Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

For the quarterly period ended:

December 31, 2019

or

For the transition period from                      to                     

Commission File Number: 001-38169

 

TYME TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

17 State Street – 7th Floor

New York, New York 10004

(Address of principal executive offices)

(Zip Code)

(212) 461-2315

(Registrant’s telephone number, including area code)

 

Not Applicable

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

 

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

 

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.

 

 

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

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

The number of shares outstanding of the registrant’s common stock on January 28, 2020 was 122,839,504.

 

---

Table of Contents

 

TABLE OF CONTENTS

 

 

 

 

---

Table of Contents

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements in this Quarterly Report on Form 10-Q are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. All statements contained in this Quarterly Report on Form 10-Q other than statements of historical facts, including statements regarding our future results of operations and financial position, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements within this report include, without limitation, statements regarding our drug candidates (including SM-88 and TYME- 18) and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned 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 cost of development and potential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials 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, that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply and the ability to achieve adequate clinical study design and start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trials may differ from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; and the factors described in the section captioned “Risk Factors,” of our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on June 12, 2019 and in the section captioned “Risk Factors” in Part II, Item 1A of this Quarterly Report, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission (available at www.sec.gov).

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

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

 

1

---

Table of Contents

 

PART I – FINANCIAL INFORMATION

Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

 

 

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

 

2

---

Table of Contents

 

Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

 

 

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

 

3

---

Table of Contents

 

Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ Equity

For the Three and Nine Months Ended December 31, 2019 and 2018

(Unaudited)

 

 

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

 

 

4

---

Table of Contents

 

Tyme Technologies, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

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

 

 

 

5

---

Table of Contents

 

Tyme Technologies, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

December 31, 2019

(Unaudited)

Note 1. Nature of Business

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

TYME is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs^TM) that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific pathways within cancer, TYME’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic requirements to cause cancer cell death.

The Company’s lead clinical CMBT program, SM-88 (racemetyrosine), is a novel, oral, monotherapy investigational agent that has been studied in approximately 180 patients, including Phase I and II clinical trials for pancreatic, prostate and other cancers. TYME recently launched its pivotal study for SM-88 in the third-line treatment of pancreatic cancer through an amendment to its ongoing TYME-88-Panc trial (“Part 2”), with the first patient dosed in the third quarter of fiscal year 2020. TYME also partnered with the Pancreatic Cancer Action Network (“PanCAN”) to study SM-88 in an adaptive randomized Phase II/III trial with registration intent known as Precision Promise^SM. In Precision Promise, SM-88 is starting as second-line monotherapy and could expand to first-line combination therapy with standard of care. HopES is a Phase II investigator-initiated trial evaluating SM-88 monotherapy in late-stage sarcomas, under the direction of principal investigator Dr. Sant Chawla and in collaboration with The Joseph Ahmed Foundation. The first sarcoma cancer patient in the HopES trial was dosed in the fourth quarter of fiscal year 2020. The Company has also completed and presented final data from its Phase II clinical trial in prostate cancer. All of SM-88’s current clinical programs, as well as its completed Phase II prostate cancer trial, study SM-88 in use with three low-dose conditioning agents: methoxsalen, phenytoin, and sirolimus. The Company is actively evaluating the expansion of its clinical program to hematological, breast, prostate and other cancers as SM-88 has demonstrated complete or partial responses in 15 different forms of cancer with a well-tolerated safety profile.

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

Liquidity

 

The condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has historically funded its operations primarily through equity offerings. In April 2019, the Company raised net proceeds of approximately $11.3 million after underwriting discounts and before expenses through an underwritten registered offering. Previously on November 2, 2017, the Company entered into an equity distribution agreement (the “Equity Distribution Agreement”) with Canaccord Genuity Inc. (“Canaccord”), with respect to an at-the-market (“ATM”) offering pursuant to which the Company, from time to time, sold shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”), having an aggregate offering price up to $30.0 million, through Canaccord, as the Company’s sales agent (the “Canaccord ATM”). In the year ended March 31, 2019, the Company raised approximately $5.8 million in aggregate gross proceeds before commissions and expenses through the Canaccord ATM and paid Canaccord aggregate commissions of $0.2 million. The Company did not sell any shares through the Canaccord ATM during the nine months ended December 31, 2019. On October 2, 2019, TYME sent notice to Canaccord that it was terminating the Equity Distribution Agreement, effective October 12, 2019.

 

On October 18, 2019, TYME entered into an Open Market Sale Agreement^SM (the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as sales agent, pursuant to which the Company may, from time to time, sell shares of Common Stock through Jefferies having an aggregate offering price of up to $30.0 million (the “Jefferies ATM”). In the quarter ended December 31, 2019, the Company raised approximately $0.6 million in aggregate gross proceeds before commissions and expenses through the Jefferies Sale Agreement and paid Jefferies aggregate commissions of $0.02 million.

 

Most recently (and subsequent to the quarter ended December 31, 2019) on January 7, 2020, the Company entered into a Securities and Purchase Agreement with Eagle Pharmaceuticals, (“Eagle”), 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. (see Note 14 - Subsequent Event). The proceeds of the aforementioned offerings are being used by the Company for continued clinical studies, drug commercialization planning and development activities and other general corporate and operating expenses.  

 

6

---

Table of Contents

 

For the nine months ended December 31, 2019, the Company had negative cash flow from operations of $13.9 million and net loss of $16.3 million, which included non-cash income of $2.6 million (related to change in fair value of warrant liability) and $4.7 million of non-cash expenses, primarily non-cash equity compensation expense. As of December 31, 2019, the Company had working capital of approximately $7.0 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 our consolidated financial statements and related notes contained in our Annual Report on Form 10-K for the year ended March 31, 2019 filed with the Securities and Exchange Commission (the “SEC”) on June 12, 2019 (the “2019 10-K”). The condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the SEC related to interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The financial information contained herein is unaudited; however, management believes all adjustments have been made that are necessary to present fairly the results for the interim periods. All such adjustments are of a normal and recurring nature. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the full year.

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

Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended March 31, 2019 included in the Company’s 2019 10-K.

Reclassifications

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

Fair Value of Financial Instruments

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

 

7

---

Table of Contents

 

Derivative Warrant Liability

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

Recent Accounting Pronouncements

 

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

 

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

 

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

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

 

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

 

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

 

 

 

8

---

Table of Contents

 

In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features. These amendments simplify the accounting for certain financial instruments with down round features. The amendments require companies to disregard the down round feature when assessing whether the instrument is indexed to its own stock, for purposes of determining liability or equity classification. This ASU is effective for the Company beginning with the quarter ending June 30, 2020. The Company has adopted this ASU effective April 1, 2019 and there was no impact on the consolidated financial statements.

 

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:

 

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

 

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

 

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

 

 

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:

 

 

9

---

Table of Contents

 

 

Note 5. Severance Payable

On March 15, 2019 the Company entered into a Release Agreement related to the separation of employment of its then-Chief Operating Officer. The agreement provides for salary continuance for five years, reimbursement of health benefits for three years and a modification to his outstanding stock options to extend the post-termination exercise period for his vested options from three months to five years. The Company recorded severance expense at its present value of $2.5 million (using a discount rate of 6%) for the year ended March 31, 2019, including $0.4 million relating to the stock option modification. The severance liability payable as of December 31, 2019 and March 31, 2019 was $1.7 million and $2.1 million, respectively.

Note 6. Fair Value Measurements

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

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

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

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

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

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

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

The Company has segregated all financial assets and liabilities that are measured at fair value on a recurring basis into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement date in the table below. Other than the warrants issued in connection with the issuance of Common Stock from the underwritten registered offering that closed on April 2, 2019, the Company had no assets or liabilities classified as Level 3 as of March 31, 2019 or December 31, 2019. 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, 2019.

The fair value of the warrants is considered a Level 3 valuation and was determined using a Monte Carlo simulation model. This model incorporated several assumptions at each valuation date including: the price of the Company’s Common Stock on the date of valuation, its expected volatility, the remaining contractual term of the warrant, the risk free interest rate over the term and estimates of the probability of fundamental transactions occurring (See Note 8 for further discussion of the issuance of Common Stock from an underwritten registered offering).

 

10

---

Table of Contents

 

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

 

 

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

 

Note 7. Debt

Insurance Note Payable

During the year ended March 31, 2019, the Company entered into a short-term financing arrangement with its insurance carrier related to payment of premium for its Director and Officer liability insurance coverage totaling $0.6 million for the policy year ending on March 18, 2020. As of December 31, 2019 and March 31, 2019, there remained a balance of $0 million and $0.6 million, respectively, recorded to insurance note payable on the accompanying consolidated balance sheets.

 

Note 8. Stockholders’ Equity

The following summarizes the common stock warrant activity for the nine months ended December 31, 2019:

 

 

At each of December 31, 2019 and March 31, 2019, 8,907,884 and 4,469,836, respectively, of common stock purchase warrants relating to securities purchase agreements were outstanding and exercisable.

 

 

11

---

Table of Contents

 

Warrants

The Company has warrants to purchase its common stock outstanding as of December 31, 2019, as follows:

 

 

At-the-Market Financing Facility

 

On October 18, 2019, the Company entered into the Sale Agreement with Jefferies, pursuant to which the Company may, from time to time, sell shares of Common Stock, having an aggregate offering price of up to $30,000,000 through Jefferies, as the Company’s sales agent. The shares will be offered and sold by the Company pursuant to its previously filed and currently effective Registration Statement on Form S-3, as amended (Reg. No. 333-211489). 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. 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.

 

On October 18, 2019, the Company commenced the Jefferies ATM and during the three months ended December 31, 2019, the Company raised approximately $0.6 million in gross proceeds via sale of 582,968 shares of Common Stock. The Company incurred $0.2 million of related costs which offset the proceeds. At December 31,2019 there remained approximately $29.4 million of availability to sell shares through the Jefferies ATM. On October 2, 2019, the Company sent notice terminating the Canaccord ATM effective October 12, 2019. During the nine months ended December 31, 2019, the Company did not sell shares under Canaccord ATM. At March 31, 2019, there remained approximately $17.9 million of availability to sell shares through the Canaccord ATM. In the year ended March 31, 2019, the Company raised approximately $5.8 million in gross proceeds through the Canaccord ATM via sale of 2,383,884 shares of Common Stock. The Company incurred $0.2 million of related costs which offset the proceeds.

 

April 2019 - Registered Offering

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

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

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

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

The Company determined that the Warrants should be recorded as a derivative liability on the condensed consolidated balance sheet due to the Warrants’ contractual provisions requiring issuance of registered common shares upon exercise and certain price protection rights. At the issuance date, the Warrants were recorded at the fair value of $7.3 million as determined using the Monte Carlo pricing simulation. The Warrants were re-measured at December 31, 2019 and the change in fair value for the three and nine months ending December 31, 2019 of approximately $(426) thousand and $2.6 million, respectively, was recorded as a component of other income (expense) within the condensed consolidated statement of operations.

 

 

12

---

Table of Contents

 

The following table details key inputs and assumptions used in the Monte Carlo simulation models used to estimate the fair value of the warrant liability as of December 31, 2019 and April 2, 2019, respectively:

 

Note 9. Commitments and Contingencies

Contract Service Providers

In the course of the Company’s normal business operations, it enters into agreements and arrangements with contract service providers to assist in the performance of its research and development and clinical research activities.

 

On June 30, 2019, the Company amended the Clinical Research Funding and Drug Supply Agreement dated October 9, 2018, with PanCAN, to enroll individuals diagnosed with pancreatic cancer in a platform style clinical research study. Stage 1 of the study was initiated in the fourth quarter of fiscal year 2020. After taking into consideration amounts already paid, the remaining estimated cost to the Company is approximately $7.0 million, subject to enrollment adjustments, and is expected to be incurred over two years.

Purchase Commitments

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 contracts are structured to match clinical supply needs for our ongoing trials and we expect the timing of associated payments to predominately occur during fiscal year 2020. Total outstanding future obligations associated with the contracts were $2.3 million at December 31, 2019.

 

Legal Proceedings

 

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

 

Note 10. Leases

 

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

 

Total Company rent expense, including short term rentals, was approximately $79,000 and $235,000 for the three and nine months ended December 31, 2019, respectively, and approximately $66,000 and $173,000 for the three and nine months ended December 31, 2018, respectively.

 

Operating lease right-of-use (“ROU”) assets and liabilities on the condensed consolidated balance sheet represents the present value of the remaining lease payments over the remaining lease terms. ROU assets also include any initial direct costs incurred and any lease payments made at or before the lease commencement date, less lease incentives received. Payments for additional monthly fees to cover the Company's share of certain facility expenses are not included in operating lease right-of-use assets and liabilities. The Company uses its incremental borrowing rate of 6.0% to calculate the present value of its lease payments, as the implicit rates in the leases are not readily determinable.

 

 

13

---

Table of Contents

 

As of December 31, 2019, the future minimum lease payments under non-cancellable operating lease agreements for which the Company has recognized operating lease right-of-use assets and lease liabilities were as follows:

 

 

 

Note 11. Related Party Transactions

 

Legal

 

Drinker Biddle & Reath LLP (“DBR”) has provided legal services to the Company. A partner of DBR was a member of the Company’s Board and had received, and was entitled to receive in the future, cash compensation payable to non-employee directors generally and equity compensation payable to non-employee directors under the Amended and Restated 2016 Stock Option Plan for Non-Employee Directors (the “2016 Director Plan”). See Note 12, Equity Incentive Plan. On September 10, 2018, the Company entered into an employment agreement with the partner and he was appointed as the Company’s Chief Legal Officer and Secretary. He ceased to be a non-employee director on September 10, 2018 and he resigned as a member of the Board, effective September 30, 2018. On September 1, 2018, the partner resigned from the partnership of DBR and he assumed the consulting role “of Counsel” with the firm.  Legal fees incurred associated with DBR were approximately $170,000 and $620,000 for the three and nine months ended December 31, 2019, respectively, and $132,000 and $794,000 for the three and nine months ended December 31, 2018, respectively. At December 31, 2019 and March 31, 2019, the Company had approximately $222,000 and $325,000, respectively, in accounts payable and accrued expenses payable to DBR.

Note 12. Equity Incentive Plan

Stock Options

As of December 31, 2019, there was approximately $5.6 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 1.53 years. As of December 31, 2019, there were 4,906,208 shares available for grant under the Company’s 2015 Equity Incentive Plan and 2016 Director Plan.

Stock based compensation expense recognized was as follows:

 

 

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.

 

14

---

Table of Contents

 

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

 

 

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

 

 

 

The intrinsic value calculated as the excess of the market value as of December 31, 2019 over the exercise price of the options, is $141,900. The market value per share as of December 31, 2019 was $1.40 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, 2019, the Company’s uncertain tax positions remain unchanged. Due to the full valuation allowance, none of the gross unrecognized tax benefits would affect the effective tax rate at December 31, 2019, if recognized.

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

Note 14. Subsequent Events    

Securities Purchase Agreement

On January 7, 2020, the Company and Eagle Pharmaceuticals, Inc. (“Eagle”) entered into a Securities Purchase Agreement (the “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 SPA provides that Eagle will, subject to certain conditions, make an additional payment of $20 million upon the occurrence of a milestone event, which is defined as the earlier of i) achievement of the primary endpoint of overall survival in its TYME-88-Panc pivotal trial; or (ii) achievement of the primary endpoint of overall survival in the PanCAN Precision Promise℠ SM-88 registration arm; or iii) U.S. Food and Drug Administration (FDA) approval of SM-88 in any cancer. 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.

 

15

---

Table of Contents

 

Co-Promotion Agreement

On January 7, 2020, the Company entered into a Co-Promotion Agreement (the “Agreement”) with Eagle, whereby Eagle agreed to provide sales representatives to cover 25% of the Company’s sales force requirements and will receive 15% of the net sales of all SM-88 products in the U.S. during the term of the Agreement. TYME will also be responsible for clinical development, regulatory approval, commercial strategy, marketing, reimbursement and manufacturing of SM-88. TYME retains the remaining 85% of net U.S. revenues and reserves the right to repurchase Eagle’s co-promotion right for $200 million.

               

\

\\

 

 

16

---

Table of Contents

 

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

The disclosures in this Quarterly Report are complementary to those made in our Annual Report on Form 10-K filed with the SEC on June 12, 2019 (the “2019 10-K”). You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing in this Quarterly Report as well as our audited financial statements, notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our 2019 Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this report and of our 2019 Form 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. As used in this report, unless the context suggests otherwise, “we,” “us,” “our,” “the Company,” “TYME” or “Tyme Technologies” refer to Tyme Technologies, Inc. together with its subsidiaries. All amounts in Management’s Discussion and Analysis of Financial Condition and Results of Operations are approximate.

Overview

 

TYME is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs^TM) that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific pathways within cancer, TYME’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic requirements to cause cancer cell death.

 

Our lead clinical CMBT program, SM-88 (racemetyrosine), is a novel, oral, monotherapy investigational agent that has been studied in approximately 180 patients, including Phase I and II clinical trials for pancreatic, prostate and other cancers. We recently 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 fiscal year 2020 and anticipated enrollment completion by the end of calendar year 2020 and data expected in 2021. We currently estimate the cost of the TYME-88-Panc trial (Part 2) to range from $15 million to $20 million, with such costs anticipated to extend through calendar year 2021. We also partnered with the Pancreatic Cancer Action Network (“PanCAN”) to study SM-88 in an adaptive randomized Phase II/III trial with registration intent known as Precision Promise^SM. In Precision Promise, SM-88 is starting as second-line monotherapy and could expand to first-line combination therapy with standard of care. The remaining estimated cost for Precision Promise Stage 1 is approximately $7.0 million, subject to enrollment adjustments, which is expected to be incurred over two years. HopES is a Phase II investigator-initiated trial evaluating SM-88 monotherapy in late-stage sarcomas, under the direction of principal investigator Dr. Sant Chawla and in collaboration with The Joseph Ahmed Foundation. The first sarcoma cancer patient in the HopES trial was dosed in the fourth quarter of fiscal year 2020. We also completed and presented final data from our Phase II clinical trial in prostate cancer. All of SM-88’s current clinical programs, as well as its completed Phase II prostate cancer trial, study SM-88 in use with three low-dose conditioning agents: methoxsalen, phenytoin, and sirolimus. The Company is actively evaluating the expansion of our clinical program to hematological, breast, prostate and other cancers as SM-88 has demonstrated complete or partial responses in 15 different forms of cancer with a well-tolerated safety profile.

Critical Accounting Policies and Significant Judgments and Estimates

This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, 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 2019 10-K.

 

17

 

---

Table of Contents

 

Derivative Warrant Liability

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

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

Recent Developments

 

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

 

 

On January 7, 2020 we entered into a securities purchase agreement with Eagle Pharmaceuticals pursuant to which we issued and sold to Eagle 10,000,000 shares of our Common Stock in return for $20 million, which was paid at closing. We are also entitled to receive $20 million in potential future milestone payments. We also entered into a co-promotion agreement (the “Agreement”) with Eagle whereby Eagle agreed to provide sales representatives to cover 25% of the Company’s sales force requirements and will receive 15% of the net sales of all SM-88 products in the U.S. during the term of the Agreement.. TYME will retain 85% of the net U.S. revenues and has the ability to repurchase Eagle’s rights under the Agreement for $200 million. (see Note 14 – Subsequent Events)

 

The first pancreatic cancer patient was dosed in Part 2 of the TYME-88-Panc pivotal trial designed to support approval of SM-88, TYME’s leading cancer metabolism-based therapy, for the third-line treatment of patients with metastatic pancreatic cancer.

 

      In January 2020 the first sarcoma cancer patient was dosed at the Sarcoma Oncology Center in the HopES Phase II trial designed to evaluate SM-88 for the treatment of high-risk sarcomas, which are ultra-rare cancers with high unmet medical need.

 

18

 

---

Table of Contents

 

Results of Operations

Three and Nine Months Ended December 31, 2019 Compared to Three and Nine Months Ended December 31, 2018

Net loss for the three months ended December 31, 2019 was $6,958,000 compared to $8,048,000 for the three months ended December 31, 2018; and the loss for the nine months ended December 31, 2019 was $16,276,000 compared to $21,786,000 for the nine months ended December 31, 2018. The decrease in losses for the three month period is due to decreased operating costs and expenses of $1,531,000 offset by $(426,000) expense change in the fair value of warrant liability. The decrease in losses for the nine month period is due to decreased operating costs and expenses of $2,841,000 and $2,594,000 income change in fair value of warrant liability.

Cash used in operating activities for the nine months ended December 31, 2019 was $13,861,000 compared to $16,108,000 for the nine months ended December 31, 2018. See Cash Flows section below for further details.

Revenues

During the three and nine month periods ended December 31, 2019 and 2018, the Company did not realize any revenues from operations. We do not anticipate any revenues until such time as one of our products has been approved for commercialization by appropriate regulatory authorities, or we enter into certain types of collaboration or licensing arrangements, none of which is anticipated to occur in the near future.

Operating Costs and Expenses

For the three months ended December 31, 2019, operating costs and expenses totaled $6,544,000 compared to $8,075,000 for the three months ended December 31, 2018, a decrease of $1,531,000. Operating costs and expenses were comprised of the following:

 

19

 

---

Table of Contents

 

For the nine months ended December 31, 2019, operating costs and expenses totaled $18,967,000 compared to $21,807,000 for the nine months ended December 31, 2018, a decrease of $2,840,000. Operating costs and expenses were comprised of the following:

Other income (expense)

For the three and nine months ended December 31, 2019, the Company had $426,000 expense and $2,594,000 of income relating to the change in fair value of the warrant liability during the period, compared to $0 for the three and nine months ended December 31, 2018.

For the three and nine months ended December 31, 2019, the Company had interest income on cash accounts of $38,000 and $186,000 compared to $29,000 for both the three and nine months ended December 31, 2018.

For the three and nine months ended December 31, 2019, the Company had interest expense of $26,000 and $89,000 primarily related to the amortization of the severance payable discount, compared to $1,000 and $7,000 for the three and nine months ended December 31, 2018.

 

Adjusted Net Loss and Adjusted Net Loss per Share

 

   Adjusted net loss for the three months ended December 31, 2019 was $4,930,000 or $0.05 per share compared to $6,048,000 or $0.06 per share for the three months ended December 31, 2018. Adjusted net loss for the nine-month period ended December 31, 2019 was $14,197,000 or $0.13 per share compared to $15,084,000 or $0.14 per share for the same period in the prior year, after adjusting for change in fair value of warrant liability and amortization of employees, directors and consultants stock options. Adjusted net loss and adjusted net loss per share are non-GAAP measures. See “Use of Non-GAAP Measures” below for a reconciliation to the comparable GAAP measures.

 

20

 

---

Table of Contents

 

Use of Non-GAAP Measures

 

   Adjusted net loss and adjusted net loss per share as presented in this report are non-GAAP measures. The adjustments relate to the change in fair value of warrant liabilities and amortization of employees, directors and consultants stock based compensation. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles ("Non-GAAP Measures"). In the reconciliation tables that follow, we present adjusted net loss and adjusted net loss per share, reconciled 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.

 

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

 

   The Non-GAAP Measures for the three and nine months ended December 31, 2019 and 2018 provide management with additional insight into the Company’s results of operations from period to period by excluding certain non-operational and non-cash charges, and are calculated using the following adjustments to net loss:

 

   a)   The warrants issued as part of an equity offering on April 2, 2019 are measured at fair value using a Monte Carlo model which takes into account, as of the valuation date, factors including the current exercise price, the remaining contractual term of the warrant, the current price of the underlying stock, its expected volatility, the risk-free interest rate for the term of the warrant and the estimates of the probability of fundamental transactions occurring. The warrant liability is revalued at each reporting period or upon exercise. Changes in fair value are recognized in the consolidated statements of operations and are excluded from adjusted net loss and adjusted net loss per share.

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

 

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

 

21

 

---

Table of Contents

 

Liquidity and Capital Resources

At December 31, 2019, we had cash and cash equivalents of $11.5 million, working capital of $7.0 million, and stockholders’ equity of $2.4 million.

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

 

Operating Activities

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

Our cash used in operating activities in the nine months ended December 31, 2018 totaled $16.1 million, which is the sum of (i) our net loss of $21.8 million, adjusted for non-cash expenses totaling $6.7 million (principally amortization of stock-based compensation, including immediately vested options granted to the Board of Directors), and (ii) changes in operating assets and liabilities of $1.0 million, primarily due to increased prepaid clinical costs of $470,000 and decreases in accounts payable and other liabilities decreases of $512,000.

Investing Activities

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

During the nine months ended December 31, 2018, our investing activities consisted of purchases of $16,000 of machinery and equipment.

Financing Activities

 

   In April 2019, the Company raised $11.3 million after underwriting discounts and before offering expenses through an underwritten registered offering of 8,000,000 shares of our common stock, $0.0001 par value per share (“Common Stock”), and 8,000,000 common stock purchase warrants (each a “Warrant”). Each Warrant entitles its holder to purchase one share of Common Stock (each, a “Warrant Share”) at an exercise price of $2.00 per Warrant Share. The Warrants expire five years from the date of issuance and vested immediately. The warrants are recorded as a derivative liability on the statement of balance sheet and will be subject to remeasurement.

 

On October 18, 2019, TYME entered into an Open Market Sale Agreement^SM (the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as sales agent, pursuant to which the Company may, from time to time, sell shares of the Company’s Common Stock, having an aggregate offering price of up to $30,000,000 (the “Jefferies ATM”). For the three and nine months ended December 31, 2019, the Company raised approximately $0.6 million in gross proceeds via sale of 582,968 shares of common stock under the Jefferies ATM. The Company incurred $0.2 million of related costs which offset the proceeds. At December 31,2019 there remained approximately $29.4 million of availability to sell shares through the Jefferies ATM.

 

Most recently (and subsequent to the quarter ended December 31,2019) on January 7, 2020, the Company entered into a Securities and Purchase Agreement with Eagle Pharmaceuticals, Inc. (“Eagle”), 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, and received proceeds of $20 million. (see Note 14 - Subsequent Event).

 

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

 

22

 

---

Table of Contents

 

 

We anticipate requiring additional capital to further fund the development of our product candidates as well as to engage in additional potential partnerships or collaborations. Significant funding will be needed in connection with the clinical development, regulatory approval and commercialization of SM-88, including as it relates to current clinical trial activity. In addition to other existing and potential trials, we currently estimate the cost of the TYME-88-Panc trial (Part 2) to range from $15 million and $20 million, with such costs anticipated to extend through calendar year 2021. We also partnered with the Pancreatic Cancer Action Network (“PanCAN”) to study SM-88 in an adaptive randomized Phase II/III trial with registration intent known as Precision Promise^SM. In Precision Promise, SM-88 is starting as second-line monotherapy and could expand to first-line combination therapy with standard of care. After taking into consideration amounts already paid, the remaining estimated cost to the Company is approximately $7.0 million, subject to enrollment adjustments, and is expected to be incurred over two years. Expansion of our currently announced clinical trials for SM-88, or advancement of current preclinical programs, could also result in additional associated costs.

 

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

 

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

Liquidity and Capital Requirements Outlook

 

The Company has historically funded its operations primarily through equity offerings of its Common Stock. During the three and nine months ended December 31, 2019, the Company raised approximately $0.6 million in gross proceeds via sale of 582,968 shares of common stock under the Jefferies ATM. The Company incurred $0.2 million of related costs which offset the proceeds. At December 31, 2019 there remained approximately $29.4 million of availability to sell shares through the Jefferies ATM.

 

Previously, on November 2, 2017, the Company entered into the Equity Distribution Agreement with Canaccord, to commence an at-the-market offering pursuant to which the Company, from time to time, sold shares of the Company’s Common Stock, having an aggregate offering up to $30 million, through Canaccord, as the Company’s sales agent (the “Canaccord ATM”). In the year ended March 31, 2018, the Company raised approximately $6.2 million in gross proceeds through the Canaccord ATM.  During the fiscal year ended March 31, 2019, the Company raised approximately $5.8 million in gross proceeds from the Canaccord ATM. On October 2, 2019, TYME sent notice to Canaccord that it was terminating the Equity Distribution Agreement, effective October 12, 2019.

 

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

 

As of December 31, 2019, the Company had cash on hand of approximately $11.5 million and working capital of approximately $7.0 million. On January 7, 2020 TYME received an additional $20 million proceeds from the sale of 10,000,000 shares of Common Stock to Eagle. (See Note 14 - Subsequent Event).

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.

We regularly evaluate opportunities to raise capital and obtain necessary, as well as opportunistic, financing. To meet our short and long-term liquidity needs, we currently expect to use existing cash balances and a variety of other means, including potential issuances of debt or equity securities in public or private financings, including the Jefferies ATM and partnerships, collaborations and/or royalty arrangements. The demand for the equity and debt of biotechnology companies like ours is dependent upon many factors, including the general state of the financial markets. During times of extreme market volatility, capital may not be available on favorable terms, if at all. Our inability to obtain such additional capital could materially and adversely affect our business operations.

 

23

 

---

Table of Contents

 

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

There is risk associated with any form of capital we may raise or seek to raise, which will vary with the type and source of capital. Additional equity financing may be dilutive to our stockholders. Debt financing may involve significant cash payment obligations and covenants that restrict our ability to operate as a business. Strategic collaborations and similar agreements may require committing operational resources, product rights or other valuable assets and may also introduce risks associated with the activities undertaken in collaboration and the ongoing relationship and interdependence between the parties. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the development of certain or all of our drug candidates or raise funds on terms that we currently consider unfavorable.

Seasonality

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

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

Not required for smaller reporting companies.

 

Evaluation of Disclosure Controls and Procedures

 

Under the supervision of and with the participation of management, including our principal executive officer and principal financial officer, we evaluated the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities and Exchange Act of 1934, as amended, as of December 31, 2019. Based on such evaluation our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective.

 

Changes in Internal Control over Financial Reporting

 

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

 

24

 

---

Table of Contents

 

PART II – OTHER INFORMATION

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

Our Annual Report on Form 10-K for the year ended March 31, 2019 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.

To achieve on our long-term business objectives, we will require substantial additional funding, which may require us to agree to restrictions on our operations or may not be available to us on acceptable terms or at all and, if not available, may require us to delay, scale back or cease our drug development programs or operations.

In addition to SM-88, we seek to advance multiple drug candidates through our research and clinical development process. The completion of the development, regulatory approval and the potential commercialization of SM-88 or any other drug candidate will require substantial funds. Our future financing requirements will depend on many factors, some of which are beyond our control, which include, but are not limited to:

 

Until we can generate sufficient drug and royalty revenue to finance our cash requirements, which we may never achieve, we expect to finance future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, royalty agreements and other marketing and distribution arrangements. The demand for the equity and debt of biotechnology companies like ours is dependent upon many factors, including the general state of the financial markets. During times of extreme market volatility, capital may not be available on favorable terms, if at all. Any additional fundraising efforts may divert management’s attention from day-to-day activities and financing may not be available to us when we need it or financings may not be available on favorable terms. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances royalty rights or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our drug candidates, technologies, future revenue streams or research programs and/or grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, as we expect to do, the ownership interests of our then existing stockholders could be diluted and the terms of these securities may include liquidation or other preferences that adversely affect stockholders’ rights.

 

25

 

---

Table of Contents

 

While we regularly consider options and opportunities to raise additional capital and obtain financing and will continue to seek capital through a number of means, there can be no assurance that additional financing will be available on acceptable terms, if at all, and our negotiating position in capital generating efforts may worsen as existing resources are used. Additionally, if we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain adequate financing when needed and on favorable terms, we may have to delay, reduce the scope of or suspend one or more of our clinical trials or research and development programs or our commercialization efforts.

We may be party to legal proceedings that could have a material adverse effect on the Company’s liquidity, financial position, and results of operations, as well as its reputation.

 

The Company has limited experience in litigation and other legal proceedings, but any lawsuit brought against us or legal proceeding that we may bring to enforce our rights could result in substantial costs, divert the time and attention of our management, result in counterclaims (whether meritorious or as a litigation tactic), result in substantial monetary judgments or settlement costs and harm our reputation, any of which could seriously harm our business. For example, during the fourth quarter of fiscal year 2019, we, along with our CEO and CFO, were named in a securities lawsuit by a purported stockholder, in which the plaintiff alleged to represent a class of stockholders and asserted claims under the Securities Exchange Act of 1934, as amended. Though such complaint was voluntarily dismissed by the plaintiff, we could be subject to lawsuits in the future and any litigation or claim against us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention of management from our core business, and harm our reputation.  

 

Further, as we continue to seek to expand, raise capital, and develop and commercialize products, we have entered into, and expect to enter into in the future, agreements and instruments, such as our outstanding warrants and co-promotion agreement (further discussed below), which are subject to interpretation and the potential for dispute. If we and the counterparty to any such agreements or holders of such instruments are unable to resolve our disagreements, such disagreements may result in lawsuits, other legal proceedings and/or protracted negotiations, including those whereby we seek to enforce our rights. Even if successful, litigation, other legal proceedings or protracted negotiations could be expensive and time consuming and could divert management’s attention from managing our business and could result in significant adverse judgments or costs of settlement, amendments to agreements or adjustments to instruments, any of which may have a material adverse effect on our liquidity, financial position, business, reputation or prospects.  

 

We have entered into a co-promotion agreement and may enter into additional license or collaboration agreements with third parties with respect to SM-88 and any other drug candidates we may develop that may place the development or promotion of our drug candidates partially or entirely outside of our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us. If such collaborations are not successful, SM-88 and any other drug candidates we may choose to develop may not reach their full market potential.

 

In January 2020, we entered into a co-promotion agreement with Eagle Pharmaceuticals, Inc. (“Eagle”), whereby Eagle agreed to provide sales representatives to cover 25% of the Company’s sales force requirements and will receive 15% of the net sales of all SM-88 products in the U.S. during the term of the agreement. TYME remains responsible for the remaining promotional effort. The co-promotion of SM-88 in the United States will be supervised by a joint sales operations committee composed of representatives from the Company and Eagle. Under the agreement, the Company will remain responsible for clinical development and commercial strategy and for the costs of seeking regulatory approval of, manufacturing and distributing SM-88.

 

The co-promotion agreement provides parameters and sales requirements, but certain specific requirements related to promotional activities and requirements will be defined in more detail and finalized as any product nears commercialization. If we and Eagle disagree on these matters, it could lead to disputes or be disruptive to sales efforts. Additionally, Eagle may change its strategic focus or pursue alternative technologies or treatments in a manner that results in reduced or delayed revenue to us. If Eagle fails to effectively promote and assist in the commercialization of our SM-88 products, our business, financial condition, results of operations and prospects could be harmed. In addition, any material alteration of the collaboration agreements, or dispute or litigation proceedings we may have with Eagle in the future could delay development programs, distract management from other business activities and generate substantial expense.

 

We may in the future enter into additional license or collaboration arrangements with other third parties with respect to SM-88 and any other drug candidates we may develop that may place the development or promotion of our drug candidates partially or entirely outside of our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us, and could be subject to similar types of risks as described above. In addition, any collaborations are and will be subject to numerous risks, which may include, but are not limited to:

 

26

 

---

Table of Contents

 

If our collaborations are not successful, or we are unable to reach agreement with a collaboration partner or disputes arise under collaboration arrangements, SM-88 and any other drug candidates we may choose to develop may not reach their full market potential, and our business, financial condition, results of operations and prospects could be harmed.

None.

None.

Not applicable.

 

Item 5.    Other Information.

None.

  

    

 

 

27

 

---

Table of Contents

 

 

 

 

28

 

---

Table of Contents

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Dated: February 5, 2020

 

 

 

 

 

29