GlycoMimetics(US:GLYC)2022-08-03 20:08Financial Data and Key Metrics Changes - As of June 30, 2022, GlycoMimetics had cash equivalents of $60.2 million, down from $90.3 million as of December 31, 2021, with expectations that current cash resources will fund operations into the third quarter of 2023 [34] - Research and development expenses decreased to $8 million for the quarter ended June 30, 2022, compared to $10.2 million for the same period in 2021, primarily due to lower clinical trial costs related to the ongoing Phase III trial of uproleselan [35] - General and administrative expenses increased to $5.5 million for the quarter ended June 30, 2022, compared to $4.2 million for the second quarter of 2021, mainly due to commercialization startup expenses for uproleselan [36] Business Line Data and Key Metrics Changes - The Phase III trial of uproleselan is currently evaluating salvage chemotherapy with or without the drug, with a primary endpoint of overall survival [10] - The Phase III population is broadly similar to the Phase I/II study regarding age, severity of AML, and prior stem cell transplantation rates, with a median age of 58 years [11] - The Phase II portion of the NCI trial has completed enrollment of 267 patients, with an interim analysis planned [13] Market Data and Key Metrics Changes - AML is one of the most common types of leukemia in adults, with a global median incidence rate of almost 2.3 cases per 100,000, and over 20,000 adults diagnosed annually in the U.S. [23] - Long-term patient outcomes in AML are poor, with approximately 70% of newly diagnosed patients relapsing within three years and a five-year overall survival rate of 29% [24] - Current standard-of-care therapies for AML are limited in achieving deep, durable remissions, with only 20% to 30% of relapsed refractory patients achieving complete remission [26] Company Strategy and Development Direction - The company is focused on advancing the development of uproleselan and preparing for its potential commercialization, with a strong emphasis on regulatory and commercial readiness [8] - GlycoMimetics aims to establish uproleselan as a first-in-class E-selectin antagonist to disrupt the standard of care in both relapsed refractory and newly diagnosed AML [21] - The company is also exploring partnerships for GMI-1687, a sickle cell disease program, while prioritizing resources on uproleselan development [17][56] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the potential of uproleselan to transform outcomes in AML patients, with a projected event trigger for overall survival expected in mid-2023 [12] - The company is committed to closely monitoring the Phase III trial and will provide updates as necessary [41] - Management emphasizes the importance of physician awareness and enthusiasm for uproleselan, indicating a significant market opportunity [30] Other Important Information - The company has received FDA fast-track and breakthrough therapy designation for uproleselan in relapsed refractory AML, facilitating rapid regulatory submissions [12] - The company is preparing for potential market entry of uproleselan and is focused on ensuring resources are allocated effectively for commercialization [19] Q&A Session Summary Question: How are the OS events tracking versus projections for the uproleselan Phase III trial? - Management confirmed that the overall survival events are still tracking in line with previous projections, expected to mature in mid-2023 [41] Question: When will initial results from the combination studies with venetoclax be available? - Management indicated that initial data might be available as early as the upcoming ASH conference, but the timeline depends on the principal investigators [43] Question: Are there differences in patient baseline characteristics between the Phase III and Phase II trials? - Management acknowledged that while the characteristics are broadly similar, there are slight differences in terms of prior remission duration and risk categories [46] Question: How often will updates be received from the NCI study? - Management stated that updates will be provided once the NCI completes their analysis, with the expectation that results will be communicated in a timely manner [50] Question: What is the status of business development activities and cash runway? - Management emphasized that business development remains a focus, particularly for GMI-1687, and that cash resources are being preserved to prioritize uproleselan [56][58]