GlycoMimetics, Inc.

Good morning, and thank you all for joining the GlycoMimetics call. At this time, all participants are in a listen-only mode. Following management's remarks, we will hold a question-and-answer session, and at that time, the lines will be open for you. If anyone should require operator assistance, please press star zero on your touchtone telephone. I would now like to turn the call over to Ms. Sherry Annis, of the Investor Relations Group at Glycomimetics. Please go ahead.

Good morning. Today we will review our accomplishments and financial results for the period ended September 30, 2021. We'll also update you on recent achievements. 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 Glycomimetics are Harit Samarjan, Chief Executive Officer, Dr. Eric Feldman, Chief Medical Officer, and Brian Hahn, Chief Financial Officer. We'll start today's call with comments from Harut and then Eric. Brian will then follow to provide an overview of the company's financial position, and then we'll open the call to Q&A. I'd like to remind you that today's call will include forward-looking statements based on current expectations. Forward-looking statements contained on this call include, but are not limited to, statements about the company's product candidates, Uprolessaland, GMI 1359, and GMI 1687, and our other pipeline programs, along with statements about expectations regarding our operations, plans for future development, and potential commercialization and cash position. Such statements represent management's judgment and intention as of today and involve assumptions, risks, and uncertainties. Lycomimetics 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 Arudh.

Arudh Dhananjani Thank you, Sherry, and good morning, everyone. This is my first earnings call as Glycomimetics Chief Executive Officer, and I'm grateful for the dedication and perseverance of our employees and the support of our board of directors, especially during my CEO transition period. I'm excited about the strong momentum and opportunities we have in front of us. In prior calls, we've shared that our operational focus is advancing Guproceran to commercialization and positioning it as a new foundational treatment in AML. Our belief is that drug combinations targeting both tumor intrinsic and microenvironment extrinsic pathways of AML will be essential for the successful clinical translation of new, more effective drug combination strategies. As a potential first-in-class therapeutic that selectively disrupts extrinsic pathways of chemo-resistance, we believe uproliferant can be transformative for AML patients. My goal is to transform glaucoma emetics from a research and clinical development organization to a commercialization powerhouse, leveraging the advancement of euprolacerin. These types of transitions have been a particular area of focus for me in the oncology-hematology space for the past two decades. With two advanced euprolacerin registration programs in AML, we have much to plan for from a path to commercialization perspective. These programs include, first, our company-sponsored phase three trial in relapsed refractory AML, and second, the National Cancer Institute's trial in older, newly diagnosed patients fit for chemotherapy. We have seen robust enrollment during the past quarter in our phase three trial. I am pleased to share that completing enrollment of 300 patients, 380 patients, in our company-sponsored Phase III trial is now imminent. Our plan is to announce this important milestone in a separate press release once it concludes shortly. As you are aware, the primary endpoint of overall survival is event-driven. Based on our current projections, we expect top-line results to come in after the year end 2022. As more events occur, our goal is to provide more precision on the timing of the top line readout. In parallel, we can also report significant CMC and regulatory achievements. We have had interactions with the FDA under breakthrough therapy designation to align on key elements of our CMC program. Consistent with that guidance, we have completed the drug product registration batches required to support our NDA submission for Euprolitheran. I'd like to thank our internal team and our CMC partners for getting us to this stage of NDA readiness. We now shift our CMC focus to making the commercial batches to support a potential global product launch. Additionally, we have also reached alignment with the FDA on the clinical pharmacology and non-clinical elements of our NDA. Our goal has been to work closely with the agency on as many aspects of the program as possible prior to the top-line readouts from our pivotal program. I'm also pleased to report today that the National Cancer Institute's Phase II portion of its Phase II-III trial is also very close to completing enrollment of the required 262 participants for the Phase II analysis of event-free survival. The anticipated eminent achievement of this milestone reflects the enthusiasm of our investigators that participated in this trial for this novel combination involving your professor. Like our own Phase III trial, Once we learn that enrollment is completed, we will issue a press release. Thereafter, if the interim event-free survival analysis is positive, the data will be transferred to us to support glycoemetics regulatory filing. Eric will provide you with more detail in his remarks. Completion of enrollment in each of these pivotal trials will be a major accomplishment. especially in light of the logistical challenges over the last year and a half associated with COVID-19. Additionally, as you may have heard, our partner, Apolomix, plans shortly to initiate their own phase 3 trial in China, evaluating Guprolaceran plus salvage chemotherapy in the relapsed refractory AML. The progress the Apolomix team has made integrating the program initiating a Phase I PK bridging study, getting breakthrough therapy designation, and now being on the cusp of initiating the Phase III registrational study has been remarkable. We couldn't have a stronger partner for uproliferant in Greater China. The groundwork we are laying out in 2021 and 2022 should enable us to file for an approval for treatment of patients in both the relapsed refractory and the newly diagnosed settings should both our trial and the NCI's trial hit their primary endpoints. To be clear, if either one is positive, we intend to pursue regulatory approval in that particular setting. I'll now turn the call to Eric to elaborate on our clinical program and to highlight the findings of our Phase I-II study recently published Eric?