GlycoMimetics, Inc.

Today's conference is scheduled to begin shortly. Please continue to stand by and thank you for your patience. Thank you. Thank you. Thank you. Thank you. Good morning, and thank you 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, then zero on your touchtone telephone. I would now like to turn the call over to Sharianne's group at Glycomimetics. Please go ahead.

Good morning. Today we will review our accomplishments and financial results for both the year end and the quarter ended December 31st, 2021. 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 Harut Suburjan, Chief Executive Officer, Brian Hahn, Chief Financial Officer, and Armand Girard, Chief Business Officer. We will start today's call with comments from Harut. Brian will follow and provide an overview of the company's financial position. We'll then open the call for Q&A. I'd 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, UPALESA land, GMI 1359, 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 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 or on the Glycomimetics website. I'll now turn the call over to Haru.

Thank you, Sherry, and good morning, everyone. 2021 was a transformative year for glycomimetics. We advanced from a research-based company to a commercially focused organization. Our number one priority was completing enrollment of our own phase three pivotal trial, evaluating uprolaceran in relapsed refractory AML patients. Towards the end of the year, recruitment for our trial increased significantly, reaching full enrollment in November. Within two weeks of enrollment completion of our trial, the Phase II portion of the NCI's Phase II-III clinical trial in newly diagnosed AML patients also completed enrollment. Both trials exceeded their patient recruitment targets with over 650 AML patients enrolled across both studies. This was a significant achievement, particularly during a global pandemic that had negatively impacted numerous clinical studies in our industry. Looking forward, our focus is preparing for a potential submission of a new drug application and the commercialization of buprenorphine. We are diligently collecting and preparing our phase three data for analysis. Our breakthrough therapy designation provided us an opportunity to interact with the FDA on numerous occasions during 2021. Based on these interactions, we believe that our non-clinical and CMC package will support registration. You should know that we have also manufactured the registration batches of drug product to support the NDA. To further enhance our NDA readiness, we are taking additional proactive steps that extend beyond clinical operations to bolster our CMC, regulatory, medical affairs, and commercialization teams. As you know, the primary endpoint for our phase three trial of overall survival is event driven. Based on our current projections, we expect top line results to come in after year end 2022. As more events occur, our goal is to provide more precision on the timing of the top line readout. With regards to the NCI-sponsored trial, we expect to receive the interim analysis of event-free survival on the 267 patients enrolled. We will press release the data when the NCI shares its analysis with us. The results will determine the next steps for this program. whether the data could support a filing for accelerated regulatory approval, whether the phase three portion will move forward, or whether the trial will stop. In the interim analysis, if the interim analysis is compelling, the NCIS data in the newly diagnosed setting will be transferred to us for regulatory filing purposes. Externally, your proletariat is getting featured in clinical journals and expert forums. In September, the Phase 1-2 data supporting Guproletharan's potential was highlighted in the online edition of Blood. The article reported that 69% of patients achieved minimal residual disease negativity, which has been shown to be the strongest predictor for overall survival in AML. The importance of achieving CR MRD negativity was highlighted in two recent publications, one by the group at Andy Anderson Cancer Center and another at the University of Wisconsin School of Medicine. In both these publications, the authors conclude that in patients with relapsed refractory AML, CR with MRD negativity was associated with the best outcomes. patients who achieved CR with MRD negativity had the lowest rates of relapse and best two-year survival, which was driven largely by an increased ability to undergo stem cell transplant. The blood article also concluded that, first, despite over 50% of patients being classified as having high-risk leukemia, we observed a 41% CR-CRI rate with the addition of uproliferin. Of note, 35% of these responses were full CRs, which highlights the quality and depth of response. Second, 50% of patients achieving a CR-CRI went on to allogenic transplant. And finally, All of this culminated in prolonged survival, which is a great outcome for patients. Just last month, the same article was published in the journal's print edition. These data were placed in a blood expert commentary by MD Anderson experts. The authors confirmed that the results of this Phase I-II study are encouraging and expressed hope that this approach of targeting the bone marrow niche will improve clinical outcomes in the Phase III trial. We are also pleased to see the role of E-Selectin antagonism being discussed in the clinical education forums. Last month, during the DAVA Oncology Acute Leukemia Forum, this novel extrinsic approach to targeting E-Selectin-mediated chemoresistance with your proletaran was highlighted during several expert presentations. During the plenary session focused on leukemia microenvironment, presentations from three medical experts reviewed data implicating E-Selectin as a key mediator of leukemic cell drug resistance and the potential role of your proletaran in deepening remissions. Collectively, This external recognition gives us great confidence of your prolesterin's potential to positively impact the lives of AML patients. Glycometics is chartering a new approach for treating leukemia. As you recall, leukemia lives in the bone marrow. There, leukemic cells induce the expression of isolectin to promote their pro-survival pathways. and also to protect themselves from the effects of chemotherapy. If we expect to have any hope of further improving outcomes in this patient population, we must disrupt these interactions. Euprolasteran represents this new approach of disrupting extrinsic factors of chemoresistance. We believe Euprolasteran has the potential to be transformative for relapsed refractory AML patients. where a high unmet medical need still remains. In addition to these achievements, 2021 was also a year of transition for us in terms of leadership. I joined the company in August when my predecessor retired. I saw an organization with a highly novel glycobiology-based approach, a pipeline of first-in-class drug candidates, and a focus on underserved patient populations. That has significant commercial potential. After seven months on the job, I continue to be enthusiastic about your program, about the pipeline, and definitely about our people. To complement our strong team, we've added three accomplished leaders. Lisa DeLuca joined us as Vice President, Regulatory Affairs. Dr. DeLuca is a veteran regulatory expert. who has previously led the strategy formation and execution of multiple global NDA submissions and product registrations. Lisa's focus will be to advance our NDA and continue to engage the FDA and other regulatory authorities. Bruce Johnson transitioned from our commercial consultant to a senior vice president and our first chief commercial officer. Bruce has over 25 years of experience in oncology, and his near-term focus will be to develop a commercialization strategy for Eupressoram, accelerate competitive readiness, deepen medical expert engagement, and broaden scientific education. Finally, Dr. Deepak Tiwari just joined us as vice president in technical operations. Deepak brings to our leadership team over 25 years of diverse technical management, not only in CMC, but also broad experience, contributing to more than 30 regulatory submissions and 15 commercial product launches throughout his career. As we move our lead product, UproLess, around forward towards the potential submission of an NDA, as well as to develop our pipeline and research product candidates, Deepak's breadth of experience and leadership will be valuable for our team. I would now like to provide insights into five additional operational highlights from 2021. First, our collaboration with Appleomics in Greater China made significant progress during the year. In January, the team secured breakthrough therapy designation in China for uproliferin and advanced from a Phase I bridging study to a Phase III registrational trial in relapsed refractory AML. Second, we announced three investigator-sponsored trials collaborating with investigators at MD Anderson, at UC Davis, and WashU at St. Louis. All three ISTs are currently enrolling patients. Our hope is that data generated by these prestigious cancer research centers will be submitted for presentation at future scientific conferences and will pave the way for expanding the breadth of clinical use of buproliferan across AML and other hematologic malignancies. Third, as for our efforts in sickle cell disease, we accelerated the development of GMI-1687, a first-in-class subcutaneously administered E-selectin antagonist for the treatment of acute vaso-occlusive crisis. We know from the post-hoc analysis of the Phase III reset and open-label extension studies with rivipenzel that early intervention is critical to achieving clinical benefit. Clinicians have told us that an on-demand therapy, either self-administered at home or given in an outpatient ER clinical setting, could be a game changer. There remains no FDA-approved therapy for the treatment of VOC, and our goal is to submit an IND to the FDA in the first half of this year. Fourth, GMI 1359. Our dual antagonist of CXCR4 and E-Selectin was showcased in the 2021 ASH meeting in December. Our collaborators at MD Anderson highlighted the potential for GMI1359 in breaking resistance in AML, particularly in patients with FLIT3 mutations. We are exploring strategic options for this program. And fifth, we are advancing our Galectin3 program. We have nominated GMI2093 as a development lead candidate after observing high affinity, specificity, and oral bioavailability. The role of Galectin-3 in cancer, fibrosis, and other inflammatory disease is emerging as a therapeutic target, and our intent is to advance this program through potential strategic partnerships. Brian? I'll now turn it over to you to provide an overview of our financial results.