tyme-10q_20220630.htm

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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:

June 30, 2022

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

For the transition period from to

Commission File Number: 001-38169

TYME TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

Delaware

45-3864597

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

1 Pluckemin Way – Suite 103

Bedminster, New Jersey 07921

(Address of principal executive offices)

(Zip Code)

(212) 461-2315

(Registrant’s telephone number, including area code)

Not Applicable

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

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


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value	TYME	Nasdaq Capital Market

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

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

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

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

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

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

The number of shares outstanding of the registrant’s common stock on August 4, 2022 was 172,206,894.

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TABLE OF CONTENTS

		Page

Special Note Regarding Forward-Looking Statements		1

General		3

	PART I- FINANCIAL INFORMATION
Item 1.	Financial Statements.	4

	Condensed Consolidated Balance Sheets as of June 30, 2022 (unaudited) and March 31, 2022.	4

	Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the three months ended June 30, 2022 and 2021.	5

	Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the three months ended June 30, 2022 and 2021.	6

	Condensed Consolidated Statements of Cash Flows (unaudited) for the three months ended June 30, 2022 and 2021.	7

	Notes to Unaudited Condensed Consolidated Financial Statements.	8

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations.	21

Item 3.	Quantitative and Qualitative Disclosures About Market Risk.	31

Item 4.	Controls and Procedures.	31

	PART II- OTHER INFORMATION

Item 1.	Legal Proceedings.	32

Item 1A.	Risk Factors.	32

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds.	34

Item 3.	Defaults Upon Senior Securities.	34

Item 4.	Mine Safety Disclosures.	34

Item 5.	Other Information.	34

Item 6.	Exhibits.	35

SIGNATURES		36

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements in this Quarterly Report on Form 10-Q are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. All statements contained in this Quarterly Report on Form 10-Q other than statements of historical facts, including statements regarding our future results of operations and financial position, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements within this report include, without limitation, statements regarding the Company’s potential merger transaction with Syros Pharmaceuticals, Inc. (“Syros”), regarding the Company’s exploration of strategic options, and regarding our drug candidates and technologies (including SM-88 and TYME- 18) and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned preclinical or clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates. The words “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” “anticipates,” and similar expressions (including their use in the negative) are intended to identify forward-looking statements. Forward-looking statements can also be identified by discussions of future matters such as: the effect of the COVID-19 pandemic and the associated impact on the national and global economy as well as impacts on the Company's ongoing clinical trials and ability to analyze data from those trials; the cost of development and potential commercialization of our lead drug candidate and of other new product candidates; expected releases of interim or final data from our clinical trials; possible collaborations; and the timing, scope, status, objectives of our ongoing and planned trials; the success of management transitions and strategic initiatives; and other statements that are not historical. The forward-looking statements contained in this report are based on management’s current expectations and projections which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include but are not limited to: the risk that the conditions to the closing of the proposed transaction with Syros are not satisfied, including the failure to obtain stockholder approval for the transactions or to complete the Syros financing in a timely manner or at all; uncertainties as to the timing of the consummation of the transactions and the ability of each of Syros and the Company to consummate the transaction; risks related to the Company’s continued listing on the Nasdaq Capital Market until closing of the proposed transactions; risks related to Syros’ and the Company’s ability to correctly estimate their respective operating expenses and expenses associated with the transactions, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company’s cash resources; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; the outcomes of any litigation, regulatory proceedings, inquiries, books and records demands or investigations to which the Company may be subject; the severity, duration, and economic impact of the COVID-19 pandemic; our ability to achieve the intended benefits of our strategic initiatives; that certain information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply, and in the ability to achieve adequate start and completion dates, as well as uncertainties in clinical trial design and patient enrollment, dropout or discontinuation rates; the possibility of unfavorable study results, including unfavorable new clinical data, additional analyses of existing data and results that may lead to a discontinuation of trials; 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 or analyses and may not support further clinical development; and 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 or other drug candidates 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 or other drug candidates; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; the ability of TYME to maintain compliance with Nasdaq listing standards; and the factors described in the section captioned “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended March 31, 2022, filed with the U.S. Securities and Exchange Commission on May 25, 2022, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission (available at www.sec.gov).

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

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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.

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GENERAL

Unless the context otherwise requires, all references in this Quarterly Report on Form 10-Q to the “Company,” “TYME,” “we,” “us” or “our” refer to Tyme Technologies, Inc., together with its subsidiaries.

Throughout this Quarterly Report on Form 10-Q, we have used terms which are defined below:


AEs	Adverse events	KOLs	Key opinion leaders
ASC	Accounting Standards Codification	LLC	Limited Liability Company
ASU	Accounting Standards Update	MOA	Mechanism of Action
ATM	At-the-Market offering	mPDAC	Metastatic Pancreatic Cancer
CBR	Clinical benefit rate	MPS	Methoxsalen, phenytoin, and sirolimus
CDK4/6	A gene that makes a protein involved in the cell cycle (the process a cell goes through each time it divides). Mutations (changes) in the CDK4/6 gene may cause cells to divide too quickly or in an uncontrolled way.	ORR	Objective response rate
CMBTs	Cancer metabolism-based therapies	OS	Overall survival
DOR	Duration of response	PanCAN	Pancreatic Cancer Action Network
EPS	Earnings Per Share	PFS	Progression free survival
FASB	Financial Accounting Standards Board	PI	Principal Investigator
FDA	Food and Drug Administration	RECIST	Response Evaluation Criteria In Solid Tumors
GAAP	Generally Accepted Accounting Principles	ROU	Right-of-use
HR+	hormone receptor positive	SAB	Staff Accounting Bulletin
HER2-	Human epidermal growth factor receptor 2 negative	SEC	U.S. Securities and Exchange Commission
IP	Intellectual Property	SPA	Securities Purchase Agreement

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PART I – FINANCIAL INFORMATION

Item 1.

Financial Statements.

Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

	June 30, 2022			March 31, 2022
	(unaudited)
Assets
Current Assets
Cash and cash equivalents	$	6,415,058		$	13,738,931
Marketable securities		70,690,123			60,611,961
Prepaid clinical costs		431,477			480,623
Prepaid expenses and other current assets		1,483,019			4,064,770
Total current assets		79,019,677			78,896,285

Operating lease right-of-use asset		28,210			38,229
Marketable securities		1,113,824			9,080,671
Total assets	$	80,161,711		$	88,015,185

Liabilities and Stockholders' Equity
Current liabilities
Accounts payable and other current liabilities (including $0 and $153,000 of related party accounts payable, respectively)	$	4,685,216		$	3,803,427
Severance payable		444,472			2,611,857
Accrued bonuses		465,133			933,082
Operating lease liability		26,488			37,332
Total current liabilities		5,621,309			7,385,698
Long-term liabilities
Severance payable, net of current portion		311,370			421,575
Warrant liability		89,559			124,480
Total liabilities		6,022,238			7,931,753
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, 172,206,894 issued and outstanding at June 30, 2022, 300,000,000 authorized, 172,206,894 issued and outstanding at March 31, 2022		17,223			17,223
Additional paid in capital		241,571,007			241,030,535
Accumulated other comprehensive loss		(533,762	)		(544,264	)
Accumulated deficit		(166,914,995	)		(160,420,062	)
Total stockholders' equity		74,139,473			80,083,432
Total liabilities and stockholders' equity	$	80,161,711		$	88,015,185

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

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Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

	Three Months Ended June 30,
	2022			2021
Revenues	$	—		$	—
Operating expenses:
Research and development		1,960,753			4,184,411
General and administrative (including $0 and $115,000 of related party legal expenses, respectively)		4,646,637			2,468,159
Total operating expenses		6,607,390			6,652,570
Loss from operations		(6,607,390	)		(6,652,570	)
Other income (expense):
Change in fair value of warrant liability		34,921			725,143
Other income		89,409			19,523
Interest expense		(11,873	)		(21,259	)
Total other income (expense)		112,457			723,407
Net loss	$	(6,494,933	)	$	(5,929,163	)
Basic and diluted loss per common share	$	(0.04	)	$	(0.03	)
Basic and diluted weighted average shares outstanding		172,206,894			172,205,452
Statements of Comprehensive Loss
Net loss	$	(6,494,933	)	$	(5,929,163	)
Other comprehensive loss
Unrealized gain (loss) on marketable securities, net of tax		10,502			(33,842	)
Comprehensive loss	$	(6,484,431	)	$	(5,963,005	)

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

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Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ Equity

For the Three Months Ended June 30, 2022 and 2021

(Unaudited)

	Common Stock				Additional					Accumulated Other			Total
	Shares		Amount		Paid-in Capital		Accumulated Deficit			Comprehensive Loss			Stockholders' Equity
Balance, April 1, 2022		172,206,894	$	17,223	$	241,030,535	$	(160,420,062	)	$	(544,264	)	$	80,083,432
Stock based compensation		—		—		540,472		—			—			540,472
Unrealized gain on available-for-sale securities		—		—		—		—			10,502			10,502
Net loss		—		—		—		(6,494,933	)		—			(6,494,933	)
Balance, June 30, 2022		172,206,894	$	17,223	$	241,571,007	$	(166,914,995	)	$	(533,762	)	$	74,139,473

Balance, April 1, 2021		172,200,644	$	17,222	$	238,572,442	$	(136,794,015	)	$	—		$	101,795,649
Proceeds from the exercise of stock options		6,250		1		6,187		—			—			6,188
Stock based compensation		—		—		643,665		—			—			643,665
Unrealized loss on available-for-sale securities		—		—		—		—			(33,842	)		(33,842	)
Net loss		—		—		—		(5,929,163	)		—			(5,929,163	)
Balance, June 30, 2021		172,206,894	$	17,223	$	239,222,294	$	(142,723,178	)	$	(33,842	)	$	96,482,497

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

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Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(Unaudited)

	Three Months Ended June 30,
	2022			2021
Cash flows from operating activities
Net loss	$	(6,494,933	)	$	(5,929,163	)
Adjustments to reconcile net loss to net cash used in operating activities
Amortization of employees, directors and consultants stock options		540,472			643,665
Change in fair value of warrant liability		(34,921	)		(725,143	)
Net amortization of premiums and discounts on marketable securities		389,117			227,303
Change in operating assets and liabilities:
Prepaid clinical costs		49,146			905,297
Prepaid expenses and other assets		2,634,261			186,635
Operating lease right-of-use asset		10,019			8,912
Accounts payable and other current liabilities		881,789			(280,959	)
Severance payable		(2,277,590	)		(167,999	)
Accrued bonuses		(467,949	)		(670,110	)
Operating lease liability		(10,844	)		(7,775	)
Net cash used in operating activities		(4,781,433	)		(5,809,337	)

Cash flows from investing activities
Purchases of marketable securities		(17,018,440	)		(65,254,424	)
Proceeds from maturities of marketable securities		14,476,000			—
Net cash used in investing activities		(2,542,440	)		(65,254,424	)

Cash flows from financing activities
Proceeds from exercise of stock options		—			6,188
Net cash provided by financing activities		—			6,188

Net decrease in cash and cash equivalents		(7,323,873	)		(71,057,573	)

Cash and cash equivalents – beginning		13,738,931			107,516,420
Cash and cash equivalents – ending	$	6,415,058		$	36,458,847

Supplemental Cash Flow Information:
Interest	$	11,873		$	21,259
Income taxes	$	—		$	—

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

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Tyme Technologies, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

June 30, 2022

(Unaudited)

Note 1. Nature of Business

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

TYME is an emerging biotechnology company developing CMBTs 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 mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic requirements to cause cancer cell death.

The Company has been focused on developing its novel compound, SM-88 and its preclinical pipeline of novel CMBT^TM programs. The Company believes that early clinical results demonstrated by SM-88 in multiple advanced cancers, including breast, sarcomas, pancreatic, and prostate, reinforce the potential of its emerging CMBT™ pipeline.

Ongoing Studies

OASIS Trial in metastatic HR+/HER2- breast cancer

The Company is collaborating with Georgetown University to support a Phase II trial, OASIS, for SM-88 in patients with metastatic breast cancer who have HR+ and HER2- disease (“HR+/HER2-”). This represents approximately 68% of the annual breast cancer diagnoses in the US each year. The OASIS trial is an investigator-initiated prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 with MPS for the treatment of metastatic HR+/HER2- breast cancer after treatment with a CDK4/6 inhibitor. This trial is designed as a two-stage trial, enrolling up to 50 patients who have failed or progressed after receiving two hormonal agents and a CDK4/6 inhibitor to receive SM-88 with MPS without additional cancer therapies. The primary endpoint of this trial is ORR, with secondary endpoints including DOR, CBR at >24 weeks, PFS, and safety. The trial is being conducted at Georgetown University at a total of five sites within the Georgetown/MEDSTAR system located in Washington DC, Maryland, and New Jersey. Patient enrollment began in 2021 with the first patient dosed in September.

HoPES Trial in sarcoma

In early 2020, the open-label Phase 2 investigator-sponsored trial of SM-88 therapy in sarcoma, HoPES, opened. This trial has two cohorts, each expecting to enroll 12 patients. The first is SM-88 with MPS as salvage treatment in patients with mixed rare sarcomas, and the other is SM-88 with MPS as maintenance treatment for patients with metastatic Ewing’s sarcoma who had not progressed on prior therapy. The primary objectives are to measure ORR and PFS. Secondary objectives include DOR, OS, CBR using RECIST, and incidence of treatment-emergent AEs. The Joseph Ahmed Foundation is sponsoring this trial, which is being conducted by PI Dr. Chawla at the Sarcoma Oncology Center in Santa Monica, CA.

Preclinical Pipeline Programs

In fiscal year 2022, the Company began a comprehensive translational preclinical program focused on SM-88 MOA and Biomarker Identification/Validation. We engaged Evotec, a leading global research and development company, to aid in the execution of these activities and we are also incorporating several complementary academic collaborations into this multi-faceted program. The overall goal of these activities is to potentially identify actionable biomarkers of sensitivity and activity to SM-88 in various cancers, complementary combination drugs strategies for SM-88, and other cancer metabolism targets that could benefit from treatment.

TYME-18 is a CMBT^TM compound that is delivered intratumorally. TYME-18 leverages a member of the bile acid family to create a potential treatment for inoperable tumors. Preliminary observations of the local administration of TYME-18, a combination of a proprietary surfactant system and natural sulfonic acid, suggested its potential as an important regulator of energy metabolism that may impede the ability of tumors to increase in size, which, in addition to its lytic functionality, could prove useful in difficult-to-treat cancers. The Company is assessing development priorities to determine if additional advancement of this program is warranted at this time.

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TYME-19 is an oral synthetic member of the bile acid family. The Company also uses bile acids in its anti-cancer drug candidate, TYME-18. Because of its expertise in bile acids and their effects, the Company was able to identify TYME-19 as a well-characterized bile acid with potential antiviral properties. Bile acids have primarily been used for liver disease; however, like all steroids, they are messenger molecules that modulate a number of diverse critical cellular processes. Bile acids can modulate lipid and glucose metabolism and can remediate dysregulated protein folding, with potentially therapeutic effects on cardiovascular, neurologic, immune, and other metabolic systems. Some agents in this class have also previously shown antiviral properties.

The Company retained virology experts at Evotec to assess the mechanisms of TYME-19. Evotec is a global drug development company that has the capability to access the multiple existing and emerging variants of the COVID-19 virus. TYME and Evotec have tested the ability of TYME-19 to interrupt the cellular pathways commonly used by viruses to produce viral proteins as well as cellular responses to viral infection that cause local inflammation. Prolonged inflammation from SARS-CoV-2 can lead to some of the severe outcomes experienced by infected patients. We aimed for the work by Evotec to provide us with information that could allow us to assess the potential path forward for the program. However, with the changes in the demand for COVID-19 therapeutic landscape, and potential capital required to advance the program, our management decided to currently pause additional development of this program.

Tumor Targeting Technology

TYME has developed a technology (“Tumor Targeting Technology”) by which the tyrosine isomer L metyrosine (L-α-methylparatyrosine) can be fused with a second therapeutic agent in a manner that creates a fusion compound that may allow targeted accumulation of the treatment by the cancer cells in a novel manner. The Company is assessing potential development paths forward for this technology.

Discontinuing Programs

Precision Promise Trial- SM-88 with MPS as 2^nd line therapy in metastatic pancreatic cancer

In October 2018 the Company partnered with PanCAN to study SM-88 in an adaptive randomized Phase II/III trial with registration intent known as Precision Promise^SM. The objective of Precision Promise is to expedite the study and approval of promising therapies for pancreatic cancer by bringing multiple stakeholders together, including academic, industry and regulatory entities. The trial began in early 2020, with SM-88 (with the conditioning agents MPS) being studied as monotherapy in a treatment arm for patients who have failed one prior line of chemotherapy.

On January 26, 2022, the Company announced the discontinuation of SM-88 with MPS in the Precision Promise trial in mPDAC upon learning from PanCAN, the trial sponsor, that it terminated the arm due to futility compared to the control of standard of care chemotherapy in second-line mPDAC. Based on the information provided by PanCAN, the OS for SM-88 with MPS in monotherapy was lower compared to standard of care chemotherapies with either Gemcitabine and Abraxane or modified FOLFIRINOX. As of June 30, 2022, remaining estimated costs to close out the trial have been expensed.

TYME-88-PANC (Part 2) (third-line Metastatic Pancreatic Cancer)

In fiscal year 2020, we launched our pivotal study for SM-88 in the third-line treatment of pancreatic cancer through an amendment to our ongoing TYME-88-Panc trial (Part 2), with the first patient dosed in the third quarter of the fiscal year. As described previously, the COVID-19 pandemic significantly impacted enrollment of this trial such that it appeared likely to complete enrollment in a similar timeline to the second-line Precision Promise pancreatic cancer trial. There was also a higher than expected dropout of patients randomized to the chemotherapy control arm, which could have potentially impacted the interpretative and regulatory utility of the data.

Following the strategic review conducted in the first half of calendar year 2021, considering, in part, the timeline and regulatory utility for this trial compared to the parallel Precision Promise trial and concentration of investment in this specific cancer, management concluded that it would be best to focus on the second-line Precision Promise trial which offers treatment options to patients earlier in their disease and includes tumor biopsy and biomarker analyses that align with the Company’s overall strategic focus on identifying targeted therapies.

In June 2021, the Company stopped enrollment and began the process of closing down the trial. It is expected to be completed in the third quarter of calendar year 2022, with remaining estimated costs to the Company of approximately $100,000.

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Merger Agreement with Syros Pharmaceuticals, Inc.

On July 3, 2022, TYME entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Syros and Tack Acquisition Corp., a Delaware corporation and wholly owned subsidiary of Syros (“Merger Sub”). Upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge with and into TYME (the “Merger”), with TYME continuing as the surviving entity and a wholly owned subsidiary of Syros. At the effective time of the Merger (the “Effective Time”), each share of common stock of Tyme, par value $0.0001 per share (the “Tyme Common Stock”), issued and outstanding immediately prior to the Effective Time will be converted into the right to receive a number of shares of fully paid and non-assessable shares of common stock of Syros, par value $0.001 per share (the “Syros Common Stock”) equal to the Exchange Ratio (as defined in the Merger Agreement). The completion of the Merger is subject to the satisfaction or waiver of certain closing conditions, including the adoption of the Merger Agreement by holders of a majority of the outstanding shares of Tyme and Syros Common Stock.

Liquidity

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

In February 2021, the Company raised $100 million in gross proceeds through a registered direct offering of 40,000,000 shares of its common stock, at a purchase price of $2.50 per share. The Company incurred $6.2 million of related costs, which offset such proceeds.

On January 7, 2020, the Company entered into an SPA with Eagle Pharmaceuticals, Inc. (“Eagle”), pursuant to which the Company raised $20.0 million through the issuance and sale to Eagle of 10,000,000 shares of common stock, at a price of $2.00 per share.

On October 18, 2019, TYME entered into an Open Market Sale Agreement^SM (as amended, the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as sales agent, pursuant to which the Company may, from time to time, sell shares of common stock through Jefferies having an aggregate offering price of up to $30.0 million (the “Jefferies ATM”). The Company did not sell any shares through the Jefferies ATM during the three months ended June 30, 2022 and June 30, 2021. At June 30, 2022, there remained approximately $22.2 million of availability to sell shares through the Jefferies ATM subject to the terms of the Sale Agreement.

The proceeds of the aforementioned offerings are being used by the Company for continued clinical studies, drug commercialization and development activities and other general corporate and operating expenses.

For the three months ended June 30, 2022, the Company had negative cash flow from operations of $4.8 million and net loss of $6.5 million, which included non-cash expenses of $0.5 million related to non-cash equity compensation, $0.4 million net amortization expense of premiums and discounts on marketable securities, and $0.8 million change in operating assets and liabilities. As of June 30, 2022, the Company had working capital of approximately $73.4 million.

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

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

Basis of Presentation

The accompanying condensed consolidated financial statements and related notes should be read in conjunction with the consolidated financial statements and related notes contained in the Company’s Annual Report on Form 10-K, as amended, for the year ended March 31, 2022 filed with the SEC (the “2022 10-K”). The condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the SEC related to interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with 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.

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The Company’s condensed consolidated financial statements include the accounts of Tyme Technologies, Inc. and its subsidiary, Tyme Inc. All intercompany transactions and balances have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in ASC and ASU of the FASB.

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended March 31, 2022 included in the Company’s 2022 10-K.

Cash and cash equivalents

Cash and cash equivalents include demand deposit accounts, money market funds and municipal debt securities. The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash equivalents are stated at fair value.

Marketable Securities

All of the Company's marketable securities are debt securities and are classified as available-for-sale in accordance with the ASC Topic 320, “Investments - Debt and Equity Securities.” Available for sale securities are carried at fair value and reported in cash equivalents and marketable securities. Marketable securities are further classified as short-term or long-term based on maturity dates and the Company’s intent in line with its investment policy to hold the securities to scheduled maturity. Unrealized gains and losses on available-for-sale securities are excluded from net loss and reported in accumulated other comprehensive loss as a separate component of stockholders' equity. Other income includes interest, dividends, amortization of purchase premiums and discounts, gain and losses on sale (or redemptions) of securities and other-than-temporary declines in the fair value of securities, if any.

For individual debt securities classified as available-for-sale securities where there has been a decline in fair value below amortized cost, the Company determines whether the decline resulted from a credit loss or other factors. In making this assessment, the Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and adverse conditions specifically related to the security, among other factors. If this assessment indicates that a credit loss exists, the present value of cash flows expected to be collected from the security is compared to the amortized cost basis of the security. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for a credit loss is recorded on our consolidated balance sheet, limited by the amount that the fair value is less than the amortized cost basis. Impairment that has not been recorded through an allowance for credit losses is recorded through other comprehensive loss, net of applicable taxes.

Fair Value of Financial Instruments

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

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.

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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 see Note 6.

Derivative Warrant Liability

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

Risks and Uncertainties

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

Current Economic Conditions

The novel coronavirus (COVID-19) pandemic, and actions taken by governments and others to reduce its spread, has negatively impacted the global economy, financial markets, and the Company’s industry and has disrupted day-to-day life and business operations. Even as certain restrictions have been lifted, new processes implemented and vaccines have become more widely available and administered, spikes in infections (including the spread of new variants) continue to be experienced and certain jurisdictions continue to impose stay-at-home orders from time to time, as conditions evolve and fluctuate around the world. Additionally, supply chain disruptions, the effect of the Russia/Ukraine war, inflation and rising interest rates and the possibility of an economic recession further exacerbate challenging economic conditions. The extent to which the continuing COVID-19 pandemic and other macroeconomic headwinds impact our product candidates and business, including patients’ willingness to participate and remain in clinical trials, the timing of meeting enrollment expectations, the ability of our third-party partners to remain operational and our access to capital markets and financing sources, depends on numerous evolving factors that are highly uncertain, cannot be accurately predicted, and may be significant.

Recent Accounting Pronouncements

The Company has reviewed the Accounting Standards Updates recently issued by the FASB, and determined that they are not applicable to the Company.

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 June 30,
	2022			2021
Basic and diluted net loss per common share calculation:
Net loss	$	(6,494,933	)	$	(5,929,163	)
Weighted average common shares outstanding — basic and diluted:		172,206,894			172,205,452
Net loss per share of common stock — basic and diluted	$	(0.04	)	$	(0.03	)

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The Company calculates net loss per share in accordance with ASC Topic 260, “Earnings per Share.” Basic net loss per share is computed by dividing net loss attributable to the Company by the weighted average number of shares of Company Common Stock outstanding for the period, and diluted EPS 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.

The following outstanding securities at June 30, 2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as they are anti-dilutive:

	June 30,
	2022		2021
Stock options		17,253,306		15,554,575
Warrants		3,104,318		3,104,318
Total		20,357,624		18,658,893

Note 4. Accounts Payable and Other Current Liabilities

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

	June 30, 2022		March 31, 2022
Legal	$	577,176	$	263,111
Consultant and professional services		1,451,807		300,051
Accounting and auditing		204,763		14,410
Research and development		2,285,779		2,776,594
Board of Directors and Scientific Advisory Board Compensation		117,139		418,389
Other		48,552		30,872
Total	$	4,685,216	$	3,803,427

Note 5. Severance Payable

The Company entered into a Release Agreement, dated March 24, 2022, pursuant to which the Chief Science Officer resigned and received severance that would be payable under his employment agreement in a lump sum payment of $2.1 million. Between April 12, 2021 and March 28, 2022, the Company also entered into separation and general release agreements with three other employees. The agreements provide separation benefits, which the Company recorded as severance expense.

In April 2021, the Company entered into a Separation and General Release Agreement related to the separation of employment of its then-Chief Medical Officer as of March 31, 2021. The agreement provides for separation benefits which the Company recorded as severance expense for the year ended March 31, 2021.

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

The aggregate severance liability payable was $0.8 million and $3.0 million as of June 30, 2022 and March 31, 2022, respectively.

6. Fair Value Measurements

The Company has segregated all financial assets and liabilities that are measured at fair value on a recurring basis into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement date in the table below. Transfers are calculated on values as of the transfer date. There were no transfers between Levels 1, 2 and 3 during the three months ended June 30, 2022 and June 30, 2021.

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The Company’s financial instruments measured at fair value on a recurring basis as of June 30, 2022 and March 31, 2022 are as follows:

			Quoted prices in active markets		Significant other observable inputs		Significant unobservable inputs
June 30, 2022	Total		(Level 1)		(Level 2)		(Level 3)
Financial assets
Cash equivalents
Money market funds	$	24,077	$	24,077	$	—	$	—
Municipal debt securities		1,360,000		—		1,360,000		—
Marketable Securities
Short-term
Commercial paper		6,426,250		—		6,426,250		—
Corporate debt securities		29,769,174		—		29,769,174		—
Municipal debt securities		34,494,699		—		34,494,699		—
Long-term
Municipal debt securities		1,113,824		—		1,113,824		—
	$	73,188,024	$	24,077	$	73,163,947	$	—
Financial liability
Warrant liability	$	89,559	$	—	$	—	$	89,559

			Quoted prices in active markets		Significant other observable inputs		Significant unobservable inputs
March 31, 2022	Total		(Level 1)		(Level 2)		(Level 3)
Financial assets
Cash equivalents
Money market funds	$	3,409,178	$	3,409,178	$	—	$	—
Marketable Securities
Short-term
Corporate debt securities		26,195,025		—		26,195,025		—
Municipal debt securities		34,416,936		—		34,416,936		—
Long-term
Corporate debt securities		6,293,015		—		6,293,015		—
Municipal debt securities		2,787,656		—		2,787,656		—
	$	73,101,810	$	3,409,178	$	69,692,632	$	—
Financial liability
Warrant liability	$	124,480	$	—	$	—	$	124,480

Fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. The fair value of cash equivalents held in money market funds is determined based on “Level 1” inputs. Marketable securities classified as Level 2 within the valuation hierarchy consist of corporate debt securities and municipal debt securities. We estimate the fair values of these marketable securities by taking into consideration valuations obtained from third-party pricing sources. These pricing sources utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include market pricing based on real-time trade data for the same or similar securities, issuer credit spreads, benchmark yields, and other observable inputs.

The fair value measurement for the May 2020 Warrant issued in conjunction with the Exchange Agreements (see Note 8 for transaction details) is based on significant inputs not observable in the market and is classified as Level 3 liability as of June 30, 2022 and March 31, 2022. The fair value of the May 2020 Warrant was determined using a Black Scholes model and included significant unobservable inputs such as volatility. The model also incorporated several observable assumptions at each valuation date including: the price of the Company’s common stock on the date of valuation, the remaining contractual term of the warrant and the risk free interest rate over the term.

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The following table details key inputs and assumptions used to estimate the fair value of the May 2020 Warrant as of June 30, 2022 and March 31, 2022 using a Black Scholes model:


	June 30, 2022			March 31, 2022
Stock price	$	0.28		$	0.35
Volatility		108	%		98	%
Remaining term (years)	1.76				2.01
Expected dividend yield		—			—
Risk-free rate		2.87	%		2.28	%

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

	June 30, 2022
Beginning balance, March 31, 2022	$	124,480
Change in fair value of May 2020 Warrant liability		(34,921	)
Ending balance, June 30, 2022	$	89,559

Note 7. Available-for-Sale-Securities

The following table summarizes available-for-sale securities recorded in cash and cash equivalents or marketable securities as of June 30, 2022 and March 31, 2022:

	June 30, 2022									March 31, 2022
	Amortized cost		Gross Unrealized Gains		Gross Unrealized Loss			Fair Value		Amortized cost		Gross Unrealized Gains		Gross Unrealized Loss			Fair Value
Money market funds	$	24,077	$	—	$	—		$	24,077	$	3,409,178	$	—	$	—		$	3,409,178
Commercial paper		6,426,250		—		—			6,426,250		—		—		—			—
Corporate debt securities		30,125,510		35		(356,371	)		29,769,174		32,831,174		—		(343,134	)		32,488,040
Municipal debt securities		37,145,949		2		(177,428	)		36,968,523		37,405,722		—		(201,130	)		37,204,592
Total	$	73,721,786	$	37	$	(533,799	)	$	73,188,024	$	73,646,074	$	—	$	(544,264	)	$	73,101,810

The following table summarizes the classification of available-for-sale securities:

	June 30, 2022		March 31, 2022
Cash and cash equivalents	$	1,384,077	$	3,409,178
Marketable securities		71,803,947		69,692,632
Total	$	73,188,024	$	73,101,810

The following table summarizes our portfolio of available-for-sale securities by contractual maturity:

	Less than 12 months					12 months or Longer					Total
	Fair Value		Net Unrealized Losses			Fair Value		Net Unrealized Losses			Fair Value		Net Unrealized Losses
Money market funds	$	24,077	$	—		$	—	$	-		$	24,077	$	—
Commercial paper		6,426,250		—			—		—			6,426,250		—
Corporate debt securities		29,769,174		(356,336	)		—		—			29,769,174		(356,336	)
Municipal debt securities		35,854,699		(147,856	)		1,113,824		(29,570	)		36,968,523		(177,426	)
Total	$	72,074,200	$	(504,192	)	$	1,113,824	$	(29,570	)	$	73,188,024	$	(533,762	)

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Note 8. Stockholders’ Equity

Common Stock

Voting

In connection with the Release Agreement, dated March 24, 2022, the Company and Mr. Hoffman also entered into a Voting Agreement, pursuant to which Mr. Hoffman agreed to vote all shares of TYME common stock beneficially owned by him in accordance with the Board’s recommendation with respect to any matter presented to the stockholders for a period of one year.

The Company and Michael Demurjian entered into a Voting Agreement, dated April 18, 2022, pursuant to which Mr. Demurjian agreed to vote all shares of TYME common stock beneficially owned by him in accordance with the board of directors of the Company’s recommendation with respect to any matter presented to the Company’s stockholders for a period of two years from the date of the agreement.

Exchange Agreements

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

Pursuant to exchange agreements (the “Share Exchange Agreements”) with Holders of the April 2019 Warrants to purchase 5,833,333 shares of Common Stock in the aggregate, the Company issued an aggregate of 2,406,250 shares of common stock (the “Exchange Shares”) in exchange for such April 2019 Warrants.

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

The Company determined that the May 2020 Warrant should be recorded as a derivative liability on the condensed consolidated balance sheet due to the May 2020 Warrant’s contractual provisions requiring issuance of registered common shares upon exercise. See Note 6 for the change in fair value disclosures.

The following summarizes the common stock warrant activity for the three months ended June 30, 2022:

	Warrant Shares of Common Stock		Weighted Average Exercise Price
Outstanding at March 31, 2022		3,104,318	$	2.77
Granted		—		—
Exchanged		—		—
Outstanding at June 30, 2022		3,104,318	$	2.77

At each of June 30, 2022 and March 31, 2022, 3,074,551, of common stock purchase warrants relating to SPAs were outstanding and exercisable.

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Warrants

The Company has warrants to purchase its common stock outstanding as of June 30, 2022, as follows:

Issued	Classification	Warrants Outstanding		Exercise Price		Expiration
December 2015	Equity		446,500	$	5.00	December 2025
February 2016	Equity		461,384	$	5.00	February 2026
July 2016	Equity		29,767	$	5.00	June 2026
May 2020	Liability		2,166,667	$	1.80	April 2024

At-the-Market Financing Facility

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

The Company did not sell any shares through the Jefferies ATM during the three months ended June 30, 2022 and June 30, 2021. At June 30, 2022, there remained approximately $22.2 million of availability to sell shares through the Jefferies ATM subject to the terms of the Sale Agreement.

Securities Purchase Agreement

On January 7, 2020, the Company and Eagle entered into the Eagle SPA, pursuant to which the Company issued and sold to Eagle 10,000,000 shares of common stock, at a price of $2.00 per share. The Eagle SPA provides that Eagle will, subject to certain conditions, make an additional payment of $20 million upon the occurrence of a milestone event, which is defined as the earlier of (i) achievement of the primary endpoint of OS in the TYME-88-Panc pivotal trial; (ii) achievement of the primary endpoint of OS in the PanCAN Precision Promise SM-88 registration arm; or (iii) FDA approval of SM-88 in any cancer indication. This payment would be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement. On July 3, 2022, Eagle entered into a Support Agreement with Syros and TYME, in which it agreed, to, among other things, vote all of its shares in TYME that it owns as of the record date for the applicable stockholder meeting (i) in favor of the adoption of the proposals required for the Merger, (ii) against any competing acquisition proposal, and (iii) against any proposal, action or agreement that would reasonably be expected to impede, interfere with, delay or postpone, prevent or otherwise impair the Merger or the other transactions contemplated by the Merger Agreement.

Registered Direct Offering

On February 8, 2021, the Company closed on its registered direct offering with several healthcare-focused institutional and other institutional investors (the “Purchasers”), pursuant to which the Company sold to the Purchasers an aggregate of 40,000,000 shares (the “Shares”) of common stock, $0.0001 par value per share. The Shares were sold at a purchase price of $2.50 per share for aggregate gross proceeds to the Company of $100 million, prior to deducting placement agent’s fees and other offering expenses payable by TYME. The Company incurred $6.2 million of related costs that offset such proceeds. The Shares were offered by the Company pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the SEC on August 12, 2020 and was declared effective on September 2, 2020 (Reg. No. 333-245033). H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

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Note 9. Commitments and Contingencies

Contract Service Providers

In the course of the Company’s normal business operations, it enters into agreements and arrangements with contract service providers to assist in the performance of its research and development and clinical research activities. At June 30, 2022, the Company’s obligations to contract service providers were $0.1 million in the aggregate.

On April 1, 2020, the Company amended the Clinical Research Funding and Drug Supply Agreement dated October 9, 2018, with PanCAN, to enroll individuals diagnosed with pancreatic cancer in a platform style clinical research study. Stage 1 of the study was initiated in the fourth quarter of fiscal year 2020. On January 26, 2022, the Company announced the discontinuation of SM-88 with MPS in the Precision Promise trial in mPDAC upon learning from PanCAN, the trial sponsor, that it terminated the arm due to futility compared to the control of standard of care chemotherapy in second-line mPDAC. As of June 30, 2022, remaining estimated costs to close out the trial have been expensed.

Purchase Commitments

The Company has entered into contracts with manufacturers to supply SM-88 and certain related conditioning agents, in order to achieve favorable pricing on supplied products. These contracts have non-cancellable elements related to the scheduled deliveries of these products in future periods. Payments are made by us to the manufacturer when the products are delivered and of acceptable quality. The outstanding future contract obligations structured to match clinical supply needs for the Company’s ongoing trials and registration activity are approximately $0.6 million and $2.4 million, respectively, at June 30, 2022.

Legal Proceedings

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

Note 10. Leases

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

Total Company rent expense, including short term rentals, was approximately $13,000 and $14,000 for the three months ended June 30, 2022 and June 30, 2021, respectively.

Operating lease 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 ROU assets and liabilities. The Company uses its incremental borrowing rate of 11.0% to calculate the present value of its lease payments, as the implicit rates in the leases are not readily determinable.

As of June 30, 2022, the future minimum lease payments under non-cancellable operating lease agreements for which the Company has recognized operating lease ROU assets and lease liabilities were as follows:

	June 30, 2022
Fiscal year 2023	$	27,468
Total remaining lease payments		27,468
Less: present value adjustment		(980	)
Total operating lease liabilities		26,488
Less: current portion		(26,488	)
Operating lease liabilities, net of current portion	$	—

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Note 11. Related Party Transactions

Legal

Faegre Drinker Biddle & Reath (“Faegre Drinker”), formerly Drinker Biddle & Reath LLP (“DBR”), has provided legal services to the Company. The Company’s Chief Legal Officer and Corporate Secretary held the consulting role “Senior Counsel” with Faegre Drinker until December 31, 2021. The Company disclosed legal fees incurred and accounts payable and accrued expenses associated with Faegre Drinker through the fiscal year end of which the related party transaction with the law firm was terminated. Faegre Drinker continues to provide services to the Company, but is no longer a related party. Legal fees incurred associated with the related party transaction with Faegre Drinker were approximately $115,000 for the three months ended June 30, 2021. At March 31, 2022, the Company had approximately $153,000 in related party transaction costs.

Note 12. Equity Incentive Plan

Stock Options

As of June 30, 2022, there was approximately $4.9 million of total unrecognized compensation expense related to non-vested stock options. The cost is expected to be recognized over the remaining weighted average service period of 2.8 years.

As of June 30, 2022, there were 7,885,273 shares available for grant under the Company’s 2015 Equity Incentive Plan and 2016 Director Plan.

Stock based compensation expense was recognized as follows:

	Three Months Ended June 30,
	2022		2021
General and administrative	$	451,000	$	471,000
Research and development		89,000		173,000
Total	$	540,000	$	644,000

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

The expected volatility of options granted has been determined using the method described under ASC 718 using the expected volatility of similar companies. The expected term of options granted to employees, non-employees and consultants in the current fiscal period has been based on the term by using the simplified method as allowed under SAB No. 110 and ASU 2018-7.

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

	June 30, 2022			June 30, 2021
Risk free interest rate	2.83% - 2.92%			0.28% - 1.01%
Expected volatility	115.36% - 115.39%			97.11% - 105.37%
Expected term (in years)	6.1			2.7 - 6.1
Dividend yield		0	%		0	%

The following is a summary of the status of the Company’s stock options for the three months ended June 30, 2022:

	Number of Options			Weighted Average Exercise Price
Outstanding at March 31, 2022		14,504,271		$	2.36
Granted		3,641,300		$	0.32
Cancelled/Forfeited		(892,265	)	$	5.47
Exercised		—		$	—
Outstanding at June 30, 2022		17,253,306		$	1.77
Options exercisable at June 30, 2022		9,387,474		$	2.55

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Stock Options Outstanding

Stock Options Vested

Range of

Exercise

Price

Number Outstanding at June 30, 2022

Weighted

Average

Exercise

Price

Weighted

Average

Remaining

Life

(Years)

Aggregate

Intrinsic

Value

Number

Vested at June 30, 2022

Weighted

Average

Exercise

Price

Aggregate

Intrinsic

Value

$0.29 - $8.75

17,253,306

1.77

7.5

9,387,474

2.55

The intrinsic value calculated as the excess of the market value as of June 30, 2022 over the exercise price of the options is $0. The market value per share as of June 30, 2022 was $0.28 as reported by the NASDAQ Capital Market.

Note 13. Income Taxes

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

The Company is required to evaluate uncertain tax positions taken or expected to be taken in the course of preparing the Company’s condensed consolidated financial statements to determine whether the tax positions are more likely than not of being sustained by the applicable tax authority. As of June 30, 2022, the Company’s uncertain tax positions remain unchanged. Due to the full valuation allowance, none of the gross unrecognized tax benefits, if recognized, would affect the effective tax rate at June 30, 2022.

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.

Note 14. Subsequent Events

Merger Agreement with Syros Pharmaceuticals, Inc.

On July 3, 2022, TYME entered into the Merger Agreement with Syros and Merger Sub. Upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge with and into TYME, with TYME continuing as the surviving entity and a wholly owned subsidiary of Syros. At the Effective Time, each share of Tyme Common Stock, issued and outstanding immediately prior to the Effective Time will be converted into the right to receive a number of shares of fully paid and non-assessable shares of Syros Common Stock equal to the Exchange Ratio (as defined in the Merger Agreement). The completion of the Merger is subject to the satisfaction or waiver of certain closing conditions, including the adoption of the Merger Agreement by holders of a majority of the outstanding shares of Tyme Common Stock.

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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 the 2022 10-K. You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing in this Quarterly Report as well as our audited financial statements, notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our 2022 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 2022 Form 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. As used in this report, unless the context suggests otherwise, “we,” “us,” “our,” “the Company,” “TYME” or “Tyme Technologies” refer to Tyme Technologies, Inc. together with its subsidiary. All amounts in Management’s Discussion and Analysis of Financial Condition and Results of Operations are approximate.

Overview

The Company has been focused on developing its novel compound, SM-88, as well as further evaluating its preclinical pipeline of novel CMBT^TM programs. The Company is also exploring options to further diversify its product candidate pipeline. The Company believes that early clinical results demonstrated by SM-88 in multiple advanced cancers, including breast, sarcomas, pancreatic and prostate, reinforce the potential of our emerging CMBT™ pipeline.

Exploration of Strategic Options and Diversification

On March 29, 2022, we announced that the Board of Directors of the Company (the “Board”) had decided to explore potential strategic options to enhance stockholder value and engaged outside financial and legal advisors to assist with that process.

The Company’s Board of Directors, the Strategic Planning Committee of the Board, and Management, along with its financial advisor,

undertook a comprehensive and thorough process of reviewing and analyzing potential strategic alternatives, in-licensing

opportunities and merger candidates to identify the opportunity that would, in the Company’s board of

directors’ view, create the most value for the Company stockholders.

On July 3, 2022, the company entered into an Agreement and Plan of Merger with Syros and Tack Acquisition Corp., a Delaware corporation and wholly owned subsidiary of Syros. Upon the consummation of the Merger, TYME will continue as the surviving entity and a wholly owned subsidiary of Syros. At the Effective Time, each share of Tyme Common Stock, issued and outstanding immediately prior to the Effective Time will be converted into the right to receive a number of shares of fully paid and non-assessable shares of Syros Common Stock equal to the Exchange Ratio (as defined in the Merger Agreement). The completion of the Merger is subject to the satisfaction or waiver of certain closing conditions, including the adoption of the Merger Agreement by holders of a majority of the outstanding shares of Tyme Common Stock. If the Merger does not close and TYME remains an independent company, it may choose to change its strategy, including, without limitation, to close down its trials and cease operations.

Strategic Review

In the first half of calendar year 2021, the Company undertook a comprehensive strategic review with the goal of aligning the Company’s development plans with core strategic goals.

The strategic review was extensive and involved internal and external assessments by industry experts, KOLs and advisors with considerable experience in the various areas we sought to probe and explore.

The strategic review process resulted in several key takeaways including, but not limited to:

•

broad activity across 15 cancer types as seen in the First in Human study and Compassionate Use program and confirmation of strong IP portfolio provides us extra development opportunities, for which focus is critical;

•

the second-line Precision Promise trial was the priority in pancreatic cancer;

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•

breast cancer is a priority indication for development as part of pipeline diversification beyond pancreatic cancer;

•

there is a need to refine our understanding of the MOA and identify biomarkers to enhance targeting of patient populations; and

•

the rapidly changing COVID-19 landscape requires a reevaluation of the market potential and development pathway for TYME-19.

The Company’s recent strategy, including ongoing studies, the Preclinical Pipeline Programs and diversification efforts, was developed based on the takeaways from the strategic review , as well as on subsequent developments. Key elements of the Company’s strategy include to (i) successfully advance the development of SM-88 across a broad range of cancers, (ii) work towards identifying actionable biomarkers for patient selection or treatment response to SM-88, (iii) continue to invest in our technology platform and expand the breadth and depth of our IP portfolio, and (iv) build a balanced portfolio of proprietary and partnered programs.

Ongoing Studies

OASIS (Metastatic HR+/HER2- Breast Cancer After CDK4/6 Inhibitors)

We are collaborating with Georgetown University to support a Phase II trial, OASIS, for SM-88 in patients with metastatic breast cancer who have HR+ and HER2- disease (“HR+/HER2-“). This represents approximately 68% of the annual breast cancer diagnose in the US each year. The OASIS trial is an investigator-initiated prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 with MPS for the treatment of metastatic HR+/ HER2- breast cancer after treatment with a CDK4/6 inhibitor. This trial is designed as a two-stage trial, enrolling up to 50 patients who have failed or progressed after receiving two hormonal agents and a CDK4/6 inhibitor to receive SM-88 with MPS without additional cancer therapies. The primary endpoint of this trial is ORR, with secondary endpoints including DOR, CBR at >24 weeks, PFS, and safety. The trial is being conducted at Georgetown University at a total of five sites within the Georgetown/MEDSTAR system located in Washington DC, Maryland, and New Jersey. Patient enrollment began in 2021 with the first patient dosed in September. We plan to provide an update on the OASIS breast cancer study during the first half of calendar year 2023.

HoPES Phase II Trial in sarcoma

In early 2020, the open-label Phase 2 investigator sponsored trial of SM-88 therapy in sarcoma, HoPES, opened. This trial has two cohorts, each expecting to enroll 12 patients. The first is SM-88 with MPS as salvage treatment in patients with mixed rare sarcomas, the other is SM-88 with MPS as maintenance treatment for patients with metastatic Ewing’s sarcoma that had not progressed on prior therapy. The primary objectives are to measure ORR and PFS. Secondary objectives include DOR, OS, CBR using RECIST, and incidence of treatment-emergent AEs. The Joseph Ahmed Foundation is sponsoring this trial, which is being conducted by PI Dr. Chawla at the Sarcoma Oncology Center in Santa Monica, CA. We anticipate that the trial enrollment will continue through the end of calendar year 2022.

Preclinical Pipeline Programs

SM-88 MOA and Biomarker Research

In fiscal year 2022, the Company began a comprehensive translational preclinical program. We engaged Evotec, a leading global research and development company to aid in the execution of these activities, and we are also incorporating several complementary academic collaborations into this multi-faceted program. The overall goal of these activities is to potentially identify actionable biomarkers of sensitivity and activity to SM-88 in various cancers, complementary combination drugs strategies for SM-88, and other cancer metabolism targets that could benefit from treatment. Additionally, the Company intends to incorporate liquid and/or tumor biopsies to future clinical trials to contribute to the biomarker identification. We anticipate this engagement will have several stages, and that it is likely to last through this fiscal year and potentially into future periods.

TYME-18 and TYME-19

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Tumor Targeting Technology

Discontinuing Programs

Precision Promise Trial- SM-88 with MPS as 2nd line therapy in metastatic pancreatic cancer

In October 2018 the Company partnered with PanCAN to study SM-88 in an adaptive randomized Phase II/III trial with registration intent known as Precision Promise^SM. The objective of Precision Promise is to expedite the study and approval of promising therapies for pancreatic cancer by bringing multiple stakeholders together, including academic, industry and regulatory entities. The trial, began in early 2020, SM-88 (with the conditioning agents MPS) is being studied as monotherapy in a treatment arm for patients who have failed one prior line of chemotherapy.

TYME-88-PANC (Part 2) (third-line Metastatic Pancreatic Cancer)

In fiscal year 2020, we launched our pivotal study for SM-88 in the third-line treatment of pancreatic cancer through an amendment to our ongoing TYME-88-Panc trial (Part 2), with the first patient dosed in the third quarter of the fiscal year. As described previously, the COVID-19 pandemic significantly impacted enrollment of this trial such that it appeared likely to complete enrollment in a similar timeline to the second-line Precision Promise pancreatic cancer trial. There has also been a higher than expected dropout of patients randomized to the chemotherapy control arm, which could potentially impact the interpretative and regulatory utility of the data.

Following the strategic review discussed above, considering, in part, the timeline and regulatory utility for this trial compared to the parallel Precision Promise trial and concentration of investment in this specific cancer, management concluded that it would be best to focus on the second-line Precision Promise trial which offers treatment options to patients earlier in their disease and includes tumor biopsy and biomarker analyses that aligns with the Company’s overall strategic focus on targeted identifying therapies.

In June 2021, the Company stopped enrollment and began the process of closing down the trial. It is expected to be completed in the third calendar quarter of 2022, with remaining estimated costs to the Company of approximately $100,000.

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COVID-19 Update and Current Economic Conditions

In March 2020, the World Health Organization categorized COVID-19 as a pandemic and the President of the United States declared the COVID-19 outbreak a national emergency. The COVID-19 pandemic, and actions taken by governments and others to reduce its spread, including travel restrictions, shutdowns of businesses deemed non-essential, and stay-at-home or similar orders, has negatively impacted the global economy, financial markets, and our industry and has disrupted day-to-day life and business operations. We continue to closely monitor the impact of COVID-19 on all aspects of our business, our clinical trials, and the safety of patients as the situation continues to evolve. We will continue to work closely with our clinical trial sites during the pandemic, and are committed to working with them to assure appropriate access for patients who are seeking clinical trial options for these advanced cancers for which the patients have limited or no other treatment options.

We have also taken important steps to protect the health and welfare of our employees, consultants and board members, by continuing to provide a fully “work-from-home” option. Additionally, supply chain disruptions, the effects of the Russia/Ukraine war, inflation and rising interest rates and the possibility of an economic recession further exacerbate challenging economic conditions. Although we have operated in the COVID-19 environment for approximately two years, there remains substantial uncertainty about the extent to which COVID-19 and other macroeconomic headwinds will impact our product candidates and business, including patients’ willingness to participate and remain in clinical trials, the timing of meeting enrollment expectations, the ability of our third-party partners to remain operational and our access to capital markets and financing sources and depends on numerous evolving factors that are highly uncertain and cannot be accurately predicted. Management continues to monitor the situation closely and intends to continue to adapt and implement process adjustments as needed.

Recent Developments

Nasdaq Notice

On June 21, 2022, the Company received notice from the Nasdaq Stock Market (“Nasdaq”) that it had granted the Company a 180-day extension to regain compliance with the Nasdaq continued listing standards. Nasdaq informed the Company that it granted the extension, in part, due to the Company’s intention to cure the deficiency during the extension period by effecting a reverse split, if necessary. The extension runs through December 19, 2022.

As previously reported, the Company received notice from Nasdaq on December 22, 2021 that the closing bid price for our common stock had been below $1.00 per share for the previous 30 consecutive business days, and that we were therefore not in compliance with the minimum bid price requirement for continued inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). Pursuant to the original notice, the Company had a 180-day period in which to regain compliance. Neither the original notice nor the extension has any immediate effect on the listing or trading of our common stock on The Nasdaq Capital Market. The Company can regain compliance with the $1.00 minimum bid listing requirement if the closing bid price of our common stock is at least $1.00 per share for a minimum of ten (10) consecutive business days during the 180-day extension period.

We are actively monitoring the minimum bid price of our common stock and are considering available options to regain compliance. We expect to seek stockholder approval to amend our certificate of incorporation to effectuate a reverse stock split in an effort of regain compliance with the $1.00 minimum bid price listing requirement and avoid delisting.

Critical Accounting Policies and Significant Judgments and Estimates

This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, warrant liability, and stock-based compensation. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no significant changes in our critical accounting policies and significant judgments and estimates as discussed in our 2022 10-K.

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Derivative Warrant Liability

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

Results of Operations

Three Months Ended June 30, 2022 Compared to Three Months Ended June 30, 2021

Net loss for the three months ended June 30, 2022 was $6,495,000 compared to $5,929,000 for the three months ended June 30, 2021. The increase in losses for the current three-month period is mostly due to an unfavorable variance of $690,000 in the change in fair value of warrant liability offset by decreased operating costs and expenses and higher investment income described below.

Cash used in operating activities for the three-months ended June 30, 2022 was $4,781,000 compared to $5,809,000 for the three months ended June 30, 2021. See “Cash Flows” section below for further details.

Revenues

During the three months ended June 30, 2022 and 2021, the Company did not realize any revenues from operations. We do not anticipate any revenues until such time as one of our product candidates has been approved for commercialization by appropriate regulatory authorities or we enter into certain types of collaboration or licensing arrangements, none of which is anticipated to occur in the near future.

Operating Costs and Expenses

For the three months ended June 30, 2022, operating costs and expenses totaled $6,608,000 compared to $6,652,000 for the three months ended June 30, 2021. Operating costs and expenses were comprised of the following:

•

Research and development expenses were $1,961,000 for the three months ended June 30, 2022, compared to $4,184,000 for the three months ended June 30, 2021, a decrease of $2,223,000. Research and development expenditures in the June 30, 2022 quarter included costs for pre-clinical studies on SM-88 MOA and biomarker studies, as well as TYME-19. Research and development costs in the June 30, 2021 included costs for the TYME-88-Panc and Precision Promise clinical trials that were discontinued in June 2021 and January 2022, respectively. Research and development activities primarily consist of the following:

Study and consulting expenses were $1,542,000 for the three months ended June 30, 2022, compared to $3,465,000 for the three months ended June 30, 2021, a decrease of $1,923,000. The decrease reflects the discontinuation of the TYME-88-Panc and Precision Promise clinical trials in June 2021 and January 2022, respectively, offset by costs incurred for the OASIS trial, SM-88 mechanism of action as well as biomarker studies.

Salary and salary-related expenses for research and development personnel were $329,000 for the three months ended June 30, 2022, compared to $546,000 for the three months ended June 30, 2021, a decrease of $217,000 primarily due to lower headcount for roles currently outsourced to consultants.

Included in research and development expense for the three months ended June 30, 2022 is $90,000 of stock-based compensation expense related to stock options granted to research and development personnel compared to $173,000 for the three months ended June 30, 2021, a decrease of $83,000 primarily attributable to fully vested grants and cancellation/forfeiture of options.

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•

General and administrative expenses were $4,647,000 for the three months ended June 30, 2022, compared to $2,468,000 for the three months ended June 30, 2021, an increase of $2,179,000. The general and administrative expenses for the respective periods include:

Other general and administrative expenses were $4,196,000 during the three months ended June 30, 2022, compared to $1,997,000 for the three months ended June 30, 2021, an increase of $2,199,000, reflecting financial advisor, clinical advisor and professional fees related to the evaluation of strategic options, including due diligence of potential counterparties, that resulted in the Company’s entry into the Merger Agreement.

Stock-based compensation expense related to stock options was $451,000 for the three months ended June 30, 2022 compared to $471,000 for the three months ended June 30, 2021, a decrease of $20,000.

Other income (expense)

For the three months ended June 30, 2022, the Company had $35,000 non-cash income relating to the change in fair value of the warrant liability during the period, compared to $725,000 non-cash income for the three months ended June 30, 2021, resulting in a $690,000 variance between the periods. See Item 1, Note 6 for details regarding changes in the fair value of the warrant liability.

For the three months ended June 30, 2022 the Company had investment income and interest income on cash accounts of $90,000 compared to $19,000 for the three months ended June 30, 2021. For the three months ended June 30, 2022, the Company had interest expense primarily related to the amortization of the severance payable discount of $12,000 compared to $21,000 for the three months ended June 30, 2021.

Adjusted Net Loss and Adjusted Net Loss per Share

After adjusting for change in fair value of warrant liability and amortization of employees, directors and consultants stock options, adjusted net loss for the three months ended June 30, 2022 was $5,990,000 or $0.03 per share compared to $6,010,000 or $0.03 per share for the three months ended June 30, 2021. Adjusted net loss and adjusted net loss per share are non-GAAP measures. See “Use of Non-GAAP Measures” below for a reconciliation to the comparable GAAP measures.

Use of Non-GAAP Measures

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

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Reconciliation of Net Loss to Adjusted Net Loss
	Three Months Ended June 30,
	2022			2021
Net loss (GAAP)	$	(6,495,000	)	$	(5,929,000	)
Adjustments:
Change in fair value of warrant liability		(35,000	)		(725,000	)
Amortization of employees, directors and consultants stock options		540,000			644,000
Adjusted net loss (non-GAAP)	$	(5,990,000	)	$	(6,010,000	)


Reconciliation of Net Loss Per Share to Adjusted Net Loss Per Share
	Three Months Ended June 30,
	2022			2021
Net loss per share (GAAP)	$	(0.04	)	$	(0.03	)
Adjustments:
Change in fair value of warrant liability	*			*
Amortization of employees, directors and consultants stock options		0.01		*
Adjusted net loss per share (non-GAAP)	$	(0.03	)	$	(0.03	)
* The effect of the change was negligible to the adjusted net loss per share.

The Non-GAAP Measures for the three months ended June 30, 2022 and 2021 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:

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

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

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.

Liquidity and Capital Resources

Liquidity and Capital Requirements Outlook

On February 8, 2021, the Company closed on a registered direct offering of 40,000,000 shares of its common stock, par value $0.0001 per share, at a purchase price of $2.50 per share. The gross proceeds of the offering were $100 million, prior to deducting placement agent’s fees and other offering expenses payable by TYME, which were approximately $6.2 million.

The Company continues to use the net proceeds of this offering for the development of our clinical and preclinical assets and for general corporate purposes, capital expenditures, working capital and general and administrative expenses. The Company’s most significant funding needs are in connection with (i) participating in the investigator-initiated HoPES clinical trial of SM-88 in sarcoma, (ii) participating in OASIS, our recently announced investigator-initiated prospective open-label Phase II trial, evaluating the efficacy and safety of SM-88 with MPS for the treatment of metastatic HR+, HER2- breast cancer after treatment, (iii) conducting

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preclinical studies of an injectable form of SM-88, (iv) conducting preclinical studies in connection with our other preclinical pipeline products, TYME-19, TYME-18 and Tumor Targeting Technology, and (v) conducting additional or related studies of other potential drug candidates. If we determine to move beyond the preclinical stage for any of our preclinical product candidates or if we pursue studies in other cancer types, our liquidity requirements will be increased. Additionally, if the Company completes the potential Merger, the Company will, among other transaction related payment obligations, be obligated to pay each of its executive officers a retention bonus within 20 days of such transaction. (See Note 14, Subsequent Event.)

Primarily as a result of its active clinical trials, including timing of enrollment, and closing out its discontinuing clinical programs, as well as other business developments, including costs associated with the potential Merger, but not taking into consideration any potential decision to close down its trials and cease operations, the Company currently anticipates that its quarterly cash operating expense will average approximately $5.0 to $7.0 million during fiscal year 2023. Management expects that the Company’s net cash usage or net “cash burn” will be less than its operating costs. However, if the proposed Merger is consummated, the Company will become a subsidiary of Syros, and the information presented herein may not be indicative of the cash resources, liquidity sources and liquidity needs of the combined company.

As of June 30, 2022, the Company had cash on hand of approximately $6.4 million and working capital of approximately $73.4 million. During the three months ended June 30, 2021, the Company established an investment policy and invested approximately $74.1 million in a portfolio of highly liquid investments and marketable securities. As of June 30, 2022, the Company had marketable securities of $71.8 million and accrued interest of $0.6 million classified in other current assets. The primary objectives of the Company’s policy are to preserve capital and diversify risk, while maintaining sufficient liquidity to meet cash flow needs.

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

The Company has historically funded its operations primarily through equity offerings of its common stock. As a clinical-stage entity, without product revenues and ongoing needs to fund our clinical development activities and general operations, we regularly evaluate opportunities to raise capital and obtain necessary, as well as opportunistic financing. To meet our short and long-term liquidity needs, we currently expect to use existing cash balances, marketable securities and a variety of other means, including potential issuances of debt or equity securities in public or private financings, option exercises, and partnerships and/or collaborations. The demand for the equity and debt of biopharmaceutical and biotechnology companies like ours is dependent upon many factors, including the general state of the financial markets. During times of extreme market volatility, capital may not be available on favorable terms, if at all. Our inability to obtain such additional capital could materially and adversely affect our business operations.

While we likely would 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. Moreover, as discussed above, should the Company be unable to maintain compliance with Nasdaq listing requirements, our ability to raise funds and, therefore, our liquidity, could be negatively impacted. See Item 1A – Risk Factors for additional information.

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

From time to time, we may also restructure our outstanding securities or seek to repurchase or redeem them if we believe doing so would provide us with additional flexibility to raise capital or is otherwise in the best interests of the Company.

Historical Financings

On January 7, 2020, the Company and Eagle Pharmaceuticals, Inc. (“Eagle”) entered into an SPA (the “Eagle SPA”), pursuant to which the Company issued and sold to Eagle 10,000,000 shares of common stock, at a price of $2.00 per share. The Eagle SPA provides that Eagle will, subject to certain conditions, make an additional payment of $20 million upon the occurrence of a milestone event, which is defined as the earlier of (i) achievement of the primary endpoint of OS in the TYME-88-Panc pivotal trial; (ii)

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achievement of the primary endpoint of OS in the PanCAN Precision Promise^SM SM-88 registration arm; or (iii) FDA approval of SM-88 in any cancer indication. This payment would be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement.

On October 18, 2019, the Company entered into an Open Market Sale Agreement^SM , which was amended on August 12, 2020 (the “Sale Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company may, from time to time, sell shares of Common Stock, having an aggregate offering price of up to $30.0 million through Jefferies, as the Company’s sales agent (the “Jefferies ATM”). As indicated in the amendment, the shares will be offered and sold by the Company pursuant to its currently effective Registration Statement on Form S-3, as amended (Reg. No. 333-245033). Any sales of Common Stock pursuant to the Sales Agreement will be made by methods deemed to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. Jefferies will use commercially reasonable efforts to sell the shares from time to time, based on the instructions of the Company. The Company will pay Jefferies a commission rate of three percent (3%) of the gross proceeds from the sales of shares of Common Stock sold pursuant to the Sale Agreement. Under the Sale Agreement, the Company is not required to use the full available amount authorized and it may, by giving notice as specified in the Sale Agreement, terminate the Sale Agreement at any time. During the three months ended June 30, 2022 and June 30, 2021, the Company did not raise any proceeds under the Jefferies ATM. As of June 30, 2022, there remained approximately $22.2 million of availability in the Jefferies ATM subject to the terms of the Sale Agreement.

In May 20, 2020, the Company entered into exchange agreements (the “Share Exchange Agreements”) with the Holders of warrants that were issued in April 2019 (the “April 2019 Warrants”). Pursuant to the Share Exchange Agreements with Holders of the April 2019 Warrants to purchase 5,833,333 shares of Common Stock in the aggregate, the Company issued an aggregate of 2,406,250 shares of Common stock (the “Exchange Shares”) in exchange for such April 2019 Warrants. Concurrently therewith, each such Holder executed and delivered to the Company a leak-out agreement (a “Share Leak-Out Agreement”) that contained trading restrictions with respect to the Exchange Shares, which (i) for the first 90 days, prohibit any sales of Exchange Shares, (ii) for the subsequent 90 days, limit sales of Exchange Shares on any day to 2.5% of that day’s trading volume of Common Stock, and (iii) prohibit new short positions or short sales on Common Stock for the combined 180 day period.

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

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

Cash Flows

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

	Three Months Ended June 30,
	2022			2021
Net cash (used in) provided by operating activities	$	(4,781,000	)	$	(5,809,000	)
Net cash (used in) provided by investing activities		(2,542,000	)		(65,254,000	)
Net cash (used in) provided by financing activities		-			6,000

Operating Activities

Our cash used in operating activities in the three months ended June 30, 2022 totaled $4.8 million, which is the sum of (i) our net loss of $6.5 million, adjusted for non-cash items of $0.5 million expense amortization of stock-based compensation and $0.4 million net amortization expense of premiums and discounts on marketable securities, and (ii) changes in operating assets and liabilities of $0.8 million.

Our cash used in operating activities in the three months ended June 30, 2021 totaled $5.8 million, which is the sum of (i) our net loss of $5.9 million, adjusted for non-cash items of $0.6 million expense amortization of stock-based compensation and $0.2 million net amortization expense of premiums and discounts on marketable securities, offset by $0.7 million income related to change in fair

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value of warrant liability.

Investing Activities

During the three months ended June 30, 2022, our investing activities consisted of the purchase of $17.0 million of marketable securities and the receipt of approximately $14.5 million of proceeds from maturities of marketable securities.

During the three months ended June 30, 2021, our investing activities consisted of the purchase of $74.1 million of marketable securities of which $65.3 million were classified as marketable securities and $8.8 million were classified as cash equivalents on the Company’s condensed consolidated balance sheet.

Financing Activities

During the three months ended June 30, 2021, our financing activities consisted of the receipt of $6,000 in proceeds from the exercise of stock options.

There was no financing activity for the three months ended June 30, 2022.

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.

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Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

Not required for smaller reporting companies.

Item 4.

Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Under the supervision of and with the participation of management, including our principal executive officer and acting principal financial officer, we evaluated the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities and Exchange Act of 1934, as amended, as of June 30, 2022. Based on such evaluation, our principal executive officer and acting principal financial officer concluded that our disclosure controls and procedures were effective.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II – OTHER INFORMATION

Item 1.

Legal Proceedings.

In connection with the Merger, on July 25, 2022, a complaint captioned Irwin v. Tyme Technologies, Inc., et al., Case No. 3:22-cv-04727 was filed in the United States District Court for the District of New Jersey against the Company and our board of directors. The complaint generally alleges violations of Sections 14(a) and 20(a) of the Exchange Act in connection with the registration statement on Form S-4 related to the proposed Merger transaction with Syros that was filed on July 18, 2022. In particular, the complaint generally alleges that the registration statement contains materially misleading and incomplete information concerning: (i) certain conflicts of interest involving our management and our Board; (ii) the background and process leading up to the Merger; (iii) Syros’ and TYME’s financial projections; (iv) the description of the fairness opinion and financial analyses performed by Piper Sandler, which acted as Syros’ financial advisor for the Merger; and (v) financial analyses performed by Moelis, which acted as TYME’s financial advisor for the Merger. The complaint seeks, among other things: an injunction enjoining consummation of the Merger, rescissory relief, an order directing the defendants to disseminate a joint proxy statement/prospectus that includes certain additional and allegedly material information, costs of the action, including plaintiff’s attorneys’ fees and experts’ fees, and any other relief the court may deem just and proper.

We believe that the complaint is wholly without merit.

We have also received correspondence from law firms claiming to represent purported stockholders of the Company, either threatening litigation, requesting books and records concerning the Merger pursuant to Section 220 of the Delaware General Corporation law (“DGCL”), or making other demands relating to the Merger including that additional disclosures be provided. We cannot predict whether any of such demands or threats will result in litigation, whether additional demands or litigation may materialize, or the outcome of litigation relating to the Merger.

Item 1A.

Risk Factors.

Our Annual Report on Form 10-K for the year ended March 31, 2022 includes a detailed discussion of our risk factors. Except as set forth below, at the time of this filing, there have been no material changes to the risk factors that were included in the Form 10-K.

The announcement and pendency of the Merger with Syros may result in disruptions to our business.

The Merger Agreement generally requires us to operate its business in the ordinary course pending completion of the Merger and restricts it from taking certain specified actions until the Merger is completed or the Merger Agreement is terminated. These restrictions may affect our ability to execute its business strategies and attain product development and other goals and may impact our financial condition, results of operations and cash flows. Further, in connection with the Merger, our current and prospective employees may experience uncertainty about their future roles with TYME following the consummation of the merger, which may materially adversely affect our ability to attract, motivate and retain key personnel. Additionally, the pursuit of the Merger may place a significant burden on Tyme management and internal resources, and will divert management’s time and attention from its day-to-day operations and the execution of our other strategic initiatives. This could adversely affect our financial results. In addition, we have incurred and will continue to incur other significant costs, expenses and fees for professional services and other transaction costs in connection with the Merger, and many of these fees and costs are payable regardless of whether or not the Merger is consummated. Any of the foregoing could adversely affect our business, our financial condition, and results of operations.

Following the Merger with Syros, the combined company may be unable to integrate successfully and realize the anticipated benefits of the Merger.

The Merger involves the combination of two companies which currently operate as independent companies. If the Merger is completed, the combined company may fail to realize some or all of the anticipated benefits of the Merger if the integration process takes longer than expected or is more costly than expected. In addition, Syros and TYME have operated and, until the completion of the Merger, will continue to operate, independently. It is possible that the integration process also could result in the diversion of each company’s management’s attention, the disruption or interruption of, or the loss of momentum in, each company’s ongoing businesses or inconsistencies in standards, controls, procedures and policies, any of which could adversely affect the combined company’s ability to maintain relationships with third parties or the ability to achieve the anticipated benefits of the Merger, or could otherwise adversely affect the business and financial results of the combined company.

If the Merger with Syros is not consummated and we are unable to identify and implement an alternative strategic option, we may choose to close down our trials and cease operations.

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On March 29, 2022, we announced that the TYME board of directors had decided to explore potential strategic options to enhance stockholder value and engaged outside financial and legal advisors to assist with that process, with the goal of ensuring that we were exploring a range of options to maximize value for TYME stockholders. Following an extensive process of evaluating strategic alternatives, on July 3, 2022, we entered into the Merger Agreement. We are devoting a substantial amount of our time and resources to consummating the Merger, however, there can be no assurance that such activities will result in the consummation of the Merger or that the Merger will deliver the anticipated benefits or enhance stockholder value. If the Merger is not consummated, we may be unable to identify and implement an alternative strategic option, in which case, we may choose to close down our trials and cease operations.

We may be unable to regain and maintain compliance with The Nasdaq Capital Market continued listing requirements, which could cause our common stock to be delisted from The Nasdaq Capital Market. This could result in the lack of a market for our common stock, cause a decrease in the value of an investment in Tyme, and adversely affect our business, financial condition, and results of operations.

Our common stock is currently listed on The Nasdaq Capital Market. To maintain the listing of our common stock on The Nasdaq Capital Market, we are required to meet certain listing requirements, including, among others, a minimum closing bid price of $1.00 per share.

On December 22, 2021, we received notice from The Nasdaq Capital Market that the closing bid price for Tyme’s common stock had been below $1.00 per share for the previous 30 consecutive business days, and that we are therefore not in compliance with the minimum bid price requirement for continued inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2), or Rule 5550(a)(2). The Nasdaq Capital Market’s notice has no immediate effect on the listing or trading of our common stock on The Nasdaq Capital Market.

The notice indicates that we will have 180 calendar days, until June 20, 2022, to regain compliance with this requirement. Tyme can regain compliance with the $1.00 minimum bid listing requirement if the closing bid price of our common stock is at least $1.00 per share for a minimum of ten (10) consecutive business days during the 180-day compliance period. We requested and were granted an additional 180-day compliance period and now have until December 19, 2022 to regain compliance.

A delisting of our common stock could negatively impact us by, among other things, reducing the liquidity and market price of our common stock and reducing the number of investors willing to hold or acquire shares, which would further restrict our ability to obtain equity financing. A suspension or delisting could also adversely affect our reputation, our relationships with our business partners and suppliers, which would have a material, adverse impact on our business, operating results and financial condition. In addition, a suspension or delisting would impair our ability to raise additional capital through equity or debt financing as well as our ability to attract and retain employees by means of equity compensation.

As of the date hereof, we had not regained compliance with Rule 5550(a)(2). We have asked our stockholders to approve an amendment to our Certificate of Incorporation to implement a reverse stock split in an effort to regain compliance with the $1.00 minimum bid listing requirement and avoid delisting.

We are involved in litigation related to the Merger and may become involved in additional litigation in connection with the Merger, and this could divert the attention of our management and harm our business, and insurance coverage may not be sufficient to cover all related costs and damages.

Various forms of stockholder litigation frequently follow the announcement of certain significant business transactions, such as a business combination transaction, including our recently announced proposed Merger transaction with Syros. Litigation often is expensive and diverts management’s attention and resources, which could adversely affect our business.

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rescissory relief, an order directing the defendants to disseminate a joint proxy statement/prospectus that includes certain additional and allegedly material information, costs of the action, including plaintiff’s attorneys’ fees and experts’ fees, and any other relief the court may deem just and proper.

We believe that the complaint is wholly without merit.

Moreover, additional lawsuits involving us or Syros may be filed in the future related to the Merger, which may impact our ability to consummate the Merger.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3.

Defaults Upon Senior Securities.

None.

Item 4.

Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.

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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, 2018. (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed with the SEC on April 2, 2018.)
3.3		Certificate of Designation of Series A Convertible Stock, dated January 7, 2020. (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed with the SEC on January 8, 2020.)
3.4		Amended and Restated By-Laws of Tyme Technologies, Inc., effective August 25, 2022. (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed with the SEC on April 29, 2022.)
10.1		Form of Nonqualified Stock Option Agreement, adopted on April 22, 2022, under the Tyme Technologies, Inc. 2015 Equity Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed with the SEC on April 29, 2022.)

10.2		Voting Agreement, effective April 18, 2022, by and between Michael Demurjian and Tyme Technologies, Inc. (Incorporated by reference to Exhibit 10.22 to our Annual Report on form 10-K filed with the SEC on May 25, 2022).****

10.3		Amendment to Release Agreement, effective April 18, 2022, by and between Michael Demurjian and Tyme Technologies, Inc. (Incorporated by reference to Exhibit 10.23 to our Annual Report on form 10-K filed with the SEC on May 25, 2022).

10.4		Form of Retention Agreement between Tyme Technologies, Inc. and certain executive officers (including James Biehl, Richard Cunningham, Jonathan Eckard, Barbara Galaini and Frank Porfido) (incorporated by reference to Exhibit 10.3 to our Current Report on Form 8-K filed with the SEC on April 29, 2022.)

10.5		Form of Indemnification Agreement between Tyme Technologies, Inc. and its individual directors and officers (incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed with the SEC on April 29, 2022.)

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

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

32.1 ^**		Section 1350 Certification of Principal Executive Officer and Principal Financial Officer.

101.INS^*		Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH^*		Inline XBRL Taxonomy Schema Document.

101.CAL^*		Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF^*		Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB^*		Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE^*		Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104		Cover Page Interactive Data File, formatted in Inline XBRL (contained in Exhibit 101.INS)

^*	Filed herewith.

^**	Furnished herewith.

^****

The personal addresses of the counterparties have been redacted from each of these exhibits.

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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: August 9, 2022

TYME TECHNOLOGIES, INC.

By:		/s/ Richard Cunningham
		Richard Cunningham
		Chief Executive Officer (Principal Executive Officer)

By:

/s/ Frank Porfido

Frank Porfido

Chief Financial Officer

(Principal Financial Officer)

By:

/s/ Barbara Galaini

Barbara Galaini

Corporate Controller

(Principal Accounting Officer)

tyme-ex311_6.htm

EXHIBIT 31.1

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

I, Richard Cunningham, certify that:

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

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

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

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

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

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

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

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

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

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

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

Date: August 9 2022		/s/ Richard Cunningham
		Richard Cunningham
		Chief Executive Officer
		(Principal Executive Officer)

tyme-ex312_8.htm

EXHIBIT 31.2

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

I, Frank Porfido, certify that:

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

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

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

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

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

Date: August 9, 2022		/s/ Frank Porfido
		Frank Porfido
		Chief Financial Officer
		(Principal Financial Officer)

tyme-ex321_7.htm

EXHIBIT 32.1

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

(18 U.S.C. SECTION 1350)

In connection with the Quarterly Report on Form 10-Q of Tyme Technologies, Inc. (the “Company”) for the quarter ended June 30, 2022, to which this certification is being filed as of the date hereof as an exhibit thereto (the “Report”), I, Richard Cunningham, Chief Executive Officer of the Company, and I, Frank Porfido, Chief Financial Officer of the Company, each certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

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

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

Date: August 9, 2022

/s/ Richard Cunningham

Richard Cunningham

Chief Executive Officer

(Principal Executive Officer)

/s/ Frank Porfido

Frank Porfido

Chief Financial Officer

(Principal Financial Officer)

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

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