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GlycoMimetics, Inc.
4/28/2022
Good morning and thank you for joining the Glycomimetics 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, the lines will be open for you. If anyone should require operator assistance, please press star then zero on your touch-tone telephone. I would like to turn the call over to Shari Annis of the Investor Relations Group at Glycomimetics. Please go ahead.
Good morning. Today we will review our accomplishments and financial results for the quarter ended March 31, 2022. The press release we issued this morning is available on the company's website at www.glycomimetics.com under the Investors tab. 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 investor relations section of the company's website. Joining me on the call today from Glycomimedics are Harut Samarjan, Chief Executive Officer, Brian Hahn, Chief Financial Officer, and Armand Girard, Chief Business Officer. We'll start today's call with comments from Harut. Brian will follow. Follow to provide an overview of the company's financial position. We'll then open the call for Q&A. I'd like to remind you that today's call will include forward-looking statements based on current expectations. Forward-looking statements on this call may include, but are not limited to, statements about the company's product candidates, you for Lesserland, GMI 1687, and other pipeline programs. along with statements about expectations regarding our operations, cash position, and data from preclinical studies or clinical trials, as well as planned or potential future development, regulatory interactions or submissions, and potential commercialization activities or strategic collaborations. Such statements represent management's judgment and intention as of today to 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 Glycomimetics' filings with the SEC, which are available from the SEC or on the Glycomimetics website. I'll now turn the call over to Haroud.
Thank you, Sherry, and good morning, everyone. In our year-end call eight weeks ago, we shared our outlook and strategy for the year ahead. We provided updates on both our regulatory and commercial redness activities, all designed to advance glycomimetics and our lead program, Uproliferan, with a focus towards commercialization. Our highest priority today is collecting and confirming the data from the 70 sites in the U.S., Europe, Canada, and Australia that enrolled a total of 388 patients in our Phase III registrational trial in relapsed refractory AML. This is an ongoing effort that will position us to move quickly to data analysis, top-line readout, and subsequent regulatory submissions once the overall survival event trigger is achieved. Today, we are updating the projected timing of the event trigger for our top line data readout. As our phase three data matures, we continue to track events in real time. Based on current projections, we now anticipate reaching our overall survival events trigger in mid 2023, with top line data disclosure shortly thereafter. Our plan is to provide updates with even more precision on the timing of this milestone. We're confident that uprolaceron will prove to be an ideal combination with standard chemotherapy. It is highly differentiated and has a mechanism of action that is complementary to the salvage therapies used today. Importantly, by targeting extrinsic factors of drug resistance in the bone marrow microenvironment, uprolaceron is molecularly, cytogenetically, and treatment regimen agnostic. The clinical and research communities are taking note. Several of the key opinion leaders shared perspectives on uprolaceran and its potential role in treating AML patients in recent medical education programs. In parallel, we have launched a comprehensive effort to prepare for uprolaceran's anticipated market entry. This effort is currently focused on scientific communications. that will be central to educating the AML community on the role of targeting extrinsic factors of chemoresistance. Some of these materials can be now viewed on our website. As you know, your proletarian is also being evaluated in the frontline AML setting by the National Cancer Institute. You'll recall that the phase two portion of this phase two three trial enrolled its last patient last November as well. As per protocol, the NCI has suspended enrollment in anticipation of its planned interim analysis. When the outcome of the NCI's event-free survival analysis of the Phase II data is communicated to us, we will issue a press release. Under the terms of our partnership with the NCI, we will be able to access the NCI's data in the newly diagnosed setting for regulatory purposes. In addition to advancing two registrational stage programs, we have several investigator-sponsored trials currently evaluating your placerans potential in additional indications. We continue to collaborate with the principal investigators of these trials. We share a goal of publishing their findings at major medical meetings as the data matures. I would now like to comment on the progress we have made with GMI1687 in sickle cell disease. I'm pleased to report that the IND-enabling program for GMI1687 has been completed. GMI1687 demonstrated no safety concerns from GLP 28-day toxicity studies in two different species. The standard battery of IND enabling studies of GMI 1687 also showed no safety concerns. We have received pre-IND guidance from the FDA that will be incorporated into our submission. And we have manufactured GMP drug product that is now on stability to support its use in first in human clinical studies. We remain on track to file the IND in the first half of this year to evaluate the compound in sickle cell disease patients with acute VOC as the lead indication. Filing the IND represents an important milestone for positioning GMI 1687 for partnerships. I remind everyone that there remains no FDA-approved therapy for the treatment of acute vaso-occlusive crisis in sickle cell patients as of today. With Euproleteron now in late-stage development, our third asset, GMI1687, about to enter the clinic, and the declared orally bioavailable lead candidate in the Galectin-3 program, we have created a pipeline of assets to accelerate our transformation to a commercially-focused organization. Consistent with this journey, last week we reduced our headcount by approximately 20%. The reductions were largely in the early-stage research and chemistry departments, while we maintained our key expertise and institutional knowledge to support our development efforts. We greatly appreciate the efforts of our colleagues who helped produce a rich pipeline of future opportunities. By streamlining basic research, we now have greater flexibility to invest in activities that will advance your proletariat's commercialization efforts. Brian, I'll now turn it over to you to provide an overview on our financial results.
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