Verastem, Inc.
For the period ended Sep 30, 2025. Filed Nov 4, 2025.
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.
Sep 30, 2025 · Filed Nov 4, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001558370-25-010757
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-04.
0001104659-25-106279
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 79 previous paragraphs and 88 current paragraphs.
28 unchanged; 40 reworded; 16 added; 2 removed; 9 previous and 4 current paragraphs rearranged.
Tables are not compared: 11 previous and 11 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 (16)
Current report
Avutometinib and Defactinib
Current report
Avutometinib and Defactinib Combination in LGSOC
Current report
Enrollment of the planned 270 patients was completed a full quarter early in September of 2025. A pre-planned Interim Analysis by an Independent Data Monitoring Committee (“IDMC”) was completed, and the IDMC recommended a modest one-time increase in enrollment to the RAMP 301 trial of 29 patients across KRAS mutation status. We expect to complete enrollment of the IDMC recommended patients by the first quarter of 2026.
Current report
Phase 1/2 Trial (known as RAMP 203 Study) - Avutometinib and Defactinib in Combination with Amgen’s LUMAKRAS* *(Sotorasib) in Patients with KRAS G12C NSCLC
Current report
Phase 1/2 Trial (known as RAMP 205 Study) - Avutometinib and Defactinib in Combination with Gemcitabine/Nab-Paclitaxel in Patients with Metastatic Adenocarcinoma of the Pancreas
Current report
We have completed enrollment of all 29 patients at the recommended phase 2 dose as of the end of the third quarter of 2025. We expect to report an update on the safety and efficacy of the RAMP 205 expansion cohort in the first half of 2026.
Current report
On September 8, 2025 updated data from GenFleet’s Phase 1/2 study of GFH375 in China was featured in a mini oral presentation at the IASLC 2025 World Conference on Lung Cancer (WCLC). At the recommended phase 2 dose of 600 mg QD, the ORR was 68.8%, both confirmed and unconfirmed, and the DCR was 93.8%. Additionally, among the 26 evaluable patients with NSCLC treated across all dose levels, the ORR was 57.7%, both confirmed and unconfirmed, and the DCR was 88.5%.
Current report
On October 19, 2025 at the European Society for Medical Oncology (“ESMO”) congress, GenFleet announced updated efficacy data from the dose expansion phase of the Phase 1/2 trial of GFH375 (known as VS-7375 in the U.S.) As of the data cutoff on September 27, 2025 GFH375 resulted in a 41% ORR and a disease control rate (“DRR”) of 96.7% at the 600 mg QD for patients with heavily pre-treated pancreatic ductal adenocarcinoma of which, the majority of patients 91.5% experienced a reduction in target lesions. 68% of the pretreated patients had received 2 or more lines of anticancer therapies with 92.4% of patients receiving gemcitabine-based regimens and more than 50% receiving fluorouracil or irinotecan-containing regimens. At month four, the overall survival (“OS”) rate was 92.2%, however, median OS has not been reached as of the announcement. The median progression-free survival (“PFS”) was 5.52 months with a median follow-up time of 5.65 months and a 4-month PFS rate of 78.2%. At evaluation, 31 (47%) of patients were still on treatment with the longest duration of treatment eclipsing one year (367 days). The most recent safety data reported was as of the data cutoff on August 27, 2025 where Grade 3 TRAEs were reported in 20 patients (30.3%) and a Grade 4 TRAE (neutropenia) occurred in one patient (1.5%). Of the 66 patients in the safety population, four patients (6.1%) had a dose reduction and two patients (3%) discontinued due to TRAEs. No TRAE-related deaths were reported. The mean relative dose intensity was 93%.
Current report
On October 27, 2025, GenFleet shared additional analyses from previously presented data at recent medical congresses evaluating GFH375 in both advanced KRAS G12D mutant PDAC and NSCLC. In a subgroup analysis, 12 patients with second line PDAC at 600 mg QD achieved an ORR of 58.3% and a DCR of 100%. In the third line or later setting, 47 PDAC patients receiving 600 mg QD achieved an ORR of 36.2% and a DCR of 95.7%. In the second line subgroup, the median progression-free survival (“mPFS”) and median overall survival (“mOS”) have not been reached. An additional analysis of gastrointestinal disorders, hematological toxicities, and liver enzyme abnormalities in 2L+ patients with PDAC (n=66) at 600 mg QD showed no adverse events Grade ≥3 occurred at rates above 8.0%. In an analysis of pre-treated patients with NSCLC at 600 mg QD, the four-month PFS rate was >75% and the mPFS has not been reached. The median follow-up time was 4.2 months. GenFleet announced that the first patient has been dosed in a Phase 1b/2 study of GFH375 combined with cetuximab or chemotherapy for advanced solid tumors on October 22, 2025.
Current report
On October 23, 2025, we announced a preliminary update on our U.S. Phase 1/2a monotherapy dose escalation trial of VS-7375 in patients with previously treated advanced KRAS G12D mutant solid tumors. In the study, VS-7375 cleared both the 400 mg QD and the 600 mg QD monotherapy doses with no dose-limiting toxicities (DLTs) observed. At the two dose levels evaluated in the U.S. cohort, no nausea, vomiting, or diarrhea greater than Grade 1 were reported. The study’s dose escalation continues with evaluation of the monotherapy 900 mg QD dose level. Of the five efficacy evaluable patients in the VS-7375-101 study, with at least one scan, four out of five patients have had a tumor reduction and are still on treatment. The remaining patients receiving either the 400 mg QD or 600 mg QD doses have not yet reached their first response assessment. In addition, no new safety signals have been observed relative to earlier data presentations in both PDAC and NSCLC by our partner, GenFleet, in its ongoing Phase 1/2 clinical study in China evaluating VS-7375 (known as GFH375).
Current report
We plan to report an interim safety and efficacy update on the Phase 1/2a trial of VS-7375 in the first half of 2026. We expect to select the recommended phase 2 dose (“RP2D”) and plan to initiate the monotherapy expansion cohorts in advanced PDAC, NSCLC and other solid tumors in the first half of 2026. We announced that we have initiated patient enrollment for the first dose escalation combination cohort evaluating VS-7375 with cetuximab in patients with advanced solid tumors, including colorectal cancer. Additionally, we expect to initiate the dose escalation cohorts in combination with chemotherapy for PDAC, and chemotherapy plus anti-PD-1 for NSCLC in the fourth quarter 2025. We expect to select the recommended phase 2 dose (“RP2D”) and plan to initiate the combination expansion cohorts in CRC, PDAC, and NSCLC in the first half of 2026. We also plan to engage with the FDA in the first half of 2026 to discuss our development path forward, including potential registration-directed clinical trials in PDAC and NSCLC.
Current report
Interest income. Interest income for the 2025 Quarter was $1.2 million, compared to $0.8 million for the 2024 Quarter. The $0.4 million increase was primarily driven by higher balances of cash equivalents during the 2025 Quarter compared to the 2024 Quarter.
Current report
8,962,503 Warrants that remain outstanding at September 30, 2025, due to an increase in our stock price resulting in the $55.9 million expense during the 2025 Quarter. The $13.5 million income for the 2024 Quarter was comprised 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 July 23, 2024 to end of 2024 Quarter.
Current report
Comparison of the nine months ended September 30, 2025 and 2024
Current report
CRO costs for the VS-7375-101 trial, partially offset by a $3.0 million development milestone payment made during the 2024 Period pursuant to the GenFleet Agreement.
Current report
*Change in fair value of warrant liability.*The change in fair value of the warrant liability was $38.0 million expense for the 2025 Period compared to $13.5 million income for the 2024 Period. The $38.0 million expense for the 2025 period was comprised of the mark-to-market adjustment for the liability classified warrants issued as part of the July 2024 Offering. The increase was driven by an increase in fair value per Warrant from December 31, 2025 to the exercise date for the 9,120,831 Warrants exercised during the 2025 Period and an increase in fair value per Warrant for the 8,962,503 Warrants that remain outstanding at September 30, 2025, due to an increase in our stock price resulting in the $38.0 million expense during the 2025 Period. The $13.5 million income for the 2024 Period was comprised 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 July 23, 2024 to end of the 2024 Period.
Removed paragraphs (2)
Previous report
Comparison of the six months ended June 30, 2025 and 2024
Previous report
*Change in fair value of warrant liability.*The change in fair value of the warrant liability of $17.9 million for the 2025 Period 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, 2024 as a result of the exercise of 2,787,499 Warrants during the period and a decrease in warrant valuation due to a lower stock price. There was no warrant liability outstanding during the 2024 Period.
Reworded paragraphs (40)
Previous wording
On May 8, 2025, the FDA approved AVMAPKI FAKZYNJA CO-PACK for the treatment of adult patients with “KRAS mt” recurrent LGSOC who received prior systemic therapy. The KRAS mt recurrent LGSOC indication has been granted approval by the FDA under the accelerated approval pathway based on the tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Current wording
On May 8, 2025, the FDA approved AVMAPKI FAKZYNJA CO-PACK for the treatment of adult patients with “KRAS mt” recurrent LGSOC who received prior systemic therapy. The KRAS mutant recurrent LGSOC indication has been granted approval by the FDA under the accelerated approval pathway based on the tumor response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
Previous wording
In December 2023, we announced the initiation of a confirmatory Phase 3 trial to evaluate the combination of avutometinib and defactinib for the treatment of patients with recurrent LGSOC entitled RAMP 301. RAMP 301 is a randomized global confirmatory trial, which is evaluating the efficacy and safety of avutometinib and defactinib versus standard of care chemotherapy or hormonal therapy in patients with recurrent LGSOC with and without a KRAS mutation. RAMP 301 will serve as the confirmatory study required by the FDA for the combination of avutometinib and defactinib for the initial indication of recurrent KRAS mt LGSOC to potentially receive full approval and has the potential to support an expanded indication regardless of KRAS mutation status. RAMP 301 is a global study with enrollment open in the United States, Australia, Canada, Europe United Kingdom, New Zealand, Japan, and Korea. Enrollment is on track, and we are targeting full enrollment by the end of 2025.
Current wording
In December 2023, we announced the initiation of a confirmatory Phase 3 trial to evaluate the combination of avutometinib and defactinib for the treatment of patients with recurrent LGSOC entitled RAMP 301. RAMP 301 is a randomized global confirmatory trial, which is evaluating the efficacy and safety of avutometinib and defactinib versus standard of care chemotherapy or hormonal therapy in patients with recurrent LGSOC with and without a KRAS mutation. RAMP 301 will serve as the confirmatory study required by the FDA for the combination of avutometinib and defactinib for the initial indication of recurrent KRAS mutant LGSOC to potentially receive full approval and has the potential to support an expanded indication regardless of KRAS mutation status. RAMP 301 is a global study with enrollment open in the United States, Australia, Canada, Europe, United Kingdom, New Zealand, Japan, and Korea.
Previous wording
On May 8, 2025, the FDA approved AVMAPKI FAKZYNJA CO-PACK in advance of its Prescription Drug User Fee Act or PDUFA action date. Following this approval, we submitted a letter to the National Comprehensive Cancer Network (“NCCN”) seeking inclusion of avutometinib plus defactinib combination therapy in its LGSOC treatment guidelines. NCCN included AVMAPKI FAKZYNJA CO-PACK in its LGSOC treatment guidelines consistent with the product’s approved indication. We submitted to NCCN the publications for RAMP 201 and FRAME in support of its consideration of the inclusion of the KRAS wild-type population evaluated in these trials in the NCCN Guidelines in July 2025. The NCCN Committee for Ovarian Cancer will holds its annual meeting in October 2025, and the Company has been informed that its submission will be reviewed at that time.
Current wording
On May 8, 2025, the FDA approved AVMAPKI FAKZYNJA CO-PACK in advance of its Prescription Drug User Fee Act or PDUFA action date. Following this approval, we submitted a letter to the National Comprehensive Cancer Network (“NCCN”) seeking inclusion of avutometinib plus defactinib combination therapy in its LGSOC treatment guidelines. NCCN included AVMAPKI FAKZYNJA CO-PACK in its LGSOC treatment guidelines consistent with the product’s approved indication. In July 2025, we submitted to NCCN the publications for RAMP 201 and FRAME in support of our request to NCCN that they consider the inclusion of AVMAPKI FAKZYNJA CO-PACK in its LGSOC treatment guidelines for the KRAS wild-type population evaluated in these trials. We were informed that our submission would be reviewed at the NCCN Committee for Ovarian Cancer annual meeting, which was held in October 2025. The results from the meeting have not yet been made public.
Previous wording
In October 2024, the Japanese Gynecologic Oncology Group dosed the first patient in a Phase 2 trial called RAMP 201J, evaluating the safety and efficacy of avutometinib in combination with defactinib in recurrent LGSOC in Japan. We expect to report initial data from RAMP 201J in Q4 2025.
Current wording
In October 2024, the Japanese Gynecologic Oncology Group dosed the first patient in a Phase 2 trial called RAMP 201J, evaluating the safety and efficacy of avutometinib in combination with defactinib in recurrent LGSOC in Japan. Preliminary safety and efficacy results from the Phase 2 RAMP 201J trial in Japan was accepted as an E-Poster at the International Gynecologic Cancer Society 2025 Annual Meeting. In the published abstract, with a data extract date of April 11, 2025, no dose limiting toxicities were observed and avutometinib and defactinib drug exposure levels were comparable to those observed in the global RAMP 201 study. Additional data, including efficacy (response rates) and updated safety will be available on November 5, 2025, when the embargo lifts.
Previous wording
Based on emerging data demonstrating improved tumor regressions in KRAS G12C-mutant NSCLC preclinical models when a FAK inhibitor is combined with a G12C inhibitor and avutometinib, defactinib was added to the RAMP 203 study in new triplet cohorts in 2024. In December 2024, we announced three patients whose cancer previously progressed on a G12C inhibitor have been treated with the triplet combination of sotorasib 960 mg administered daily on a continuous schedule and avutometinib 3.2 mg twice-weekly plus defactinib 200 mg twice-daily. Avutometinib and defactinib are administered on a three out of four weeks schedule. There were no dose limiting toxicities observed in the first triplet combination cohort. Planned dose level evaluation cohorts for the triplet combination completed enrollment in first quarter of 2025. We expect to present an interim update of safety and efficacy from both the doublet and triplet data in the fourth quarter of 2025.
Current wording
Based on emerging data demonstrating improved tumor regressions in KRAS G12C-mutant NSCLC preclinical models when a FAK inhibitor is combined with a G12C inhibitor and avutometinib, defactinib was added to the RAMP 203 study in new triplet cohorts in 2024. In December 2024, we announced three patients whose cancer previously progressed on a G12C inhibitor have been treated with the triplet combination of sotorasib 960 mg administered daily (“QD”) on a continuous schedule and avutometinib 3.2 mg twice-weekly plus defactinib 200 mg twice-daily. Avutometinib and defactinib are administered on a three out of four weeks schedule. There were no dose limiting toxicities observed in the first triplet combination cohort. Planned dose level evaluation cohorts for the triplet combination completed enrollment in first quarter of 2025. We expect to present an interim update of safety and efficacy from both the doublet and triplet data in the fourth quarter of 2025.
Previous wording
dose level 1, of the six additional patients, five remain on therapy and continue to be monitored for response given the initial length of time to response. We completed enrollment in quarter 1 of 2025. In May 2025, we announced as of April 25, 2025, 60 patients (12 per cohort) had been treated in one of five dose regimens with the combination of avutometinib and defactinib with gemcitabine and Nab-paclitaxel in frontline metastatic pancreatic ductal adenocarcinoma (“PDAC”). In the dose level 1 cohort, 12 patients received 2.4 mg of avutometinib twice a week, 200 mg of defactinib twice a day for 3 weeks out of every 4 and 800 mg/m2 of gemcitabine and 125 mg/m2 of Nab-paclitaxel on a schedule of day 1, day 8 and day 15. In dose level 1, 83% (10/12) of patients achieved partial responses (8 confirmed and 2 unconfirmed who remain on treatment). Given these results, we have selected dose level 1 as the recommended phase 2 dose, has met the pre-defined criteria to advance beyond the first stage of the expansion study, and is now enrolling up to 29 patients at this dose level. Adverse events across all dose cohorts remained generally consistent with the previously announced safety and tolerability profile, and no new safety signals have emerged.
Current wording
A dose level “0” has been added to the RAMP 205 study protocol that evaluates 3.2 mg of avutometinib twice a week, 200 mg of defactinib twice a day for three weeks out of every four weeks with 800 mg/m2 of gemcitabine and 100 mg/m2 of Nab-paclitaxel on a schedule of day 1, day 8, and day 15. All dose levels have been expanded to 12 patients each, including six additional patients recently enrolled to dose level 1, where it was reported five out of six patients reported an objective response rate at the American Society of Clinical Oncology (“ASCO”) 2024 Annual Meeting. At dose level 1, of the six additional patients, five remained on therapy and continued to be monitored for response given the initial length of time to response. We completed enrollment in quarter one of 2025. In May 2025, we announced as of April 25, 2025, 60 patients (12 per cohort) had been treated in one of five dose regimens with the combination of avutometinib and defactinib with gemcitabine and Nab-paclitaxel in frontline metastatic pancreatic ductal adenocarcinoma (“PDAC”). In the dose level 1 cohort, 12 patients received 2.4 mg of avutometinib twice a week, 200 mg of defactinib twice a day for 3 weeks out of every 4 and 800 mg/m2 of gemcitabine and 125 mg/m2 of Nab-paclitaxel on a schedule of day 1, day 8 and day 15. In dose level 1, 83% (10/12) of patients achieved partial responses (8 confirmed and 2 unconfirmed who remained on treatment). Given these results, we have selected dose level 1 as the recommended phase 2 dose to expand enrollment from the initial 12 patients to a total of 29 patients.
Previous wording
In August 2023, we entered into a collaboration and option agreement (the “GenFleet Agreement”) with GenFleet Therapeutics (Shanghai), Inc. (“GenFleet”)pursuant to which GenFleet granted us options to obtain exclusive development and commercialization rights worldwide outside of mainland China, Hong Kong, Macau, and Taiwan for up to three oncology programs targeting RAS pathway driven cancers (the “GenFleet Options”). Under the GenFleet Agreement, we can exercise our GenFleet Options on a program-by-program basis. The collaboration builds on the strengths of both companies in oncology small molecule drug development, enabling us to partner our clinical development and regulatory expertise with GenFleet’s accomplished discovery capabilities. This synergistic collaboration includes our experience and established network of collaborators, including scientific and clinical experts in RAS biology and RAS pathway-driven cancers and GenFleet’s accomplishments with its KRAS G12C inhibitor program. In December 2023, we announced the selection of an oral and selective KRAS G12D (ON/OFF) inhibitor entitled VS-7375 (known as GFH375 in China) with a potential best-in-class profile as the lead program from our collaboration with GenFleet. An investigational new drug (“IND”) application by GenFleet in China for VS-7375 was cleared in June 2024. In July 2024, GenFleet began dosing several patients in a Phase 1/2 trial in China that is evaluating VS-7375 in patients with KRAS G12D-mutated advanced solid tumors. The Phase 1/2 study is being conducted in approximately 20 hospitals in China. The Phase 1 study was used to determine the recommended Phase 2 dose, and the Phase 2 study will further evaluate the efficacy and safety of VS-7375 in patients with advanced solid tumors, such as PDAC, CRC, and NSCLC.
Current wording
In August 2023, we entered into a collaboration and option agreement (the “GenFleet Agreement”) with GenFleet Therapeutics (Shanghai), Inc. (“GenFleet”)pursuant to which GenFleet granted us options to obtain exclusive development and commercialization rights worldwide outside of mainland China, Hong Kong, Macau, and Taiwan for up to three oncology programs targeting RAS pathway driven cancers (the “GenFleet Options”). Under the GenFleet Agreement, we can exercise our GenFleet Options on a program-by-program basis. The collaboration builds on the strengths of both companies in oncology small molecule drug development, enabling us to partner our clinical development and regulatory expertise with GenFleet’s accomplished discovery capabilities. This synergistic collaboration includes our experience and established network of collaborators, including scientific and clinical experts in RAS biology and RAS pathway-driven cancers and GenFleet’s accomplishments with its KRAS G12C inhibitor program. In December 2023, we announced the selection of an oral and selective KRAS G12D (ON/OFF) inhibitor entitled VS-7375 (known as GFH375 in China) with a potential best-in-class profile as the lead program from our collaboration with GenFleet. An investigational new drug (“IND”) application by GenFleet in China for VS-7375 was cleared in June 2024. In July 2024, GenFleet began dosing several patients in a Phase 1/2 trial in China that is evaluating VS-7375 in patients with KRAS G12D-mutated advanced solid tumors. The Phase 1/2 study is being conducted in
Previous wording
On January 14, 2025, we announced the early exercise of the GenFleet Option with respect to VS-7375. We filed an IND application in the United States for VS-7375 during the first quarter of 2025. In April 2025 we announced the FDA clearance of the IND, and in June 2025 we announced we dosed our first patient with VS-7375 in our U.S. Phase 1/2a clinical trial evaluating VS-7375 in patients with advanced KRAS G12D solid tumors. We expect to report a preliminary update on the Phase 1 monotherapy dose escalation in Q4 2025. Subject to the results of the Phase 1 monotherapy dose escalation, the Company plans to initiate monotherapy expansion cohorts in both advanced PDAC and NSCLC. Additionally, we expect to initiate the dose escalation cohorts in combination with cetuximab, chemotherapy, and chemotherapy with checkpoint-inhibitor for CRC, PDAC, and NSCLC, respectively, in Q4 2025. Subject to the results of the Phase 1 dose escalation combinations cohorts with VS-7375, the Company plans to initiate a combination expansion cohort in CRC, PDAC, and NSCLC. Verastem and GenFleet shared preclinical data at American Association for Cancer Research meeting in April 2025.
Current wording
On January 14, 2025, we announced the early exercise of the GenFleet Option with respect to VS-7375. We filed an IND application in the United States for VS-7375 during the first quarter of 2025. In April 2025 we announced the FDA clearance of the IND, and in June 2025 we announced we dosed our first patient with VS-7375 in our U.S. Phase 1/2a clinical trial evaluating VS-7375 in patients with advanced KRAS G12D solid tumors entitled VS-7375-101.
Previous wording
At the ASCO 2025 Annual Meeting, GenFleet announced updated data from the dose escalation phase of the Phase 1/2 trial of GFH375 (known as VS-7375 in the U.S.). GenFleet reported that 62 patients were enrolled in the Phase 1 portion of the study in China, receiving oral doses ranging from 100 to 900 mg daily. In the study, 98% of patients had metastatic disease, and 75% had received ≥2 prior lines of therapy. As of the data cutoff of May 16, 2025, 23 efficacy-evaluable patients with PDAC and 12 efficacy-evaluable patients with NSCLC, who received daily dosages of 400 or 600 mg and had at least one post-treatment tumor assessment, achieved an objective response rate (“ORR”) of 52% and a disease control rate (DCR) of 100%, and an ORR of 42% and a DCR of 83%, respectively. As of the cutoff date
Current wording
At the ASCO 2025 Annual Meeting, GenFleet announced updated data from the dose escalation phase of the Phase 1/2 trial of GFH375 (known as VS-7375 in the U.S.). GenFleet reported that 62 patients were enrolled in the Phase 1 portion of the study in China, receiving oral doses ranging from 100 to 900 mg QD. In the study, 98% of patients had metastatic disease, and 75% had received ≥2 prior lines of therapy. As of the data cutoff of May 16, 2025, 23 efficacy-evaluable patients with PDAC and 12 efficacy-evaluable patients with NSCLC, who received daily dosages of 400 or 600 mg and had at least one post-treatment tumor assessment, achieved an objective response rate (“ORR”) of 52% and a disease control rate (“DCR”) of 100%, and an ORR of 42% and a DCR of 83%, respectively. As of the cutoff date of March 31, 2025, GenFleet reported that there were no dose-limiting toxicities observed across all dose levels (100-900 mg QD), and the treatment-related adverse events (“TRAEs”) were mostly Grade 1/2. The most common TRAEs occurring in at least 20% of patients were diarrhea, nausea, vomiting, and anemia. TRAEs ≥ Grade 3 consisted mainly of decreased neutrophil count (8%) and diarrhea (5%). No TRAE-related deaths were reported.
Previous wording
Our operations to date have been focused on organizing and staffing our company, business planning, raising capital, identifying and acquiring potential product candidates, undertaking preclinical studies and clinical trials for our product candidates and initiating U.S. commercial operations following the approval of COPIKTRA through our ownership period ending in September 2020 and in anticipation of the approval of AVMAPKI FAKZYNJA CO-PACK. We have financed our operations to date primarily through public and private offerings of our common stock, pre-funded warrants, and warrants, offerings of convertible notes, sales of common stock under our at-the-market equity offering program, our loan and security agreement executed with Hercules in March 2017, as amended, the Loan Agreement with Oxford, our Note Purchase Agreement, the upfront payments and milestone payments under our license and collaboration agreements with Sanofi, CSPC, and Yakult, the upfront payment and milestone payments received under the Secura APA, and sales of Series B Convertible Preferred Stock. Additionally, from our U.S. commercial launch of COPIKTRA on September 24, 2018, through our ownership period ending in September 2020, we financed a portion of our operations through product revenue. From our U.S. commercial launch of AVMAPKI FAKZYNJA CO-PACK on May 8 th, 2025, we are financing a portion of our operations through product revenue.
Current wording
Our operations to date have been focused on organizing and staffing our company, business planning, raising capital, identifying and acquiring potential product candidates, undertaking preclinical studies and clinical trials for our product candidates and initiating U.S. commercial operations following the approval of COPIKTRA through our ownership period ending in September 2020 and in anticipation of and following the approval of AVMAPKI FAKZYNJA CO-PACK in May 2025. We have financed our operations to date primarily through public and private offerings of our common stock, pre-funded warrants, and warrants, offerings of convertible notes, sales of common stock under our at-the-market equity offering program, our loan and security agreement executed with Hercules in March 2017, as amended, the Loan Agreement with Oxford, our Note Purchase Agreement, the upfront payments and milestone payments under our license and collaboration agreements with Sanofi, CSPC, and Yakult, the upfront payment and milestone payments received under the Secura APA, and sales of Series B Convertible Preferred Stock. Additionally, from our U.S. commercial launch of COPIKTRA on September 24, 2018, through our ownership period ending in September 2020, we financed a portion of our operations through product revenue. From our U.S. commercial launch of AVMAPKI FAKZYNJA CO-PACK on May 8 th, 2025, we are financing a portion of our operations through product revenue.
Previous wording
As of June 30, 2025, we had an accumulated deficit of $1,033.6 million. Our net loss was $25.9 million, $78.0 million, $8.3 million and $42.1 million for the three and six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had cash, cash equivalents, and investments of $164.3 million. In accordance with applicable accounting standards, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within 12 months after the date of the issuance of the consolidated financial statements. We anticipate operating losses may continue for the foreseeable future and we continue to incur operating costs to execute our strategic plan, including costs related to research and development of our product candidates and commercial activities. As a result of the assessment in accordance with the applicable accounting standards, these conditions raise substantial doubt about our ability to continue as a going concern for 12 months after the date the condensed consolidated financial statements are issued.
Current wording
As of September 30, 2025, we had an accumulated deficit of $1,132.1 million. Our net loss was $98.5 million, $176.6 million, $24.0 million and $66.1 million for the three and nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had cash, cash equivalents, and investments of $137.7 million. In accordance with applicable accounting standards, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within 12 months after the date of the issuance of the consolidated financial statements. We anticipate operating losses may continue for the foreseeable future and we continue to incur operating costs to execute our strategic plan, including costs related to research and development of our product candidates and commercial activities. As a result of the assessment in accordance with the applicable accounting standards, these conditions raise substantial doubt about our ability to continue as a going concern for 12 months after the date the condensed consolidated financial statements are issued.
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
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
Previous wording
and estimates about matters that are uncertain at the time we make the estimate, and different estimates—which also would have been reasonable—could have been used, which would have resulted in different financial results.
Current wording
We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as “critical” because these specific areas generally require us to make judgments and estimates about matters that are uncertain at the time we make the estimate, and different estimates—which also would have been reasonable—could have been used, which would have resulted in different financial results.
Previous wording
The critical accounting policies we identified in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024, related to revenue recognition, collaborative agreements, accrued and prepaid research and development expenses, and stock-based compensation. During the six months ended June 30, 2025, there were no material changes to our critical accounting policies.
Current wording
The critical accounting policies we identified in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024, related to revenue recognition, collaborative agreements, accrued and prepaid research and development expenses, and stock-based compensation. During the nine months ended September 30, 2025, there were no material changes to our critical accounting policies.
Previous wording
*Product Revenue, Net.*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, 2025 (the “2025 Quarter”) we recorded approximately $2.1 million of net product revenue. We had no product revenue during the three months ended June 30, 2024 (the “2024 Quarter”).
Current wording
*Product Revenue, Net.*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 September 30, 2025 (the “2025 Quarter”) we recorded approximately $11.2 million of net product revenue. We had no product revenue during the three months ended September 30, 2024 (the “2024 Quarter”).
Previous wording
*Costs of sales – product.*Costs of sales – product for the 2025 Quarter of approximately $0.3 million consisted of costs associated with the manufacturing of AVMAPKI FAKZYNJA CO-PACK, royalties owed to Chugai, Pfizer, and the Institute for Cancer Research (“ICR”) on such sales, and certain period 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 AVMAPKI FAKZYNJA CO-PACK were recorded as research and development expense. Certain of the costs of AVMAPKI FAKZYNJA CO-PACK units recognized as revenue during the 2025 Quarter, or less than $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 had no cost of sales – product during the 2024 Quarter.
Current wording
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 of the costs of AVMAPKI FAKZYNJA CO-PACK units recognized as revenue during the 2025 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 had no cost of sales – product during the 2024 Quarter.
Previous wording
*Costs of sales –intangible amortization.*Cost of sales – intangible amortization for the 2025 Quarter of approximately $0.1 million was related to finite-lived intangible assets related to AVMAPKI FAKZYNJA CO-PACK which we recognized and began amortizing in the 2025 Quarter. There was no cost of sales – intangible amortization the 2024 Quarter.
Current wording
*Costs of sales –intangible amortization.*Cost of sales – intangible amortization for the 2025 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. There was no cost of sales – intangible amortization the 2024 Quarter.
Previous wording
*Research and development expense.*Research and development expense for the 2025 Quarter was $24.8 million compared to $18.1 million for the 2024 Quarter. The $6.7 million increase from the 2024 Quarter to the 2025 Quarter was primarily driven by an increase of $2.4 million in contract research organization (“CRO”) costs, an increase of $2.0 million in investigator fees, an increase of $1.5 million in personnel costs, including non-cash stock compensation, and an increase of $0.8 million in clinical supply costs.
Current wording
*Research and development expense.*Research and development expense for the 2025 Quarter was $29.0 million, compared to $24.8 million for the 2024 Quarter. The $4.2 million increase was primarily driven by a $3.0 million increase in drug substance/product manufacturing costs, a $2.6 million increase in contract research organization (“CRO”) costs, and a $1.6 million increase in investigator fees. These increases were partially offset by a $3.0 million milestone payment made during the 2024 Quarter pursuant to the GenFleet Agreement.
Previous wording
The $4.1 million increase in avutometinib+ defactinib – LGSOC was primarily driven by an increase in RAMP 301 trial costs as the trial continues to advance and enroll more patients. The $0.6 million decrease in avutometinib + defactinib – NSCLC was primarily driven by a decrease in RAMP 202 trial costs. The $1.7 million decrease in avutometinib and defactinib manufacturing and non-clinical trial specific expenses was driven by a reduction in manufacturing and study activities, as well as safety consulting services. The $2.4 million increase in GenFleet related expenses was primarily driven by drug product costs for the 7375-101 study.
Current wording
The $1.6 million increase in avutometinib+ defactinib – LGSOC was primarily driven by an increase in RAMP 301 trial costs as the trial continues to advance and enroll more patients. The $1.7 million decrease in avutometinib and defactinib manufacturing and non-clinical trial specific expenses was primarily driven by decreased drug substance costs and decreased consulting costs. The $2.3 million increase in GenFleet and VS-7375 related expenses was primarily driven by increased drug substance costs and CRO costs for the 7375-101 study, partially offset by a $3.0 million development milestone payment made during the 2024 Quarter pursuant to the GenFleet Agreement.
Previous wording
Selling, general and administrative expense. Selling, general and administrative expense for the 2025 Quarter was $20.7 million compared to $10.2 million for the 2024 Quarter. The increase of $10.5 million from the 2024 Quarter to the 2025 Quarter primarily resulted from the increase of $8.1 million of consulting and professional fees related to the launch of avutometinib and defactinib in KRAS mt LGSOC, an increase of $2.7 million in personnel costs including non-cash based stock compensation, an increase of $1.0 million in travel and other costs, partially offset by a decrease of $1.3 million in commercial operations expenses.
Current wording
*Selling, general and administrative expense.Selling, general and administrative expense for the 2025 Quarter was $21.0 million compared to $12.3 million for the 2024 Quarter. The increase of $8.7 million from the 2024 Quarter to the 2025 Quarter primarily resulted from the increase of $8.2 million of [consulting and professional fees] primarily related to the launch of AVMAPKI FAKZYNJA CO-PACK for the treatment of KRAS mutant recurrent LGSOC, an increase of $2.3 million in personnel costs including non-cash based stock compensation, an increase of $1.2 million in commercial operations expenses, partially offset by a decrease of $3.0 million in July 2024 Offering financing fees in the 2024 Quarter. *
Previous wording
Other expense. Other expense for the 2025 Quarter and 2024 Quarter was less than $0.1 million. Other expense for the 2025 Quarter and 2024 Quarter was comprised of transaction losses due to changes in foreign currency exchange rates.
Current wording
Other expense. Other expense for the 2025 Quarter was less than $0.1 million compared to $0.1 million for the 2024 Quarter. Other expense for the 2025 Quarter and 2024 Quarter was comprised of transaction losses due to changes in foreign currency exchange rates.
Previous wording
*Interest expense.*Interest expense for the 2025 Quarter was $0.2 million compared to $1.1 million for the 2024 Quarter. The $0.9 million decrease from the 2024 Quarter was primarily driven by termination of the Loan Agreement with Oxford on January 13, 2025 resulting in a reduction of interest expense recorded in the 2025 Quarter. The Company has elected to record interest expense associated with the Notes within change in fair value of Notes on the condensed statements of operations and comprehensive loss.
Current wording
*Interest expense.*Interest expense for the 2025 Quarter was $0.3 million compared to $1.1 million for the 2024 Quarter. The $0.8 million decrease from the 2024 Quarter was primarily driven by termination of the Loan Agreement with Oxford on January 13, 2025 resulting in a reduction of interest expense recorded in the 2025 Quarter. The Company has elected to record interest expense associated with the Notes within change in fair value of Notes on the condensed statements of operations and comprehensive loss.
Previous wording
*Change in fair value of warrant liability.*The change in fair value of the warrant liability of $20.3 million 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, 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. There was no warrant liability outstanding during the 2024 Quarter.
Current wording
*Change in fair value of warrant liability.*The change in fair value of the warrant liability was $55.9 million expense for the 2025 Quarter compared to $13.5 million income for the 2024 Quarter. The $55.9 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 increase was driven by an increase in fair value per Warrant from June 30, 2025 to the exercise date for the 5,166,666 Warrants exercised during the 2025 Quarter and an increase in fair value per Warrant for the
Previous wording
*Change in fair value of Notes.*We elected the fair value option for the Notes and therefore the changes in fair value, including interest, other than changes that are directly attributable to instrument specific credit risk are recorded as change in fair of Notes in the condensed statements of operations and comprehensive loss. The change in fair value for the 2025 Quarter of $3.0 million was primarily driven by interest on the Notes and a reduction in the risk-free rate during the 2025 Quarter. There were no Notes outstanding in the 2024 Quarter.
Current wording
*Change in fair value of Notes.*We elected the fair value option for the Notes and therefore the changes in fair value, including interest, other than changes that are directly attributable to instrument specific credit risk are recorded as change in fair of Notes in the condensed statements of operations and comprehensive loss. The change in fair value for the 2025 Quarter of $2.7 million was primarily driven by interest on the Notes and a reduction in the risk-free rate during the 2025 Quarter. There were no Notes outstanding in the 2024 Quarter.
Previous wording
*Product Revenue, Net.*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, 2025 (the “2025 Period”) we recorded approximately $2.1 million of net product revenue. We had no product revenue during the six months ended June 30, 2024 (the “2024 Period”).
Current wording
*Product Revenue, Net.*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 nine months ended September 30, 2025 (the “2025 Period”) we recorded approximately $13.4 million of net product revenue. We had no product revenue during the nine months ended September 30, 2024 (the “2024 Period”).
Previous wording
*Costs of sales – product.*Costs of sales – product for the 2025 Period of approximately $0.3 million consisted of costs associated with the manufacturing of AVMAPKI FAKZYNJA CO-PACK, royalties owed to Chugai, Pfizer, and ICR on such sales, and certain period costs. We 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 of the costs of AVMAPKI FAKZYNJA CO-PACK units recognized as revenue during the 2025 Period, or less than $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 had no cost of sales – product during the 2024 Period.
Current wording
*Costs of sales – product.*Costs of sales – product for the 2025 Period of approximately $2.0 million consisted of costs associated with the manufacturing of AVMAPKI FAKZYNJA CO-PACK, royalties owed to Chugai, Pfizer, and ICR on such sales, and certain period costs. We 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 of the costs of AVMAPKI FAKZYNJA CO-PACK units recognized as revenue during the 2025 Period, 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 had no cost of sales – product during the 2024 Period.
Previous wording
*Costs of sales –intangible amortization.*Cost of sales – intangible amortization for the 2025 Period of approximately $0.1 million was related to finite-lived intangible assets related to AVMAPKI FAKZYNJA CO-PACK which we recognized and began amortizing in the 2025 Period. There was no cost of sales – intangible amortization the 2024 Period.
Current wording
*Costs of sales –intangible amortization.*Cost of sales – intangible amortization for the 2025 Period of approximately $0.4 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. There was no cost of sales – intangible amortization during the 2024 Period.
Previous wording
2025 period was primarily driven by a $6.0 million GenFleet option payment related to VS-7375, a $4.7 million increase in CRO costs, a $2.5 million increase in investigator fees, a $2.3 million increase in personnel costs including non-cash stock compensation, a $2.1 million increase in drug substance and drug product manufacturing costs, and a $0.9 million increase in clinical supply costs. These increases were partially offset by a $0.3 million decrease in investigator-sponsored trial (“IST”) expenses.
Current wording
Research and development expense.* *Research and development expense for the Period was $82.9 million compared to $60.5 million for the 2024 Period. The $22.4 million increase in R&D expense from the 2024 period to the 2025 period was primarily driven by a $7.4 million increase in CRO costs, a $5.1 million increase in drug substance and drug product manufacturing costs, a $4.2 million increase in investigator fees, a $3.6 million increase in personnel costs, including non-cash stock-based compensation, a$6.0 million GenFleet Option payment related to VS-7375 in the 2025 Period, a $0.8 million increase in clinical supply costs, and a $0.7 million increase in pre-clinical expenses. These increases were partially offset by a $3.0 million milestone payment made to GenFleet in the 2024 Period, and a $2.4 million decrease in consulting expenses.
Previous wording
The $8.2 million increase in avutometinib+ defactinib – LGSOC is primarily driven by an increase in RAMP 301 trial costs as the trial continues to advance and enroll more patients. The $1.9 million decrease in avutometinib + defactinib – NSCLC is primarily driven by a decrease in RAMP 202 trial costs. The $1.3 million increase in avutometinib + defactinib – pancreatic cancer is primarily driven by fully utilizing the PanCAN Grant in the second quarter of 2024 and therefore there was no offsetting reduction in expense in the 2025 Period. The $2.7 million decrease in avutometinib and defactinib manufacturing and non-clinical trial specific expenses was driven by a reduction in study activities and safety consulting services. The $9.8 million increase in GenFleet related expenses was primarily driven by the $6.0 million GenFleet Option payment with respect to VS-7375.
Current wording
The $9.8 million increase in avutometinib+ defactinib – LGSOC is primarily driven by an increase in RAMP 301 trial costs as the trial continues to advance and enroll more patients. The $1.9 million decrease in avutometinib+ defactinib – NSCLC is primarily driven by a decrease in RAMP 202 trial costs. The $1.6 million increase in avutometinib + defactinib – pancreatic cancer is primarily driven by fully utilizing the PanCAN Grant in the second quarter of 2024 and therefore there was no offsetting reduction in expense in the 2025 Period. The $4.4 million decrease in avutometinib and defactinib manufacturing and non-clinical trial specific expenses was driven by decreased drug metabolism and pharmacokinetics testing costs, decreased consulting costs, and decreased drug substance manufacturing costs. The $12.1 million increase in GenFleet/ VS-7375 related expenses is driven primarily by the $6.0 million GenFleet Option payment with respect to VS-7375 the 2025 Period, drug substance and product manufacturing costs and
Previous wording
Selling, general and administrative expense. Selling, general and administrative expense for the 2025 Period was $35.7 million compared to $20.6 million for the 2024 Period. The increase of $15.1 million from the 2024 Period to the 2025 Period was primarily driven by an $11.7 million increase in consulting and professional fees, a $3.7 million increase in personnel costs including non-cash stock-based compensation, a $1.1 million financing cost fee related to the Note Purchase Agreement and the 2025 Private Placement, and a $1.1 million increase in travel, conference, and other expenses. These increases were partially offset by a $2.5 million decrease in commercial operations expenses.
Current wording
*Selling, general and administrative expense.Selling, general and administrative expense for the 2025 Period was $56.7 million compared to $32.8 million for the 2024 Period. The increase of $23.9 million from the 2024 Period to the 2025 Period was primarily driven by a $19.9 million increase in consulting and professional fees related to the launch of AVMAPKI FAKZYNJA CO-PACK for the treatment of KRAS mutant recurrent LGSOC, and a $5.9 million increase in personnel costs including non-cash stock-based compensation. These increases were partially offset by a $1.4 million decrease in commercial operations expenses and a $0.5 million decrease in in travel, conference, and other expenses. *
Previous wording
Other expense. Other expense for the 2025 Period and the 2024 Period was less than $0.1 million. Other expense for the 2025 Period and 2024 Period was comprised of transaction losses due to changes in foreign currency exchange rates.
Current wording
Other expense. Other expense for the 2025 Period was $0.2 million compared to $0.1 million for 2024 Period. Other expense for the 2025 Period and 2024 Period was comprised of transaction losses due to changes in foreign currency exchange rates.
Previous wording
*Interest income.*Interest income for the 2025 Period was $1.8 million compared to $2.4 million for the 2024 Period. The decrease of $0.6 million from the 2024 Period to the 2025 Period in interest income was primarily due to the decrease in investment balances on short term investments and cash equivalents and a decrease in interest rates on securities during each respective quarter.
Current wording
*Interest income.*Interest income for the 2025 Period was $3.0 million compared to $3.2 million for the 2024 Period. The decrease of $0.2 million from the 2024 Period to the 2025 Period in interest income was primarily due to the decrease in investment balances on short term investments and cash equivalents and a decrease in interest rates on securities during each respective period.
Previous wording
*Interest expense.*Interest expense for the 2025 Period was $0.4 million compared to $2.3 million for the 2024 Period. The decrease of $1.9 million from the 2024 Periodwas primarily driven by termination of the Loan Agreement with Oxford on January 13, 2025 resulting in a reduction of interest expense recorded in the 2025 Period. The Company
Current wording
*Interest expense.*Interest expense for the 2025 Period was $0.7 million compared to $3.4 million for the 2024 Period. The decrease of $2.7 million from the 2024 Periodwas primarily driven by termination of the Loan Agreement with Oxford on January 13, 2025 resulting in a reduction of interest expense recorded in the 2025 Period. The Company has elected to record interest expense associated with the Notes within change in fair value of Notes on the condensed statements of operations and comprehensive loss.
Previous wording
*Change in fair value of Notes.*We elected the fair value option for the Notes and therefore the changes in fair value, including interest, other than changes that are directly attributable to instrument specific credit risk are recorded as change in fair of Notes in the condensed statements of operations and comprehensive loss. The change in fair value for the 2025 Period of $7.4 million was primarily driven by interest on the Notes and a reduction in the risk-free rate during the 2025 Period. There were no Notes outstanding in the 2024 Period.
Current wording
*Change in fair value of Notes.*We elected the fair value option for the Notes and therefore the changes in fair value, including interest, other than changes that are directly attributable to instrument specific credit risk are recorded as change in fair of Notes in the condensed statements of operations and comprehensive loss. The change in fair value for the 2025 Period of $10.2 million was primarily driven by interest on the Notes and a reduction in the risk-free rate during the 2025 Period. There were no Notes outstanding in the 2024 Period.
Previous wording
We have financed our operations to date primarily through public and private offerings of our common stock, pre-funded warrants, and warrants, offerings of convertible notes, sales of common stock under our at-the-market equity offering program, our loan and security agreement executed with Hercules in March 2017, as amended, the Loan Agreement with Oxford, our Note Purchase Agreement, the upfront payments and milestone payments under our license and collaboration agreements with Sanofi, CSPC, and Yakult, the upfront payment and milestone payments received under the Secura APA, and sales of Series B Convertible Preferred Stock. Additionally, from our U.S. commercial launch of COPIKTRA on September 24, 2018, through our ownership period ending in September 2020, we financed a portion of our operations through product revenue. As of September 30, 2020, we have sold our COPIKTRA license and no longer sell COPIKTRA in the United States. We expect to finance a portion of our business through future potential milestones and royalties received pursuant to the Secura APA.
Current wording
We have financed our operations to date primarily through public and private offerings of our common stock, pre-funded warrants, and warrants, offerings of convertible notes, sales of common stock under our at-the-market equity offering program, our loan and security agreement executed with Hercules in March 2017, as amended, the Loan Agreement with Oxford, our Note Purchase Agreement, the upfront payments and milestone payments under our license and collaboration agreements with Sanofi, CSPC, and Yakult, the upfront payment and milestone payments received under the Secura APA, and sales of Series B Convertible Preferred Stock. Additionally, we have financed a portion of our operations through product revenue, including from AVMAPKI FAKZYNJA CO-PACK, beginning with our U.S. commercial launch in May 2025 and from COPIKTRA, from its U.S. commercial launch in September 2018 through our sale of the COPIKTRA license in September 2020. We expect to finance a portion of our business through future potential milestones and royalties received pursuant to the Secura APA.
Previous wording
As of June 30, 2025, we had $164.3 million of cash, cash equivalents, and investments. We primarily invest our cash, cash equivalents and investments in U.S. Government money market funds, U.S. government agency bonds, corporate bonds and commercial paper of publicly traded companies.
Current wording
As of September 30, 2025, we had $137.7 million of cash, cash equivalents, and investments. We primarily invest our cash, cash equivalents and investments in U.S. Government money market funds, U.S. government agency bonds, corporate bonds and commercial paper of publicly traded companies.
Previous wording
Operating activities. 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 $84.2 million and $43.4 million for the 2025 Period and the 2024 Period, respectively. 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. Non-cash charges and adjustments for the 2024 Period were primarily related to a change in fair value of preferred stock tranche liability and stock-based compensation expense. Our cash inflow from operating activities due to changes in operating assets and liabilities was $12.9 million for the 2025 Period. Our cash outflow from operating activities due to changes in operating assets and liabilities was $12.5 million for the 2024 Period. 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 increase of $0.8 million in prepaid expenses, other current assets and other assets. Cash outflow due to changes in operating assets and liabilities for the 2024 Period was primarily driven by an increase of $10.0 million of accounts receivable, $0.8 million of grant receivable, a decrease of $0.7 million of accrued expenses and other liabilities, a decrease of $0.5 million of accounts payable, and a decrease of $0.3 million of deferred liabilities. The increases in both periods in prepaid expenses, other current assets, and other asserts is exclusive of cash received from PanCAN and
Current wording
Operating activities. 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 $123.3 million and $78.7 million for the 2025 Period and the 2024 Period, respectively. 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. Non-cash charges and adjustments for the 2024 Period were primarily related to the changes in fair value of the preferred stock tranche liability, the change in fair value of warrant liability and stock-based compensation expense. Our cash inflow from operating activities due to changes in operating assets and liabilities was $15.8 million for the 2025 Period primarily driven by an increase of $21.6 million in accrued expenses and other liabilities, and an increase of $4.5 million in accounts payable, partially offset by an increase of $6.7 million in accounts receivable, an increase of $1.9 million in prepaid expenses, other current assets and other assets, and an increase of $1.8 million in inventory. Ourcash outflow due to changes in operating assets and liabilities was $0.9 million for the 2024 Period was primarily driven by a decrease of $2.7 million in accounts payable, an increase of $1.9 million in prepaid expenses, other current assets and other assets, a decrease of $0.3 million in deferred liabilities, and an increase of $0.2 million in grant receivable partially offset by an increase of $4.2 million of accrued expenses and other liabilities. The increases or decreases in both periods in prepaid expenses, other current assets, and other asserts are exclusive of cash received from PanCAN and used on the
Previous wording
used on the RAMP 205 study. Cash used in operating activities was $71.3 million and $55.9 million for the 2025 Period and the 2024 Period, respectively.
Current wording
RAMP 205 study. Cash used in operating activities was $107.6 million and $79.7 million for the 2025 Period and the 2024 Period, respectively.
Previous wording
*Investing activities.*There was no cash used in investing activities for the 2025 Period. The cash provided by investing activities for the 2024 Period relates to maturities of investments of $60.0 million, partially offset by a purchase of property and equipment of less than $0.1 million.
Current wording
*Investing activities.*The cash used in investing activities for the 2025 Period relates to the purchase of intangible assets of $8.3 million. The cash provided by investing activities for the 2024 Period relates to maturities of investments of $60.0 million, partially offset by a purchase of property and equipment of less than $0.1 million.
Previous wording
Financing activities. The cash provided by financing activities for the 2025 Period represents $75.0 million of proceeds received pursuant to the Note Purchase Agreement, approximately $69.9 million of proceeds received from our 2025 Private Placement, $22.7 million of proceeds received pursuant to the Stock 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. The cash provided by financing activities for the 2024 Period represents $1.3 million of proceeds received from insurance premium financing and $0.2 million of proceeds received from exercise of stock options and our employee stock purchase plan, partially offset by $0.8 million of payments on insurance premium financing, $0.2 million of payments of deferred issuance costs, and $0.2 million of fees paid to the Lenders to amend our Loan Agreement with Oxford. 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 Payableto 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.
Current wording
Financing activities. The cash provided by financing activities for the 2025 Period represents $100.1 million of proceeds from issuance of common stock and pre-funded warrants, $75.0 million of proceeds received pursuant to the Note Purchase Agreement, $31.9 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 from exercise of stock options and employee stock purchase program, partially offset by the $42.6 million repayment of our Loan Agreement, and $1.0 million of payments for insurance premium financing. The cash provided by financing activities for the 2024 Period represents $53.8 million of net proceeds received from the issuance of shares of common stock, pre-funded warrants, and warrants as part of the July 2024 Offering, $1.3 million of proceeds received from insurance premium financing and $0.2 million of proceeds received from exercise of stock options and our employee stock purchase plan, partially offset by $1.2 million of payments on insurance premium financing, and $0.2 million of fees paid to the Lenders to amend our Loan Agreement with Oxford. 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 Payableto 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.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor
Current report — wording carried from elsewhere
approximately 20 hospitals in China. The Phase 1 study was used to determine the recommended Phase 2 dose, and the Phase 2 study will further evaluate the efficacy and safety of VS-7375 in patients with advanced solid tumors, such as PDAC, CRC, and NSCLC.
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
*Costs of sales – product.*Costs of sales – product for the 2025 Quarter of approximately $1.7 million consisted of costs associated with the manufacturing of AVMAPKI FAKZYNJA CO-PACK, royalties owed to Chugai, Pfizer, and the Institute for Cancer Research (“ICR”) on such sales, and certain period costs. The Company began capitalizing
Rearranged previous paragraphs (9)
Previous report — wording carried elsewhere
A dose level “0” has been added to the RAMP 205 study protocol that evaluates 3.2 mg of avutometinib twice a week, 200 mg of defactinib twice a day for three weeks out of every four weeks with 800 mg/m 2 of gemcitabine and 100 mg/m 2 of Nab-paclitaxel on a schedule of day 1, day 8, and day 15. All dose levels have been expanded to 12 patients each, including six additional patients recently enrolled to dose devel 1, where it was reported five out of six patients reported an objective response rate at the American Society of Clinical Oncology (“ASCO”) 2024 Annual Meeting. At
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of March 31, 2025, GenFleet reported that there were no dose-limiting toxicities observed across all dose levels (100-900 mg QD), and the treatment-related adverse events (“TRAEs”) were mostly Grade 1/2. The most common TRAEs occurring in at least 20% of patients were diarrhea, nausea, vomiting, and anemia. TRAEs ≥ Grade 3 consisted mainly of decreased neutrophil count (8%) and diarrhea (5%). No TRAE-related deaths were reported.
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We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as “critical” because these specific areas generally require us to make judgments
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*Sale of COPIKTRA license and related assets revenue.*Sale of COPIKTRA license and related assets revenue for the 2025 Quarter was $0.0 million compared to $10.0 million for the 2024 Quarter. Sale of COPIKTRA license and related assets revenue for the 2024 Quarter was comprised of one sales milestone payment of $10.0 million due to Secura achieving cumulative worldwide net sales of COPIKTRA exceeding $100.0 million during the 2024 Quarter. We received the $10.0 million milestone payment in July 2024.
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*Interest income.*Interest income for the 2025 Quarter was $0.8 million compared to $1.0 million for the 2024 Quarter. The decrease of $0.2 million from the 2024 Quarter to the 2025 Quarter in interest income was primarily due to the decrease in investment balances on short term investments and cash equivalents and a decrease in interest rates on securities during each respective quarter.
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*Change in fair value of preferred stock tranche liability.*The change in fair value of the preferred stock tranche liability was $0.0 million for the 2025 Quarter compared to $10.2 million income for the 2024 Quarter. The change in fair value of preferred stock tranche liability was comprised of the mark-to-market adjustment related to the second tranche right issued as part of the Securities Purchase Agreement. The preferred stock tranche liability expired in July 2024 and therefore was not outstanding during the 2025 Quarter. The fair value of the preferred stock tranche liability
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decreased from $10.2 million at the beginning of the 2024 Quarter to $0.0 million at the end of the 2024 Quarter resulting in $10.2 million income in the 2024 Quarter.
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Research and development expense.* *Research and development expense for the Period was $53.9 million compared to $35.8 million for the 2024 Period. The $18.2 million increase in R&D expense from the 2024 period to the
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has elected to record interest expense associated with the Notes within change in fair value of Notes on the condensed statements of operations and comprehensive loss.