Syndax(US:SNDX)2022-05-10 00:13Financial Data and Key Metrics Changes - The net loss for Q1 2022 was $37.2 million or $0.63 per share, compared to a net loss of $27.7 million or $0.54 per share for the same period last year, primarily due to increased clinical activities [52][55]. - The company ended Q1 2022 with $397.9 million in cash and cash equivalents, with a cash runway extending into the second half of 2024 [53]. Business Line Data and Key Metrics Changes - Enrollment in pivotal Phase 2 trials for Revumenib (SNDX-5613) is on track, with three trials ongoing for different indications in acute leukemia [10][14]. - Axatilimab is currently in the pivotal AGAVE-201 trial for chronic graft versus host disease (cGVHD), with top-line data expected in 2023 [11][40]. Market Data and Key Metrics Changes - The company anticipates being the first to achieve regulatory approval for a menin inhibitor, which is expected to enhance long-term value [15]. - The potential market opportunity for Revumenib in treating NPM1 and MLLR mutant acute leukemias is significant, addressing up to 12,500 patients annually [26]. Company Strategy and Development Direction - The company aims to expand its lead assets into new indications and build a commercial organization to support potential product launches [8][12]. - There is a focus on pursuing business development opportunities to augment the pipeline with promising molecules [9]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's solid balance sheet and the support from a strong pharmaceutical partner to advance development [8]. - The company is optimistic about completing enrollment in at least one of the ongoing trials this year and expects to file for regulatory approval in 2023 [14][15]. Other Important Information - The company plans to hire its first Chief Commercial Officer to lead the build-out of its commercial organization later this year [12]. - The collaboration with Incyte aims to maximize the development of axatilimab and explore additional indications in fibrotic diseases [42]. Q&A Session Summary Question: Recruitment cadence for AUGMENT-101 trial - Management indicated that they have three independent trials enrolling and have not provided guidance on which will finish first, but they expect top-line data in the first half of 2023 [65][66]. Question: Statistical plan for AUGMENT-101 - The primary endpoint is the percentage of patients achieving CR/CRh, with no prespecified requirement for durability [69][80]. Question: Durability requirements for filing - There is no durability requirement for filing, but a median duration of response of at least four to six months has been acceptable in the past [79]. Question: Assessment of MRD negativity in INTERCEPT trial - MRD negativity for MLR patients is assessed using flow cytometry [86]. Question: Rationale for combinations with ASTX727 - The combination is being explored as it allows for an all-oral regimen, which is of interest to investigators [88]. Question: Benchmarks for BEAT-AML trial - The overall response rate for frontline Ven/Aza is in the mid-60s, with lower CR rates [92]. Question: Competitive landscape for menin inhibitors - The company believes it is in the lead for developing menin inhibitors and is focused on leveraging its first-mover advantage [98].