Verastem (VSTM) 2025 Conference September 03, 2025 03:55 PM ET Speaker0So welcome to the Cantor Fitzgerald Global Healthcare Conference. I'm Pete Stabropoulos, a biotech analyst with Cantor. With us we have Verastem, a company we cover. And I'm pleased to introduce Dan Patterson, CEO and Jonathan Packer, Chief Scientific Officer. So welcome and let's just start off with a brief introduction of yourselves and a brief description of the company for those who may not be familiar.Speaker1Sure. So we develop sma ...

Verastem (VSTM) came out with a quarterly loss of $0.39 per share versus the Zacks Consensus Estimate of a loss of $0.85. This compares to a loss of $0.31 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +54.12%. A quarter ago, it was expected that this drug developer would post a loss of $0.72 per share when it actually produced a loss of $0.96, delivering a surprise of -33.33%. Over the last four quarters, the company has su ...

Financial Data and Key Metrics Changes - The company reported $2.1 million in net product revenue for the first six weeks post-launch, with a cost of sales of $400,000 for 2025 compared to zero in 2024 [25][26] - Non-GAAP adjusted net loss was $41.4 million or $0.63 per share diluted for 2025, compared to a loss of $16.5 million or $0.61 per share diluted for 2024 [27] - The company ended 2025 with cash, cash equivalents, and investments of $164.3 million, bolstered by a $75 million private placement [27][28] Business Line Data and Key Metrics Changes - The FDA approved AvmapKefaxin Jakobak for KRAS mutated recurrent LGSOC, marking a significant milestone for the company [5][6] - The commercial launch of Abnapti Faxinga Copac has shown early traction with $2.1 million in revenue within six weeks [6][11] Market Data and Key Metrics Changes - The company has seen coverage from major insurers in the U.S., representing over 80% of lives, indicating strong market access [10][21] - The initial uptake of the product has been encouraging, with a mix of prescriptions from both academic and community settings [50][51] Company Strategy and Development Direction - The company aims to establish Abnapti Faxinga Copac as the new standard of care for KRAS mutated recurrent LGSOC, fundamentally changing the treatment paradigm [6][8] - Future milestones include advancing clinical programs and maintaining strong momentum in the commercial launch [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's potential impact on patients with high unmet needs and emphasized the importance of ongoing engagement with healthcare providers [10][22] - The company is optimistic about the second half of the year, expecting to build on early achievements and continue executing its strategic imperatives [16][29] Other Important Information - The company has entered into multiple agreements with specialty distributors and oncology group purchasing organizations to enhance market reach [16][21] - The NCCN committee plans to review the company's submission for broader treatment recommendations in October [20][75] Q&A Session Summary Question: Can you talk about the degree of off-label use currently seen? - Management noted that while they do not promote off-label uses, they have observed utilization in both labeled and wild-type populations, with reimbursement not being an issue to date [34][35] Question: What are the key indicators being tracked for launch performance? - Management indicated that they are monitoring engagement with healthcare providers, patient access, and overall market dynamics to gauge launch momentum [41][45] Question: What is the experience with payers regarding reimbursement? - Management reported that early experiences with payers have been positive, with minimal pushback and effective reimbursement processes in place [56][58] Question: How might the launch curve evolve with the integration of specialty distributors? - Management expects a steady uptick in patient adoption as the full distribution network is established, with ongoing engagement efforts to support this growth [66][77] Question: What is the current size of the sales force and future plans? - The company launched with a focused team of 16 sales representatives and currently has no plans to increase this number [99]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35403 Verastem, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdict ...

Zacks Consensus Estimate This drug developer is expected to post quarterly loss of $0.85 per share in its upcoming report, which represents a year-over-year change of -174.2%. Revenues are expected to be $15.67 million, up 56.7% from the year-ago quarter. Estimate Revisions Trend The consensus EPS estimate for the quarter has been revised 1.17% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates ...

Group 1 - The article discusses the combination of avutometinib and defactinib for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) and its commercial potential [2] - The author has a long position in Verastem, Inc. (NASDAQ: VSTM), indicating a positive outlook on the company's stock [3] - The article emphasizes the importance of innovative companies developing breakthrough therapies and pharmaceuticals with potential acquisition catalysts [2] Group 2 - The author has been involved in the healthcare investment sector for several years, focusing on biotech and life-saving therapies [2] - The article does not provide specific financial data or performance metrics related to Verastem, Inc. or the discussed drug combination [2]

Core Insights - Verastem, Inc. (VSTM) is viewed positively despite challenges related to data readouts and drug approval uncertainty [1] Company Analysis - The company operates in the biotech sector, focusing on drug development and clinical trials [1] - There is a commitment to educating investors about the scientific aspects of the business, emphasizing the importance of due diligence in biotech investments [1]

Verastem (VSTM) 2025 Conference Summary Company Overview - **Company**: Verastem - **Industry**: Biotechnology - **Focus**: Development of small molecules targeting the RAS pathway, specifically for cancer treatment Key Points and Arguments Recent Achievements - Verastem received its first FDA approval for low-grade serous ovarian cancer (LGSOC), a rare cancer with no prior approved treatments [4][5] - The approval was granted almost two months early due to a priority review, indicating strong FDA engagement [5] - The company successfully refinanced its debt and completed fundraising to support the launch in a challenging market environment [6] Pipeline Developments - Verastem advanced its pipeline by in-licensing the G12D program from Genfleet, with promising frontline pancreatic ductal adenocarcinoma (PDAC) data showing an 83% response rate [7][20] - The G12D variant is identified as the largest KRAS variant in cancer, presenting a significant commercial opportunity compared to G12C inhibitors [19] Clinical Data and Feedback - Initial data from a Chinese trial indicated a strong efficacy for the G12D inhibitor, although there were concerns regarding adverse events (AEs) related to gastrointestinal issues [11][12] - The company plans to optimize dosing regimens based on feedback from experienced investigators [14][18] Market Potential - Approximately 6,000 to 8,000 women in the U.S. are living with LGSOC, highlighting a high unmet medical need [33] - Patients typically cycle through therapies for about ten years, indicating a long-term market opportunity for Verastem's treatments [34] Launch Strategy - The launch of the LGSOC treatment is expected to see steady growth over time rather than an immediate influx of patients, as many are on active therapy [37] - The company has established a robust patient assistance program to mitigate the impact of pricing on patients [46] Regulatory and Reimbursement Updates - Verastem is actively pursuing reimbursement and has not faced significant pushback from payers so far [40] - The company has applied for NCCN guidelines, which could facilitate quicker uptake among KRAS mutant patients [43] Future Catalysts - Key upcoming milestones include the performance of the LGSOC launch, updated data from the lung cancer study, and progress on the frontline PDAC program [60] - The company is also focused on expanding its G12D inhibitor studies into colorectal cancer (CRC) and other indications [23] International Development - In Europe, Verastem is seeking regulatory guidance on whether Phase II data will suffice for approval, while in Japan, a bridging study is underway for conditional approval [54] Additional Important Insights - The G12D program is expected to be a game-changer in the treatment landscape for PDAC, with a response rate significantly higher than current standard therapies [21] - The company is leveraging preclinical data to explore combinations with other therapies, indicating a strategic approach to enhance treatment efficacy [25][26] This summary encapsulates the critical developments and strategic outlook for Verastem, highlighting its innovative pipeline and market potential in the biotechnology sector.

RAMP 205 Data Update - Dose Level 1 in RAMP 205 demonstrated an 83% unconfirmed ORR (10/12 patients) and a 66.7% confirmed ORR (8/12 patients) in frontline metastatic PDAC[48] - Dose Level 1 also showed a 92% disease control rate (11/12 patients) for at least 4 cycles[48] - In RAMP 205, 92% (48/52) of patients showed tumor reduction across all dose cohorts[57] - Approximately 180,000 total incident PDAC patients globally represent a high unmet need, with a 5-year relative survival rate of 13.3%[20, 22] VS-7375 KRAS G12D Inhibitor - VS-7375 is a KRAS G12D (ON/OFF) inhibitor with IC50 values of 2 nM for GppNp-bound (ON/active) and 6 nM for GDP-bound (OFF/inactive) KRAS G12D[68] - Preclinical data indicates that VS-7375 is more efficacious than KRAS ON inhibitors in reducing tumor growth in KRAS G12D models[73] - In a KRAS G12D colorectal cancer model, the addition of Cetuximab with VS-7375 induced complete responses in all mice[78] - KRAS G12D mutations account for 26% of all KRAS mutations and are prevalent in pancreatic and colorectal cancers[84] Clinical Development Plans - The company plans to launch a Phase 3 study in 1L mPDAC in 2026[103, 113] - The company is initiating enrollment for the Phase 1/2a trial of VS-7375 in advanced solid tumors in the US, starting with an efficacious dose level of 400 mg QD[108, 113]

Summary of Conference Call Company and Industry Overview - The conference call primarily discusses Verastem Oncology and its focus on developing treatments for cancers with high unmet needs, particularly pancreatic cancer and KRAS-driven cancers [1][2][51]. Key Points and Arguments Product Pipeline and Innovations - Verastem has several investigational drugs, including: - **Vutametinib**: A RAFmAbK inhibitor. - **Defactinib**: A FAC inhibitor. - **G12D inhibitor**: A drug developed in collaboration with Genfleet Therapeutics [2][24]. - The recently approved drug, **Avmapke Faxingia Copac**, was approved on May 8, two months ahead of schedule [2]. Clinical Data and Efficacy - In a study of low-grade serous ovarian cancer, there was a **44% overall response rate** with unprecedented durability [3]. - The **Ramp 205 study** focused on untreated, pathologically proven metastatic pancreatic cancer, showing an **83% radiographic response rate** at the first dose level tested, significantly higher than the typical 30% response rate for standard treatments [12][13]. - The study also reported a **92% control rate** for disease progression after four cycles of therapy, which is notably higher than historical comparators [13]. Treatment Landscape for Pancreatic Cancer - Pancreatic cancer has a **5-year survival rate of only 13.3%**, with adenocarcinoma survival rates dropping below 8% [6][7]. - The majority of pancreatic cancer patients have **KRAS mutations**, with G12D being the most common [7]. - Current treatment regimens lack consensus on effectiveness, and many patients experience recurrence [9]. Mechanism of Action - The drugs discussed aim to block the **RasRaf pathway** and the **FAC pathway**, with a focus on the duality and synergy of these treatments [10][11]. - The combination of vutametinib and defactinib, along with chemotherapy, has shown promising preclinical synergy [11]. Future Development Plans - Verastem plans to expand the **Ramp 205 trial** to include additional patients and is preparing for a randomized trial set to initiate in 2026 [52]. - The company is also exploring combinations with other therapies, particularly for newly diagnosed and borderline resectable pancreatic cancer patients [53]. Market Potential - There are approximately **61,000 patients annually** in the U.S. diagnosed with KRAS G12D mutations across various cancers, indicating a significant market opportunity [36][46]. Important but Overlooked Content - The discussion highlighted the importance of managing **GI toxicities** associated with treatments, which are common in oncology but manageable [66][72]. - The pharmacokinetics (PK) of the drugs are crucial, with a focus on ensuring effective dosing schedules that patients can tolerate [40][41]. - The potential for **brain metastases** in lung cancer patients treated with KRAS inhibitors was raised, emphasizing the need for further studies in this area [48]. This summary encapsulates the key points from the conference call, focusing on Verastem Oncology's advancements in cancer treatment, particularly for pancreatic cancer, and the promising data from their clinical studies.