Syndax(US:SNDX)2024-05-08 20:08Financial Data and Key Metrics Changes - The company reported $522 million in cash equivalents and investments as of March 31, expected to provide runway through 2026 [53] - Operating expenses for Q1 were $79.5 million, with R&D expenses at $56.5 million and SG&A expenses at $23 million [82] - For Q2, the company expects R&D expenses to be $50 million to $55 million and total operating expenses to be $80 million to $85 million [54] Business Line Data and Key Metrics Changes - Revumenib received priority review from the FDA for the treatment of adult and pediatric relapsed or refractory KMT2A rearranged acute leukemia, with a PDUFA date of September 26, 2024 [39] - The company completed enrollment in the NPM1 AML cohort of the AUGMENT-101 pivotal trial, with data expected in Q4 2024 [37][68] - Axatilimab's BLA filing was granted priority review for chronic GVHD, with a PDUFA date of August 28, 2024 [71] Market Data and Key Metrics Changes - KMT2Ar and NPM1 acute leukemias represent up to 40% of all AML patients, with an addressable market opportunity of approximately $750 million in the US for relapsed or refractory KMT2Ar acute leukemia [49] - The total addressable market for both KMT2Ar and NPM1 in the relapsed or refractory setting is estimated to approach $2 billion in the US [50] Company Strategy and Development Direction - The company aims to launch two first-in-class products, revumenib and axatilimab, in Q3 2024, focusing on building relationships with healthcare providers and payers [45][46] - The strategy includes in-licensing and developing new molecules with differentiated profiles, emphasizing the importance of capital allocation for future business development [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming product launches and the potential market impact, highlighting the urgency of treatment for patients with acute leukemia [77][78] - The company is actively engaging with payers to ensure timely access and reimbursement for revumenib, anticipating coverage for 90% of lives prior to approval [48][104] Other Important Information - The company is preparing for a significant increase in operating expenses in the second half of the year due to R&D and commercial organization build-out [28] - The company has a robust publication plan to detail the clinical benefits of its products to the prescribing community [44] Q&A Session Summary Question: Importance of NCCN guidelines for new indications - Management plans to engage with the NCCN committee for inclusion in guidelines post-approval, leveraging data presentations at medical congresses [106] Question: Expectations around colorectal cancer data - The company is conducting a Phase 1 trial in metastatic colorectal cancer and plans to provide updates in Q2 [108] Question: Sales force size and overlap of providers - The sales force will be adequately sized to cover 95% of the opportunity, with significant overlap in providers treating both leukemia and chronic GVHD [22][24]