GlycoMimetics, Inc.

Good morning, and thank you for joining the GlycoMimetics Q2 2022 earnings 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 Christian Deneen Long, Company Counsel at GlycoMimetics. Please go ahead.

Good morning. Today we will review our business updates and financial results for the quarter ended June 30, 2022. The press release we issued this morning is available on the company's website at 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 Harut Samerjian, Chief Executive Officer, Brian Hahn, Chief Financial Officer, and Bruce Johnson, Chief Commercial Officer. We will start today's call with comments from Harut, who will provide a broad overview of the business and the progress of our pipeline programs. followed by commentary from Bruce on the potential market opportunity for Upril Esalon. Brian will then provide detail on the company's financial position and will open the call for Q&A. I would 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, Upril Esalon, GMI 1687, and our 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 pre-commercialization activities or strategic collaborations. 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 on the Glycomimetics website. I'll now turn the call over to Haroud.

Thank you, Christian, and good morning, everyone. Over the past quarter, we have continued to ramp up our regulatory and commercial readiness activities as we advance the development of our lead program, Uprolacerant. currently in a phase three registrational trial in relapsed refractory acute myeloid leukemia, or AML, and continue building a strong foundation for our potential evolution to a commercial stage company. Experienced and dedicated leadership with a track record of successfully commercializing oncology and hematology assets is crucial to this evolution, which is why we are excited to have Bruce, our Chief Commercial Officer on today's call to share additional detail on these ongoing efforts. First, however, let me provide an overview of the business. As shared last quarter, one of our top priorities continues to be cleaning the data from the 70 sites and 388 patients participating in our phase three clinical trial across the US, Europe, Canada, and Australia. The placebo-controlled trial is evaluating salvage chemotherapy with or without uproliferan. Recall that the primary endpoint of this trial is overall survival, and as we have previously disclosed, the Phase III trial was powered at 90% to detect a hazard ratio of 0.68 or better. Today, for the first time, I'd like to share an overview of the patient demographics from our Phase III trial. When designing our Phase III trial, our goal was to generally reflect our Phase I-II patient population and exclude patients that are not likely to benefit from the therapy. I'm pleased to say that Phase III population is broadly similar to that of the completed Phase I-II study with respect to age, severity of AML, prior stem cell transplantation rate, and distribution of relapse and refractory patients. the median age was 58 years old. 33.5% of the Phase III participants were refractory patients, with the other 66.5% falling into the relapse category. Of the relapse patients, 19% of the Phase III population had a prior duration of remission less than six months. In terms of prior therapeutic background of this Phase III population, 18% previously had hematopoietic stem cell transplantation, or HSCT, while 16% had undergone more than two induction regimes. ELN risk stratification was broadly consistent with Phase I-II population. For a more detailed breakdown, you can find the full patient demographics table in our earnings press release. Bottom line is, The patient population enrolled in the Phase II and in the Phase III programs with your Prolazaran in the relapsed refractory setting are broadly similar and reflect the patient population clinicians are seeing in their practice. As for the timing of the event trigger, we have previously disclosed our projection of mid-year 2023 for this milestone, with disclosure of the top-line data results shortly thereafter. We will continue to monitor events and provide appropriate updates to this projection as needed. As a reminder, we have already been granted FDA Fast-Track and Breakthrough Therapy designations for uparaciran and relapsed refractory AML, allowing us to rapidly move to regulatory submissions. As we draw closer to this milestone next year, we remain confident that by disrupting the protective interaction within the bone marrow microenvironment, buprolesterone has the potential to transform outcomes in AML patients by hopefully achieving deeper, more durable remissions, higher rates of measurable residual disease, MRD negativity, bridging more patients to potentially curative stem cell transplants, and ultimately improving overall survival. In addition to our phase three registration trial, Uproliferin is also being evaluated by the National Cancer Institute, or NCI, in an independent, randomized, open-label trial in frontline, newly diagnosed AML patients who are 60 years and older. This clinical study is evaluating whether the addition of Uproliferin to a standard cytarabine-donorubicin regime of 7 plus 3 in older adults with improved patient outcomes. The Phase II portion of this Phase II-III trial completed enrollment of 267 patients last November. And as per protocol, the NCI has suspended further enrollment in anticipation of its planned interim analysis. When the outcome of the NCI's event-free survival analysis of the Phase II trial is communicated to us, we plan to issue a press release. To be clear, The NCI trial gives us the opportunity to demonstrate benefits in a distinct patient population and potentially expand our label to include frontline AML. I'd also like to reiterate that in addition to advancing two registration stage programs, we have several investigator-sponsored trials currently evaluating your proletarian potential in additional hematological indications. Studies are underway to demonstrate the benefits of adding Gifrolasteram to venetoclax HMA combinations in patients ineligible for intensive chemotherapy, as well as in combination with salvage therapy for secondary or treatment-related AML. We continue to collaborate with the principal investigators of these trials with a mutual goal of publishing their findings at major medical meetings. These trials provide glycoemetics with the opportunity to expand the potential application of uproliferan into additional areas of unmet medical needs, and we are greatly appreciative of our investigator partners for their efforts to advance this goal. We believe the enthusiasm of clinicians to engage with uproliferan in this manner reflects both the high degree of unmet needs in this patient population and the exciting potential that uproliferin has to address these gaps in the care continuum. Our pipeline of innovative glycobiology-based therapies extends beyond uproliferin, and I would now like to turn to recent updates on the progress we have made with our sickle cell disease program, GMI1687. I am pleased to report that the FDA accepted our IND application to proceed with a phase one clinical trial of GMI 1687 in healthy volunteers. While we are encouraged by this positive update, in line with our existing business strategy, we are focusing company resources on your proletarian development and potential commercialization. Consistent with our past communications, with this IND acceptance, we believe 1687 is well positioned for partnership to further advance this promising molecule. As a reminder, GMI1687 is a highly potent E-Selectin antagonist initially being developed to treat acute vaso-occlusive crisis or pain crisis in sickle cell disease patients. E-Selectin is believed to play a major role in the cascade of events leading to clots and blockages that cause patients pain crisis, which could ultimately lead to events like a stroke or permanent organ damage. Because GMI 1687 offers the potential for self-administration in an injectable subcutaneous dosing form via a pre-filled syringe or auto-injector, it could be administered at the onset of the pain crisis to disrupt the underlying inflammatory cascade and restore normal blood flow, potentially blocking damage and pain created by occluding blood flow to the organs. Given that there are currently no FDA-approved therapies in the treatment of acute VOCs in sickle cell patients, we are optimistic about the promise of this program to address the high unmet need and long-term health consequences for this population. Despite recent advances in the treatment of sickle cell disease, The impact on reducing, on reduction of frequency and severity of the VOCs has been limited for the nearly 100,000 patients in the U.S. We look forward to continuing to provide updates as we review potential next steps for this program. As we continue to advance the Phase III uproliferant trial towards its overall survival events trigger, currently expected in mid-2023, and make progress across the rest of our pipeline with the recent acceptance of our IND application for our next asset, GMI 1687, we have established strong momentum in our continued evolution to a commercially-focused organization. We are hard at work preparing for your Proleteran's anticipated market entry, and I'd like to hand the call to Bruce to provide detail on the team's early commercial development work the market opportunity, as well as an overview of the current AML landscape. Ruth?