GlycoMimetics, Inc.

Good morning, and thank you for joining the GlycoMimetics Q1 2023 earnings call. At this time, our participants are in listen-only mode. Following the management's remarks, we will hold a question and answer session. At that time, lines will be open for you. If anyone should require operator assistance, please press star, then zero on your touchtone phone. I would now like to turn the call over to Christian Deneen Long, Company Counsel at Glycomimetics. Please go ahead.

Good morning. Today we will review our business updates and financial results for the quarter ended March 31, 2023. The press release we issued this morning 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 our website. Joining me on the call today from GlycoMimetics are Harit Samarjan, Chief Executive Officer, Brian Hahn, Chief Financial Officer, and Dr. Edwin Rock, Chief Medical Officer. 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, Uber-Lessolan, or our other pipeline programs. along with statements of our expectations regarding operations, the conduct of or data from clinical trials, planned or potential development activities, regulatory interactions or submissions, pre-commercialization activities, and our cash position. Such statements represent management's judgment and intention as of today and involve assumptions, risks, and uncertainties. Glycomimetics undertakes no obligation to update or revise any forward-looking statements. 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 our website. I'll now turn the call over to Harit.

Thank you, Christian, and good morning, everyone. We have continued to make excellent progress advancing your cholesterol and clinical development and setting the stage for our transition to a commercial stage company. At the heart of this progress is our ongoing pivotal phase three trial, of buprenorphine in patients with relapsed and refractory AML, which continues to be projected to reach its final survival event trigger within the first half of 2024. Patients in this study continue to live longer than expected, leading to a median follow-up prior to primary analysis that is currently greater than 27 months. This slower-than-expected accumulation of survival events presents an ongoing ethical obligation to evaluate potential benefits from buprenorphine in the observed results. Accordingly, in February 2023, we carried out an interim utility analysis based on 80% of plant survival events that incorporated a highly conservative analysis threshold. This conservative threshold preserved statistical power of the original analysis plan. An independent data monitoring committee conducted an interim analysis of the unblinded data and recommended we continue to the originally planned final analysis. Importantly, the DMC noted no safety concerns. Thanks to our team's excellent performance in preparing the clinical trial database and enabling the interim utility analysis, we're well positioned to complete trial analysis rapidly after the final survival events trigger projected to occur within the first half of 2024. We're optimistic and excited about Guproletharan's potential to improve overall survival in relapsed refractory AML and are fully focused on delivering the potential of this important first-in-class therapy for patients in need of new, more effective treatment options. we remain keenly aware of our ongoing ethical obligation to patients to evaluate potential benefit of buprolacerin as soon as possible. We will continue to monitor primary event accumulation closely to ensure that this potentially important treatment option reaches patients who need it. As part of our strategy to explore potential buprolacerin benefits in patients across the AML spectrum, We're proud to work alongside the National Cancer Institute and the Alliance for Clinical Trials in Oncology. The Alliance will conduct a pre-planned interim analysis of event-free survival in its ongoing Phase 2-3 clinical trial, evaluating Giflaciran in newly diagnosed older adults with AML who are fit for chemotherapy. We expect to provide updates on the outcome of interim analysis when available. With our experienced team and cash runway to fund operations late into fourth quarter of 2024, we're well positioned to execute on our strategy and continue advancing our Euclid-SRAN development program, including our pivotal phase three trial in relapsed refractory AML. On today's call, I'm happy to be joined by our CFO, Brian Hahn, and CMO, Dr. Ed Rock. Ed, I'll pass it over to you to give more details on our ongoing trial.