Verastem, Inc.

Good afternoon and welcome to Veristem Oncology's fourth quarter and full year 2025 earnings conference call. My name is Desiree and I will be your call operator today. Please note this event is being recorded. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. I will now turn the call over to Julissa Viana, Vice President of Corporate Communications, Investor Relations, and Patient Advocacy at Veristem Oncology. Please go ahead.

Thank you, operator. Welcome, everyone, and thank you for joining us today to discuss Verisim's fourth quarter and full year 2025 financial results and recent business updates. This afternoon, we issued a press release detailing these results, along with a slide presentation that we will reference during our call today. Both are available on the investor relations section of our website. Before we begin, let me point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Additionally, today, we'll be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today. Joining me on today's call to deliver prepared remarks and take your questions are Dan Patterson, President and Chief Executive Officer, Mike Crowther, Chief Commercial Officer, Dr. Michael Kaufman, President of Development, and Dan Calkins, Chief Financial Officer. I will now turn the call over to Dan. Thank you, Delisa.

Good afternoon, and thanks for joining our call today. 2025 was a truly transformative year for Veristem as we transitioned to a commercial stage company following our FDA approval of the first treatment specifically for KRAS mutated recurrent low-grade serous ovarian cancer, nearly two months ahead of our PDUFA date. For the launch period of May through December 2025, we delivered 30.9 million of net product revenue and 17.5 million for the fourth quarter. I'm pleased to report that the strategies we put in place to guide our commercial launch continue to yield meaningful results. We continue to see steady growth driven by consistent adoption among both academic centers and community oncologists. Before I continue, I want to address the updated NCCN ovarian cancer guidelines that were released last week and mentioned in our press release today. The guidelines did not expand the recommendation for rudimentinib plus defactinib to include patients with the recurrent LGSOC without a KRAS mutation. This does not change our launch trajectory. Everything we've been doing for the launch has been based on the guidelines that include the combination as a category 2A recommendation for KRAS mutated recurrent LGSOC. We're disappointed for the patients with KRAS wild-type recurrent LGSOC who currently have no targeted FDA-approved treatment options specifically for their disease and face a particularly poor prognosis. Across three separate clinical trials, the FRAME study, RAMP201, and RAMP201J, we've observed what we believe are robust objective response rates for patients with recurrent LGSLC with and without KRAS mutations. We remain committed to advancing the clinical evidence through longer-term follow-up analyses from the RANF 201 study in 2026, and completing our ongoing confirmatory RANF 301 phase three clinical trial, which includes patients with and without KRAS mutations, and look forward to sharing these data next year with the NCCN and the medical community to support future guideline consideration. This clinical conviction and our confidence in our data is what underpins our commercial execution As Mike will share with you shortly, we have an opportunity to continue to drive more growth through the expansion of our prescriber base and increasing their comfort to use AvMapKey Faxinja Copac as first recurrence. With this approval, we've proven that precision targeting of RASMapK pathway with the combination of Arutamate and Plus-Defactonate can deliver meaningful outcomes for patients. Cancer is highly dependent on this pathway for its growth and approaches that block just a single node in this pathway are generally insufficient for deep and durable anti-cancer activity. The cancer will compensate by activating other signaling proteins within the RAS pathway or in parallel pathways. This is what differentiates azimutinib plus defactin and is defining our success in the market in the clinic. The team's execution through the early phases of the launch has enabled us to quickly deliver this medicine to patients living with a rare ovarian cancer who previously had no approved treatment options specifically for their disease. Likewise, our R&D team has made great strides in advancing key strategic clinical trials. As with LGSOC, the combination of avutametinib plus defactinib has shown promising anti-tumor activity in pancreatic cancer, a highly KRAS-driven cancer. And our RAMP205 trial in first-line metastatic pancreatic cancer we're combining avutametinib and difactinib with standard of care chemotherapy to improve response rates and other outcomes. Avutametinib can help to inhibit tumor growth, while difactinib works to inhibit SAC to reduce the stromal density in the pancreatic cancer tumor and address adaptive resistance to avutametinib. The updated data we shared at ASCO last year demonstrates the potential for this combination in treating one of the most challenging cancers. In addition to the Ibutametinib-Defactinib combination, we're targeting RAS-driven cancers with other novel therapies. This includes our other exciting pipeline program, VS7375, which has the potential best-in-class oral KRAS G12D on-off inhibitor. Building on the unprecedented data from our partner in China, we moved VS7375 into the clinic last year with a multi-indication trial strategy. Recent feedback from the FDA has given us a clear strategic path forward for clinical development. As a result, we'll be amending our existing VS-7375-101 trial protocol and separating out disease-specific Phase II registration-directed trials. This added clarity will help us move this program toward a potential accelerated approval pathway. Given the early results, we believe VS7375 has the strong potential to be the preferred agent in treating KRAS G12D-driven cancers like pancreatic, lung, and colorectal. Michael will provide a more fulsome update shortly. With all our clinical studies, we've made disciplined, data-driven decisions to prioritize those with the greatest potential impact for patients living with RAS-driven cancers. This was demonstrated in our decision to accelerate the VS-7375 program towards registration-directed studies and with the discontinuation of our glutamate plus defactant program in lung cancer in light of an evolving treatment landscape despite an interesting clinical signal. We have a wealth of opportunity but limits to our resources and will continue to prioritize the opportunities with the highest value. We'll continue to closely manage our expenses, and with our last financing and the exercise of the remaining cash warrants, we've extended our cash runway into the first half of 2027, giving us what we need to advance our near-term milestones. In fact, we believe the LGSOC franchise will be self-sustaining in the second half of this year, with COPAC revenues funding both the commercial operations and any ongoing clinical trials for A plus D. Our focus remains on identifying value-creating, non-dilutive opportunities in this challenging environment as we advance our clinical programs and deliver for patients and shareholders alike. With that, I'll turn the call over to Mike. Mike?