GlycoMimetics, Inc.

Good morning, and thank you for joining the GlycoMimetics Q3 2023 earnings call. At this time, all participants are in 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. 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 September 30, 2023. The press release 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 candidates, UPRO-LSLN and GMI 1687, along with statements about the progress and timing of clinical trials being conducted by us or our collaborators, planned or potential regulatory agency interactions or submissions, development plans and activities, pre-launch preparations, the company's cash position and runway, and our expectations regarding data readouts from clinical trials. 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 the Glycomimedics website. I'll now turn the call over to Giroud.

Thank you, Christian, and good morning, everyone. In the third quarter, we continue to make strong progress advancing our clinical pipeline as we evolve into a commercial state organization. We remain committed to executing on our vision to delivery of Ploveran to AML patients in need of new treatment options while we leverage our unique glycobiology approach to develop innovative medicines in additional diseases such as sickle cell. Today, I would like to highlight three drivers that position us well to advance these programs in the coming year. First, we continue to expect top-line results from our pivotal Phase III study of UplusRand in relapsed and refractory AML by the end of Q2 2024 and remain encouraged about the unprecedented median follow-up time. Should trial results be positive, we expect US filing by end of 2024. Second, as part of our ongoing commitment to evaluate utility of UplusRand across AML, researchers from MD Anderson will present updated clinical data from their investigator-initiated trial in treated secondary AML at the American Society of Hematology meeting this December. Lastly, for GMI1687 and our sickle cell disease program, the Phase Ia study remains on track for safety data by the end of Q1 2024. With addition of the time-based analysis option to our pivotal Phase III study of uplasoran in relapse and refractory AML, we expect to report top-line results by the end of Q2 2024. We look forward to unveiling these data at this important milestone for patients, investigators, and the company. While recently FDA-approved drugs have shown encouraging results in limited AML subpopulations, we're optimistic that UplusRAN has the potential to improve patient outcomes irrespective of mutation profile, cytogenetic risk, or treatment backbones. Building on the promise of cuplaserine in relapsed and refractory AML, we are excited to explore its broader potential across different age groups and disease settings through studies run by partners and independent investigators. For example, at the upcoming ASH annual meeting in San Diego, researchers from the MD Anderson Cancer Center will present updated clinical data from their Phase 1b2 study evaluating euplaciran with cladribine and low-dose cytarabine in treated secondary AML patients. We are grateful to be collaborating with leading organizations, including MD Anderson, the National Cancer Institute, and the Dana-Farber Cancer Institute. The commitment of our partners underscores euplaciran's potential to improve and prolong lives for a broad spectrum of AML patients. We look forward to providing updates as these investigator-initiated clinical trials continue. Finally, we expect to announce safety data from our Phase 1A study of GMI1687 by end of Q1 2024. We expect these data will advance us towards our aspiration to develop GMI1687 as a patient-controlled point-of-care therapy to interrupt early sickle cell pain crisis before need to seek emergency care. We will evaluate next steps shortly thereafter. As our clinical pipeline has progressed, we have strategically expanded our commercial and medical affairs capabilities, and we are now executing critical pre-launch activities ahead of top-line euphylaxis readout expected in Q2 2024. Our educational disease awareness activities target academic and community hematologists that care for AML patients. Recently, we welcomed Dr. Gaetano Bonifacio as our Vice President of Global Medical Affairs and Deborah Peralta as our Vice President of Commercial Operations. Gaetano and Deborah bring decades of hematology launch experience, and we are pleased to have the opportunity to leverage their expertise during this transformative point in our company's evolution. Now, turning to our finances, we have a cash runway to fund operations into late Q4 2024. allowing us to continue executing our clinical development plan. On today's call, I'm happy to be joined by our CFO, Brian Hahn, and our CMO, Dr. Ed Rock. I'll now pass it over to Ed to share more details on our ongoing trials.