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GlycoMimetics, Inc.
5/9/2024
Good morning, and thank you for joining the GlycoMimetics Investor and Analyst. On this note, this event is being recorded. Today's remarks will be followed by a question and answer session with the management team. Please dial in via telephone to participate. I would now like to turn the conference over to Christian Denning-Long, Company Counsel at GlycoMimetics. Please go ahead.
Good morning. Today we will review top-line results from our Phase III study of our lead drug candidate, upralesolin. A press release was issued this morning and is available on the company's website at glycomimetics.com. This call is being recorded, and a dial-in phone replay will be available for 24 hours after the close of the call. The webcast replay will also be available for 30 days in the Investors section of the company's website. On the call today from Glycomimedics are Harit Samarjan, Chief Executive Officer, and Dr. Edwin Rock, Chief Medical Officer. Brian Hahn, the company's Chief Financial Officer, will also be available for the question and answer session. Today's call will include forward-looking statements based on our current expectations. Forward-looking statements may include, but are not limited to, statements about the company's product candidate, UproLessolan, and analysis of data from the company-sponsored Phase III clinical trial. the progress and timing of clinical trials being conducted by our collaborators, including expectations regarding data readout from those trials, planned or potential data presentation, regulatory and development plans and activities, and the company's cash burn and budget plan. Such statements represent management's judgment and intention as of today and involve assumptions, risks, and uncertainties. Glycomatics undertakes no obligation to update or revise any forward-looking statement. For information concerning the risk factors that could affect the company, please refer to Glycomimetics filings with the SEC, which are available from the SEC or through the Glycomimetics website. I'll now turn the call over to Haroud.
Thank you, Christian. Good morning, everyone. Earlier today, we announced top-line results from our pivotal Phase III study of buprenorphine or placebo in combination with MEK or FAI for the treatment of relapsed refractory acute myeloid leukemia. Unfortunately, the study did not achieve a statistical significant improvement in overall survival in the intent to treat population. Adverse events were consistent with known side effect profiles of the respective chemotherapies used in the study. While this is not the outcome we were hoping for, with data collected from 388 patients and an unprecedented follow-up of over three years, there will be important learnings from this study. We are diligently and rapidly evaluating the full data set with medical, statistical, and regulatory experts and we plan to share further updates as appropriate. We intend to present the comprehensive data analysis at an upcoming medical meeting and are developing a plan to discuss these data with the FDA given the significant unmet patient need. I want to take a moment to offer my sincerest gratitude to the investigators, trial sites, and most importantly, the patients and families for their dedication in this large, well-controlled randomized trial. I also want to thank the glycoemetics team for working tirelessly to develop Gupilatran and our investors for their support. We remain dedicated to exploring Gupilatran's potential in AML. As a reminder, the National Cancer Institute is sponsoring an ongoing Phase 2-3 trial evaluating Gupilatran in newly diagnosed older patients with AML who are fit for intensive chemotherapy. We look forward to sharing results from this trial when they become available. I will now turn the call over to Ed.
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