GlycoMimetics(US:GLYC)2023-05-03 15:43Financial Data and Key Metrics Changes - The company's research and development expenses decreased to $5.4 million for the quarter ended March 31, 2023, compared to $9.6 million for the same period in 2022, primarily due to lower clinical trial costs [9] - General and administrative expenses increased to $5.5 million for the quarter ended March 31, 2023, compared to $5.1 million for the same period in 2022, mainly due to commercial readiness planning expenses for uproleselan [9] - As of March 31, 2023, cash and cash equivalents were $65 million, up from $47.9 million as of December 31, 2022, following a $28.7 million raise from sales of common stock [27] Business Line Data and Key Metrics Changes - The pivotal Phase III trial of uproleselan in patients with relapsed and refractory AML is projected to reach its final survival event trigger within the first half of 2024, with a median follow-up of over 27 months [4][25] - The NCI Alliance Phase II/III trial is evaluating uproleselan in newly diagnosed older adults with AML, with an expected improvement in median event-free survival from seven to eleven months [7][25] Market Data and Key Metrics Changes - The incidence of AML increases with age, with over half of AML patients being older than 60 at diagnosis, highlighting the need for new therapies for this demographic [7] Company Strategy and Development Direction - The company is focused on advancing uproleselan's clinical development and preparing for its potential commercialization, aiming to transition into a commercial stage company [4][27] - The partnership with the National Cancer Institute and the Alliance for Clinical Trials in Oncology is part of the strategy to explore uproleselan's benefits across the AML spectrum [5][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about uproleselan's potential to improve overall survival in relapsed refractory AML and emphasized the ethical obligation to evaluate its benefits as soon as possible [23][29] - The independent data monitoring committee's interim analysis showed no safety concerns, preserving statistical power for the final analysis [25] Other Important Information - The company is well-funded to complete ongoing trials and continue its transformation into a commercial stage company capable of delivering impactful medicines [29] Q&A Session Summary Question: What is the current projection for the primary endpoint for the R&R AML Phase III data? - Management confirmed that the final overall survival event trigger is expected in the first half of 2024, with ongoing projections being communicated [12][46] Question: Are there any updates on the pipeline development outside of uproleselan? - Management indicated that while there are ongoing discussions regarding GMI 1687, the primary focus remains on uproleselan at this time [44][51] Question: How should expenses be anticipated as the company prepares for the uproleselan launch? - Management anticipates a burn rate of about $10 million per quarter for 2023 and into 2024, with further guidance to be provided after trial results [52]