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. [Operator Instructions] I would now like to turn the call over to Christian Dinneen-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 @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 Harout Semerjian, 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 Harout, who will provide a broad overview of the business and updates on uproleselan development program, followed by Ed with additional commentary on uproleselan 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, uproleselan 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 pre-commercialization activities and 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 our filings with the SEC, which are available from the SEC or on our website. I'll now turn the call over to Harout.

Thank you Christian and good morning everyone. This past quarter, we made substantial progress with our pivotal Phase 3 trial of uproleselan 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 are 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 uproleselan Phase 3 study protocol. We believe this Interim Utility Analysis should 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 followup data from previous AML, 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 3 population is broadly similar to that of our completed Phase 1/2 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 3 study is slower accumulation of blinded pooled 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 uproleselan 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…

Thanks Harout, and thanks to everyone for joining our call today. Let me begin with how uproleselan could fit into the AML treatment landscape. As a reminder, AML is the second most common type of leukemia and the highest cause of death among all patients with leukemia. About 55,000 people in the U.S. are now living with AML and more than 20,000 adults are diagnosed annually. People with AML suffer dismal outcomes. After frontline therapy about 70% of newly diagnosed patients relapse within three years. Five-year survival languishes at 29%. Despite introduction in the last five years of several new therapies, high unmet medical need persists given AML's heterogeneity and drug resistance. E: As Harout explained, in our pivotal Phase 3 study of uproleselan in relapsed and refractory AML, blinded pooled survival events show that people in this trial are living longer than would be expected based on historical benchmarks. As such, we approached FDA in late summer about adding an interim analysis to assess whether this slow survival event accumulation relates to uproleselan study treatment and uproleselan benefit. The FDA cleared our plan at a meeting earlier this fall. Interim analysis will occur once about 80% of original planned events are observed. The study's Independent Data Monitoring Committee is expected to meet by the end of Q1, 2023 to consider whether to continue to the original 100% OS events trigger or alternatively to recommend immediate and complete trial analysis if efficacy data from study treatment with uproleselan plus standard chemotherapy is observed to be compelling. Recent overall survival benchmarks in relapsed and refractory AML are between five and seven months. The target survival hazard ratio in our Phase 3 study is 0.68. That represents a 32% reduction in risk of death at any point in time. Regulators, patients, and…

Thank you, Ed. As of September 30, 2022, GlycoMimetics had cash and cash equivalence of $51.6 million as compared to $90.2 million as of December 31, 2021. Q3 cash burn slowed to $8.6 million as compared to $30.1 million over the first two quarters of 2022. We expect our current cash resources will fund our operations to the end of 2023 as a result of a decrease in expenses driven by the transition of the Phase 3 relapsed refractory AML clinical trial to follow up, completion of key uproleselan commercial manufacturing activities, and realization of savings from the headcount reduction in the first quarter of 2022. Allocation of resources will continue to prioritize the advancement of the uproleselan development program, including key regulatory and pre-commercial activities. The company's research and development expenses decreased to $4.9 million for the third quarter ended September 30, 2022 as compared to $13.3 million to the same period in 2021. Decreased expenses were primarily due to lower global Phase 3 clinical trial and development costs as patients enrollment ended in November, 2021. The company's general and administrative expenses decreased to $3.8 million for the quarter ended September 30, 2022 as compared to $4.1 million for the third quarter of 2021, primarily due to lower professional fees. I'd now like to turn the call back to Harout.

Thank you, Brian. As today's update, demonstrate this is a very exciting time for us at GlycoMimetics. Given longer blinded pool survival than expected in our Phase 3 study we look forward to conducting this analysis, this interim analysis. Regardless of whether the interim analysis demonstrates that the data is compelling enough to expedite registrational filings or we continue the study as planned through the finer overall survival events trigger, we're confident and excited about the potential for uproleselan to improve outcomes in the relapsed refractory AML and remain committed to bringing this product to market as quickly as possible. We're proud of our sustained clinical progress, not just in this pivotal Phase 3 study of uproleselan in relapsed refractory AML, but also in the ISTs that Ed just described. Though these are preliminary results from a limited number of patients, they continue to illuminate uproleselan's encouraging potential in additional important AML patient populations. In parallel with these clinical activities, our experienced commercial team, led by Bruce, continues to prepare our organization to successfully deliver uproleselan to patients if approved. These exciting advancements position us well to continue working toward our goal of improving the lives of patients with cancer and inflammatory diseases, and we look forward to sharing updates with you on future calls. I'd now like to open the lines for questions. Operator?

Thank you. [Operator Instructions] Our first question comes from Ed White at H.C. Wainwright. Ed, your line is open.

Good morning. Thanks for taking my questions. Regarding the potential IDMC meeting and determination in the first quarter of 2023, perhaps you can just discuss potential regulatory time and development timelines following that data if it is positive?

Yes. Good morning, Ed. Good to hear your voice. So as we said the, we anticipate the Independent Data Monitoring Committee to meet by end quarter one to really discuss one of two possibilities with this Utility Interim Analysis. We either continue the trial as planned at the 100% events, which currently we anticipate, we move that date from mid-year 2023 to around year end 2023 or if there's compelling efficacy seen by the IDMC, then they will recommend to the company the stopping of the trial and the immediate un-blinding of the trial. To your question, Ed, what happens then? Obviously, we're very committed if whenever that – the data happens, be it at the interim analysis or by the year end, remember we have Fast Track Orphan Designation and we are already discussing with the FDA as you've seen as part of our interim analysis. So we want to make sure that we're as part of that, Fast Track and of course the Breakthrough Designation, we rapidly move forward with our regulatory pathway and our regulatory team is really ready and waiting for that moment to happen Ed, so stay tuned.

Okay, thanks. And you did a good job discussing the potential opportunity in the U.S. How should we be thinking of potential opportunities outside the U.S.?

Yes of course, I mean, we're first focusing on the U.S. and given it's the largest market with the largest opportunity and the first one, obviously, but at the same time Ed as a reminder for everyone, our trial is well balanced in its enrollment between the U.S. and ex-U.S. So we have significant presence as well in terms of patient enrollment and medical activities, ex-U.S. as well. So the plan would be, the moment we're moving forward in the U.S. then we will focus on ex-U.S. But maybe Bruce, do you want to add a couple of maybe thoughts or color for Ed of some of the activities ex-U.S.?

Yes, thank you, Ed. I mean, we're continuing to engage medical experts around the globe. We're getting very encouraging feedback on their reception of the data thus far in our current development program. As Harout mentioned, we do have ongoing discussions with regulatory authorities in Europe and fully plan to pursue registration in a variety of major markets around the globe. I would say also with that, we are keeping all options on the table, certainly as well as, certainly potential partnerships, et cetera. But we're exploring all options as we look at the opportunity for uproleselan.

Thanks. And perhaps the last question if I may, just regarding the ISTs, how should we be thinking about the potential there for the company to follow suit and look at these potential indications? Will you be waiting to well after potential approval or is this something that you're looking at now and perhaps we can see something in 2023?

Yes, so basically what we're doing Ed, as a reminder for everyone, we're pursuing, we believe that uproleselan has a role to play across all populations in AML, from the naïve, treatment naive to the really difficult to treat secondary AML. So the plan is to really make sure that from a regulatory pathway, we pursue our pivotal trial in relapsed refractory AML. So that's really our big anchor. And additional peril to that is the NCI trial in the frontline setting. These are both registrational grade trials, that are moving and advancing and maturing, the data is maturing as we speak. And then you have these additional ISTs that really supplement the understanding of the role of uproleselan across different AML subpopulations. Remember, these are populations that are all, I would say, have a high unmet medical need at different levels. And there is an opportunity to pursue the addition of uproleselan to other standard therapies because we believe with the low toxicity profile of uproleselan, and if it's able to generate additive efficacy, then it has the potential to really be adopted across all AML populations. So the whole idea is first we pursue our pivotal trials. Obviously we want to make sure we get to market, but then as the data is emerging, there is a significant opportunity to really advance the clinical development program with uproleselan beyond what will possibly the first indication of relapsed refractory.

Great.

Does that help Ed?

It does. Thank you very much.

Thank you.

[Operator Instructions] All right. As there are no more questions, I'd like to hand the call back to Mr. Semerjian.

Thank you, Operator. Thank you to everyone for joining our call today. We will also be presenting at several upcoming investor conferences, including Stifel and Jefferies in London this month. We look forward to speaking with many of you then. Thank you very much. Back to you operator.

That concludes today's call. You may now disconnect. Thank you.