.34

 

Less: Exercised

 

 

(301,959

)

 

 

 

 

Outstanding at December 31, 2018

 

 

5,283,915

 

 

$

3.35

 

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

April 2019

 

Liability

 

 

8,000,000

 

 

 

2.00

 

 

April 2024

 

At-the-Market Financing Facility

On November 2, 2017,

During the six months ended September 30, 2019, the Company entered into the Equity Distribution Agreement with Canaccord, to commence the ATM Financing Facility pursuant to which the Company may, from time to time,did not sell shares of the Company’s Common Stock having an aggregate offering price up to $30,000,000 throughunder Canaccord as the Company’s sales agent. For the nine months ended DecemberATM. At September 30, 2019 and March 31, 2018, the Company sold 1,779,872 shares for net proceeds after commissions of $4,052,000.  At December 31, 2018,2019, there remained approximately $19,600,000$17.9 million of availability to sell shares through the facility. UnderIn the ATM Financing Facility,year ended March 31, 2019, the Company is not required to issueraised approximately $5.8 million in gross proceeds through the full available amount authorized and it may be cancelled at any time.Canaccord ATM via sale of 2,383,884 shares of Common Stock. The Company incurred $0.2 million of related costs which offset the proceeds. On October 25, 2018,2, 2019, the Company decided to discontinue use ofsent notice terminating the Canaccord ATM Financing Facility for at leasteffective October 12, 2019, and on October 18, 2019, the remainder of calendar year 2018, to be reassessed in calendar year 2019. The Company has concluded it intends to reopencommenced the use of theJefferies ATM Financing Facility shortly after the filing of this Form 10-Q (see Part 2. Item 5. Other Information)Note 14 -Subsequent Events).


 

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PublicApril 2019 - Registered Offering

In March 2018,April 2019, the Company raised approximately $23,288,000 in gross proceeds through a publiccompleted an underwritten registered offering (the “Offering”) of 10,350,0008,000,000 shares of its Common Stock.Stock at a price of $1.50 per share. The Offering was made pursuanttotal net proceeds of the offering were $11.3 million after deducting underwriter’s discounts and before expenses related to the Company’s registration statement on Form S-3 (Registration No. 333-211489), which was declared effective byOffering.

As part of the U.S. Securities and Exchange Commission on August 16, 2017, a base prospectus dated August 16, 2017 and a prospectus supplement dated March 1, 2018.

Share Registration

On December 31, 2018, TYME filed a registration statement on Form S-3 (Registration No. 333-229104) withOffering, the Securities and Exchange Commissioninvestors received warrants to register the resale of 12,093,745purchase up to 8,000,000 shares of the Company’s Common Stock at an exercise price of $2.00 per share (the “Warrants”). 

The Warrants participate with common stock on a one-for-one basis for distribution dividends or other assets of the Company.

The exercise price of the Warrants is subject to adjustment upon the occurrence of specific events, including 5,254,148 issuablestock dividends, stock splits, combinations and reclassifications of the Company’s Common Stock. Subject to certain exceptions, if the Company issues or sells Common Stock or other securities convertible into Common Stock during the term of the Warrants at a per share price less than the exercise price of the Warrants, or if the Company subsequently reduces the exercise price of equity-linked instruments that were outstanding on April 2, 2019, the exercise price of the Warrants will be reduced to such lower sale or exercise price.

The Company determined that the Warrants should be recorded as a derivative liability on the condensed consolidated balance sheet due to the Warrants’ contractual provisions requiring issuance of registered common shares upon exercise and certain price protection rights. At the issuance date, the Warrants were recorded at the fair value of warrants, currently held by our security holders named therein. This registration$7.3 million as determined using the Monte Carlo pricing simulation. The Warrants were re-measured at September 30, 2019 and the change in fair value for the three and six months ending September 30, 2019 of approximately $81 thousand and $3.0 million, respectively, was recorded as a component of other income (expense) within the condensed consolidated statement referred to above is not yet effective.  of operations.

The securities were previously issued in connection with private financings completed during calendar years 2015, 2016following table details key inputs and 2017 as well as in private transactions with certain affiliates. Securities associated with these financings had not previously been registered. The Company is not selling any securities under this registration statement and will not receive any proceeds from the sale of our securities by the selling security holders, although we could receive certain proceeds upon the exercise of outstanding warrants referred toassumptions used in the registration statement.    Monte Carlo simulation models used to estimate the fair value of the warrant liability as of September 30, 2019 and April 2, 2019, respectively:

 

 

September 30,  2019

 

 

April 2, 2019

 

Stock price

 

$

1.19

 

 

$

1.85

 

Volatility

 

 

58

%

 

 

48

%

Remaining term (years)

 

4.51

 

 

 

5.00

 

Expected dividend yield

 

 

 

 

 

 

Risk-free rate

 

 

1.55

%

 

 

2.28

%

 

Note 8.9. 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 June 30, 2019, 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 is expected to start in the third quarter of fiscal year 2020. After taking into consideration amounts already paid, the remaining estimated cost to the Company is approximately $7.0 million, subject to enrollment adjustments, and is expected to be incurred over two years.

Purchase Commitments

During the fiscal year ended March 31, 2018, theThe Company has entered into two contracts with manufacturers to supply certain components used in SM-88SM- 88 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 contracts are structured to match clinical supply needs for our ongoing trials and we expect the timing of the remaining associated payments to predominately occur during fiscal year 2020. During the three months ended September 30, 2018, the purchase commitment under one of the contracts was cancelled without penalty. During the three months ended December 31, 2018, the remaining contract was amended, increasing the contractual obligation by $338,000. Total outstanding future obligations associated with commitmentsthe contracts were $1,074,486$2.1 million at December 31, 2018, a decrease of $602,514 from $1,677,000 at March 31, 2018.

In January 2019, the Company entered into an additional contract with a manufacturer for certain components used in SM-88 with an aggregated estimated cost to the Company of $550,000.  Production and costs commenced in January 2019 and material is expected to be delivered in fiscal 2020.

Lease

In November 2018, the Company entered into a two-year lease for new office space in New Jersey with a monthly rent of $2,289 for the first six months and $4,292 for the remaining term. As per the lease agreement, the lease commencement is dependent on the performance of certain improvements by the landlord which were not completed as of December 31, 2018. As such, this lease is not accounted for in the accompanying financial statements as of December 31, 2018.September 30, 2019.

 

 

 

10

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 Legal Proceedings

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. The Company is 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.

Note 10. Leases

The Company leases office space in New York and office space and furniture in New Jersey. The New York rent obligation has been prepaid through August 30, 2020, the end of the lease. The New Jersey leases expire in February 2021.  

Total Company rent expense, including short term rentals, was approximately $79,000 and $156,000 for the three and six months ended September 30, 2019, respectively, and approximately $65,000 and $108,000 for the three and six months ended September 30, 2018, respectively.

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 6.0% to calculate the present value of its lease payments, as the implicit rates in the leases are not readily determinable.

As of September 30, 2019, 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:

 

 

September 30, 2019

 

Remainder of fiscal year 2020

 

$

32,000

 

Fiscal year 2021

 

 

58,000

 

Total remaining lease payments

 

 

90,000

 

Less: present value adjustment

 

 

(3,000

)

Total operating lease liabilities

 

 

87,000

 

Less: current portion

 

 

(60,000

)

Operating lease liabilities, net of current portion

 

$

27,000

 

 

Note 9.11. Related Party Transactions

Legal

Drinker Biddle & Reath LLP (“DBR”) has provided legal services to the Company. A partner of DBR was a member of the Company’s Board of Directors and had received, and was entitled to receive in the future, cash compensation payable to non-employee directors generally and equity compensation payable to non-employee directors generally under the Amended and Restated 2016 Stock Option Plan for Non-Employee Directors.Directors (the “2016 Director Plan”). See Note 12, Equity Incentive Plan. On September 10, 2018, the Company entered into an employment agreement with the partner and he was appointed as the Company’s Chief Legal Officer and Secretary.  He ceased to be a non-employee director on September 10, 2018 and he resigned as a member of the Board, effective September 30, 2018. On September 1, 2018, the partner resigned from the partnership of DBR and he assumed the consulting role “of Counsel” with the firm.  DuringLegal fees incurred associated with DBR were approximately $97,000 and $249,000 for the three and ninesix months ending December 31,ended September 30, 2019, respectively, and $251,000 and $651,000 for the three and six months ended September 30, 2018, and 2017, approximately $132,000, $794,000, $588,000, and $1,559,000, respectively, have been incurred as legal fees associated with DBR.respectively. At December 31, 2018September 30, 2019 and March 31, 2018,2019, the Company had approximately $181,000$104,000 and $384,000,$325,000, respectively, in accounts payable and accrued expenses payable to DBR.

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Note 10.12. Equity Incentive Plan

Stock Options

As of December 31, 2018,September 30, 2019, there was approximately $9,271,000$7.2 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 11.24 year.years. As of December 31, 2018,September 30, 2019, there were 4,657,1224,631,012 shares available for grant under the Equity Incentive Plans.

On July 30, 2018, the Board approved modifications to the vesting terms of stock options awarded to employees and the Board of Directors under theCompany’s 2015 Equity Incentive Plan on May 24, 2018 which previously vested over a four-year period (with 25% of the award vesting on the one-year anniversary of grant and the remaining vesting in pro rata quarterly increments), and were modified to vest instead on a three-year vesting schedule, vesting in pro rata quarterly increments. No other terms of these options were modified.  Due to the accelerated vesting as a result of these modifications, the Company recorded an additional $432,000 of expense during the nine months ended December 31, 2018.

2016 Director Plan.

Stock based compensation expense recognized was as follows:

 

 

Three Months Ended

December 31,

 

 

Nine Months Ended

December 31,

 

 

Three Months Ended

September 30,

 

 

Six Months Ended                   September 30,

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

General and administrative

 

$

1,316,000

 

 

$

1,400,000

 

 

$

4,548,000

 

 

$

3,300,000

 

 

$

833,000

 

 

$

1,390,000

 

 

$

1,788,000

 

 

$

3,232,000

 

Research and development

 

 

684,000

 

 

 

1,600,000

 

 

 

2,154,000

 

 

 

3,300,000

 

 

 

613,000

 

 

 

793,000

 

 

 

1,283,000

 

 

 

1,470,000

 

Total

 

$

2,000,000

 

 

$

3,000,000

 

 

$

6,702,000

 

 

$

6,600,000

 

 

$

1,446,000

 

 

$

2,183,000

 

 

$

3,071,000

 

 

$

4,702,000

 

 

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. The expected term of options granted to non-employees110 and consultants was based on the grant’s full contractual life. Effective July 1, 2018, the Company adopted ASU 2018-07 and, as such, the expected term is determined using the simplified method for options granted to non-employees and consultants.

Prior to the three months ended December 31, 2017, the Company used the full contractual term as the expected term in its Black Scholes model to estimate stock option value. The Company used the full contractual term because there was no history of exercise activity and the stock was thinly-traded on the OTC Market.

Beginning in the three months ended December 31, 2017, the Company determined the use of the simplified method was more appropriate than the full contractual term due to the increased trading volume and activity during the quarter and the increased market and demand for shares.

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Based on these factors, the Company deemed it no longer appropriate to use the full contractual term for expected life, because these changes in the business indicate the likelihood that there will be exercise activity before completion of the full contractual term.

The Company considered other methods to estimate expected term other than the simplified method. However, as noted above, there is no historical exercise data to provide a reasonable basis upon which to estimate expected term due to the limited period of time its equity shares have been publicly traded and no other refined estimate of expected life that is appropriate.2018-7.

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

 

 

December 31,

2018

 

 

December 31,

2017

 

 

September 30,

2019

 

 

September 30,

2018

 

Risk free interest rate

 

 

2.90

%

 

 

2.13

%

 

1.38% - 2.38%

 

 

 

2.86%

 

Expected volatility

 

 

74.89

%

 

 

83.41

%

 

71.14% - 76.22%

 

 

 

75.08%

 

Expected term (in years)

 

5.8 years

 

 

7.6 years

 

 

2.5 - 6

 

 

5.97

 

Dividend yield

 

 

0

%

 

 

0

%

 

 

0%

 

 

 

0%

 

 

The following is a summary of the status of the Company’s stock options as of December 31, 2018:September 30, 2019:

 

 

 

Number of

Options

 

 

Weighted

Average

Exercise

Price

 

Outstanding at March 31, 2018

 

 

5,438,072

 

 

$

5.11

 

Granted

 

 

3,643,233

 

 

 

2.65

 

Exercised

 

 

(100,000

)

 

 

2.70

 

Forfeited/Cancelled

 

 

(50,000

)

 

 

2.33

 

Outstanding at December 31, 2018

 

 

8,931,305

 

 

 

4.15

 

Options exercisable at December 31, 2018

 

 

4,893,714

 

 

 

4.90

 

 

 

Number of

Options

 

 

Weighted

Average

Exercise

Price

 

Outstanding at March 31, 2019

 

 

8,953,527

 

 

$

4.13

 

Granted

 

 

3,057,280

 

 

 

1.48

 

Outstanding at September 30, 2019

 

 

12,010,807

 

 

 

3.46

 

Options exercisable at September 30, 2019

 

 

6,851,269

 

 

 

4.43

 

 

 

 

 

 

 

Stock Options Outstanding

 

 

Stock Options Vested

 

 

 

 

 

 

Stock Options Outstanding

 

 

Stock Options Vested

 

Range of

Exercise

Price

 

Number

Outstanding

at

December 31,

2018

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Life

(Years)

 

 

Aggregate

Intrinsic

Value

 

 

Number

Vested at

December 31,

2018

 

 

Weighted

Average

Exercise

Price

 

 

Aggregate

Intrinsic

Value

 

 

Number

Outstanding at

September 30, 2019

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Life

(Years)

 

 

Aggregate

Intrinsic

Value

 

 

Number

Vested at

September 30, 2019

 

 

Weighted

Average

Exercise

Price

 

 

Aggregate

Intrinsic

Value

 

$2.25-$8.75

 

 

8,931,305

 

 

$

4.15

 

 

 

8.13

 

 

$

5,563,315

 

 

 

4,893,714

 

 

$

4.90

 

 

$

1,644,654

 

$1.04 - $8.75

 

 

12,010,807

 

 

$

3.46

 

 

 

7.87

 

 

$

17,500

 

 

 

6,851,269

 

 

$

4.43

 

 

$

1,000

 

 

The intrinsic value which is calculated as the excess of the market value as of December 31, 2018September 30, 2019 over the exercise price of the options, is approximately $5,563,000 and $1,645,000 for outstanding stock options and vested stock options, respectively.zero. The market value per share as of December 31, 2018September 30, 2019 was $3.69$1.19 as reported by the NASDAQ Capital Market.

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Table of Contents

Note 11.13. 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, 2018,September 30, 2019, the Company’s uncertain tax positions remain unchanged. Due to the full valuation allowance, none of the gross unrecognized tax benefits would affect the effective tax rate at December 31, 2018,September 30, 2019, if recognized.

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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Table of Contents

On December 22, 2017 the U.S. Tax Cuts and Jobs Act (“the Act”) was signed into legislation. The Act changed the Federal statutory tax rate to 21% for tax years beginning January 1, 2018. Because the Company has a full valuation allowance against its net deferred tax asset, the rate change has no effect on the Company’s income tax expense.

Note 12.14. Subsequent Events

In JanuaryTermination of Equity Distribution Agreement

   On October 2, 2019, 784,312 warrants were exercisedthe Company sent notice to Canaccord that it was terminating the equity distribution agreement, dated November 2, 2017, by and between the parties. Under the terms of the Equity Distribution Agreement, the termination became effective on October 12, 2019.

Initiation of a cashless basis resulting in the issuance of 151,651 shares.new ATM Facility

On January 28, 2019, a purported stockholder filed a securities lawsuit against us and our CEO and CFO.  The plaintiff purported to represent a class of stockholders for the period from March 14, 2018 through JanuaryOctober 18, 2019, inclusive. Duethe Company entered into the Sale Agreement with Jefferies, pursuant to which the Company may, from time to time, sell shares of Common Stock, having an aggregate offering price of up to $30,000,000 through Jefferies, as the Company’s sales agent. The shares will be offered and sold by the Company pursuant to its previously filed and currently effective Registration Statement on Form S-3, as amended (Reg. No. 333-211489). 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 recent status ofSale Agreement. Under the complaint,Sale Agreement, the Company is unablenot required to estimate a potential loss or range of loss, ifuse the full available amount authorized and it may, by giving notice as specified in the Sale Agreement, terminate the Sale Agreement at any at this time (see Part II, Item 1. Legal Proceedings).

.\

\\

 

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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 SEC on June 12, 2019 (the “2019 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.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 2019 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 Annual Report on2019 Form 10-K, filed on June 13, 2018, 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 lead clinical CMBT program, SM-88 (racemetyrosine), is a novel, oral, monotherapy investigational agent that has been studied in approximately 180 patients over five years, including Phase I and II clinical trials for pancreatic, prostate and other cancers. We recently launched our pivotal study for SM-88 in third-line treatment of pancreatic cancer through an amendment to our ongoing TYME-88-Panc trial (Part 2). We currently expect enrollment to begin in the fourth quarter of calendar year 2019, with anticipated enrollment completion by the end of calendar year 2020, and data expected in 2021. We currently estimate the cost of the TYME-88-Panc trial (Part 2) to range from $15 million to $20 million, with expected completion of enrollment by the end of calendar year 2020, and with such costs anticipated to extend through calendar year 2021. We also partnered with the Pancreatic Cancer Action Network (“PanCAN”) to study SM-88 in an adaptive Phase II/III trial known as Precision PromiseSM, which we believe can serve as a pivotal trial. In Precision Promise, SM-88 is starting as second-line monotherapy and could expand to first-line combination therapy with standard of care. A Phase II investigator-initiated trial evaluating SM-88 monotherapy in late-stage sarcomas was also launched in May 2019, under the direction of principal investigator Dr. Sant Chawla and in collaboration with The Joseph Ahmed Foundation. Enrollment is expected to start the third quarter of fiscal year 2020. We also recently completed and presented final data from our Phase II clinical trial in prostate cancer. All of SM-88’s current clinical programs, as well as its recently completed Phase II prostate cancer trial, study SM-88 in use with three low-dose conditioning agents: methoxsalen, phenytoin, and sirolimus. We are actively evaluating the expansion of our clinical program to other cancers, particularly prostate, breast and blood cancers, as SM-88 has demonstrated complete or partial responses in 15 different forms of cancer with a well-tolerated safety profile.

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, revenue recognition, deferred revenuewarrant 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 Form 10-K filed with the SEC on June 13, 2018 (the “2018 10-K”).2019 10-K.

OverviewDerivative Warrant Liability

We are a clinical stage biotechnology company developing cancer therapeuticsCertain freestanding common stock warrants that are intendedrelated 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 and certain price protection provisions. Warrants of this type are subject to re-measurement

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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 which cause the warrants to be broadly effective across many tumor typestreated as derivatives. Each warrant of this type is initially recorded at fair value on date of grant using the Monte Carlo simulation model, and have low toxicity profiles. Unlike targeted therapies that attemptis subsequently re-measured to regulate specific mutations within cancer,fair value at each subsequent balance sheet date. Changes in fair value of the Company’s therapeutic approach is designed to take advantagewarrant are recognized as a component of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system.  We have ongoing IND-enabled Phase II clinical trials in metastatic pancreatic cancer and biomarker recurrent prostate cancer.  In September 2018, we announced an investigator-initiated Phase II trial of SM-88 in patients with previously treated metastatic sarcoma. On October 9, 2018, the Company entered into a Clinical Research Funding and Drug Supply Agreement with the Pancreatic Cancer Action Network, Inc., a non-profit tax-exempt organization (“PanCAN”) whereby SM-88 will be included as an experimental armother income (expense) in the novel Precision Promise adaptive pivotal trial platform sponsored by PanCAN. We are actively evaluatingconsolidated statement of operations. The Company will continue to adjust the expansionliability for changes in fair value until the earlier of our clinical programs to other typesthe exercise or expiration of cancer and may also seek to pursue the development of oncology drug candidates in addition to SM-88, our lead clinical program.warrant.

Recent Developments

Consistent with our overall corporate mission of developing effective cancer therapies that can extend patients’ lives while not compromising on the quality of life gained, during the three and nine months ended December 31, 2018September 30, 2019 and subsequently, we note the following activities:

Launched Pivotal Stage of TYME-88-PANC Trial to Evaluate SM-88 for Third-Line Treatment of Patients with Metastatic Pancreatic Cancer Development Updates:

In JanuaryThe pivotal stage of the TYME-88-Panc trial was launched to evaluate the clinical benefits of our lead CMBT candidate, oral SM-88, for third-line treatment of patients with metastatic pancreatic cancer. We currently expect enrollment to begin in the fourth quarter of calendar year 2019, TYME announcedwith an enrollment target of 250 patients.

Presented Final Data at the European Society for Medical Oncology Congress 2019 (“ESMO 2019”) from SM-88 Phase II Prostate Cancer Study Demonstrating Encouraging Clinical Benefit in Patients with Recurrent Prostate Cancer

We presented final data from our Phase II trial of SM-88 in patients with non-metastatic biochemical-recurrent prostate cancer at the European Society of Medical Oncology Congress held on September 27- October 1, 2019 in Barcelona, Spain. Based on data as of September 2019, the study demonstrated that itsSM-88 had encouraging efficacy and safety outcomes for prostate cancer patients where sparing testosterone is important. The study also showed that reduction of circulating tumor cells, which we believe is emerging as an important prognostic indicator, may prove to be a better surrogate for patient outcomes than prostate specific antigens, particularly for SM-88 and other non-hormonal agents.

Presented Supporting Data at ESMO 2019 from the TYME-88-Panc Phase II Study Demonstrating Overall Survival Trends, Well Tolerated Safety, and Quality of Life Data in Patients with Advanced Pancreatic Cancer

Phase II TYME-88-Panc is a two-part, open label Phase II clinical trial, TYME-88-Panc,study evaluating SM-88 as an oral monotherapy in end-stage patients with advanced pancreatic cancer,cancer. Part 1 was designed to determine optimal doses for pivotal testing. Data and analysis from Part 1 were presented at the European Society of Medical Oncology Congress held on September 27- October 1, 2019 in Barcelona, Spain. Based on data as of April 2019, SM-88 demonstrated encouraging preliminaryoverall results and a well-tolerated safety profile.

The preliminary

Presented Positive Circulating Tumor Cell Data from TYME-88-Panc Phase II results involved 38 heavily pretreated patientsStudy in Patients with radiographically progressive metastatic pancreatic cancer who had received a median of two prior systemic therapies and had significant disease related morbidity before receiving TYME’s investigational agent. TYME-88-Panc is a two-stage Phase II study intended to determine optimal dosing and assess if early clinical benefit supported further development of SM-88 in pancreatic cancer. This study is being performed under a TYME IND with input fromAdvanced Pancreatic Cancer at the FDA prior to study initiation. As a Phase II, open-label study, the design involved comparison of two dose levels with an independent Data and Safety Monitoring Board determining continuation.American Association for Cancer Research (“AACR”) PANC 2019

 

14TYME also presented data based on information available as of April 2019 from Part 1 of TYME-88-Panc at the AACR Special Conference on Pancreatic Cancer in September 2019. The data demonstrated encouraging results and a well-tolerated safety profile.

Hematologist Susan O’Brien Joined TYME’s Medical Advisory Board

Dr. O’Brien has been a principal investigator for more than 40 funded clinical research protocols and has authored more than 800 articles in peer-reviewed journals, 30 invited articles, and numerous book chapters and abstracts. After 30 years at the MD Anderson Cancer Center, she is currently the Associate Director for Clinical Science for the Chao Family Comprehensive Cancer Center, Medical Director of the Sue and Ralph Stern Center for Cancer Clinical Trials and Research, and the Chao Family Endowed Chair for Cancer Clinical Science at the University of California Irvine. She is the hematology representative to the Southwest Oncology Group Executive Committee, and the Hematology Editor for the journal Cancer. She serves on the Medical Scientific Advisory

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Preliminary resultsBoard for the Leukemia and Lymphoma Society.

Announced New Collaboration with NYU Langone to Advance TYME’s Cancer Metabolism-Based Therapy, SM-88 to advance the development of innovative treatments for patients with metastatic cancers, including pancreatic cancer

The purpose of this academic preclinical collaboration is to help inform the first stagedevelopment of clinical therapies, focusing on identifying potential future biomarkers or combination approaches to treat cancer.

Presented Updated Data at ESMO GI 2019 from SM-88 Phase II TYME-88-Panc usingstudy Demonstrating Encouraging Overall Survival Trends in Patients with Advanced Pancreatic Cancer

TYME presented data based on information available as of January 6,April 2019 from Part 1 of TYME-88-Panc at the European Society of Medical Oncology 21st World Congress on Gastrointestinal Cancer (ESMO GI) on July 4, 2019 in Barcelona, Spain. The data demonstrated encouraging results, a well-tolerated safety profile and that 68%certain efficacy indicators correlated with greater overall survival.

Based on data available as of October 25, 2019, we analyzed patient responses reported in position emission topography (PET”) scans, which are utilized for the PET Response in Solid Tumors (“PERCIST”) criteria. 60% (12/20) of the evaluable patients (19 of 28) were alive atachieved a median follow-up of 4.3+ months (with further survival data to be evaluatedPERCIST clinical benefit rate (“CBR”), which is defined as thethose patients and study progress) and that patients also avoided significant grade 4/5 toxicities normally associated with standard of care treatments. Median survival had also not been reached on an intent-to-treat (ITT) basis, with 60% (23 of 38) of patients still alive. In addition, to assess the natural history for survival, as a comparator, in these advanced cancer patients, TYME performed a review of published studies to determine expected patient outcomes in collaboration with PanCAN.

The Company believes that these outcomes justify further development of SM-88. The results compare favorably to the analysis of 19 prospective second-line+ pancreatic cancer trials where the mean and median reported survival after progressing on second-line therapy was 3 months1based on reported historical trials. TYME-88-Panc also demonstrated monotherapy activity with SM-88 in some patients based on common measures of anti-tumor activity, including computed tomography (CT), positron emission tomography (PET), and reductions in biomarkers carcinoembryonic antigen (CEA), CA-19.9 and circulating tumor cell (CTC) burden.

As of January 6, 2019, the study reported that SM-88 was well tolerated with only 2 out of 31 (6.5%) serious adverse events deemedwho achieved at least potentially-relateda stable disease. There was a 72% reduction in the risk of death (p=0.11, HR = 0.28) as compared to the study drug. These SAEs both occurred in one patient,those patients who continued on thedid not achieve at PERCIST CBR.

TYME 18

TYME-18 is a cancer metabolism-based investigational SM-88 treatment.

The 88-Panc research results are from an investigational study. SM-88 is not approvedcancer therapy designed for the treatmentintra-tumoral delivery of patients with advanced pancreatic cancer. 

PanCAN’s Novel “Precision Promise (SM)” Adaptive Pivotal Pancreatic Cancer Trials

In calendar year 2019, PanCAN’s Precision Promise(SM) plans to launch its adaptive pivotal trials at 14 high-volume pancreatic cancer treatment centers in the United States, which represent some of the nation’s most prestigious medical institutions and oncologists in the field. Initiation of the first adaptive randomized pivotal trial evaluating SM-88 as second-line monotherapy in patients with pancreatic cancer is expected for the first half of 2019. SM-88 is expected to be evaluated in an adaptive pivotal trial as a first line combination therapy with gemcitabine (Gemzar®) and nab-paclitaxel (Abraxane®) in patients with pancreatic cancer. The primary end point of these randomized trials is expected to be overall survival.

SM-88: Phase II Prostate Cancer Trial

The Company is nearing enrollment completion of its multi-center, open label Phase II study of patients with biomarker-recurrent prostate cancer who have rising prostate specific antigen (PSA) levels and no radiographically detectable lesions. The Company will provide updated data from this trial at the 2019 ASCO Genitourinary Cancers Symposium, which will be held February 14-16, 2019.

SM-88 as Maintenance Therapy for Advanced Ewing’s Sarcoma Patients and as Salvage Therapy for Sarcoma Patients (HopES)

This is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following standard primary or palliative treatments for Ewing's sarcoma patients with a high risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. The Joseph Ahmed Foundation, a 501(c) not for profit organization is providing funding and patient support for this investigator-initiated Phase II (HopES) trial of SM-88 in patients with previously-treated metastatic sarcoma. The trial is expected to begin in the first quarter of 2019.


1

Manax et al 2019 J Clin Oncol 37, 2019 (suppl 4; abstr 226)

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TYME-18: Pre-Clinical Trial

In addition to SM-88, we have been conducting pre-clinical studies in TYME-18. This is a novel intra-tumoral delivered therapy designedmedicine to increase the permeability of cancer cells while delivering an agenta therapy that will have a selective cytotoxic effect on the tumor. TYME-18 is distinct in composition, but like SM-88, it is designedaims to decreaseenhance the viabilitysusceptibility of a cancer cells in ato the highly acidic and toxic tumor microenvironment, while minimizing the impact to normal tissues.

InAs we announced earlier in 2019, in initial preclinical xenograft mouse studies, TYME-18 was able to completely resolve over 90%90 percent (11/12 mice) of established colorectal cancer tumors in test animals within 12 days observing that 11 of 12 test animals were tumor free on day 12 of treatment. This is compared toversus an average of over 600%600 percent growth in the control animals. Additionally, there was no detected necrosis of the normal tissue surrounding the tumor site or other identified toxicities in the animals treated animals duringwith TYME-18. A subsequent study repeated the same time period. The Company plansefficacy results, with 11 of 12 TYME-18 treated mice showing complete resolution of targeted lesions. We plan to continue with the development of TYME-18 in solid tumors and plans to provide details of an IND-enabling program over the coming months.in calendar year 2020.

Animal Health

Our co-founders, Mr. Hoffman and Mr. Demurjian, hold certain intellectual property rights with respect to the treatment18


Table of cancer in non-humans. Following interest from third parties in potential animal health partnerships, a committee of independent members of our Board of Directors is leading discussions with our co-founders to obtain intellectual property rights such that the Company would have the ability to pursue cancer therapeutics in animal health.    Contents

Results of Operations

Three and NineSix Months Ended December 31, 2018September 30, 2019 Compared to Three and NineSix Months Ended December 31, 2017September 30, 2018

Net loss for the three months ended December 31, 2018September 30, 2019 was $8,048,000$6,126,000 compared to $5,561,000$7,015,000 for the three months ended December 31, 2017;September 30, 2018; and the loss for the ninesix months ended December 31, 2018September 30, 2019 was $21,786,000$9,318,000 compared to $13,656,000$13,738,000 for the ninesix months ended December 31, 2017.September 30, 2018. The increasesdecreases in losses were primarilyis due to decreased operating costs and expenses related toof $768,000 and $1,309,000 for the Phase II pancreaticthree and prostate cancer clinical trials, new key personnel hires, andsix month periods as highlighted below. The six month period loss was also reduced by the initiation$3,000,000 change in fair value of pre-clinical animal testing.warrant liability.   

Revenues

During the three and ninesix month periods ended December 31,September 30, 2019 and 2018, and 2017, the Company did not realize any revenues from operations. The Company doesWe do not anticipate recognizing any revenues until such time as (1) one of our product candidatesproducts has been approved for marketing by appropriate regulatory authorities, which is not anticipated to occur in the near future, or (2) we enter into a collaboration or licensing arrangement.arrangements, none of which is anticipated to occur in the near future.

Operating Costs and Expenses

For the three months ended December 31, 2018,September 30, 2019, operating costs and expenses totaled $8,075,000$6,245,000 compared to $5,561,000$7,013,000 for the three months ended December 31, 2017, representing an increaseSeptember 30, 2018, a decrease of $2,514,000.$768,000. Operating costs and expenses were comprised of the following:

Research and development expenses were $4,525,000$3,118,000 for the three months ended December 31, 2018,September 30, 2019, compared to $2,586,000$3,444,000 for the three months ended December 31, 2017, representing an increaseSeptember 30, 2018, a decrease of $1,939,000.$326,000. 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 $3,184,000$1,822,000 for the three months ended December 31, 2018,September 30, 2019, compared to $688,000$1,961,000 for the three months ended December 31, 2017, representing an increaseSeptember 30, 2018, a decrease of $2,496,000$139,000 between the comparable periods. The increasedecrease is mainly attributable to expandedthe timing of activity related to Part 1 of our TYME-88-Panc trial and our recently completed Phase II prostate clinical activities, primarily our pancreatic and prostate cancer clinical trials and the newly-initiated small scale pre-clinical animal testing. The study costs are anticipated to vary among future accounting periods as we continue to develop our drug candidates and seek governmental approval of such drug candidates.trial.

 

o

Salary and salary related expenses for research and development personnel were $657,000$675,000 for the three months ended December 31, 2018,September 30, 2019, compared to $298,000$653,000 for the three months ended December 31,2017,September 30, 2018, an increase of $359,000$22,000 between the comparable periods, primarily due to costs associated with an increased employee base, including the fiscal year 2019 bonus accrual.partially offset by a research and development payroll tax credit.

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o

Included in research and development expense for the three months ended December 31, 2018September 30, 2019 is $684,000$613,000 of stock based compensation expense related to stock options granted to research and development personnel compared to $1,600,000$793,000 for the three months ended December 31, 2017 representingSeptember 30, 2018, a decrease of $916,000$180,000 between comparable periods. TheThe decrease in expense is primarily due to fully-vested optionassociated with the prior year’s fully vested grants having no current year expense, partially offset by new grants issued in the three months ended December 31, 2017 that resulted in a one-time compensation expense and was not repeated in the three months ended December 31, 2018.  current year.

General and administrative expenses were $3,550,000$3,127,000 for the three months ended December 31, 2018,September 30, 2019, compared to $2,975,000$3,569,000 for the three months ended December 31, 2017, representing an increaseSeptember 30, 2018, a decrease of $575,000.$442,000. The general and administrative expenses for the respective periods include:

 

o

Stock based compensation expense related to stock options and warrants of $833,000 for the three months ended September 30, 2019 compared to $1,390,000 for the three months ended September 30, 2018, a decrease of $557,000, primarily attributable to higher prior year expense associated with modification of vesting provisions of previously-issued grants and the granting of fully-vested options to the Board of Directors during the three months ended September 30, 2018.

o

During the three months ended December 31, 2018, excluding the stock based compensation costs noted below,September 30, 2019, other general and administrative expenses were $2,234,000$2,294,000 compared to $1,575,000$2,179,000 in the same period in the prior year. The increase of approximately $659,000$115,000 primarily resulted from higher salary and salaryemployee related expenses due to costs associated with an increased employee base and the fiscal year 2019 bonus accrual,higher professional services, partially offset by lower bonus accruals (due to timing), as well as lower legal expenses.

o

Stock based compensation expense related to stock options granted was $1,316,000 for the three months ended December 31, 2018 compared to $1,400,000 for the three months ended December 31, 2017, representing a decrease of $84,000, primarily due to more options granted in prior periods fully vesting on the grant date rather than vesting over a period of time.and other professional fees.

For the ninesix months ended December 31, 2018,September 30, 2019, operating costs and expenses totaled $21,807,000$12,423,000 compared to $14,047,000$13,732,000 for the ninesix months ended December 31, 2017, representing an increaseSeptember 30, 2018, a decrease of $7,760,000.$1,309,000. Operating costs and expenses were comprised of the following:

Research and development expenses were $5,839,000 for the six months ended September 30, 2019, compared to $6,454,000 for the six months ended September 30, 2018, a decrease of $615,000. Substantially all research and

Research and development expenses were $10,979,000 for the nine months ended December 31, 2018, compared to $6,402,000 for the nine months ended December 31, 2017, representing an increase

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Table of $4,577,000. 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:Contents

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 $7,093,000$3,295,000 for the ninesix months ended December 31, 2018,September 30, 2019, compared to $2,225,000$3,899,000 for the ninesix months ended December 31, 2017, representing an increaseSeptember 30, 2018, a decrease of $4,868,000$604,000 between the comparable periods. The increasedecrease is mainly attributable to expandedthe timing of activity related to Part 1 of our TYME-88-Panc Phase II and our recently completed Phase II prostate clinical activities, primarily our new pancreatic and prostate cancer clinical trials and the pre-clinical animal testing, which was initiated in fiscal year 2019. The study costs are anticipated to vary between future accounting periods as we continue to develop our drug candidates and seek governmental approval of such drug candidates.trial.  

 

o

Salary and salary related expenses for research and development personnel were $1,718,000$1,254,000 for the ninesix months ended December 31, 2018,September 30, 2019, compared to $849,000$1,030,000 for the ninesix months ended December 31, 2017, representingSeptember 30, 2018, an increase of $869,000$224,000 between the comparable periods, primarily due to costs associated with an increased employee base, partially offset by a research and the fiscal year 2019 bonus accrual.development payroll tax credit.

 

o

Included in research and development expense for the ninesix months ended December 31, 2018September 30, 2019 is $2,154,000$1,283,000 of stock based compensation expense related to stock options granted to research and development personnel compared to $3,300,000$1,470,000 for the ninesix months ended December 31, 2017 representingSeptember 30, 2018, a decrease of $1,146,000$187,000 between comparable periods. TheThe decrease in expense is due to fully-vested optionassociated with the prior year’s fully vested grants in the nine months ended December 31, 2017 that resulted in a one-time compensation expense. This decrease washaving no current year expense, partially offset by the amortization of expensenew grants issued in the nine months ended December 31, 2018 related to options granted to employees during fiscal year 2019.current year.

General and administrative expenses were $10,828,000$6,584,000 for the ninesix months ended December 31, 2018,September 30, 2019, compared to $7,644,000$7,278,000 for the ninesix months ended December 31, 2017, representing an increaseSeptember 30, 2018, a decrease of $3,184,000.$694,000. The general and administrative expenses for the respective periods include:

 

o

Stock based compensation expense related to stock options was $1,788,000 for the six months ended September 30, 2019 compared to $3,232,000 for the six months ended September 30, 2018, a decrease of $1,444,000, primarily due to higher expenses in the prior year associated with modification of vesting provisions of previously-issued grants and the granting of fully-vested options to the Board of Directors in the six months ended September 30, 2018.

o

During the ninesix months ended December 31, 2018, excluding the stock based compensation costs noted below,September 30, 2019, other general and administrative expenses were $6,280,000$4,796,000 compared to $4,344,000$4,046,000 in the same period in the prior year. The increase of approximately $1,936,000$750,000 primarily resulted from increases in salary and salary related expenses, due tohigher employee-related costs associated with anour increased employee base, higher professional servicesfees, and insurance,warrant issuance costs. These costs were partially offset by lower legal expenses.

o

Stock based compensation expense related to stock options granted was $4,548,000 for the nine months ended December 31, 2018 compared to $3,300,000 for the nine months ended December 31, 2017, representing an increase of $1,248,000, primarily attributable to the modification of vesting provisions of grants previously issued, the issuance of options to members of the Board of Directors, employees, and management in fiscal year 2019, over the comparable periods, offset by options which became fully vested in fiscal year 2018.accounting and auditing services.

Other income (expense)

17For the three and six months ended September 30, 2019, the Company had $81,000 and $3,019,000 of income relating to the change in fair value of the warrant liability during the period, compared to $0 for the three and six months ended September 30, 2018.

For the three and six months ended September 30, 2019, the Company had interest income on cash accounts of $67,000 and $148,000 compared to $0 for both the three and six months ended September 30, 2018.

For the three and six months ended September 30, 2019, the Company had interest expense of $29,000 and $62,000 primarily related to the amortization of the severance payable discount, compared to $2,000 and $6,000 for the three and six months ended September 30, 2018.

Adjusted Net Loss and Adjusted Net Loss per Share

   Adjusted net loss for the three months ended September 30, 2019 was $4,761,000 or $0.04 per share compared to $4,832,000 or $0.05 per share for the three months ended September 30, 2018. Adjusted net loss for the six-month period ended September 30, 2019 was $9,266,000 or $0.08 per share compared to $9,036,000 or $0.09 per share for the same period in the prior year, after adjusting for change in fair value of warrant liability and amortization of employees, directors and consultants stock options. 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 and amortization of employees, directors and consultants stock based compensation. 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

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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 September 30,

 

 

Six Months Ended September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net loss (GAAP)

 

$

(6,126,000

)

 

$

(7,015,000

)

 

$

(9,318,000

)

 

$

(13,738,000

)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of warrant liability

 

 

(81,000

)

 

 

 

 

 

(3,019,000

)

 

 

 

Amortization of employees, directors and consultants stock options

 

 

1,446,000

 

 

 

2,183,000

 

 

 

3,071,000

 

 

 

4,702,000

 

Adjusted net loss (non-GAAP)

 

$

(4,761,000

)

 

$

(4,832,000

)

 

$

(9,266,000

)

 

$

(9,036,000

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30,

 

 

Six Months Ended September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net loss per share (GAAP)

 

$

(0.05

)

 

$

(0.07

)

 

$

(0.08

)

 

$

(0.14

)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of warrant liability

 

*

 

 

 

 

 

 

(0.03

)

 

 

 

Amortization of employees, directors and consultants stock options

 

 

0.01

 

 

 

0.02

 

 

 

0.03

 

 

 

0.05

 

Adjusted net loss per share (non-GAAP)

 

$

(0.04

)

 

$

(0.05

)

 

$

(0.08

)

 

$

(0.09

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

      * 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 six months ended September 30, 2019 and 2018 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:

   a)   The warrants issued as part of an equity offering on April 2, 2019 are 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 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.

   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.

21


Table of Contents

 

Other income (expense)

For the three months ended December 31, 2018, the Company had other income of $29,000. The other income was attributed to interest income earned on bank deposits. For the three months ended December 31, 2017, the Company had other income of $0.    

For the nine months ended December 31, 2018, the Company had other income of $29,000 compared to $390,000 for the nine months ended December 31, 2017. Other income for the nine months ended December 31, 2017 was attributed to the remeasurement of the derivative liability relating to anti-dilution provisions of two private placement offerings in March 2017 and April 2017.  The anti-dilution provisions expired in September 2017.  

Liquidity and Capital Resources

At December 31, 2018,September 30, 2019, we had cash and cash equivalents of $16,733,000,$15.3 million, working capital of $14,271,000,$11.5 million, and stockholders’ equity of $15,710,000.$7.3 million.

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

 

 

Nine Months Ended

December 31,

 

 

Six Months Ended September 30,

 

 

2018

 

 

2017

 

 

2019

 

 

2018

 

Net cash (used in) provided by operating activities

 

$

(16,108,000

)

 

$

(8,202,000

)

 

$

(9,566,000

)

 

$

(10,904,000

)

Net cash (used in) provided by investing activities

 

 

(16,000

)

 

 

 

 

 

 

 

 

(16,000

)

Net cash (used in) provided by financing activities

 

 

3,881,000

 

 

 

8,525,000

 

 

 

10,571,000

 

 

 

3,013,000

 

Operating Activities

Our cash used in operating activities in the ninesix months ended December 31, 2018September 30, 2019 totaled $16,108,000,$9.6 million, which is the sum of (i) our net loss of $21,786,000, less$9.3 million, adjusted for non-cash income of $3.0 million (related to change in fair value of warrant liability) and non-cash expenses totaling $6,710,000$3.0 million (principally amortization of stock-based compensation), and (ii) changes in operating assets and liabilities of $1,032,000,$0.3 million, primarily due to increased prepaid clinical costspayment of $470,000accrued 2019 bonuses for $1.5 million in the first quarter of fiscal year 2020, which was offset by the accrual of $859,000 for the current fiscal year with the remainder comprised of changes in asset and decreases in accounts payable and other liabilities of $522,000.liability accounts.

Our cash used in operating activities in the ninesix months ended December 31, 2017September 30, 2018 totaled $8,202,000,$10.9 million, which is the sum of (i) our net loss of $13,656,000, less$13.7 million, adjusted for non-cash expenses totaling $6,255,000$4.7 million (principally amortization of stock-based compensation)compensation, including immediately vested options granted to the Board of Directors), and (ii) changes in operating assets and liabilities of $801,000.$1.9 million, primarily due to the payment of accrued 2018 bonuses for $1.2 million in the first quarter of fiscal year 2019, which was offset by the accrual of $691,000 for the year ended March 31, 2019. Additionally, prepaid clinical costs increased $634,000 and accounts payable and other liabilities decreased $416,000.

Investing Activities

No cash was used in investing activities for the six months ended September 30, 2019.

During the ninesix months ended December 31,September 30, 2018, our investing activities consisted of purchases of $16,000 of propertymachinery and equipment.

No cash was used in investing activities for the nine months ended December 31, 2017.

Financing Activities

During the nine months ended December 31, 2018, there was $3,881,000 of financing activities, consisting of $4,052,000 of proceeds from the issuance of Common Stock from the Company’s ATM Financing Facility pursuant to the Equity Distribution Agreement, dated November 2, 2017 (the “Equity Distribution Agreement”), by and between the Company and Canaccord Genuity LLC (“Canaccord”), proceeds from the exercise of stock options of $270,000 and offset by insurance note payments of $441,000.

During the nine months ended December 31, 2017, our financing activities consisted of the following:

In April 2017,2019, the Company raised $2,727,000 in gross proceeds$11.3 million after underwriting discounts and before offering expenses through a private placement (“April 2017 Private Placement”)an underwritten registered offering of 1,069,6038,000,000 shares of our common stock, $0.0001 par value per share (“Common StockStock”), and 1,069,6038,000,000 common stock purchase warrants (each a “Warrant”). Each Warrant entitles its holder to purchase one share of Common Stock (each, a “Warrant Share”) at an exercise price of $3.00$2.00 per Warrant Share. The warrantsWarrants expire twofive years from the date of issuance and vest immediately. The warrants are included within additional paid-in capitalrecorded as a derivative liability on the statement of stockholders’ equitybalance sheet and will not be subject to remeasurement. The Company collected approximately $175,000 of subscription receivables in the quarter ended June 30, 2017.

 

18


Table   During the six months ended September 30, 2019, the Company made payments of Contents$597,000 on the insurance note payable related to premiums for its Director and Officer liability insurance coverage.

 

Liquidity and Capital Requirements Outlook

During fiscal year 2018, we raised net proceeds of approximately $28.1 million through the issuance of our Common Stock. Most recently in March 2018, we raised aggregate net proceeds of $21.9 million after underwriting discounts and commissions and expenses of the offering through an underwritten public offering. Previously, on November 2, 2017, the Company entered into the Equity Distribution Agreement with Canaccord, to commence the ATM Financing Facility pursuant to which the Company may, from time to time, subject to certain rules and regulations, sell shares of the Company’s Common Stock, having an aggregate offering price up to $30.0 million, through Canaccord as the Company’s sales agent. In the year ended March 31, 2018, the Company raised approximately $6.2 million in aggregate gross proceeds before commissions and expenses through the ATM Financing Facility and incurred related costs, including commissions to Canaccord, of approximately $0.3 million. During fiscal year 2019, for the three and nine months ended December 31, 2018, the Company sold 282,555 and 1,779,872 shares of Common Stock and received net proceeds after commissions of $0.7 million and $4.0 million, respectively. The Company paid commissions to Canaccord of $0.022 million and $0.125 million during the three and nine months ended December 31, 2018. The Company is using the net proceeds raised through the ATM Financing Facility for general corporate purposes and to fund its operating activities. On October 25, 2018, the Company decided to discontinue use of its at-the-market (“ATM”) financing facility for at least the remainder of calendar year 2018, to be reassessed in calendar year 2019. The Company has concluded it intends to reopen the ATM Financing Facility for potential use shortly after the filing of this Form 10-Q (see Part 2. Item 5. Other Information).

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 significantSignificant funding needs continue towill be needed in connection with conducting immediatecompleting Phase II clinical trials of our SM-88 drug candidate for pancreatic cancer and prostate cancer, participating in the Precision Promise adaptive Phase II/III pancreatic trial platform sponsored by PanCAN, participating in an investor-initiatedinvestigator-initiated clinical trial of SM-88 in sarcoma, and conducting additional or related studies and investigations, including small-scale pre-clinical studies related to the mechanism of action of our lead clinical program SM-88 and other potential drug candidates. The Company’s financing needs also relate to expenses associated with initiation of Part 2 of its participationTYME-88-Panc trial SM-88, which will be a pivotal trial for patients with third line pancreatic cancer. The SM-88 pivotal trial to study SM-88 for third-line treatment of pancreatic cancer initiated in theSeptember 2019. The Precision Promise adaptive pivotal pancreatic trial platform sponsored by PanCAN. Precision Promise

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Table of Contents

is expected to launch in the first halfthird quarter of fiscal year 2020. We currently estimate the cost of the TYME-88-Panc trial (Part 2) to range from $15 million and $20 million, with expected completion of enrollment by the end of calendar year 2019. Primarily as a result2020, and with such costs anticipated to extend through calendar year 2021. The greater scale of its active clinicalthese trials is expected to lead to increased costs, including providing SM-88 for use by the launch of the Precision Promise trial, and the pause in enrollment and initiation of Stage 2 of the Company’s ongoing- Phase II trial in pancreatic cancer, the Company currently anticipates that its quarterly cash usage, or “cash burn rate”, will approximate $5 million for the quarter ending March 31, 2019. The burn rate for the quarter ending December 31, 2018 was $5.3 million, $0.6 million higher than the previous quarter due to higher clinical expenses, including $1 million payment to PanCAN for initial program set up costs.  Ifsubjects. Furthermore, if we determine to move beyond the pre-clinical stage for any of our pre-clinical trials or if we amend Stage 2 of the Company’s ongoing Phase II trial in pancreatic cancer and proceed with Phase II or significantly expand currently active clinical trials, our liquidity requirements will be increased.

As

Primarily as a result of Decemberits active clinical trials, the expected launch of the Precision Promise trial, and the initiation of Part 2 of the Company’s ongoing TYME-88-PANC trial, as well as other business developments, the Company currently anticipates that its quarterly cash usage, or “cash burn rate”, to average between $5.0 million and $6.0 million per quarter for fiscal year 2020.

During the six months ended September 30, 2018, there was $3,013,000 of financing activities, consisting of $3,338,000 of proceeds from the issuance of Common Stock from the Company’s at-the-market offering pursuant to the Equity Distribution Agreement, dated November 2, 2017 (the “Equity Distribution Agreement”), by and between the Company and Canaccord Genuity LLC (“Canaccord”), and offset by insurance note payments.

Liquidity and Capital Requirements Outlook

The Company has historically funded its operations primarily through equity offerings of its Common Stock. Previously, on November 2, 2017, the Company entered into the Equity Distribution Agreement with Canaccord, to commence an at-the-market offering pursuant to which the Company, from time to time, sold shares of the Company’s Common Stock, having an aggregate offering price up to $30,000,000, through Canaccord, as the Company’s sales agent (the “Canaccord ATM”). In the year ended March 31, 2018, the Company hasraised approximately $6,152,000 in gross proceeds through the Canaccord ATM.  During the fiscal year ended March 31, 2019, the Company raised approximately $5,844,000 in gross proceeds from the Canaccord ATM. At September 30, 2019, there remained approximately $17.9 million of availability to sell shares through the Canaccord ATM. On October 2, 2019, TYME sent notice to Canaccord that it was terminating the Equity Distribution Agreement, effective October 12, 2019. On October 18, 2019, TYME entered into an Open Market Sale AgreementSM (the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as sales agent, pursuant to which the Company may, from time to time, sell shares of the Company’s Common Stock, having an aggregate offering price of up to $30,000,000(the “Jefferies ATM”). See Item 1. Note 14 - Subsequent Events.

As further discussed under “Financing Activities” above, in April 2019, the Company raised approximately $11.3 million, net of underwriting discounts and before offering expenses, through an underwritten registered offering of 8,000,000 shares of our Common Stock and 8,000,000 common stock purchase warrants.

As of September 30, 2019, the Company had cash on hand of approximately $16.7$15.3 million and working capital of approximately $14.3$11.5 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. The Company has developed an operational plan that manages expenses and delays initiation of certain operational initiatives to focus on core programs if appropriate funding is not available.

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, including ourthe Jefferies ATM, Financing Facility, option exercises, and partnerships, collaborations and/or collaborations.royalty arrangements. The demand for the equity and debt of 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.

 

1923


Table of Contents

 

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.

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.

Our management,

Evaluation of Disclosure Controls and Procedures

Under the supervision of and with the participation of management, including our Chief Executive Officerprincipal executive officer and Chief Financial Officer, hasprincipal financial officer, we evaluated the effectiveness of our disclosure controls and procedures, (asas 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 the end of the period covered by this Quarterly Report on Form 10-Q.September 30, 2019. Based on such evaluation our principal executive officer and in light of the material weaknesses described below identified by Messrs. Hoffman and Taylor disclosed in our Annual Report on Form 10-K for the year ended March 31, 2018, our Chief Executive Officer and Chief Financial Officer haveprincipal financial officer concluded that as of December 31, 2018, our disclosure controls and procedures were not effective. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

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

The matters involving internal controls and procedures that our management considered to be material weaknesses were as follows:

Ineffective information technology general controls (“ITGC”) and application controls within the Company’s general ledger system, disbursement solution and payroll solution, including:

o

Insufficient segregation of duties;

o

Lack of review controls over activity by administrative users;

o

Validation of information and reports used by management.

Ineffective controls over period end financial disclosure and reporting processes, including:

o

Lack of a formal closing process;

o

Lack of communication with non-finance business personnel and sufficient review of business activities, including significant transactions, to determine proper accounting and reporting;

o

Insufficient management oversight of outside accounting and financial reporting advisory firm.

Lack of sufficient and timely review over account balances, including inadequate support and description of reconciling items.

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Table of Contents

 

Management is implementing certain practices and procedures to address the foregoing material weaknesses and significant deficiencies with plans to complete the remediation of the foregoing deficiencies in the future. Such remediation efforts are discussed below under “Management’s Remediation Initiatives.”

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

Management’s Remediation Initiatives

Management is in the process of implementing certain practices and procedures to address the foregoing material weaknesses with plans to complete the remediation of the foregoing deficiencies in the future. Such remediation efforts are discussed below.

Management’s Actions and Plans to Remediate Material Weaknesses:

Management believes that progress has been made during the quarter ended December 31, 2018, and through the date of this report, to remediate the underlying causes of the material weaknesses in internal control over financial reporting and has taken the following steps to remediate such material weaknesses:

We have a detailed remediation plan in place with target deadlines for completion.

We have increased the frequency of our periodic meetings with our outside accounting and financial reporting advisory firm and enhanced the discussion of operating results, significant transactions, internal controls, conclusions reached regarding technical accounting matters and financial reporting disclosures.

We have evaluated the control functionality within the disbursement, general ledger, and human resources systems that provide key control functionality. Within these systems, we have modified and improved security administration and other access level and systemic controls. Where this is inherently limited, we have designed compensating controls outside such system.

We have established a disclosure committee that includes both finance and non-finance representatives responsible for ensuring the accuracy, completeness, timeliness and consistency of public disclosure.

We have added resources to the finance function and continue to establish processes that segregate duties consistent with control objectives.  

We have enhanced and formalized our financial close process including more and improved analytical reviews.

We have improved processes that allow for proactive review of significant transactions, including the creation of a centralized repository for significant agreements.

Management plans to further remediate the material weaknesses as follows:

We continue to formalize processes and policies, including processes and policies for IT general controls. Where necessary, we will implement relevant key controls.

We will establish a periodic review by financial management of account balance detail, journal entry posting activity and account reconciling items.

We are modifying and creating improved reports that are relied upon in making financial and business decisions.

The material weaknesses will not be considered remediated until the applicable remedial controls operate for a sufficient period and management has concluded, through testing, that the controls are operating effectively.

Changes in Internal Control over Financial Reporting

Other than as described above under “Management Remediation Initiatives”, there have been

There were no changes in our internal control over financial reporting that occurred during our three monthsthe quarter ended December 31, 2018September 30, 2019, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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Table of Contents

 

PART II – OTHER INFORMATION

Item 1.

Legal Proceedings.

On January 28, 2019,We are not currently a purported stockholder filed a securities lawsuitparty to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us andthat we believe could have a material adverse effect on us, our CEO and CFO.  The plaintiff purported to represent a class of stockholders for the period from March 14, 2018 through January 18, 2019, inclusive. The case is styled Canas v. Tyme Technologies Inc., et al., and was filed in the U.S. District Court for the Southern District of New York. The complaint asserts claims under Securities Exchange Act Section 10(b) (and Rule 10b-5) against all defendants and Section 20(a) control person liability against the individual defendants. In general, the plaintiff’s allegations focus on events during the period from March 14, 2018 through January 18, 2019 and contends that the defendants provided inadequatebusiness, operating results or misleading disclosure at various times during the period concerning its Phase II clinical trial for SM-88 in pancreatic cancer. The plaintiff seeks a determination that the proceeding may be maintained as a class action and certification of the plaintiff as class representative. The plaintiff also seeks damages on behalf of the class, as well as interest, fees and other costs, but does not provide an estimate of damages in the complaint. Due to the recent status of the complaint, the Company is unable to estimate a potential loss or range of loss, if any, at this time. We intend to defend the lawsuit vigorously.financial condition.

Item 1A.Risk Factors.

Our Annual Report on Form 10-K for the year ended March 31, 20182019 includes a detailed discussion of our risk factors.  AtExcept as set forth below, at the time of this filing, in additionthere have been no material changes to the risk factors that were included in the Form 10-K,10-K.

We will require substantial additional funding, which may require us to agree to restrictions on our operations or may not be available to us on acceptable terms or at all and, if not available, may require us to delay, scale back or cease our drug development programs or operations.

In addition to SM-88, we seek to advance multiple drug candidates through our research and clinical development process. The completion of the following should be carefully considered.

Health care reform measures could hinder or preventdevelopment and the commercial successpotential commercialization of SM-88 or any other drug product we may develop.

In the United States, there have been and we expect therecandidate will continue to be, a number of legislative and regulatory changes to the healthcare system that could affect ourrequire substantial funds. Our future revenue and profitability and the future revenue and profitability of our potential customers. Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system,financing requirements will depend on many factors, some of which are intended to contain or reduce beyond our control, which include, but are not limited to:

the number and characteristics of drug candidates that we pursue;

the scope, progress, timing, cost and results of nonclinical and clinical development and research;

the costs, timing and outcome of medical productsour seeking and services. For example, on December 22, 2017, President Trump signed into law new federal tax legislation that includes a provision repealing, effective January 1, 2019, obtaining U.S. Food & Drug Administration, European Medicines Agency and other non-U.S. regulatory approvals;

the tax-based shared responsibility payment imposed by the ACA on certain individuals who failcosts associated with manufacturing SM-88, as well as other potential drug candidates, and establishing sales, marketing and distribution capabilities;

our ability to maintain, qualifying health coverage for allexpand and defend the scope of our intellectual property (“IP”) portfolio, including the amount and timing of any payments we may be required to make in connection with the licensing, filing, defense and enforcement of any patents or part of a year that is commonly referred to as the “individual mandate.” Since the enactment of the Tax Act, there have been additional amendments to certain provisions of the ACA, and we expect the current Trump administration may continue to seek to modify, repeal, or otherwise invalidate all, or certain provisions of, the ACA. It is uncertain other IP rights;

the extent to which any such changes may impact we acquire or in-license other products or technologies;

our business or financial condition. need and ability to increase our overall capacity and hire additional administrative, managerial, scientific, operational and medical personnel

Additionally, on May 30, 2018, the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Acteffect of 2017 (the “Right to Try Act”), was signed into law. The law, among other things, provides a federal framework for certain patients with life-threatening diseases to access certain investigational new drugcompeting products that have completedmay limit market penetration of SM-88 and any other drug candidates we may develop;

the amount and timing of revenues, if any, we receive from commercial sales of SM-88 or any other drug candidates for which we receive marketing approval in the future; and

our need to implement additional internal systems and infrastructure, including financial and reporting systems; and the economic and other terms, timing of and ultimate success of any future collaboration, licensing or other arrangements, including the timing of achievement of milestones and receipt of any milestone or royalty payments under such agreements.

Until we can generate sufficient drug and royalty revenue to finance our cash requirements, which we may never achieve, we expect to finance future cash needs through a Phase I clinical trialcombination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, royalty agreements and that are undergoing investigationother marketing and distribution arrangements. The demand for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trialsthe equity and without obtaining FDA permission underdebt of biotechnology companies like ours is dependent upon many factors, including the FDA expanded access program. There is no obligation for a drug manufacturer to make its drug productsgeneral state of the financial markets. During times of extreme market volatility, capital may not be available on favorable terms, if at all. Any additional fundraising efforts may divert management’s attention from day-to-day activities and financing may not be available to eligible patientsus when we need it or financings may not be available on favorable terms. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances royalty rights or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our drug candidates, technologies, future revenue streams or research programs and/or grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, as a resultwe expect to do, the ownership interests of our then existing stockholders could be diluted and the Rightterms of these securities may include liquidation or other preferences that adversely affect stockholders’ rights.

While we regularly consider options and opportunities to Try Act.

There have been,raise additional capital and likelyobtain financing and will continue to seek capital through a number of means, there can be legislativeno assurance that additional financing will be available on acceptable terms, if at all, and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

our ability to set a price we believe is fair for our drug products;

our ability to generate revenue and achieve or maintain profitability; and

the availability of capital.

 

25

 

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Table of Contents

 

The recently passed comprehensive tax reform bill could adversely affect our businessnegotiating position in capital generating efforts may worsen as existing resources are used. Additionally, if we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain adequate financing when needed and financial condition.

The recently enacted Tax Cuts and Jobs Acton favorable terms, we may have to delay, reduce the scope of 2017 (the “Tax Act”) federal income tax law, among other things, contains significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%, limitation of the tax deduction for interest expense to 30% of adjusted earnings (except for certain small businesses), limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks,or suspend one time taxation of offshore earnings at reduced rates regardless of whether they are repatriated, elimination of U.S. tax on foreign earnings (subject to certain important exceptions), immediate deductions for certain new investments instead of deductions for depreciation expense over time, and modifying or repealing many business deductions and credits (including reducing the business tax credit for certain clinical testing expenses incurred in the testing of certain drugs for rare diseases or conditions). Notwithstanding the reduction in the corporate income tax rate, the overall impact of the new federal tax law is uncertain and our business and financial condition could be adversely affected. In addition, it is unknown if and to what extent various states will conform to the newly enacted federal tax law. The impact of this tax reform on holdersmore of our common stock is likewise uncertainclinical trials or research and could be adverse. We urge our stockholders to consult with their legal and tax advisors with respect to this legislation and the potential tax consequences of investing in or holding our common stock.

Use of social media could give rise to liability, breaches of data security, or reputational harm.

We and our employees use social media to communicate externally. There is risk that the use of social media by usdevelopment programs or our employees to communicate about our product candidates or business may give rise to liability, lead to the loss of trade secrets or other intellectual property, or result in public exposure of personal information of our employees, clinical trial patients, customers, and others. Furthermore, negative posts or comments about us or our product candidates in social media could seriously damage our reputation, brand image, and goodwill. Any of these events could have a material adverse effect on our business, prospects, operating results, and financial condition and could adversely affect the price of our common stock.commercialization efforts.

 

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.

As previously disclosed, The Company decided to discontinue use of its ATM Financing Facility on October 25, 2018 for at least the remainder of calendar year 2018 and to reassess the use of the ATM Facility to sell common stock in calendar year 2019.  After such review, the Company intends to reopen the ATM Financing Facility for potential use.  Sales of Common Stock under the facility could begin as early as two business days after the filing of this Form 10-Q.None.

  

    

 

 

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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, 20182018. (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

 

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.)

 

 

 

 

 

  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 Chief Executive Officer and ChiefPrincipal 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.

 

Management contract or compensatory plan or arrangement.

* 

Filed herewith.

**

Furnished herewith.

 

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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 11,November 4, 2019

 

TYME TECHNOLOGIES, INC.

 

 

By:

 

/s/ Steve Hoffman

 

 

Steve Hoffman

 

 

Chief Executive Officer

(Principal Executive Officer)

 

 

By:

 

/s/ Ben R. Taylor

 

 

Ben R. Taylor

 

 

President and Chief Financial Officer

 

 

(Principal Financial Officer)

 

By:

 

/s/ Barbara Galaini

 

 

Barbara Galaini

 

 

Corporate Controller

(Principal Accounting Officer)

 

 

 

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