GlycoMimetics, Inc.

Good morning, and thank you for joining the GlycoMimetics Q3 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. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising you your hand is raised. I would now like to turn the call over to Christian Deneen Long, the company counsel at GlycoMimetics. Please go ahead.

Good morning. Today we will review our business updates and financial results for the quarter ended September 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 Samarjian, Chief Executive Officer, Brian Hahn, Chief Financial Officer, Dr. Ed Rock, Chief Medical Officer, and Bruce Johnson, our Chief Commercial Officer. We will start today's call with comments from Harut, who will provide a broad overview of the business and updates on the UproSLN development program, followed by Ed with additional commentary on UproSLN clinical studies, including both company and investigator-sponsored trials. Brian will then provide details on the company's financial position before we 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 candidate, Yupra Lesolan, and our other pipeline programs, along with expectations regarding our operations, cash position, and the conduct of or data from clinical trials, as well as planned or potential development regulatory interactions or submissions, and free commercialization activities and strategic collaborations. Such statements represent management's judgment and attention 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 our filings with the SEC, which are available from the SEC or on our website. I'll now turn the call over to Haru.

Thank you, Christian, and good morning, everyone. This past quarter, we made substantial progress with our pivotal phase three trial of buproleteran in combination with chemotherapy in patients with relapsed refractory acute myeloid leukemia, and we further strengthened our foundation in line with our goal to become a commercial stage company. We're particularly excited to share with you today that the U.S. Food and Drug Administration recently cleared the addition of an interim utility analysis to our Euprolastera Phase III study protocol. We believe this interim utility analysis to be essential given that the blinded pooled patient population in our study is living longer than expected. As part of our decision, we conducted careful analysis of the follow-up data from previous AML trials. We engaged in multiple discussions with medical experts, and we met with the FDA in order to validate our plan. As a reminder, we completed enrollment of our pivotal trial one year ago this same week, and as we announced in our second quarter earnings call, the Phase III population is broadly similar to that of our completed Phase I-II study with respect to age, severity of AML, prior stem cell transplantation rates, and distribution of relapse and refractory patients, which taken together gives us confidence that we recruited the appropriate patient population. The Phase III study's slower accumulation of blinded pools through survival events prompts us to extend the overall survival event trigger projection for final analysis from mid-year 2023 to around year-end 2023. Simultaneously, we see an ethical need for this interim analysis to address the possibility that this slowdown in patient events may relate to benefit from uproliferant study therapy. As part of the interim analysis, the study's Independent Data Monitoring Committee, or DMC, is expected to meet by the end of Q1 2023. They will consider whether to continue to the original 100% overall survival events trigger or If the efficacy data for treatment with uproceran in combination with standard chemotherapy is observed to be compelling, they'll recommend immediate unblinding and trial analysis completion. We owe it to AML patients to assess the drivers for slower accumulation of blinded pooled survival events in this disease, which remains one with high unmet need and limited treatment options. Importantly, This interim analysis preserves 95% of the original design's alpha and enables us to maintain the study blind if the independent DMC recommends continuation to final analysis. Regardless of whether the DMC's recommendation enables us to expedite registrational filings or we continue the study as originally planned, We are excited by Euphyllaciran's potential to improve outcomes in relapsed refractory AML and help patients achieve deeper, more durable remissions that bridge them to potential curative stem cell transplantation and improve overall survival. From a commercialization standpoint, we continue to focus on three key areas. First, to drive awareness and educate medical experts on E-Selectin biology in AML. and UProlaceran's unique and differentiated mechanism of action. Second, to drive awareness of UProlaceran's clinical development program. And third, to expand our partnership with global medical community. Bruce Johnson, our chief commercial officer, will be available for Q&A to discuss these ongoing efforts, which we expect to position us well as we approach key phase three milestones. Overall, the third quarter marked a period of significant progress and steady execution for glycoemetics. We have the team in place to advance uprolaceran and deliver the therapy to patients who need it. I'm pleased to be joined on this call by Dr. Ed Rock, who we welcomed to glycoemetics just a few short months ago as our chief medical officer. He will provide additional context on our phase three how it compares with other historical, large, randomized AML trials, and how this comparison reinforces our confidence in uproliferant's potential to address significant unmet need for more effective AML therapies. Ed will also share updates on investigator-sponsored uproliferant trials. Two posters will be presented at the upcoming American Society of Hematology annual meeting that represent the first clinical data presentations for this therapy outside of company-sponsored trials. These posters provide support for our belief in the potential broad utility of uproliferant across the AML spectrum from treatment naive to notoriously unresponsive treated secondary disease. Ed, I'll pass it on to you to share more details.