GlycoMimetics, Inc.

Good morning, and thank you for joining the GlycoMimetics fourth quarter and full year 2022 earnings call. At this time, all participants are listed on the mode. Following the management's remarks, we will hold a question and answer session. At that time, lines will be open for you. 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 and full year ended December 31, 2022. The press release we issued this morning is available on the company's website at glycomimetics.com. This call is being recorded. 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. 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, upralesolin, or our other pipeline programs, along with statements of our expectations regarding our operations, the conduct of or data from clinical trials, planned or potential development activities, regulatory interactions or submissions, pre-commercialization activities, potential strategic collaborations, 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 statement. For information concerning the risk factors that could affect the company, please refer to our filings with the SEC which are available from the SEC or through our website. I'll now turn the call over to Haroud.

Thank you, Christian, and good morning, everyone. In 2022, we made great strides in our continued organizational evolution as we aspire to become a commercial stage company poised to deliver important medicines to patients with significant unmet needs. To deliver on this aspiration, we are focused on three key areas. First, strengthening our leadership team to support commercialization, Second, sustaining strong clinical progress for our pivotal phase three study of Eupalus RAN. And third, raising capital to continue the trial through final analysis as patients continue to live longer. I'm proud to say that we have made significant progress in all three areas. At this crucial point in our company's life cycle, strong clinical and commercial leadership is more essential than ever. We have hired highly capable and experienced leaders, including Dr. Edwin Rock as Chief Medical Officer, Deepak Tiwari as Vice President of Technical Operations, Bruce Johnson as Chief Commercial Officer, and most recently, Chinmaya Rath as our new Chief Business Officer. Ed provides critical oversight, strategic guidance, and regulatory insight as we advance through the late stages of clinical development, while Chinmaya applies his expertise from over two decades as biotech and pharmaceutical companies to oversee our corporate strategy and early-stage pipeline programs. In parallel, Bruce and his team remain hard at work educating the market on Eupolastiran's differentiated mechanism of action, driving awareness of the unmet medical needs in relapsed refractory AML, and leading key commercial readiness activities to ensure we're well-positioned to deliver Eupolastiran, if approved, to patients in need. Deepak and his team continue planning and preparing for commercial supply following recent completion of the API validation batches of buprolasterine. Turning to our second key focus area, the execution of our pivotal phase three study of buprolasterine in relapsed refractory AML. In this study, patients continue to live longer than expected. leading to a median follow-up prior to primary analysis in our study that is currently greater than 25 months, which is remarkable. As a reminder, the final survival event trigger based on projections that reflect this longer follow-up duration is currently expected to occur in the first half of 2024. Last fall, based on slower accumulation of survival events, we recognized an ethical need to address the possibility that this slowdown in survival events may relate to benefits from eupalasterone study therapy. Following consultation with medical experts on the blinded pool data, we aligned with the FDA to establish an interim utility analysis in our phase three study protocol at approximately 80% of the planned survival events. In preparation for this interim analysis, our team partnered with the clinical trial community to ensure thorough data cleaning ahead of the final database lock. The interim analysis, which employed a very high statistical threshold in order to preserve the statistical integrity of the originally planned final overall survival analysis, was conducted in February of this year, 2023. The Independent Data Monitoring Committee recommended we continue to the originally planned final analysis, while noting there were no safety concerns. Later in the call, Ed will provide additional context on the high threshold used at interim analysis and how this preserves statistical integrity for the final analysis. As noted earlier, median follow-up for our study of rupalacerin is currently greater than 25 months. Given this extended median follow-up duration, we have assessed other relapsed refractory AML studies for the time from randomization to primary analysis. To our knowledge, as our study continues to mature, it is on track to have the longest follow-up of any study in relapsed refractory AML at the point of primary analysis, at potentially more than three years. We are encouraged by this continued demonstration of Eupalasterin's safety profile and remain optimistic about Eupalasterin's potential in light of the extended median follow-up duration in our study and the fact that patients continue to live longer than previously expected. Finally, we're pleased to announce in February that we completed a $32.9 million financing, which is expected to extend our cash runway to the end of 2024. We're encouraged by the support we received from a science-driven investor base, recognizing the potential of our Phase III study and clinical programs. This funding ensures our organization is well-positioned to continue advancing our pivotal Phase III study of upyletharan in the relapsed refractory AML. On today's call, I'm pleased to be joined by our CFO, Brian Hahn, and CMO, Dr. Ed Rock. Ed, I'll pass it over to you to share more detail on the interim analysis and other recent study developments.