Verastem Oncology Q1 2024 Financial Results and Business Updates

Verastem Oncology, a biopharmaceutical company focusing on developing new cancer treatments, shared significant business updates and financial results for the first quarter ending March 31, 2024.

Key achievements in Q1 2024 include receiving FDA Orphan Drug Designation for the combination of avutometinib and defactinib in treating recurrent low-grade serous ovarian cancer (LGSOC). This designation emphasizes the distinctiveness and rarity of this cancer type, underscoring the urgent need for novel therapeutic options. Dan Paterson, President and CEO, expressed enthusiasm about commencing the planned rolling NDA submission and sharing topline data for this combination therapy in Q2 2024. Additionally, Verastem plans to unveil initial results from the RAMP 205 trial in first-line metastatic pancreatic cancer at the 2024 ASCO Annual Meeting.

The company is actively enrolling participants and activating trial sites in the U.S., Australia, and the UK for the Phase 3 RAMP 301 trial. This trial compares the avutometinib and defactinib combination against standard chemotherapy or hormonal therapy for recurrent LGSOC. In March 2024, the FDA granted Orphan Drug Designation to avutometinib (alone or combined with defactinib) for all patients with recurrent LGSOC. Multiple abstracts from Verastem were selected for presentation at the Society of Gynecologic Oncology’s 2024 Annual Meeting.

Verastem will announce updated topline data from the RAMP 201 trial in LGSOC to align with the start of their rolling NDA submission for avutometinib and defactinib in Q2 2024. Preparations for a U.S. commercial launch in 2025 are underway, with plans to engage European and Japanese regulatory authorities to meet patient needs globally.

In the realm of non-small cell lung cancer (NSCLC), Verastem received FDA Fast Track Designation for avutometinib in combination with KRAS G12C inhibitors, including Mirati’s adagrasib and Amgen’s sotorasib, for treating KRAS G12C-mutated metastatic NSCLC. Data updates from the Phase 1/2 RAMP 203 and 204 trials, which explore these combinations, are anticipated in the second half of 2024.

Additionally, Verastem announced that the initial safety and efficacy data from the RAMP 205 trial, evaluating avutometinib and defactinib with standard care gemcitabine and nab-paclitaxel in first-line metastatic pancreatic cancer, will be presented at the ASCO Annual Meeting in 2024.

Verastem is also collaborating with GenFleet Therapeutics on the oral KRAS G12D (ON/OFF) inhibitor, GFH375 (VS-7375). The investigational new drug (IND) application for GFH375 has been submitted in China, with a Phase 1 trial expected to begin in the second half of 2024.

The company has strengthened its executive team with the appointment of John Hayslip, M.D., as Chief Medical Officer in April 2024. Financially, Verastem ended Q1 2024 with $110.1 million in cash, cash equivalents, and investments. Total operating expenses for the quarter were $28.1 million, up from $19.3 million in Q1 2023, reflecting increased R&D and preparation costs for the potential launch of avutometinib and defactinib in LGSOC. The net loss for Q1 2024 was $33.9 million, compared to $15.7 million in the previous year.

These advancements underscore Verastem Oncology’s commitment to developing and commercializing new, effective treatments for cancer patients, particularly those with RAS/MAPK-driven tumors. The company continues to progress its robust pipeline through strategic clinical trials, collaborations, and regulatory engagements, aiming to bring innovative therapies to market and improve patient outcomes worldwide.