Verastem, Inc.
For the period ended Sep 30, 2025. Filed Nov 4, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 4, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
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Item 1. Condensed Consolidated Financial Statements (unaudited)
CONDENSED CONSOLIDATED BALANCE SHEETS
** (in thousands, except per share amounts)**
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | | | | | | | |
| · · September 30, · · December 31, · | |||||||
| · 2025 · 2024 | |||||||
| Assets · · · · · · | |||||||
| Current assets: | | | | | | | |
| Cash and cash equivalents | | $137,706 | | $88,818 | | ||
| Accounts receivable, net | | | 6,716 | | | — | |
| Inventory | | | 1,794 | | | — | |
| Grant receivable | | | 200 | | | 200 | |
| Prepaid expenses and other current assets | | 7,640 | | 5,943 | | ||
| Total current assets | | 154,056 | | 94,961 | | ||
| Property and equipment, net | | 20 | | 32 | | ||
| Right-of-use asset, net | | | 730 | | | 1,405 | |
| Restricted cash | | | — | | | 241 | |
| Intangible assets, net | | | 16,705 | | | — | |
| Other assets | | 5,341 | | 4,899 | | ||
| Total assets | | $176,852 | | $101,538 | | ||
| Liabilities, convertible preferred stock and stockholders’ equity | | | | | | | |
| Current liabilities: | | | | | | | |
| Accounts payable | | $9,888 | | $4,026 | | ||
| Accrued expenses, short-term | | | 44,721 | | 25,952 | | |
| Note payable | | | 188 | | | — | |
| Vendor financing arrangement, short-term | | | 4,122 | | | — | |
| Lease liability, short-term | | 793 | | 995 | | ||
| Total current liabilities | | 59,712 | | 30,973 | | ||
| Non-current liabilities: | | | | | | ||
| Long-term debt | | | 78,124 | | | 40,724 | |
| Vendor financing arrangement, long-term | | | 6,250 | | | — | |
| Lease liability, long-term | | | — | | | 535 | |
| Warrant liability | | | 48,292 | | | 58,199 | |
| Total liabilities | | 192,378 | | 130,431 | | ||
| Convertible preferred stock: | | | | | | | |
| Series B Convertible Preferred Stock, $0.0001 par value; 944 shares designated at September 30, 2025 and December 31, 2024, respectively; 0 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | | | — | | | — | |
| Stockholders’ equity: | | | | | | | |
| Preferred stock, $0.0001 par value; 5,000 shares authorized: | | | | | | | |
| Series A Convertible Preferred Stock, $0.0001 par value; 0 shares and 1,000 shares designated at September 30, 2025 and December 31, 2024, respectively, 0 shares and 1,000 shares issued and outstanding at September 30, 2025 and at December 31, 2024, respectively | | | — | | | — | |
| Common stock, $0.0001 par value; 300,000 shares authorized, 66,749 and 44,784 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | | 7 | | 4 | | ||
| Additional paid-in capital | | 1,114,004 | | 926,630 | | ||
| Accumulated other comprehensive income | | 2,545 | | — | | ||
| Accumulated deficit | | | (1,132,082) | | | (955,527) | |
| Total stockholders’ (deficit) | | (15,526) | | (28,893) | | ||
| Total liabilities, convertible preferred stock and stockholders’ equity | | $176,852 | | $101,538 | | ||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATION****S AND COMPREHENSIVE LOSS
** (in thousands, except per share amounts)**
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended September 30, · · Nine months ended September 30, · | |||||||||||||
| · 2025 · 2024 · 2025 · 2024 | |||||||||||||
| Revenue: | | | | | | | | | | | | | |
| Product revenue, net | | $11,242 | | $— | | $13,379 | | $— | | ||||
| Sale of COPIKTRA license and related assets | | | — | | | — | | | — | | | 10,000 | |
| Total revenue | | 11,242 | | — | | 13,379 | | 10,000 | | ||||
| Operating expenses: | | | | | | | | | | | | | |
| Cost of sales - product | | | 1,670 | | | — | | | 1,988 | | | — | |
| Cost of sales - intangible amortization | | | 290 | | | — | | | 418 | | | — | |
| Research and development | | | 28,989 | | | 24,754 | | | 82,925 | | | 60,523 | |
| Selling, general and administrative | | 21,008 | | | 12,276 | | 56,702 | | | 32,843 | | ||
| Total operating expenses | | 51,957 | | 37,030 | | 142,033 | | | 93,366 | | |||
| Loss from operations | | (40,715) | | (37,030) | | (128,654) | | | (83,366) | | |||
| Other expense | | | (37) | | | (77) | | | (186) | | | (131) | |
| Interest income | | 1,182 | | 831 | | 2,964 | | 3,181 | | ||||
| Interest expense | | (319) | | (1,148) | | (723) | | (3,416) | | ||||
| Loss on debt extinguishment | | | — | | | — | | | (1,826) | | | — | |
| Change in fair value of preferred stock tranche liability | | | — | | | — | | | — | | | 4,189 | |
| Change in fair value of warrant liability | | | (55,881) | | | 13,457 | | | (37,977) | | | 13,457 | |
| Change in fair value of Notes | | | (2,748) | | | — | | | (10,153) | | | — | |
| Net loss | | $(98,518) | | $(23,967) | | $(176,555) | | $(66,086) | | ||||
| Net loss per share—basic and diluted | | $(1.35) | | $(0.60) | | $(2.73) | | $(2.11) | | ||||
| | | | | | | | | | | | | | |
| Weighted average common shares outstanding used in computing net loss per share—basic and diluted | | | 73,157 | | | 40,258 | | | 64,561 | | | 31,350 | |
| | | | | | | | | | | | | | |
| Net loss | | $(98,518) | | $(23,967) | | $(176,555) | | $(66,086) | | ||||
| Unrealized gain (loss) on available-for-sale securities | | — | | — | | — | | (13) | | ||||
| Change in fair value of Notes attributable to instrument specific credit risk | | | 2,745 | | | — | | | (2,545) | | | — | |
| Comprehensive loss | | $(95,773) | | $(23,967) | | $(179,100) | | $(66,099) | | ||||
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ (DEFICIT) EQUITY
(in thousands, except share data)
| | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · · · · · · · · · Accumulated · · · · Total | |||||||||||||||||||||||
| · · · · · · · · · · · · Additional · · other · · · · stockholders' | |||||||||||||||||||||||
| · · Series A Convertible Preferred Stock · · Common stock · · paid-in · · comprehensive · · Accumulated · · equity | |||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · capital · income · (deficit) · (deficit) | |||||||||||||||||||||||
| Balance at December 31, 2024 | | 1,000,000 | | $— | | 44,784,350 | | $4 | | $926,630 | | $— | | $(955,527) | | $(28,893) | | ||||||
| Net loss | | — | | | — | | — | | | — | | | — | | | — | | | (52,103) | | (52,103) | | |
| Change in fair value of Notes attributable to instrument specific credit risk | | — | | | — | | — | | | — | | | — | | | 6,639 | | | — | | 6,639 | | |
| Stock-based compensation expense | | — | | | — | | — | | | — | | | 1,788 | | | — | | | — | | | 1,788 | |
| Issuance of common stock resulting from at-the-market transactions | | — | | | — | | 4,000,000 | | | 1 | | | 22,735 | | | — | | | — | | | 22,736 | |
| Issuance of common stock resulting from vesting of restricted stock units | | — | | | — | | 114,010 | | | — | | | — | | | — | | | — | | | — | |
| Issuance of common stock, net of issuance costs of $74K | | — | | | — | | 1,416,939 | | | — | | | 7,426 | | | — | | | — | | 7,426 | | |
| Issuance of common stock upon exercise of warrants | | — | | | — | | 1,166,666 | | | — | | | 9,952 | | | — | | | — | | | 9,952 | |
| Issuance of stock under Employee Stock Purchase Plan | | — | | | — | | 8,033 | | | — | | | 22 | | | — | | | — | | | 22 | |
| Balance at March 31, 2025 | | 1,000,000 | | $— | | 51,489,998 | | $5 | | $968,553 | | $6,639 | | $(1,007,630) | | $(32,433) | | ||||||
| Net loss | | — | | | — | | — | | | — | | | — | | | — | | | (25,934) | | (25,934) | | |
| Change in fair value of Notes attributable to instrument specific credit risk | | — | | | — | | — | | | — | | | — | | | (1,349) | | | — | | (1,349) | | |
| Stock-based compensation expense | | — | | | — | | — | | | — | | | 3,413 | | | — | | | — | | 3,413 | | |
| Issuance of common stock resulting from vesting of restricted stock units | | — | | | — | | 483,644 | | | — | | | — | | | — | | | — | | | — | |
| Issuance of common stock upon exercise of pre-funded warrants | | — | | | — | | 2,499,665 | | | — | | | — | | | — | | | — | | — | | |
| Issuance of common stock, and pre-funded warrants, net of issuance cost of $5,072 | | — | | | — | | 3,429,287 | | | 1 | | | 69,932 | | | — | | | — | | 69,933 | | |
| Issuance of common stock upon exercise of warrants | | — | | | — | | 2,787,499 | | | — | | | 22,426 | | | — | | | — | | 22,426 | | |
| Issuance of common stock upon conversion of Series A Preferred Stock | | (1,000,000) | | | — | | 833,332 | | | — | | | — | | | — | | | — | | — | | |
| Balance at June 30, 2025 | | — | | $— | | 61,523,425 | | $6 | | $1,064,324 | | $5,290 | | $(1,033,564) | | $36,056 | | ||||||
| Net Loss | | — | | | — | | — | | | — | | | — | | | — | | | (98,518) | | (98,518) | | |
| Change in fair value of Notes attributable to instrument specific credit risk | | — | | | — | | — | | | — | | | — | | | (2,745) | | | — | | (2,745) | | |
| Stock-based compensation expense | | — | | | — | | — | | | — | | | 2,178 | | | — | | | — | | 2,178 | | |
| Issuance of common stock resulting from vesting of restricted stock units | | — | | | — | | 44,023 | | | — | | | — | | | — | | | — | | | — | |
| Issuance of stock under Employee Stock Purchase Plan | | — | | | — | | 8,308 | | | — | | | 29 | | | — | | | — | | | 29 | |
| Issuance of common stock from exercise of options | | — | | | — | | 6,424 | | | — | | | 44 | | | — | | | — | | | 44 | |
| Issuance of common stock upon exercise of warrants | | — | | | — | | 5,166,666 | | | 1 | | | 47,429 | | | — | | | — | | 47,430 | | |
| Balance at September 30, 2025 | | — | | $— | | 66,748,846 | | $7 | | $1,114,004 | | $2,545 | | $(1,132,082) | | $(15,526) | | ||||||
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · · · · · · · · · · · · · · Accumulated · · · · | |||||||||||||||||||||||||||||
| · · · · · · · · · · · · Additional · · other · · · · Total | |||||||||||||||||||||||||||||
| · · Series B Convertible Preferred Stock · · · Series A Convertible Preferred Stock · · Common stock · paid-in · comprehensive · Accumulated · stockholders' | |||||||||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Shares · Amount · capital · income (loss) · (deficit) · equity | |||||||||||||||||||||||||||||
| Balance at December 31, 2023 | | 1,200,000 | | $21,159 | | 1,000,000 | | $— | | 25,281,150 | | $3 | | $882,248 | | $13 | | $(824,890) | | $57,374 | | ||||||||
| Net loss | | — | | | — | | | — | | | — | | — | | | — | | | — | | | — | | | (33,863) | | (33,863) | | |
| Unrealized loss on available-for-sale marketable securities | | — | | | — | | | — | | | — | | — | | | — | | | — | | | (17) | | | — | | (17) | | |
| Issuance of common stock resulting from vesting of restricted stock units | | — | | | — | | | — | | | — | | 14,444 | | | — | | | — | | | — | | | — | | — | | |
| Issuance of common stock resulting from exercise of stock options | | — | | | — | | | — | | | — | | 4,600 | | | | | | 36 | | | | | | | | | 36 | |
| Issuance of common stock under Employee Stock Purchase Plan | | — | | | — | | | — | | | — | | 7,475 | | | — | | | 49 | | | — | | | — | | 49 | | |
| Stock-based compensation expense | | — | | | — | | | — | | | — | | — | | | — | | | 1,483 | | | — | | | — | | | 1,483 | |
| Balance at March 31, 2024 | | 1,200,000 | | $21,159 | | 1,000,000 | | $— | | 25,307,669 | | $3 | | $883,816 | | $(4) | | $(858,753) | | $25,062 | | ||||||||
| Net loss | | — | | | — | | | — | | | — | | — | | | — | | | — | | | — | | | (8,256) | | (8,256) | | |
| Unrealized loss on available-for-sale marketable securities | | — | | | — | | | — | | | — | | — | | | — | | | — | | | 4 | | | — | | 4 | | |
| Issuance of common stock resulting from vesting of restricted stock units | | — | | | — | | | — | | | — | | 12,986 | | | — | | | — | | | — | | | — | | | — | |
| Stock-based compensation expense | | — | | | — | | | — | | | — | | — | | | — | | | 1,905 | | | — | | | — | | | 1,905 | |
| Issuance of common stock, and pre-funded warrants, net of issuance cost of $6,351 | | — | | | — | | | — | | | — | | 1,555,579 | | | — | | | 136 | | | — | | | — | | | 136 | |
| Balance at June 30, 2024 | | 1,200,000 | | | 21,159 | | 1,000,000 | | | — | | 26,876,234 | | $3 | | $885,857 | | $— | | $(867,009) | | $18,851 | | ||||||
| Net loss | | — | | | — | | | — | | | — | | — | | | — | | | — | | | — | | | (23,967) | | (23,967) | | |
| Issuance of common stock and pre-funded warrants, net of issuance costs of | | — | | | — | | | — | | | — | | 13,333,334 | | | 1 | | | 14,220 | | | | | | — | | 14,221 | | |
| Issuance of common stock resulting from vesting of restricted stock units | | — | | | — | | | — | | | — | | 44,300 | | | — | | | — | | | — | | | — | | | — | |
| Stock-based compensation expense | | — | | | — | | | — | | | — | | — | | | — | | | 1,935 | | | — | | | — | | 1,935 | | |
| Issuance of common stock under Employee Stock Purchase Plan | | — | | | — | | | — | | | — | | 7,756 | | | — | | | 20 | | | — | | | — | | 20 | | |
| Balance at September 30, 2024 | | 1,200,000 | | | 21,159 | | | 1,000,000 | | | — | | 40,261,624 | | $4 | | $902,032 | | $— | | $(890,976) | | $11,060 | | |||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW****S
(in thousands)
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Nine months ended September 30, · | |||||||
| · 2025 · 2024 · | |||||||
| Operating activities | | | | | | | |
| Net loss | | $(176,555) | | $(66,086) | | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | |
| Depreciation | | 12 | | | 19 | | |
| Amortization of acquired intangible assets | | | 418 | | | — | |
| Non-cash operating lease cost | | | (62) | | | (145) | |
| Stock-based compensation expense | | 7,379 | | 5,323 | | ||
| Amortization of deferred financing costs, debt discounts and premiums and discounts on available-for-sale marketable securities | | | 29 | | | (212) | |
| Change in fair value of preferred stock tranche liability | | | — | | | (4,189) | |
| Change in fair value of warrant liability | | | 37,977 | | | (13,457) | |
| Non-cash change in fair value of Notes | | | 5,670 | | | — | |
| Loss on debt extinguishment | | | 1,826 | | | — | |
| Changes in operating assets and liabilities: | | | | | | | |
| Accounts receivable, net | | | (6,716) | | | — | |
| Grant receivable | | | — | | | (200) | |
| Inventory | | | (1,794) | | | — | |
| Prepaid expenses, other current assets and other assets | | (1,898) | | (1,884) | | ||
| Accounts payable | | 4,518 | | (2,746) | | ||
| Accrued expenses and other liabilities | | 21,641 | | 4,232 | | ||
| Deferred liabilities | | — | | (327) | | ||
| Net cash used in operating activities | | (107,555) | | (79,672) | | ||
| Investing activities | | | | | | | |
| Purchases of property and equipment | | | — | | | (28) | |
| Purchases of intangible asset | | | (8,279) | | | — | |
| Maturities of investments | | — | | 60,000 | | ||
| Net cash (used in) provided by investing activities | | (8,279) | | 59,972 | | ||
| Financing activities | | | | | | | |
| Proceeds from long-term debt | | | 75,000 | | | — | |
| Repayment of long-term debt | | | (42,580) | | | — | |
| Fees paid to Lenders for Loan Agreement amendment | | | — | | | (150) | |
| Proceeds from insurance premium financing | | | 1,180 | | | 1,298 | |
| Payments on insurance premium financing | | | (992) | | | (1,165) | |
| Payments on deferred issuance costs | | | — | | | — | |
| Proceeds from the exercise of stock options and employee stock purchase program | | | 96 | | | 241 | |
| Proceeds from exercise of warrants | | | 31,923 | | | 39,595 | |
| Proceeds from the issuance of common stock and pre-funded warrants, net | | | 100,095 | | | 14,221 | |
| Net cash provided by financing activities | | 164,722 | | | 54,040 | | |
| Increase in cash, cash equivalents and restricted cash | | 48,888 | | 34,340 | | ||
| Cash, cash equivalents and restricted cash at beginning of period | | 89,059 | | 79,076 | | ||
| Cash, cash equivalents and restricted cash at end of period | | $137,947 | | $113,416 | | ||
| Supplemental disclosure of non-cash investing and financing activities | | | | | | | |
| Conversion of warrant liability into additional paid-in capital upon warrant exercise | | | 47,884 | | | — | |
| Purchases of intangible asset in accounts payable and accrued expenses | | | 8,844 | | | — | |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of business
Verastem, Inc. (the “Company”) is a 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. On May 8, 2025, the U.S. Food and Drug Administration (the “FDA”) approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (“KRAS”) mutant (“KRAS mt”) recurrent low grade serous ovarian cancer (“LGSOC”) who received prior systemic therapy. The Company markets AVMAPKI FAKZYNJA CO-PACK in the United States. 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.
The condensed consolidated financial statements include the accounts of Verastem Securities Company and Verastem Europe GmbH, wholly-owned subsidiaries of the Company. All financial information presented has been consolidated and includes the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
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, market acceptance and commercial success of AVMAPKI FAKZYNJA CO-PACK, or any of the Company’s product candidates following receipt of regulatory approval, inability to obtain marketing approval for additional indications or product candidates, protection of proprietary technology and the continued ability to obtain adequate financing to fund the Company’s future operations. If the Company does not successfully commercialize AVMAPKI FAKZYNJA CO-PACK or any of its other product candidates, it will be unable to generate product revenue or achieve profitability and may need to raise additional capital.
As of September 30, 2025, the Company had cash, cash equivalents, and investments of $137.7 million. 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 condensed consolidated financial statements. The Company anticipates operating losses may continue for the foreseeable future 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 activities. 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 condensed consolidated financial statements are issued.
The Company expects to finance its operations with its existing cash, cash equivalents and investments, through future net product revenues, through potential future milestones and royalties received pursuant to the Company’s Asset Purchase Agreement (“Secura APA”) with Secura, pursuant to the Company’s Note Purchase Agreement (as defined herein) (seeNote 10. Debt), or through other strategic financing opportunities that could include, but are not limited to collaboration agreements, offerings of its equity, or the incurrence of debt. However, given the risks associated with these potential strategic or financing opportunities, they are not deemed probable for purposes of the going concern assessment. If the Company fails to obtain additional capital or generate sufficient revenue from its commercialization activities in the future, it may be unable to complete its planned preclinical studies and clinical trials and obtain approval of certain investigational product candidates from the FDA or foreign regulatory authorities. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern.
2. Summary of significant accounting policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01 under the assumption that the Company will continue as a going concern for the next twelve months. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements, or any adjustments that might result from the uncertainty related to the Company’s ability to continue as a going concern. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2025. For further information, refer to the financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 20, 2025.
Significant Accounting Policies
The significant accounting policies are described inNo**te 2.Significant accounting policiesin the* *Company’s Annual Report on Form 10-K for the year ended December 31, 2024. During the nine months ended September 30, 2025, there were no material changes to the significant accounting policies, except for significant accounting policies over product revenue, net, accounts receivable, net, inventory and intangible assets, each of which is detailed below.
Product Revenue, Net – The Company sells AVMAPKI FAKZYNJA CO-PACK to a limited number of specialty pharmacies and specialty distributors in the United States. 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. 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 reimbursment of AVMAPKI FAKZYNJA CO-PACK.
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). Product revenues are recorded at the wholesale acquisition costs, net of applicable reserves for variable consideration. 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. 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. 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. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled with respect to sales made.
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. 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”). For the nine months ended September 30, 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. Actual amounts of consideration ultimately received may differ from the Company’s estimates. 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.
Trade Discounts and Allowances: 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. In addition, the Company compensates its specialty pharmacy and specialty distributor customers for sales order management, data, distribution, and certain other services. 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 condensed consolidated statements of operations and comprehensive loss.
Third-Party Payer Chargebacks, Discounts and Fees: 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. In some cases, customers will charge the Company for the difference between what they pay for AVMAPKI FAKZYNJA CO-PACK and the ultimate selling price to the Third-Party Purchasers to whom they sell the product. 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. 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. 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.
Government Rebates: The Company is subject to discount and rebate payment obligations under various government programs including Federal and state Medicaid programs, Medicare, and others. 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 condensed consolidated balance sheets. 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.
Other Patient Support Initiatives: 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. 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. 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 condensed consolidated balance sheets.
Product Returns: 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. 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. 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.
The Company’s return policy generally allows for eligible returns of AVMAPKI FAKZYNJA CO-PACK for credit under the following circumstances:
| ● | Receipt of damaged product; |
| ● | Shipment errors that were a result of an error by the Company; |
| ● | 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; |
| ● | Quantities of product received by a customer in excess of quantity ordered; |
| ● | Product subject to a recall; and |
| ● | Product that the Company, at its sole discretion, has specified can be returned for credit. |
As of September 30, 2025, the Company has not received any returns.
Accounts Receivable, Net
Accounts receivable, net consists of amounts due from customers, net of applicable revenue reserves. Accounts receivable have standard payments that generally require payment within 30 to 90 days. 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. Based on our latest assessment of the collectability of the Company’s accounts receivable, an allowance for credit loss is not deemed necessary at September 30, 2025.
Inventory
Inventories are stated at the lower of cost or estimated net realizable value. We determine the cost of inventories using the standard cost method, which approximates actual cost based on a first-in, first out basis. Inventories consist primarily of third-party manufacturing costs. The Company began capitalizing inventory upon receiving FDA approval for AVMAPKI FAKZYNJA CO-PACK on May 8, 2025. 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.
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. Such impairment charges, should they occur, are recorded within cost of sales – product within the condensed consolidated statements of operations and net loss. The determination of whether inventory costs will be realizable requires estimates by management. 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 condensed consolidated statements of operations and comprehensive loss.
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.
Intangible Assets* *
The Company records finite-lived intangible assets related to certain capitalized milestone payments at their fair value. 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. Intangible assets are amortized using the economic consumption method if anticipated future revenues can be reasonably estimated. The straight-line method is used when future revenues cannot be reasonably estimated.
The Company assesses its finite-lived intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. 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 information regarding future projected sales for the product. 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 condensed consolidated balance sheets. 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.
Recently issued accounting standards updates
In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). 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. The standard is effective for public companies for all annual periods beginning after December 15, 2024, with early adoption permitted. ASU 2023-09 will be effective for the Company beginning with its 2025 annual financial statements. The Company is in the process of evaluating the impact that the adoption of this ASU may have on its condensed consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU No 2024-03—Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”). The guidance in ASU 2024-03 is intended to require more detailed disclosures about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face of the income statement. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to all prior periods presented in the financial statements. The Company is in the process of evaluating the impact that the adoption of this ASU may have on its condensed consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU No. 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”). 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. Entities must evaluate whether there is “significant development uncertainty,” such as unresolved novel functionality or substantially revised performance requirements, before meeting this capitalization threshold. 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. Entities may adopt the amendments prospectively, retrospectively, or under a modified transition approach. The Company is in the process of evaluating the impact that the adoption of this ASU may have on its condensed 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 condensed consolidated financial statements upon future adoption.
Concentrations of credit risk and off-balance sheet risk
Cash, cash equivalents, investments and trade accounts receivable are financial instruments that potentially subject the Company to concentrations of credit risk. The Company mitigates this risk by maintaining its cash and cash equivalents and investments with high quality, accredited financial institutions. The management of the Company’s investments is not discretionary on the part of these financial institutions. As of September 30, 2025, the Company’s
cash, cash equivalents and investments were deposited atfour 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.
As of September 30, 2025 there weresix customers that cumulatively made 100% of the Company’s trade accounts receivable balance andtwo customers who cumulatively made up more than 60% of the Company’s trade accounts receivable balance. The Company assesses the creditworthiness of all its customers and sets and reassesses customer credit limits to ensure collectability of any trade accounts receivable balances are assured.
For each of the three and nine months ended September 30, 2025, there weretwo customers who each individually accounted for greater than 10% of the Company’s total revenues. Thesetwo customers accounted for revenues of $9.7 million and $11.5 million, respectively, for the three and nine months ended September 30, 2025.
Proceeds from Grants
In May 2022, the Company was awarded the “Therapeutic Accelerator Award” grant from Pancreatic Cancer Network (“PanCAN”) for up to$3.8 million (the “PanCAN Grant”). In August 2022, PanCAN agreed to provide the Company with an additional$0.5 million for the collection and analysis of patient samples. The grant is supporting a Phase 1b/2 clinical trial of GEMZAR (gemcitabine) and ABRAXANE (Nab-paclitaxel) in combination with avutometinib and defactinib entitled RAMP 205. The RAMP 205 trial is evaluating whether combining avutometinib (to target KRAS mutant, which is found in more than 90% of pancreatic adenocarcinomas), and defactinib (to reduce stromal density and adaptive resistance to avutometinib) to the standard GEMZAR/ABRAXANE regimen improves outcomes for patients with such pancreatic cancers. The Company recognizes grants as contra research and development expense in the consolidated statement of operations and comprehensive loss on a systematic basis over the periods in which the Company recognizes as expenses the related costs for which the grants are intended to compensate. Eligible expenses incurred in excess of grant payments received up to the total amount of the PanCAN Grant are recorded as a grant receivable. Through September 30, 2025, the Company has received$4.1 million of cash proceeds which was initially recorded as deferred liabilities on the balance sheet. The Company recorded$0.0 million of the proceeds as a reduction of research and development expense for both the three and nine months ended September 30, 2025. As of September 30, 2025, and December 31, 2024, the company recorded a grant receivable of$0.2 million related to the PanCAN Grant in the condensed consolidated and consolidated balance sheets.
3. Cash, cash equivalents and restricted cash
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| · September 30, 2025 · December 31, 2024 | ||||
| Cash and cash equivalents | | $137,706 | | $88,818 |
| Restricted cash | | 241 | | 241 |
| Total cash, cash equivalents and restricted cash | | $137,947 | | $89,059 |
Amounts included in restricted cash as of September 30, 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. The letters of credit are included in prepaid expenses and other current assetson the condensed consolidated balance sheets as of September 30, 2025, and in non-current restricted cash as of December 31, 2024.
4. Fair value of financial instruments
The Company determines the fair value of its financial instruments based upon the fair value hierarchy, which prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:
| Level 1 inputs | Quoted prices in active markets for identical assets or liabilities that the Company can access at the measurement date. |
|---|---|
| Level 2 inputs | Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. |
| Level 3 inputs | Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. |
Items Measured at Fair Value on a Recurring Basis
The following table presents information about the Company’s financial instruments that are measured at fair value on a recurring basis (in thousands):
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · September 30, 2025 | ||||||||
| Description · Total · Level 1 · Level 2 · Level 3 | ||||||||
| Financial assets · · · · · · · · · · · · | ||||||||
| Cash equivalents | | $81,151 | | $81,151 | | $— | | $— |
| Total financial assets | | $81,151 | | $81,151 | | $— | | $— |
| Warrant liability | | $48,292 | | $— | | $— | | $48,292 |
| Notes | | $78,124 | | $— | | $— | | $78,124 |
| Total financial liabilities | | $126,416 | | $— | | $— | | $126,416 |
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · December 31, 2024 | ||||||||
| Description · · Total · Level 1 · Level 2 · Level 3 | ||||||||
| Financial assets · · · · · · · · · · · · | ||||||||
| Cash equivalents | | $63,304 | | $63,304 | | $— | | $— |
| Total financial assets | | $63,304 | | $63,304 | | $— | | $— |
| Warrant liability | | $58,199 | | $— | | $— | | $58,199 |
| Total financial liabilities | | $58,199 | | $— | | $— | | $58,199 |
The Company’s cash equivalents consist of U.S. Government money market funds. The 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. The pricing services utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validates the prices provided by third party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by the pricing services as of September 30, 2025, or December 31, 2024.
Warrant Liability
A warrant liability was recorded as a result the July 2024 Offering (as defined herein) (seeNote 15. Capital Stock). The fair value measurement of the warrant liability is classified as Level 3 under the fair value hierarchy. The fair value of the warrant liability at inception and September 30, 2025, 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.
Below are the inputs used to value the warrant liability at December 31, 2024 and September 30, 2025:
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · December 31, 2024 · · September 30, 2025 | |||||
| Risk-free interest rate | 4.17% | | 4.02% | ||
| Volatility | 137% | | 77% | ||
| Dividend yield | — | | | — | |
| Remaining term (years) | 1.1 | | | 0.3 | |
The following table represents a reconciliation of the warrant liability (in thousands):
| | | | | |
|---|---|---|---|---|
| December 31, 2024 | | | $58,199 | |
| Fair value of warrants exercised | | | | (47,884) |
| Fair value adjustment | | | | 37,977 |
| September 30, 2025 | | | $48,292 |
Note Purchase Agreement
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)(seeNote 10. Debt). 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. 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. At January 13, 2025, the Company utilized a discount rate between 11.9%-12.4% and at September 30, 2025, the Company utilized a discount rate between 12.8%-13.2%. The fair value of the Notes at September 30, 2025 was determined to be $78.1 million which differed from the contractual principal amount of $75.0 million by $3.1 million. Significant increases or decreases in any of these inputs in isolation could result in a significantly lower or higher fair value measurement.
Oxford Loan Agreement
The fair value of the Company’s Term Loans (as defined herein) (seeNote 10. Debt) pursuant to the Loan Agreement (as defined herein) (seeNote 10. Debt) was determined using a discounted cash flow analysis with current applicable rates for similar instruments as of the condensed consolidated balance sheet dates. The Company estimates 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.
5. Investments
Cash, cash equivalents, restricted cash and investments consist of the following (in thousands):
| · · · · · · · · · · · · · | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| | September 30, | ||||||||
| · · · Gross · Gross · · | |||||||||
| · · Amortized · · Unrealized · · Unrealized · · Fair | |||||||||
| · Cost · Gains · Losses · Value | |||||||||
| Cash, cash equivalents & restricted cash: · · · · · · · · · · · · · | |||||||||
| Cash and money market accounts | | $137,947 | | $— | | $— | | $137,947 | |
| Total cash, cash equivalents & restricted cash | | $137,947 | | $— | | $— | | $137,947 | |
| · · · · · · · · · · · · · | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| · December 31, 2024 · | |||||||||
| · · · Gross · Gross · · · | |||||||||
| · Amortized · Unrealized · Unrealized · Fair · | |||||||||
| · Cost · Gains · Losses · Value | |||||||||
| Cash, cash equivalents & restricted cash: · · · · · · · · · · · · · | |||||||||
| Cash and money market accounts | | $89,059 | | $— | | $— | | $89,059 | |
| Total cash, cash equivalents & restricted cash | | $89,059 | | $— | | $— | | $89,059 | |
There wereno realized gains or losses on investments for the three or nine months ended September 30, 2025 or September 30, 2024. Accrued interest receivable is excluded from the amortized cost and estimated fair value of the Company's investments. Accrued interest receivable of$0.1 million is presented within prepaid expenses and other current assets on the condensed consolidated balance sheets on September 30, 2025. There wasno accrued interest receivable on December 31, 2024. There wereno securities in an unrealized loss position as of September 30, 2025, or December 31, 2024.
6. Accrued expenses
Accrued expenses consist of the following (in thousands):
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · September 30, 2025 · December 31, 2024 | |||||||
| | | | | | | | |
| Accrued clinical trial expenses | | $13,086 | | $10,915 | | ||
| Accrued contract manufacturing expenses | | | 5,360 | | | 3,748 | |
| Accrued other research and development expenses | | | 2,017 | | | 1,359 | |
| Accrued compensation and related benefits | | 7,809 | | 6,245 | | ||
| Accrued professional fees | | 663 | | 620 | | ||
| Accrued consulting fees | | 1,437 | | 1,613 | | ||
| Accrued interest | | | — | | | 316 | |
| Accrued commercialization costs | | 4,632 | | 803 | | ||
| Accrued milestone payments & royalties | | | 9,549 | | | — | |
| Accrued other | | 168 | | 333 | | ||
| Total accrued expenses | | $44,721 | | $25,952 | | ||
7. Product revenue reserves and allowances
Since 2025, the Company’s sole source of product revenue has been from sales of AVMAPKI FAKZYNJA CO-PACK in the United States. The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2025 (in thousands):
| · · · · · · · · · · · · · · · | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Trade · · Third Party Payer · · Government · · · · · · | |||||||||||||
| · · discounts · · chargebacks, · · rebates and · · · · · · | |||||||||||||
| · · and · · discounts · · other · · · · · · | |||||||||||||
| · allowances · and fees · incentives · Returns · Total | |||||||||||||
| Balance at December 31, 2024 | | $— | | $— | | $— | | $— | | $— | |||
| Provision related to sales in the current year | | 467 | | | 231 | | | 2,035 | | | 165 | | 2,898 |
| Adjustments related to prior period sales | | — | | | — | | | — | | | — | | — |
| Credits and payments made | | (315) | | | (15) | | | (108) | | | — | | (438) |
| Ending balance at September 30, 2025 | | $152 | | $216 | | $1,927 | | $165 | | $2,460 | |||
Trade discounts and Payer chargebacks and discounts are recorded as a reduction to accounts receivable, net on the condensed consolidated balance sheets. Trade allowances and Payer fees, government rebates, other incentives and returns are recorded as a component of accrued expenses on the condensed consolidated balance sheets.
8. Inventory
Inventory consists of the following (in thousands):
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · September 30, 2025 · December 31, 2024 | |||||
| Raw materials | | $— | | $— | |
| Work in process | | 1,780 | | — | |
| Finished goods | | 14 | | — | |
| Total inventory | | $1,794 | | $— | |
At September 30, 2025, all of our inventory was related to AVMAPKI and FAKZYNJA. 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. 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. At September 30, 2025, we determined that a reserve related to inventory was not required.
9. Intangible Assets
The Company’s intangible assets consist of the following (in thousands):
| · · · · · · | |||||
|---|---|---|---|---|---|
| · September 30, 2025 · Weighted-Average Remaining Amortization Period (Years) | |||||
| Acquired and in-licensed rights | | $17,123 | | 15.0 years | |
| Less: accumulated amortization | | (418) | | | |
| Total intangible assets, net | | $16,705 | | | |
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). Refer toNote 18. License, collaboration and commercial agreements for further discussion of the Pfizer Agreement and License Agreement.
The Company recorded approximately $0.3 million and $0.4 million in cost of sales – intangible amortization expense related to finite-lived intangible assets during the three and nine months ended September 30, 2025, respectively, using straight-line methodology. Estimated future cost of sales- intangible amortization expense for finite-lived intangible assets as of September 30, 2025 is as follows (in thousands):
| | | | |
|---|---|---|---|
| Year ending December 31, · · Amount | |||
| 2025 (remaining three months) | | | 278 |
| 2026 | | | 1,117 |
| 2027 | | | 1,117 |
| 2028 | | | 1,117 |
| 2029 | | | 1,117 |
| Thereafter | | | 11,959 |
| Total future amortization | | $16,705 | |
10. Debt
Note Purchase Agreement
On January 13, 2025 (the “Closing Date”), the Company entered into a 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 Capital Management LLC, as purchasers (together with other purchasers party thereto from time to time, the “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. On the Closing Date, the Company issued and sold an initial Note in an aggregate principal amount$75.0 million. In addition, the Company may issue and sell additional Notes with aggregate principal amount of up to$75.0 million as follows:
| i. | at the option of the Company, a second sale (the “Second Sale”) of $25.0 million principal amount of Notes, at any time prior to December 31, 2025, upon the FDA approval sufficient for the promotion and sale of avutometinib and defactinib for the treatment of LGSOC and subject to certain other customary conditions precedent; and |
| ii. | at the option of the Company, a third sale (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. |
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 Closing Date or the date on which all amounts owing to the Purchasers under the Note Purchase Agreement have been paid in full (the “Maturity Date”). For the first eight (8) quarters following the 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. Through September 30, 2025, the Company has not elected to defer any interest through its paid-in-kind option. 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%.
Beginning on January 13, 2025 and continuing until the Maturity Date, the 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. “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. 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. The outstanding principal amount of the Notes, interest accrued thereon and any other amounts owing to the Purchasers under the Note Purchase Agreement will be due intwo equal instalments on (a) the sixth anniversary of the Closing Date, and (b) the Maturity Date.
All of the Notes may be redeemed prior to the Maturity Date at the option of the Company, subject to payment of the Repayment Amount (as defined in the Note Purchase Agreement). The Purchasers may demand redemption of the Notes prior to the 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. 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. The Repayment Amount is (a)135% of the principal amount of the Notes if redemption occurs before the second anniversary of the Closing Date upon a Change of Control; (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 Closing date; and (c) thereafter,195% of the principal amount of the Notes if redemption occurs after the third anniversary the 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.
The Note Purchase Agreement contains no financial covenants. 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. 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.
A portion of the proceeds of the Note Purchase Agreement were used to repay the Company’s obligations under the Loan Agreement (as defined below) in full. The Loan Agreement was terminated concurrently with entry into the Note Purchase Agreement.
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. 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. 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. 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 condensed consolidated statements of operations. 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. Changes in fair value caused by instrument-specific credit risk are presented separately in other comprehensive income or loss within the condensed statements of equity (deficit). The portion of total 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 condensed consolidated statements of operations and comprehensive loss. Under the fair value option, debt issuance costs are expensed as incurred. The Company incurred $0.8 million of debt issuance costs, of which $0.0 million and $0.8 million were recorded within selling, general and administrative expense in the condensed consolidated statements of operations for the three and nine months ended September 30, 2025, respectively.
The Company determined the fair value of the Notes on January 13, 2025 was $75.0 million. The following table reconciles the change in fair value of the Notes during the nine months ended September 30, 2025 (in thousands):
| | | | | |
|---|---|---|---|---|
| Beginning fair value balance at January 13, 2025 | | | $75,000 | |
| Change in fair value reported in statements of operations | | | | 10,153 |
| Change in fair value reported in comprehensive loss | | | | (2,545) |
| Interest and revenue participation payments | | | | (4,484) |
| Ending fair value at September 30, 2025 | | | $78,124 |
As of September 30, 2025, future principal payments under the Note Purchase Agreement are due as follows (in thousands):
| | | | |
|---|---|---|---|
| 2025 | | | — |
| 2026 | | | — |
| 2027 | | | — |
| 2028 | | | — |
| 2029 | | | — |
| 2030 | | | — |
| 2031 | | | 37,500 |
| 2032 | | | 37,500 |
| Total principal payments | | $75,000 |
Loan Agreement
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”). 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.
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:
| i. | $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”). 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. |
|---|
| ii. | $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”). 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. |
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| iii. | $50.0 million (the “Term E Loan”), at the sole discretion of the Lenders. |
|---|
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. Interest was payable monthly in arrears on the first calendar day of each calendar month. 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 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. All unpaid principal and accrued and unpaid interest with respect to each Term Loan were due and payable in full on March 1, 2027.
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”). 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. All Term Loans were subject to a facility fee of 0.5% of the principal amount.
The Loan Agreement containedno 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. 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. 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.
The Company assessed all terms and features of the Loan Agreement in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the Loan Agreement, including put and call features. The Company determined that all features of the Loan Agreement were clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's financial statements. The Company reassesses the features on a quarterly basis to determine if they require separate accounting. There have been no changes to the Company’sassessment.
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”). 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. 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. All liens on the Company’s assets to secure the loans under the Loan Agreement have been terminated and released. The Payoff Amount, excluding accrued interest, exceeded the carrying amount of the Term Loan on January 13, 2025 by$1.8 million. As a result the Company recorded a loss on debt extinguishment of$1.8 million included in the condensed statements of operations and comprehensive loss for the nine months ended September 30, 2025.
The debt issuance costs and the Final Payment Fee have been recorded as a debt discount which were accreted to interest expense through the maturity date of the Term Loan using the effective interest method. The components of the carrying value of the Term Loan as of December 31, 2024, are detailed below (in thousands):
| | | |
|---|---|---|
| | December 31, 2024 | |
| Principal loan balance | $40,000 | |
| Final Payment Fee | | 1,172 |
| Debt issuance costs, net of accretion | | (448) |
| Total Long-term debt, net of discount | | 40,724 |
The following table sets forth total interest expense for the three and nine-month periods ended September 30, 2025 and 2024 (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended September 30, · · Nine months ended September 30, | ||||||||||||
| · · 2025 · · 2024 · · 2025 · · 2024 | ||||||||||||
| Contractual Interest | | $319 | | $947 | | $694 | | $2,835 | ||||
| Amortization of debt discount and issuance costs | | | — | | | 71 | | | 29 | | | 204 |
| Amortization of Final Payment Fee | | | — | | | 130 | | | — | | | 377 |
| Total | | $319 | | $1,148 | | $723 | | $3,416 | ||||
11. Leases
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. The lease term commenced on April 15, 2014 and it was scheduled to expire on September 30, 2019. Effective February 15, 2018, the Company amended its lease agreement to relocate within the facility to another location consisting of 27,810 square feet of office space (the “February 2018 Amended Lease Agreement”). The February 2018 Amended Lease Agreement extended the expiration date of the lease from September 2019 through June 2025. Pursuant to the February 2018 Amended Lease Agreement, the initial annual base rent amount was approximately $0.7 million, which increased during the lease term to $1.1 million for the last 12-month period. Effective November 1, 2024, the Company amended the February 2018 Amended Lease Agreement to extend the expiration date from June 2025 to June 2026 (the “November 2024 Amended Lease Agreement”). The payment terms of the November 2024 Amended Lease Agreement are $1.1 million per annum through the expiration date in June 2026.
The Company has accounted for its Needham, Massachusetts office space as an operating lease. The Company’s lease contains an option to renew and extend the lease terms and an option to terminate the lease prior to the expiration date. The Company has not included the lease extension or the termination options within the right-of-use asset and lease liability on the condensed consolidated balance sheets as neither option is reasonably certain to be exercised. The Company’s lease includes variable non-lease components (e.g., common area maintenance, maintenance, consumables, etc.) that are not included in the right-of-use asset and lease liability and are reflected as an expense in the period incurred. The Company does not have any other operating or finance leases.
As of September 30, 2025, a right-of-use asset of $0.7 million and lease liability of $0.8 million are reflected on the condensed consolidated balance sheets. The elements of lease expense were as follows (dollar amounts in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended September 30, · · Nine months ended September 30, | ||||||||||||
| · · 2025 · · 2024 · · 2025 · · 2024 | ||||||||||||
| Lease Expense | | | | | | | | | | | | |
| Operating lease expense | | $255 | | $221 | | $756 | | $664 | ||||
| Total Lease Expense | | $255 | | $221 | | $756 | | $664 | ||||
| Other Information - Operating Leases | | | | | | | | | | | | |
| Operating cash flows paid for amounts included in measurement of lease liabilities | | $273 | | $273 | | $819 | | $808 | ||||
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | | | | | | September 30, 2025 | |
| Other Balance Sheet Information - Operating Leases | | | | | | | |
| Weighted average remaining lease term (in years) | | | | | | 0.7 | |
| Weighted average discount rate | | | | | | 9.8% | |
| Maturity Analysis | | | | | | | |
| 2025 | | | | | | 273 | |
| 2026 | | | | | | 546 | |
| Total | | | | | $819 | | |
| Less: Present value discount | | | | | | (26) | |
| Lease Liability | | | | | $793 | |
12. Notes Payable
In January 2025, the Company entered into a finance agreement with FIRST Insurance Funding (“First Insurance”). Pursuant to the terms of the agreement, First Insurance loaned the Company the principal amount of $1.2 million, which accrues interest at 6.9% per annum, to fund a portion of the Company’s insurance policies. Pursuant to the agreement with First Insurance, the Company made an initial payment of $0.3 million and is required to make monthly payments of $0.1 million through November 2025 including principal and interest. The agreement assigns First Insurance a first priority lien and security interest in the financed insurance policies. The outstanding balance at September 30, 2025 was $0.2 million recorded as note payable on the condensed consolidated balance sheets.
13. Vendor Financing Arrangement
The Company and IQVIA, Inc. (“IQVIA”) have entered into a master services agreement (“IQVIA Master Services Agreement”) for the Company’s strategic collaboration with IQVIA to leverage IQVIA’s infrastructure and established commercialization solutions to complement the Company’s launch strategy for AVMAPKI FAKZYNJA CO-PACK in patients with KRAS mutant recurrent LGSOC. 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$10.4 million as of September 30, 2025. The Company expects to pay the amounts recorded as vendor financing arrangement liabilities during 2026. The Company has recorded interest expense of$0.2 million and$0.4 million for the three and nine months ended September 30, 2025, respectively, associated with the extended payment terms.
14. Segment Reporting
The Company hasone operating segment which is the business of researching, developing and commercializing drugs for the treatment of patients with cancer. While the Company group consists of entities incorporated in both the U.S. and Germany, the Company manages all business activities on a consolidated basis for the purposes of assessing
performance, making operating decisions, and allocating Company resources. The Company’s Chief Operating Decision Maker (the “CODM”) is its President and Chief Executive Officer. The measure of segment assets is the same as reported on the condensed consolidated balance sheets as total assets. The CODM assesses performance based on consolidated net loss that is also reported on the statements of operations and comprehensive loss. The CODM uses net loss to monitor budget versus actual results and to determine how to allocate resources and capital in line with the Company’s overall strategy and goals. The accounting policies of the Company's segment are the same as those described inNote 2. Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
The table below is a summary of segment net loss including significant segment expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended September 30, · · Nine months ended September 30, | ||||||||||||
| | | 2025 | 2024 | | 2025 | 2024 | ||||||
| Revenue: | | | | | | | | | | | | |
| Product revenue, net | | $11,242 | | $— | | $13,379 | | $— | ||||
| Sale of COPIKTRA license and related assets(1) | | | — | | | — | | | — | | | 10,000 |
| Expenses: | | | | | | | | | | | | |
| Cost of sales - product | | | 1,670 | | | — | | | 1,988 | | | — |
| Cost of sales - intangible amortization | | | 290 | | | — | | | 418 | | | — |
| Research and development expenses(2) | | | 28,412 | | | 24,177 | | | 80,938 | | | 58,383 |
| Commercial expenses(2) | | | 9,594 | | | 2,170 | | | 22,282 | | | 8,421 |
| Medical affairs expenses(2) | | | 3,047 | | | 1,291 | | | 7,615 | | | 3,833 |
| General and administrative expenses(2) | | | 6,764 | | | 7,440 | | | 21,414 | | | 16,767 |
| Stock-based compensation expense | | | 2,178 | | | 1,935 | | | 7,379 | | | 5,323 |
| Depreciation expense | | | 2 | | | 7 | | | 12 | | | 19 |
| Interest income | | | (1,182) | | (831) | | | (2,964) | | (3,181) | ||
| Interest expense | | 319 | | 1,148 | | 723 | | 3,416 | ||||
| Loss on debt extinguishment | | | — | | | — | | | 1,826 | | | — |
| Change in fair value of preferred stock tranche liability | | | — | | | — | | | — | | | (4,189) |
| Change in fair value of warrant liability | | | 55,881 | | | (13,457) | | | 37,977 | | | (13,457) |
| Change in fair value of Notes | | | 2,748 | | | — | | | 10,153 | | | — |
| Other segment items(3) | | | 37 | | | 87 | | | 173 | | | 751 |
| Net loss | | $(98,518) | | $(23,967) | | $(176,555) | | $(66,086) | ||||
| (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. See Note 18. License, collaboration and commercial agreements for further discussion. |
| (2) | This category is exclusive of non-cash stock-based compensation and severance expense. |
| (3) | Other segment items primarily include severance expense and transactions losses and gains due to foreign currency fluctuations. |
15. Capital stock
April 2025 Private Placement
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. The 2025 Private Placement closed on April 28, 2025.
The exercise price of each April 2025 Pre-Funded Warrant equals$0.0001 per underlying share of common stock. 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. 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. 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; 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%. In 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.
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. Additionally, the April 2025 Pre-Funded Warrants do not provide any guarantee of value or return. Accordingly, the April 2025 Pre-Funded Warrants are classified as a component of permanent equity. The net proceeds of the 2025 Private Placement were approximately $69.9 million, after deducting placement agent fees and other expenses.
Stock Purchase Agreement
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. The Company received net proceeds of$7.4 million after deducting for offering costs which was recorded as component of permanent equity during the nine months ended September 30, 2025. In addition, pursuant to the Stock Purchase Agreement, the Company granted the SPA Investors, for a period ofthree 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
On July 23, 2024, the Company entered into an underwriting agreement with Guggenheim Securities, LLC and Cantor Fitzgerald & Co. (“Cantor”), as representatives of the several underwriters relating to the underwritten offering, issuance and sale by the Company of: (i)13,333,334 shares of the Company’s common stock, and accompanying warrants (the “Warrants”) to purchase up to 13,333,334 shares of common stock; and (ii) to certain investors, pre-funded warrants (the “July 2024 Pre-Funded Warrants”) to purchase up to 5,000,000 shares of common stock and accompanying Warrants to purchase 5,000,000 shares of common stock (collectively, the “July 2024 Offering”). Each share of common stock was sold with an accompanying Warrant at a combined price of $3.00, and each July 2024 Pre-Funded Warrant was sold together with an accompanying Warrant at a combined price of $2.999, which is equal to the combined offering price per share of common stock and accompanying Warrant less the $0.001 exercise price of each July 2024 Pre-Funded Warrant. The July 2024 Offering closed on July 25, 2024. The Company received approximately $50.8 million in net proceeds, after deducting underwriting discounts and commissions and offering expenses.
Each July 2024 Pre-Funded Warrant has an exercise price equal to $0.001 per underlying share of common stock. 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.
Each Warrant has an exercise price equal to$3.50. Each Warrant is exercisable forone share of the Company’s common stock (or, in certain limited circumstances in lieu of a share of common stock, a pre-funded warrant forone share of the Company’s common stock at the warrant exercise price less the exercise price of the pre-funded warrant purchased). The Warrants are exercisable as of July 25, 2024 until their expiration on January 25, 2026. The Warrants are exercisable in cash or, in certain limited circumstances only, by means of a cashless exercise.
The exercise price and the number of shares of common stock issuable upon exercise of each Warrant or July 2024 Pre-Funded Warrant, as applicable, is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Company’s common stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders.
The Company may not effect the exercise of any Warrant or July 2024 Pre-Funded Warrant, and a holder will not be entitled to exercise any portion of any Warrant or July 2024 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 exceed 4.99% (or such higher percentage up to 19.99%, at the election of the holder) of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise, which percentage may be increased or decreased at the holder’s election upon 61 days’ notice to the Company subject to the terms of such Warrants or July 2024 Pre-Funded Warrants, as applicable, provided that such percentage may in no event exceed 19.99%. In the event that the exercise of a Warrant would cause the holder to beneficially own in excess of 4.99% (or such higher percentage up to 19.99%, at the election of the holder) of the total number shares of the Company’s common stock outstanding immediately after giving effect to such exercise, the holder of a Warrant may elect to purchase a pre-funded warrant forone share of the Company’s common Stock, rather than a share of common stock, at the Warrant exercise price less the exercise price of the pre-funded warrant purchased.
In addition, upon the consummation of an acquisition (as described in the Warrants agreements and July 2024 Pre-Funded Warrants agreements, as applicable), each Warrant and July 2024 Pre-Funded Warrant will automatically be converted into the right of the holder of such Warrant or July 2024 Pre-Funded Warrant, as applicable, to receive the kind and amount of securities, cash or other property that such holders would have received had they exercised such Warrant or July 2024 Pre-Funded Warrant, as applicable, immediately prior to such acquisition, without regard to any limitations on exercise contained in the Warrant agreements or July 2024 Pre-Funded Warrant agreements.
The Warrants meet the definition of a derivative pursuant to FASB Accounting Standard Codification (“ASC”) 815, Derivatives and Hedging, and do not meet the derivative scope exception given the Warrants do not qualify under the indexation guidance. As a result, the Warrants were initially recognized as liabilities and measured at fair value using the Black-Scholes valuation model with subsequent changes in fair value recorded in earnings. The Warrants were recorded at a fair value of $39.6 million upon issuance and the Company allocated $39.6 million of the proceeds as warrant liability. In December 2024,250,000 Warrants were exercised for 250,000 shares of common stock. The fair value of the 250,000 Warrants at the exercise date was $0.5 million, which was reclassified from warrant liability to additional paid-in capital during the forth quarter of 2024. In March 2025,1,166,666 Warrants were exercised for 1,166,666 shares of common stock. The fair value of the 1,166,666 Warrants on their exercise dates was $5.9 million, which was reclassified from warrant liability to additional paid-in capital. In May 2025,2,787,499 Warrants were exercised for 2,787,499 shares of common stock. The fair value of the 2,787,499 Warrants on their exercise dates was $12.7 million, which was reclassified from warrant liability to additional paid-in capital during the second quarter of 2025. During the third quarter of 2025,5,166,666 Warrants were exercised for 5,166,666 shares of common stock. The fair value of the 5,166,666 Warrants on their exercise dates was $29.3 million, which was reclassified from warrant liability to additional paid-in capital during the third quarter of 2025. On September 30, 2025, the fair value of the 8,962,503 outstanding Warrants was determined to be $48.3 million and the Company recorded this amount as warrant liability on the condensed consolidated balance sheets. The Company recorded the mark-to-market adjustment of $34.5 million and $50.0 million for the three and nine months ended September 30, 2025, respectively under change in fair value of warrant liability within the condensed consolidated statements of operations and 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. Additionally, the July 2024 Pre-Funded Warrants do not provide any guarantee of value or return. Accordingly, the July 2024 Pre-Funded Warrants are classified as a component of permanent equity. The Company allocated$15.4 million of the proceeds to the July 2024 Pre-Funded Warrants and shares of common stock issued. 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. During the third quarter of 2025, no July 2024 Pre-Funded Warrants were exercised.
June 2023 Public Offering
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%.
Each June 2023 Pre-Funded Warrant had an exercise price equal to $0.001 per share of common stock. The exercise price and the number of shares of common stock issuable upon exercise of each June 2023 Pre-Funded Warrant was subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Company’s common stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders. The June 2023 Pre-Funded Warrants were exercisable as of June 21, 2023, did not expire and were exercisable in cash or by means of a cashless exercise. In addition, upon the consummation of an acquisition (as described in the June 2023 Pre-Funded Warrant agreements), each June 2023 Pre-Funded Warrant would have automatically been converted into the right of the holder of such June 2023 Pre-Funded Warrant to receive the kind and amount of securities, cash or other property that such holders would have received had they exercised such June 2023 Pre-Funded Warrant immediately prior to such acquisition, without regard to any limitations on exercise contained in the June 2023 Pre-Funded Warrants.
The June 2023 Pre-Funded Warrants could not have required cash settlement, were freestanding financial instruments that were legally detachable and separately exercisable from the shares of common stock with which they were issued, were immediately exercisable, and did not embody an obligation for the Company to repurchase its common stock shares and permitted the holders to receive a fixed number of shares of common stock upon exercise. Additionally, the June 2023 Pre-Funded Warrants did not provide any guarantee of value or return. Accordingly, the June 2023 Pre-Funded Warrants were classified as a component of permanent equity. 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.
During the second quarter of 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 September 30, 2025, there wereno June 2023 Pre-Funded Warrants outstanding.
Series B Convertible Preferred Stock
On January 24, 2023, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain purchasers pursuant to which the Company agreed to sell and issue to the purchasers in a private placement (the “Private Placement”) up to 2,144,160 shares of its Series B convertible preferred stock, par value $0.0001 per share (the “Series B Convertible Preferred Stock”), intwo tranches. On January 24, 2023, the Company filed the Certificate of Designation of the Preferences, Rights and Limitations of the Series B Convertible Preferred Stock (the “Series B Convertible Preferred Stock Certificate of Designation”) setting forth the preferences, rights and limitations of the Series B Convertible Preferred Stock with the Secretary of State of the State of Delaware. The Series B Convertible Preferred Stock Certificate of Designation became effective upon filing.
Each share of the Series B Convertible Preferred Stock is convertible into 3.5305 shares of the Company’s common stock, at the option of the holders at any time, subject to certain limitations, including that the holder will be prohibited from converting Series B 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 a conversion blocker, which is initially set at 9.99% (the “Conversion Blocker”) of the total common stock then issued and outstanding immediately following the conversion of such shares of Series B Convertible Preferred Stock. 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.
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”).
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-May 2023 reverse stock split (the “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”). 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. If the Second Tranche Right conditions are satisfied, the Company anticipates receiving gross proceeds from the second 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.
The Series B Convertible Preferred Stock ranks (i) senior to the common stock; (ii) senior to all other classes and series of equity securities of the Company that by their terms do not rank senior to the Series B Convertible Preferred Stock; (iii) senior to all shares of the Company’s Series A Convertible Preferred Stock the equity securities described in (i)-(iii), the “Junior Stock”); (iv) on parity with any class or series of capital stock of the Company hereafter created specifically ranking by its terms on parity with the Series B Convertible Preferred Stock (the “Parity Stock”); (v) junior to any class or series of capital stock of the Company hereafter created specifically ranking by its terms senior to any Series B Convertible Preferred Stock (“Senior Stock”); 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.
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.
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: (a) amend, alter, modify or repeal (whether by merger, consolidation or otherwise) the Series B Convertible Preferred Stock Certificate of Designation, the Company’s certificate of incorporation, or the Company’s bylaws in any manner that adversely affects the rights, preferences, privileges or the restrictions provided for the benefit of, the Series B Convertible Preferred Stock; (b) issue further shares of Series B Convertible Preferred Stock or increase or decrease (other than by conversion) the number of authorized shares of Series B Convertible Preferred Stock; (c) authorize or issue any Senior Stock; or (d) enter into any agreement to do any of the foregoing that is not expressly made conditional on obtaining the affirmative vote or written consent of the majority of then-outstanding Series B Convertible Preferred Stock. Holders of Series B 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. Shares of Series B Convertible Preferred Stock are otherwise not entitled to dividends.
The Company initially classified the first tranche of the Series B Convertible Preferred Stock as temporary equity in the consolidated balance sheets as the Company could have been required to redeem the Series B Convertible Preferred Stock if the Company could not convert the Series B Convertible Preferred Stock into shares of common stock for any reason, including due to any applicable laws or by the rules or regulations of any stock exchange, interdealer quotation system, or other self-regulatory organization with jurisdiction over the Company which is not solely in the control of the Company. If the Company was required to redeem the Series B Convertible Preferred Stock, it would have been based upon the volume-weighted-average price of common stock on an as converted basis on the date the holders provided a conversion notice to the Company. On October 18, 2024, holders of the Series B Convertible Preferred Stock elected to convert 1,200,000 shares of Series B Convertible Preferred Stock for 4,236,568 shares of the Company’s common stock and consequently, the Company issued 4,236,568 shares of its common stock to holders of the Series B Convertible Preferred Stock. 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. As of September 30, 2025, there wereno shares of Series B Convertible Preferred Stock outstanding.
The Company evaluated the Second Tranche Right under Accounting Standard Codification 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. The Company then determined the Second Tranche Right should be liability classified pursuant to ASC 480. As a result, the Company classified the Second Tranche Right as a non-current liability within the condensed consolidated balance sheets and the Second Tranche Right was initially recorded at fair value and is subsequently re-measured at fair value at the end of each reporting period. The fair value of the Second Tranche Right on the date of issuance was determined to be $6.9 million based on a Monte-Carlo valuation and the Company allocated $6.9 million of the Series B Convertible Preferred Stock Proceeds to this liability and recorded this amount as preferred stock tranche liability. On March 31, 2024 and December 31, 2023, the fair value of the Second Tranche Right was determined to be$10.2 million, and$4.2 million, respectively, and the Company recorded the mark to market adjustment of$6.0 million under change in fair value of preferred stock tranche liability within the condensed statements of operations and comprehensive loss for the three months ended March 31, 2024. The Second Tranche Right expired in July 2024 and is no longer outstanding.
The Company determined that all other features of the securities offered pursuant to the Securities Purchase Agreement were clearly and closely associated with the equity host and did not require bifurcation or the fair value of the feature was immaterial to the Company's condensed consolidated financial statements. There has been no change to Company’s original assessment.
Series A Convertible Preferred Stock
On November 4, 2022, the Company entered into an 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”).
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. 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.
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. 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. 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. Shares of Series A Convertible Preferred Stock were otherwise not entitled to dividends.
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.
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. 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.
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. As of September 30, 2025, there wereno shares of Series A Convertible Preferred Stock outstanding.
At-the-market equity offering program
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”). 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”). During the three and nine months ended September 30, 2025, the Company sold 0 shares and 4,000,000 shares, respectively, under the ATM Programs for net proceeds of approximately$0.0 million and
$22.7 million, respectively, after deducting commissions and other offering expenses. There wereno shares sold under the ATM Programs for the nine months ended September 30, 2024.
16. Stock-based compensation
Option Exchange Program
On January 17, 2024, the Company’s stockholders, upon recommendation of the board of directors, approved a one-time stock option exchange program (the “Option Exchange Program”) for certain employees, executive officers and non-employee directors of the Company who held certain underwater options and remained employed or otherwise engaged by the Company through the completion of the Exchange Offer (as defined herein). The Company’s offer to participate in the Option Exchange Program commenced on February 8, 2024, and expired on March 8, 2024 (the “Exchange Offer”). Pursuant to the Exchange Offer,42 eligible holders elected to exchange, and the Company accepted for cancellation, eligible options to purchase an aggregate of 603,330 shares of the Company’s common stock (the “Exchanged Options”). On March 11, 2024, promptly following the expiration of the Exchange Offer, the Company granted new options to purchase 603,330 shares of common stock (the “New Options”), pursuant to the terms of the Exchange Offer and the Amended and Restated 2021 Equity Incentive Plan. The exercise price of the New Options granted was $11.44 per share, which was the closing price of the Company’s common stock on the Nasdaq Capital Market on the grant date of the New Options.
The exchange of stock options was treated as a modification for accounting purposes. As a result of the Option Exchange Program, the Company will recognize incremental stock-based compensation expense of $1.7 million over the requisite service period of the New Options, which istwo orfour years depending on whether the Exchanged Options were vested at the time of exchange. Since the Exchanged Options were not at-the-money on the modification date, the Company was precluded from utilizing the simplified method as described in SEC Staff Accounting Bulletin Topic 14.D.2 to calculate the expected term as a key assumption in the Black-Scholes pricing model. Therefore, the Company utilized the binomial lattice model to calculate the fair value of the Exchanged Options immediately prior to the exchange. The Company utilized the Black-Scholes option-pricing model to calculate the fair value of the New Options on the modification date. The Company will recognize the remaining unamortized stock compensation expense for the Exchanged Options on the modification date over the original requisite service period of the Exchanged Options.
Stock options
A summary of the Company’s stock option activity and related information for the nine months ended September 30, 2025 is as follows:
| | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| · Shares · Weighted-average exercise price per share · Weighted-average remaining contractual term (years) · Aggregate intrinsic value (in thousands) | |||||||||||
| Outstanding at December 31, 2024 | 2,479,037 | | $11.43 | | 8.3 | | $843 | | |||
| Granted | 599,500 | | | 6.07 | | | | | | | |
| Exercised/Released | (6,424) | | | 6.93 | | | | | | | |
| Forfeited/cancelled | (108,812) | | | 6.23 | | | | | | | |
| Expired | | (625) | | | 95.88 | | | | | | |
| Outstanding at September 30, 2025 | 2,962,676 | | $10.52 | 7.9 | | $4,743 | | ||||
| Vested at September 30, 2025 | 1,463,081 | | $13.11 | | 7.2 | | $1,927 | | |||
The fair value of each stock option granted during the nine months ended September 30, 2025 and 2024 was estimated on the grant date using the Black-Scholes option-pricing model using the following weighted-average assumptions:
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Nine months ended September 30, | |||||
| · · 2025 · · 2024 | |||||
| Risk-free interest rate | 3.98% | | 4.14% | ||
| Volatility | 107% | | 98% | ||
| Dividend yield | — | | | — | |
| Expected term (years) | 5.9 | | | 5.8 | |
Restricted stock units
A summary of the Company’s restricted stock unit activity and related information for the nine months ended September 30, 2025 is as follows:
| · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · Shares · Weighted-average grant date fair value per share | ||||||
| Outstanding at December 31, 2024 | | 1,010,233 | | $6.29 | | |
| Granted | | 1,132,374 | | $5.73 | | |
| Vested | | (642,000) | | $5.97 | | |
| Forfeited/cancelled | | | (45,539) | | $7.31 | |
| Outstanding at September 30, 2025 | | 1,455,068 | | $5.96 | | |
Employee stock purchase plan
At the Special Meeting of Stockholders, held on December 18, 2018, the stockholders approved the 2018 Employee Stock Purchase Plan (“2018 ESPP”). On June 21, 2019, the board of directors of the Company amended and restated the 2018 ESPP, to account for certain non-material changes to the plan’s administration and, effective May 30, 2023, in connection with the Reverse Stock Split, the board of directors amended and restated the 2018 ESPP to account for the adjustments to the share reserves (the “Amended and Restated 2018 ESPP”). The Amended and Restated 2018 ESPP provides eligible employees with the opportunity, through regular payroll deductions, to purchase shares of the Company’s common stock at 85% of the lesser of the fair market value of the common stock on (a) the date the option is granted, which is the first day of the purchase period, and (b) the exercise date, which is the last business day of the purchase period. The Amended and Restated 2018 ESPP generally allows fortwo six-month purchase periods per year beginning in January and July, or such other periods as determined by the compensation committee of the Company’s board of directors. The fair value of shares expected to be purchased under the Amended and Restated 2018 ESPP was calculated using the following weighted-average assumptions:
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Nine months ended September 30, | |||||
| · · 2025 · · 2024 | |||||
| Risk-free interest rate | 4.29% | | 5.31% | ||
| Volatility | 87% | | 115% | ||
| Dividend yield | — | | | — | |
| Expected term (years) | 0.5 | | | 0.5 | |
For the nine months ended September 30, 2025 and 2024, the Company recognized less than $0.1 million in each period of stock-based compensation expense under the Amended and Restated 2018 ESPP. During the nine months ended September 30, 2025, the Company issued 16,341 shares of common stock for proceeds of $0.1 million under the Amended and Restated 2018 ESPP.
17. Net loss per share
Basic 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. 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 in July 2024, the exercise of which requires little or no consideration for the delivery of shares of common stock. 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 employee stock purchase plan shares (using the “treasury stock” method), and the 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 anti-dilutive.
The following potentially dilutive securities were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended September 30, · · Nine months ended September 30, · | |||||||||
| · 2025 · 2024 · 2025 · 2024 | |||||||||
| Outstanding stock options | 2,962,676 | 2,376,932 | | 2,962,676 | 2,376,932 | | |||
| Outstanding restricted stock units | | 1,455,068 | | 1,045,358 | | 1,455,068 | | 1,045,358 | |
| Warrants | | 8,962,503 | | 18,333,334 | | 8,962,503 | | 18,333,334 | |
| Employee stock purchase plan | | 9,468 | | 8,088 | | 9,468 | | 8,088 | |
| Series A Convertible Preferred Stock | | — | | 833,333 | | — | | 833,333 | |
| Series B Convertible Preferred Stock | | — | | 4,236,570 | | — | | 4,236,570 | |
| Total potentially dilutive securities | 13,389,715 | 26,833,615 | | 13,389,715 | 26,833,615 | | |||
18. License, collaboration and commercial agreements
Pfizer, Inc.
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. The Company has the right to grant sublicenses under the foregoing licensed rights, subject to certain restrictions.
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. 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. The Company recorded a$15.0 million intangible asset related to these payments on the condensed consolidated balance sheets and will record$0.5 million of interest expense related to the Second Pfizer Milestone. 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. The future milestone payments are contingent in nature and will be recognized if and when the respective contingencies are resolved. Pfizer is also eligible to receive high single to mid-double-digit royalties on future net sales of the products. The Company’s 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.
License Agreement
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”). This agreement coversone of the four patent families that the Company has exclusively licensed and are owned by either Chugai or the third party. Pursuant to the License Agreement, the Company became obligated to pay $2.1 million in the nine months ended September 30, 2025 and is further obligated to pay up to $2.3 million upon achievement of certain milestones. The future milestone payments are contingent in nature and will be recognized if and when the respective contingencies are resolved.
GenFleet Therapeutics (Shanghai), Inc.
On August 24, 2023, the Company entered into 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. In January 2025, the Company exercised its GenFleet Option with respect to VS-7375 and made a $6.0 million payment to GenFleet.
The Company made an upfront payment of $2.0 million to GenFleet in September 2023 and will provide $1.5 million of research support over the first three years of the GenFleet Agreement. In addition, pursuant to the GenFleet Agreement, upon achievement of certain milestones, and upon the Company exercising its GenFleet Options, GenFleet will be entitled to receive payments of up to $622.0 million, inclusive of (i) up to $154.0 million upon achievement of certain development and commercialization milestones, (ii) up to $450.0 million upon achievement of certain sales milestones, and (iii) up to $18.0 million upon exercise of all three GenFleet Options. The Company paid GenFleet a $3.0 million milestone during the three months ended September 30, 2024 upon GenFleet achieving a development milestone. The Company has also agreed to pay GenFleet royalties on net sales of licensed products in the Territory ranging from the mid to high single digits.
The Company may terminate the GenFleet Agreement in its entirety or on a program-by-program basis by providing 90 days written notice to GenFleet. Either party may terminate the GenFleet Agreement in its entirety or on a program-by-program and country-by-country basis, with 60 days’ written notice for the other party’s material breach if such party fails to cure the breach. Either party may also terminate the GenFleet Agreement in its entirety upon certain insolvency events involving the other party.
The Company expensed $6.0 million in January 2025, related to the GenFleet Option payment made within research and development expense in the condensed consolidated statements of operations and comprehensive loss. The other future milestone payments are contingent in nature and will be recognized if and when the respective contingencies are resolved. 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
On August 10, 2020, the Company and Secura signed the Secura APA and on September 30, 2020, the transaction closed.
Pursuant to the Secura APA, the Company sold to Secura its exclusive worldwide license, including related assets, for the research, development, commercialization, and manufacture in oncology indications of products containing duvelisib. 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. 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. 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. 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.
The Company evaluated the Secura APA in accordance ASC 606 as the Company concluded that the counterparty, Secura, is a customer. The Company identified a bundled performance obligation consisting of delivery of the duvelisib global license and intellectual property, certain existing duvelisib inventory, certain duvelisib contracts and clinical trials, certain regulatory approvals, and certain regulatory documentation and books and records (the “Bundled Secura Performance Obligation”).
The Company concluded that the duvelisib global license and intellectual property were not distinct within the context of the contract (i.e. separately identifiable) because the other assets including certain existing duvelisib inventory, certain duvelisib contracts and clinical trials, certain regulatory approval, and certain regulatory documentation and books and records do not have stand-alone value from other duvelisib global license and intellectual property and Secura could not benefit from them without the duvelisib global license and intellectual property. Consistent with the guidance under ASC 606-10-25-16A, the Company disregarded immaterial promised goods and services when determining performance obligations.
The Company has 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.
During the three and nine months ended September 30, 2025, the Company hasnot recognized any revenue associated with the Secura APA. During the three months ended June 30, 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. During the three and nine months ended September 30, 2024, the Company recognized$0.0 million and$10.0 million, respectively, of sale of COPIKTRA license and related assets revenue within the statements of operations and comprehensive loss. 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 September 30, 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: 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. All future potential milestone payments were fully constrained as the risk of significant revenue reversal related to these amounts has not yet been resolved.
19. Income taxes
The Company didnot record a federal or state income tax provision or benefit for the nine months ended September 30, 2025 or 2024, due to the expected loss before income taxes to be incurred for the years ended December 31, 2025 and 2024, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets.
On July 4, 2025, the One Big Beautiful Bill Act was signed into law in the U.S. It contains a broad range of tax reform provisions affecting businesses, including extending and modifying many provisions of the Tax Cuts and Jobs Act. Certain provisions will take effect beginning in 2026, while others apply retroactively to January 1, 2025. The Company is evaluating the full effects of the legislation on its estimated annual effective tax rate and cash tax position but expects that the legislation will likely not have a material impact on its financial statements**.**
20. Commitments and contingencies
The Company entered into a lease agreement for approximately 27,810 square feet of office space in Needham, Massachusetts. Please refer toNote 11. Leasesfor further details regarding the minimum aggregate future lease commitments as of September 30, 2025. In conjunction with the execution of the February 2018 Amended Lease Agreement and November 2024 Amended Lease Agreement, the Company has provided a security deposit in the form of a letter of credit in the amount of $0.2 million as of September 30, 2025. The amount is included in prepaid expenses and other current assets on the consolidated balance sheets as of September 30, 2025.
As of September 30, 2025, the Company has committed to spend approximately $55.6 million under the IQVIA Master Services Agreement which the Company expects to spend in the next three to four years. As of September 30, 2025, approximately $14.0 million of this commitment is included within vendor financing arrangements, accrued expenses, and accounts payable on the condensed balance sheet. Pursuant to the terms of various other agreements, the Company may be required to pay various development, regulatory and commercial milestones. In addition, the Company may be required to pay significant royalties on future sales. The payment of these amounts, however, is contingent upon the occurrence of various future events, which have a high degree of uncertainty of occurring.
21. Subsequent events
The Company reviews all activity subsequent to the end of the quarter but prior to issuance of the condensed consolidated financial statements for events that could require disclosure or that could impact the carrying value of assets or liabilities as of the balance sheet date. The Company is not aware of any material subsequent events.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.