Verastem, Inc.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
View on SEC.govAbout this filing
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.
Jun 30, 2026 · Filed Aug 6, 2026
VSTM$8.41-10.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001104659-26-057114
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001104659-26-092007
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 70 previous paragraphs and 106 current paragraphs.
38 unchanged; 26 reworded; 32 added; 4 removed; 2 previous and 10 current paragraphs rearranged.
Tables are not compared: 19 previous and 27 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (32)
Current report
safety profile with no new safety signals. Nine patients remain on treatment, and follow-up continues as survival data matures.
Current report
Expected key milestones:
Current report
Sale of COPIKTRA license and related assets
Current report
Sale of COPIKTRA license and related assets revenue for the 2026 Quarter was $15.0 million compared to $0.0 million for the 2025 Quarter. Sale of COPIKTRA license and related assets revenue for the 2026 Quarter consisted of one sales milestone of $15.0 million due to Secura achieving cumulative worldwide net sales of COPIKTRA exceeding $200.0 million since the closing of the Secura APA during the 2026 Quarter. The $15.0 million milestone payment was received by us in July 2026.
Current report
Cost of sales – product.
Current report
Cost of sales – intangible amortization.
Current report
Research and development expense for the 2026 Quarter was $41.3 million, compared to $24.8 million for the 2025 Quarter. The $16.6 million increase was primarily driven by a $7.4 million increase in investigator fees, a $5.5 million increase in contract research organization (“CRO”) costs, a $2.1 million increase in drug substance and drug product manufacturing costs, and a $1.6 million increase in personnel costs, including non-cash stock-based compensation.
Current report
site costs, and any other third-party expenses directly attributable to the development of the product candidates;
Current report
The $14.4 million increase in VS-7375 clinical trial expenses was primarily attributable to higher CRO costs and investigator fees resulting from increased enrollment in the TARGET-D 101 trial, as well as study start-up and initiation activities for three Phase 2 TARGET-D trials. The $1.2 million increase in personnel costs, excluding stock-based compensation, was primarily attributable to increased headcount. The $1.1 million increase in VS-7375 manufacturing and non-clinical trial specific costs, was primarily attributable to increases in drug manufacturing and drug supply costs in support of the growing TARGET-D program.
Current report
Selling, general and administrative expense for the 2026 Quarter was $27.4 million compared to $20.7 million for the 2025 Quarter. The $6.7 million increase was primarily driven by a $4.3 million increase in commercial operations expenses, a $2.6 million increase in personnel costs, including non-cash based stock-based compensation expense, a $1.2 million increase in other general and administrative expenses. These increases were partially offset by a $1.4 million decrease in consulting and professional fees.
Current report
There was no change in fair value of the warrant liability for the 2026 Quarter compared to $20.3 million income for the 2025 Quarter. There was no change in the fair value of the warrant liability for the 2026 Quarter as all the outstanding Warrants were either exercised or expired as of January 25, 2026. The $20.3 million income for the 2025 Quarter consisted of the mark-to-market adjustment for the liability classified Warrants issued as part of the July 2024 Offering. The liability classified warrants decreased in value from December 31, 2024 as a result of the exercise of 2,787,499 Warrants during the quarter and a decrease in warrant valuation due to a lower stock price.
Current report
Income tax expense.
Current report
Income tax expense for the 2026 Quarter was $0.8 million compared to no income tax expense in the 2025 Quarter. The income tax expense within the 2026 Quarter was primarily a result of interest being owed under IRC section 453A related to the $15.0 million milestone payment from Secura because it was an installment sale.
Current report
Comparison of the six months ended June 30, 2026 and 2025
Current report
Product Revenue, Net.
Current report
Sale of COPIKTRA license and related assets
Current report
Sale of COPIKTRA license and related assets revenue for the 2026 Period was $15.0 million compared to $0.0 million for 2025 Period. Sale of COPIKTRA license and related assets revenue for the 2026 Period consisted of one sales milestone of $15.0 million due to Secura achieving cumulative worldwide net sales of COPIKTRA exceeding $200.0 million since the closing of the Secura APA during the 2026 Period. The $15.0 million milestone payment was received by us in July 2026.
Current report
Cost of sales – product.
Current report
Cost of sales – intangible amortization.
Current report
Research and development expense.
Current report
Selling, general and administrative expense* *
Current report
Other expense
Current report
Other expense for the 2026 Period and 2025 Period was $0.1 million in both periods. Other expense for the 2026 Period and 2025 Period consisted of transaction losses due to changes in foreign currency exchange rates.
Current report
Interest income
Current report
Interest income for the 2026 Period was $2.4 million, compared to $1.8 million for the 2025 Period. The $0.6 million increase was primarily driven by higher balances of cash equivalents and investments during the 2026 Period compared to the 2025 Period.
Current report
Interest expense
Current report
Loss on debt extinguishment.
Current report
There was no loss on debt extinguishment in the 2026 Period. The loss on debt extinguishment for the 2025 Period of $1.8 million represents the loss recognized on early extinguishment of our Loan Agreement. On January 13, 2025, we repaid in full all principal, accrued and unpaid interest, fees, and expenses under the Loan Agreement in an aggregate amount of $42.7 million (the “Payoff Amount”). The Payoff Amount, excluding accrued interest, exceeded the carrying amount of the Term Loans on January 13, 2025 by $1.8 million which was recorded as a loss on debt extinguishment.
Current report
Income tax expense.
Current report
Income tax expense for the 2026 Period was $0.8 million compared to no income tax expense in the 2025 Period. The income tax expense within the 2026 Period was primarily a result of interest being owed under IRC section 453A related to the $15.0 million milestone payment from Secura because it was an installment sale.
Current report
increase of $0.8 million in prepaid expenses, other current assets and other assets. The increases in both periods in prepaid expenses, other current assets, and other assets is exclusive of cash received from PanCAN and used on the RAMP 205 study. Cash used in operating activities was $96.0 million and $71.3 million for the 2026 Period and the 2025 Period, respectively.
Current report
The cash provided by investing activities was $0.2 million for the 2026 Period, compared with no investing activities for the 2025 Period. Investing activities during the 2026 Period consisted of $16.3 million of maturities of investments, partially offset by $16.0 million of purchases of investments.
Removed paragraphs (4)
Previous report
7375 was generally well-tolerated across all monotherapy dose levels evaluated to date. Patients (n=23) receiving VS-7375 at either 400 mg QD, 600 mg QD or 900 mg QD with a mean duration of therapy of 1.6 months (0.7-5.6), reported no drug related liver function test abnormalities. As of the January 30, 2026 data cutoff, there was no drug-related neutropenia greater than Grade 2 and rates of nausea, vomiting and diarrhea remained lower than those reported by our partner in China. We also reported that the FDA requested the Company develop separate Phase 2 trial protocols for their trials in PDAC, NSCLC and CRC, where we are seeking marketing authorization.
Previous report
Costs of sales – product.
Previous report
Costs of sales – intangible amortization.
Previous report
The cash used in investing activities for the 2026 Quarter relates to the purchase of investments of $16.0 million. There were no cash inflows or outflows related to investing activities during the 2025 Quarter.
Reworded paragraphs (26)
Previous wording
We are a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with challenging RAS/MAPK pathway-driven cancers. We market AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) in the United States (“U.S.”), the first treatment specifically FDA-approved for adults with KRAS-mutated recurrent LGSOC who have received prior systemic therapy.
Current wording
We are a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with challenging RAS/MAPK pathway-driven cancers. We market AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) in the United States (“U.S.”), the first treatment specifically FDA-approved for adults with KRAS-mutated LGSOC who have received prior systemic therapy.
Previous wording
Our pipeline includes clinical-stage programs, preclinical research programs and externally partnered early-stage programs. Our focus is on novel small molecule drugs developed both as monotherapy and in combination, which inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including targeting RAS directly with KRAS G12D inhibition, targeting the pathway downstream with RAF/MEK inhibition, and targeting the parallel pathway that drives resistance with FAK inhibition. Our focus is to expeditiously develop and deliver transformative therapies that truly change outcomes for people living with RAS/MAPK pathway-driven cancers.
Current wording
Our pipeline includes clinical-stage programs, preclinical research programs and externally partnered research programs. Our focus is on novel small molecule drugs developed both as monotherapy and in combination, which inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including targeting RAS directly with KRAS G12D inhibition, targeting the pathway downstream with RAF/MEK inhibition, and targeting the parallel pathway that drives resistance with FAK inhibition. Our goal is to expeditiously develop and deliver transformative therapies that truly change outcomes for people living with RAS/MAPK pathway-driven cancers.
Previous wording
The combination is being evaluated in an ongoing international Phase 3 trial, RAMP 301, in recurrent LGSOC with or without a KRAS mutation. The trial was fully enrolled, as of December 2025, and will serve as a confirmatory study for the initial indication and has the potential to expand the indication regardless of KRAS mutation status. The results will also be leveraged for potential geographic expansion.
Current wording
The combination is being evaluated in an ongoing international Phase 3 trial, RAMP 301, in recurrent LGSOC with or without a KRAS mutation. The trial was fully enrolled, as of December 2025, and serves as a confirmatory study for the initial indication and has the potential to expand the indication regardless of KRAS mutation status. The results will also be leveraged for potential geographic expansion. We expect to report a topline readout of the primary endpoint in the RAMMP 301 trial in middle of 2027.
Previous wording
VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 has a differentiated profile compared to other RAS inhibitors. Based on preclinical data, VS-7375 offers dual, potent inhibition of both ON and OFF states of KRAS G12D. We believe this correlates with better in vivo efficacy and durability versus ON-only RAS inhibitors. VS-7375 has demonstrated a high affinity for KRAS G12D with long residence time (18-24 hours) in preclinical models. We believe this correlates with a more rapid and durable suppression of pERK signaling (which controls growth and cell survival) when compared to other ON-only KRAS G12D inhibitors in tumor cell lines. The selective inhibition of VS-7375 to KRAS G12D has shown, in preclinical models, to spare T cell proliferation to maintain a normal healthy immune response, versus a RAS-multi-inhibitor which impairs T cell proliferation at increasing concentrations of drug. The once daily oral dosing of VS-7375 achieves exposures corresponding to maximal tumor regressions across preclinical models for pancreatic, lung and colorectal cancers. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for (VS-7375-101) was cleared, and initiated a Phase 1/2 clinical trial in June 2025 in patients with advanced KRAS G12D mutant solid tumors, including pancreatic ductal adenocarcinoma (“PDAC”), non-small cell lung cancer (“NSCLC”) and colorectal cancer (“CRC”).
Current wording
VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 has a differentiated profile compared to other RAS inhibitors. Based on preclinical data, VS-7375 offers dual, potent inhibition of both ON and OFF states of KRAS G12D. We believe this correlates with better in vivo efficacy and durability versus ON-only RAS inhibitors. VS-7375 has demonstrated a high affinity for KRAS G12D with long residence time (18-24 hours) in preclinical models. We believe this correlates with a more rapid and durable suppression of pERK signaling (which controls growth and cell survival) when compared to other ON-only KRAS G12D inhibitors in tumor cell lines. The selective inhibition of VS-7375 to KRAS G12D has shown, in preclinical models, to spare T cell proliferation to maintain a normal healthy immune response, versus a RAS-multi-inhibitor, which impairs T cell proliferation at increasing concentrations of drug. The once daily (“QD”) oral dosing of VS-7375 achieves exposures corresponding to maximal tumor regressions across preclinical models for pancreatic, lung and colorectal cancers. Verastem announced in April 2025 that the U.S. Investigational New Drug (“IND”) application for (VS-7375-101) was cleared and initiated a Phase 1/2 clinical trial in June 2025 in patients with advanced KRAS G12D mutant solid tumors, including PDAC, non-small cell lung cancer (“NSCLC”) and colorectal cancer (“CRC”).
Previous wording
In the Phase 1/2 study the Company cleared multiple monotherapy dose levels with no dose-limiting toxicities (DLTs) and no major toxicities and continues to dose-escalate. The Company also cleared multiple dose levels in combination with cetuximab with no DLTs and higher doses are being evaluated. The Company continues to enroll patients across various cohorts in the Phase 1/2 study. Following recent feedback from the FDA, the Company is amending its Phase 1/2 trial protocol to separate out disease-specific Phase 2 registration-directed trials for KRAS G12D mutated 2L PDAC, 2L/3L NSCLC and 2L+ CRC.
Current wording
In April 2026 we branded the trials as the VS-7375 TARGET-D Clinical Trial Program. TARGET-D 101 (VS-7375-101) is a Phase 1/2 dose escalation, dose expansion and combination-evaluation trial. In the TARGET-D 101 Phase 1/2 study, the Company cleared multiple monotherapy dose levels, including the 1200 mg QD dose with no dose-limiting toxicities (“DLTs”) and no major toxicities. Patients continue to be evaluated at the 1200 mg QD dose level. The Company also cleared multiple dose levels in combination with cetuximab with no DLTs. The Company completed targeted enrollment in patients with pancreatic and lung cancer monotherapy cohorts and the colorectal cancer combination cohort with cetuximab in the Phase 1/2 study. Following feedback from the FDA, the Company amended its Phase 1/2 trial protocol to separate out disease-specific Phase 2 registration-directed trials for KRAS G12D mutated second line (“2L”) PDAC, 2L/ third line (“3L”) NSCLC and 2L or later CRC.
Previous wording
We shared multiple updates from GenFleet Therapeutics, our partner developing VS-7375, known as GFH375, in China.
Current wording
We shared updates from GenFleet Therapeutics, our partner developing VS-7375, known as GFH375, in China.
Previous wording
As of March 31, 2026, we had an accumulated deficit of $1,201.6 million. Our net loss was $36.6 million and $52.1 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had cash, cash equivalents, and investments of $181.7 million. In accordance with applicable accounting standards, we are required to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within twelve months after the date of the issuance of these condensed consolidated financial statements.
Current wording
As of June 30, 2026, we had an accumulated deficit of $1,236.3 million. Our net loss was $34.7 million, $71.3 million, $25.9 million, $78.0 million for the three and six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had cash, cash equivalents, and investments of $136.4 million. In accordance with applicable accounting standards, we are required to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within twelve months after the date of the issuance of these condensed consolidated financial statements.
Previous wording
In our Annual Report on Form 10-K for the year ended December 31, 2025, filed on March 4, 2026, we disclosed that our existing cash resources, including proceeds from exercise of warrants in January 2026, along with revenue we expected to generate from sales of AVMAPKI FAKZYNJA CO-PACK, was expected to be sufficient to fund our planned operations through twelve months from the date of issuance of those consolidated financial statements. As of March 4, 2026, our liquidity analysis excluded projected expenses for the Phase 2 studies entitled TARGET-D 201, TARGET-D 202, and TARGET-D 203, as we had not yet formally committed to the spend for those studies. Subsequent to the filing of our Annual Report on Form 10-K for the year ended December 31, 2025, we initiated TARGET-D-201, TARGET-D 202, and TARGET-D 203, resulting in a significant increase in projected research and development expenses. Consequently, the significant increase in costs we now expect to incur raises substantial doubt about our ability to continue as a going concern within the twelve months after the date of the issuance of these consolidated financial statements.
Current wording
In our Annual Report on Form 10-K for the year ended December 31, 2025, filed on March 4, 2026, we disclosed that our existing cash resources, including proceeds from exercise of warrants in January 2026, along with revenue we expected to generate from sales of AVMAPKI FAKZYNJA CO-PACK, was expected to be sufficient to fund our planned operations through twelve months from the date of issuance of those consolidated financial statements. Subsequent to the filing of our Annual Report on Form 10-K for the year ended December 31, 2025, we initiated TARGET-D 201, TARGET-D 202, and TARGET-D 203, resulting in a significant increase in projected research and development expenses. Consequently, the significant increase in costs we now expect to incur raises substantial doubt about our ability to continue as a going concern within the twelve months after the date of the issuance of these condensed consolidated financial statements.
Previous wording
We expect to finance our operations with our existing cash, cash equivalents and investments, through potential future milestones and royalties received pursuant to the Secura APA, through the Note Purchase Agreement, through future product revenues or through other strategic financing opportunities that could include, but are not limited to collaboration agreements, offerings of our 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 we fail to obtain additional capital or generate sufficient revenue from our commercialization activities in the future, we may be unable to complete our 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 our ability to continue as a going concern.
Current wording
these potential strategic or financing opportunities, they are not deemed probable for purposes of the going concern assessment. If we fail to obtain additional capital or generate sufficient revenue from our commercialization activities in the future, we may be unable to complete our 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 our ability to continue as a going concern.
Previous wording
preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of certain assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements, and the amounts of revenues and expenses during the reported periods.
Current wording
Our discussion and analysis of our financial condition and results of operations is based upon our condensed consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of certain assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements, and the amounts of revenues and expenses during the reported periods.
Previous wording
We began commercial sales of AVMAPKI FAKZYNJA CO-PACK within the United States in May 2025, following receipt of FDA marketing approval on May 8, 2025. For the three months ended March 31, 2026 (the “2026 Quarter”) we recorded approximately $18.7 million of net product revenue. We did not recognize any product revenue during the three months ended March 31, 2025 (the “2025 Quarter”).
Current wording
We began commercial sales of AVMAPKI FAKZYNJA CO-PACK within the United States in May 2025, following receipt of FDA marketing approval on May 8, 2025. For the three months ended June 30, 2026 (the “2026 Quarter”) we recorded approximately $25.1 million of net product revenue. For the three months ended June 30, 2025 (the “2025 Quarter”) we recorded approximately $2.1 million of net product revenue.
Previous wording
Costs of sales – product for the 2026 Quarter of approximately $2.8 million consisted of costs associated with the manufacturing of AVMAPKI FAKZYNJA CO-PACK, royalties owed on such sales, and certain period costs including inventory write downs. 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 AVMAPKI FAKZYNJA CO-PACK were recorded as research and development
Current wording
Cost of sales – product for the 2026 Quarter was $3.8 million compared to $0.3 million for the 2025 Quarter. Cost of sales – product for the 2026 Quarter and 2025 Quarter consisted of costs associated with the manufacturing of AVMAPKI FAKZYNJA CO-PACK, royalties owed on such sales, and certain period costs including inventory write downs. 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 AVMAPKI FAKZYNJA CO-PACK were recorded as research and development expense. Certain costs of AVMAPKI FAKZYNJA CO-PACK units recognized as revenue during the 2026 Quarter and 2025 Quarter, or approximately $0.2 million and less than $0.1 million, respectively, were expensed prior to obtaining regulatory approval, therefore, are not included in cost of sales*–* product during this period. We expect cost of sales - product to increase in relation to product revenues as we deplete these inventories.
Previous wording
Cost of sales – intangible amortization for the 2026 Quarter of approximately $0.3 million was related to finite-lived intangible assets related to AVMAPKI FAKZYNJA CO-PACK which we recognized and began amortizing during the second quarter of 2025. We did not recognize any cost of sales – intangible amortization for the 2025 Quarter.
Current wording
Cost of sales – intangible amortization for the 2026 Quarter and 2025 Quarter of approximately $0.3 million and $0.1 million, respectively, was related to finite-lived intangible assets related to AVMAPKI FAKZYNJA CO-PACK which we recognized and began amortizing during the second quarter of 2025.
Previous wording
Other expense for the 2026 Quarter was less than $0.1 million compared to $0.1 million for the 2025 Quarter. Other expense for the 2026 Quarter and 2025 Quarter was comprised of transaction losses due to changes in foreign currency exchange rates.
Current wording
Other expense for the 2026 Quarter and 2025 Quarter was $0.1 million. Other expense for the 2026 Quarter and 2025 Quarter consisted of transaction losses due to changes in foreign currency exchange rates.
Previous wording
Interest income for the 2026 Quarter was $1.3 million, compared to $1.0 million for the 2025 Quarter. The $0.3 million increase was primarily driven by higher balances of cash equivalents during the 2026 Quarter compared to the 2025 Quarter.
Current wording
Interest income for the 2026 Quarter was $1.1 million, compared to $0.8 million for the 2025 Quarter. The $0.3 million increase was primarily driven by higher balances of cash equivalents during the 2026 Quarter compared to the 2025 Quarter.
Previous wording
Interest expense for the 2026 Quarter was $0.4 million compared to $0.2 million for the 2025 Quarter. The $0.2 million increase from the 2025 Quarter was primarily driven by interest expense incurred as part of the vendor financing arrangement resulting in an increase of interest expense recorded in the 2026 Quarter.
Current wording
Interest expense for the 2026 Quarter was $0.4 million compared to $0.2 million for the 2025 Quarter. The $0.2 million increase from the 2025 Quarter to the 2026 Quarter was primarily driven by interest expense incurred as part of the vendor financing arrangement.
Previous wording
The change in fair value of Notes was $1.9 million for the 2026 Quarter compared to $4.4 million during the 2025 Quarter. We elected the fair value option for the Notes and therefore changes in fair value, including interest, other than changes that are directly attributable to instrument specific credit risk are recorded as change in fair value of Notes in the condensed statements of operations and comprehensive loss. The decrease in change in fair value in the 2026 Quarter is a result of the 2025 Quarter change in fair value being higher due to the revaluation of the note from its notional value to its fair value following issuance of the Notes in January 2025.
Current wording
The change in fair value of Notes was $1.8 million for the 2026 Quarter compared to $3.0 million for the 2025 Quarter. We elected the fair value option for the Notes and therefore changes in fair value, including interest, other than changes that are directly attributable to instrument specific credit risk are recorded as change in fair value of Notes in the condensed statements of operations and comprehensive loss. The change in fair value of Notes for the 2026 Quarter of $1.8 million was primarily driven by interest on the Notes. The change in fair value of Notes for the 2025 Quarter of $3.0 million was primarily driven by interest on the Notes and a reduction in risk free rate during the 2025 Quarter resulting in higher valuation of the Notes.
Previous wording
Research and development expense for the 2026 Quarter was $38.2 million, compared to $29.2 million for the 2025 Quarter. The $9.1 million increase was primarily driven by a $4.7 million increase in investigator fees, a $3.7 million increase in drug substance and drug product manufacturing costs, a $3.1 million increase in clinical supply costs, a $2.7 million increase in contract research organization (“CRO”) costs, and a $1.9 million increase in personnel costs, including stock-based compensation. These increases were partially offset by a $6.0 million decrease in license fees, reflecting an Option exercise fee payment made during the 2025 Quarter pursuant to the GenFleet Agreement, and a $1.0 million decrease in consulting expenses.
Current wording
Research and development expense for the 2026 Period was $79.6 million, compared to $53.9 million for the 2025 Period. The $25.6 million increase was primarily driven by a $12.1 million increase in investigator fees, an $8.2 million increase in CRO costs, a $5.8 million increase in drug substance and drug product manufacturing costs, a $3.4 million increase in personnel costs, including non-cash based stock-based compensation, a $3.0 million increase in clinical supply costs and a $0.4 million increase in investigator sponsored trial expenses. These increases were partially offset by a $6.0 million decrease in license fees, reflecting an Option exercise fee payment made during the 2025 Period pursuant to the GenFleet Agreement, and a $1.3 million decrease in consulting expenses.
Previous wording
The $1.0 million increase in avutometinib+ defactinib – LGSOC was primarily driven by an increase in RAMP 301 trial costs as the study continues to advance and enroll more patients. The $0.9 million decrease in avutometinib and defactinib manufacturing and non-clinical trial specific expenses was primarily driven by decreases in drug substance costs, drug product costs and consulting costs. The $7.2 million increase in GenFleet and VS-7375 related expenses was primarily driven by increased drug substance, drug product, CRO and trial specific investigator costs for the 7375-101 study, partially offset by the $6.0 million Option exercise fee incurred to license VS-7375 in the 2025 Quarter pursuant to the GenFleet Agreement. The $1.7 million increase in personnel costs is driven by increased headcount.
Current wording
The $23.0 million increase in VS-7375 clinical trial expenses was primarily attributable to higher CRO costs and investigator fees resulting from increased enrollment in the TARGET-D 101 trial, as well as study start-up and initiation activities for three Phase 2 TARGET-D studies. The $0.3 million decrease in VS-7375 manufacturing and non-clinical trial specific costs was driven by $6.0 million Option exercise fee incurred to license VS-7375 in the 2025 Period pursuant to the GenFleet Agreement, partially offset by increased VS-7375 drug substance and drug product costs in the 2026 Period. The $2.9 million increase in personnel costs, excluding stock-based compensation, was primarily attributable to increased headcount.
Previous wording
Selling, general and administrative expense for the 2026 Quarter was $22.3 million compared to $15.0 million for the 2025 Quarter. The $7.3 million increase was primarily driven by a $4.7 million increase in personnel costs, including non cash based stock-based compensation expense, a $2.2 million increase in commercial operations expenses, a $0.9 million increase in travel and conferences and other general and administrative expenses, and a $0.3 million increase in consulting and professional fees. These increases were partially offset by a $0.8 million decrease in financing fees related to the Note Purchase Agreement incurred in the 2025 Quarter.
Current wording
Selling, general and administrative expense for the 2026 Period was $49.7 million compared to $35.7 million for the 2025 Period. The $14.0 million increase was primarily driven by a $7.4 million increase in personnel costs, including non-cash based stock-based compensation expense, a $6.5 million increase in commercial operations expenses, a $2.0 million increase in other general and administrative expenses. These increases were partially offset by a $1.1 million decrease in consulting and professional fees and a $0.8 million decrease in financing fees related to the Note Purchase Agreement incurred in the 2025 Period.
Previous wording
The change in fair value of the warrant liability was $9.3 million income for the 2026 Quarter compared to $2.4 million expense for the 2025 Quarter. The $9.3 million income for the 2026 Quarter and $2.4 million expense for the 2025 Quarter was comprised of the mark-to-market adjustment for the liability classified Warrants issued as part of the July 2024 Offering. The liability classified warrants decreased in value from December 31, 2025 to when 8,391,666 Warrants were exercised in January 2025 primarily driven by a reduction our stock price and the expiration of 37,500 Warrants, resulting in $9.3 million income during the 2026 Quarter. The liability classified warrants increased in value from December 31, 2024 to when 1,166,666 Warrants were exercised in March 2025 and March 31, 2025 primarily driven by an increase in our stock price, resulting in a $2.4 million expense during the 2025 Quarter.
Current wording
The change in fair value of the warrant liability was $9.3 million income for the 2026 Period compared to $17.9 million income for the 2025 Period. The $9.3 million income for the 2026 Period and $17.9 million income for the 2025 Period consisted of the mark-to-market adjustment for the liability classified Warrants issued as part of the July 2024 Offering. The liability classified warrants decreased in value from December 31, 2025 to when 8,391,666 Warrants were exercised in January 2026 primarily driven by a reduction in our stock price and the expiration of 37,500 Warrants, resulting in $9.3 million income during the 2026 Period. The $17.9 million income for the 2025 Period consisted of the mark-to-market adjustment for the warrants issued as part of the July 2024 Offering which decreased primarily due to the decrease in our stock price from December 31, 2024 to when warrants were exercised during the 2025 Period and at the end of the 2025 Period.
Previous wording
As of March 31, 2026, we had $181.7 million in cash, cash equivalents, and investments. We primarily invest our cash, cash equivalents and investments in U.S. Government money market funds, government bonds, corporate bonds and commercial paper of publicly traded companies.
Current wording
As of June 30, 2026, we had $136.4 million in cash, cash equivalents, and investments. We primarily invest our cash, cash equivalents and investments in U.S. Government money market funds, government bonds, corporate bonds and commercial paper of publicly traded companies.
Previous wording
The following table sets forth the primary sources and uses of cash for the 2026 Quarter and the 2025 Quarter (in thousands):
Current wording
The following table sets forth the primary sources and uses of cash for the 2026 Period and the 2025 Period (in thousands):
Previous wording
The use of cash in both periods resulted primarily from our net losses adjusted for non-cash charges and changes in the components of working capital. Our cash outflow from net losses adjusted for non-cash charges and adjustments was $43.5 million and $42.9 million for the 2026 Quarter and the 2025 Quarter, respectively. Non-cash charges and adjustments for the 2026 Quarter were primarily related to the change in fair value of warrant liability and stock-based compensation expense. Non-cash charges and adjustments for the 2025 Quarter were primarily related to non-cash changes in fair value of the Notes, the change in fair value of warrant liability, loss on debt extinguishment and stock-based compensation expense.
Current wording
The use of cash in both periods resulted primarily from our net losses adjusted for non-cash charges and changes in the components of working capital. Our cash outflow from net losses adjusted for non-cash charges and adjustments was $74.6 million for the 2026 Period and $84.2 million for the 2025 Period. Non-cash charges and adjustments for the 2026 Period were primarily related to the change in fair value of common stock warrant liability and stock-based compensation expense. Non-cash charges and adjustments for the 2025 Period were primarily related to the change in fair value of warrant liability, non-cash changes in fair value of the Notes, loss on debt extinguishment and stock-based compensation expense.
Previous wording
Our cash outflow from operating activities due to changes in operating assets and liabilities was $8.6 million for the 2026 Quarter, primarily driven by a $3.1 million decrease in accrued expenses and other liabilities, $2.8 million decrease in accounts payable, a $1.3 million increase in accounts receivable, a $0.9 million increase in prepaid expenses, other current assets and other assets, and $0.5 million increase in inventory. Our cash inflow from operating activities due to changes in operating assets and liabilities was $4.3 million for the 2025 Quarter. Cash inflow due to changes in operating assets and liabilities for the 2025 Quarter was primarily driven by an increase of $3.2 million in accounts payable and an increase of $2.7 million in accrued expense and other liabilities, partially offset by an increase of $1.6 million in prepaid expenses, other current assets and other assets. Cash used in operating activities was $52.1 million and $38.7 million for the 2026 Quarter and the 2025 Quarter, respectively.
Current wording
Our cash outflow from operating activities due to changes in operating assets and liabilities was $21.4 million for the 2026 Period. Our cash inflow from operating activities due to changes in operating assets and liabilities was $12.9 million for the 2025 Period. Cash outflow due to changes in operating assets and liabilities for the 2026 Period was primarily driven by an increase of $20.1 million in accounts receivable, an increase of $6.5 million in prepaid expenses, other current assets and other assets, and an increase of $0.6 million in inventory, partially offset by an increase of $5.7 million in accounts payable, accrued expenses and other liabilities. Cash inflow due to changes in operating assets and liabilities for the 2025 Period was primarily driven by an increase of $6.6 million in accrued expenses and other liabilities, an increase of $6.3 million in accrued expenses, long-term, and an increase of $4.0 million in accounts payable, offset by an increase of $2.1 million in accounts receivable, an increase of $1.2 million in inventory, and an
Previous wording
The cash provided by financing activities for the 2026 Period represents $29.4 million of proceeds from the exercise of Warrants, $0.7 million of proceeds received from insurance premium financing, and less than $0.1 million of proceeds received from exercise of stock options and employee stock purchase program, partially offset by the $1.3 million repayment of our vendor financing arrangement, and $0.2 million of payments for insurance premium financing. The cash provided by financing activities for the 2025 Quarter represents $75.0 million of proceeds received pursuant to the Note Purchase Agreement, $22.7 million of proceeds received under the August 2021 ATM, $7.4 million of proceeds received pursuant to the Stock Purchase Agreement, $4.1 million of proceeds from the exercise of Warrants, $1.2 million of proceeds received from insurance premium financing, and less than $0.1 million of proceeds received related to our employee stock purchase plan, partially offset by the $42.6 million repayment of our Loan Agreement, and $0.4 million of payments for insurance premium financing. Refer toNote 10. Debt to our unaudited condensed consolidated financial statements included in this quarterly report for additional details on the Note Purchase Agreement and Loan Agreement;Note 15. Capital Stock to our unaudited condensed consolidated financial statements included in this quarterly report for additional details on the 2025 Private Placement, the Note Purchase Agreement, and the Warrants;Note 12. Notes Payable to our unaudited condensed consolidated financial statements included in this quarterly report for additional details on the finance agreement with First Insurance related to insurance premium financing and the monthly payments of principal and interest related thereto;Note 13. Vendor Financing Arrangement to our unaudited condensed consolidated financial statements included in this quarterly report for additional details on the vendor finance agreement with IQVIA related to the master service agreement.
Current wording
The cash provided by financing activities for the 2026 Period represents $29.4 million of proceeds from the exercise of Warrants, $0.7 million of proceeds received from insurance premium financing, and $0.1 million of proceeds received from the exercise of stock options and our employee stock purchase plan, partially offset by $2.5 million of repayments under the vendor financing arrangement and $0.5 million of payments for insurance premium financing. The cash provided by financing activities for the 2025 Period represents $100.1 million of net proceeds received from the issuance of common stock and pre-funded warrants, $75.0 million of proceeds received pursuant to the Note Purchase Agreement, $13.8 million of proceeds from the exercise of Warrants, $1.2 million of proceeds received from insurance premium financing, and less than $0.1 million of proceeds received related to our employee stock purchase plan, partially offset by the $42.6 million repayment of our Loan Agreement, and $0.7 million of payments for insurance premium financing. Refer toNote 10. Debt to our unaudited condensed consolidated financial statements included in this quarterly report for additional details on the Note Purchase Agreement and Loan Agreement;Note 15. Capital Stock to our unaudited condensed consolidated financial statements included in this quarterly report for additional details on the 2025 Private Placement, the Stock Purchase Agreement and the Warrants;Note 12. Notes Payable to our unaudited condensed consolidated financial statements included in this quarterly report for additional details on the finance agreement with AFCO Premium Credit LLC related to insurance premium financing and the monthly payments of principal and interest related thereto;Note 13. Vendor Financing Arrangement to our unaudited condensed consolidated financial statements included in this quarterly report for additional details on the vendor finance agreement with IQVIA related to the master service agreement.
Rearranged current paragraphs (10)
Current report — wording carried from elsewhere
We expect to finance our operations with our existing cash, cash equivalents and investments, through potential future milestones and royalties received pursuant to the Secura APA, through the Note Purchase Agreement, through future product revenues or through other strategic financing opportunities that could include, but are not limited to collaboration agreements, offerings of our equity, or the incurrence of debt. However, given the risks associated with
Current report — wording carried from elsewhere
“N/M” - Percentage change is not meaningful (N/M) where the prior period amount is zero or not comparable.
Current report — wording carried from elsewhere
We began commercial sales of AVMAPKI FAKZYNJA CO-PACK within the United States in May 2025, following receipt of FDA marketing approval on May 8, 2025. For the six months ended June 30, 2026 (the “2026 Period”) we recorded approximately $43.7 million of net product revenue. For the six months ended June 30, 2025 (the “2025 Period”) we recorded approximately $2.1 million of net product revenue.
Current report — wording carried from elsewhere
Cost of sales – product for the 2026 Period was $6.5 million compared to $0.3 million for the 2025 Period. Cost of sales – product for the 2026 Period and 2025 Period consisted of costs associated with the manufacturing of AVMAPKI FAKZYNJA CO-PACK, royalties owed on such sales, and certain period costs including inventory write downs. 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 AVMAPKI FAKZYNJA CO-PACK were recorded as research and development expense. Certain costs of AVMAPKI FAKZYNJA CO-PACK units recognized as revenue during the 2026 Period and 2025 Period, or approximately $0.3 million and less than $0.1 million, respectively, were expensed prior to obtaining regulatory approval, therefore, are not included in cost of sales*–* product during this period. We expect cost of sales - product to increase in relation to product revenues as we deplete these inventories.
Current report — wording carried from elsewhere
Cost of sales – intangible amortization for the 2026 Period and 2025 Period of approximately $0.6 million and $0.1 million, respectively, was related to finite-lived intangible assets related to AVMAPKI FAKZYNJA CO-PACK which we recognized and began amortizing during the second quarter of 2025.
Current report — wording carried from elsewhere
The table below summarizes our direct research and development expenses for our product/ product candidates/ projects and our unallocated research and development costs for the 2026 Period and the 2025 Period.
Current report — wording carried from elsewhere
Interest expense for the 2026 Period was $0.7 million compared to $0.4 million for the 2025 Period. The $0.3 million increase from the 2025 Period was primarily driven by interest expense incurred as part of the vendor financing arrangement.
Current report — wording carried from elsewhere
Change in fair value of warrant liability
Current report — wording carried from elsewhere
Change in fair value of Notes
Current report — wording carried from elsewhere
The change in fair value of Notes was $3.7 million for the 2026 Period compared to $7.4 million during the 2025 Period. We elected the fair value option for the Notes and therefore changes in fair value, including interest, other than changes that are directly attributable to instrument specific credit risk are recorded as change in fair value of Notes in the condensed statements of operations and comprehensive loss. The change in fair value of Notes for the 2026 Period of $3.7 million was primarily driven by interest and Revenue Participation Payments on the Notes. The change in fair value of Notes for the 2025 Period of $7.4 million was primarily driven by interest on the Notes and a reduction in risk free rate during the 2025 Period resulting in higher valuation of the Notes.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
Our discussion and analysis of our financial condition and results of operations is based upon our condensed consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles. The
Previous report — wording carried elsewhere
expense. Certain costs of AVMAPKI FAKZYNJA CO-PACK units recognized as revenue during the 2026 Quarter, or approximately $0.1 million, were expensed prior to obtaining regulatory approval, therefore, are not included in cost of sales*–* product during this period. We expect cost of sales - product to increase in relation to product revenues as we deplete these inventories. We did not recognize any cost of sales – product during the 2025 Quarter.