Verastem Oncology Q2 2024 Financial Results and Business Updates

Verastem Oncology, a biopharmaceutical company specializing in cancer treatments, has recently announced significant business developments and its financial results for the second quarter ending June 30, 2024. The company has made notable strides, including the initiation of a rolling New Drug Application (NDA) submission for a combination therapy of avutometinib and defactinib targeting recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). Additionally, updated topline results from the RAMP 201 trial and promising interim results from an ongoing first-line metastatic pancreatic cancer trial have been shared.

In the second half of 2024, Verastem plans to present mature data from the RAMP 201 trial, complete the NDA submission with this data, and share interim topline data from their lung cancer programs.

For the LGSOC treatment, Verastem has initiated a rolling NDA submission for the combination of avutometinib and defactinib for adults with recurrent KRAS mutant LGSOC who have undergone at least one prior systemic therapy. The company shared interim data from the RAMP 201 trial in May 2024, showing strong overall response rates and durable responses. The NDA submission is expected to be completed by the end of 2024, after submitting mature safety and efficacy data from the RAMP 201 trial. Additionally, the international confirmatory Phase 3 RAMP 301 trial is underway, with site activations across the U.S., Australia, Europe, and the UK. Preparations for a potential U.S. commercial launch in 2025 are in progress, alongside plans to engage with European and Japanese regulatory authorities.

In terms of lung cancer research, the RAMP 203 trial involves patients previously treated with KRAS G12C inhibitors, now receiving a combination therapy of avutometinib, defactinib, and sotorasib. Interim data from this study and the RAMP 204 trial, which evaluates avutometinib combined with adagrasib, are expected in the second half of 2024.

The company has also presented preliminary safety and efficacy results from the ongoing RAMP 205 trial in first-line metastatic pancreatic cancer. Initial results, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024, indicated high partial response rates among patients. The FDA granted Orphan Drug Designation to the combination of avutometinib and defactinib for pancreatic cancer treatment in July 2024, with further data expected in early 2025.

Additionally, GenFleet Therapeutics’ investigational drug GFH375 (VS-7375), an oral KRAS G12D inhibitor, received clearance in China in June 2024, with the first patient dosed in a Phase 1/2 trial in July 2024. Verastem plans to commence development studies outside China after initial data evaluation.

Verastem has strengthened its executive team with the appointment of Dr. John Hayslip as Chief Medical Officer in April 2024 and Nate Sanburn as Chief Business Officer in June 2024. Financially, Verastem raised approximately $51.1 million through a public offering in July 2024 and received a $10 million milestone payment from Secura Bio, Inc. for achieving $100 million in worldwide net sales of COPIKTRA.

In the second quarter of 2024, Verastem reported total revenue of $10 million and ended the quarter with $83.4 million in cash, cash equivalents, and investments. Including the funds raised in July and the milestone payment from Secura, the company’s assets totaled $144.5 million as of June 30, 2024. Operating expenses for the second quarter were reported at $28.3 million, with research and development expenses at $18.1 million. The net loss for the quarter was $8.3 million, or $0.31 per share.

In summary, Verastem Oncology has shown significant progress in its clinical trials, strengthened its financial position, and expanded its executive team, all contributing to its mission of developing and commercializing new cancer treatments.