Traws Pharma, Inc.
For the period ended Dec 31, 2024. Filed Mar 31, 2025.
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FY2024 · Filed Mar 31, 2025
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Notes to Consolidated Financial Statements
1. Nature of Business
The Company
Traws Pharma, Inc. (“Traws Pharma” or the “Company”), formerly known as Onconova Therapeutics, Inc., was incorporated in the State of Delaware on December 22, 1998 and commenced operations on January 1, 1999. The Company's headquarters are located in Newtown, Pennsylvania. On April 1, 2024, the Company acquired Trawsfynydd Therapeutics, Inc., a Delaware corporation (“Trawsfynydd”), through a merger and the name change to Traws Pharma was effected. The Company accounted for the transaction as an asset acquisition as substantially all of the fair value of the gross assets acquired was concentrated intwo programs that were grouped as a single identifiable in-process research & development (“IPR&D”) asset. Traws Pharma is a clinical stage biopharmaceutical company aiming to address unmet medical needs in respiratory viral diseases and cancer. The viral respiratory disease program includes an oral antiviral drug candidate for influenza and an oral inhibitor drug candidate of the SARS-CoV-2 Mpro (“3CL protease”). In the cancer program, Traws Pharma is developing the novel, proprietary multi-kinase CDK2/4/6 inhibitor narazaciclib for refractory endometrial cancer and potentially for other cancers.
Reverse Stock Split
In September 2024, the Board of Directors of the Company (the “Board”) approved aone-for-25 reverse stock split of the Company’s outstanding shares of common stock (the “Reverse Stock Split”). Each 25 shares of the Company’s common stock, par value of $0.01 per share, issued and outstanding immediately prior to the Reverse Stock Split automatically reclassified, combined, converted and changed intoone fully paid and nonassessable share of common stock, par value of $0.01 per share. In addition, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding options, warrants and convertible preferred stock entitling the holders to purchase shares of the Company’s common stock, and the number of shares reserved for issuance pursuant to the Company’s 2021 Incentive Compensation Plan (the “2021 Plan”), including pursuant to outstanding restricted stock units outstanding thereunder, was reduced proportionately. No fractional shares were issued as a result of the Reverse Stock Split. Instead, the Company’s stockholders who otherwise would have been entitled to a fraction of a share received a full share of common stock. All common stock, per share and related information presented in the financial statements and accompanying notes for periods prior to the date of the Reverse Stock Split have been retroactively adjusted to reflect the Reverse Stock Split.
Liquidity
The Company has incurred recurring operating losses since inception. For the year ended December 31, 2024, the Company incurred a net loss of $166,523,000 and as of December 31, 2024, the Company had generated an accumulated deficit of $649,154,000. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of its product candidates and its preclinical programs, strategic alliances and its administrative organization. At December 31, 2024, the Company had cash and cash equivalents of $21,338,000. Based on current projections, the Company believes that it does not have sufficient cash and cash equivalents to support its operations for more than one year following the date that these financial statements are issued. As a result of these conditions, substantial doubt exists about the Company’s ability to continue as a going concern.
The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy. Management plans to explore various dilutive and non-dilutive sources of funding, including equity financings, strategic alliances, business development and other sources. The future success of the Company is dependent upon its ability to obtain additional funding. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on the Company’s business, results of operations and financial condition. There can be no assurance, however, that the Company will be successful in obtaining such funding in sufficient amounts, on terms acceptable to the Company, or at all.
Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development, and commercialization of biotechnology products, the Company may have based this estimate on assumptions that may prove to be wrong, and the Company's operating plan may change as a result of many factors currently unknown to the Company. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
The Company received multiple notifications from The Nasdaq Stock Market LLC (“Nasdaq”) staff (the “Staff”) in 2024 regarding non-compliance with continued listing requirements. On February 25, 2025, the Company received a letter from Nasdaq confirming that the Company has regained compliance with Listing Rule 5550(b)(1) related to minimum stockholders’ equity requirements, as required by the Hearings Panel of Nasdaq’s decision dated December 13, 2024. Pursuant to Listing Rule 5815(d)(4)(B), the Company will be subject to a mandatory panel monitor for a period of one year from the date of such letter.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Trawsfynydd Therapeutics LLC, Trawsfynydd Therapeutics AU Ltd, Throxavir Therapeutics AU Pty Ltd, and Onconova Europe GmbH. All significant intercompany transactions have been eliminated.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets, liabilities, and equity and the amount of revenues and expenses. Actual results could differ significantly from those estimates. The most significant estimates and assumptions that management considers in the preparation of the Company's financial statements relate to prepaid and accrued research and development costs; the valuation of consideration transferred in acquiring the assets of Trawsfynydd; and inputs used in the Black-Scholes model for stock-based compensation expense and Series A Warrant (as defined below) liability.
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in assessing performance. The Company hasone operating segment. The Company’s chief operating decision maker (“CODM”) is the chief executive officer. The Company’s CODM manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All the Company’s long-lived assets are held in the United States.
Concentrations of Credit Risk and Off-Balance Sheet Risk
Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains a portion of its cash and cash equivalent balances in the form of money market accounts with financial institutions that management believes are creditworthy. The Company hasno financial instruments with off-balance sheet risk ofloss.
At December 31, 2024 the Company had $20,508,000 of its cash and cash equivalents in money market funds that invest in a portfolio of liquid, high-quality debt securities issued by the U.S. government.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original or remaining maturity from the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. During the years ended December 31, 2024 and 2023, the Company received $510,000 and $1,391,000, respectively, of interest income primarily from a money market mutual fund that invests primarily in U.S. government obligations. The interest income is included in Other income, net in the Statement of Operations.
Deferred Financing Costs
The Company capitalizes costs that are directly associated with in-process equity and debt financing until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred financing costs are expensed.
Asset Acquisitions
Acquisitions of assets or a group of assets that do not meet the definition of a business are accounted for as asset acquisitions, with a cost accumulation model used to determine the cost of the acquisition. Common stock issued as consideration in an acquisition of assets is generally measured based on the acquisition date fair value of the equity interests issued. Direct transaction costs are recognized as part of the cost of an acquisition of assets. Intangible assets that are acquired in an asset acquisition for use in research and development activities that have an alternative future use are capitalized as in-process research and development, or IPR&D. Acquired IPR&D that has no alternative future use is expensed immediately in the consolidated statements of operations and comprehensive loss.
Tax Incentive Receivable
The Company is eligible to receive a cash refund from the Australian Taxation Office for eligible research and development (“R&D”) expenditures under the Australian Research and Development Tax Incentive Program (the “Australian Tax Incentive”). The Australian Tax Incentive is recognized as a reduction to R&D expense when the relevant expenditure has been incurred, the amount can be reliably measured and that the Australian Tax Incentive will be received. The Company’s Australian subsidiaries began operations in the second quarter of 2024, and the Company has recognized reductions to R&D expenses of $1,543,000 for the year ended December 31, 2024.
Redeemable Convertible Preferred Stock
The Company records shares of redeemable convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs. The Company has historically applied the guidance from the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) 480-10-S99-3A,SEC Staff Announcement: Classification and Measurement of Redeemable Securities, and classified the redeemable convertible preferred stock outside of stockholders’ equity because, if conversion to common stock is not approved by the stockholders, the redeemable convertible preferred stock would have been redeemable at the option of the holders for cash equal to the closing price of the common stock on the last trading day prior to the holder’s redemption request. The Company determined that at the time, the conversion and redemption are outside of the Company’s control. Additionally, the Company determined the conversion and redemption features did not require bifurcation as derivatives. In September 2024, and in connection with the Company’s stockholder approval to allow for the conversion of outstanding preferred stock into common stock, the preferred stockholders right to request redemption expired. Immediately following the stockholder approval and related conversions to common stock, the Company reclassified the remaining preferred stock and related carrying value to permanent equity within the accompanying consolidated balance sheet as of December 31, 2024, and the preferred stock is no longer subject to temporary equity guidance within ASC 480-10-S99-3A.
Fair Value of Financial Instruments
The Company accounts for financial instruments under ASC 820,Fair Value Measurements (“ASC 820”). This statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. To increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels as follows:
Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 — observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and
Level 3 — assets and liabilities whose significant value drivers are unobservable.
The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, accounts payable, and accrued liabilities approximate their respective fair values because of the short-term nature of these accounts.
The following fair value hierarchy table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| | Fair value measurement at reporting date using | |||||||
| December 31, 2024 · (Level 1) · · (Level 2) · · (Level 3) | ||||||||
| Assets: | | | | | | | | |
| Cash and cash equivalents - money market funds | $20,508,000 | | $ | - | | $ | - | |
| Liabilities: | | | | |||||
| Warrant liabilities - Series A Warrants | $ | - | | $ | - | | $13,125,000 | |
| Warrant liabilities - Pre-funded Warrants | | - | | | 29,369,000 | | | - |
| Total warrant liabilities | $ | - | | $29,369,000 | | $13,125,000 | ||
| | | | | | | | | |
| December 31, 2023 | | | | | | | | |
| Assets: | | | | | | | | |
| Cash and cash equivalents - money market funds | $20,559,000 | | $ | - | | $ | - | |
On December 29, 2024, the Company entered into a Securities Purchase Agreement with several investors (the “December 2024 Purchase Agreement”) for the sale of (i) up to 3,630,205 Class A Units (“Class A Units”), each Class A Unit consisting of (a)one share of common stock orone pre-funded warrant to initially purchaseone share of common stock, and (b)one Series A Warrant to purchaseone share of common stock (“Series A Warrants”) and (ii)289,044 Class B Units”, and together, with the Class A Units, the “Units”), each Class B Unit consisting ofone pre-funded warrant andone Series A Warrant. The fair value of the pre-funded warrants is the intrinsic value of the pre-funded warrants due to their nominal exercise price. The fair value of the Series A Warrants was calculated using the Black-Scholes option pricing model and is revalued to fair value at the end of each reporting period until the earlier of the exercise or expiration of the Series A Warrants. The fair value of the Series A Warrant liability was estimated using the Black-Scholes option pricing model using the following assumptions:
| | | |
|---|---|---|
| | | December 31, 2024 (Issuance date) |
| Expected term of warrants (years) | | 1 year |
| Risk-free interest rate | | 4.2% |
| Expected volatility | | 126.9% |
| Dividend yield | | $ - |
The warrant liabilities were initially measured at fair value at the day of issuance and on a recurring basis. The changes in fair value of warrant liabilities will be recognized as part of the consolidated statements of operations. As the warrants were issued on December 31, 2024, no change in warrant liability has been recorded during the year ended December 31, 2024.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The following estimated useful lives were used to depreciate the Company’s assets:
| | | |
|---|---|---|
| | Estimated Useful Life | |
| Lab equipment | 5-6 years | |
| Software | 3 years | |
| Computer and office equipment | 5-6 years | |
| Leasehold improvements | Shorter of the lease term or estimated useful life |
Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized.
The Company reviews long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the assets’ book value to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceeds their fair value, which is measured based on the projected discounted future net cash flows generated from the assets. No impairment losses have been recorded through December 31, 2024.
Warrant Accounting
The Company evaluates all of its financial instruments, including issued share purchase warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC Topic 480,Distinguishing Liabilities from Equity, ASC Topic 505,Equity, and ASC Topic 815,Derivatives and Hedging (“ASC 815”). The Company accounts for the Series A Warrants and pre-funded warrants issued in December 2024 in accordance with the guidance contained in ASC 815 under which the warrants do not meet the criteria for equity treatment and must
be recorded as liabilities. Accordingly, the Company classifies the Series A Warrants and pre-funded warrants as liabilities at their fair value and adjust the liability to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized in the Company’s consolidated statements of operations. As the Series A Warrants and pre-funded warrants were issued on December 31, 2024, no change in warrant liability has been recorded during the year ended December 31, 2024.
Foreign Currency
The reporting currency of the Company and its U.S. subsidiaries is the U.S. dollar. The functional currency of the Company’s Australian subsidiary is the U.S. dollar. Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than the U.S. dollar are included in operations in the period in which the transaction occurs and reported within the other income, net in the consolidated statements of operations. The functional currency for the Company’s German subsidiary is the euro. Translation adjustments are included as a component of accumulated other comprehensive income and gains and losses resulting from exchange rate changes on such transactions are reflected within the Company’s statements of comprehensive loss.
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606,Revenue from Contracts with Customers (“ASC 606”). The Company applies ASC 606 to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
The Company derives revenue from its collaboration and licensing agreements.
License, Collaboration and Other Revenues
The Company enters into licensing and collaboration agreements, under which it licenses certain of its product candidates’ rights to third parties. The Company recognizes revenue related to these agreements in accordance with ASC 606. The terms of these arrangements typically include payment from third parties of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of the licensed product.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its agreements, the Company performs the five steps described above. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success.
Licensing of Intellectual Property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able
to use and benefit from the license. For licenses that are bundled with other performance obligations, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front-fees. The Company evaluates the measure of progress each reporting period, and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensees, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in their period of adjustment.
Manufacturing supply service: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide material rights to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded when the customer obtains control of the goods, which is upon shipment.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some of all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements.
The Company recognized revenue under its license and collaboration agreement with SymBio as follows (Note 13):
| · · · · · · | ||||
|---|---|---|---|---|
| · · Year ended December 31, | ||||
| · 2024 · 2023 | ||||
| Symbio · · · · · · | ||||
| Upfront license fee recognition over time | | $226,000 | | $226,000 |
Deferred revenue is as follows:
| | | | |
|---|---|---|---|
| · · Symbio | |||
| | Upfront Payment | ||
| Deferred balance at December 31, 2023 | | $3,017,000 | |
| Recognition to revenue | | | (226,000) |
| Deferred balance at December 31, 2024 | | $2,791,000 | |
Research and Development Expenses
R&D costs are charged to expense as incurred. These costs include, but are not limited to, license fees related to the acquisition of in-licensed products; employee-related expenses, including salaries, benefits and travel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical trials and preclinical studies; the cost of acquiring, developing and manufacturing clinical trial materials; facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and costs associated with preclinical activities and regulatory operations.
Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued R&D expense, as the case may be.
Income Taxes
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. The deferred tax asset primarily includes net operating loss and tax credit carry forwards, accrued expenses not currently deductible and the cumulative temporary differences related to certain research and patent costs, which have been charged to expense in the accompanying statements of operations but have been recorded as assets for income tax purposes. The portion of any deferred tax asset for which it is more likely than not that a tax benefit will not be realized must then be offset by recording a valuation allowance. A full valuation allowance has been established against all of the deferred tax assets (Note 11), as it is more likely than not that these assets will not be realized given the Company’s history of operating losses. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position. The amount for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position.
Stock-Based Compensation Expense
The Company applies the provisions of ASC Topic 718,Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and non-employees, including employee stock options, stock appreciation rights, performance stock units and restricted stock units.
Share-based payment transactions with employees are recognized as compensation expense over the requisite service period based on their estimated fair values. ASC 718 also requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the term and expected lives, to estimate the grant date fair value of equity-based compensation and requires the recognition of the fair value of stock compensation in the statement of operations.
Clinical Trial Expense Accruals
As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts
that are too high or too low for any particular period. For the years ended December 31, 2024 and 2023, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials.
Net Loss Per Share
For purposes of net loss per share, the Series C Preferred shares have the same characteristics as common stock and have no liquidation or other material preferential rights over common stock and accordingly, have been considered as a second class of common stock in the computation of net loss per share regardless of their legal form. Losses are allocated between the common shares and the Series C Preferred on a pro rata basis as they share equally in losses and residual net assets on an as-converted basis.
Basic loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period, including pre-funded warrants. The pre-funded warrants to purchase common stock are included in the calculation of basic and diluted net loss per share as the exercise price of $0.01 per share is non-substantive and is virtually assured.
Diluted loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as stock options, unvested restricted stock units, and common stock warrants, which would result in the issuance of incremental shares of common stock. Basic and diluted net loss per share data is the same due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive.
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:
| · · · · | ||
|---|---|---|
| | | December 31, |
| | 2024 | 2023 |
| Warrants | 3,919,249 | 12,310 |
| Stock Options | 423,107 | 92,441 |
| Unvested restricted stock units | 22,421 | 9,888 |
| | 4,364,777 | 114,639 |
Recently Adopted Accounting Pronouncements
The Company adopted the FASB’s Accounting Standards Update 2020-06,Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), effective as of January 1, 2024 using the modified retrospective method. Among other amendments, ASU 2020-06 eliminates the cash conversion and beneficial conversion feature models in ASC 470-20 that require an issuer of certain convertible debt and preferred stock to separately account for embedded conversion features as a component of equity, as well as changed the accounting for diluted earnings-per-share for convertible instruments and contracts that may be settled in cash or stock. Additionally, ASU 2020-06 requires that the if-converted method, which is more dilutive than the treasury stock method, be used for all convertible instruments. The Company applied ASU 2020-06 to all redeemable convertible preferred stock during 2024, accordingly the Company did not apply the cash conversion or beneficial conversion feature models in its analysis of the redeemable convertible preferred stock.
In November 2023, the FASB issued ASU 2023-07,Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires public companies to disclose for each reportable segment the significant expense categories and amounts for such expenses. The Company incorporated the improved segment disclosures in the summary of significant accounting policies, herein.
Recently Issued but not yet Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09,* Income Taxes* (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which expands the disclosure required for income taxes. This ASU is effective for fiscal years beginning after December 16, 2024, with early adoption permitted. The amendment should be applied on a prospective
basis while retrospective application is permitted. The Company is currently evaluating the effect of this ASU on its disclosures.
In November 2024, the FASB issued ASU 2024-03,Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented on the consolidated statement of operations. The guidance in this ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial statements and disclosures.
3. Asset Acquisition
On April 1, 2024, the Company acquired Trawsfynydd, in accordance with the terms of an Agreement and Plan of Merger, dated April 1, 2024 (the “Merger Agreement”), pursuant to which the Company acquired Trawsfynydd’s tivoxavir marboxil and TRX01 programs and assumed certain liabilities associated with the acquired assets (the “Merger”). The upfront consideration included (i) the issuance of 141,982 shares of common stock of the Company at an aggregate fair value of $3,550,000, (ii) the issuance of 10,359 shares of Series C Convertible Preferred Stock (“Series C Preferred”) at an aggregate fair value of $93,232,000, and (iii) the assumption of all Trawsfynydd stock options (the “assumed options”) immediately outstanding prior to the transaction at an aggregated fair value of $7,085,000.
Each share of Series C Preferred was initially convertible into 10,000 shares of common stock, subject to the Beneficial Ownership Limitation (defined below). Post Reverse Stock Split, each share of Series C Preferred converts into 400 shares of common stock, and is still subject to the Beneficial Ownership Limitation (defined below). The fair value of the shares issued to Trawsfynydd and options assumed was based on the closing stock price of the Company’s common stock on April 1, 2024 of $1.00, less a discount 10.0% related to unregistered share restrictions of the preferred shares.
The Company accounted for the transaction as an asset acquisition as the Company acquired inputs and no substantive processes or outputs. The assets acquired in the transaction were measured based on the estimated fair value of the consideration paid of $112,543,000, which included direct transactions costs of $8,676,000. Tungsten Partners LLC (“Tungsten”) acted as financial advisor to the Company in connection with the Merger. As partial compensation for services rendered by Tungsten, the Company issued to Tungsten and its affiliates and designees an aggregate of 6,747 shares of common stock and 535 shares of Series C Preferred.
The consideration paid and the relative fair values of the assets acquired and liabilities assumed were as follows:
| | | | |
|---|---|---|---|
| Consideration transferred: | | | |
| Common stock | | $3,550,000 | |
| Series C Preferred | | | 93,232,000 |
| Assumed options | | | 7,085,000 |
| Company transaction costs settled in equity | | | 4,984,000 |
| Company transaction costs paid in cash | | | 3,692,000 |
| Total consideration transferred | | $112,543,000 | |
| | | | |
| Assets acquired: | | | |
| Cash and cash equivalents | | $44,000 | |
| Total assets acquired | | $44,000 | |
| | | | |
| Liabilities assumed: | | | |
| Accrued expenses and other current liabilities | | $4,965,000 | |
| Total liabilities assumed | | | 4,965,000 |
| Net assets acquired | | | (4,921,000) |
| In-process research and development | | | 117,464,000 |
| Net assets acquired | | $112,543,000 |
The Company elected to follow the asset acquisition approach and the Trawsfynydd IPR&D assets acquired have no alternative future use to the Company. As a result, the Company charged $117,464,000 to expense within its consolidated statement of operations for the year ended December 31, 2024.
The Company’s board of directors (“Board”) approved the Merger Agreement and the related transactions, and the consummation of the Merger was not subject to approval of Company stockholders. In accordance with the Merger Agreement, three directors were appointed to the Board, and there were several changes to management, each effective as of the Closing.
Concurrently with the Closing of the Merger, the Company entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of common stock as of the applicable record date (April 15, 2024), including those holders receiving shares of common stock in connection with the Merger, is entitled toone contractual contingent value right (each, a “CVR”) entitling the holder to certain distributions of net proceeds and net sales of Traws Pharma’s two leading cancer candidates, subject to, and in accordance with, the terms and conditions of the CVR Agreement, for each share of common stock held by such holder as of the applicable record time.
The distributions in respect of the CVRs will be made on a quarterly basis, and will be subject to a number of deductions, subject to certain exceptions or limitations, including but not limited to for certain taxes and certain out-of-pocket expenses incurred by Traws Pharma. At the time of Merger and again at December 31, 2024, the value ascribed to the CVR liability was de minimis given the uncertainty related to the success of the underlying oncology programs.
Pursuant to the Merger Agreement, the Company agreed to hold a stockholders’ meeting to submit, among other proposals, the following proposals to its stockholders for their consideration: (i) the approval of the conversion of shares of Series C Preferred into shares of common stock in accordance with the rules of the Nasdaq Stock Market LLC, the Merger Agreement and the Certificate of Designation (the “Conversion Proposal”) and (ii) the approval of an amendment to the Company’s Certificate of Incorporation (as amended, “Charter”), to increase the authorized shares of common stock from 125,000,000 to 250,000,000 (the “Share Increase Proposal” and together with the Conversion Proposal, the “Meeting Proposals”). In connection with these matters, the Company agreed to file a proxy statement on Schedule 14A with the SEC. Such proxy statement was filed on August 9, 2024. At a special meeting of the stockholders held on September 16, 2024, the Company’s stockholders approved the Meeting Proposals.
4. Balance Sheet Detail
Prepaid expenses and other current assets:
| · · · · · · | ||||
|---|---|---|---|---|
| · · December 31, | ||||
| · · 2024 · 2023 | ||||
| Research and development | | $1,514,000 | | $1,060,000 |
| Manufacturing | | — | | 186,000 |
| Insurance | | 156,000 | | 174,000 |
| Other | | 178,000 | | 401,000 |
| | | $1,848,000 | | $1,821,000 |
Property and Equipment:
| · · · · · · | ||||
|---|---|---|---|---|
| · · December 31, | ||||
| · 2024 · 2023 | ||||
| Computer and office equipment | | $84,000 | | $84,000 |
| Less accumulated depreciation | | (74,000) | | (62,000) |
| | | $10,000 | | $22,000 |
Depreciation and amortization expense was $12,000 and $16,000 for the years ended December 31, 2024 and 2023, respectively.
Accrued expenses and other current liabilities:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · · 2024 · 2023 | ||||||
| Research and development | | $2,331,000 | | $2,196,000 | ||
| Employee compensation | | 265,000 | | 1,002,000 | ||
| Professional fees | | | 525,000 | | | 177,000 |
| | | $3,121,000 | | $3,375,000 | ||
5. Commitments and Contingencies
Litigation
In the normal course of business, the Company from time to time is named as a party to legal claims and actions. The Company records a loss contingency reserve for a legal proceeding when the potential loss is considered probable and can be reasonably estimated. The Company has not recorded any amounts for loss contingencies as of December 31, 2024.
On June 17, 2024, Steven M. Fruchtman informed the Board of his intent to resign from his positions of President and Chief Scientific Officer, Oncology and indicated to the Company that Dr. Fruchtman believes his resignation to be for "good reason" under the terms of his employment agreement and his expectation of compensation commensurate therewith and in connection with a change in control. The Board accepted Dr. Fruchtman’s resignation effective immediately but disagrees with the characterization of the events set forth in the letter. The Company believes that no severance payments are due to Dr. Fruchtman under the terms of his employment agreement as it pertains to termination for good reason events. At December 31, 2024, the Company determined a range of possible loss associated with Dr. Fruchtman’s claim to bezero to $1.5 million. While the Company intends to defend itself against these claims, and believes it has strong arguments to prevail in the litigation, there can be no assurance that the Company will prevail on its claims.
Contingent Value Rights
The Company issued CVRs to common stockholders as of April 15, 2024 and may be obligated to make future distributions to such CVR holders in connection with entering into strategic arrangements related to its oncology programs
and/or future royalty payments related to the successful commercialization of such programs. Refer to discussion of Contingent Value Rights within Note 3.
6. Redeemable Convertible Preferred Stock and Stockholders’ (Deficit) Equity
As a result of the stockholder approval of the Meeting Proposals at the special meeting of the Company’s stockholders held on September 16, 2024, certain of the Series C Preferred shares issued in connection with the acquisition of Trawsfynydd and the concurrent private placement of securities were converted into 2,012,973 shares of the Company’s common stock. In connection with the increase in common shares outstanding due to the December 2024 Purchase Agreement (as defined below), certain investors converted an additional 42.45 Series C Preferred shares into 16,980 shares of the Company’s common stock to maintain the Beneficial Ownership Limitation. As of December 31, 2024,7,398 shares of Series C Preferred remained outstanding.
Series C Preferred shares have no voting rights. Certain provisions of the Series C Preferred are as follows:
Dividends: Series C Preferred participates in any dividends with common stockholders on an as-converted basis
Liquidation: In the event of the liquidation, dissolution, or winding up of the affairs of the Company, whether voluntary or involuntary (a “Liquidation”), the holders of Series C Preferred shall rank on parity with common stockholders as to the distributions of assets.
Redemption: In the event the Company is unable to obtain an affirmative stockholder vote to permit conversion within nine months after the initial issuance of the Series C Preferred, each holder of Series C Preferred may elect, at the holder’s option, to have the shares of Series C Preferred be redeemed by the Company at an amount equal to the last reported closing trading price of the common stock at such time on an as-converted to common stock basis, as further described in the Certificate of Designation relating to the Series C Preferred. The redemption right expired in connection with the Company obtaining the affirmative stockholder vote on the Conversion Proposal in September 2024. Immediately following the stockholder vote, any outstanding shares of Series C Preferred not converted were reclassified as permanent equity within the Company’s consolidated balance sheet as of September 30, 2024.
Beneficial Ownership Limitation: A holder of Series C Preferred is prohibited from converting shares of Series C Preferred into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 19.9% of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”)
Securities Purchase Agreements
On December 29, 2024, the Company entered into the December 2024 Purchase Agreement for the sale of (i) up to 3,630,205 Class A Units, each Class A Unit consisting of (a)one share of common stock orone pre-funded warrant to initially purchaseone share of common stock, and (b)one Series A Warrant and (ii)289,044 Class B Units, each Class B Unit consisting ofone pre-funded warrant andone Series A Warrant. The purchase price per Class A Unit was $5.103 and the purchase price per Class B Unit was $5.093. The Units sold pursuant to the December 2024 Purchase Agreement were issued to the purchasers thereunder on December 31, 2024.
The Series A Warrants have an exercise price of $13.42 per share of common stock, and, subject to certain beneficial ownership limitations described in the Series A Warrants, will be exercisablesix months after issuance and will expire on the earlier of (a) subject to the fulfilment of the Equity Conditions (as defined in the December 2024 Purchase Agreement), thirty (30) Trading Days (as defined in the December 2024 Purchase Agreement) after the last of the following data readouts to occur, as announced by the Company: (i) Ferret animal model Bird Flu data, (ii) non-human primate Bird Flu data, or (iii) Phase 2a Influenza A human clinical data and (b) the 5-year anniversary of the closing date of the December 2024 Purchase Agreement. The pre-funded warrants have an exercise price of $0.01 per share, and subject to certain beneficial ownership limitations described in the pre-funded warrants, are exercisable and do not expire. The exercise price of the Series A Warrants and pre-funded warrants will be subject to adjustment for stock splits, reverse splits, and similar capital transactions as described in the Series A Warrants and pre-funded warrants.
The Company also entered into an agreement with Tungsten (through its Broker-Dealer, Finalis Securities LLC), pursuant to which Tungsten agreed to serve as exclusive placement agent for the offering. The Company has agreed to pay Tungsten a cash fee equal to 8.25% of the aggregate gross proceeds raised in this offering from certain investors who are not affiliated with the Company and a cash fee equal to 4.125% of the aggregate gross proceeds raised in this offering with respect to certain investors that are affiliates of the Company.
The net proceeds to the Company from the offering was approximately $18.1 million, after deducting placement agent’s fees and other estimated offering expenses with approximately $20.0 million gross proceeds at closing through the sale of shares of common stock and pre-funded warrants and up to another $52.6 million upon exercise of Series A Warrants issued with the offering if exercised in full prior to expiration thereof.
On April 1, 2024, the Company entered into a Securities Purchase Agreement (the “April 2024 Securities Purchase Agreement”) with TPAV, LLC (“TPAV”), an affiliate of Torrey Pines, and OrbiMed Private Investments VIII, LP (“OrbiMed”), an affiliate of OrbiMed Advisors (together, the “Investors”). Pursuant to the April 2024 Securities Purchase Agreement, the Company issued and sold an aggregate of (i)19,879 shares of common stock and (ii)1,578 shares of Series C Preferred (the “Private Investment in Public Equity” or “PIPE Securities”) for an aggregate purchase price of approximately $14.0 million (collectively, the “Financing”). The closing of the Financing occurred concurrently with the closing of the Merger on April 1, 2024 (the “Financing Closing Date”). Subject to the Beneficial Ownership Limitation, each share of Series C Preferred was converted into 400 shares of common stock (on a post-split basis) upon Board approval in September 2024.
Registration Rights Agreement
On April 1, 2024, in connection with the April 2024 Securities Purchase Agreement, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the holders of common stock and Series C Preferred signatory thereto. Pursuant to the Registration Rights Agreement, the Company was required to prepare and file a resale registration statement with the SEC within 90 calendar days following the Financing Closing Date (the “Filing Deadline”), with respect to the shares of common stock underlying the PIPE Securities and the common stock to be issued upon conversion of the Series C Preferred issued to the signatories to the Registration Rights Agreement in the Merger, subject to the Beneficial Ownership Limitation. The Company filed such registration statement within the Filing Deadline on July 1, 2024 which was declared effective on August 28, 2024.
7. Warrants
Common stock warrants are accounted for in accordance with applicable accounting guidance provided in ASC Topic 815,Derivatives and Hedging - Contracts in Entity’s Own Equity (ASC Topic 815), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. The conditions within ASC 815-40 are not subject to a probability assessment. The equity classified warrants do not fall under the liability criteria within ASC 480 Distinguishing Liabilities from Equity as they are not puttable and do not represent an instrument that has a redeemable underlying security. The equity classified warrants do meet the definition of a derivative instrument under ASC 815, but are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent equity if freestanding. The Series A Warrants and pre-funded warrants issued in connection with the December 2024 Purchase Agreement do not meet the scope exception under ASC 815 and, therefore, are classified as liabilities. The weighted average grant date fair value of the warrants issued during the year ended December 31, 2024 was$5.88. The fair value of the Series A Warrant and pre-funded warrant liability exceeded the net proceeds received in connection with the December 2024 Purchase Agreement, resulting in the recognition of Series A and pre-funded warrant expense of $24,438,000 in the consolidated statements of operations.
Warrants outstanding and warrant activity (reflects the number of common shares as if the warrants were converted to common stock) for the year ended December 31, 2024 is as follows:
| | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | Balance | | | | | | | | Balance |
| · · · · Exercise · · Expiration · · December 31, · · Warrants · · Warrants · · Warrants · · December 31, | |||||||||||||||||
| Description · Classification · Price · Date · 2023 · Issued · Exercised · Expired · 2024 | |||||||||||||||||
| Non-tradable pre-funded warrants | | Equity | | $56.25 | | none | | 141 | | — | | — | | — | | 141 | |
| Non-tradable pre-funded warrants | | Equity | | $56.25 | | none | | 199 | | — | | — | | — | | 199 | |
| Non-tradable warrants | | Equity | | $75.00 | | November 2024 | | 9,780 | | — | | — | | (9,780) | | — | |
| Non-tradable warrants | | Equity | | $163.59375 | | December 2024 | | 679 | | — | | — | | (679) | | — | |
| Non-tradable warrants | | Equity | | $168.86250 | | December 2024 | | 1,851 | | — | | — | | (1,851) | | — | |
| Non-tradable pre-funded warrants | | Liability | | $0.01 | | none | | — | | 3,311,052 | | — | | — | | 3,311,052 | |
| Series A Warrants | | Liability | | $13.42 | | Variable | | — | | 3,919,249 | | — | | — | | 3,919,249 | |
| | | | | | | | | | 12,650 | | 7,230,301 | | — | | (12,310) | | 7,230,641 |
8. Stock-Based Compensation
In connection with the Merger in April 2024, the Company assumed all Trawsfynydd stock options outstanding, each becoming an option to purchase shares of the Company’s common stock. The total number of Company shares subject to such options is 365,547.
The Company’s 2018 Omnibus Incentive Compensation Plan (the “2018 Plan”) was unanimously approved by the Board on May 24, 2018 and was approved by the Company’s stockholders on June 27, 2018.
The 2018 Plan was amended and restated (as amended, the “Amended 2018 Plan”) following unanimous approval of the Board on April 24, 2019 and was approved by the Company’s stockholders on June 17, 2019. The Amended 2018 Plan allowed for an additional 1,572 shares of the Company’s common stock to be issued under the Amended Plan with respect to awards made on and after June 17, 2019. The maximum aggregate number of shares of the Company’s common stock that may be issued pursuant to outstanding stock options granted under the Amended 2018 Plan is 1,073.
The 2021 Plan was unanimously approved by the Board on May 28, 2021 and was approved by the Company’s stockholders on July 30, 2021. Upon stockholders’ approval of the 2021 Plan, no further awards have been or will be made under the amended 2018 Plan. Under the 2021 Plan, the Company may grant incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation rights and other stock-based awards to employees, non-employee directors, consultants, and advisors.
The 2021 Plan was amended and restated (as so amended, the “First A&R 2021 Plan”) following unanimous approval of the Board on May 23, 2022 and approval by the Company’s stockholders on August 18, 2022. The First A&R 2021 Plan allowed for the issuance of an additional 80,000 shares of the Company’s common stock with respect to awards made under the First A&R 2021 Plan on and after August 18, 2022. The First A&R 2021 Plan was further amended and restated (as so amended, the “Second A&R 2021 Plan”) following unanimous approval of the Board on October 10, 2024 and approval by the Company’s stockholders on October 31, 2024 to provide for the issuance of an additional 300,000 shares of the Company’s common stock.
In September 2024, the shares reserved for issuance under the First A&R 2021 Plan were proportionally reduced in connection with the Reverse Stock Split. At December 31, 2024, there were 357,142 shares available for future issuance with respect to new awards and outstanding awards under the Second A&R 2021 Plan.
Stock-based compensation expense includes stock options granted to employees and non-employees and has been reported in the Company’s statements of operations and comprehensive loss in either R&D expenses or general and administrative expenses depending on the function performed by the optionee. No net tax benefits related to the stock-based compensation costs have been recognized since the Company’s inception. The Company recognized stock-based compensation expense related to stock options and restricted stock units as follows for the years ended December 31, 2024 and 2023:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year ended December 31, | ||||||
| · 2024 · 2023 | ||||||
| Research and development | | $181,000 | | $715,000 | ||
| General and administrative | | | 1,209,000 | | | 586,000 |
| Total stock-based compensation expense | | $1,390,000 | | $1,301,000 | ||
A summary of stock option activity for the twelve months ended December 31, 2024 is as follows:
| · · · · · · · · · · | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| | Options Outstanding | ||||||||
| · · · · · · · Weighted · · · | |||||||||
| · · · · Weighted- · · Average · · | |||||||||
| · · · · Average · · Remaining · · Aggregate | |||||||||
| · · Number · · Exercise · · Contractual · · Intrinsic | |||||||||
| · of Shares · Price · Term (in years) · Value | |||||||||
| Balance, December 31, 2023 | 92,441 | | $76.05 | 8.53 | | $21,000 | |||
| Trawsfynydd options exchanged in connection with acquisition | | 365,547 | | $1.24 | | 8.87 | | | — |
| Granted | 6,560 | | $8.50 | | — | | — | ||
| Forfeitures | (18,745) | | $22.07 | | — | | — | ||
| Expired | (22,696) | | $327.10 | | — | | — | ||
| Balance, December 31, 2024 | 423,107 | | $11.89 | 8.75 | | $2,698,000 | |||
| Exercisable at December 31, 2024 | 381,922 | | $13.01 | 8.74 | | $2,394,000 | |||
The Company accounts for all stock-based payments made to employees, non-employees and directors using an option pricing model for estimating fair value. Accordingly, stock-based compensation expense is measured based on the estimated fair value of the awards on the date of grant. Compensation expense is recognized for the portion that is ultimately expected to vest over the period during which the recipient renders the required services to the Company using the straight-line single option method.
The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options at the grant date. The Black-Scholes model requires the Company to make certain estimates and assumptions, assumptions related to the expected price volatility of the common stock, the period during which the options will be outstanding, the rate of return on risk-free investments and the expected dividend yield for the Company’s stock.
As of December 31, 2024, there was $126,000 of unrecognized compensation expense related to the unvested stock options which is expected to be recognized over a weighted-average period of approximately 1.7 years.
The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the following:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Year ended December 31, · | |||||||
| · 2024 · 2023 | |||||||
| Risk-free interest rate | | 3.46% | | 4.0% | |||
| Expected volatility | | 117.9% | | 122.8% | |||
| Expected term | | 6.00 | years | | 5.74 | years | |
| Expected dividend yield | | —% | | —% | |||
| Weighted average grant date fair value | | $7.36 | | $21.25 | | ||
The weighted-average valuation assumptions were determined as follows:
| ● | Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. |
| ● | Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected term of its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin (SAB) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option. |
| ● | Expected stock price volatility: Expected volatility is based on the historical volatility of the Company’s common stock. |
| ● | Expected annual dividend yield: The Company has never paid, and does not expect to pay, dividends in the foreseeable future. Accordingly, the Company assumed an expected dividend yield of 0.0%. |
On August 2, 2021, the compensation committee of the Board approved restricted stock unit grants to certain of the Company’s employees (the “2021 RSUs”). An aggregate of 4,188 service-based RSUs were issued at a grant date fair value of $129.75. The 2021 RSUs will be settled in stock, vest 33% on each of the first and second anniversary of the date of grant, and vest 34% on the third anniversary of the date of grant. The 2021 RSUs were granted under the 2021 Plan.
On February 7, 2022, the compensation committee of the Board approved restricted stock unit grants to certain of the Company’s employees (“2022 RSUs”). An aggregate of 5,934 service-based RSUs were issued at a grant date fair value of $45.50. The 2022 RSUs will be settled in stock, vest 33% on each of the first and second anniversary of the date of grant, and vest 34% on the third anniversary of the date of grant. The 2022 RSUs were granted under the 2021 Plan.
On June 10, 2022, the compensation committee of the Board approved restricted stock unit grants to certain of the Company’s employees (“2022 RSU Awards”). An aggregate of 968 service-based RSUs were issued at a grant date fair value of $33.25. The 2022 RSU Awards will be settled in stock, vest 33% on each of the first and second anniversary of the date of grant, and vest 34% on the third anniversary of the date of grant. The 2022 RSU Awards were granted under the 2021 Plan.
On March 13, 2023, the compensation committee of the Board approved restricted stock unit grants to certain of the Company’s employees (“2023 RSUs”). An aggregate of 6,769 service-based RSUs were issued at a grant date fair value of $18.25. The 2023 RSUs will be settled in stock, vest 33% on each of the first and second anniversary of the date of grant, and vest 34% on the third anniversary of the date of grant. The 2023 RSUs were granted under the First A&R 2021 Plan.
On April 1, 2024, the compensation committee of the Board approved restricted stock unit grants as inducement awards to certain of the Company’s employees who joined the Company on April 1, 2024 in connection with the Merger (“Inducement RSUs”). An aggregate of 21,200 service-based RSUs were issued at a grant date fair value of $25.00. The Inducement RSUs will be settled in stock, vest 25% on each of the first four anniversaries of the date of grant. The Inducement RSUs were granted outside of the Company’s incentive plans in accordance with Nasdaq Listing Rule 5635(c)(4).
A summary of RSU activity for the twelve months ended December 31, 2024 is as follows:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| | 2021 RSUs | | 2022 RSUs | | 2022 RSU Awards | | 2023 RSUs | | Inducement RSUs |
| Outstanding and unvested January 1, 2024 | 1,032 | | 2,980 | | 440 | | 5,436 | | - |
| Granted | - | | - | | - | | - | | 21,200 |
| Vested | (200) | | (1,490) | | (220) | | (1,812) | | - |
| Forfeited/Cancelled | (832) | | (1,207) | | - | | (2,906) | | - |
| Outstanding and unvested December 31, 2024 | - | | 283 | | 220 | | 718 | | 21,200 |
At December 31, 2024, the unrecognized compensation cost related to unvested service-based RSUs was $443,000, which will be recognized over the remaining service period of 3.2 years.
Grants of PSUs and SARs
During 2020 and 2021, the compensation committee of the Board and the Board approved a cash bonus program of cash-settled stock appreciation right (“SAR”) awards to the Company’s employees and non-employee directors, and cash-settled performance stock unit (“PSU”) awards to the Company’s employees. These awards were granted outside of the Amended 2018 Plan and the 2021 Plan. As the Company’s stock price has decreased since these awards were issued, their impact on the results of operations and balance sheet of the Company was not material during 2024 or 2023.
9. Restructuring
On April 8, 2024, Traws Pharma terminated 11 of its 17 employees, some of whom have been retained as consultants. The associated severance costs of $884,000 were expensed in the second quarter of 2024. The Company recorded these restructuring charges based on each employee’s role to the respective research and development and general and administrative operating expense categories on its consolidated statements of operations and comprehensive loss. The Company paid all severance costs as of December 31, 2024.
10. Segment Information
The Company hasone operating segment. The Company’s chief operating decision maker (“CODM”) is the chief executive officer. The Company’s CODM manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All the Company’s long-lived assets are held in the United States.
The accounting policies of its segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for its segment based on net loss, which is reported on the consolidated statements of operations and comprehensive loss. The measure of segment assets is reported on the balance sheet as total assets. The CODM uses cash forecast models in deciding how to invest into the segment. The CODM analyzes the Company’s net loss and monitors budget versus actual results to assess the performance of the Company.
The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended December 31, 2024 and 2023:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Years ended December 31, | ||||||
| · 2024 · 2023 | ||||||
| Revenue | | $226,000 | | $226,000 | ||
| Less: | | | | | | |
| Acquired in-process research and development | | 117,464,000 | | | — | |
| Research and development expenses: | | | | | | |
| Preclinical & clinical development | | | 7,441,000 | | | 4,060,000 |
| Personnel related | | | 2,787,000 | | | 2,400,000 |
| Other research and development (a) | | | 2,619,000 | | | 4,970,000 |
| Total research and development expenses | | 12,847,000 | | 11,430,000 | ||
| General and administrative expenses: | | | | | | |
| Professional & consulting fees | | | 5,954,000 | | | 2,162,000 |
| Personnel related | | | 3,035,000 | | | 3,264,000 |
| Other general and administrative (b) | | | 3,300,000 | | | 3,668,000 |
| Total general and administrative | | | 12,289,000 | | | 9,094,000 |
| Series A warrant and pre-funded warrant expense | | | 24,438,000 | | | — |
| Other income, net | | (289,000) | | (1,350,000) | ||
| Net loss | | $(166,523,000) | | $(18,948,000) | ||
| | | | | | | |
(a)Other research and development expenses include stock based compensation, manufacturing, formulation, development, and consulting fees.
(b)Other general and administrative expenses include stock based compensation, public company costs, and insurance.
11. Income Taxes
The Company accounts for income taxes under FASB ASC 740 (“ASC 740”). Deferred income tax assets and liabilities are determined based upon differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
Income taxes have been based on the following income (loss) before income tax expense:
| · · · · · · | ||||
|---|---|---|---|---|
| · · December 31, | ||||
| · 2024 · 2023 | ||||
| Domestic | | $(161,830,000) | | $(18,949,000) |
| Foreign | | (4,696,000) | | 1,000 |
| | | $(166,526,000) | | $(18,948,000) |
As of December 31, 2024, the Company had federal net operating loss (“NOL”) carry forwards of $128,054,000, state NOL carry forwards of $34,934,000, foreign NOL of $219,000 and federal research and development tax credit carry forwards of $0, which may be available to reduce future taxable income. The federal NOL, that was generated before the 2024 tax year, and the tax credit carry forwards will begin to expire at various dates starting in 2025. The state NOL carry forwards will begin to expire at various dates starting in 2025. In accordance with Section 382 of the Internal Revenue Code of 1986, as amended, a change in equity ownership of greater than 50% within a three-year period results in an annual limitation on the Company’s ability to utilize its NOL carryforwards created during the tax periods prior to the change in ownership. The Company has determined that they have gone through an ownership change during 2024 and is currently in process of completing an ownership change analysis pursuant to Section 382. Because the Company has incurred cumulative net operating losses since inception, all tax years remain open to examination by U.S. federal and state income tax authorities.
The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized. The Company recognizedno material adjustment for unrecognized income tax benefits. Through December 31, 2024, the Company hadno unrecognized tax benefits or related interest and penalties accrued.
The principal components of the Company’s deferred tax assets are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| | 2024 | 2023 | ||||
| Deferred tax assets: | | | | | | |
| Net operating loss carryovers | | $28,324,000 | | $74,029,000 | ||
| R&D tax credits | | — | | 93,031,000 | ||
| Non-qualified stock options | | 2,509,000 | | 641,000 | ||
| Deferred revenue | | 696,000 | | 752,000 | ||
| Fixed assets | | 2,000 | | 1,000 | ||
| Accrued expenses | | 459,000 | | 486,000 | ||
| Capitalized research and development costs | | 4,839,000 | | 5,339,000 | ||
| Healthcare withholding - SARs | | | 11,000 | | | 12,000 |
| Deferred tax assets | | 36,840,000 | | 174,291,000 | ||
| | | | | | | |
| Less valuation allowance | | (36,840,000) | | (174,291,000) | ||
| Net deferred tax assets | | $— | | $— | ||
ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against its deferred tax assets at December 31, 2024. The Company experienced a net change in valuation allowance of $(137,452,000) and $4,157,000 for the years ended December 31, 2024 and 2023, respectively.
A reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows:
| | | | | | |
|---|---|---|---|---|---|
| · · December 31, · | |||||
| · 2024 · 2023 · | |||||
| Federal income tax expense at statutory rate | | 21.0% | 21.0% | ||
| Permanent items | (17.9) | | (0.1) | | |
| Foreign permanent items | | (0.7) | | — | |
| Foreign rate differential | | 0.1 | | — | |
| State income tax, net of federal benefit | 0.5 | | 5.4 | | |
| State expirations | | — | | (8.6) | |
| Tax credits | — | | 17.7 | | |
| Change in valuation allowance | 83.6 | | (21.9) | | |
| Deferred tax adjustment | | (1.0) | | (9.4) | |
| State tax rate change | | — | | — | |
| Sec 382 expirations | | (84.0) | | — | |
| Other | (1.6) | | (4.1) | | |
| Effective income tax rate | —% | —% | |||
**12.**Research and Development Arrangements and Related Party Transactions
Research and development arrangements with unrelated parties
The Company has entered into various licensing and right-to-sublicense agreements with educational institutions for the exclusive use of patents and patent applications, as well as any patents that may develop from research being
conducted by such educational institutions in the field of anticancer therapy, genes and proteins. Results from this research have been licensed to the Company pursuant to these agreements. Under one of these agreements with Temple University (“Temple”), the Company is required to make annual maintenance payments to Temple and royalty payments based upon a percentage of sales generated from any products covered by the licensed patents, with minimum specified royalty payments. Asno sales had been generated through December 31, 2024 under the licensed patents, the Company has not incurred any royalty expenses related to this agreement. In addition, the Company is required to pay Temple a percentage of any sublicensing fees received by the Company.
Research and development arrangements with related parties
Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement with ChemDiv, Inc. (“ChemDiv”). Pursuant to the Master Research and Development Agreement, ChemDiv provided services related to preclinical drug discovery to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger. Dr. Nikolay Savchuk, COO of the Company and a director on the Board, is a stockholder of ChemDiv and a member of its board of directors. Subsequent to the Merger and through December 31, 2024, the Company made payments to ChemDiv of $5,024,000 which primarily relate to services completed prior to the Merger. During the year ended December 31, 2024, $460,000 was expensed as R&D in the Company’s consolidated statements of operations related to ChemDiv’s services, of which $10,000 was included in accounts payable as of December 31, 2024 in the Company’s consolidated balance sheets.
Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement with Viriom, Inc. (“Viriom”). Pursuant to the Master Research and Development Agreement, Viriom provided services related to virology to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger. Nikolay Savchuk, COO of the Company, serves as President of Viriom and as a member of its board of directors. Dr. Savchuk has investment control of Viriom and indirectly holds a significant number of its shares of common stock through a limited liability company of which Dr. Savchuk is the managing member and equity holder. Dr. Robert R. Redfield, M.D., our Chief Medical Officer, serves as a strategic advisor and member of Viriom’s board of directors. Additionally, Dr. C. David Pauza Ph.D., our Chief Science Officer, served as the Chief Science Officer of Viriom until April 1, 2024, after which time he resigned from any position with Viriom; and Iain Dukes, Executive Chairman of the Company, served as CEO of Viriom and as a member of its board of directors. During the year ended December 31, 2024, $128,000 was expensed as R&D in the Company’s consolidated statements of operations related to Viriom’s services, of which $113,000 and $15,000 was included in accounts payable and accrued expenses, respectively, as of December 31, 2024, in the Company’s consolidated balance sheets.
Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement with Expert Systems, Inc. (“Expert”). Pursuant to the Master Research and Development Agreement, Expert provided drug development and consulting services to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger. An immediate family member of Dr. Savchuk has significant ownership in Expert. During the year ended December 31, 2024, $149,000 was expensed in the Company’s consolidated statements of operations related to Expert’s services. As of December 31, 2024, $77,000 and $72,000 was included in accounts payable and accrued expenses, respectively, in the Company’s consolidated balance sheets.
License Agreement with related party
In addition, prior to consummation of the Merger, Trawsfynydd entered into a License Agreement (the “Viriom License Agreement”) with Viriom, pursuant to which Trawsfynydd obtained an exclusive, royalty-free, sublicensable, world-wide license to certain Viriom patents, applications, and technical information (collectively, the “Viriom Licensed IP”) to make, have made, use, sell, offer for sale and import several classes of novel compounds related to the treatment and prevention of viral diseases, specifically for use of the Viriom Licensed IP in the development of treatment and methods to prevent viral disease in Canada, China, the European Union, Hong Kong, Japan, the United States and all areas covered by PCT applications for the Viriom Licensed IP. No annual license fees, royalties, or milestone payments are required. Additionally, pursuant to the Viriom License Agreement, Trawsfynydd obtained the right to control prosecution, defense of infringement and enforcement. As a result of the Merger, the rights and obligations of Trawsfynydd under the Viriom License Agreement were transferred to the Company (through its subsidiaries).
Unless terminated earlier pursuant to the agreement, the Viriom License Agreement shall remain in force and effect for the life of the last-to-expire patent included in the Viriom Licensed IP or last-to-be abandoned patent application licensed under the agreement, whichever is later. The Viriom License Agreement can be terminated by either party due to the material breach of either party (subject to a cure period).
Related party purchase of securities
In connection with the Merger, on April 1, 2024, TPAV purchased 13,489 shares of Company common stock and 1,070.93 shares of Series C Preferred Stock for an aggregate purchase price of $9,499,995 pursuant to the April 2024 Purchase Agreement. Nikolay Savchuk, the Company’s Chief Operating Officer and a director on the Board, serves as the sole manager on the board of managers of TPAV.
Additionally, TPAV purchased 96,348 Class B Units, consisting of pre-funded warrants to purchase 96,348 shares of Company common stock and Series A Warrants to purchase 96,348 shares of Company common stock for an aggregate purchase price of $491,664 in the December 2024 financing.
Werner Cautreels, our Chief Executive Officer and a member of our Board, also purchased 96,348 Class B Units, consisting of pre-funded warrants to purchase 96,348 shares of Company common stock and Series A Warrants to purchase 96,348 shares of Company common stock for an aggregate purchase price of $491,664 in the December 2024 financing.
13. License and Collaboration Agreements
SymBio Agreement
In July 2011, the Company entered into a license agreement with SymBio Pharmaceuticals Limited (“SymBio”), which has been subsequently amended, granting SymBio an exclusive, royalty-bearing license for the development and commercialization of rigosertib in Japan and Korea. Under the SymBio license agreement, SymBio is obligated to use commercially reasonable efforts to develop and obtain market approval for rigosertib inside the licensed territory and the Company has similar obligations outside of the licensed territory. The Company has also entered into an agreement with SymBio providing for it to supply SymBio with development-stage product. Under the SymBio license agreement, the Company also agreed to supply commercial product to SymBio under specified terms that will be included in a commercial supply agreement to be negotiated prior to the first commercial sale of rigosertib. The supply of development-stage product and the supply of commercial product will be at the Company’s cost plus a defined profit margin. Sales of development-stage product have been de minimis. The Company has additionally granted SymBio a right of first negotiation to license or obtain the rights to develop and commercialize compounds having a chemical structure similar to rigosertib in the licensed territory.
Under the terms of the SymBio license agreement, the Company received an upfront payment of $7,500,000 in 2011. In addition, the Company could receive regulatory, development and sales-based milestone payments as well as royalty payments at percentage rates ranging from the mid-teens to 20% based on net sales of rigosertib by SymBio.
Royalties will be payable under the SymBio agreement on a country-by-country basis in the licensed territory, until the later of the expiration of marketing exclusivity in those countries, a specified period of time after first commercial sale of rigosertib in such country, or the expiration of all valid claims of the licensed patents covering rigosertib or the manufacture or use of rigosertib in such country. If no valid claim exists covering the composition of matter of rigosertib or the use of or treatment with rigosertib in a particular country before the expiration of the royalty term, and specified competing products achieve a specified market share percentage in such country, SymBio’s obligation to pay the Company royalties will continue at a reduced royalty rate until the end of the royalty term. In addition, the applicable royalties payable to the Company may be reduced if SymBio is required to pay royalties to third-parties for licenses to intellectual property rights necessary to develop, use, manufacture or commercialize rigosertib in the licensed territory. The license agreement with SymBio will remain in effect until the expiration of the royalty term. However, the SymBio license agreement may be terminated earlier due to the uncured material breach or bankruptcy of a party, or force majeure. If
SymBio terminates the license agreement in these circumstances, its licenses to rigosertib will survive, subject to SymBio’s milestone and royalty obligations, which SymBio may elect to defer and offset against any damages that may be determined to be due from the Company. In addition, the Company may terminate the license agreement in the event that SymBio brings a challenge against it in relation to the licensed patents, and SymBio may terminate the license agreement without cause by providing the Company with written notice within a specified period of time in advance of termination.
The Company assessed the SymBio arrangement in accordance with ASC 606 and determined that its performance obligations under the SymBio agreement include the exclusive, royalty-bearing, sublicensable license to rigosertib, the research and development services to be provided by the Company and its obligation to serve on a joint committee. The Company concluded that the license was not distinct since it was of no benefit to SymBio without the ongoing research and development services and that, as such, the license and the research and development services should be bundled as a single performance obligation. Since the provision of the license and research and development services are considered a single performance obligation, the $7,500,000 upfront payment is being recognized as revenue ratably through December 2037, the expected period over which the Company expects the research and development services to be performed.
SymBio’s purchases of rigosertib as development-stage product or for commercial requirements represent options under the agreement and revenues are therefore recognized when control of the product is transferred, which is typically when shipped. If SymBio orders the supplies from the Company, the Company expects the pricing for this supply to equal its third-party manufacturing cost plus a pre-negotiated percentage, which will not result in a significant incremental discount to market rates. In January 2018, the agreement was amended to provide SymBio a discount of 35% on future purchases, limited to a cumulative total amount of $300,000.
HanX Narazaciclib (ON 123300) Agreement
In December 2017, the Company entered into a license and collaboration agreement with HanX Biopharmaceuticals, Inc. (“HanX”), a company focused on development of novel oncology products, for the further development, registration and commercialization of narazaciclib in Greater China. Narazaciclib is a preclinical compound which the Company believes has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. The key feature of the collaboration was that HanX provided all funding required for the Chinese IND enabling studies necessary in order to seek IND approval by the National Medical Products Administration (“Chinese FDA”). The Chinese IND was approved in January 2020. The Company and HanX also intended for these studies underlying the Chinese IND approval, to meet the US FDA standards for IND approval. Accordingly, such studies were used by the Company for an IND filing with the US FDA in November 2020. In September 2020, a Phase 1 Study with narazaciclib in cancer patients was initiated in China. The Company maintains global rights to the study and study data outside of China. The US FDA Study May Proceed letter was issued in December 2020. Enrollment into the US phase 1 study (“Study 19-01”) commenced in May 2021.
If the compound receives regulatory approval and is commercialized, the Company would receive regulatory and commercial milestone payments, as well as royalties on sales in the Greater China territory.
Pint Agreement
On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement (the “Pint License Agreement”) and a Securities Purchase Agreement (the “Pint Securities Purchase Agreement”) with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to as “Pint”).
Under the terms of the Pint License Agreement, the Company granted Pint an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and commercialize any pharmaceutical product (the “Pint Licensed Product”) containing rigosertib in all uses of rigosertib in humans in Latin American countries (the “Pint Territory”, including Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, French Guiana, British Guiana, Suriname, Guatemala, Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela).
Pint agreed to make an upfront equity investment in the Company’s common stock. In addition, the Company could receive additional regulatory, development and sales-based milestone payments, an additional equity investment, as well
as tiered, double digit royalties based on net aggregate net sales in the Pint Territory. Pint and the Company have also agreed to enter into a supply agreement providing for Pint purchasing rigosertib and the Pint Licensed Product from the Company within 90 days of FDA approval of an NDA for the Pint Licensed Product.
Pint may terminate the Pint License Agreement in whole (but not in part) at any time upon 45 days’ prior written notice. The Pint License Agreement also contains certain provisions for termination by either party in the event of breach of the Pint License Agreement by the other party, subject to a cure period, or bankruptcy of the other party.
In addition, under the Pint Securities Purchase Agreement, if the FDA approves the NDA for the Pint Licensed Product, Pint will reimburse the Company for certain research and development expenses. Half of the reimbursement amount will be paid in cash, the other half of the amount will be by an equity investment at a premium to the average of the volume weighted average price of common stock for the ten consecutive trading days ended on the day the FDA approves the NDA.
Knight Agreement
In November 2019, the Company entered into a Distribution, License and Supply Agreement (the “Knight License Agreement”) with Knight Therapeutics Inc. (“Knight”). Under the terms of the Knight License Agreement, the Company granted Knight (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and manufacture any product (the “Knight Licensed Product”) containing rigosertib for Canada (and Israel should Knight exercise its option) (the “Knight Territory”) and in human uses (the “Knight Licensed Field”), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to commercialize the Knight Licensed Product in the Knight Territory and in the Knight Licensed Field.
Knight has also agreed to obtain from the Company all of Knight’s requirements of the Knight Licensed Products for the Knight Territory, and the Company has agreed to supply Knight with all of its requirements of the Knight Licensed Products. The Company may, at its discretion, use the services of a contract manufacturer to manufacture and package the Knight Licensed Products.
In addition, the Company has granted Knight an exclusive right of first refusal with respect to all or any part of the Knight Territory, to store, market, promote, sell, offer for sale and/or distribute any ROFR Products. As used in the Knight License Agreement, “ROFR Products” means all products other than the Knight Licensed Product that are owned, licensed, or controlled by the Company as of the effective date and all improvements thereto.
The Company is eligible to receive clinical, regulatory and sales-based milestone payments. The Company is also eligible to receive tiered double-digit royalties based on net sales in the Knight Territory.
The Knight License Agreement is for a term of 15 years from the launch on a country-by-country basis in the Knight Territory and contains customary provisions for termination by either party in the event of breach of the Knight License Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee.
Specialised Therapeutics Asia Pte. Ltd. Agreement
On December 18, 2019, the Company entered into a Distribution, License and Supply Agreement (the “STA License Agreement”) with Specialised Therapeutics Asia Pte. Ltd. (“STA”). Under the terms of the STA License Agreement, the Company granted STA (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and manufacture any product (the “STA Licensed Product”) containing rigosertib for Australia and New Zealand (the “STA Territory”) and in human uses (the “Field”), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to commercialize the STA Licensed Product in the STA Territory and in the Field.
STA has also agreed to obtain from the Company all of STA’s requirements of the STA Licensed Products for the STA Territory, and the Company has agreed to supply STA with all of its requirements of the STA Licensed Products.
The Company may, at its discretion, use the services of a contract manufacturer to manufacture and package the STA Licensed Products.
The Company may be entitled to receive clinical, regulatory and sale-based milestone payments. The Company may also be entitled to receive tiered double-digit royalties based on net sales in the Territory.
The License Agreement is for a term of 15 years from the launch on a country-by-country basis in the Territory and contains customary provisions for termination by either party in the event of breach of the License Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee.
14. Subsequent Events
At the Market Offering Agreement
On March 10, 2025, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with Citizens JMP Securities, LLC (“Citizens”), pursuant to which the Company may offer and sell shares of its common stock, having aggregate sales price of up to $50,000,000 (subject to certain limitations set forth in the ATM Agreement), from time to time, to or through Citizens, acting as sales agent and/or principal.
Amendment of Series A Warrants and pre-funded warrants
On February 18, 2025, the Company and certain of the purchasers of Units in the December 2024 offering entered into amendments to the Series A Warrants (the “Series A Warrant Amendment”), pursuant to which the Series A Warrants issued to such purchasers were amended to (i) increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the Series A Warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company, (ii) revise the expected volatility rate to be applied for purposes of determining the Black Scholes Value of the Series A Warrants to be utilized for calculating consideration payable to the holders of the Series A Warrants in connection with a Fundamental Transaction that is not within the Company’s control, and (iii) remove Section 3(h) of the Series A Warrants, which, under certain circumstances, provided for adjustments to the exercise price of the Series A Warrants in the event of a reverse stock split, stock consolidation, or a recapitalization or similar event involving the Company’s common stock based on the volume weighted average price of the Company’s common stock over theeleven trading day period commencing five trading days immediately preceding such event and thefive trading days immediately following such event.
Subsequent to the year ended December 31, 2024, certain purchasers exercised their pre-funded warrants for an aggregate of 1,382,559 shares of our common stock. On March 27, 2025, the Company and those purchasers holding all pre-funded warrants outstanding as of such date entered into amendments to the pre-funded warrants (the “PFW Amendment”), pursuant to which the pre-funded warrants issued to such purchasers were amended to increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the pre-funded warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the outstanding common stock of the Company.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.