Icovamenib Program - Icovamenib, a menin inhibitor, demonstrates significant and durable HbA1c reductions, up to approximately 1.5%, sustained well beyond the end of treatment[5] - In a Phase 2a study (COVALENT-111), a 12-week oral dosing of Icovamenib led to a placebo-adjusted HbA1c reduction of 1.5% (p=0.02) at Week 26 in patients with severe insulin-deficient diabetes[71] - At Week 26, patients with Severe Insulin-Deficient Diabetes (SIDD) showed a 53% mean increase in C-peptide levels after Icovamenib treatment[60] - Icovamenib has a $6 billion+ estimated U S revenue potential based on 10% penetration at $10,000 per year in the target T2D patients[7, 15] BMF-650 Program - BMF-650, an oral GLP-1 RA, is built on a similar scaffold as orforglipron, aiming for best-in-class status with an optimized exposure profile[7] - Preclinical studies of BMF-650 showed approximately 2 to 3-fold greater oral bioavailability compared to orforglipron[100] - In obese cynomolgus monkeys, BMF-650 demonstrated meaningful appetite suppression over a 6-day treatment period[110, 112] - In a weight loss study in obese cynomolgus monkeys, BMF-650 at 30 mg/kg resulted in a 15.2% average weight reduction from baseline over 28 days[126, 133] Financials and Milestones - For the three months ended March 31, 2025, Biomea Fusion reported a net loss of $29.262 million, or $0.80 per share[139] - As of March 31, 2025, Biomea Fusion had $36.2 million in cash, cash equivalents, and restricted cash[139]

Financial Data and Key Metrics Changes - Syndax reported net revenue of $20 million for RevuForge in Q1 2025, marking the first full quarter of its launch [8][35] - Nictimvo generated $13.6 million in net revenue for the first two months of its launch, with Syndax reporting a collaboration loss of only $200,000 for this period [8][36] - The company maintained a strong financial position with $602.1 million in cash and equivalents as of March 31, 2025 [9][38] Business Line Data and Key Metrics Changes - RevuForge's launch has seen strong adoption, with 44% of tier one and tier two accounts ordering the product as of March, up from one-third in February [16][17] - Nictimvo has been administered in over 1,250 infusions year-to-date, with approximately 95% of top accounts ordering the product [25][26] Market Data and Key Metrics Changes - The current indication for RevuForge targets an estimated 2,000 patients in the U.S. with relapsed or refractory acute leukemia, representing a market opportunity of $750 million [22] - The total addressable market for Nictimvo is estimated to be between $1.5 billion to $2 billion, targeting 6,500 chronic GVHD patients in the U.S. [27][10] Company Strategy and Development Direction - Syndax aims to position RevuForge as the first menin inhibitor included in clinical guidelines for treating relapsed or refractory mutant NPM1 AML [13] - The company is focused on executing strategic launch imperatives to ensure long-term competitive immunity ahead of potential market entrants [23] - The EVOLVE-two trial is a pivotal frontline study for Rebuminav, aiming for accelerated approval and full approval based on dual primary endpoints [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong commercial opportunities for both RevuForge and Nictimvo, highlighting the unmet medical needs and the compelling profiles of their medicines [8][10] - The company anticipates that RevuForge will be the first menin inhibitor approved in the frontline setting, with ongoing engagement with the FDA on their submissions [11][14] Other Important Information - The company has submitted a supplemental new drug application (sNDA) for RevuForge, seeking priority review for treating relapsed or refractory mutant NPM1 AML [10] - The FDA's real-time oncology review program is expected to facilitate quicker approvals for their submissions [11] Q&A Session Summary Question: What are you seeing regarding repeat prescribers for RevuForge? - Management noted that 44% of tier one and tier two accounts have ordered, with about 80% of those ordering more than once, indicating a growing user base [43][46] Question: Are you seeing a similar pace of patients receiving transplants with RevuForge as in clinical trials? - Management stated that anecdotal information suggests patients are being taken to transplant, but it is too early to provide definitive data [52][53] Question: Can you share any color on month-over-month trends for new patient adds for RevuForge in Q1? - Management indicated that while they are not providing specific numbers yet, they are happy with the steady stream of new patients and refill rates [58][60] Question: What portion of the $20 million revenue stems from refill dynamics versus new patient starts? - Management mentioned that both refill and new patient dynamics are building, but specific data is still maturing [101][102]