1 unchanged sentence
Limitations on Effectiveness of Controls and Procedures
−Removed: In designing and evaluating our disclosure controls and procedures and internal control over financial reporting, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.
+Added: In designing and evaluating our disclosure controls and procedures and internal control over financial reporting, management recognizes that any controls and procedures, no matter how well designed and operated, can provide
+Added: only reasonable assurance of achieving the desired control objectives.
In addition, the design of disclosure controls and procedures and internal control over financial reporting must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
18 unchanged sentences
Trading Plans of Our Directors and Officers
−Removed: During our fiscal quarter ended December 31, 2024, n o n e of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) entered into, modified (as to amount, price or timing of trades) or terminated (i) contracts, instructions or written plans for the purchase or sale of our securities that are intended to satisfy the conditions specified in Rule 10b5-1(c) under the Exchange Act for an affirmative defense against liability for trading in securities on the basis of material nonpublic information or (ii) non-Rule 10b5-1 trading arrangements (as defined in Item 408(c) of Regulation S-K) .
+Added: During the fiscal quarter ended December 31, 2025, n o n e of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) entered into, modified (as to amount, price or timing of trades) or terminated (i) contracts, instructions or written plans for the purchase or sale of our securities that are intended to satisfy the conditions specified in Rule 10b5-1(c) under the Exchange Act for an affirmative defense against liability for trading in securities on the basis of material nonpublic information or (ii) non-Rule 10b5-1 trading arrangements (as defined in Item 408(c) of Regulation S-K) .
+Added: Other Information
+Added: Trading Plans of Our Directors and Officers
+Added: During the fiscal quarter ended December 31, 2025, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) entered into, modified (as to amount, price or timing of trades) or terminated (i) contracts, instructions or written plans for the purchase or sale of our securities that are intended to satisfy the conditions specified in Rule 10b5-1(c) under the Exchange Act for an affirmative defense against liability for trading in securities on the basis of material nonpublic information or (ii) non-Rule 10b5-1 trading arrangements (as defined in Item 408(c) of Regulation S-K).
+Added: Note Purchase Agreement Amendment
+Added: The information set forth below is included for the purpose of providing disclosure under “Item 1.01 — Entry into a Material Definitive Agreement,” and “Item 2.03 — Creation of a Direct Financial Obligation or an Obligation Under an Off-Balance Sheet Arrangement of a Registrant” of Form 8-K.
+Added: On March 2, 2026, Verastem, Inc.
+Added: (the “Company”) amended its Note Purchase Agreement, dated January 13, 2025 (as amended, the “Note Purchase Agreement”) with RGCM SA LLC, as Purchaser Agent, Oberland Capital Management LLC and certain funds managed by Oberland Capital Management LLC, as purchasers.
+Added: The amendment extends the outside date for the period during which the Company may draw the Second Purchase (as defined in the Note Purchase Agreement) from December 31, 2025 to June 30, 2026.
+Added: A copy of the amendment is attached as Exhibit 10.50 to this Annual Report on Form 10-K and is incorporated herein by reference.
+Added: The forgoing summary of the amendment does not purport to be complete and is qualified in its entirety by reference to the complete text of the amendment and the Note Purchase Agreement.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
47 unchanged sentences
D escription of Securities
−Removed: Form of Pre-Funded Warrant.
−Removed: (incorporated by reference to Exhibit 4.1 to the Form 8-K filed by the Registrant with the Securities and Exchange Commission on June 21, 2023).
Form of Pre-Funded Warrant to Purchase Stock (incorporated by reference to Exhibit 4.1 to the Form 8-K filed by the Registrant with the Securities and Exchange Commission on July 25, 2024).
Form of Warrant to Purchase Stock (incorporated by reference to Exhibit 4.2 to the Form 8-K filed by the Registrant with the Securities and Exchange Commission on July 25, 2024).
+Added: Registration Rights Agreement, dated April 25, 2025, by and among Verastem, Inc.
+Added: and the investors party thereto (incorporated by reference to Exhibit 10.2 to Form 8-K filed by the Registrant with the Securities and Exchange Commission on April 25, 2025)
+Added: Form of Pre-Funded Warrant (incorporated by reference to Exhibit 10.3 to Form 8-K filed by the Registrant with the Securities and Exchange Commission on April 25, 2025)
+Added: Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to Form 8-K filed by the Registrant with the Securities and Exchange Commission on November 17, 2025)
Form of Incentive Stock Option Agreement under 2012 Incentive Plan (incorporated by reference to Exhibit 10.3 to Amendment No.
11 unchanged sentences
Form of Restricted Stock Unit Agreement under Amended and Restated 2012 Incentive Plan (incorporated by reference to Exhibit 10.9 of the Registrant’s Annual Report on Form 10-K filed by the Registrant on March 13, 2018)
−Removed: Form of Inducement Award Nonstatutory Stock Option Agreement (incorporated by reference to Exhibit 4.4 to the Registration Statement on Form S-8 filed by the Registrant with the Securities and Exchange Commission on December 19, 2014)
Form of Inducement Award Nonstatutory Stock Option Agreement (incorporated by reference to Exhibit 10.11 of the Registrant’s Annual Report on Form 10-K filed by the Registrant on March 13, 2018)
3 unchanged sentences
First Amendment of Lease Agreement, dated February 15, 2018, between the Registrant and 117 Kendrick DE, LLC, as successor-in-interest to Intercontinental Fund III 117 Kendrick Street, LLC (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed by the Registrant on May 3, 2018)
−Removed: Second Amendment of Lease Agreement, dated November 1, 2024, between the Registrant and 117 Kendrick DE, LLC
+Added: Second Amendment of Lease Agreement, dated November 1, 2024, between the Registrant and 117 Kendrick DE, LLC (incorporated by reference to Exhibit 10.13 to the Annual Report on Form 10-K filed by the Registrant on March 20, 2025)
Employment Agreement, dated August 2, 2023, by and between Verastem, Inc.
and Daniel W.
−Removed: Paterson (incorporated by reference to Exhibit 10.1 to the Form 8-K filed by the Registrant with the Securities and Exchange Commission on August 4, 2023).
+Added: Paterson (incorporated by reference to Exhibit 10.14 on Form 10-K filed by the Registrant with the Securities and Exchange Commission on March 20, 2025).
License Agreement, dated July 11, 2012, by and between the Registrant and Pfizer Inc.
7 unchanged sentences
and Chugai Pharmaceutical, Co.
+Added: (incorporated by reference to Exhibit 10.18 on Form 10-K filed by the Registrant with the Securities and Exchange Commission on March 20, 2025).
Second Amendment to License Agreement for CKI27, dated August 12, 2021, between Verastem, Inc.
and Chugai Pharmaceutical Co.
+Added: (incorporated by reference to Exhibit 10.19 on Form 10-K filed by the Registrant with the Securities and Exchange Commission on March 20, 2025).
Third Amendment to License Agreement for CKI27, dated May 10, 2023, between Verastem, Inc.
and Chugai Pharmaceutical Co.
+Added: (incorporated by reference to Exhibit 10.20 on Form 10-K filed by the Registrant with the Securities and Exchange Commission on March 20, 2025).
Form of Restricted Stock Unit Agreement under the 2012 Incentive Plan (incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q filed by the Registrant on May 7, 2020)
38 unchanged sentences
dated as of August 24, 2023.
+Added: (incorporated by reference to Exhibit 10.44 on Form 10-K filed by the Registrant with the Securities and Exchange Commission on March 20, 2025).
Form of Restricted Stock Unit Agreement under the Amended and Restated 2021 Equity Incentive Plan.
−Removed: Insider Trading Policy
+Added: (incorporated by reference to Exhibit 10.45 on Form 10-K filed by the Registrant with the Securities and Exchange Commission on March 20, 2025).
+Added: First Amendment to the License Agreement, dated April 3, 2025, by and between the Registrant and Pfizer Inc.
+Added: (incorporated by reference to Exhibit 10.1 to Form 10-Q filed by the Registrant with the Securities and Exchange Commission on August 7, 2025)
+Added: Securities Purchase Agreement, dated April 25, 2025, by and among Verastem, Inc.
+Added: and the investors party thereto (incorporated by reference to Exhibit 10.1 to Form 8-K filed by the Registrant with the Securities and Exchange Commission on April 25, 2025)
+Added: Separation Agreement dated December 19, 2025 by and between Verastem, Inc.
+Added: and Matthew Ros (incorporated by reference to Exhibit 10.1 to Form 8-K filed by the Registrant with the Securities and Exchange Commission on December 19, 2025)
+Added: Amendment Number One to Note Purchase Agreement, dated as of October 31, 2025 by and among Verastem, Inc., RGCM SA LLC, Oberland Capital Management LLC and certain funds managed by Oberland Capital Management LLC.
+Added: Amendment Number Two to Note Purchase Agreement, dated as of March 2, 2026 by and among Verastem, Inc., RGCM SA LLC, Oberland Capital Management LLC and certain funds managed by Oberland Capital Management LLC.
+Added: Insider Trading Policy (incorporated by reference to Exhibit 19.1 on Form 10-K filed by the Registrant with the Securities and Exchange Commission on March 20, 2025).
Subsidiaries of the Registrant
Consent of Ernst & Young LLP
−Removed: Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a)
−Removed: Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a)
+Added: Certification of Principal Executive Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
+Added: Certification of Principal Financial and Accounting Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Chief Executive Officer pursuant to 18 U.S.C.
4 unchanged sentences
Press Release issued by Verastem, Inc.
−Removed: on March 20, 2025 (furnished herewith).
+Added: on March 4, 2026
Inline XBRL Instance Document
54 unchanged sentences
Consolidated Statements of Operations and Comprehensive Loss
−Removed: Consolidated Statements of Stockholders’ (Deficit) Equity
+Added: Consolidated Statements of Convertible Preferred Stock and Stockholders’ (Deficit) Equity
Consolidated Statements of Cash Flows
5 unchanged sentences
(the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders’ (deficit) equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with U.S.
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with U.S.
generally accepted accounting principles.
−Removed: The Company’s Ability to Continue as a Going Concern
−Removed: The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
−Removed: As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations, has a working capital deficiency, and has stated that substantial doubt exists about the Company’s ability to continue as a going concern.
−Removed: Management’s evaluation of the events and conditions and management’s plans regarding these matters are also described in Note 1.
−Removed: The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
18 unchanged sentences
Description of the Matter
−Removed: As summarized in Note 4 to the consolidated financial statements, the Company’s accrued clinical expenses were $10.9 million at December 31, 2024, which included the estimated obligation for clinical trial expenses incurred as of December 31, 2024 but not paid as of that date.
−Removed: In addition, the Company’s total prepaid expenses and other current assets were $5.9 million, which included amounts that were paid in advance of services incurred pursuant to clinical trials.
−Removed: As discussed in Note 2 to the consolidated financial statements, the Company records clinical trial expenses as incurred.
+Added: As summarized in Note 7 to the consolidated financial statements, accrued clinical trial expenses were $14.3 million at December 31, 2025, which included the estimated obligation for clinical trial expenses related to contract research organizations, based upon estimates of costs incurred as of December 31, 2025, but not paid as of that date.
+Added: In addition, total prepaid expenses and other current assets were $7.6 million at December 31, 2025, which included amounts that were paid in advance of services incurred pursuant to the agreements with contract research organizations.
+Added: As discussed in Note 2 to the consolidated financial statements, the Company
+Added: records clinical trial expenses as incurred.
The Company’s determination of costs incurred for certain development activities, such as clinical trial expenses, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, and information provided to the Company by its vendor on their actual costs incurred or level of effort expended.
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 on the consolidated balance sheets as prepaid expenses and other current assets or accrued expenses.
−Removed: Auditing the Company’s accrued and prepaid clinical trial expenses was especially challenging due to the volume of information received from vendors that perform services on the Company’s behalf.
−Removed: While the Company’s estimates of accrued and prepaid clinical trial expenses are primarily based on information received from its vendors for each study, the Company is required to make an estimate for additional costs incurred.
−Removed: Additionally, due to the long duration of clinical trials and the timing of vendor invoices, the actual amounts incurred are not typically known at the time the financial statements are issued.
How We Addressed the Matter in Our Audit
−Removed: To evaluate the accrued and prepaid clinical trial expenses, our audit procedures included, among others, testing the accuracy and completeness of the underlying data used in the estimates and evaluating the significant assumptions used by management to estimate the recorded accruals and prepayments.
−Removed: We obtained third party confirmation from the Company’s most significant contract research organizations to validate the underlying data used in management’s estimate.
−Removed: We corroborated the progress of research and development activities associated with clinical trials through discussion with the Company’s research and development personnel that oversee the clinical activities.
−Removed: In addition, we performed analytics over fluctuations in accruals and prepaids by vendor throughout the period subject to audit and compared subsequent invoices received from third parties to amounts accrued.
+Added: To test the accrued and prepaid clinical trial expenses related to contract research organizations, our audit procedures included, among others, reviewing agreements with contract research organizations to corroborate key financial and contractual terms, and testing the accuracy and completeness of the underlying data used in the accrued and prepaid expense computations.
+Added: We also evaluated management’s estimates of the progress of the clinical trials by making direct inquiries of the Company’s research and development personnel that oversee the clinical trial activities and confirming information directly with the contract research organizations.
+Added: In addition, we performed analytical procedures over accrued and prepaid clinical trial expenses by clinical trial, throughout the period subject to audit, and compared subsequent invoices received from contract research organizations to amounts accrued.
/s/ Ernst & Young LLP
7 unchanged sentences
Cash and cash equivalents
−Removed: Short-term investments
+Added: Accounts receivable, net
Grant receivable
4 unchanged sentences
Restricted cash
−Removed: Liabilities, convertible preferred stock and stockholders’ equity
+Added: Intangible assets, net
+Added: Liabilities, convertible preferred stock and stockholders’ (deficit) equity
Current liabilities:
Accounts payable
−Removed: Accrued expenses
−Removed: Deferred liabilities
+Added: Accrued expenses, short-term
+Added: Vendor financing arrangement, short-term
Lease liability, short-term
2 unchanged sentences
Long-term debt
+Added: Vendor financing arrangement, long-term
Lease liability, long-term
−Removed: Preferred stock tranche liability
Warrant liability
2 unchanged sentences
Series B Convertible Preferred Stock, $ 0.0001 par value;
−Removed: 944 shares and 2,144 shares designated at December 31, 2024 and December 31, 2023, respectively;
−Removed: 0 shares and 1,200 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively
+Added: 944 shares designated at December 31, 2025 and December 31, 2024, respectively;
+Added: 0 shares issued and outstanding at December 31, 2025 and December 31, 2024 , respectively
Stockholders’ equity:
2 unchanged sentences
Series A Convertible Preferred Stock, $ 0.0001 par value;
−Removed: 1,000 shares designated, 1,000 shares issued and outstanding at December 31, 2024 and December 31, 2023
+Added: 0 shares and 1,000 shares designated at December 31, 2025 and December 31, 2024, respectively, 0 shares and 1,000 shares issued and outstanding at December 31, 2025 and at December 31, 2024, respectively
Common stock, $ 0.0001 par value;
3 unchanged sentences
Accumulated deficit
−Removed: Total stockholders’ (deficit) equity
−Removed: Total liabilities, convertible preferred stock and stockholders’ (deficit) equity
+Added: ( 1,164,998 )
+Added: Total stockholders’ equity (deficit)
+Added: Total liabilities, convertible preferred stock and stockholders’ equity
See accompanying notes to the consolidated financial statements.
3 unchanged sentences
Year Ended December 31,
+Added: Product revenue, net
Sale of COPIKTRA license and related assets
1 unchanged sentence
Operating expenses:
+Added: Cost of sales - product
+Added: Cost of sales - intangible amortization
Research and development
2 unchanged sentences
Loss from operations
−Removed: Other income (expense)
+Added: Other expense
Interest income
Interest expense
+Added: Loss on debt extinguishment
Change in fair value of preferred stock tranche liability
Change in fair value of warrant liability
+Added: Change in fair value of Notes
Net loss before taxes
3 unchanged sentences
Unrealized gain (loss) on available-for-sale securities
+Added: Change in fair value of Notes attributable to instrument specific credit risk
Comprehensive loss
3 unchanged sentences
(in thousands, except share data)
−Removed: comprehensive
+Added: stockholders'
Series B Convertible Preferred Stock
Series A Convertible Preferred Stock
−Removed: stockholders'
−Removed: Balance at December 31, 2021
−Removed: Unrealized loss on available-for-sale marketable securities
−Removed: Issuance of Series A Convertible Preferred Stock in exchange for common stock
−Removed: Issuance of common stock under Employee Stock Purchase Plan
−Removed: Issuance of common stock resulting from vesting of restricted stock units
−Removed: Issuance of common stock resulting from exercise of stock options
−Removed: Issuance of common stock resulting from at-the-market transactions, net
−Removed: Stock-based compensation expense
+Added: comprehensive
Balance at December 31, 2022
17 unchanged sentences
Balance at December 31, 2024
+Added: Change in fair value of long-term debt attributable to instrument specific credit risk
+Added: Stock-based compensation expense
+Added: Issuance of common stock under Employee Stock Purchase Plan
+Added: Issuance of common stock resulting from vesting of restricted stock units
+Added: Issuance of common stock upon exercise of warrants
+Added: Issuance of common stock upon exercise of options
+Added: Issuance of common stock upon conversion of Series A Preferred Stock
+Added: ( 1,000,000 )
+Added: Issuance of common stock upon exercise of pre-funded warrants
+Added: Issuance of common stock resulting from at-the-market transactions
+Added: Issuance of common stock, net of issuance costs of $ 74 K
+Added: 2025 Private Placement issuance of common stock, and pre-funded warrants, net of issuance cost of $ 5,072
+Added: November 2025 Public Offering issuance of common stock, and pre-funded warrants, net of issuance cost of $ 6,617
+Added: Balance at December 31, 2025
+Added: ( 1,164,998 )
See accompanying notes to the consolidated financial statements.
5 unchanged sentences
Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Amortization of acquired intangible assets
Non-cash operating lease cost
3 unchanged sentences
Change in fair value of warrant liability
+Added: Non-cash change in fair value of Notes
+Added: Loss on debt extinguishment
Changes in operating assets and liabilities:
8 unchanged sentences
Purchases of property and equipment
+Added: Purchases of intangible assets
Purchases of investments
Maturities of investments
−Removed: Net cash provided by (used in) investing activities
+Added: Net cash (used in) provided by investing activities
Financing activities
−Removed: Payments for loan amendment
+Added: Proceeds from the issuance of common stock and pre-funded warrants, net
+Added: Proceeds from the issuance of warrants
Proceeds from issuance of Series B Convertible Preferred Stock, net
−Removed: Proceeds from long-term debt, net
+Added: Proceeds from exercise of warrants
+Added: Proceeds from long-term debt
+Added: Repayment of long-term debt
+Added: Payments for loan amendment
Repayment of 2018 Notes
2 unchanged sentences
Proceeds from the exercise of stock options and employee stock purchase program
−Removed: Proceeds from the issuance of common stock and pre-funded warrants, net
−Removed: Proceeds from the issuance of warrants
−Removed: Proceeds from exercise of warrants
Net cash provided by financing activities
4 unchanged sentences
Cash paid for interest
+Added: Cash paid for income tax expense
Supplemental disclosure of non-cash investing and financing activities
3 unchanged sentences
Conversion of Series B Convertible Preferred Stock to common stock
−Removed: Conversion of warrant liability to common stock upon warrant exercise
+Added: Conversion of warrant liability into additional paid-in capital upon warrant exercise
Right of use asset obtained in exchange for operating lease liability
+Added: Purchases of intangible assets in accounts payable and accrued expenses
See accompanying notes to the consolidated financial statements.
1 unchanged sentence
Verastem, Inc.
−Removed: (the “Company”) is a late-stage development biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with ras sarcoma (“RAS”)/ mitogen activated pathway kinase (“MAPK”) pathway-driven cancers.
−Removed: The Company’s pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition and KRAS G12D inhibition.
−Removed: The Company’s most advanced product candidates, avutometinib and defactinib, are being investigated in both preclinical and clinical studies for the treatment of various solid tumors, including, but not limited to low grade serous ovarian cancer (“LGSOC”), non-small cell lung cancer (“NSCLC”) and pancreatic cancer.
−Removed: The Company believe that avutometinib may be beneficial as a therapeutic, as a single agent or when used together in combination with defactinib, other agents, other pathway inhibitors, or other current and emerging standard of care treatments in cancers that do not adequately respond to currently available therapies.
+Added: (the “Company”) is a biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with challenging RAS/MAPK pathway-driven cancers.
+Added: The Company markets AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules;
+Added: defactinib tablets) in the U.S., the first treatment specifically FDA-approved for adults with KRAS-mutated recurrent LGSOC who have received prior systemic therapy.
+Added: AVMAPKI FAKZYNJA CO-PACK received accelerated approval in the U.S.
+Added: on May 8, 2025.
+Added: The Company’s pipeline is focused on novel small molecule drugs developed both as monotherapy and in combination, which inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including targeting RAS directly with KRAS G12D inhibition, targeting the pathway downstream with RAF/MEK inhibition, and targeting the parallel pathway that drives resistance with FAK inhibition.
+Added: The Company’s focus is to expeditiously develop and deliver transformative therapies that truly change outcomes for people living with RAS/MAPK pathway-driven cancers.
The consolidated financial statements include the accounts of Verastem Securities Company and Verastem Europe GmbH, wholly-owned subsidiaries of the Company.
1 unchanged sentence
All intercompany balances and transactions have been eliminated in consolidation.
−Removed: The Company is subject to the risks associated with other life science companies, including, but not limited to, possible failure of preclinical testing or clinical trials, competitors developing new technological innovations, inability to obtain marketing approval of the Company’s product candidates, avutometinib and defactinib, market acceptance and commercial success of the Company’s product candidates, avutometinib and defactinib, following receipt of regulatory approval, and, protection of proprietary technology and the continued ability to obtain adequate financing to fund the Company’s future operations.
−Removed: If the Company does not obtain marketing approval and successfully commercialize its product candidates, avutometinib and defactinib, following regulatory approval, it will be unable to generate product revenue or achieve profitability and may need to raise additional capital.
−Removed: As of December 31, 2024, the Company had cash, cash equivalents, and investments of $ 88.8 million.
+Added: The Company is subject to the risks associated with other life science companies, including, but not limited to, possible failure of preclinical testing or clinical trials, competitors developing new technological innovations, commercial success of the Company’s marketed product AVMAPKI FAKZYNJA CO-PACK, inability to obtain marketing approval of the Company’s product candidates, market acceptance and commercial success of the Company’s product candidates following receipt of regulatory approval, and, protection of proprietary technology and the continued ability to obtain adequate financing to fund the Company’s future operations.
+Added: Until such time, if ever, that the Company can generate substantial product revenues or achieve profitability, it may need to raise additional capital.
+Added: As of December 31, 2025, the Company had cash and cash equivalents of $ 205.0 million and an additional $ 29.4 million in proceeds in January 2026 from the exercise of Warrants (see Note 20.
+Added: Subsequent Events ).
In accordance with applicable accounting standards, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within 12 months after the date of the issuance of these consolidated financial statements.
−Removed: The Company anticipates operating losses may continue for the foreseeable future since the Company does not yet have regulatory approval to sell any of its product candidates, and the Company continues to incur operating costs to execute its strategic plan, including costs related to research and development of its product candidates and commercial readiness activities.
−Removed: As a result of the assessment in accordance with the applicable accounting standards, these conditions raise substantial doubt about the Company’s ability to continue as a going concern for 12 months after the date the consolidated financial statements are issued.
−Removed: The Company expects to finance its operations with its existing cash, cash equivalents and investments, through potential future milestones and royalties received pursuant to the Company’s Asset Purchase Agreement (“Secura APA”) with Secura Bio, Inc.
−Removed: (“Secura”), pursuant to the Company’s Note Purchase Agreement (the “Note Purchase Agreement”) with RGCM SA LLC, as purchaser agent, Oberland Capital Management LLC (“Oberland”) and certain funds managed by Oberland, as purchasers (together with the other purchasers party thereto referred as the “Note Purchase Agreement Purchasers”), or through other strategic financing opportunities that could include, but are not limited to collaboration agreements, future offerings of its equity, or the incurrence of debt.
−Removed: However, given the risks associated with these potential strategic or financing opportunities, they are not deemed probable for purposes of the going concern assessment.
−Removed: If the Company fails to obtain additional future capital, it may be unable to complete its planned preclinical studies and clinical trials and obtain approval of certain investigational product candidates from the U.S.
+Added: The Company expects its existing cash resources, including the proceeds from the exercise of Warrants in January 2026, along with revenue it expects to generate from sales of AVMAPKI FAKZYNJA CO-PACK and the availability to draw down $ 25.0 million under the Second Purchase (defined herein) pursuant to the Company’s Note Purchase Agreement (defined herein) (see Note 8.
+Added: Long-term debt ) will be sufficient to fund its planned operations through 12 months from the date of issuance of these consolidated financial statements.
+Added: As of December 31, 2024, the Company had concluded that there was substantial doubt about its ability to continue as a going concern primarily due to anticipated operating losses for the foreseeable future since the Company did not yet have regulatory approval to sell any of its product candidates, and the Company continued to incur operating costs to execute its strategic plan, including costs related to research and development of its product candidates and commercial readiness activities.
+Added: The Company’s increased cash and cash equivalents position as of December 31, 2025, forecasted net product revenue following regulatory approval of AVMAPKI FAKZYNJA CO-PACK on May 8, 2025, and ability to draw down on the Second Purchase pursuant to the Note Purchase Agreement, alleviated the substantial doubt.
+Added: The Company expects to finance its operations with its existing cash and cash equivalents, through revenue generated from sales of AVMAPKI FAKZYNJA CO-PACK, through potential future milestones and royalties received pursuant to the Company’s Asset Purchase Agreement (“Secura APA”) with Secura Bio, Inc.
+Added: (“Secura”), note drawdowns pursuant to the Note Purchase Agreement, or through other strategic financing opportunities that could include, but are not limited to collaboration agreements, future offerings of its equity, or the incurrence of debt.
+Added: However, there is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders.
+Added: If the Company fails to obtain additional future capital or generate sufficient net product revenue, it may be unable to complete its planned preclinical studies and clinical trials and obtain approval of certain investigational product candidates from the U.S.
Food and Drug Administration (“FDA”) or foreign regulatory authorities.
−Removed: Therefore, there is substantial doubt about the Company’s ability to continue as a going concern.
Reverse Stock Split
4 unchanged sentences
The number of shares of common stock that the Company is authorized to issue remains at 300,000,000 shares and the par value of its common stock remains unchanged at $ 0.0001 per share.
−Removed: The Company has retroactively restated the share and per share amounts in the consolidated financial statements for the 12 months ended December 31, 2023 and 2022, to give retroactive effect to the Reverse Stock Split.
−Removed: Proportionate adjustments were made to the per share exercise price and number of shares of common stock issuable under all outstanding stock options, convertible notes and preferred stock.
−Removed: In addition, proportionate adjustments have been made to the number of shares of common stock issuable upon vesting of the restricted stock units and the number of shares of common stock reserved for the Company’s equity incentive compensation plans.
−Removed: The consolidated statements of convertible preferred stock and stockholders’ equity reflect the impact of the Reverse Stock Split by reclassifying from “common stock” to “additional paid-in capital” in an amount equal to the par value of the decreased shares resulting from the Reverse Stock Split the years ended December 31, 2023, and 2022.
+Added: The Company has retroactively restated the share and per share amounts in the consolidated financial statements for the year ended December 31, 2023, to give retroactive effect to the Reverse Stock Split.
+Added: The consolidated statements of convertible preferred stock and stockholders’ equity reflect the impact of the Reverse Stock Split by reclassifying from “common stock” to “additional paid-in capital” in an amount equal to the par value of the decreased shares resulting from the Reverse Stock Split the year ended December 31, 2023.
Significant accounting policies
1 unchanged sentence
The accompanying financial statements of the Company have been prepared in accordance with U.S.
−Removed: generally accepted accounting principals (“GAAP”) under the assumption that the Company will continue as a going concern for the next 12 months.
+Added: generally accepted accounting principles (“GAAP”) under the assumption that the Company will continue as a going concern for the next 12 months.
Accordingly, they do not include any adjustments that might result from the uncertainty related to the Company’s ability to continue as a going concern.
2 unchanged sentences
GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.
−Removed: On an ongoing basis, management evaluates its estimates, including but not limited to estimates related to revenue recognition, accrued and prepaid clinical trial expense and other general accruals, stock-based compensation expense, its preferred stock tranche liability and its warrant liability.
+Added: On an ongoing basis, management evaluates its estimates, including but not limited to estimates related to revenue recognition, accrued and prepaid clinical trial expense and other general accruals, stock-based compensation expense, long-term debt, and its warrant liability.
The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable.
2 unchanged sentences
Operating segments are defined as components of an enterprise about which separate discrete information is available and regularly reviewed by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.
−Removed: The Company views its operations and manages its business in one operating segment, which is the business of researching, developing and commercializing drugs for the treatment of patients with cancer.
−Removed: All material long-lived assets of the Company reside in the United States.
+Added: The Company views its operations and manages its business in
+Added: one operating segment, which is the business of researching, developing and commercializing drugs for the treatment of patients with cancer.
+Added: All material long-lived assets of the Company reside in the U.S.
Proceeds from grants
5 unchanged sentences
Eligible expenses incurred in excess of grant payments received up to the total amount of the PanCAN Grant are recorded as a grant receivable.
−Removed: Through December 31, 2024 the Company has received $ 4.1 million of cash proceeds which was initially recorded as deferred liabilities on the balance sheet.
+Added: Through December 31, 2025, the Company has received $ 4.1 million of cash proceeds that were initially recorded as deferred liabilities on the balance sheet.
The Company recorded $ 0.0 million, $ 2.0 million and $ 2.0 million of the proceeds as a reduction of research and development expense during the years ended December 31, 2025, 2024, and 2023, respectively.
−Removed: As of December 31, 2024, the company recorded $ 0.2 million as a grant receivable related to the PanCAN Grant in the consolidated balance sheet.
−Removed: As of December 31, 2023, the Company recorded $ 0.3 million as deferred liabilities related to the PanCAN Grant in the consolidated balance sheet.
+Added: As of December 31, 2025, the Company had $ 0.2 million as a grant receivable and no deferred liabilities related to the PanCAN Grant recognized on the consolidated balance sheet.
Cash, cash equivalents and restricted cash
9 unchanged sentences
Total cash, cash equivalents and restricted cash
−Removed: Amounts included in restricted cash as of December 31, 2024 is cash held to collateralize outstanding letters of credit provided as a security deposit for the Company’s office space located in Needham, Massachusetts in the amount of $ 0.2 million.
−Removed: Amounts included in restricted cash as of December 31, 2023 represent (i) cash held to collateralize outstanding letters of credit provided as a security deposit for the Company’s office space located in Needham, Massachusetts in the amount of $ 0.2 million and (ii) cash received pursuant to the PanCAN Grant restricted for expenditures for specific research and development activities in the amounts of $ 0.9 million.
−Removed: The letters of credit are included in non-current restricted cash on the consolidated balance sheets as of December 31, 2024 and December 31, 2023.
−Removed: Cash held pursuant to the PanCAN Grant is included in prepaid expenses and other current assets on the consolidated balance sheet as of December 31, 2023.
+Added: Amounts included in restricted cash as of December 31, 2025 and December 31, 2024 represent cash held to collateralize outstanding letters of credit provided as a security deposit for the Company’s office space located in Needham, Massachusetts in the amount of $ 0.2 million.
+Added: The letters of credit are included in prepaid expenses and other current assets on the consolidated balance sheet as of December 31, 2025, and in non-current restricted cash as of December 31, 2024.
+Added: There were no realized gains or losses on cash equivalents for the years ended December 31, 2025, 2024 or 2023.
+Added: Accrued interest receivable is excluded from the amortized cost and estimated fair value of the Company’s cash equivalents.
+Added: Accrued interest receivable of $ 0.2 million is presented within prepaid expenses and other current assets on the consolidated balance sheets on December 31, 2025.
+Added: There was no accrued interest receivable as of December
+Added: There were no debt securities in an unrealized loss position as of December 31, 2025, or December 31, 2024.
+Added: Cash, cash equivalents and restricted cash consist of the following (in thousands):
+Added: December 31, 2025
+Added: Cash, cash equivalents & restricted cash:
+Added: Cash and money market accounts
+Added: Total cash, cash equivalents & restricted cash
+Added: December 31, 2024
+Added: Cash, cash equivalents & restricted cash:
+Added: Cash and money market accounts
+Added: Total cash, cash equivalents & restricted cash
Fair value of financial instruments
15 unchanged sentences
Warrant liability
+Added: Total financial liabilities
December 31, 2024
1 unchanged sentence
Cash equivalents
−Removed: Short-term investments
Total financial assets
−Removed: Preferred stock tranche liability
+Added: Warrant liability
+Added: Total financial liabilities
The investments and cash equivalents have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third party pricing services or other market observable data.
4 unchanged sentences
Warrant liability
−Removed: A warrant liability was recorded as a result the July 2024 Offering (defined herein) (see Note 7.
+Added: A warrant liability was recorded in connection with the July 2024 Offering (defined herein) (see Note 10.
Capital Stock ).
The fair value measurement of the warrant liability is classified as Level 3 under the fair value hierarchy.
−Removed: The fair value of the warrant liability at inception and December 31, 2024, was determined using the Black-Scholes valuation model.
+Added: The fair value of the warrant liability at December 31, 2025 and December 31, 2024, was determined using the Black-Scholes valuation model.
The inputs to the Black-Scholes valuation model include the risk-free rate, stock price volatility, expected dividends and remaining term.
Significant increases or decreases in any of those inputs in isolation could result in a significantly lower or higher fair value measurement.
−Removed: Below are the inputs used to value the warrant liability at July 23, 2024 and December 31, 2024:
+Added: Below are the inputs used to value the warrant liability at December 31, 2025 and December 31, 2024:
December 31, 2025
−Removed: July 23, 2024
+Added: December 31, 2024
Risk-free interest rate
2 unchanged sentences
The following table represents a reconciliation of the warrant liability (in thousands):
−Removed: July 23, 2024
−Removed: Fair value of warrants exercised
−Removed: Fair value adjustment
December 31, 2024
−Removed: Preferred Stock tranche liability
−Removed: A preferred stock tranche liability was recorded as a result of the entry into the Series B Convertible Preferred Stock Securities Purchase Agreement (defined herein) (see Note 7.
−Removed: Capital Stock) .
−Removed: The fair value measurement of the preferred stock tranche liability is classified as Level 3 under the fair value hierarchy.
−Removed: The fair value of the preferred stock tranche liability was determined using a Monte-Carlo simulation.
−Removed: The inputs to the Monte-Carlo include the risk-free rate, stock price volatility, expected dividends and remaining term.
−Removed: Significant increases or decreases in any of those inputs in isolation could result in a significantly lower or higher fair value measurement.
−Removed: The preferred stock tranche liability expired in July 2024 and is no longer outstanding.
−Removed: Below are the inputs used to value the preferred stock tranche liability at December 31, 2023:
−Removed: December 31, 2023
−Removed: Risk-free interest rate
−Removed: Dividend yield
−Removed: Remaining term (years)
−Removed: The following table represents a roll forward for the year ended December 31, 2024 of the preferred stock right liability (in thousands):
−Removed: January 1, 2024
+Added: Fair value of warrants exercised
Fair value adjustment
December 31, 2025
+Added: Note Purchase Agreement
+Added: The fair value of the Notes pursuant to the Note Purchase Agreement represents the present value of estimated future payments, including interest, principal, Repayment Amount, and Revenue Participation Payments (each as defined in the Note Purchase Agreement) (see Note 8.
Long-term debt ) .
−Removed: The fair value of the Company’s long-term debt is determined using a discounted cash flow analysis with current applicable rates for similar instruments as of the consolidated balance sheet date.
−Removed: The carrying value of the Company’s long-term debt as of December 31, 2024 and December 31, 2023, was approximately $ 40.7 million and $ 40.1 million, respectively.
−Removed: The Company estimates that the fair value of its long-term debt as of December 31, 2024 and December 31, 2023, was approximately $ 41.1 million and $ 39.6 million, respectively.
+Added: The fair value measurement is based on significant Level 3 unobservable inputs such as the probability and timing of Revenue Participation Payments, Repayment Amount, and the discount rate.
+Added: The Company determined the fair value of the Notes utilizing a discounted cash flow model of estimated future payments including interest, principal, Repayment Amount and Revenue Participation Payments utilizing a discount rate calculated as the term matched risk-free rate plus credit spread.
+Added: At January 13, 2025, the Company utilized a discount rate between 11.9 %- 12.4 % and at December 31, 2025, the Company utilized a discount rate between 12.6 %- 13.0 %.
+Added: The fair value of the Notes at December 31, 2025 was determined to be $ 76.3 million which differed from the contractual principal amount of $ 75.0 million by $ 1.3
+Added: Significant increases or decreases in any of these inputs in isolation could result in a significantly lower or higher fair value measurement.
+Added: Oxford Loan Agreement
+Added: The fair value of the Company’s Term Loans (as defined herein) pursuant to the Loan Agreement (as defined herein) (see Note 10.
+Added: Long-term debt ) was determined using a discounted cash flow analysis with current applicable rates for similar instruments as of the consolidated balance sheet dates.
+Added: The Company estimated that the fair value of its Term Loans was approximately $ 41.1 million at December 31, 2024 which differed from its carrying value of approximately $ 40.7 million.
The fair value of the Company’s long-term debt was determined using Level 3 inputs.
−Removed: Investments and cash equivalents consist of investments in a U.S.
−Removed: Government money market funds, overnight repurchase agreements collateralized by government agency securities or U.S.
−Removed: Treasury securities, corporate bonds and commercial paper of publicly traded companies that are classified as available-for-sale pursuant to Accounting Standards Codification (“ASC”) Topic 320, Investments—Debt and Equity Securities .
−Removed: The Company classifies investments available to fund current operations as current assets on its consolidated balance sheets.
−Removed: Debt securities are carried at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity, until such gains and losses are realized.
−Removed: The fair value of these securities is based on quoted prices for identical or similar assets.
−Removed: The Company reviews investments for impairment whenever the fair value of a investment is less than the amortized cost and evidence indicates that a investment’s carrying amount is not recoverable.
−Removed: Unrealized losses are evaluated for impairment under ASC Topic 326, Financial Instruments - Credit Losses (“ASC 326”), to determine if the impairment is credit-related or noncredit-related.
−Removed: Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings, and noncredit-related impairment is recognized in other comprehensive income (loss).
−Removed: Evidence considered in this assessment includes reasons for the impairment, compliance with our investment policy, the severity of the impairment, collectability of the security, and any adverse conditions specifically related to the security, an industry, or geographic area.
−Removed: Realized gains and losses are determined using the specific identification method and are included in interest income in the consolidated statements of operations and comprehensive loss.
−Removed: There were no realized gains or losses on investments for the years ended December 31, 2024, 2023 or 2022.
−Removed: Accrued interest receivable is excluded from the amortized cost and estimated fair value of the Company’s investments.
−Removed: There was no accrued interest receivable as of December 31, 2024.
−Removed: Accrued interest receivable of $ 0.1 million is presented within prepaid expenses and other current assets on the consolidated balance sheets as of December 31, 2023.
−Removed: There were zero and two debt securities in an unrealized loss position at each of December 31, 2024, and December 31, 2023, respectively.
−Removed: None of these investments had been in an unrealized loss position for more than 12 months as of December 31, 2023.
−Removed: The Company considered the decline in the market value for these securities to be primarily attributable to current economic conditions and not credit related.
−Removed: At December 31, 2023, the Company had the intent and ability to hold such securities until recovery.
−Removed: As a result, the Company did not record any charges for credit-related impairments for its investments as of December 31, 2023.
−Removed: The following is a summary of available-for-sale securities with unrealized losses for less than 12 months as of December 31, 2024 and 2023 (in thousands):
−Removed: December 31, 2024
−Removed: December 31, 2023
−Removed: Corporate bonds, agency bonds and commercial paper (due within 1 year)
−Removed: Total available-for-sale securities in an unrealized loss position
−Removed: Cash, cash equivalents, restricted cash and investments consist of the following (in thousands):
−Removed: December 31, 2024
−Removed: Cash, cash equivalents & restricted cash:
−Removed: Cash and money market accounts
−Removed: Total cash, cash equivalents & restricted cash:
−Removed: December 31, 2023
−Removed: Cash, cash equivalents & restricted cash:
−Removed: Cash and money market accounts
−Removed: Total cash, cash equivalents & restricted cash:
−Removed: Corporate bonds, agency bonds and commercial paper (due within 1 year )
−Removed: Total investments
−Removed: Total cash, cash equivalents, restricted cash and investments
Concentrations of credit risk and off-balance sheet risk
−Removed: Cash and cash equivalents, investments, and trade accounts receivable are financial instruments that potentially subject the Company to concentrations of credit risk.
−Removed: The Company mitigates this risk by maintaining its cash and cash equivalents and investments with high quality, accredited financial institutions.
+Added: Cash and cash equivalents and trade accounts receivable are financial instruments that potentially subject the Company to concentrations of credit risk.
+Added: The Company mitigates this risk by maintaining its cash and cash equivalents with high quality, accredited financial institutions.
The management of the Company’s investments is not discretionary on the part of these financial institutions.
−Removed: As of December 31, 2024, the Company’s cash, cash equivalents and investments were deposited at four financial institutions and it has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.
−Removed: For the year ended December 31, 2024 and December 31, 2022 there was one customer, Secura, who individually accounted for all of the Company’s revenue.
+Added: As of December 31, 2025, the Company’s cash, cash equivalents were deposited at four financial institutions and it has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.
+Added: As of December 31, 2025 there were five customers that cumulatively made up 100 % of the Company’s trade accounts receivable balance and two customers who cumulatively made up more than 60 % of the Company’s trade accounts receivable balance.
+Added: For the year ended December 31, 2025, there were two customers who each individually accounted for greater than 10% of the Company’s total revenues, for a total of $ 27.4 million.
+Added: For the year ended December 31, 2024, there was one customer, Secura, who individually accounted for all of the Company’s revenue.
Refer to Note 16.
13 unchanged sentences
No impairment losses have been recorded through December 31, 2025.
+Added: Cloud Computing Implementation Costs
+Added: The Company incurs costs to implement cloud computing arrangements that are hosted by third-party vendors.
+Added: In accordance with Accounting Standard Codification (“ASC”) 350-40, Goodwill and Other, Internal-Use Software, for cloud computing arrangements that meet the definition of a service contract, the Company capitalizes qualifying implementation costs incurred during the application development stage as a component of prepaid expenses and other current assets and other assets.
+Added: Capitalization of these costs concludes once the project is substantially complete, and the software is ready for the Company's intended use.
+Added: Once available for its intended use, the capitalized costs are amortized on a straight-line basis over the term of the associated hosting arrangement, and are included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss.
+Added: Costs related to data conversion, overhead, general and administrative activities, and training are expensed as incurred.
+Added: Post-configuration training and maintenance costs will be expensed as incurred.
+Added: As of December 31, 2025, prepaid expenses and other current assets, and other long-term assets, included approximately $ 0.4 million each of capitalized implementation costs on the consolidated balance sheet.
+Added: For the year ended December 31, 2025, the Company recorded amortization expense associated with cloud computing implementation costs of approximately $ 0.3 million recorded within selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss.
Research and development costs
47 unchanged sentences
(ii) identify the performance obligations in the contract;
−Removed: (iii) determine the transaction price;
+Added: (iii) determine the
+Added: transaction price;
(iv) allocate the transaction price to the performance obligations in the contract;
3 unchanged sentences
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.
−Removed: Sales of intellectual property
−Removed: For sales of license and intellectual property, that include sale-based royalties, including milestone payments based on a level of sales, the Company evaluates whether the royalties and sales-based milestones are considered probable of being achieved and estimates the amount of royalties to include over the contractual term using the expected value method and estimates the sales-based milestones using the most likely amount method.
+Added: P roduct Revenue, Net - The Company sells AVMAPKI FAKZYNJA CO-PACK to a limited number of specialty pharmacies and specialty distributors in the United States.
+Added: The specialty pharmacies dispense AVMAPKI FAKZYNJA CO-PACK directly to patients while the specialty distributors resell AVMAPKI FAKZYNJA CO-PACK to healthcare entities who then resell AVMAPKI FAKZYNJA CO-PACK to patients.
+Added: In addition to distribution agreements with specialty distributors, the Company also enters into arrangements with (1) certain government agencies and various private organizations (“Third-Party Purchasers”), which may provide for chargebacks or discounts with respect to the purchase of AVMAPKI FAKZYNJA CO-PACK, and (2) Medicare and Medicaid, which may provide for certain rebates with respect to their reimbursement of AVMAPKI FAKZYNJA CO-PACK.
+Added: The Company recognizes revenue on sales of AVMAPKI FAKZYNJA CO-PACK when a customer obtains control of the product, which occurs at a specific point in time (typically upon delivery).
+Added: Product revenues are recorded at the wholesale acquisition costs, net of applicable reserves for variable consideration.
+Added: Components of variable consideration include trade discounts and allowances, Third-Party Payer chargebacks and discounts, government rebates, product returns, other patient focused allowances, such as voluntary co-pay assistance, benefits verification, and other patient support programs that are offered within contracts between the Company and customers, payors, and other indirect customers relating to the Company’s sale of AVMAPKI FAKZYNJA CO-PACK.
+Added: These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable or a current liability.
+Added: These estimates take into consideration a range of possible outcomes based upon relevant factors such as, customer contract terms, information received from third parties regarding the anticipated payor mix for AVMAPKI FAKZYNJA CO-PACK, known market events and trends, industry data, and forecasted customer buying and payment patterns.
+Added: Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled with respect to sales made.
+Added: The amount of variable consideration included within a transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under contracts will not occur in a future period.
+Added: The Company’s analyses contemplate the application of the constraint in accordance with Financial Accounting Standards Board (the “FASB”) Accounting Standard Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”).
+Added: For the twelve months ended December 31, 2025, the Company determined a material reversal of revenue would not occur in a future period for the estimates detailed below and, therefore, transaction prices would not be reduced further.
+Added: Actual amounts of consideration ultimately received may differ from the Company’s estimates.
+Added: If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
+Added: Trade Discounts and Allowances:
+Added: The Company generally provides customers with invoice discounts on sales of AVMAPKI FAKZYNJA CO-PACK for prompt payment and other discounts, which are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized.
+Added: In addition, the Company compensates its specialty pharmacy and specialty distributor customers for sales order management, data, distribution, and certain other services.
+Added: The Company has determined such services are not distinct from the Company’s sale of AVMAPKI FAKZYNJA CO-PACK to the specialty pharmacy and specialty distributor customers and, therefore, these payments have also been recorded as a reduction of revenue within the consolidated statements of operations and comprehensive loss.
+Added: Third-Party Payer Chargebacks, Discounts and Fees:
+Added: The Company executes contracts with Third-Party Purchasers which allow for eligible purchases of AVMAPKI FAKZYNJA CO-PACK at prices lower than the wholesale acquisition cost.
+Added: In some cases, customers will charge the Company for the difference between what they pay for
+Added: AVMAPKI FAKZYNJA CO-PACK and the ultimate selling price to the Third-Party Purchasers to whom they sell the product.
+Added: Reserves will generally be established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable, net.
+Added: Chargeback amounts will generally be determined at the time of resale to the qualified Third-Party Purchasers by customers, and the Company generally will issue credits for such amounts within a few weeks of the customer’s notification to the Company of the resale.
+Added: The reserves for chargebacks are expected to consist of credits that the Company expects to issue for units that remain in customer inventories at the end of each reporting period that the Company expects will be sold to Third-Party Purchasers, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit.
+Added: In addition, the Company compensated certain Third-Party Payers for administrative services, such as account management and data reporting.
+Added: These administrative service fees have also been recorded as a reduction of net product revenue within the consolidated statements of operations and comprehensive loss.
+Added: Government Rebates:
+Added: The Company is subject to discount and rebate payment obligations under various government programs including Federal and state Medicaid programs, Medicare, and others.
+Added: These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses on the consolidated balance sheets.
+Added: The Company’s liability for these rebates consist of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in customer inventories at the end of each reporting period.
+Added: Other Patient Support Initiatives:
+Added: Other patient support initiatives that the Company offers include voluntary co-pay assistance programs, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors.
+Added: The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive for product that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period.
+Added: The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses on the consolidated balance sheets.
+Added: Product Returns:
+Added: Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company either directly or through one of its distribution channels.
+Added: The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized.
+Added: The Company estimates product return liabilities using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel.
+Added: The Company’s return policy generally allows for eligible returns of AVMAPKI FAKZYNJA CO-PACK for credit under the following circumstances:
+Added: ● Receipt of damaged product;
+Added: ● Shipment errors that were a result of an error by the Company;
+Added: ● Expired product that is returned during the period beginning three months prior to the product’s expiration and ending six months after the expiration date;
+Added: ● Quantities of product received by a customer in excess of quantity ordered;
+Added: ● Product subject to a recall;
+Added: ● Product that the Company, at its sole discretion, has specified can be returned for credit.
+Added: As of December 31, 2025, the Company has not received any returns.
+Added: Sales of intellectual property - For sales of license and intellectual property, that include sale-based royalties, including milestone payments based on a level of sales, the Company evaluates whether the royalties and sales-based milestones are considered probable of being achieved and estimates the amount of royalties to include over the contractual term using the expected value method and estimates the sales-based milestones using the most likely amount method.
If it is probable that a significant revenue reversal would not occur, the associated royalty and milestone value is included in the transaction price.
4 unchanged sentences
Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.
−Removed: Collaborative arrangements
+Added: Accounts Receivable, Net
+Added: Accounts receivable, net consists of amounts due from customers, net of applicable revenue reserves.
+Added: Accounts receivable have standard payments that generally require payment within 30 to 90 days.
+Added: Management determines the allowance for credit loss by regularly evaluating individual customer receivables and considering a customer’s financial condition, credit history and current economic conditions.
+Added: Based on the Company’s latest assessment of the collectability of its accounts receivable, an allowance for credit loss is not deemed necessary at December 31, 2025.
+Added: Inventories are stated at the lower of cost or estimated net realizable value.
+Added: The Company determined the cost of inventories using the standard cost method, which approximates actual cost based on a first-in, first out basis.
+Added: Inventories consist primarily of third-party manufacturing costs.
+Added: The Company began capitalizing inventory upon receiving FDA approval for AVMAPKI FAKZYNJA CO-PACK on May 8, 2025.
+Added: Prior to the FDA approval of AVMAPKI FAKZYNJA CO-PACK, expenses associated with the manufacturing of the Company's products were recorded as research and development expense.
+Added: The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified.
+Added: Such impairment charges, should they occur, are recorded within cost of sales – product within the consolidated statements of operations and net loss.
+Added: The determination of whether inventory costs will be realizable requires estimates by management.
+Added: If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required which would be recorded as a cost of sales - product in the consolidated statements of operations and comprehensive loss.
+Added: Shipping and handling costs for product shipments are recorded as incurred in cost of sales - product along with costs associated with manufacturing the product, and any inventory write-downs.
+Added: Intangible Assets
+Added: The Company records finite-lived intangible assets related to certain capitalized milestone payments at their fair value.
+Added: These assets are amortized over their remaining useful lives, which are estimated based on the shorter of the remaining underlying patent life or the estimated useful life of the underlying product.
+Added: Intangible assets are amortized using the economic consumption method if anticipated future revenues can be reasonably estimated.
+Added: The straight-line method is used when future revenues cannot be reasonably estimated.
+Added: The Company assesses its finite-lived intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist.
+Added: Events that could result in an impairment, or trigger an impairment assessment, include the receipt of additional clinical or nonclinical data regarding the Company’s drug products or a potentially competitive drug candidate, significant changes in the manner of our use of the acquired assets, or new
+Added: information regarding future projected sales for the product.
+Added: If impairment indicators are present or changes in circumstance suggest that impairment may exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each finite-lived intangible asset to its carrying value on the consolidated balance sheets.
+Added: If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the finite-lived intangible asset and recognize an impairment loss if the carrying value of the finite-lived intangible asset exceeds its fair value.
Collaborative arrangements
21 unchanged sentences
Basic net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period.
−Removed: For purposes of calculating net loss per share, weighted-average number of common shares outstanding includes the weighted average effect of the pre-funded warrants issued in June 2023 and July 2024, as the exercise of which requires little or no consideration for the delivery of shares of common stock.
−Removed: Diluted net loss per common share is calculated by increasing the denominator by the weighted-average number of additional shares that could have been outstanding from securities convertible into common stock, such as the warrants issued in July 2024, stock options, restricted stock units, and ESPP (using the “treasury stock” method), the Company’s 5.00 % Convertible Senior Notes due 2048 (the “2018 Notes”), Series A Convertible Preferred Stock, and Series B Convertible Preferred Stock (using the “if-converted” method), unless their effect on net loss per share is antidilutive.
+Added: For purposes of calculating net loss per share, weighted-average number of common shares outstanding includes the weighted average effect of pre-funded warrants as the exercise of which requires little or no consideration for the delivery of shares of common stock.
+Added: Diluted net loss per common share is calculated by increasing the denominator by the weighted-average number of additional shares that could have been outstanding from securities convertible into common stock, such as the warrants issued in July 2024, stock options, restricted stock units, and ESPP (using the “treasury stock” method), Series A Convertible Preferred Stock, and Series B Convertible Preferred Stock (using the “if-converted” method), unless their effect on net loss per share is antidilutive.
Under the “if-converted” method, convertible instruments that are-in-the-money, are assumed to have been converted as of the beginning of the period or when issued, if later.
3 unchanged sentences
Recently Adopted Accounting Standards Updates
−Removed: In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280):
−Removed: Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and by extending the disclosure requirements to entities with a single reportable segment.
−Removed: The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.
−Removed: The Company adopted the guidance for the fiscal year ended December 31, 2024.
−Removed: There was no impact to the Company’s reportable segments and additional required disclosures have been included in Note 9.
−Removed: Segment Reporting .
−Removed: Recently issued accounting standards updates
In December 2023, the FASB issued ASU No.
2 unchanged sentences
The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction.
−Removed: The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted.
−Removed: The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its consolidated financial statements.
+Added: The Company has adopted and applied the guidance under this ASU for the year ended December 31, 2025, using the prospective transition method.
+Added: Income Taxes in the accompanying notes to the consolidated financial statements for further detail.
+Added: Recently issued accounting standards updates
In November 2024, the FASB issued ASU No 2024-03—Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):
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The Company is in the process of evaluating the impact of this new guidance on its consolidated financial statements.
+Added: In September 2025, the FASB issued ASU No.
+Added: 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40):
+Added: Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”).
+Added: This standard modernizes the accounting for internal-use software by removing references to prescriptive development stages and instead requiring capitalization of costs once (1) management has authorized and committed to funding the software project, and (2) it is probable the project will be completed and placed in service.
+Added: Entities must evaluate whether there is “significant development uncertainty,” such as unresolved novel functionality or substantially revised performance requirements, before meeting this capitalization threshold.
+Added: ASU 2025-06 is effective for annual reporting periods beginning after December 15, 2027, and interim periods within such annual reporting periods, with early adoption permitted.
+Added: Entities may adopt the amendments prospectively, retrospectively, or under a modified transition approach.
+Added: The Company is in the process of evaluating the impact that the adoption of this ASU may have on its consolidated financial statements and related disclosures.
Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or have a material effect on the consolidated financial statements upon future adoption.
+Added: Product revenue reserves and allowances
+Added: Since 2025, the Company’s sole source of product revenue has been from sales of AVMAPKI FAKZYNJA CO-PACK in the United States.
+Added: The following table summarizes activity in each of the product revenue allowance and reserve categories for the twelve months ended December 31, 2025 (in thousands):
+Added: Third Party Payer
+Added: Balance at December 31, 2024
+Added: Provision related to sales in the current year
+Added: Adjustments related to prior period sales
+Added: Credits and payments made
+Added: Ending balance at December 31, 2025
+Added: Trade discounts and Payer chargebacks and discounts are recorded as a reduction to accounts receivable, net on the consolidated balance sheets.
+Added: Trade allowances and Payer fees, government rebates, other incentives and returns are recorded as a component of accrued expenses on the consolidated balance sheets.
+Added: Inventory consists of the following (in thousands):
+Added: December 31, 2025
+Added: December 31, 2024
+Added: Raw materials
+Added: Work in process
+Added: Finished goods
+Added: Total inventory
+Added: At December 31, 2025, all of the Company’s inventory was related to AVMAPKI and FAKZYNJA.
+Added: In May 2025, the FDA approved AVMAPKI FAKZYNJA CO-PACK, at which time the Company began to capitalize costs to manufacture AVMAPKI FAKZYNJA CO-PACK.
+Added: Prior to FDA approval of AVMAPKI FAKZYNJA CO-PACK, all costs related to the manufacturing of AVMAPKI and FAKZYNJA and related material were charged to research and development expense in the period incurred.
+Added: At December 31, 2025, the Company determined that a reserve related to inventory was not required.
+Added: Intangible Assets
+Added: The Company’s intangible assets consist of the following (in thousands):
+Added: December 31, 2025
+Added: Weighted-Average Remaining Amortization Period (Years)
+Added: Acquired and in-licensed rights
+Added: accumulated amortization
+Added: Total intangible assets, net
+Added: The Company's finite-lived intangible assets are the result of milestone payments due under the Pfizer Agreement (defined herein) and the License Agreement (defined herein).
+Added: Refer to Note 16.
+Added: License, collaboration and commercial agreements for further discussion of the Pfizer Agreement and License Agreement.
+Added: The Company recorded approximately $ 0.7 million in cost of sales – intangible amortization expense related to finite-lived intangible assets during the twelve months ended December 31, 2025 using straight-line methodology.
+Added: Estimated future cost of sales- intangible amortization expense for finite-lived intangible assets as of December 31, 2025 is as follows (in thousands):
+Added: Year ending December 31,
+Added: Total future amortization
Property and equipment, net
6 unchanged sentences
Total property and equipment, net
−Removed: The Company recorded less than $0.1 million, $ 0.1 million, and $ 0.1 million in depreciation expense for the years ended December 31, 2024, 2023, and 2022, respectively .
+Added: The Company recorded less than $0.1 million, less than $0.1 million, and $0.1 million in depreciation expense for the years ended December 31, 2025, 2024, and 2023, respectively .
Accrued expenses
3 unchanged sentences
Accrued clinical trial expenses
+Added: Accrued milestone payments & royalties
+Added: Accrued compensation and related benefits
+Added: Accrued commercialization costs
Accrued contract manufacturing expenses
Accrued other research and development expenses
−Removed: Accrued compensation and related benefits
−Removed: Accrued professional fees
Accrued consulting fees
+Added: Accrued professional fees
Accrued interest
−Removed: Accrued commercialization costs
Accrued other
1 unchanged sentence
Long-term debt
−Removed: On March 25, 2022 (the “Loan Agreement Closing Date”), the Company entered into a loan and security agreement (the “Loan Agreement”) with Oxford, as collateral agent and a lender, and Oxford Finance Credit Fund III LP, as a lender (“OFCF III” and together with Oxford, the “Lenders”), pursuant to which the Lenders have agreed to lend the Company up to an aggregate principal amount of $ 150.0 million in a series of term loans (the “Term Loans”).
−Removed: On January 4, 2024, the Company amended the Loan Agreement to extend the date by which it may draw down the Term C Loan from March 31, 2024 to March 31, 2025.
−Removed: In January 2025, the Company entered into a Note Purchase Agreement pursuant to which the Company issued an initial sale of $ 75.0 million principal amount of Notes.
−Removed: The Company used a portion of the initial sale of Notes to repay in full all principal, accrued and unpaid interest, fees and expenses under the Loan Agreement with the Lenders.
−Removed: Refer to Note 16.
−Removed: Subsequent Events for further discussion.
−Removed: Pursuant to the Loan Agreement, as amended, the Company received an initial Term Loan of $ 25.0 million on the Loan Agreement Closing Date, and drew down the second term loan of $ 15.0 million (the “Term B Loan”) on March 22, 2023.
−Removed: As of December 31, 2024 the Company was able to borrow an additional $ 110.0 million of Term Loans at its option upon the satisfaction of certain conditions as follows:
+Added: Note Purchase Agreement
+Added: On January 13, 2025 (the “Note Purchase Agreement Closing Date”), the Company entered into the Note Purchase Agreement (the “Note Purchase Agreement”) with RGCM SA LLC, as purchaser agent, Oberland Capital Management LLC (“Oberland”) and certain funds managed by Oberland, as purchasers (together with the other purchasers party thereto referred as the “Note Purchase Agreement Purchasers”) pursuant to which the Company may sell to the Purchasers, and the Purchasers may buy from the Company, notes (the “Notes”) in an aggregate principal amount not to exceed $ 150.0 million.
+Added: On the Note Purchase Agreement Closing Date, the Company issued and sold an initial Note in an aggregate principal amount $ 75.0 million.
+Added: In addition, the Company may issue and sell additional Notes with aggregate principal amount of up to $ 75.0 million as follows :
+Added: at the option of the Company, the a second purchase (the “Second Purchase”) of $ 25.0 million principal amount of Notes, at any time prior to December 31, 2025, upon the FDA’s approval sufficient for the promotion and sale of avutometinib and defactinib for the treatment of LGSOC and subject to certain other customary conditions precedent.
+Added: In March 2026, the Company amended the Note Purchase Agreement to extend the date by which it may draw down the Second Purchase from December 31, 2025 to June 30, 2026 (see Note 20.
+Added: Subsequent Events ).
+Added: at the option of the Company, the, a third purchase (the “Third Purchase”) of up to $ 50.0 million principal amount of Notes, at any time prior to December 31, 2026, provided that trailing six-month worldwide net sales of avutometinib and defactinib are at least $ 55.0 million and subject to certain other customary conditions precedent.
+Added: The outstanding principal amount of the Notes bear interest at a rate per annum equal to the sum of (i) the greater of the Term SOFR (as defined in the Note Purchase Agreement) and 4.29 % , and (ii) 3.71 % , subject to adjustment in certain circumstances set forth in the Note Purchase Agreement and an overall cap of 9.75 % , payable quarterly in arrears until the seventh anniversary of the Note Purchase Agreement Closing Date or the date on which all amounts owing to the Note Purchase Agreement Purchasers under the Note Purchase Agreement have been paid in full (the “Note Purchase Agreement Maturity Date”).
+Added: For the first eight quarters following the Note Purchase Agreement Closing Date, at the Company’s option, up to 50 % of the interest due may be paid-in-kind and added to the then-outstanding principal balance of the Notes.
+Added: Through December 31, 2025, the Company has not elected to defer any interest through its paid-in-kind option.
+Added: Upon the occurrence and during the continuance of an Event of Default (as defined in the Note Purchase Agreement) under the Note Purchase Agreement, the then-applicable interest rate on all outstanding obligations may be increased by an additional 5.00 % .
+Added: Beginning on January 13, 2025 and continuing until the Note Purchase Agreement Maturity Date, the Note Purchase Agreement Purchasers will receive 1.00 % (the “Revenue Participation Percentage”) of the first $ 100.0 million of net sales of each Included Product (as defined in the Note Purchase Agreement) by the Company or its affiliates or licensees in each calendar year, payable quarterly.
+Added: “Included Products” is defined in the Note Purchase Agreement to include (a) avutometinib and defactinib, including any product that contains either one of the foregoing in combination with any other active ingredient(s), and (b) all other compounds, chemical entities or pharmaceutical products being designed, developed, licensed, manufactured or commercialized by the Company or its subsidiaries from time to time.
+Added: The Revenue Participation Percentage will increase pro rata immediately upon the occurrence of the Second Purchase and the Third Purchase, such that the Revenue Participation Percentage shall increase to a maximum of 2.00 % in the event that $ 150 million in aggregate principal amount of Notes has been purchased pursuant to the Note Purchase Agreement following the Third Purchase.
+Added: The outstanding principal amount of the Notes, interest accrued thereon and any other amounts owing to the Note Purchase Agreement Purchasers under the Note Purchase Agreement will be due in two equal instalments on (a) the sixth anniversary of the Note Purchase Agreement Closing Date, and (b) the Note Purchase Agreement Maturity Date.
+Added: All of the Notes may be redeemed prior to the Note Purchase Agreement Maturity Date at the option of the Company, subject to payment of the Repayment Amount (as defined in the Note Purchase Agreement).
+Added: The Note Purchase Agreement Purchasers may demand redemption of the Notes prior to the Note Purchase Agreement Maturity Date in the event of a Change of Control (as defined in the Note Purchase Agreement) of the Company or an Event of Default (as defined in the Note Purchase Agreement) under the Note Purchase Agreement, subject to payment of the Repayment Amount.
+Added: The Repayment Amount is due at the earlier of the Maturity Date and when payment of all obligations under the Note Purchase Agreement are otherwise due.
+Added: The Repayment Amount is:
+Added: (a) 135 % of the principal amount of the Notes if redemption occurs before the second anniversary of the Note Purchase Agreement Closing Date upon a Change of Control;
+Added: (b) if the preceding clause (a) does not apply, 175 % of the principal amount of the Notes if redemption occurs prior to the third anniversary the Note Purchase Agreement Closing date;
+Added: and (c) thereafter, 195 % of the principal amount of the Notes if redemption occurs after the third anniversary the Note Purchase Agreement Closing Date, minus, in each case, the sum of regularly scheduled interest paid in cash, payments of principal in cash, and payments of revenue participation in cash prior to such redemption date.
+Added: The Note Purchase Agreement contains no financial covenants .
+Added: The Company’s obligations under the Note Purchase Agreement are subject to customary covenants, including limitations on the Company’s ability to dispose of assets, undergo a change of control, merge with or acquire other entities, incur debt, incur liens, pay dividends or other distributions to holders of its capital stock, repurchase stock and make investments, in each case subject to certain exceptions.
+Added: The Company’s obligations under the Note Purchase Agreement are secured by a security interest on substantially all of the Company’s and its subsidiaries’ assets, including its intellectual property related to avutometinib and defactinib, and a negative pledge on intellectual property related to the Company’s collaboration and option agreement with GenFleet (the “GenFleet Agreement”), subject to certain exceptions relating to the Company’s development of its intellectual property.
+Added: A portion of the proceeds of the Note Purchase Agreement were used to repay the Company’s obligations under the Loan Agreement in full.
+Added: The Loan Agreement was terminated concurrently with entry into the Note Purchase Agreement.
+Added: The Company assessed the terms and features of the Note Purchase Agreement and determined that the Company is eligible to elect the fair value option under ASC 825, Financial Instruments .
+Added: The Note Purchase Agreement contains various embedded features and the election of the fair value option allows the Company to bypass analysis of potential embedded derivatives and further analysis of bifurcation of any recognized financial liabilities.
+Added: Under the fair value option, the financial liability is initially measured at its fair value on the issuance date and subsequently remeasured at estimated fair value on a recurring basis at each reporting date.
+Added: Changes in the fair value of the Note Purchase Agreement, which include accrued interest, if any, are recorded as a component of change in fair value of Notes in the consolidated statements of operations.
+Added: The Company has not elected to present interest expense separately from changes in fair value and therefore will not separately present interest expense associated with the Note Purchase Agreement.
+Added: Changes in fair value caused by instrument-specific credit risk are presented separately in other comprehensive income or loss within the consolidated statements of equity (deficit).
+Added: The portion of total
+Added: changes in fair value of Notes attributable to changes in instrument-specific credit risk are determined through specific measurement of periodic changes in the discount rate assumption exclusive of base market changes and are presented as a component of comprehensive income (loss) in the accompanying consolidated statements of operations and comprehensive loss.
+Added: Under the fair value option, debt issuance costs are expensed as incurred.
+Added: The Company incurred $ 0.8 million of debt issuance costs which were recorded within selling, general and administrative expense in the consolidated statements of operations for the year ended December 31, 2025.
+Added: The Company determined the fair value of the Notes on January 13, 2025 was $ 75.0 million.
+Added: The following table reconciles the change in fair value of the Notes during the years ended December 31, 2025
+Added: Beginning fair value balance at January 13, 2025
+Added: Change in fair value reported in statements of operations
+Added: Change in fair value reported in comprehensive loss
+Added: Interest and revenue participation payments
+Added: Ending fair value at December 31, 2025
+Added: As of December 31, 2025, future principal payments under the Note Purchase Agreement are due as follows (in thousands):
+Added: Total principal payments
+Added: Loan Agreement
+Added: On March 25, 2022 (the “Loan Agreement Closing Date”), the Company entered into a loan and security agreement (the “Original Loan Agreement”) with Oxford Finance, LLC (“Oxford”), as collateral agent and a lender, and Oxford Finance Credit Fund III LP, as a lender (“OFCF III” and together with Oxford, the “Lenders”), pursuant to which the Lenders agreed to lend the Company up to an aggregate principal amount of $ 150.0 million in a series of term loans (the “Term Loans”).
+Added: On January 4, 2024, the Company amended the Original Loan Agreement (as amended, the “Loan Agreement”) to extend the date by which it may draw down the Term C Loan from March 31, 2024, to March 31, 2025.
+Added: Pursuant to the Loan Agreement, the Company received an initial Term Loan of $ 25.0 million on the Loan Agreement Closing Date, and drew down the second term loan of $ 15.0 million (the “Term B Loan”) on March 22, 2023, and could have borrowed an additional $ 110.0 million of Term Loans at its option upon the satisfaction of certain conditions as follows:
$ 25.0 million (the “Term C Loan”), when the Company has received accelerated or full approval from the FDA of avutometinib for the treatment of LGSOC (the “Term C Milestone”).
−Removed: The Company may draw the Term C Loan within 60 days after the occurrence the Term C Milestone, but no later than March 31, 2025.
+Added: The Company could have drawn the Term C Loan within 60 days after the occurrence of the Term C Milestone, but no later than March 31, 2025.
$ 35.0 million (the “Term D Loan”), when the Company has achieved at least $ 50.0 million in gross product revenue calculated on a trailing six-month basis (the “Term D Milestone”).
−Removed: The Company may draw the Term D Loan within 30 days after the occurrence of the Term D Milestone, but no later than March 31, 2025.
+Added: The Company could have drawn the Term D Loan within 30 days after the occurrence of the Term D Milestone, but no later than March 31, 2025.
$ 50.0 million (the “Term E Loan”), at the sole discretion of the Lenders.
−Removed: The Term Loans bear interest at a floating rate equal to (a) the greater of (i) the one-month CME Secured Overnight Financing Rate and (ii) 0.13 % plus (b) 7.37 % , subject to an overall floor and cap.
−Removed: Interest on the outstanding amounts was is payable monthly in arrears on the first calendar day of each calendar month.
−Removed: As a result of the Term B Loan drawdown, beginning (i) April 1, 2025, or (ii) April 1, 2026, if either (A) avutometinib has received FDA approval for the treatment of LGSOC or (B) COPIKTRA has received FDA approval for the treatment of PTCL, the Company is required to repay the Term Loans in consecutive equal monthly payments of principal, together with applicable interest, in arrears.
−Removed: All unpaid principal and accrued and unpaid interest with respect to each Term Loan was due and payable in full on March 1, 2027.
−Removed: The Company is required to make a final payment of 5.0 % of the original principal amount of the Term Loans that are drawn, payable at maturity or upon any earlier acceleration or prepayment of the Term Loans (the “Final Payment Fee”).
−Removed: The Company may prepay all, but not less than all, of the Term Loans, subject to a prepayment fee equal to (i) 3.0 % of the principal amount of the applicable Term Loan if prepaid on or before the first anniversary date of the funding date of such Term Loan, (ii) 2.0 % of the principal amount of the applicable Term Loan if prepaid after the first anniversary and on or before the second anniversary of the funding date of such Term Loan, and (iii) 1.0 % of the principal amount of the applicable Term Loan if prepaid after the second anniversary of the applicable funding date of such Term Loan.
−Removed: All Term Loans are subject to a facility fee of 0.5 % of the principal amount.
−Removed: The Loan Agreement contains no financial covenants.
+Added: The Term Loans bore interest at a floating rate equal to (a) the greater of (i) the one-month CME Secured Overnight Financing Rate and (ii) 0.13 % plus (b) 7.37 % , subject to an overall floor and cap.
+Added: Interest was payable monthly in arrears on the first calendar day of each calendar month.
+Added: As a result of the Term B Loan drawdown, beginning (i) April 1, 2025, or (ii) April 1, 2026, if either (A) avutometinib h as received FDA approval for the treatment of LGSOC or (B) COPIKTRA has received FDA approval for the treatment of peripheral T-cell lymphoma, the Company would have been required to repay the Term Loans in consecutive equal monthly payments of principal, together with applicable interest, in arrears.
+Added: All unpaid principal and accrued and unpaid interest with respect to each Term Loan were due and payable in full on March 1, 2027.
+Added: The Company was required to make a final payment of 5.0 % of the original principal amount of the Term Loans that are drawn, payable at maturity or upon any earlier acceleration or prepayment of the Term Loans (the “Final Payment Fee”).
+Added: The Company could have prepaid all, but not less than all, of the Term Loans, subject to a prepayment fee equal to (i) 3.0% of the principal amount of the applicable Term Loan if prepaid on or before the first anniversary date of the funding date of such Term Loan, (ii) 2.0 % of the principal amount of the applicable Term Loan if prepaid after the first anniversary and on or before the second anniversary of the funding date of such Term Loan, and (iii) 1.0 % of the principal amount of the applicable Term Loan if prepaid after the second anniversary of the applicable funding date of such Term Loan.
+Added: All Term Loans were subject to a facility fee of 0.5 % of the principal amount.
+Added: The Loan Agreement contained no financial covenants.
The Loan Agreement included customary events of default, including, among others, payment defaults, breach of representations and warrants, covenant defaults, judgment defaults, insolvency and bankruptcy defaults, and a material adverse change.
−Removed: The occurrence of an event of default could result in the acceleration of the obligations under the Loan Agreement, termination of the Term Loan commitments and the right to foreclose on the collateral securing the obligations.
−Removed: Pursuant to the Loan Agreement, during the existence of an event of default, the Term Loans will accrue interest at a rate per annum equal to 5.0 % above the otherwise applicable interest rate.
+Added: The occurrence of an event of default could have resulted in the acceleration of the obligations under the Loan Agreement, termination of the Term Loan commitments and the right to foreclose on the collateral securing the obligations.
+Added: During the existence of an event of default, the Term Loans would have accrued interest at a rate per annum equal to 5.0 % above the otherwise applicable interest rate.
In connection with the Loan Agreement, the Company granted Oxford a security interest in all of the Company’s personal property now owned or hereafter acquired, excluding intellectual property (but including the right to payments and proceeds of intellectual property), and a negative pledge on intellectual property.
3 unchanged sentences
The Company reassesses the features on a quarterly basis to determine if they require separate accounting.
−Removed: There have been no changes to the Company ’s assessment through December 31, 2024.
−Removed: The debt issuance costs and the Final Payment Fee have been recorded as a debt discount which are being accreted to interest expense through the maturity date of the Term Loan using the effective interest method.
−Removed: The components of the carrying value of the debt as of December 31, 2024, and 2023 (in thousands):
−Removed: December 31, 2024
+Added: There have been no changes to the Company ’s assessment.
+Added: Concurrently with the closing of the Note Purchase Agreement, on January 13, 2025, the Company terminated its Loan Agreement and repaid in full the balance of its obligations under the Loan Agreement of approximately $ 42.7 million (the “Payoff Amount”).
+Added: The Payoff Amount included the Final Payment Fee of $ 2.0 million, which was due at the earlier of prepayment or loan maturity, and certain prepayment fees as set forth in the Loan Agreement, a prepayment penalty fee of $ 0.6 million, and unpaid interest of $ 0.1 million.
+Added: Upon the Lender’s receipt of the Payoff Amount, the Loan Agreement was terminated along with the Lender’s commitment to provide funding under any future term loans.
+Added: All liens on the Company’s assets to secure the loans under the Loan Agreement have been terminated and released.
+Added: The Payoff Amount, excluding accrued interest, exceeded the carrying amount of the Term Loan on January 13, 2025 by $ 1.8 million.
+Added: As a result the Company recorded a loss on debt extinguishment of $ 1.8 million included in the consolidated statements of operations and comprehensive loss for the twelve months ended December 31, 2025.
+Added: The debt issuance costs and the Final Payment Fee were recorded as a debt discount which were accreted to interest expense through the maturity date of the Term Loan using the effective interest method.
+Added: The components of the carrying value of the Term Loan as of December 31, 2024, are detailed below (in thousands):
December 31, 2024
8 unchanged sentences
Amortization of Final Payment Fee
−Removed: As of December 31, 2024, future principal payments due were as follows (in thousands):
−Removed: Total principal payments
On April 15, 2014, the Company entered into a lease agreement for approximately 15,197 square feet of office and laboratory space in Needham, Massachusetts.
28 unchanged sentences
Under the amended and restated certificate of incorporation, the Company’s board of directors has the authority, without further action by the stockholders, to issue up to 5,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or restrictions thereon and to increase or decrease the number of shares of any such series, but not below the number of shares of such series then outstanding.
−Removed: As of December 31, 2024 and 2023, the Company had reserved the following shares of common stock for the issuance of common stock for vested restricted stock units, the exercise of stock options, employee stock purchase plan, Series A Convertible Preferred Stock conversions to shares of common stock, the issuance and conversion of Series B Convertible Preferred Stock, and exercise of warrants and pre-funded warrants (in thousands):
+Added: As of December 31, 2025 and 2024, the Company had reserved the following shares of common stock for the issuance of common stock for vested restricted stock units, the exercise of stock options, employee stock purchase plan, Series A Convertible Preferred Stock conversions to shares of common stock, and exercise of warrants and pre-funded warrants (in thousands):
Shares reserved under Equity Compensation Plans
2 unchanged sentences
Shares reserved for Series A Convertible Preferred Stock
−Removed: Shares reserved for Series B Convertible Preferred Stock
Shares reserved for Warrants
3 unchanged sentences
The holders of the common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors.
+Added: November 2025 Public Offering
+Added: On November 13, 2025, the Company entered into an Underwriting Agreement (the “November 2025 Public Offering”) with several Underwriters to sell in a public offering 8,543,794 shares of the Company’s common stock, at a price to the public of $ 7.25 per share, less the underwriting discounts and commissions, and, in lieu of shares of common stock to certain investors, pre-funded warrants (the “November 2025 Pre-Funded Warrants”) to purchase up to an aggregate of 3,870,000 shares of common stock at a price to the public of $ 7.2499 per share of common stock underlying a pre-funded warrant, which represents the per share public offering price for the shares of common stock
+Added: less the $ 0.001 per share exercise price for each such share of common stock underlying a November 2025 Pre-Funded Warrant.
+Added: Furthermore, as part of the Underwriting Agreement, Greenshoe Options (“November 2025 Overallotment Options”) were granted to the Underwriters to purchase up to an aggregate of 1,862,069 shares of the Company’s Common Stock, par value $ 0.0001 per share, at a price to the Underwriters of $ 7.25 per share, less the underwriting discounts and commissions.
+Added: On November 14, 2025, the underwriters exercised their Overallotment Options in full and the Company issued 1,862,069 additional shares of common stock at the price of $ 7.25 per share.
+Added: The exercise price of each November 2025 Pre-Funded Warrant equals $ 0.0001 per underlying share of common stock.
+Added: The exercise price and the number of shares of common stock issuable upon exercise of each November 2025 Pre-Funded Warrant is subject to appropriate adjustment in the event of certain stock dividends, stock splits, stock combinations, or similar events affecting the Company’s common stock.
+Added: The November 2025 Pre-Funded Warrants are exercisable in cash or by means of a cashless exercise and will not expire until the date the November 2025 Pre-Funded Warrants are fully exercised.
+Added: The November 2025 Pre-Funded Warrants may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof (together with its affiliates) immediately following such exercise would exceed a specified beneficial ownership limitation.
+Added: The November 2025 Pre-Funded Warrants cannot require cash settlement, are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its common stock shares and permit the holders to receive a fixed number of shares of common stock upon exercise.
+Added: Additionally, the November 2025 Pre-Funded Warrants do not provide any guarantee of value or return.
+Added: Accordingly, the November 2025 Pre-Funded Warrants are classified as a component of permanent equity.
+Added: The net proceeds of the 2025 Public Offering were approximately $ 96.9 million, after deducting underwriting fees and other expenses.
+Added: April 2025 PIPE Transaction
+Added: On April 25, 2025, the Company entered into a securities purchase agreement with certain institutional accredited investors (the “PIPE Investors”), pursuant to which the Company sold to the PIPE Investors, in a private placement (the “2025 Private Placement”), an aggregate of 3,429,287 shares of the Company’s common stock at an offering price of $ 7.00 per share and, in lieu of common stock to certain PIPE Investors, pre-funded warrants to purchase an aggregate of 7,285,713 shares of common stock (the “April 2025 Pre-Funded Warrants,”) at an offering price of $ 6.9999 per April 2025 Pre-Funded Warrant.
+Added: The 2025 Private Placement closed on April 28, 2025.
+Added: The exercise price of each April 2025 Pre-Funded Warrant equals $ 0.0001 per underlying share of common stock.
+Added: The exercise price and the number of shares of common stock issuable upon exercise of each April 2025 Pre-Funded Warrant is subject to appropriate adjustment in the event of certain stock dividends, stock splits, stock combinations, or similar events affecting the Company’s common stock.
+Added: The April 2025 Pre-Funded Warrants are exercisable in cash or by means of a cashless exercise and will not expire until the date the April 2025 Pre-Funded Warrants are fully exercised.
+Added: The April 2025 Pre-Funded Warrants may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof (together with its affiliates) immediately following such exercise would exceed a specified beneficial ownership limitation;
+Added: provided, however, that a holder may increase or decrease the beneficial ownership limitation by giving 61 days ’ notice to the Company, but not to any percentage in excess of 19.99 % .
+Added: I n addition, upon the occurrence of a fundamental transaction (as described in the April 2025 Pre-Funded Warrant), each April 2025 Pre-Funded Warrant will have the right to receive, upon exercise of such April 2025 Pre-Funded Warrant, the kind and amount of securities, cash or other property that such holders would have received had they exercised such April 2025 Pre-Funded Warrant immediately prior to such fundamental transaction without regard to any limitations on exercise contained in the April 2025 Pre-Funded Warrants.
+Added: The April 2025 Pre-Funded Warrants cannot require cash settlement, are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its common stock shares and permit the holders to receive a fixed number of shares of common stock upon exercise.
+Added: Additionally, the April 2025 Pre-Funded Warrants do not provide any guarantee of value or return.
+Added: Accordingly, the April 2025 Pre-Funded Warrants are classified as a component of permanent equity.
+Added: The net proceeds of the 2025 Private Placement were approximately $ 69.9 million, after deducting placement agent fees and other expenses.
+Added: Stock Purchase Agreement
+Added: In connection with the Note Purchase Agreement, on January 13, 2025, the Company entered into a Stock Purchase Agreement (the “Stock Purchase Agreement”) with the certain funds managed by Oberland and affiliates thereof (the “SPA Investors”), pursuant to which the SPA Investors purchased an aggregate of 1,416,939 shares of the Company’s common stock, at a price of $ 5.2931 per share, based on the trailing 30-trading day volume-weighted average price of the Company’s common stock, as of the date of the Stock Purchase Agreement.
+Added: The Company received net proceeds of $ 7.4 million after deducting for offering costs which was recorded as component of permanent equity during the year ended December 31, 2025.
+Added: In addition, pursuant to the Stock Purchase Agreement, the Company granted the SPA Investors, for a period of three years following the closing on January 13, 2025, a right to participate in any equity offerings consummated by the Company in an amount up to $ 2.5 million, subject to certain limitations and exclusions set out in the Stock Purchase Agreement.
July 2024 Public Offering
7 unchanged sentences
Each July 2024 Pre-Funded Warrant has an exercise price equal to $ 0.001 per underlying share of common stock.
−Removed: The July 2024 Pre-Funded Warrants are exercisable as of July 25, 2024, do not expire and are exercisable in cash or by means of a cashless exercise.
+Added: The July 2024 Pre-Funded Warrants are exercisable as of July 25, 2024, do not expire and are exercisable in cash or by means of cashless exercise.
Each Warrant has an exercise price equal to $ 3.50 .
9 unchanged sentences
The warrants were recorded at a fair value of $ 39.6 million upon issuance and the Company allocated $ 39.6 million of the proceeds to this liability and recorded this amount as warrant liability.
−Removed: On December 23, 2024, 250,000 Warrants were exercised for shares of common stock.
−Removed: The fair value of the 250,000 Warrants at the exercise date was $ 0.5 million, which was reclassified from warrant liability into additional paid-in-capital.
−Removed: On December 31, 2024, the fair value of the remaining 18,083,334 Warrants was determined to be $ 58.2 million and the Company recorded this amount as warrant liability on the consolidated balance sheets.
−Removed: The Company recorded the mark-to-market adjustment of $ 19.1 million for the year ended December 31, 2024, under change in fair value of warrant liability within the consolidated statements of operations and loss.
+Added: During the year ended December 31, 2025 and 2024, 9,654,168 Warrants and 250 Warrants, respectively, were exercised for shares of common stock and the fair value of the Warrants on the respective exercise dates was $ 50.0 million and $ 0.5 million, respectively, which was reclassified from warrant liability to additional paid in capital.
+Added: On December 31, 2025 and 2024, the fair value of the outstanding 8,429,166 Warrants and 18,083,334 Warrants, respectively, was determined to be $ 35.6 million and $ 58.2 million, respectively and the Company recorded this amount as warrant liability on the consolidated balance sheets.
+Added: During the year ended December 31, 2025 and 2024, the Company recorded the mark-to-market adjustment of $ 27.5 million and $ 19.1 million, respectively, under change in fair value of warrant liability within the consolidated statements of operations and comprehensive loss.
The July 2024 Pre-Funded Warrants cannot require cash settlement, are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock and Warrants with which they were issued, are immediately exercisable, and do not embody an obligation for the Company to repurchase its common stock shares and permit the holders to receive a fixed number of shares of common stock upon exercise.
2 unchanged sentences
The Company allocated $ 15.4 million of the proceeds to the July 2024 Pre-Funded Warrants and shares of common stock issued.
+Added: During the second quarter of 2025, the holders exercised 2,500,000 July 2024 Pre-Funded Warrants, exercise price $ 0.001 per share, via cashless exercise resulting in the issuance of 2,499,665 shares of common stock.
+Added: During the third quarter of 2025, no July 2024 Pre-Funded Warrants were exercised.
The Company incurred a total of $ 4.2 million in issuance costs, which the Company allocated to the Warrants, and 2024 Pre-Funded Warrants and shares of common stock consistent with the allocation of proceeds.
2 unchanged sentences
June 2023 Public Offering
−Removed: On June 15, 2023, the Company entered into an underwriting agreement (the “June 2023 Underwriting Agreement”) with RBC Capital Markets, LLC and Cantor, as representatives of several underwriters (the “June 2023 Underwriters”) to offer 7,181,409 shares of the Company’s common stock, at a price to the public of $ 9.75 per share, less the underwriting discounts and commissions, and, in lieu of shares of common stock to certain investors, pre-funded warrants (the “June 2023 Pre-Funded Warrants”) to purchase up to an aggregate of 1,538,591 shares of common stock at a price to the public of $ 9.749 per share of common stock underlying a pre-funded warrant, which represents the per share public offering price for the shares of common stock less the $ 0.001 per share exercise price for each such share of common stock underlying a June 2023 Pre-Funded Warrant (the “June 2023 Offering”).
−Removed: In addition, the Company granted the June 2023 Underwriters an option to purchase, at the public offering price less underwriting discounts and commissions, an additional 1,308,000 shares of common stock, exercisable for 30 days from the date of the June 2023 Underwriting Agreement, which the June 2023 Underwriters exercised in full on June 16, 2023.
−Removed: The June 2023 Offering closed on June 21, 2023.
+Added: In June 2023, in an underwritten offering, the Company offered 8,489,409 shares of the Company’s common stock, at a price to the public of $ 9.75 per share, less the underwriting discounts and commissions, and, in lieu of shares of common stock to certain investors, pre-funded warrants (the “June 2023 Pre-Funded Warrants”) to purchase up to an aggregate of 1,538,591 shares of common stock at a price to the public of $ 9.749 per share of common stock underlying a pre-funded warrant, which represents the per share public offering price for the shares of common stock less the $ 0.001 per share exercise price for each such share of common stock underlying a June 2023 Pre-Funded Warrant.
The Company could not have effected the exercise of any June 2023 Pre-Funded Warrant, and a holder was not entitled to exercise any portion of any June 2023 Pre-Funded Warrant if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates) would have exceeded 9.99 % of the number of shares of common stock outstanding immediately after giving effect to the exercise, which percentage could have been increased or decreased at the holder’s election upon 61 days ’ notice to the Company subject to the terms of such June 2023 Pre-Funded Warrant, provided that such percentage in no event exceeded 19.99 % .
7 unchanged sentences
After deducting for commissions and other offering expenses, the Company received net proceeds of approximately $ 91.4 million from the sale of 8,489,409 shares of common stock and June 2023 Pre-Funded Warrants to purchase up to 1,538,591 shares of common stock.
−Removed: During the year ended December 31, 2024, the holders exercised the June 2023 Pre-Funded Warrants representing 1,538,591 underlying shares of common stock, exercise price $ 0.0001 per share, via cashless exercise resulting in the issuance of 1,538,201 shares of common stock.
+Added: During the year ended December 31, 2024, the holders exercised all of the June 2023 Pre-Funded Warrants representing 1,538,591 underlying shares of common stock, at an exercise price $ 0.0001 per share, via cashless exercise resulting in the issuance of 1,538,201 shares of common stock.
As of December 31, 2024 there were no June 2023 Pre-Funded Warrants outstanding.
5 unchanged sentences
Holders of the Series B Convertible Preferred Stock are permitted to increase the Conversion Blocker to an amount not to exceed 19.99 % upon 60 days ’ notice.
−Removed: The Company agreed to sell and issue in the first tranche of the Private Placement 1,200,000 shares of Series B Convertible Preferred Stock at a purchase price of $ 25.00 per share of Series B Convertible Preferred Stock (equivalent to $ 7.0812 per share of common stock on a post-Reverse Stock Split basis).
+Added: The Company agreed to sell and issue in the first tranche of the Private Placement 1,200,000 shares of Series B Convertible Preferred Stock at a purchase price of $ 25.00 per share of Series B Convertible Preferred Stock (equivalent to $ 7.0812 per share of common stock).
The first tranche of the Private Placement closed on January 27, 2023.
The Company received gross proceeds from the first tranche of the Private Placement of approximately $ 30.0 million, before deducting fees to the placement agent and other offering expenses payable by the Company (“Series B Convertible Preferred Stock Proceeds”).
−Removed: In addition, the Company agreed to sell and issue in the second tranche of the Private Placement 944,160 shares of Series B Convertible Preferred Stock at a purchase price of $ 31.77 per share of Series B Convertible Preferred Stock (equivalent to $ 9.00 per share of common stock on a post-Reverse Stock Split basis) if at any time within 18 months following the closing of the first tranche the 10-day volume weighted average price of the Company’s common stock (as quoted on Nasdaq and as calculated by Bloomberg) should reach at least $ 13.50 per share, such threshold reflects an adjustment to account for the Reverse Stock Split (which may be further adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as needed) with aggregate trading volume during the same 10-day period of at least $ 25 million (the “Second Tranche Right”).
+Added: In addition, the Company agreed to sell and issue in the second tranche of the Private Placement 944,160 shares of Series B Convertible Preferred Stock at a purchase price of $ 31.77 per share of Series B Convertible Preferred Stock (equivalent to $ 9.00 per share of common stock) if at any time within 18 months following the closing of the first tranche the 10-day volume weighted average price of the Company’s common stock (as quoted on Nasdaq and as calculated by Bloomberg) should reach at least $ 13.50 per share, such threshold reflects an adjustment to account for the Reverse Stock Split (which may be further adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as needed) with aggregate trading volume during the same 10-day period of at least $ 25 million (the “Second Tranche Right”).
The second tranche of the Private Placement is expected to close within seven trading days of meeting the second tranche conditions and will be subject to additional, customary closing conditions.
6 unchanged sentences
and (vi) junior to all of the Company’s existing and future debt obligations, including convertible or exchangeable debt securities, in each case, as to distributions of assets upon liquidation, dissolution or winding up of the Company, whether voluntarily or involuntarily and as to the right to receive dividends.
−Removed: In the event of the liquidation, dissolution or winding up of the affairs of the Company, whether voluntary or involuntary, after payment or provision for payment of the debts and other liabilities of the Company, and subject to the prior and superior rights of any Senior Stock, each holder of shares of Series B Convertible Preferred Stock will be entitled to receive, in preference to any distributions of any of the assets or surplus funds of the Company to the holders of the common stock and any of the Company’s securities that are Junior Stock and pari passu with any distribution to the holders of any Parity Stock, an amount equal to $ 1.00 per share of Series B Convertible Preferred Stock, plus an additional amount equal to any dividends declared but unpaid on such shares, before any payments shall be made or any assets distributed to holders of the common stock or any of our securities that Junior Stock.
+Added: In the event of the liquidation, dissolution or winding up of the affairs of the Company, whether voluntary or involuntary, after payment or provision for payment of the debts and other liabilities of the Company, and subject to the prior and superior rights of any Senior Stock, each holder of shares of Series B Convertible Preferred Stock will be entitled to receive, in preference to any distributions of any of the assets or surplus funds of the Company to the holders of the common stock and any of the Company’s securities that are Junior Stock and pari passu with any distribution to the holders of any Parity Stock, an amount equal to $ 1.00 per share of Series B Convertible Preferred Stock, plus an additional amount equal to any dividends declared but unpaid on such shares, before any payments shall be made or any assets distributed to holders of the common stock or any of the Company’s securities that are Junior Stock.
So long as any shares of the Series B Convertible Preferred Stock remain outstanding, the Company cannot without the affirmative vote or consent of the holders of majority of the shares of the Series B Convertible Preferred Stock then-outstanding, in which the holders of the Series B Convertible Preferred Stock vote separately as a class:
10 unchanged sentences
Upon conversion, the Company reclassified $ 21.2 million from Series B Convertible Preferred Stock to common stock and additional paid in capital on the consolidated balance sheet.
−Removed: As of December 31, 2024, there are 0 shares of Series B Convertible Preferred Stock outstanding.
+Added: As of December 31, 2025 and 2024, there are 0 shares of Series B Convertible Preferred Stock outstanding.
The Company evaluated the Second Tranche Right under ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and determined that it met the requirements for separate accounting from the initial issuance of Series B Convertible Preferred Stock as a freestanding financial instrument.
8 unchanged sentences
The Company reassesses the features on a quarterly basis to determine if they require separate accounting.
−Removed: There have been no changes to the Company’s original assessment through December 31, 2024.
+Added: There were no changes to the Company’s original assessment.
Series A Convertible Preferred Stock
−Removed: On November 4, 2022, the Company e ntered into an exchange agreement (the “Exchange Agreement”) with Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS LP and MSI BVF SPV, LLC (collectively referred to as “BVF”), pursuant to which BVF exchanged 833,333 shares of the Company’s common stock (as adjusted to account for the Reverse Stock Split) for 1,000,000 shares of newly designated Series A convertible preferred stock, par value $ 0.0001 per share (the “Series A Convertible Preferred Stock”) (the “Exchange”).
−Removed: Each share of the Series A Convertible Preferred Stock is convertible into 0.833 shares of the Company’s common stock (as adjusted to account for the Reverse Stock Split) at the option of the holder at any time, subject to certain limitations, including that the holder will be prohibited from converting Preferred Stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock above the Conversion Blocker, initially set at 9.99 % , of the total common stock then issued and outstanding immediately following the conversion of such shares of Preferred Stock.
−Removed: Holders of the Series A Convertible Preferred Stock are permitted to increase the Conversion Blocker to an amount not to exceed 19.99 % upon 60 days ’ notice.
−Removed: Shares of Series A Convertible Preferred Stock generally have no voting rights, except as required by law and except that the consent of a majority of the holders of the outstanding Series A Convertible Preferred Stock will be required to amend the terms of the Series A Convertible Preferred Stock.
−Removed: In the event of the Company’s liquidation, dissolution or winding up, holders of Series A Convertible Preferred Stock will participate pari passu with any distribution of proceeds to holders of common stock.
−Removed: Holders of Series A Convertible Preferred Stock are entitled to receive when, as and if dividends are declared and paid on the common stock, an equivalent dividend, calculated on an as-converted basis.
−Removed: Shares of Series A Convertible Preferred Stock are otherwise not entitled to dividends.
−Removed: The Series A Convertible Preferred Stock (i) senior to any class or series of capital stock of the Company hereafter created specifically ranking by its terms junior to the Series A Convertible Preferred Stock;
+Added: On November 4, 2022, the Company e ntered into an exchange agreement (the “Exchange Agreement”) with Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS LP and MSI BVF SPV, LLC (collectively referred to as “BVF”), pursuant to which BVF exchanged 833,333 shares of the Company’s common stock for 1,000,000 shares of newly designated Series A convertible preferred stock, par value $ 0.0001 per share (the “Series A Convertible Preferred Stock”) (the “Exchange”).
+Added: Each share of the Series A Convertible Preferred Stock was convertible into 0.833 shares of the Company’s common stock at the option of the holder at any time, subject to certain limitations, including that the holder was prohibited from converting the Series A Convertible Preferred Stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock above the Conversion Blocker, initially set at 9.99 % , of the total common stock then issued and outstanding immediately following the conversion of such shares of the Series A Convertible Preferred Stock.
+Added: Holders of the Series A Convertible Preferred Stock were permitted to increase the Conversion Blocker to an amount not to exceed 19.99 % upon 60 days ’ notice.
+Added: Shares of Series A Convertible Preferred Stock generally had no voting rights, except as required by law and except that the consent of a majority of the holders of the outstanding Series A Convertible Preferred Stock was required to amend the terms of the Series A Convertible Preferred Stock.
+Added: In the event of the Company’s liquidation, dissolution or winding up, holders of Series A Convertible Preferred Stock would have participated pari passu with any distribution of proceeds to holders of common stock.
+Added: Holders of Series A Convertible Preferred Stock were entitled to receive when, as and if dividends were declared and paid on the common stock, an equivalent dividend, calculated on an as-converted basis.
+Added: Shares of Series A Convertible Preferred Stock were otherwise not entitled to dividends.
+Added: The Series A Convertible Preferred Stock were (i) senior to any class or series of capital stock of the Company hereafter created specifically ranking by its terms junior to the Series A Convertible Preferred Stock;
(ii) on parity with the common stock and any class or series of capital stock of the Company created specifically ranking by its terms on parity with the Series A Convertible Preferred Stock;
and (iii) junior to the Series B Convertible Preferred Stock and to any class or series of capital stock of the Company created specifically ranking by its terms senior to any Series A Convertible Preferred Stock, in each case, as to distributions of assets upon liquidation, dissolution or winding up of the Company, whether voluntarily or involuntarily.
−Removed: The Company evaluated the Series A Convertible Preferred Stock for liability or equity classification under ASC 480 and determined that equity treatment was appropriate because the Series A Preferred Stock did not meet the definition of the liability under ASC 480.
−Removed: Additionally, the Series A Preferred Stock is not redeemable for cash or other assets (i) on a fixed or determinable date, (ii) at the option of the holder, or (iii) upon the occurrence of an event that is not solely within control of the Company.
+Added: The Company evaluated the Series A Convertible Preferred Stock for liability or equity classification under ASC 480 and determined that equity treatment was appropriate because the Series A Convertible Preferred Stock did not meet the definition of the liability under ASC 480.
+Added: Additionally, the Series A Convertible Preferred Stock were not redeemable for cash or other assets (i) on a fixed or determinable date, (ii) at the option of the holder, or (iii) upon the occurrence of an event that is not solely within control of the Company.
As such, the Company recorded the Series A Convertible Preferred Stock as permanent equity.
+Added: In June 2025, holders of the Series A Convertible Preferred Stock elected to convert all 1,000,000 shares of Series A Convertible Preferred Stock for 833,332 shares of the Company’s common stock and consequently, the Company issued 833,332 shares of its common stock to holders of the Series A Convertible Preferred Stock.
+Added: As of December 31, 2025, there were no shares of Series A Convertible Preferred Stock outstanding.
At-the-market equity offering programs
In August 2021, the Company entered into a sales agreement with Cantor pursuant to which the Company can offer and sell up to $ 100.0 million of its common stock at the current market prices from time to time through Cantor as sales agent (the “August 2021 ATM”).
−Removed: During the years ended December 31, 2024, 2023, and 2022, the Company sold 0 shares, 0 shares, and 1,964,448 shares, respectively, under the August 2021 ATM for net proceeds of approximately $ 0.0 million, $ 0.0 million, and $ 27.4 million, respectively, (after deducting commissions and other offering expenses) .
+Added: In August 2025, the Company entered into a separate sales agreement with Cantor pursuant to which the Company can offer and sell up to $ 100.0 million of its common stock at the current market prices from time to time through Cantor as sales agent (the “August 2025 ATM” and together with the August 2021 ATM, the “ATM Programs”).
+Added: During the years ended December 31, 2025, 2024, and 2023, the Company sold 4,000,000 shares, 0 shares, and 0 shares, respectively, under the ATM Programs for net proceeds of approximately $ 22.7 million, $ 0.0 million, and $ 0.0 million, respectively, (after deducting commissions and other offering expenses) .
Stock-based compensation
5 unchanged sentences
All of the $ 9.4 million, $ 7.3 million, and $ 5.9 million of stock-based compensation expense recorded during the years ended December 31, 2025, 2024 and 2023, respectively, was recorded to additional paid-in capital.
−Removed: The Company has awards outstanding under two equity compensation plans, the Amended and Restated 2021 Equity Incentive Plan (the “Amended 2021 Plan”), and the Amended and Restated 2012 Incentive Plan (the “2012 Plan”), as well as the inducement award program.
+Added: The Company has awards outstanding under two equity compensation plans, the Amended and Restated 2021 Equity Incentive Plan (the “2021 Plan”), and the Amended and Restated 2012 Incentive Plan (the “2012 Plan”), as well as the inducement award program.
Terms of stock award agreements, including vesting requirements, are determined by the board of directors, subject to the provisions of the individual plans.
2 unchanged sentences
At the Company’s 2024 Annual General Meeting of Shareholders in May 2024, the Company’s shareholders approved the Amended 2021 Plan.
−Removed: The Amended 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSUs and other stock-based awards.
−Removed: The number of shares of common stock initially reserved for issuance under the Original 2021 Plan was (i) 1,991,666 which is the sum of 1,104,177 shares plus the number of shares available for issuance under the 2012 Plan as of the date the Company’s Board of Directors approved the 2021 Plan ( 887,489 shares) plus (ii) the number of shares of the Company’s common stock underlying awards under the 2012 Plan and the 2010 Equity Incentive Plan (the “ 2010 Plan”) that expire, terminate or are surrendered without delivery of shares, are forfeited to or repurchased by the Company, or otherwise become available again for grant under the terms of the 2012 Plan or the 2010 Plan, as applicable.
+Added: The Amended 2021 Plan together with the Original 2021 Plan is referred to as the 2021 Plan.
+Added: The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSUs and other stock-based awards.
+Added: The number of shares of common stock initially reserved for issuance under the Original 2021 Plan was (i) 1,991,666 plus (ii) the number of shares of the Company’s common stock underlying awards under the 2012 Plan and the 2010 Equity Incentive Plan (the “ 2010 Plan”) that expire, terminate or are surrendered without delivery of shares, are forfeited to or repurchased by the Company, or otherwise become available again for grant under the terms of the 2012 Plan or the 2010 Plan, as applicable.
The Amended 2021 Plan increased the maximum number of shares available for issuance by 3,200,000 shares.
−Removed: As of December 31, 2024, under the Original 2021 Plan and Amended 2021 Plan, the Company has granted stock options for 2,198,923 shares of common stock, of which 323,349 have been forfeited and 21,978 have been exercised, and granted RSUs for 1,219,720 shares of common stock, of which 47,679 have been forfeited and 172,697 have vested.
−Removed: As of December 31, 2024, 2,850,675 shares remain available for future issuance under the Amended 20221 Plan.
+Added: As of December 31, 2025, under the 2021 Plan, the Company has granted stock options for 2,590,423 shares of common stock, of which 418,541 have been forfeited and 34,402 have been exercised, and granted RSUs for 2,268,761 shares of common stock, of which 105,361 have been forfeited and 852,679 have vested.
+Added: As of December 31, 2025, 1,567,799 shares remain available for future issuance under the 2021 Plan.
The exercise price of each option has been equal to the closing price of a share of the Company’s common stock on the grant date.
19 unchanged sentences
In September 2023, the Board of Directors authorized and reserved 500,000 additional shares of common stock under this program.
+Added: In September 2025, the Board of Directors authorized and reserved 400,000 additional shares of common stock under this program.
The program is governed by the terms of the 2021 Plan, but shares issued pursuant to the program are not issued under the 2021 Plan.
15 unchanged sentences
The Company is recognizing the remaining unamortized stock compensation expense for the Exchanged Options on the modification date over the original requisite service period of the Exchanged Options.
−Removed: At December 31, 2024 there was $ 0.7 million of unrecognized compensation cost related to Exchanged Options that the Company expects to recognize over a remaining weighted-average period of 0.9 years.
+Added: At December 31, 2025, there was no unrecognized compensation cost related to Exchanged Options.
A summary of the Company’s stock option activity and related information for the year ended December 31, 2025, is as follows:
5 unchanged sentences
Forfeited/cancelled
−Removed: Cancelled under the Option Exchange Program
−Removed: Granted under the Option Exchange Program
Outstanding at December 31, 2025
8 unchanged sentences
The fair value of stock options that vested during the years ended December 31, 2025, 2024, and 2023 was $ 3.7 million, $ 3.5 million, and $ 3.1 million, respectively.
−Removed: The aggregate intrinsic value of options exercised (i.e., the difference between the market price at exercise and the price paid by employees to exercise the option) during the years ended December 31, 2024, 2023, and 2022 was $ 0.1 million, $ 0.0 million, and less than $ 0.1 million, respectively.
+Added: The aggregate intrinsic value of options exercised (i.e., the difference between the market price at exercise and the price paid by employees to exercise the option) during the years ended December 31, 2025, 2024, and 2023 was $ 0.1 million, $ 0.1 million, and $ 0.0 million, respectively.
At December 31, 2025 there was $ 5.4 million of total unrecognized compensation cost related to unvested stock options and the Company expects to recognize this cost over a remaining weighted-average period of 2.2 years.
23 unchanged sentences
Expected term (years)
−Removed: For the years ended December 31, 2024, 2023, and 2022, the Company has recognized less than $ 0.1 million, less than $ 0.1 million, and $ 0.1 million, respectively, of stock-based compensation expense under the Amended and Restated 2018 ESPP.
−Removed: During the year ended December 31, 2024, 2023, and 2022, the Company issued 15,231 shares, 14,270 shares and 10,194 shares, respectively, of common stock for proceeds of $ 0.1 million, $ 0.1 million and $ 0.2 million, respectively under the Amended and Restated 2018 ESPP.
+Added: For the years ended December 31, 2025, 2024, and 2023, the Company has recognized less than $ 0.1 million of stock-based compensation expense each year under the Amended and Restated 2018 ESPP.
+Added: During the years ended December 31, 2025, 2024, and 2023, the Company issued 16,341 shares, 15,231 shares and 14,270 shares, respectively, of common stock for proceeds of $ 0.1 million in each year under the Amended and Restated 2018 ESPP.
Segment Reporting
10 unchanged sentences
Year ended December 31,
+Added: Product revenue, net
Sale of COPIKTRA license and related assets
+Added: Cost of sales - product
+Added: Cost of sales - intangible amortization
Research and development expenses (1)
6 unchanged sentences
Interest expense
+Added: Loss on debt extinguishment
Change in fair value of preferred stock tranche liability
Change in fair value of warrant liability
+Added: Change in fair value of Notes
Other segment items (2)
Income tax expense
−Removed: (1) The Company’s revenue is comprised of milestones and royalties received pursuant to the Secura APA for which the Company has completed its performance obligations in 2020.
−Removed: License, collaboration and commercial agreements for further discussion.
(1) This category is exclusive of non-cash stock-based compensation and severance expense.
3 unchanged sentences
Basic EPS excludes dilution and is computed by dividing net loss by the weighted average number of shares outstanding for the period.
−Removed: For the years ended December 31, 2024, 2023, and 2022 net loss, basic and diluted EPS are the same as the assumed exercise of stock options, RSUs, ESPP, the 2018 Notes, Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Warrants are anti-dilutive.
+Added: For the years ended December 31, 2025, 2024, and 2023 net loss, basic and diluted EPS are the same as the assumed exercise of stock options, RSUs, ESPP, Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Warrants are anti-dilutive.
The following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
6 unchanged sentences
Total potentially dilutive securities
−Removed: Income tax expense of $ 0.2 million for the year ended December 31, 2024 was comprised of interest under IRC section 453A related to the $ 10.0 million milestone payment from Secura because it was an installment sale.
+Added: There was no income tax expense for the years ended December 31, 2025 and 2023.
+Added: The Company recorded income tax expense of $ 0.2 million for the year ended December 31, 2024 comprised of a federal income tax payment due to interest under IRC section 453A related to the $ 10.0 million milestone payment from Secura because it was an installment sale.
+Added: This payment was made in 2025.
Refer to Note.
2 unchanged sentences
Year ended December 31,
−Removed: Current tax expense:
Current income tax expense:
−Removed: Deferred income tax expense
+Added: Total current income tax expense
+Added: Total deferred income tax expense
Total income tax expense
−Removed: A reconciliation of income taxes computed using the U.S.
−Removed: federal statutory rate to that reflected in operations follows:
+Added: As further described in Note 2, Summary of Significant Accounting Policies , the Company elected to prospectively adopt the guidance in ASU 2023-09.
+Added: The following table is a reconciliation of our effective income tax rate to the statutory federal income tax rate for the year ended December 31, 2025 in accordance with the guidance in ASU 2023-09:
+Added: Year ended December 31, 2025
+Added: US federal statutory rate
+Added: State and local income tax benefit, net of federal benefit
+Added: Research and development tax credits
+Added: Change in the valuation allowance
+Added: Nontaxable or nondeductible items
+Added: Change in fair value of warrant liability
+Added: Stock-based compensation
+Added: Effective income tax rate
+Added: The following table is a reconciliation of the Company’s effective income tax rate to the statutory federal income tax rate for the year ended December 31, 2024 in accordance with the guidance prior to the adoption of ASU 2023-09:
+Added: Year ended December 31, 2024
Income tax benefit using U.S.
8 unchanged sentences
Effective income tax rate
−Removed: On October 4, 2023, Massachusetts enacted tax law changes which included the adoption of a single sales apportionment factor effective on January 1, 2025.
−Removed: On December 4, 2024, Massachusetts subsequently enacted supplemental legislation modifying Massachusetts' single sales apportionment factor in certain circumstances.
−Removed: As required under ASC 740, the Company has accounted for the deferred tax impacts of this tax law change in the period the tax law was enacted.
−Removed: The impact of the tax law change is offset by a change in valuation allowance.
The principal components of the Company’s deferred tax assets and liabilities are as follows (in thousands):
14 unchanged sentences
Net deferred tax asset
−Removed: The Tax Cuts and Jobs Act (“TCJA”) requires taxpayers to capitalize and amortize research and development (“R&D”) expenditures under section 174 for tax years beginning after December 31, 2021.
−Removed: This rule became effective for the Company during 2022.
−Removed: The Company will amortize these costs for tax purposes over 5 years for R&D performed in the U.S.
−Removed: and over 15 years for R&D performed outside the U.S.
The Company has recorded a valuation allowance against its deferred tax assets at December 31, 2025 and 2024 because the Company’s management believes that it is more likely than not that these assets will not be fully realized.
−Removed: The decrease in the valuation allowance of approximately $ 19.0 million in the year ended December 31, 2024, primarily relates to the loss of NOL carryforwards and research and development credits which the Company deemed would otherwise expire unused due to Section 382 of the IRC and similar provisions under state law discussed in the next paragraph.
+Added: The increase in the valuation allowance of approximately $ 46.0 million in the year ended December 31, 2025, primarily relates to federal and state NOLs and credits.
As of December 31, 2025, the Company had federal and state NOL carryforwards of approximately $ 460.5 million and $ 99.5 million, respectively, which are available to reduce future taxable income.
10 unchanged sentences
Due to the Company’s full valuation allowance the write off of certain NOL carryforwards and R&D and OD credits did not have any impact to the statements of operation and comprehensive loss.
+Added: The Tax Cuts and Jobs Act (“TCJA”) requires taxpayers to capitalize and amortize research and development (“R&D”) expenditures under section 174 for tax years beginning after December 31, 2021.
+Added: This rule became effective for the Company during 2022.
+Added: The Company is amortizing these costs for tax purposes over 5 years for R&D performed in the U.S.
+Added: and over 15 years for R&D performed outside the U.S.
+Added: The One Big Beautiful Bill Act ("OBBBA") was passed and became effective for the Company during 2025.
+Added: The legislation includes, among other provisions, permanent full expensing for certain business assets, changes to the interest deduction limitation under Section 163(j), amendments to international tax provisions including the global intangible low-taxed income (“GILTI”) and foreign-derived intangible income (“FDII”) regimes, the permanent extension of the controlled foreign corporation (“CFC”) look-through rule, as well as modifications to the treatment of research and development expenditures mentioned above.
+Added: Congress modified the treatment for research and development expenditures by adding new Section 174A, which applies for tax years beginning after December 31, 2024.
+Added: Section 174A permits the immediate deduction of domestic R&D expenditures or, at the taxpayer’s election, capitalization and amortization over a period of at least five years beginning when the related benefits are first realized.
+Added: Foreign R&D expenditures continue to be capitalized and amortized over 15 years.
+Added: Transition provisions allow taxpayers either to continue amortizing amounts capitalized under the TCJA rules or to deduct remaining unamortized domestic R&D expenditures in the first tax year beginning after December 31, 2024.
+Added: The Company has elected to continue amortizing previously capitalized domestic R&D expenditures over the remaining amortization period permitted under OBBBA.
+Added: On October 4, 2023, Massachusetts enacted tax law changes which included the adoption of a single sales apportionment factor effective on January 1, 2025.
+Added: On December 4, 2024, Massachusetts subsequently enacted supplemental legislation modifying Massachusetts' single sales apportionment factor in certain circumstances.
+Added: As required under ASC 740, the Company has accounted for the deferred tax impacts of this tax law change in the period the tax law was enacted.
+Added: The impact of the tax law change is offset by a change in valuation allowance.
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 following resolution of any potential contingencies present related to the tax benefit.
−Removed: From inception and through December 31, 2024, the Company had no unrecognized tax benefits or related interest , and penalties accrued.
+Added: From inception and through December 31, 2025, the
+Added: Company had no unrecognized tax benefits or related interest , and penalties accrued.
The Company has not conducted a study of R&D credit and OD credit carryforwards.
13 unchanged sentences
The amount is included in non-current restricted cash on the consolidated balance sheets as of December 31, 2025, and 2024.
−Removed: As of December 31, 2024, the Company has committed to spend approximately $ 60.0 million under the IQVIA Master Services Agreement which the Company expects to spend in the next three to four years.
−Removed: As of December 31, 2024, approximately $ 0.7 million of this commitment is included within accrued expenses.
+Added: As of December 31, 2025, the Company has committed to spend approximately $ 48.1 million under the IQVIA Master Services Agreement which the Company expects to spend in the next two to three years.
+Added: As of December 31, 2025, approximately $ 13.7 million of this commitment is included within vendor financing arrangements, accrued expenses, and accounts payable on the consolidated balance sheets.
Pursuant to the terms of various other agreements, the Company may be required to pay various development, regulatory and commercial milestones.
2 unchanged sentences
License, collaboration and commercial agreements
+Added: On July 11, 2012, the Company entered into a license agreement (the “Pfizer Agreement”) with Pfizer (“Pfizer”) under which Pfizer granted the Company worldwide, exclusive rights to research, develop, manufacture and commercialize products containing certain of Pfizer’s inhibitors of FAK, including defactinib, for all therapeutic, diagnostic and prophylactic uses in humans.
+Added: The Company has the right to grant sublicenses under the foregoing licensed rights, subject to certain restrictions.
+Added: Upon entering into the Pfizer Agreement, the Company made a one-time cash payment to Pfizer in the amount of $ 1.5 million and issued 16,001 shares of its common stock.
+Added: In April 2025, the Company entered into an amendment to the Pfizer Agreement such that a $ 7.5 million milestone became payable upon FDA approval of AVMAPKI FAKZYNJA CO-PACK on May 8, 2025 (the “First Pfizer Milestone”), and $ 8.0 million milestone (the “Second Pfizer Milestone”) is payable upon the one-year anniversary of the FDA approval of AVMAPKI FAKZYNJA CO-PACK.
+Added: The Company recorded a $ 15.0 million intangible asset related to these payments on the consolidated balance sheets and will record $ 0.5 million of interest expense related to the Second Pfizer Milestone.
+Added: Pfizer is also eligible to receive up to $ 2.0 million in developmental milestones and up to an additional $ 110.0 million based on the successful attainment of regulatory and commercial sales milestones.
+Added: The future milestone payments are contingent in nature and will be recognized if and when the respective contingencies are resolved.
+Added: Pfizer is also eligible to receive high single to mid-double-digit royalties on future net sales of the products.
+Added: The Company’s
+Added: royalty obligations with respect to each product in each country begin on the date of first commercial sale of the product in that country, and end on the later of 10 years after the date of first commercial sale of the product in that country or the date of expiration or abandonment of the last claim contained in any issued patent or patent application licensed by Pfizer to the Company that covers the product in that country.
+Added: License Agreement
+Added: In the second quarter of 2025, the Company entered into an agreement with a third party to obtain an exclusive license for certain patents and intellectual property related to avutometinib and defactinib (the “License Agreement”).
+Added: This agreement covers one of the four patent families that the Company has exclusively licensed and are owned by either Chugai or the third party.
+Added: Pursuant to the License Agreement, the Company became obligated to pay $ 2.1 million in the year ended December 31, 2025 and is further obligated to pay up to $ 2.3 million upon achievement of certain milestones.
+Added: The Company recorded $ 2.1 million within intangible assets related to these payments on the consolidated balance sheets.
+Added: The future milestone payments are contingent in nature and will be recognized if and when the respective contingencies are resolved.
GenFleet Therapeutics (Shanghai), Inc.
−Removed: On August 24, 2023, the Company entered into a collaboration and option agreement (“GenFleet Agreement”) with GenFleet, pursuant to which GenFleet granted the Company the option to obtain exclusive development and commercialization rights worldwide outside of mainland China, Hong Kong, Macau, and Taiwan (the “Territory”) for up to three oncology programs targeting RAS pathway driven cancers (the “GenFleet Options”).
+Added: On August 24, 2023, the Company entered into the GenFleet Agreement, pursuant to which GenFleet granted the Company the option to obtain exclusive development and commercialization rights worldwide outside of mainland China, Hong Kong, Macau, and Taiwan (the “Territory”) for up to three oncology programs targeting RAS pathway driven cancers (the “GenFleet Options”).
The Company may exercise its GenFleet Options on a program-by-program basis.
7 unchanged sentences
Either party may also terminate the GenFleet Agreement in its entirety upon certain insolvency events involving the other party.
−Removed: During the year ended December 31, 2024, the Company expensed $ 3.0 million related to the development milestone payment made within research and development expense in the consolidated statements of operations and comprehensive loss.
−Removed: During the year ended December 31, 2023, the Company expensed $ 2.0 million related to the upfront payment within research and development expense in the consolidated statements of operations and comprehensive loss.
−Removed: The future milestone payments are contingent in nature and will be recognized if and when the respective contingencies are resolved.
−Removed: If the Company elects to exercise further GenFleet Options, the related expense will be recognized if and when each respective GenFleet Option is elected.
+Added: The Company expensed $ 6.0 million in January 2025, related to the GenFleet Option payment within
+Added: research and development expense in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2025.
+Added: The other future milestone payments are contingent in nature and will be recognized if and when the respective contingencies are resolved.
+Added: If the Company elects to exercise further GenFleet Options, the related payment will be recognized if and when each respective GenFleet Option is elected.
Secura Bio, Inc.
2 unchanged sentences
The sale included certain intellectual property related to duvelisib in oncology indications, certain existing duvelisib inventory, claims and rights under certain contracts pertaining to duvelisib.
−Removed: Pursuant to the Secura APA, Secura assumed all operational and financial responsibility for activities that were part of the Company’s duvelisib oncology program, including all commercialization efforts related to duvelisib in the United States and Europe, as well as the Company’s ongoing duvelisib clinical trials.
+Added: Pursuant to the Secura APA,
+Added: Secura assumed all operational and financial responsibility for activities that were part of the Company’s duvelisib oncology program, including all commercialization efforts related to duvelisib in the United States and Europe, as well as the Company’s ongoing duvelisib clinical trials.
Further, Secura assumed all obligations with existing collaboration partners developing and commercializing duvelisib, which include Yakult, Honsha Co., Ltd.
(“Yakult”), CSPC Pharmaceutical Group Limited (“CSPC”) and Sanofi.
−Removed: Additionally, Secura assumed all royalty payment obligations due under the amended and restated license agreement with Infinity.
+Added: Additionally, Secura assumed all royalty payment obligations due under the amended and restated license agreement with Infinity Pharmaceuticals, Inc.
Pursuant to the terms of the Secura APA, Secura has paid the Company an up-front payment of $ 70.0 million in September 2020 and has agreed to pay the Company (i) regulatory milestone payments up to $ 45.0 million, consisting of a payment of $ 35.0 million upon receipt of regulatory approval of COPIKTRA in the United States for the treatment of peripheral T-cell lymphoma and a payment of $ 10.0 million upon receipt of the first regulatory approval for the commercial sale of COPIKTRA in the European Union for the treatment of peripheral T-cell lymphoma, (ii) sales milestone payments of up to $ 50.0 million, consisting of $ 10.0 million when total worldwide net sales of COPIKTRA exceed $ 100.0 million, $ 15.0 million when total worldwide net sales of COPIKTRA exceed $ 200.0 million and $ 25.0 million when total worldwide net sales of COPIKTRA exceed $ 300.0 million, (iii) low double-digit royalties on the annual aggregate net sales above $ 100.0 million in the United States, European Union, and the United Kingdom of Great Britain and Northern Ireland and (iv) 50 % of all royalty, milestone and sublicense revenue payments payable to Secura under the Company’s existing license agreements with Sanofi, Yakult, and CSPC, and 50 % of all royalty and milestone payments payable to Secura under any license or sublicense agreement entered into by Secura in certain jurisdictions.
4 unchanged sentences
Consistent with the guidance under ASC 606-10-25-16A, the Company disregarded immaterial promised goods and services when determining performance obligations.
−Removed: During the year ended December 31, 2024, Secura achieved $ 100.0 million of total worldwide net sales of COPIKTRA which triggered a $ 10.0 million sales milestone payment to the Company under the Secura APA.
+Added: The Company determined that the upfront payment of $ 70.0 million, future potential milestone payments and royalties including from Secura’s sublicensees should be allocated to the delivery of the Bundled Secura Performance Obligation.
+Added: During the years ended December 31, 2025 and 2023, the Company has no t recognized any revenue associated with the Secura APA.
+Added: During the year end ended December 31, 2024, Secura achieved $ 100.0 million of total worldwide net sales of COPIKTRA which triggered a $ 10.0 million sales milestone payment to the Company under the Secura APA.
The Company received the $ 10.0 million milestone payment in July 2024.
−Removed: During the year ended December 31, 2024, the Company recognized $ 10.0 million of sale of COPIKTRA license and related assets revenue within the consolidated statements of operations and comprehensive loss.
−Removed: The Company determined that all other future potential milestones and royalties were excluded from the transaction price, as all other milestone amounts were fully constrained under the guidance as of December 31, 2024.
+Added: The Company determined all future potential milestones and royalties were excluded from the transaction price, as all other milestone amounts were fully constrained under the guidance as of December 31, 2025.
As part of the Company’s evaluation of the constraint, the Company considered several factors in determining whether there is significant uncertainty associated with the future events that would result in the milestone payments.
Those factors included:
−Removed: the likelihood and magnitude of revenue reversals related to future milestones, the amount of variable consideration that is highly susceptible to factors outside of the Company’s influence, the uncertainty about the consideration is not expected to be resolved for an extended period of time, and lack of significant history of selling COPIKTRA outside of the United States.
−Removed: All future potential milestone and royalty payments were fully constrained as the risk of significant revenue reversal related to these amounts has not yet been resolved.
−Removed: During the year ended December 31, 2023, the Company determined all future potential milestones were excluded from the transaction price, as all other milestone amounts were fully constrained under the guidance as of December 31, 2023.
−Removed: During the year ended December 31, 2022, the Company recognized $ 2.6 million of sale of COPIKTRA license and related assets revenue within the statements of operations and comprehensive loss.
−Removed: The sale of COPIKTRA license and related assets revenue for the year ended December 31, 2022 related to one regulatory milestone for $ 2.5 million achieved by Secura’s sublicensee, CSPC, and $ 0.1 million related to royalties on COPIKTRA sales in the year ended December 31, 2022, and future royalties expected to be received pursuant to the Secura APA that were not constrained.
−Removed: The Company determined all other future potential milestones were excluded from the transaction price, as all other milestone amounts were fully constrained under the guidance as of December 31, 2022.
+Added: the likelihood and magnitude of revenue reversals related to future milestones, the amount of variable consideration that is highly susceptible to factors outside of the Company’s influence and the uncertainty about the consideration is not expected to be resolved for an extended period of time.
+Added: All future potential milestone payments were fully constrained as the risk of significant revenue reversal related to these amounts has not yet been resolved.
Notes Payable
−Removed: In February 2024, the Company entered into a finance agreement with AFCO.
−Removed: Pursuant to the terms of the agreement, AFCO loaned the Company the principal amount of $ 1.3 million, which accrued interest at 8.3 % per annum, to fund a portion of the Company’s insurance policies.
−Removed: The Company was required to make monthly payments of $ 0.1 million through October 2024 including principal and interest.
−Removed: The agreement assigned AFCO a security interest in (i) all unearned premiums and dividends which may have become payable under the insurance policies financed pursuant to this agreement, (ii) loss payments which reduce the unearned premiums, and (iii) the Company’s interest in any state insurance guarantee fund related to any of the insurance policies financed pursuant to this agreement.
+Added: In January 2025, the Company entered into a finance agreement with FIRST Insurance Funding (“First Insurance”).
+Added: Pursuant to the terms of the agreement, First Insurance loaned the Company the principal amount of $ 1.2 million, which accrued interest at 6.9 % per annum, to fund a portion of the Company’s insurance policies.
+Added: Pursuant to the agreement with First Insurance, the Company made an initial payment of $ 0.3 million and made monthly payments of $ 0.1 million through November 2025 including principal and interest.
+Added: The agreement assigned First Insurance a first priority lien and security interest in the financed insurance policies.
The outstanding balance at December 31, 2025 was $ 0.0 million.
4 unchanged sentences
The Company made contributions to the 401(k) Plan of approximately $ 1.3 million, $ 1.0 million and $ 0.8 million in each of the years ended December 31, 2025, 2024, and 2023.
+Added: Vendor Financing Arrangement
+Added: Pursuant to the IQVIA Master Services Agreement, the Company has extended payment terms with respect to a portion of the services provided and has recorded a vendor financing arrangement liability of $ 10.3 million as of December 31, 2025.
+Added: The Company expects to pay the amounts recorded as vendor financing arrangement liabilities during 2026 and 2027.
Subsequent events
1 unchanged sentence
The Company is not aware of any material subsequent events other than the following:
−Removed: Note Purchase Agreement
−Removed: On January 13, 2025, (the “Note Purchase Agreement Closing Date”), the Company entered into the Note Purchase Agreement, pursuant to which the Company may sell to the Note Purchase Agreement Purchasers, and the Note Purchase Agreement Purchasers may buy from the Company, notes (“Notes”) in an aggregate principal amount not to exceed $ 150.0 million.
−Removed: On January 13, 2025, the Company issued an initial sale of $ 75.0 million principal amount of Notes and may issue an additional $ 75.0 million consisting of the following:
−Removed: ● at the option of the Company, the Second Sale of $ 25.0 million principal amount of Notes, at any time prior to December 31, 2025, upon the FDA’s approval sufficient for the promotion and sale of avutometinib and defactinib for the treatment of LGSOC and subject to certain other customary conditions precedent;
−Removed: ● at the option of the Company, the Third Sale of up to $ 50.0 million principal amount of Notes, at any time prior to December 31, 2026, provided that trailing six-month worldwide net sales of avutometinib and defactinib are at least $ 55.0 million and subject to certain other customary conditions precedent.
−Removed: Pursuant to the Note Purchase Agreement, on the Note Purchase Agreement Closing Date the Company sold Notes in an aggregate principal amount of $ 75.0 million and received net proceeds of approximately $ 32.3 million after repaying the balance of its obligations under its Loan Agreement, but before payment of certain expenses payable by the Company.
−Removed: The outstanding principal amount of the Notes bear interest at a rate per annum equal to the sum of (i) the greater of the Term SOFR (as defined in the Note Purchase Agreement) and 4.29 % , and (ii) 3.71 % , subject to adjustment in certain circumstances set forth in the Note Purchase Agreement and an overall cap of 9.75 % , payable quarterly in arrears until the seventh anniversary of the Note Purchase Agreement Closing Date or the date on which all amounts owing to the Note Purchase Agreement Purchasers under the Note Purchase Agreement have been paid in full (the “Note Purchase Agreement Maturity Date”).
−Removed: For the first eight quarters following the Note Purchase Agreement Closing Date, at the Company’s option, up to 50 % of the interest due may be paid-in-kind and added to the then-outstanding principal balance of the Notes.
−Removed: Upon the occurrence and during the continuance of an Event of Default (as defined in the Note Purchase Agreement) under the Note Purchase Agreement, the then-applicable interest rate on all outstanding obligations may be increased by an additional 5.00 % .
−Removed: Beginning on January 13, 2025 and continuing until the Note Purchase Agreement Maturity Date, the Note Purchase Agreement Purchasers will receive 1.00 % of the first $ 100.0 million of net sales of each Included Product (as defined in the Note Purchase Agreement) by the Company or its affiliates or licensees in each calendar year, payable quarterly.
−Removed: “Included Products” is defined in the Note Purchase Agreement to include (a) avutometinib and defactinib, including any product that contains either one of the foregoing in combination with any other active ingredient(s), and (b) all other compounds, chemical entities or pharmaceutical products being designed, developed, licensed, manufactured or commercialized by the Company or its subsidiaries from time to time.
−Removed: The Revenue Participation Percentage will increase pro rata immediately upon the occurrence of the Second Sale and the Third Sale, such that the Revenue Participation Percentage shall increase to a maximum of 2.00 % in the event that $ 150 million in aggregate principal amount of Notes has been purchased pursuant to the Note Purchase Agreement following the Third Sale.
−Removed: The outstanding principal amount of the Notes, interest accrued thereon and any other amounts owing to the Note Purchase Agreement Purchasers under the Note Purchase Agreement will be due in two equal instalments on (a) the sixth anniversary of the Note Purchase Agreement Closing Date, and (b) the Note Purchase Agreement Maturity Date.
−Removed: All of the Notes may be redeemed prior to the Note Purchase Agreement Maturity Date at the option of the Company, subject to payment of the Repayment Amount (as defined in the Note Purchase Agreement).
−Removed: The Note Purchase Agreement Purchasers may demand redemption of the Notes prior to the Note Purchase Agreement Maturity Date in the event of a Change of Control (as defined in the Note Purchase Agreement) of the Company or an Event of Default (as defined in the Note Purchase Agreement) under the Note Purchase Agreement, subject to payment of the Repayment Amount.
−Removed: If redeemed prior to the Note Purchase Agreement Maturity Date, the Repayment Amount will be:
−Removed: (a) 135 % of the principal amount of the Notes if redemption occurs before the second anniversary of the Note Purchase Agreement Closing Date upon a Change of Control;
−Removed: (b) if the preceding clause (a) does not apply, 175 % of the principal amount of the Notes if redemption occurs prior to the third anniversary the Note Purchase Agreement Closing date;
−Removed: and (c) thereafter, 195 % of the principal amount of the Notes if redemption occurs after the third anniversary the Note Purchase Agreement Closing Date, minus, in each case, the sum of regularly scheduled interest paid in cash, payments of principal in cash, and payments of revenue participation in cash prior to such redemption date.
−Removed: The Note Purchase Agreement contains no financial covenants.
−Removed: The Company’s obligations under the Note Purchase Agreement are subject to customary covenants, including limitations on the Company’s ability to dispose of assets, undergo a change of control, merge with or acquire other entities, incur debt, incur liens, pay dividends or other distributions to holders of its capital stock, repurchase stock and make investments, in each case subject to certain exceptions.
−Removed: The Company’s obligations under the Note Purchase Agreement are secured by a security interest on substantially all of the Company’s and its subsidiaries’ assets, including its intellectual property related to avutometinib and defactinib, and a negative pledge on intellectual property related to the GenFleet Agreement, subject to certain exceptions relating to the Company’s development of its intellectual property.
−Removed: Stock Purchase Agreement
−Removed: In connection with the Note Purchase Agreement, on January 13, 2025, the Company entered into a Stock Purchase Agreement (the “Stock Purchase Agreement”) with the certain funds managed by Oberland and affiliates thereof (the “SPA Investors”), pursuant to which the SPA Investors purchased an aggregate of 1,416,939 shares of the Company’s common stock, $ 0.0001 par value per share, at a price of $ 5.2931 per share, based on the trailing 30-trading day volume-weighted average price of the Company’s stock.
−Removed: The Company received gross proceeds of $ 7.5 million.
−Removed: In addition, pursuant to the Stock Purchase Agreement, the Company granted the SPA Investors, for a period of three years following the closing on January 13, 2025, a right to participate in any equity offerings consummated by the Company in an amount up to $ 2.5 million, subject to certain limitations and exclusions set out in the Stock Purchase Agreement.
−Removed: Repayment of Loan Agreement
−Removed: Substantially concurrently with the closing of the Note Purchase Agreement, on January 13, 2025, the Company terminated its Loan Agreement and repaid in full the balance of its obligations under the Loan Agreement of approximately $ 42.7 million (the “Payoff Amount”).
−Removed: The Payoff Amount included the Final Payment Fee, which was due at the earlier of prepayment or loan maturity, and certain prepayment fees as set forth in the Loan Agreement.
−Removed: Effective upon the Lender’s receipt of the Payoff Amount, the Loan Agreement has been terminated along with the Lender’s commitment to provide funding under any future term loans.
−Removed: Exercise of GenFleet Option
−Removed: In January 2025, the Company exercised early its GenFleet Option with respect to VS-7375 and consequently made a payment of $ 6.0 million to GenFleet.
−Removed: At-the-market equity offering program issuance
−Removed: In January 2025, the Company sold 4,000,000 shares under the August 2021 ATM for net proceeds of approximately $ 22.7 million (after deducting commissions and other offering expenses).
+Added: Warrants exercise
+Added: In January 2026, 8,391,666 Warrants were exercised.
+Added: As a result, the Company issued 8,391,666 shares of common stock and received net proceeds of $ 29.4 million.
+Added: Note Purchase Agreement amendment
+Added: In March 2026, the Company amended the Note Purchase Agreement to extend the date the Company may draw the Second Purchase from December 31, 2025 to June 30, 2026.
+Added: Refer to Note 8.
+Added: Long-term debt for additional details on the Note Purchase Agreement.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.