GlycoMimetics, Inc.

Good morning, and thank you all for joining Glycomimetics Call. At this time, all participants are listen-only mode. Following management 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 touch-tone telephone. I would now like to turn the call over to Sherry Ines of Investor Relations Group at Glycomimetics. Please go ahead.

Good morning. Today we will review our accomplishments and financial results for the period ended June 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.glycomamedics.com under the Investors tab. This call is being recorded. A dial-in phone reply 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 Rachel King, Chief Executive Officer, Dr. Eric Feldman, Chief Medical Officer, and Brian Hahn, Chief Financial Officer. Our new CEO, Harut Samarjan, is also on the call with us this morning. We'll start today's call with comments from Rachel and Eric, Brian will follow Rachel to provide an overview of the company's financial position, and Harut will add some initial comments. We'll then 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, you professor, Lance, GMI 1359, and GMI 1687, and our other pipeline programs, along with our operations and cash position. 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 Glycomimedics filings with the SEC, which are available from the SEC or on the Glycomimedics website. I'll now turn the call over to Rachel.

Thank you, Sherry. As we've said in prior calls, our primary operational focus is on advancing three uprolestolant administration programs in AML. Our company-sponsored Phase III trial in relapse refractory AML, the National Cancer Institute's trial in newly diagnosed patients, and the registration study in China being conducted by our partner, Apalomax. I'm pleased to report today that recruitment rates in both our own Phase III and the National Cancer Institute's Phase II portion of its Phase II-III trial continue to support an expectation that enrollment will be completed by the end of this year. During the quarter, and just after it's closed, we announced the initiation of three new investigator-sponsored trials, or ISTs, that expand the breadth of our UPRLS land clinical research activities. There are now six trials evaluating upralesolan, including three registration trials and three ISTs. The support of clinicians who are enrolling patients in our global studies and now the new ISTs has made it possible to broaden the scope of our upralesolan clinical research to address unmet needs of patients with hematologic malignancies. Leading clinicians, academic centers, collaborative networks, and regulatory agencies are working with us as upralesolan continues to garner significant attention and interest The breakthrough therapy designations granted by both the FDA and the Chinese Health Authority, we believe, have added momentum for this program worldwide. To reiterate, we're confirming that we anticipate completion of enrollment of all 380 patients in our company-sponsored registration trial by the end of this year. As you know, the readout on the primary endpoint is event-driven. As we approach completion of enrollment and as we acquire additional data on events to date, we plan to give guidance as to timing of top-line data. In parallel, the NCI-sponsored Phase II Registration Trial that's enrolling uprolessment in newly diagnosed older adults with AML also continues to accrue participants at a steady pace. Based on the public information provided by NCI to date, we continue to anticipate that the trial will complete enrollment of the Phase II portion by year end, supporting a subsequent interim analysis of event-free survival, or EFS, in the trial's initial 262 patients. To be clear, if the NCI Alliance's interim analysis is positive, the data will be transferred to glycomimetics to support our regulatory filings. Together, the glycomimetics and NCI-sponsored programs will constitute a large data set of over 500 AML patients. We would anticipate filing for approval for treatment of patients in both settings should both trials hit their primary endpoints. Epilomics last quarter announced that it had dosed the first patient in Greater China, in a Phase I clinical trial for treatment of adults with relapse or refractory AML. This study is a bridging study that's expected to allow Apilomix to expeditiously advance development to a Phase III registration trial in Greater China. Beyond working with the NCI and Apilomix, we've now announced three new trials in which uprolesline is being paired with a variety of chemotherapy regimens and other AML and multiple myeloma therapies. These investigator-sponsored trials complement our registration trials and should begin to produce data in 2022. They provide us three additional perspectives and could well provide a basis for expanding use of UPRO-Less land across the AML spectrum and potentially beyond AML as well. I'd like to add that all three of the institutions sponsoring these trials have collaborated with us in the past and reflect the growing enthusiasm for UPRO that I mentioned before. I'd now like to turn to Dr. Eric Feldman, our Chief Medical Officer, to describe each of these in a bit more detail. Eric?