Good morning and thank you all for joining GlycoMimetics Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following management's remarks, we will hold a brief question-and-answer session, and at that time the lines will be open for you. [Operator Instructions]. I would now like to turn the call over to Ms. Shari Annes of the Investor Relations Group at GlycoMimetics. Please go ahead.

Good morning. Today, we will review our accomplishments and financial results for the third quarter of 2020. We'll also be updating you on several more recent achievements primarily related to emerging data from the Phase 3 RESET trial evaluating rivipansel in vaso-occlusive crisis in sickle cell disease. 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 in the Investor Relations section of the company's website for 30 days. Joining me on the call from GlycoMimetics are Rachel King, Chief Executive Officer; Brian Hahn, Senior VP and Chief Financial Officer; and Dr. Helen Thackray, our Senior VP of Clinical Development and Chief Medical Officer. We will start today's call with comments from Rachel, and after that, Helen will review the new data with rivipansel. Following our sickle cell update, Brian will provide an overview of the company's financial position. And we'll then open the call for Q&A. Our Co-Founder and Chief Scientific Officer, Dr. John Magnani, will join us in the Q&A to address your questions on the emerging preclinical data. 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, uproleselan, rivipansel, GMI-1687, and GMI-1359, and our other pipeline programs as well as the potential impact of the ongoing global COVID-19 pandemic on our clinical development operations and cash burn. 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 statements. 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, are on the GlycoMimetics website. I'd now like to turn the call over to Rachel.

Thank you, Shari, and thank you all for joining our call this morning. Let me begin by saying that the third quarter's momentum continues as we speak today. In both the oncology and sickle cell programs, we're making progress on two key objectives. First, to complete enrollment of our Phase 3 trial of uproleselan in the second half of next year; and second, following on encouraging additional analysis of the RESET study data and return of our rights to work in sickle cell disease, to identify whether there's an opportunity for GlycoMimetics to move ahead to develop the therapy to treat acute vaso-occlusive crisis or VOC in sickle cell disease. I'll begin with the uproleselan program. Enrollment in the company-sponsored pivotal Phase 3 trial, evaluating uproleselan in patients with relapsed refractory acute myeloid leukemia or AML continues according to plan. After a slowdown at most of our sites in the earliest stages of the pandemic, the pace of enrollments of the trial has returned to forecasted levels. As a result we're maintaining our prior guidance, we expect to complete enrollment in the second half of 2021. In our collaboration with the National Cancer Institute or NCI, enrollment in that Phase 3 pivotal trial has also recovered after an initial slowdown due to the pandemic. Their focus is treating a newly diagnosed AML patient who is fit for intensive chemotherapy in 60 years of age or older. Enthusiasm for both of these trials continues to be strong, highlighting uproleselan's potential to provide benefits across several clinical endpoints, including improving chemotherapy outcome such as depth or duration of remission and overall survival and ameliorating some of the serious adverse events of intensive cytotoxic chemotherapy. As we said before, we believe, our data supports our vision of uproleselan as a foundational treatment for…

Thank you, Rachel. Our first analysis of new supportive data from the rivipansel Phase 3 RESET trial was reported at the Virtual FSCDR meeting in September. Their investigators presented new efficacy and biomarker data. In particular, the data pointed to statistically significant improvements for patients treated early in acute vaso-occlusive crisis and the primary efficacy endpoint of time to readiness for discharge compared to placebo. For the group's treated within 26.4 hours of onset of pain, which represents the first quartile, this primary endpoint analysis demonstrated a P value of 0.03, a hazard ratio of 0.58, and a median improvement of 56.3 hours compared to placebo. In other words, if treatment with rivipansel was initiated early, patients receiving rivipansel were ready for discharge median of over two days earlier than those patients randomized to placebo. The context for this is the Phase 3 RESET trial, which evaluated 345 patients who are experiencing acute VOC and required hospitalization for treatment. We enrolled patients six years and above with a mean age of 22 years. Since we're often asked, I can explain that the Time To Readiness For Discharge or TTRFD endpoint was the endpoint specifically agreed to with the FDA. It reflects achievements of multiple clinical criteria assessing healthcare utilization, and a patient's medical improvement prior to leaving the hospital, including no longer needing IV opioids, IV hydration, or other related treatments. These are generally the criteria that physicians and patients assess to determine when the patient is ready to manage his or her care with oral medications and therefore to be discharged from the hospital to home. Equally important, we observed that patients treated with rivipansel showed a rapid, deep, sustained, and statistically significant reduction in soluble E-selectin, a biomarker of vascular inflammation that is known to increase in acute…

Thank you, Helen. In addition to the exciting new rivipansel data, indicating that E-selectin antagonism can reverse the course of acute painful episodes if used early, the data was obtained with GMI-1687 has been well received and recognized with oral presentations at recent conferences and in December at ASH. This drug candidate is an E-selectin antagonist; it's more potent than more specific than rivipansel. We believe self-administration could move available treatment for acute VOC not only into the outpatient setting, but potentially also into the home setting. Our September 24 oral presentation preliminary preclinical data at the FSCDR Meeting supported development of GMI-1687 as a possible follow-on to rivipansel, including that this product candidate has the potential for subcutaneous self-administration permutable to use in the outpatient setting. At ASCAT, in late October, another oral presentation disclosed new data from two different preclinical models and showed the drug candidate efficacy as a subcutaneously administered treatment for VOC that prevents sickle red blood cell adherence to inflamed vasculature inhibits vessel occlusion and restores normal blood flow. And at the upcoming ASH meeting an abstract has been accepted for oral presentation. But we once again highlight the product candidate potential for intravenous and subcutaneous administration to treat VOC by inhibiting occlusions and restoring blood flow, a mouse model of VOC sickle disease is featured. We believe, we could be at a turning point in the treatment of acute VOC. We now have statistically significant data showing the benefit of early intervention. This finding has renewed interest in rivipansel, but also highlighted the relevance of GMI-1687 as a possible superior follow-on product candidate that could change the face of VOC treatment by allowing patients to treat early in crisis at home. The idea of treating early has numerous precedents, including most recently the evolving treatment of hereditary angioedema and other acute inflammatory condition. It can seek treatment with GMI-1687, potentially altering the treatment paradigm in a similar fashion to patients being able potentially to treat themselves at home at early sign of the acute event to disrupt the underlying inflammatory cascade. I'd now like to turn to Brian, to both review the quarter's financial results and to provide his perspective on our financial condition. Brian?

Thank you, Rachel. As of September 30, 2020, GlycoMimetics had cash and cash equivalents of $142.9 million, as compared to $158.2 million, as of December 31, 2019. During the quarter, the company received a $1 million clinical development milestone from Apollomics pursuant to the Company's collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan. The company's research and development expenses were $10.7 million for each of the quarters ended September 30, 2020 and 2019. The company's research and development expenses decreased to $33.2 million for the nine months ended September 30, 2020, as compared to $35.6 million for the same period in 2019. Manufacturing and formulation expenses decreased in the three and nine months ended September 30, 2020, as compared to the same periods in 2019, as a result of lower raw material costs purchased in 2020. These decreases were offset by higher clinical expenses due to the increased enrollment in the ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML and the Phase 2/3 clinical trial being conducted by the National Cancer Institute in 2020 as compared to 2019. Contract research services, consulting and other costs were lower in the three and nine months ended September 30, 2020, as research activities were affected at outside universities and travel by research and development personnel was largely eliminated due to the COVID-19 pandemic. Now turning to G&A expenses. The Company's general and administrative expenses increased to $4.1 million for the third quarter ended September 30, 2020, as compared to $3.4 million for the third quarter of 2019. General and administrative expenses for the nine months ended September 30, 2020, increased to $12.7 million as compared to $10.5 million in the same period in 2019. Personnel-related expenses increased due to additional general and administrative headcount, and annual salary adjustments awarded in the first quarter of 2020. Patent, legal fees, consulting and other professional expenses, including directors and officer's insurance premiums, increased as compared to 2019. Other general and administrative expenses decreased for the three and nine months ended September 30, 2020, as compared to the same periods in 2019, due to lower travel, meals and conference registration expenses as a result of travel restrictions imposed during the COVID-19 pandemic. I'll now turn the call back over to Rachel.

Thank you, Brian. But before opening up the call to your questions, I'd like to reiterate our confidence in our clinical pipeline and of course in our specialized GlycoMimetics chemistry platform. Our chemistry insights have fueled several innovations that we believe have the potential to improve the standard of care in AML and may do the same in sickle cell disease and other diseases as well. Now operator, please open the call for questions.

Your first question comes from Ed White with H.C. Wainwright.

So maybe I'll just start with rivipansel and 1689. I'm curious to know, I know you haven't made a decision and you said that it is -- the timing isn't there yet to make the decision. But what information do you need to make a decision for rivipansel to advance? And then also on 1687, how are you thinking about that development? Will you be preparing an IND and looking to move into clinical development? Or do you have to decide first on what to do with rivipansel before you make a decision on the path forward for 1687?

Yes. Thanks Ed, thanks for your question. So let me put this into context. As you recall, a year ago, we weren't doing anything in sickle cell disease. And after the disappointing outcomes of RESET study, we weren't anticipating to do anything in sickle cell disease. What's changed for us, which we think is exciting and open some opportunities for us potentially is that we have this new analysis from the RESET study that shows the potential for early treatment benefits. And in addition, as part of Pfizer, turning back the program to us, we now have the rights to go-forward in sickle cell disease generally, which we did not have as long as the program is licensed to Pfizer. So that gives us an opportunity to look at the pipeline that we have, and to compare the opportunities and to decide what makes sense to go-forward. And we're very encouraged by both what we've seen with the RESET study and what we see with the preclinical data with 1687. So we're reviewing those in each the context of the other. And there are couple of things that we're looking at as we decide what makes sense for us to go-forward. With respect to rivipansel, we're planning to complete the data analysis as Helen described, and we expect that at ASH, we will make a data presentation that will be substantially complete as to what we've learned from the RESET study. We've also -- we will look at that in the context of getting FDA input and looking at what we think it would require to take 1687 forward. And as we evaluate and compare the opportunities with those two programs then we'll be making a decision about what makes sense. But again, I think in, look to put this into context, we do feel that the combination of the RESET data and the 1687 data are both encouraging with respect to potential opportunities in sickle cell disease. And we're now evaluating those to determine what path forward makes most sense.

Okay, great, thank you. And just on Upro, you have your license agreement in Greater China; will you be giving an abstract dates on the development there and the potential for timelines and everything in Greater China? And then also, if you complete enrollment in the second half of 2021 in your Phase 3 trial, when could we expect to see data?

So with respect to Upro in China, we will give updates as that program progresses. And I think the next thing you might expect to hear would be an announcement when the study begins in China. So we will give updates as that progresses. As far as the timing of data, that depends on two things. The data from the Upro trial, one is of course, completion of enrollment. And the second is establishment or achievement of a certain number of events. And so we need to see how both of those play out, as we said, we do expect enrollment to complete in the second half of 2021. And then at that point, you may have a sense of how we're looking at terms of number of events. Unfortunately, in this trial by events, what I mean by that is the number of patients who have died in the aggregate population that then would enable us to compare treatment versus a placebo arm. So we need to follow-up for both of those. And then we'll be able to look to-date, but we do anticipate that the cash that the company currently has on hand would get us through that data readout.

Great, thanks. And then my last question is just on 1359. Great to hear that the study has restarted, I think you had been expecting to enroll six to 12 patients. Can you give us an update as to how many have enrolled so far? And what -- you said that we should expect to see data in the first half of 2021. What data will we see at that time? Thank you.

Sure. Sure. So we haven't given specific updates on numbers of patients, but as you indicated, we do expect to see a small number of patients. And just let remind you, what we are looking for in that study. That's the first trial of that drug candidate in patients. And it gives us an opportunity to look at some PKPD biomarkers for the first time. And specifically, we're looking at biomarkers related to mobilization of certain cell types, for example, mobilization of normal hematopoietic stem cells, and mobilization of cancer cells that could be resident in the bone. So we're looking for a first indication of those PKPD biomarkers, also gathering some additional safety data. And in the aggregate, what we anticipate is that that data would then put us in a position to move into what we might consider to be a more traditional expanded trial in a patient population, or we begin to look at more traditional efficacy related endpoints. We've not yet defined what that patient population would be. In this group, obviously, we're looking at breast cancer patients. We've also seen some preclinical data from this program in osteosarcoma, as well as other interesting indications. So we think there are a number of ways we could go with it. But we do expect that the initial data would be biomarker related data.

Your next question is from Stephen Willey with Stifel.

Hi, this is Ellen on for Steve. Thank you for taking our questions and congrats on the data, you've been able to present recently. So I know you're pretty limited in what you can provide in terms of rivipansel and next steps. But can you provide any details on timing of maybe when you're having these discussions with FDA or when you expect to have these discussions with regards to next steps?

So we haven't provided specific guidance, and we wouldn't on any specific conversations that we might have with the agency. But what we do, what we will commit to is that once we have evaluated both any input we have from the agency as well as data that we have in hand, that at that time, when we've made a decision about what we think are the definitive next steps, then we will provide guidance on that.

Okay, great. And I think you mentioned this, but with regards to the upcoming data presentations at ASH for rivipansel, are those presentations representative of kind of the last basket post-hoc analyses we'll be seeing from RESET or do you expect to be sharing kind of more data, I mean throughout early 2021?

We do believe that the data presentation at ASH will be a substantially complete presentation on the data from the rivipansel program to-date. And as Helen indicated, we anticipate that will include data from the RESET study as well as data analyzed from the open-label extension trial. So we expect that the data at ASH will be a substantially complete data presentation. I can't say that there might be some additional data that could be presented in publications going forward. But I think the ASH data would be a substantially complete presentation of the data.

Okay, great. And then maybe one on uproleselan, with regards to that AML Phase 3 trial, I know you've mentioned that enrollment has resumed its normal pace. That being said, as COVID is starting to spike in the U.S. again, do you expect to take any COVID mitigation measures going forward to make sure that enrollment kind of stays on track? Or do you expect that to just not be an issue for whatever reason?

Well, I can't obviously predict what the impact of COVID may be. And that's certainly a concern, I think for all of us in many respects. With respect to the clinical trial itself, though. What we have seen is that because of the way the study is designed and the way the patients are treated, we think that it is well-positioned to advance through potential COVID impact. And I can turn to Helen for more specific comments on that. But I generally observed that as compared to trials and other settings, we think a trial in the acute AML setting may be better positioned, as you said to weather COVID-related delays, but it's some, we certainly can't predict what those might look like as the pandemic progresses. But, Helen, could you comment further on the situation with the clinical trial?

Yes, yes, thank you. So we do know that patients with acutely diagnosed refractory AML or relapsed require treatment that is in the hospital setting for the intensive chemotherapy that they receive that is an acute need and one that proceeds regardless of the situation with the pandemic so patients do need to be hospitalized for treatments. And that means that they’re coming in for treatment and participating in the trial. In terms of mitigation, there is one other element of the trial that I would mention that as we have seen giving some advantage to continuing accrual over the course of the pandemic and that is the global nature of the trial. So we're not limited to any one country or region in terms of the sites participating in the trial. We have sites in North America, in Europe, and in Australia. And when we have seen one region or area with increased severity of the pandemic, we've had other areas with more routine operations in terms of their hospital procedures and patient care. And so that has allowed the trial to have a steady pace of enrollment as we would have expected globally in the aggregate, while there may be more local effects here and there as local areas are responding to pandemic in their region.

Thank you, Helen. It's unlikely an elective therapy, I think that's the key point. Do you have another question?

Okay. Yes thank you so much for the color and again congrats on all the recent progress.

Sure. Thank you.

[Operator Instructions]. Your next question is from Zegbeh Jallah with ROTH Capital.

Good morning, guys. And again, congrats on the abstract at ASH particularly oral presentations, I was really excited. I think I'll just ask two quick ones here. The first one is on rivipansel; I'm excited that this will be in oral at ASH. So a lot of clinicians will get to see the updated post-hoc data, but I was just curious as you've been engaging with KOLs and what some of that feedback has been like, I know we're planning to have our own KOL call coming up. But I was just wondering what your feedback has been?

Yes. So I think that's a question I'd also turn to Helen, obviously at this point, or yes, well let me just turn that to Helen.

Thank you, Rachel, and thank you for the question. It's been very interesting. We are hearing, I think and in discussions with the investigators who've been involved in the trial, confidence that the inhibition of E-selectin is having a clinical effect as seen in this front group of patients from a trial who are treated early, the biomarker data is extremely supportive of that. And there's I think excitement about the potential for a therapeutic candidate that could be used to treat this. And as you know that there remains the complete unmet need for therapies that would interrupt the acute vaso-occlusive process and so there has been strong interest engagements and excitement from the investigators around the evolving data set as we learn more about the effects of this approach and those treated early in acute VOC.

Yes, I think another perspective that we could add to this is that there is a -- as we think about this, there's the potential for the development of a new paradigm for how patients are counseled with respect to VOC. Currently many times, patients are told to stay home, they're counseled to do all they can to manage the pain at home. And course, many people, understand that they are reluctant to go to the emergency room where the standard of care is the delivery of opioids. If there were an alternative that could provide relief, that could actually change the paradigm of how patients are advised, they may be advised to go earlier to the emergency room, and to seek an earlier intervention in the crisis, which I think is an interesting opportunity. And something that's also -- something that's being recognized by the KOL. So we certainly also look forward to more KOL engagement as the data becomes even more widely known today, oral presentation at ASH.

Thanks, guys. And then just the other follow-up here excited to see that by Upro plus HMA data will be an oral presentation as well, even though the preclinical study outcome. I got excited about this one when I saw some early data at ASH last year, been pounding the table on it, so quite excited and just thinking because these are huge studies. And these are going to be long studies, if this is something that you're going to explore clinically as well. So are you thinking about potentially partnering this and then at what stage would you want to kind of get it as far as you can before partnering or would you be open to some kind of partnership as early as possible?

Yes, so thank you. And yes, we're also very excited about the combination data with the -- with Upro, venetoclax, and the HMA. As you know venetoclax has really come in as an important new treatment option for patients with AML. But sometimes the -- although the response rates are good, the CRs as a percentage of total responses is not what you'd like to see. And sometimes the responses are not as durable as one might like to see. So the preclinical data really is exciting to us in that we do think that it does support moving this combination into the clinic. So we remain very focused in terms of our operations on getting the Phase 3 trial finished with the Upro in the relapsed refractory setting, as you know. But we have had some very strong interest from investigators in pursuing these combination therapies. So we're looking at how we might in a very cost effective way take this forward in the clinic, and when we have specific plans with regard to that, we'll certainly let you know. And so I think I guess I would have to say stay tuned. What we're looking at is, is there a cost effective way for us to begin to get an early look at the potential of this combination in the clinic. And as we bring together this one, we will certainly let you know.

Thanks, Helen. Appreciate it.

Not Helen, it's Rachel apologies.

Yes, both of us thank you.

At this time, there are no questions. Speaker, do you have any closing remarks?

Just to thank everyone for participating in today's call, and we really, we appreciate your questions, your interest and your support with the company. Thank you.

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone have a great day.