BOSTON–Verastem Oncology reported a narrower net loss and higher product revenue for the third quarter of 2026 as the company advanced its experimental KRAS-targeted cancer therapy, VS-7375, toward pivotal clinical trials in pancreatic, lung and colorectal cancers.
The biotechnology company reported a net loss of $74.7 million, or 74 cents per share, compared with a loss of $98.5 million, or $1.35 per share, in the same period last year.
Net product revenue from AVMAPKI FAKZYNJA CO-PACK, the company’s approved combination treatment for certain patients with recurrent low-grade serous ovarian cancer, increased to $24 million from $11.2 million a year earlier.
Operating expenses rose to $99.2 million from $52 million, reflecting increased investment in clinical development and commercial operations.
Research and development expenses climbed 137% to $68.8 million from $29 million, primarily because of higher clinical trial costs, drug manufacturing expenses, contract research activities and personnel-related spending.
Selling, general and administrative expenses increased 26% to $26.5 million from $21 million, driven by personnel and commercialization costs.
Verastem ended September with $172.8 million in cash, cash equivalents and investments, including proceeds from a $50 million royalty financing arrangement completed in August.
The company subsequently raised approximately $250 million in gross proceeds through an October public offering. Including those proceeds, its pro forma cash position stood at approximately $422.8 million as of September 30.
Verastem expects its financial resources, together with anticipated product revenue, to support operations into the first half of 2028.
The funding is expected to support multiple late-stage clinical trials of VS-7375, an investigational oral treatment designed to inhibit the KRAS G12D mutation, which is associated with several difficult-to-treat cancers.
“During the third quarter, we made significant progress with VS-7375, our potential best-in-class oral KRAS G12D (ON/OFF) inhibitor. Our first U.S. clinical data established a new monotherapy efficacy benchmark in metastatic pancreatic cancer and showed early but encouraging antitumor activity in colorectal and lung cancers, all driven by KRAS G12D, while continuing to demonstrate a manageable safety and tolerability profile without many of the on-target toxicities associated with pan-RAS approaches,” said Dan Paterson, President and Chief Executive Officer of Verastem Oncology.
Paterson said the company plans to begin its Phase 3 TARGET-D 301 trial in first-line KRAS G12D-mutated metastatic pancreatic cancer before the end of 2026, following discussions with the U.S. Food and Drug Administration.
The planned three-arm study will evaluate VS-7375 in combination with anti-EGFR therapy as a chemotherapy-free option and alongside gemcitabine and nab-paclitaxel, compared with standard chemotherapy selected by investigators.
Verastem also expects to discuss Phase 3 trial designs for colorectal and non-small cell lung cancers with the FDA before year-end.
The company’s recent clinical findings showed promising early antitumor activity across several cancer types.
In patients with metastatic pancreatic cancer who had received at least one previous treatment, VS-7375 produced a confirmed objective response rate of 41%, with nine of 22 patients experiencing measurable tumor shrinkage meeting the study’s response criteria.
Among eight patients receiving the drug as second-line treatment, four achieved confirmed responses, representing a 50% response rate.
The disease control rate in the broader pancreatic cancer group was 86%, while the six-month progression-free survival rate was 67%.
In non-small cell lung cancer, VS-7375 demonstrated a confirmed objective response rate of 43% among 23 previously treated patients receiving a 600-milligram daily dose.
Early findings from eight previously untreated lung cancer patients receiving VS-7375 alongside chemotherapy and pembrolizumab showed an objective response rate of 75%.
In metastatic colorectal cancer, preliminary results showed an objective response rate of 33% among six patients treated with VS-7375 in combination with anti-EGFR therapy after at least two previous treatment regimens. One response was confirmed and the other remained unconfirmed.
The company cautioned that several of these findings are based on small patient groups and require further evaluation in larger clinical studies.
Safety data from the ongoing TARGET-D 101 Phase 1/2 program showed that VS-7375 was generally manageable at the doses evaluated.
At the 900-milligram daily dose, 2% of patients discontinued treatment because of adverse events, while Grade 3 treatment-related adverse events occurred in 10% of patients. Most treatment-related side effects were low-grade gastrointestinal events.
Verastem is continuing enrollment in three Phase 2 registration-directed studies evaluating VS-7375 in pancreatic, lung and colorectal cancers.
Enrollment in the pancreatic and colorectal cancer studies is expected to be completed by the end of 2026, while enrollment in the lung cancer study is projected to conclude during the second quarter of 2027.
The company also expects to report additional clinical data from its VS-7375 program throughout 2027.
Meanwhile, Verastem continues expanding the commercial and clinical development of AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib.
The treatment received FDA accelerated approval in May 2025 for adults with KRAS-mutated recurrent low-grade serous ovarian cancer who previously received systemic therapy.
The company said strong prescription refill activity supported third-quarter sales, although fewer new patients began treatment because of seasonal factors, commercial team changes and evolving treatment patterns.
The FDA recently accepted a new drug application for a blister-pack presentation of AVMAPKI FAKZYNJA CO-PACK and granted Priority Review, with a decision expected by February 7, 2027.
The new packaging is intended to make treatment administration more convenient and support medication adherence.
Verastem also reported additional findings from its Phase 2 RAMP 201 study evaluating avutometinib and defactinib in patients with recurrent low-grade serous ovarian cancer.
Molecular profiling data presented at the International Gynecologic Cancer Society’s 2026 Annual Global Meeting showed response rates of 22% among patients with NRAS- or BRAF-mutated tumors and 18% among patients whose tumors lacked KRAS, NRAS and BRAF mutations.
An analysis comparing study results with an external control group also suggested improvements in progression-free survival and response rates across certain patient populations.
The company expects to report the primary endpoint results from its Phase 3 RAMP 301 confirmatory trial in mid-2027.
In a separate corporate development, Verastem announced that Michael P. Bailey will become President and Chief Executive Officer on January 1, 2027, succeeding Paterson, who plans to retire from his executive position.
Paterson will remain on the company’s Board of Directors and serve as an advisor following the transition.
Verastem also expanded its research collaboration with GenFleet Therapeutics, selecting a second development program focused on cancers driven by the RAS/MAPK signaling pathway.
Under an amended agreement, Verastem will lead preclinical and clinical development of the program outside China, while GenFleet will retain an option for development rights in China.
The company discontinued a previously selected third research program because of technical challenges.
Verastem said its immediate priorities include launching the Phase 3 pancreatic cancer trial, advancing its lung and colorectal cancer programs and continuing the commercialization of AVMAPKI FAKZYNJA CO-PACK.
