Verastem (NasdaqCM: VSTM) Conference Call Summary Company Overview - Verastem is focused on small molecules in the RAS pathway, which is commonly implicated in hard-to-treat cancers. The company has a commercial product that has seen a successful launch in its first three quarters, and it is developing a best-in-class G12D inhibitor in a competitive market [5][6][7]. Commercial Business and Product Launch - The company launched AVMAPKI FAKZYNJA for low-grade serous ovarian cancer (LGSOC) about eight months ago, reporting a 50% increase in sales from Q2 to Q3 to Q4, indicating a strong growth trajectory [6][7]. - The response rate for LGSOC treatment is over 40%, significantly higher than the standard of care response rate of 5%-16% [6][7]. - Patients in the trial stayed on treatment for an average of 18 months, suggesting a potential annuity-like revenue model [7]. Prescription Trends and Market Adoption - Broad adoption of the drug is observed, particularly among top academic institutions and large practices, which account for about half of the patient population [9][10]. - The company has agreements with Group Purchasing Organizations (GPOs) that facilitate access to key opinion leaders and streamline the sales process [10]. - Reimbursement has been favorable, with both on-label and off-label uses being covered, although off-label patients tend to stay on therapy for shorter durations [11][12]. Clinical Trials and Future Prospects - The confirmatory trial for the G12D inhibitor has completed accrual, with results expected around mid-next year. This trial is crucial for promoting the drug more actively [14][19]. - The RAMP 301 study has increased its enrollment from 270 to 300 patients to ensure robust data collection, with a focus on progression-free survival (PFS) as the primary endpoint [19][21]. - The company is optimistic about the potential market size for the RAMP 301 indication, estimating 6,000 to 10,000 patients in the U.S. [29]. RAMP 205 Study Insights - The RAMP 205 study, which combines the G12D inhibitor with standard chemotherapy for pancreatic cancer, reported an unprecedented 83% confirmed response rate [32][34]. - The study emphasizes the importance of maintaining full doses of chemotherapy to achieve optimal response rates [31][32]. KRAS G12D Inhibitor Development - The KRAS G12D inhibitor (VS-7375) has shown promising results in trials, with a 58% response rate in second-line pancreatic cancer and a 69% response rate in advanced metastatic lung cancer [41][42]. - The drug has a dual on/off profile, excellent bioavailability, and a long residence time, differentiating it from other RAS inhibitors [42]. - The U.S. trials are focused on improving tolerability compared to previous studies, with plans to potentially increase the dose based on positive tolerability data [44][45]. Long-term Development Strategy - Verastem plans to pursue a broad opportunity in various cancers, including colorectal and lung cancers, with both single-agent and combination therapies [53][66]. - The company is also exploring accelerated approval options for its drugs based on promising early data [50][52]. Conclusion - Verastem is in a strong position with its innovative therapies targeting hard-to-treat cancers, showing promising early sales and clinical trial results. The company is focused on expanding its market presence and ensuring robust data collection to support future growth and approval strategies [6][29][34].

Key Takeaways VSTM shares rise nearly 8% after announcement of preliminary Q4 and FY2025. Verastem expects $17.5M Q4 and $30.9M FY2025 Avmapki Fakzynja Co-pack revenues.VSTM ended 2025 with about $205M cash and sees its LGSOC program becoming self-sustaining by 2H 2026.Verastem’s (VSTM) shares rallied nearly 8% following the release of preliminary sales numbers for the fourth quarter and full-year 2025.VSTM’s top line currently comprises product revenues from Avmapki Fakzynja Co-pack, complemented by milest ...

Core Insights - Verastem, Inc. (VSTM) shares increased by 4.60 percent, or $0.29, reaching $6.59 following the announcement of preliminary fourth-quarter results [1] - The company reported net product revenue of approximately $17.5 million for Q4 2025 and full-year revenue of about $30.9 million for AVMAPKI FAKZYNJA CO-PACK [1] - Verastem emphasized a strong cash position that extends its financial runway into the first half of 2027 [1] Stock Performance - The stock opened at $6.42, compared to a previous close of $6.30, and traded within a range of $6.42 to $7.00 on the New York Stock Exchange [2] - The last bid was $4.96, while the ask was $8.30, with a trading volume of approximately 2,734,477 shares, exceeding the average volume of 2,006,367 [2] - Verastem's 52-week stock price range is between $4.01 and $11.25 [2]

Financial Projections - Verastem expects AVMAPKI™ FAKZYNJA™ CO-PACK net product revenues of approximately $17.5 million for Q4 2025 and approximately $30.9 million for the full year 2025[1][4]. - As of December 31, 2025, Verastem reported cash, cash equivalents, and investments of $205 million, which increases to $234 million when including net proceeds from exercised cash warrants[1][4]. - The company anticipates that the LGSOC commercial launch and development program will be self-sustaining by the second half of 2026[1][4]. Clinical Trials and Development - The ongoing RAMP 301 Phase 3 trial for AVMAPKI FAKZYNJA CO-PACK is fully enrolled and aims to confirm the initial indication for KRAS-mutated recurrent LGSOC[1][5]. - In the RAMP 201J Phase 2 trial in Japan, a confirmed overall response rate (ORR) of 38% was achieved among 16 efficacy evaluable patients, with a 57% ORR in KRAS-mutated patients[1][5]. - Verastem plans to report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027[1][8]. - The company is advancing VS-7375, a selective oral KRAS G12D inhibitor, in an international Phase 1/2 trial for advanced KRAS G12D solid tumors[1][8]. - Verastem expects to provide an update on the safety and efficacy of the RAMP 205 expansion cohort in Q2 2026[1][9]. Regulatory Approvals and Collaborations - The FDA approved AVMAPKI™ FAKZYNJA™ CO-PACK for KRAS-mutated recurrent LGSOC on May 8, 2025, with continued approval contingent on confirmatory trial results[1][13]. - The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers, with VS-7375 being the lead program[1][19]. - Verastem Oncology is focused on developing and commercializing new medicines for patients with RAS/MAPK pathway-driven cancers, with a pipeline that includes novel small molecule drugs targeting critical signaling pathways[21]. Product Information and Safety - The company markets AVMAPKI™ FAKZYNJA™ CO-PACK in the U.S., which is designed to inhibit cancer cell survival and tumor growth[21]. - The company advises against the concomitant use of AVMAPKI FAKZYNJA CO-PACK with strong and moderate CYP3A4 inhibitors and inducers, as well as warfarin and certain gastric acid reducing agents[20]. - The use of AVMAPKI FAKZYNJA CO-PACK may impair fertility in both males and females[20]. Risks and Forward-Looking Statements - Forward-looking statements indicate potential risks and uncertainties related to the commercialization of product candidates and the conduct of clinical trials, which may affect actual results[22]. - There are risks associated with the FDA's review process, including potential delays and regulatory uncertainties that could impact product approval and commercialization[22]. - Investors are cautioned not to place considerable reliance on forward-looking statements due to inherent risks in research and development[22]. - The company’s Annual Report on Form 10-K for the year ended December 31, 2024, details additional risks and uncertainties[22]. Contact Information - For inquiries, the Vice President of Corporate Communications can be contacted via provided email addresses[23].

The Company announced today updated data from the ongoing RAMP201J Phase 2 clinical trial in Japan evaluating the combination in patients with LGSOC with or without a KRAS mutation. As of the data cutoff on January 30, 2026, 16 patients were efficacy evaluable by investigator assessment, having at least one post-baseline assessment with a median follow-up of 10 months. Of the 16 total patients, a confirmed overall response rate (ORR) of 38% (6/16) was achieved. Among patients with KRAS-mutated recurrent LGS ...

Group 1 - The article discusses the potential of Verastem, Inc. (VSTM) and highlights the RAMP-203 study as a significant opportunity for the company, particularly regarding the Avutometinib combination therapy [2] - The author, Terry Chrisomalis, has extensive experience in the biotech sector and runs the Biotech Analysis Central service, which provides in-depth analysis and a model portfolio of biotech stocks [2] - The Biotech Analysis Central service includes over 600 articles and aims to assist healthcare investors in making informed decisions [2] Group 2 - The article does not contain any specific financial data or performance metrics related to Verastem, Inc. or the biotech industry [1][3][4]

Group 1 - TEN Holdings Inc. announced a $2.25 million private placement of 991,000 shares at $2.27 per share, resulting in a 17% increase in shares to $1.65 in after-hours trading [1] - Fonar Corp. shares surged 24% to $18.18 after announcing a definitive agreement for a "take private" sale [1] - CapsoVision Inc. submitted its 510(k) application to the FDA for its AI-assisted module for CapsoCam Plus, leading to an 11% decline in shares to $11.58 [1] - Verastem Inc. intends to discontinue the RAMP 203 clinical study in advanced KRAS G12C-mutated non-small cell lung cancer, causing shares to fall 2.7% to $7.55 [1] - Dermata Therapeutics Inc. closed a $12.4 million private placement priced at-the-market under Nasdaq rules, with shares jumping 10.2% to $2.05 in after-hours trading [1]

Core Viewpoint - Verastem Oncology has decided to discontinue the RAMP 203 clinical trial for advanced KRAS G12C-mutated non-small cell lung cancer (NSCLC) to reallocate resources towards the clinical development of VS-7375, an oral KRAS G12D inhibitor, targeting advanced NSCLC and other solid tumors [1]. Group 1 - Verastem Oncology is a biopharmaceutical company focused on developing new medicines for patients with RAS/MAPK pathway-driven cancers [1]. - The decision to discontinue the RAMP 203 trial was based on the evaluation of interim data [1]. - The company aims to concentrate its efforts on the development of VS-7375, which is positioned as a promising treatment option for advanced NSCLC and other solid tumors [1].

Summary of Verastem Conference Call Company Overview - **Company**: Verastem - **Focus**: Development of small molecules targeting the RAS pathway, specifically in oncology, with a recent launch of two drugs: avutometinib for low-grade serous ovarian cancer and a G12D inhibitor [2][3] Key Points on Drug Launch and Market Dynamics - **Launch Expectations**: 2026 is anticipated to be a pivotal year for Verastem, with ongoing efforts to manage the launch of avutometinib while advancing the G12D inhibitor [2][4] - **Market Size Concerns**: There are ongoing discussions about the ultimate market size for their drugs, with performance metrics improving quarterly, which helps clarify market potential [4][5] - **Patient Dynamics**: The treatment landscape is characterized by patients needing continuous therapy, with Verastem aiming to be the first choice for patients switching from their current therapies [5][6] - **Patient Population**: Women with low-grade serous ovarian cancer typically live with the disease for an average of 10 years, with KRAS mutant patients living longer (12 years) compared to wild type (7 years) [8] Market Breakdown - **Target Institutions**: Approximately half of the patients are treated at around 100 key institutions, which are the primary focus for the sales force [8][9] - **Prescribing Trends**: The majority of prescriptions are currently driven by gynecologic oncologists (GynOnc), with a slight skew towards academic institutions during the early launch phase [10] Clinical Trials and Data - **RAMP 301 Trial**: Enrollment is expected to complete next quarter, with initial results anticipated in the second half of 2027 [15][17] - **Interim Analysis**: A planned interim analysis indicated positive results, leading to the addition of more patients to the trial [16] Competitive Landscape in KRAS Inhibitors - **Current Competitors**: The KRAS space is competitive, with various approaches being explored. Verastem's G12D inhibitor is positioned as potentially best in class due to its high affinity for both on and off states of KRAS [19][22] - **Clinical Data Comparison**: Preclinical data shows better durability and response rates for Verastem's G12D inhibitor compared to competitors, with reported response rates of 69% in lung cancer and 58% in second-line pancreatic cancer [23][24] Safety and Tolerability - **Adverse Events**: Verastem's approach includes proactive measures to manage tolerability, with lower rates of discontinuation due to adverse events compared to competitors [25][27] - **Patient Management**: The company employs oncology nurse educators to ensure optimal treatment practices are followed in clinics [14] Future Directions - **Combination Therapies**: Verastem is exploring combination therapies, including a Cetuximab combination for colorectal cancer, which is seen as a significant opportunity [30][34] - **Resistance Mechanisms**: The company is actively researching resistance mechanisms to improve the efficacy of their treatments [31][33] Conclusion - **Outlook for 2026**: Verastem is focused on maintaining momentum from the drug launch and accelerating the development of the G12D program, indicating a busy year ahead [35]

Verastem (NasdaqCM: VSTM) Conference Call Summary Company Overview - Verastem is focused on developing small molecules targeting the RAS pathway, with a commercial product launched earlier in the year for low-grade serous ovarian cancer, specifically two drugs: avutometinib and defactinib [3][4] - The company reported a successful launch, beating sales expectations by approximately 100% in both partial and full quarters since approval [3][4] Core Business and Product Performance - The core business around avutometinib and defactinib is expected to be self-sustaining within the next two to three quarters [4] - The company is also developing a G12D inhibitor, having initiated a phase one trial in the U.S. after leveraging data from a Chinese study [4][5] - Early signs of efficacy have been observed, with no dose-limiting toxicities reported in the U.S. trial [5] Market Dynamics and Patient Impact - Low-grade serous ovarian cancer has no prior FDA-approved treatments, affecting 4,000 to 8,000 women in the U.S. [3][7] - Current therapies have low response rates (5% to 13%), making the approval of Verastem's drugs significant for patient care [7] - The average treatment duration in trials was 18 months, indicating potential for a growing patient base over time [9][10] Reimbursement and Guidelines - The company has submitted for NCCN guideline inclusion, which could enhance visibility and ease reimbursement processes [11][12] - Initial reimbursement challenges are being addressed, with positive data packets aiding acceptance [11][12] Distribution Strategy - Verastem employs a closed distribution model through specialty pharmacies, focusing on personalized patient care [16][17] - The sales strategy includes targeting large organizations and group purchasing organizations to maximize outreach [17][18] Clinical Trials and Regulatory Updates - The RAMP301 study's Independent Data Monitoring Committee recommended enrolling 29 additional patients, indicating favorable conditions for the trial [19][21] - The final analysis of the study is expected in the second half of 2027, with no changes to regulatory timelines [23] Expansion Beyond Ovarian Cancer - Verastem is also exploring treatments for pancreatic cancer, reporting an unprecedented 83% confirmed response rate in a study [25][26] - The company is optimistic about obtaining breakthrough therapy designation from the FDA based on ongoing results [26] G12D Program Collaboration - Verastem collaborates with GenFleet to develop a G12D inhibitor, with promising early results reported [28][29] - The G12D inhibitor has shown a 69% response rate in non-small cell lung cancer and a 58% response rate in second-line pancreatic cancer [33][34] Future Milestones - Key upcoming milestones include quarterly earnings, additional data from ongoing studies, and updates on the G12C lung cancer study [43] - The company aims to maximize the use of its approved drug while rapidly advancing the G12D program [41][42] Conclusion - Verastem is positioned to make significant impacts in the oncology space with its innovative therapies targeting RAS-driven cancers, backed by strong clinical data and strategic collaborations [3][25][28]