GlycoMimetics, Inc.

Good morning and thank you for joining the GlycoMimetics Q4 and full year 2023 earnings call. At this time, all participants are on a listen-only mode. Following management's remarks, we will hold a question and answer session. At that time, lines will be open for you. I would 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 year ended December 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 the company's website. On the call today from Glycomimetics are Harut Samarjan, Chief Executive Officer, Brian Hahn, Chief Financial Officer, Dr. Edwin Rock, Chief Medical Officer, and Bruce Johnson, Chief Commercial 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 candidates, Yupra-Lessolan and GMI 1687, the progress and timing of clinical trials being conducted by us or our collaborators, including our expectations regarding data readout from those trials, planned or potential regulatory agency interactions or submissions, development plans and activities, pre-launch preparations, and the company's cash position and runway. Such statements represent management's judgment and intention as of today and involve assumptions, risks, and uncertainties. Glycomimedex 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 the Glycomimedex website. I'll now turn the call over to Haru.

Thank you, Christian, and good morning, everyone. In 2023, we made great strides on the path towards becoming a commercial company. Building on the advances we made in 2023, I believe 2024 will be a transformational year for our glycomatics. In the second quarter of this year, we expect to report top-line results from our Phase III trial of our lead drug candidate, Euplastran. This is a significant milestone that can fundamentally impact our company's trajectory while potentially helping patients affected with relapsed and refractory acute myeloid leukemia to live longer. I want to thank the entire glycometics team, our shareholders, collaborators, investigators, trial sites, and patients for their trust, commitment, and resilience during this multi-year phase three trial, which has now reached clinical maturity. Thanks to everyone's combined efforts, we're now very close to unblinding this pivotal trial, and should the data support it, we are ready to execute next steps rapidly. Today, I would like to highlight three key strategic areas driving the transformation of glycomimetics. First, based on our prior alignment with the FDA, we are triggering the time-based analysis for our pivotal Phase III trial of Uplusland in relapse and refractory AML and expect top-line results in Q2 2024. We remain encouraged by the median follow-up time, which is now well over three years. remarkably long for the relapse and refractory population. Pending positive results, we expect to submit a new drug application in the U.S. by the end of this year. Second, we are further advanced. We have further advanced our commercial readiness and continue to execute critical prelaunch activities, including the expansion of our commercial and medical affairs capabilities and educational disease awareness activities. We completed the phase 1A first in human trial for GMI 1687, a second generation E-Selectant antagonist being evaluated as an outpatient self-administered subcutaneous therapy to potentially alleviate sickle cell vasoclusive events. I'm excited to share that our phase 1A has met its primary and secondary endpoints with no dose-limiting toxicities or other safety signals. As we look ahead to 2024 and beyond, we believe glycoemetics is well-positioned to deliver innovative glycobiology-based medicines to patients in need of new treatment options, beginning with Eupalessoran. Despite recent advancements in AML therapies, there remains a significant unmet patient need, especially in terms of bending the survival curve upwards for relapse and refractory patients. With positive pivotal data, Eupalessoran has the potential to prolong survival for patients with relapse and refractory AML. This initial setting has a 650 million to 850 million near-term potential market opportunity in the U.S. alone, which could more than double when considering the frontline AML market. Our important partnerships with MD Anderson, the National Cancer Institute, and the Dana-Farber Cancer Institute underscore Uplusland's unique mechanism of action and potential for broad utility across the AML spectrum. Now, turning to our financers, our disciplined approach focusing on targeted investments provides a current cash runway through year-end 2024. This positions the company to be financed through our upcoming clinical milestones, data readout, and potential NDA submission. On today's call, I'm happy to be joined by our CFO, Brian Hahn, CMO, Dr. Ed Rock, and our CCO, Bruce Johnson. I'll now pass it over to Ed to share more details on our ongoing trial.