GlycoMimetics(GLYC) - 2024 Q1 - Quarterly Results

Clinical Trials and Research - Uproleselan (GMI-1271) is currently in a Phase 3 trial for relapsed/refractory acute myeloid leukemia (R/R AML) with 388 patients enrolled, and topline results are expected to be announced in Q2 2024[4] - The Phase 2 trial for newly diagnosed "fit" AML has fully enrolled 267 patients, sponsored by the National Cancer Institute (NCI)[4] - In the Phase 1/2 trials, Uproleselan demonstrated a complete response (CR) rate of 35% in R/R AML patients and 52% in newly diagnosed patients aged 60 and above[17] - The median overall survival for Uproleselan in the Phase 3 trial was reported at 13 months compared to 12.3 months for the placebo arm[34] - The combination of Uproleselan with 7&3 chemotherapy is being evaluated in a Phase 2/3 trial for patients aged 60 and above, with a total enrollment of 267 patients completed[52] - Uproleselan demonstrated a median overall survival (mOS) of 13 months compared to 12.3 months in the control group, with a follow-up duration of 37 months as of March 2024[48] - The VALOR trial showed a mOS of 7.5 months versus 6.1 months, with a total enrollment of 711 patients[48] - In the ADMIRAL trial, mOS was reported at 9.3 months compared to 5.6 months, with 371 patients enrolled[48] - GlycoMimetics reported a 39% overall response rate (ORR) in a very high-risk patient population treated with Uproleselan combined with Cladribine and Low Dose Ara-C[61] Product Development and Designations - GlycoMimetics has received Breakthrough Therapy designation for Uproleselan in AML, highlighting its potential in addressing significant unmet medical needs[10] - The company is developing GMI-1687 for sickle cell disease (SCD) with a Phase 1a trial completed, targeting vaso-occlusive crises[5] - The company is developing a novel oral Galectin-3 antagonist targeting sickle cell disease (SCD) vaso-occlusive crisis, aimed for self-administration during crises[83] - GlycoMimetics has received Breakthrough Therapy, Fast Track, and Orphan designations for its first-in-class compounds, indicating potential broad utility[77] Market and Patient Demographics - Approximately 20,380 new AML cases are estimated in the U.S. annually, with around 12,000 patients eligible for intensive chemotherapy[24] - Approximately 20,380 newly diagnosed AML patients are expected annually in the U.S., with around 12,000 being eligible for intensive chemotherapy[50] Strategic Partnerships and Market Expansion - GlycoMimetics is partnered with Apollomics for the development of its products in Greater China, expanding its market reach[9] - The company is focusing on expanding its market presence through innovative therapies and clinical trials[49] Commitment to Research and Development - GlycoMimetics plans to submit comprehensive analysis results for presentation at an upcoming medical conference, reflecting ongoing commitment to research and development[34] - GlycoMimetics is committed to developing on-demand disease-modifying therapies to empower patients in managing their conditions[71] - The company is updating its financial guidance, reflecting ongoing clinical trial progress and pipeline developments[80]