On August 6, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported financial results for the second quarter ended June 30, 2026, and highlighted recent business progress.

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"The second quarter marked meaningful progress across our commercial business and pipeline programs, with strong quarter-over-quarter growth for AVMAPKI FAKZYNJA CO-PACK driven by new patient starts and increased refills," said Dan Paterson, president and chief executive officer at Verastem Oncology. "In the first-half clinical update for VS-7375, we demonstrated encouraging activity across multiple KRAS G12D-driven tumors, including pancreatic, colorectal, and non-small cell lung cancers. VS-7375 demonstrated dose-dependent anti-tumor activity, favorable PK supporting target exposure, and a manageable safety and tolerability profile without many of the on-target toxicities seen with panRAS approaches. With the first patients dosed across our three registration-directed Phase 2 trials, we expect to complete enrollment by year-end. We remain focused on advancing what we believe is a differentiated KRAS G12D inhibitor with the potential to fundamentally change outcomes and the treatment experience for patients with KRAS G12D-driven cancers, and we look forward to sharing additional clinical data in October."

Mr. Paterson added, "The incremental $90 million in non-dilutive funding strengthens our balance sheet and allows us to get beyond key data read outs, continue evaluating strategic partnerships, and preserve strategic flexibility as we evaluate future financing opportunities."

Second Quarter 2026 and Recent Updates

AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets)

· AVMAPKI FAKZYNJA CO-PACK generated net product revenue of $25.1 million for the second quarter of 2026.
· In July, updated data from the RAMP 201 Japan study were presented at the Annual Meeting of the Japanese Society of Gynecologic Oncology (JSGO) held July 17-19, 2026, in Sapporo, Japan. As of May 29, 2026, 16 efficacy-evaluable patients with recurrent low-grade serous ovarian cancer (LGSOC) had received avutometinib plus defactinib, with a median follow up of 12.4 months. The combination achieved a 44% overall response rate and a 94% disease control rate across all patients. Response rates were 71% in patients with KRAS-mutated tumors and 22% in those with KRAS wild-type tumors, with disease control rates of 100% and 89%, respectively. Overall, 94% of patients experienced tumor shrinkage, and 11 of 16 patients remained on treatment at the data cutoff.

· On June 17, the Company announced positive updated results from the RAMP 205 Phase 1b/2a recommended phase 2 dose cohort of 29 patients evaluating avutometinib plus defactinib in combination with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic ductal carcinoma (PDAC). As of the June 5, 2026 data cutoff (median follow-up of 9.8 months) the combination achieved a 52% confirmed objective response rate (cORR), with both an 86% overall survival rate and 68% progression-free survival rate at six months. The combination demonstrated a consistent safety profile with no new safety signals. Nine patients remain on treatment, and follow-up continues as survival data matures.
· On May 8, the Company announced the launch of the new LGSOC Resource Guide to support people living with LGSOC.
· On April 30, the Company announced the launch of a new healthcare professional and patient marketing campaign, Reimagine Recurrent Low-Grade Serous Ovarian Cancer), to drive awareness of AVMAPKI FAKZYNJA CO-PACK.
· On April 10, the Company announced new two-year median follow-up data from the Phase 2 RAMP 201 trial that demonstrated durable benefit of avutometinib plus defactinib across both KRAS-mutant and KRAS wild-type patients with recurrent LGSOC, with discontinuation rates due to adverse events consistent with the primary analysis. The data were presented at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women’s Cancers. A new exposure-response analysis was also presented at SGO that demonstrated that the approved dose and schedule of avutometinib plus defactinib achieved the optimal therapeutic effect.

Expected Key Milestones:

· Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027.
· Continue to pursue regulatory paths for potential expansion of recurrent LGSOC into Europe and Japan.

VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor in Advanced Solid Tumors

· On July 28, July 22, and June 16, the Company announced the first patient was dosed in the TARGET-D 203 colorectal cancer (CRC), TARGET-D 202 non-small cell lung cancer (NSCLC), and TARGET-D 201 PDAC clinical trials, respectively, marking the initiation of patient enrollment across all three TARGET-D registration-directed Phase 2 studies.
· At the end of June, the Company completed target enrollment in TARGET-D 101 PDAC and NSCLC monotherapy cohorts and CRC cetuximab combination cohorts. More than 200 patients have been treated with VS-7375 in the TARGET-D 101 dose escalation and expansion study.
· The Company has also cleared the 1200 mg daily (QD) dose of VS-7375 with no dose-limiting toxicities (DLTs) observed. Patients will continue to be evaluated at this dose in the TARGET-D 101 dose escalation study to support Project Optimus requirements, with no changes to the current study designs for the Phase 2 TARGET-D 201, 202, and 203 clinical trials.
· On June 23, the Company announced a preliminary update and progress from the VS-7375 clinical development program. The data presented continued to support a differentiated profile for VS-7375, demonstrating encouraging anti-tumor activity across multiple KRAS G12D-driven tumor types, including metastatic PDAC, metastatic CRC, and advanced NSCLC, with evidence of dose-dependent activity, favorable pharmacokinetics (PK) supporting target exposure, and a favorable, manageable safety and tolerability profile. Patient follow-up continues to mature across both monotherapy and combination cohorts.

· On June 23, the Company announced its and Erasca, Inc.’s intent to enter into an agreement to evaluate VS-7375 with Erasca’s potential best-in-class oral pan-RAS molecular glue, ERAS-0015, across KRAS G12D mutant solid tumor models. In July, the companies executed an agreement, enabling the planned preclinical evaluation. Subject to the outcome of the preclinical evaluation and execution of a definitive agreement, the Companies intend to explore a future clinical trial collaboration to evaluate the combination in patients with advanced solid tumors.
· On June 3, the Company announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic NSCLC who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially.
· On May 7, the Company reported continued progress in the Phase 1/2 TARGET-D 101 trial, including advancement to the 1200 mg QD dose and PK data supporting target plasma exposure at the 900 mg QD dose.

Expected Key Milestones:

· Report updated VS-7375 clinical data in October 2026.
· Complete enrollment across all three TARGET-D Phase 2 trials by the end of 2026.
· Meet with the FDA before the end of the year to review Phase 3 pivotal trial designs in 1L mPDAC, 1L mCRC, and 1L advanced NSCLC.
· Enroll the first patient in each of the Phase 3 pivotal trials in the first half of 2027.

Corporate Updates

· On May 26, the Company announced the appointment of Michael P. Bailey to its Board of Directors.
· Today, the Company also reported that it has signed a non-dilutive, royalty financing agreement with Oberland Capital. Under the terms of the deal, the Company will receive up to $75 million in cash, with $50 million at closing on August 28, 2026, plus up to $25 million at the Company’s option provided that its calendar quarterly worldwide net sales of AVMAPKI FAKZYNJA CO-PACK are at least $40 million prior to May 15, 2027.
· Secura Bio, Inc. achieved $200 million of cumulative worldwide net sales of COPIKTRA during Q2 2026, entitling Verastem to a $15 million milestone payment, which was received in July 2026.

Second Quarter 2026 Financial Results

Verastem Oncology ended the second quarter of 2026 with cash, cash equivalents, and investments of $136.4 million. On a pro forma basis, inclusive of the $50.0 million non-dilutive royalty financing arrangement that is expected to close on August 28, 2026, subject to satisfaction of closing conditions, and the $15.0 million net sales milestone from Secura, cash, cash equivalents and investments were $201.4 million as of June 30, 2026. Based on Verastem’s pro forma cash position, expected revenues from AVMAPKI FAKZYNJA CO-PACK sales, and access to the future tranche from the Oberland facility, Verastem believes it has sufficient capital to fund operations into the second half of 2027.

Total revenue for the three months ended June 30, 2026 (the "2026 Quarter") was $40.1 million, compared to $2.1 million for the three months ended June 30, 2025 (the "2025 Quarter").

Net product revenue for the 2026 Quarter was $25.1 million, compared to $2.1 million in net product revenue recognized for the 2025 Quarter. The Company began commercial sales of the AVMAPKI FAKZYNJA CO-PACK within the U.S. following receipt of FDA approval in May 2025.

Sale of COPIKTRA license and related assets revenue for the 2026 Quarter was $15.0 million, due upon Secura achieving cumulative worldwide net sales of COPIKTRA exceeding $200.0 million during the 2026 Quarter.

Total operating expenses for the 2026 Quarter were $72.8 million, compared to $45.9 million for the 2025 Quarter. Cost of sales was $4.0 million for the 2026 Quarter, compared to $0.4 million for the 2025 Quarter.

Research & development expenses for the 2026 Quarter were $41.3 million, compared to $24.8 million for the 2025 Quarter. The increase of $16.5 million, or 67%, was primarily due to increased costs for investigator fees, contract research organization costs, drug product manufacturing, and personnel costs, including non-cash stock-based compensation.

Selling, general & administrative expenses for the 2026 Quarter were $27.4 million, compared to $20.7 million for the 2025 Quarter. The increase of $6.7 million, or 32%, was primarily due to higher costs for personnel, including non-cash stock-based compensation and commercial operations.

Net loss (GAAP basis) for the 2026 Quarter was $34.7 million, or $0.35 per share (basic and diluted), compared to $25.9 million, or $0.39 per share (basic) for the 2025 Quarter.

Non-GAAP adjusted net loss for the 2026 Quarter was $30.6 million, or $0.31 per share (basic), compared to non-GAAP adjusted net loss of $41.3 million, or $0.62 per share (basic), for the 2025 Quarter. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.

Conference Call and Webcast

Verastem will host a conference call and webcast today at 4:30 p.m. ET to review the second quarter 2026 financial results and recent business updates. To access the live audio webcast of the call, along with accompanying slides, please visit the "Events & Presentations" page in the Investor section of the Company’s website, View Source A replay of the webcast will be archived and available following the event.

(Press release, Verastem, AUG 6, 2026, View Source [SID1234669806])