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| Statement |
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| So we're well-positioned to continue executing our clinical development plan |
| With a cash runway to fund operations late into fourth quarter of 2024 GlycoMimetics is well positioned for a catalyst rich next 12 months |
| We're very excited now to be able to be in a situation where we're able to start the Phase 1a of 1687, a compound we believe in, we have the deep expertise, as you know, in this area in sickle cell, and bringing that expertise on our second generation, E-selectin antagonist, that is potent and subcutaneously bioavailable |
| But I'm very excited about the ability to start 1687 and put yet another GlycoMimetics product in a first-in-human study in the marketplace |
| And the fact that we're able to fund it, we're able to move it forward, it's a great, great step |
| Today, we would like to highlight three major advancements that position us well for a catalyst rich upcoming 12 months |
| Obviously, we don't know who's on what arm, but we're very encouraged by this updates and the fact that now we have the option of the time-based analysis on top, gives us certainty, clarity, and of course, on a database that's going to be mature |
| So we do believe that the vast majority of this patient population unfortunately will continue to have Vaso-Occlusive Crisis, and providing an option that is on demand at the start of that drive, as it was different crisis is going to be a tremendous help for this patient population |
| And on the other side of the spectrum, gene therapies, which are very exciting |
| We're also proud to expand our uproleselan development strategy by exploring its potential in people with all ages who are living with AML |
| Recent progress in pediatric development underscores our commitment to explore uproleselan's potential to help AML patients of all ages |
| This past quarter, we achieved three key advances in the development of uproleselan for pediatric patients |
| These three areas of progress each represent potential long term value drivers for our company |
| And we're excited that we have now this option of the time-based analysis should the 295 events not be reached by next year, we believe we're going to have a mature database, given the three years median follow-up, given the two years plus of post-transplant follow-up as well, for the vast majority of patients, that we're going to have a mature database |
| We're excited to expand uproleselan's potential utility to pediatric patients and look forward to sharing more information with you as these studies advance |
| The RATIFY trial of Midostaurin in newly diagnosed with mutant AML patients less than 60 years of age provides a regulatory precedent for our path forward |
| Thus GMI may uniquely offer a differentiated approach with potential to interrupt Vaso-Occlusive Crisis events at time of onset |
| And that medical community is very active, that patient community is very active |
| We're grateful that the NCI and Boston Children's Hospital teams are assessing uproleselan for treatment of pediatric AML patients |
| Together, we achieved multiple milestones in the last quarter that can drive long term value for our organization, including reaching an agreement with FDA to add the option of a time-based analysis to our Phase 3 study of uproleselan, which will enable us to announce top line results by the end of Q2 2024, initiating research of uproleselan in pediatric patients with the announcement of the trials led by the NCI and Dana Farber Cancer Institute |
| Now regarding our GlycoMimetics study drug platform, we're proud to share that we will initiate a Phase 1a single ascending dose trial of GMI-1687 later this quarter |
| Two years post-transplant is an important milestone in that after two years the graft versus leukemia effective stem cell transplantation has had time to develop fully |
| So things continue to be on track |
| And last broadening our pipeline to advance GMI-1687 to a first-in-human study |
| Given that we now have definitive timing for our data readout by the end of second quarter 2024, we will be able to utilize budget contingencies to advance the first-in-human study of GMI-1687, while maintaining our anticipated cash burn of roughly $10 million per quarter, with cash runway into late fourth quarter 2024 |
| 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 |
| If successful, that would reduce need for intravenous therapy and sickle cell Vaso-Occlusive Crisis and provide a patient-controlled point-of-care treatment option available at pain crisis onset |
| Roger Song Excellent, thank you |
| And thanks to all of you on the line for joining our call today |
| Excellent question, Roger |
| Statement |
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| In both trials death events slowed appreciably after interim analysis |
| As a result, incidence of AML relapse after two years post-transplant is low |
| I apologize |
| And given where the markets were, the financial constraints we had, we really had to double down on our Phase 3 |
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