GlycoMimetics(US:GLYC)2023-03-29 15:09Financial Data and Key Metrics Changes - As of December 31, 2022, GlycoMimetics had cash and cash equivalents of $47.9 million, down from $90.3 million as of December 31, 2021 [11] - Expenses for the second half of 2022 decreased to $19.2 million compared to $30.4 million in the first half of 2022 [11] - Research and development expenses decreased to $5.9 million for Q4 2022 from $12.9 million in Q4 2021, primarily due to lower global Phase III clinical study costs [11] - General and administrative expenses increased to $4.7 million for Q4 2022 from $4.5 million in Q4 2021, mainly due to higher pre-commercial expenses for uproleselan [11] Business Line Data and Key Metrics Changes - The pivotal Phase III study of uproleselan in relapsed/refractory AML continues to show promising results, with a median follow-up of over 25 months [7] - The transplant rate in the study is above the 31% rate observed in the preceding Phase I/II trial, with a low patient dropout rate of about 3% [9] Market Data and Key Metrics Changes - The company completed a financing round in February 2023, raising $32.9 million, which is expected to extend the cash runway to the end of 2024 [12][23] - The study is on track to have the longest follow-up of any study in relapsed/refractory AML at the point of primary analysis, potentially exceeding three years [23][25] Company Strategy and Development Direction - The company is focused on strengthening its leadership team, sustaining clinical progress for uproleselan, and raising capital for continued trials [6] - GlycoMimetics aims to evolve into a commercial stage company capable of delivering important new medicines to patients [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the interim analysis of the Phase III study, which found no safety concerns and recommended continuing to the final analysis [12] - The company remains focused on delivering new options to patients waiting for better standard care therapies for AML [25] Other Important Information - The interim analysis employed a high statistical threshold to preserve the integrity of the final analysis, with no safety concerns noted [24] - The company is engaging with the medical community to raise awareness of uproleselan's unique mechanism of action [32] Q&A Session Summary Question: When do you expect data for the NCI sponsored trial to come out? - Management indicated that there has been no official update from NCI, and it is reasonable to assume that data may be delayed similar to the Phase III study [14] Question: What is the status of GMI-1687? - The company is currently focused on uproleselan and is open to partnerships for GMI-1687 but is not actively pursuing a Phase I trial at this time [29] Question: How does the statistical team predict the event timing? - The statistical team has developed a robust projection tool considering various patient characteristics, and updated projections indicate the full event trigger is expected in H1 2024 [31]