GlycoMimetics, Inc.

Good morning, and thank you for joining the GlycoMimetics Q2 2023 earnings call. At this time, all participants are in listen-only mode. Following 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 telephone. 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 June 30, 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. Joining me on the call today from Glycomimedics are Haroun 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 about the conduct of and our collaborators' clinical trials, plans or potential regulatory agency interactions or submissions, development plans and activities, pre-commercialization preparations, the company's operations, cash position and runway, and our expectations regarding data from clinical trials. Such statements represent management's judgment and intention as of today and involve assumptions, risks, and uncertainties. Glycomimedics 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 GlycoMimetics website. I'll now turn the call over to Haru.

Thank you, Christian. Good morning, everyone. This is a transformational time for our company as we continue to advance our clinical pipeline and to evolve ourselves into a commercial stage organization. Today, we would like to highlight three major advancements that position us well for a catalyst-rich upcoming 12 months. First, the FDA cleared a protocol amendment for our phase three uprolacilam study that will enable us to report top-line results by the end of Q2 2024. Second, we continue to broaden our clinical development strategy for uprolacilam by moving forward with our pediatric development plan. And third, we plan to further expand our clinical pipeline and initiate a first-in-human Phase 1A study for GMI 1687 in the third quarter of this year. These three areas of progress each represent potential long-term value drivers for our company. In June, the FDA cleared the addition of a protocol amendment to our Phase III study of rupalacilam for relapsed and refractory acute myeloid leukemia. This amendment adds a time-based analysis option that will enable us to announce top-line results by the end of Q2 2024. Final analysis will evaluate effects of rupalacilam on relapsed and refractory AML in a clinically mature database with more than three years of median follow-up. The analysis will also incorporate at least two years of post-transplant data for a large majority of patients remaining on study who received stem cell transplantation. Dr. Ed Rock, our chief medical officer, will provide additional information on the significance of this timing later in this call. The option for time-based analysis aligns with regulatory precedent for an approved AML therapy and reflects our commitment to delivery of Placilan to relapse and refractory AML patients in need of new therapy options as soon as possible. With top-line results expected by the end of Q2 2024, we continue to pursue pre-commercialization activities while also advancing additional pipeline programs. We're also proud to expand our Euplaceran development strategy by exploring its potential in people with all ages who are living with AML. This past quarter, we achieved three key advances in the development of euplaciran for pediatric patients. The FDA agreed to our proposed Initial Pediatric Study Plan, or IPSP, establishing a regulatory path forward to study euplaciran as a therapeutic option for pediatric AML patients. The NCI notified us that they will initiate a Phase I-II dose escalation study to investigate safety and early activity of buprolacillin plus salvage therapy for relapsed and refractory pediatric AML. And finally, in June, the first pediatric patient was treated in an investigator-initiated Phase I-II study of buprolacillin plus a pre-transplant regimen for AML treatment. This important milestone is the first step in evaluating buprolacillin in pediatric patients. The study is being led by Dr. John Horan of the Boston Children's Hospital and Dana-Farber Cancer Institute. We're grateful that the NCI and Boston Children's Hospital teams are assessing Euproxoran for treatment of pediatric AML patients, and we look forward to learning more about its potential impact in this vulnerable patient population. In the third quarter, we plan to initiate a Phase Ia study of GMI1687 in healthy volunteers to evaluate the drug's safety, tolerability, and pharmacokinetics. GMI1687 is a second-generation E-selectin antagonist with potential uses in diverse inflammatory diseases. Our initial focus will be on sickle cell disease. GMI1687 has been shown in preclinical models to be highly subcutaneously bioavailable. and this Phase Ia study is a vital first step in its clinical development. Turning to our finances, we have a cash runway to fund operations late into the fourth quarter of 2024, so we're well-positioned to continue executing our clinical development plan. Our pivotal Phase III trial in the relapsed and refractory AML remains on track for a top-line readout at the end of Q2 2024. and we will begin a phase 1A study of GMI 1687 in the coming weeks. On today's call, I'm happy to be joined by our CFO, Brian Hahn, and CMO, Dr. Ed Rock. Ed, I'll now pass it on to you to share more details on our ongoing trials.