GlycoMimetics, Inc.

Good morning, and thank you for joining the GlycoMemetics call. At this time, all participants are in 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 then zero on your touch-tone telephone. I would now like to turn the call over to Sherri Annis of Investor Relations Group at GlycoMemetics. Please go ahead. Good morning.

Today we will review our accomplishments and financial results for the period ended March 31, 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 replay will be available for 24 hours after the close of the call. The webcast replay will also be available in the investor relations section of the company's website for 30 days. Joining me on the call today are from Glycomimetics are Rachel King, Chief Executive Officer, and Brian Hahn, Chief Financial Officer. We'll start today's call with comments from Rachel. Brian will follow Rachel to provide an overview of the company's financial position and will then open the call for Q&A. Our Chief Scientific Officer, Dr. John Mignone, and our Chief Medical Officer, Dr. Eric Feldman, will join us in the Q&A to address your questions. 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, Perlesa Land, 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 Glycomimetics Filings with the SEC, which are available from the SEC or on the Glycomimetics website. I'll now turn the call over to Rachel.

Thank you, Sherry. This year is an important one for Glycomimetics. Our primary operational focus is on advancing the two U.P.L.S. land registration programs in AML. Leading clinicians, academic centers, collaborative networks, and regulatory agencies are working with us here in the U.S. and abroad as Euperlesland continues to garner significant attention and interest. We believe the progress being made in both registration trials stands as testimony to the excitement around this program, as do the breakthrough therapy designations granted by both the FDA and the Chinese Health Authority. Glycolamedic's pivotal Phase III trial in relapsed refractory AML continued to enroll patients in the U.S., Australia, and in Europe at a steady pace through the first quarter of this year. A remaining number of sites continue to be activated in Europe and in the U.S. as we make a final push toward reaching our target enrollment numbers. Once again, we're confirming that we anticipate completion of enrollment of all 380 patients by the end of this year. In parallel, the NCI-sponsored Phase 2-3 registration trial that's evaluating euproleslin in newly diagnosed older adults with AML also continues to accrue participants at a steady pace. Based on the information provided by the 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. Together, the GlycoLimetics and NCI-sponsored programs will constitute a large data set of patients treated with Euprolessland and intensive chemotherapy. If both are positive, we would anticipate filing for approval for treatment of patients in both settings. Our collaboration with Apalomix in China underscores the broad global community interest in upralesolan. And in January of this year, upralesolan was designated as a breakthrough therapy in China for the treatment of relapsed refractory ANL, complementing a prior designation by the FDA. In addition, Apalomix also announced in March that it had dosed the first patient in greater China in a Phase I clinical trial for treatment of adults with relapsed or refractory AML. This is a bridging study that's expected to allow Apalomix to expeditiously advance development to a Phase III trial in Greater China. Beyond working with the NCI and Apalomix, we're continuing to receive significant interest from clinicians at key centers of excellence who would like to pair you for Lushland with a variety of chemotherapy regimens and other AML therapies. As the year progresses, We expect to announce initiation of multiple investigator-sponsored trials, or ISTs, designed to extend use of uprolexilin across the AML spectrum and potentially beyond AML as well. For example, the preclinical research that combined uprolexilin, venetoclax, and a hypomethylating agent, or HMA, sheds light on the novel benefits uprolexilin could provide in combination with these important therapies. Similar to venetoclax, we may have one of the few drugs that, in chemotherapy combos, actually improves survival outcomes. Importantly and uniquely, upraleslin may improve outcomes without incremental toxicity. As you know, uptake on venetoclax HMA in the frontline unfit AML setting has been strong. And while 60% to 70% of patients achieve a response, the responses are incomplete in approximately half the patients, reducing durability and leading to relapse. Thus, there remains a significant unmet need. This broad clinical program of company-sponsored, NCI-sponsored, and investigator-sponsored trials supports our single, unified vision, namely to establish UPRO as a foundational therapy across the entire spectrum of AML. Whereas most other AML therapies and developments are focusing on narrow patient populations as defined by certain genetic markers, UPRO targets the bone marrow microenvironment, by inhibiting pathways that protect cancer cells from the effects of chemotherapy. This is a novel approach that we expect could be broadly applicable across the spectrum and range of therapies used for relapsed refractory or newly diagnosed patients. As you know, uprolessland is an E-selected antagonist. The scientific rationale for targeting E-selectin and the role it plays within the bone marrow microenvironment as a driver for AML resistance is robust. In addition, our preclinical data supports Eupoleculans protective effects against certain toxicities of chemo, such as mucositis. You'll recall that in our year end call in March, we described the data and research that had been presented at multiple scientific and medical meetings last year. If you haven't already done so, I urge you to visit the scientific publication section of our website to review this exciting work. As we continue to make progress in our pipeline, our plan is to submit abstracts on key research findings to medical meetings in the U.S. and abroad. This past month, at the meeting of the American Association for Cancer Research, or AACR, we were invited to present a poster on our ongoing Phase 1B study of GMI1359, a dual antagonist of E-Selectin and CXCR4. This Phase 1B clinical trial was designed as a proof-of-concept study to evaluate pharmacodynamic or PD markers such as CT34 mobilization of circulating tumor cells into the periphery, downregulation of soluble E-Selectin, and other biomarkers of biological activity, following both single ascending and multiple doses within the same patient. Our goal was to use these PD markers to confirm on-target biologic activity. We believe we've accomplished this objective as the clinical and preclinical data presented at AACR demonstrate that GMI1359 is clearly hitting both targets. This provides us confidence that the drug candidate could be broadly active in disrupting the tumor microenvironment with added evidence of immune activation. Based on our findings, we're evaluating indications for moving the program forward in the clinic. In the sickle cell setting, based on input from the FDA with respect to ripopansil, as well as feedback from KOLs, we're focusing development on GMI1687, We have initiated IND enabling activities with treatment of acute VOC as the potential lead indication. We and others believe that GMI 1687 may be ideally suited for this indication as it would enable patients to potentially self-administer treatment early in their VOC crisis. As we've shown clearly from the phase three reset and open label extension clinical analyses, early intervention is particularly important to improve clinical outcomes in this acute setting. The intended profile of GMI 1687 as a fast-acting, on-demand, and self-administered drug candidate also dovetails nicely with the continued shift in patient care to the outpatient setting, a trend which has accelerated during the pandemic. We'll keep you posted as to progress with the 1687 program as we get closer to first in human dosing, which we anticipate will occur in 2022. Our research efforts continue to progress, particularly in the galactin field. Also at AACR, our research team presented new evidence on the effects of one of our galactin-3 antagonists in a cancer model. This adds to a robust and broad foundation of preclinical data that demonstrates the high potency and selectivity of our galactin-3 antagonists. The potency and selectivity of our compounds distinguish us from competitive approaches, and we intend to roll out additional data as we move toward our goal of selecting a lead candidate for clinical development. Also during the first quarter, we promoted Dr. Eric Feldman to Senior Vice President and Chief Medical Officer. Eric is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders. As CMO, he plays a critical role in overseeing the broad clinical pipeline for Eucalyptus Land as well as for programs in our advancing pipeline. Importantly, our current cash position provides a runway through key milestones, and Brian will now comment on our financial results.