Verastem Oncology (Nasdaq: VSTM) reported initial Phase 1/2 response data for VS-7375 across several KRAS G12D-mutated cancers and priced a $250 million underwritten offering to fund further clinical development.
VS-7375 is an investigational oral drug designed to inhibit both the active and inactive states of KRAS G12D, a mutation found in pancreatic, colorectal, lung and other cancers. No therapy specifically targeting KRAS G12D has received U.S. Food and Drug Administration approval.
The October 14 update included 22 previously treated patients with metastatic pancreatic ductal adenocarcinoma who received 900 mg of VS-7375 once daily. After a median follow-up of 6.4 months, nine patients had confirmed objective responses, producing a 41% confirmed response rate.
Among eight patients receiving VS-7375 as second-line treatment, four had confirmed responses. Five of 14 patients treated in the third- or fourth-line setting responded. The company also reported two complete responses across the broader group, although only one had been confirmed at the data cutoff.
Sixteen of the 22 patients remained on treatment. The disease-control rate was 86%, while the six-month landmark progression-free and overall-survival rates were 67% and 80%, respectively.
The results remain preliminary and came from a small, uncontrolled study. Without a randomized comparator, the data cannot establish whether VS-7375 improves survival relative to existing treatment. Follow-up also remains limited, and the response estimates could change as the study matures.
Verastem separately reported a 43% confirmed response rate among 23 previously treated non-small cell lung cancer patients receiving the 600 mg dose. In colorectal cancer, two of six patients receiving 900 mg with an anti-EGFR treatment responded, including one confirmed and one unconfirmed response.
Across 48 patients receiving 900 mg monotherapy, 10% experienced Grade 3 treatment-related adverse events and 2% discontinued because of adverse events. The most common treatment-related events were primarily low-grade nausea, vomiting and diarrhea.
CEO Daniel Paterson said the pharmacokinetic and biomarker findings “support the target coverage and antitumor activity observed to date.”
Verastem has reached alignment with the FDA on a three-arm Phase 3 study in first-line metastatic pancreatic cancer. The trial will compare two VS-7375-based combinations with standard chemotherapy and is expected to open by the end of 2026.
The company priced 30,937,500 common shares at $8 each and pre-funded warrants covering another 312,503 shares at $7.9999 per warrant. The offering is expected to generate approximately $250 million in gross proceeds and close around October 15, subject to customary conditions.
Verastem plans to use the proceeds for clinical development, including the VS-7375 program, working capital and general corporate purposes. The offering materially increases the company’s outstanding share count and dilutes existing shareholders.
Verastem reported $136.4 million in cash, cash equivalents and investments as of June 30, 2026. Second-quarter revenue was $40.1 million, while its net loss was approximately $34.7 million.
Upcoming Catalysts
- Expected opening of the first-line pancreatic-cancer Phase 3 trial by year-end
- Additional colorectal and pancreatic-cancer combination data in 2026
- Initial first-line pancreatic-cancer combination data in the first quarter of 2027
- Phase 2 TARGET-D 201 pancreatic-cancer data in the second quarter of 2027
- Further Phase 2 lung- and colorectal-cancer results during 2027
Sources
- Verastem reports VS-7375 clinical results — October 14, 2026
- Verastem prices $250 million offering — October 14, 2026
- Verastem Form 10-Q for the quarter ended June 30, 2026
Editorial Disclosure
This article is based entirely on publicly available information, including company announcements and SEC filings. Securities discussed or referenced include Verastem Inc. (Nasdaq: VSTM). Biotech Stocks Daily has not received compensation from Verastem, its management, investor relations representatives or any third party for this specific article. Biotech Stocks Daily may have current or past paid business relationships with other companies, which do not influence the content or conclusions of this article. No staff member or principal of Biotech Stocks Daily holds a position in any security mentioned at the time of publication.
Confirmed sources include Verastem’s October 14, 2026 clinical-results and offering announcements and its Form 10-Q for the quarter ended June 30, 2026. Information concerning VS-7375’s mechanism, clinical activity, safety profile and anticipated development timelines originated primarily from Verastem and has not been independently validated by Biotech Stocks Daily.
VS-7375 remains investigational and has not received regulatory approval. The reported results came from small, non-randomized cohorts with limited follow-up. Response rates from early clinical development may change as additional patients are enrolled and the data mature. They may not predict results from randomized or pivotal trials. One of the two reported complete responses in pancreatic cancer remained unconfirmed at the data cutoff.
The $250 million offering was expected to close around October 15, 2026, subject to customary conditions. The issuance of 30,937,500 common shares causes substantial dilution, while the accompanying pre-funded warrants may create additional dilution when exercised. Gross proceeds are reported before underwriting discounts, commissions and other offering expenses.
Financial information reflects Verastem’s position as of June 30, 2026 and does not include the net proceeds from the October offering. The company reported ongoing operating losses and expects continued expenses related to clinical development and commercialization.
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