The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
The Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
Tyme Technologies, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
December 31, 2021
(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 CMBTsTM that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific 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 is currently focused on developing its novel compound, SM-88, its preclinical pipeline of novel CMBTTM programs, as well as TYME 19 as a potential therapeutic for SARS CoV-2 diseases. The Company believes that early clinical results demonstrated by SM-88 in multiple advanced cancers, including pancreatic, prostate, sarcomas and breast, 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 73% 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 to receive SM-88 with MPS without additional therapies in patients who have failed or progressed after receiving two hormonal agents and a CDK4/6 inhibitor. 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 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 and the trial is being conducted by PI Dr. Chawla at the Sarcoma Oncology Center in Santa Monica, CA. We anticipate that the trial will complete enrollment by the end of the first half of calendar year 2022.
Preclinical Pipeline Programs
The Company has begun a comprehensive translational preclinical program focused on SM-88 MOA and Biomarker Identification/Validation. We have engaged Evotec, a leading global research and development company, to aid in the execution of these activities and 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 be targeted for treatment. Later in the program, the Company intends to incorporate liquid and tumor biopsies into future clinical trials to contribute to the biomarker identification. TYME anticipates this preclinical engagement will have several stages, and that it is likely to last through this fiscal year and also into future periods.
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Table of Contents
TYME-18 is a CMBT compound under development that is delivered intratumorally. TYME-18 leverages a member of the bile acid family to create a potential treatment for inoperable tumors. Preliminary observations of the local administration of TYME-18, a combination of a proprietary surfactant system and natural sulfonic acid, suggested its potential as an important regulator of energy metabolism that may impede the ability of tumors to increase in size, which, in addition to its lytic functionality, could prove useful in difficult-to-treat cancers. In initial preclinical xenograft mouse studies, TYME-18 was able to completely resolve over 90 percent (11/12 mice) of established colorectal tumors within 12 days versus an average of over 600 percent growth in the control animals.
TYME-19 is an oral synthetic member of the bile acid family. The Company also uses bile acids in its anticancer 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. In in vitro preclinical testing, TYME-19 prevented COVID-19 viral replication at doses without meaningful cytotoxicity to the treated cells. Previous independent preclinical research has also shown select bile acids may have had broad antiviral activity.
The Company has retained virology experts at Evotec to assess the MOAs of TYME-19. Evotec is one of a select number of global drug development companies with the capabilities to access the multiple existing and emerging variants of the COVID-19 virus. TYME and Evotec are testing 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 expect the work by Evotec will provide us with critical information allowing us to assess the current and potential future utility of TYME-19 in treating COVID-19.
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. This method of tumor targeting is predicated on the metabolic phenomenon in which cancer cells consume higher quantities of non-essential amino acids, including tyrosine, from their surrounding environment to support their growth because they cannot make enough of these amino acids. Tumor Targeting Technology is an investigational approach in the preclinical phase of development that is not approved in the U.S. for any disease indication and requires further preclinical development, which the Company plans to initiate this year.
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 PromiseSM. 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 overall survival for SM-88 with MPS in monotherapy was lower compared to standard of care chemotherapies with either Gemcitabine and Abraxane or modified FOLFIRINOX. The estimated remaining cost to the Company is approximately $0.3 million.
TYME-88-PANC (Part 2) (third-line Metastatic Pancreatic Cancer)
In fiscal year 2020, TYME launched its 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 it was 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 rate of patients randomized to the chemotherapy control arm, which could have potentially impacted the interpretative and regulatory utility of the data.
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Table of Contents
Following the strategic review discussed below, 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.
Therefore, the Company decided to stop enrollment and begin the process of closing down the trial. Patients currently on therapy are allowed to continue treatment until progression or unacceptable toxicity. The closing of this trial is expected to require several months to complete. In the nine months ended December 31, 2021, the Company expensed $708,000 of estimated closeout costs. The trial’s remaining ongoing expense to the Company is approximately $1.1 million, and is expected to be incurred over the next six months.
The accompanying condensed consolidated financial statements include the results of operations of Tyme Technologies, Inc. and its wholly-owned subsidiary, Tyme, Inc.
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 AgreementSM (as amended, the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as sales agent, pursuant to which the Company may, from time to time, sell shares of common stock through Jefferies having an aggregate offering price of up to $30.0 million (the “Jefferies ATM”). The Company did not sell any shares through the Jefferies ATM during the nine months ended December 31, 2021. In the nine months ended December 31, 2020, the Company raised approximately $6.1 million in aggregate gross proceeds through the Jefferies ATM and paid commissions and expenses of $0.3 million. At December 30, 2021, there remained approximately $22.2 million of availability to sell shares through the Jefferies ATM.
The proceeds of the aforementioned offerings are being used by the Company for continued clinical studies, drug commercialization and development activities and other general corporate and operating expenses.
For the nine months ended December 31, 2021, the Company had negative cash flow from operations of $14.0 million and net loss of $16.8 million, which included non-cash expenses of $1.9 million related to non-cash equity compensation and $1.2 million net amortization expense of premiums and discounts on marketable securities, offset by $1.6 million income change in fair value of warrant liability. As of December 31, 2021, the Company had working capital of approximately $71.1 million.
Management has concluded that substantial doubt does not exist regarding the Company’s ability to satisfy its obligations as they come due during the twelve-month period following the issuance of these financial statements. This conclusion is based on the Company’s assessment of qualitative and quantitative conditions and events, considered in aggregate as of the date of issuance of these financial statements that are known and reasonably knowable. Among other relevant conditions and events, the Company has considered its operational plans, liquidity sources, obligations due or expected, funds necessary to maintain the Company’s operations, and potential adverse conditions or events as of the issuance date of these financial statements.
Note 2. Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements and related notes should be read in conjunction with the consolidated financial statements and related notes contained in the Company’s Annual Report on Form 10-K for the year ended March 31, 2021 filed with the SEC on June 10, 2021 (the “2021 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
9
Table of Contents
recurring nature. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the full year.
The Company’s condensed consolidated financial statements include the accounts of Tyme Technologies, Inc. and its subsidiary, Tyme Inc. All intercompany transactions and balances have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in 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, 2021 included in the Company’s 2021 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.
10
Table of Contents
Level 3: Pricing inputs are unobservable for the assets. Level 3 assets include private investments that are supported by little or no market activity. Level 3 valuations are for instruments that are not traded in active markets or are subject to transfer restrictions and may be adjusted to reflect illiquidity and/or non-transferability, with such adjustment generally based on available market evidence. In the absence of such evidence, management’s best estimate is used.
An adjustment to the pricing method used within either Level 1 or Level 2 inputs could generate a fair value measurement that effectively falls in a lower level in the hierarchy. The Company had no material re-measurements of fair value with respect to financial assets and liabilities, during the periods presented, other than those assets and liabilities that are measured at fair value on a recurring basis 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 as conditions evolve and fluctuate around the world. The extent to which the continuing COVID-19 pandemic impacts our product candidates and business, including patients’ willingness to participate and remain in clinical trials, the timing of meeting enrollment expectations, the ability of our third-party partners to remain operational and our access to capital markets and financing sources, depends on numerous evolving factors that are highly uncertain, cannot be accurately predicted, and may be significant.
Recent Accounting Pronouncements
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Amendments include removal of certain exceptions to the general principles of ASC 740 , Income Taxes and simplification in several other areas such as accounting for a franchise tax (or similar tax) that is partially based on income. ASU 2019-12 is effective for public business entities for annual reporting periods beginning after December 15, 2020, and interim periods within those reporting periods. The Company adopted the pronouncement as of April 1, 2021 and the adoption of this standard did not have a material impact on its condensed consolidated financial statements and disclosures.
11
Table of Contents
In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) and has since modified the standard with several ASUs (collectively, “Topic 326”). Topic 326 requires companies to present a financial asset (or a group of financial assets) measured at amortized cost and available for sale debt securities net of the amounts expected to be collected. Prior U.S. GAAP delayed recognition of the full amount of credit losses until the loss was probable of occurring. Under this ASU, the income statement will reflect an entity’s current estimate of all expected credit losses. The measurement of expected credit losses will be based upon historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down of the security. Early adoption is permitted. The guidance is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted the pronouncement as of April 1, 2021 and the adoption of this standard did not have a material impact on its condensed consolidated financial statements and disclosures.
In August 2020, the FASB issued ASU No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40). ASU No. 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, the new guidance modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation.
The amendments in ASU No. 2020-06 are effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. FASB also specified that an entity should adopt the guidance as of the beginning of its annual fiscal year and is not permitted to adopt the guidance in an interim period. The Company adopted the pronouncement as of April 1, 2021 and the adoption of this standard did not have a material impact on its condensed consolidated financial statements and disclosures.
Note 3. Net Loss Per Common Share
The following table sets forth the computation of basic and diluted net loss per common share for the periods indicated:
|
|
Three Months Ended
December 31,
|
|
|
Nine Months Ended December 31,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Basic and diluted net loss per common share calculation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(5,317,664
|
)
|
|
$
|
(6,120,711
|
)
|
|
$
|
(16,811,537
|
)
|
|
$
|
(21,797,060
|
)
|
Weighted average common shares outstanding — basic and diluted:
|
|
|
172,206,894
|
|
|
|
130,172,441
|
|
|
|
172,206,417
|
|
|
|
127,611,426
|
|
Net loss per share of common stock — basic and diluted
|
|
$
|
(0.03
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.17
|
)
|
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 December 31, 2021 and 2020 have been excluded from the computation of diluted weighted average shares outstanding, as they are anti-dilutive:
|
|
December 31,
|
|
|
|
2021
|
|
|
2020
|
|
Stock options
|
|
|
14,458,198
|
|
|
|
15,456,522
|
|
Warrants
|
|
|
3,104,318
|
|
|
|
3,104,318
|
|
Total
|
|
|
17,562,516
|
|
|
|
18,560,840
|
|
12
Table of Contents
Note 4. Accounts Payable and Other Current Liabilities
Accounts payable (including accounts payable to a related party – see Note 11) and other current liabilities consisted of the following:
|
|
December 31,
2021
|
|
|
March 31,
2021
|
|
Legal
|
|
$
|
252,780
|
|
|
$
|
454,139
|
|
Consultant and professional services
|
|
|
149,743
|
|
|
|
176,957
|
|
Accounting and auditing
|
|
|
6,167
|
|
|
|
55,349
|
|
Research and development
|
|
|
2,992,984
|
|
|
|
2,657,202
|
|
Board of Directors and Scientific Advisory Board Compensation
|
|
|
420,711
|
|
|
|
435,594
|
|
Other
|
|
|
21,122
|
|
|
|
63,149
|
|
Total
|
|
$
|
3,843,507
|
|
|
$
|
3,842,390
|
|
Note 5. Severance Payable
During the nine months ended December 31, 2021, the Company entered into Separation and General Release Agreements with two 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 as of December 31, 2021 and March 31, 2021 was $1.0 million and $1.6 million, 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 nine months ended December 31, 2021.
The Company’s financial instruments measured at fair value on a recurring basis as of December 31, 2021 and March 31, 2021 are as follows:
|
|
|
|
|
|
Quoted
prices in
active
markets
|
|
|
Significant
other
observable
inputs
|
|
|
Significant
unobservable
inputs
|
|
December 31, 2021
|
|
Total
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
Financial assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
2,818,614
|
|
|
$
|
2,818,614
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Marketable Securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
|
21,613,527
|
|
|
|
—
|
|
|
|
21,613,527
|
|
|
|
—
|
|
Municipal debt securities
|
|
|
32,643,748
|
|
|
|
—
|
|
|
|
32,643,748
|
|
|
|
—
|
|
Long-term
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
|
11,851,787
|
|
|
|
—
|
|
|
|
11,851,787
|
|
|
|
—
|
|
Municipal debt securities
|
|
|
4,553,532
|
|
|
|
—
|
|
|
|
4,553,532
|
|
|
|
—
|
|
|
|
$
|
73,481,208
|
|
|
$
|
2,818,614
|
|
|
$
|
70,662,594
|
|
|
$
|
—
|
|
Financial liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability
|
|
$
|
312,517
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
312,517
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability
|
|
$
|
1,931,921
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,931,921
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
Table of Contents
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 warrant issued in conjunction with the Exchange Agreements (see Note 8 for transaction details) (the “May 2020 Warrant”) is based on significant inputs not observable in the market and is classified as Level 3 liability as of December 31, 2021 and March 31, 2021. 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.
The following table details key inputs and assumptions used to estimate the fair value of the May 2020 Warrant as of December 31, 2021 and March 31, 2021 using a Black Scholes model:
|
|
May 2020 Warrant
|
|
|
May 2020 Warrants
|
|
|
|
December 31, 2021
|
|
|
March 31, 2021
|
|
Stock price
|
|
$
|
0.60
|
|
|
$
|
1.78
|
|
Volatility
|
|
|
89
|
%
|
|
|
78
|
%
|
Remaining term (years)
|
|
2.25
|
|
|
|
3.01
|
|
Expected dividend yield
|
|
|
—
|
|
|
|
—
|
|
Risk-free rate
|
|
|
0.79
|
%
|
|
|
0.35
|
%
|
The following table summarizes activity for liabilities measured at fair value using Level 3 significant unobservable inputs:
|
|
December 31, 2021
|
|
Beginning balance, March 31, 2021
|
|
$
|
1,931,921
|
|
Change in fair value of May 2020 Warrant liability
|
|
|
(1,619,404
|
)
|
Ending balance, December 31, 2021
|
|
$
|
312,517
|
|
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 December 31, 2021:
|
|
December 31, 2021
|
|
|
|
Amortized cost
|
|
|
Gross Unrealized Gains
|
|
|
Gross Unrealized Loss
|
|
|
Fair Value
|
|
Money market funds
|
|
$
|
2,818,614
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,818,614
|
|
Corporate debt securities
|
|
|
33,589,518
|
|
|
|
—
|
|
|
|
(124,204
|
)
|
|
|
33,465,314
|
|
Municipal debt securities
|
|
|
37,237,272
|
|
|
|
3,565
|
|
|
|
(43,557
|
)
|
|
|
37,197,280
|
|
Total
|
|
$
|
73,645,404
|
|
|
$
|
3,565
|
|
|
$
|
(167,761
|
)
|
|
$
|
73,481,208
|
|
The following table summarizes the classification of available-for-sale securities:
|
|
December 31, 2021
|
|
|
March 31, 2021
|
|
Cash and cash equivalents
|
|
$
|
2,818,614
|
|
|
$
|
—
|
|
Marketable securities
|
|
|
70,662,594
|
|
|
|
—
|
|
Total
|
|
$
|
73,481,208
|
|
|
$
|
—
|
|
14
Table of Contents
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
|
|
$
|
2,818,614
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,818,614
|
|
|
$
|
—
|
|
Corporate debt securities
|
|
|
21,613,527
|
|
|
|
(61,301
|
)
|
|
|
11,851,787
|
|
|
|
(62,903
|
)
|
|
|
33,465,314
|
|
|
|
(124,204
|
)
|
Municipal debt securities
|
|
|
32,643,748
|
|
|
|
(17,547
|
)
|
|
|
4,553,532
|
|
|
|
(22,445
|
)
|
|
|
37,197,280
|
|
|
|
(39,992
|
)
|
Total
|
|
$
|
57,075,889
|
|
|
$
|
(78,848
|
)
|
|
$
|
16,405,319
|
|
|
$
|
(85,348
|
)
|
|
$
|
73,481,208
|
|
|
$
|
(164,196
|
)
|
Note 8. Stockholders’ Equity
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. 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 April 2019 Warrants. Concurrently therewith, such Holder executed and delivered to the Company a leak-out agreement that contained trading restrictions on sales of Common Stock issued upon exercise of the May 2020 Warrant that are substantially similar to the restrictions on Exchange Shares in the Share Leak-Out Agreement, provided that the leak-out restrictions will only apply to the first 893,750 shares of Common Stock issued pursuant to the May 2020 Warrant.
The April 2019 Warrants were remeasured as of May 20, 2020, before the exchange, using the Monte Carlo pricing simulation resulting in a fair value of approximately $7.3 million, and the change in fair value from March 31, 2020 to the fair value before the exchange of approximately $3.7 million was recorded as an expense component of other income (expense) within the condensed consolidated statement of operations. The key assumptions in applying the Monte Carlo simulation model were as follows: $1.70 stock price, 73% volatility, 3.87 years remaining term, 0.28% risk free rate and the probability of fundamental transactions occurring.
At May 20, 2020, the fair value of the 2,406,250 shares issued under the Share Exchange Agreements was approximately $3.4 million and resulted in a gain on exchange of approximately $1.9 million.
The exercise price of the May 2020 Warrant is subject to adjustment upon the occurrence of specific events, including stock dividends, stock splits, combinations and reclassifications of the Company’s Common Stock.
The Company determined that the May 2020 Warrant should be recorded as a derivative liability on the condensed consolidated balance sheet due to the May 2020 Warrant’s contractual provisions requiring issuance of registered common shares upon exercise. At May 20, 2020, the May 2020 Warrant was recorded at the fair value of $1.7 million as determined using the Black Scholes model and the change in fair value before and after the exchange of $0.3 million was recorded as a gain on warrant exchange as a component of other income (expense) within the condensed consolidated statement of operations. The key assumptions in applying the Black Scholes model were as follows: $1.64 stock price, 73% volatility, 3.87 years remaining term, 0.27% risk free rate and 7% discount for lack of marketability. The change in fair value of the May 2020 Warrant from May 20, 2020 through December 31, 2020 of $0.7 million income was recorded as a component of other income (expense) within the condensed consolidated statement of operations.
15
Table of Contents
The following summarizes the common stock warrant activity for the nine months ended December 31, 2021:
|
|
Warrant
Shares of
Common Stock
|
|
|
Weighted Average Exercise Price
|
|
Outstanding at March 31, 2021
|
|
|
3,104,318
|
|
|
$
|
2.77
|
|
Granted
|
|
|
—
|
|
|
|
—
|
|
Exchanged
|
|
|
—
|
|
|
|
—
|
|
Outstanding at December 31, 2021
|
|
|
3,104,318
|
|
|
$
|
2.77
|
|
At each of December 31, 2021 and March 31, 2021, 3,074,551, of common stock purchase warrants relating to SPAs were outstanding and exercisable.
Warrants
The Company has warrants to purchase its common stock outstanding as of December 31, 2021, 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 nine months ended December 31, 2021. During the nine months ended December 31, 2020, the Company raised approximately $6.1 million in gross proceeds through the sale of 4,453,939 shares of Common Stock and incurred $0.3 million of related costs that offset the proceeds. At December 31, 2021, there remained approximately $22.2 million of availability to sell shares through the Jefferies ATM.
Securities Purchase Agreement
On January 7, 2020, the Company and Eagle entered into the Eagle SPA, pursuant to which the Company issued and sold to Eagle 10,000,000 shares of common stock, at a price of $2.00 per share. The Eagle SPA provides that Eagle will, subject to certain conditions, make an additional payment of $20 million upon the occurrence of a milestone event, which is defined as the earlier of (i) achievement of the primary endpoint of 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.
16
Table of Contents
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.
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 December 31, 2021, the Company’s obligations to contract service providers were $0.2 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 December 31, 2021, 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 $0.9 million and $2.5 million, respectively, at December 31, 2021.
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 $17,000 and $45,000 for the three and nine months ended December 31, 2021 and $14,000 and $155,000 for the three and nine months ended December 31, 2020.
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.
17
Table of Contents
As of December 31, 2021, 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:
|
|
December 31, 2021
|
|
Fiscal year 2022
|
|
$
|
7,848
|
|
Fiscal year 2023
|
|
|
43,164
|
|
Total remaining lease payments
|
|
|
51,012
|
|
Less: present value adjustment
|
|
|
(3,129
|
)
|
Total operating lease liabilities
|
|
|
47,883
|
|
Less: current portion
|
|
|
(40,071
|
)
|
Operating lease liabilities, net of current portion
|
|
$
|
7,812
|
|
Note 11. Related Party Transactions
Legal
Faegre Drinker Biddle & Reath (“Faegre Drinker”), formerly Drinker Biddle & Reath LLP (“DBR”), has provided legal services to the Company. The Company’s Chief Legal Officer and Corporate Secretary holds the consulting role “Senior Counsel” with Faegre Drinker. Legal fees incurred associated with Faegre Drinker were approximately $47,000 and $313,000 for the three and nine months ended December 31, 2021, respectively, and $127,000 and $523,000 for the three and nine months ended December 31, 2020. At December 31, 2021 and March 31, 2021, the Company had approximately $46,000 and $87,000, respectively, in accounts payable and accrued expenses payable to Faegre Drinker.
Note 12. Equity Incentive Plan
Stock Options
As of December 31, 2021, there was approximately $5.1 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 3.0 years.
As of December 31, 2021, there were 10,680,381 shares available for grant under the Company’s 2015 Equity Incentive Plan and 2016 Director Plan.
Stock based compensation expense was recognized as follows:
|
|
Three Months Ended
December 31,
|
|
|
Nine Months Ended December 31,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
General and administrative
|
|
$
|
468,000
|
|
|
$
|
490,000
|
|
|
$
|
1,419,000
|
|
|
$
|
1,589,000
|
|
Research and development
|
|
|
136,000
|
|
|
|
295,000
|
|
|
|
445,000
|
|
|
|
1,149,000
|
|
Total
|
|
$
|
604,000
|
|
|
$
|
785,000
|
|
|
$
|
1,864,000
|
|
|
$
|
2,738,000
|
|
The Company uses the Black-Scholes option pricing model to determine the fair value of stock options granted. For employees and non-employees, the compensation expense is amortized on a straight-line basis over the requisite service period, which approximates the vesting period. The Company accounts for forfeitures as they occur, rather than estimating forfeitures as of an award’s grant date.
The expected volatility of options granted has been determined using the method described under ASC 718 using the expected volatility of similar companies. The expected term of options granted to employees, non-employees and consultants in the current fiscal period has been based on the term by using the simplified method as allowed under SAB No. 110 and ASU 2018-7.
The weighted average assumptions used to determine such values are presented in the following table:
|
|
December 31,
2021
|
|
|
December 31,
2020
|
|
Risk free interest rate
|
|
0.28% - 1.01%
|
|
|
0.17% - 0.53%
|
|
Expected volatility
|
|
97.11% - 105.37%
|
|
|
88.02% - 101.67%
|
|
Expected term (in years)
|
|
2.7 - 6.1
|
|
|
2.8 - 6.1
|
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
18
Table of Contents
The following is a summary of the status of the Company’s stock options for the nine months ended December 31, 2021:
|
|
Number of
Options
|
|
|
Weighted
Average
Exercise
Price
|
|
Outstanding at March 31, 2021
|
|
|
12,588,068
|
|
|
$
|
2.92
|
|
Granted
|
|
|
3,569,500
|
|
|
$
|
1.38
|
|
Cancelled/Forfeited
|
|
|
(1,693,120
|
)
|
|
$
|
3.96
|
|
Exercised
|
|
|
(6,250
|
)
|
|
$
|
0.99
|
|
Outstanding at December 31, 2021
|
|
|
14,458,198
|
|
|
$
|
2.41
|
|
Options exercisable at December 31, 2021
|
|
|
8,895,950
|
|
|
$
|
3.11
|
|
|
|
|
|
|
|
Stock Options Outstanding
|
|
|
Stock Options Vested
|
|
Range of
Exercise
Price
|
|
Number Outstanding at December 31, 2021
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Life
(Years)
|
|
|
Aggregate
Intrinsic
Value
|
|
|
Number
Vested at December 31, 2021
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Aggregate
Intrinsic
Value
|
|
$0.95 - $8.75
|
|
|
14,458,198
|
|
|
$
|
2.41
|
|
|
|
7.2
|
|
|
$
|
-
|
|
|
|
8,895,950
|
|
|
$
|
3.11
|
|
|
$
|
-
|
|
The intrinsic value calculated as the excess of the market value as of December 31, 2021 over the exercise price of the options is $0. The market value per share as of December 31, 2021 was $0.60 as reported by the NASDAQ Capital Market.
Note 13. Income Taxes
A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. The Company weighed available positive and negative evidence and concluded that a full valuation allowance should continue to be maintained on its net deferred tax assets.
The Company is required to evaluate uncertain tax positions taken or expected to be taken in the course of preparing the Company’s condensed consolidated financial statements to determine whether the tax positions are more likely than not of being sustained by the applicable tax authority. As of December 31, 2021, the Company’s uncertain tax positions remain unchanged. Due to the full valuation allowance, none of the gross unrecognized tax benefits, if recognized, would affect the effective tax rate at December 31, 2021.
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
The Company evaluates events or transactions that occur after the balance sheet date but prior to the issuance of consolidated financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure.
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 overall survival for SM-88 with MPS in monotherapy was lower compared to standard of care chemotherapies with either Gemcitabine and Abraxane or modified FOLFIRINOX.
The Precision Promise trial is an adaptive randomized Phase 2/3 trial in mPDAC for patients treated in both first-line and second-line therapies. SM-88 (racemetyrosine) with MPS (10 mg methoxsalen, 50 mg phenytoin, and 0.5 mg sirolimus) was the first therapy to join this trial and was being studied as a standalone monotherapy in second-line patients versus control arms of standard of care regimens of either Gemcitabine and Abraxane or modified FOLFIRINOX.
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