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Edited Transcript of GLYC earnings conference call or presentation 7-Nov-19 1:30pm GMT

Q3 2019 GlycoMimetics Inc Earnings Call

Gaithersburg Nov 16, 2019 (Thomson StreetEvents) -- Edited Transcript of GlycoMimetics Inc earnings conference call or presentation Thursday, November 7, 2019 at 1:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Brian M. Hahn

GlycoMimetics, Inc. - Senior VP, CFO & Secretary

* Helen M. Thackray

GlycoMimetics, Inc. - Senior VP of Clinical Development & Chief Medical Officer

* Rachel K. King

GlycoMimetics, Inc. - President, CEO & Director

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Conference Call Participants

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* Edward Patrick White

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Lyla Youssef

Cowen and Company, LLC, Research Division - Research Associate

* Nirav Y. Shelat

Piper Jaffray Companies, Research Division - Research Analyst

* Stephen Douglas Willey

Stifel, Nicolaus & Company, Incorporated, Research Division - Director

* Shari Annes;GlycoMimetics, Inc.;Investor Relations

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Presentation

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Operator [1]

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Good morning, and thank you for joining the GlycoMimetics call.

(Operator Instructions)

I would now like to turn the call over to Shari Annes of the Investor Relations Group at GlycoMimetics. Ma'am, please go ahead.

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Shari Annes;GlycoMimetics, Inc.;Investor Relations, [2]

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Good morning. Today, we will highlight the key developments of 2019's third quarter. The press release we issued this morning on our Q3 financials 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 today from GlycoMimetics are Rachel King, Chief Executive Officer; Brian Hahn, Senior VP and Chief Financial Officer; and Dr. Helen Thackray, Senior VP of Development and Chief Medical Officer.

We'll start today's call with comments from Rachel, and after that, Brian will 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 contained on this call include, but are not limited to, statements about the company's wholly-owned product candidate uproleselan, GMI-1359 and rivipansel, GlycoMimetics' product candidate exclusively licensed to Pfizer as well as our other pipeline programs. 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'd now like to turn the call over to Rachel.

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [3]

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Thank you, Shari, and thank you all for joining our call. This morning, I'd like to highlight the new data that we'll be presenting at the ASH Meeting in December, after which I'll describe the third quarter's developments. ASH has always been an important meeting for us, and this year is no different. Yesterday, ASH published the abstracts accepted for presentation at the meeting, and I'm pleased to share with you this morning highlights of the GlycoMimetics abstracts that will be presented in Orlando. Importantly, we'll report new data that reinforce both our understanding of how E-selectin acts as a driver of environment-mediated drug resistance in AML and the potential of uproleselan to improve patient outcomes by breaking chemoresistance. Specifically, we're presenting multiple looks at E-selectin ligand expression in preclinical and clinical settings that correlate high E-selectin ligand expression on leukemic cells with poor survival in adults and children.

I'd like to focus your attention on 2 of the abstracts in particular. The first was submitted by collaborators at the Fred Hutchinson Cancer Research Center in Seattle. It describes identification of a unique gene expression signature that's a surrogate for E-selectin ligand expression and that strongly correlates with outcomes in pediatric AML. Specifically, the investigators looked at over 20 genes that are involved in glycosylation of cells and correlated them to overall survival. What was striking was the following observation: out of the many genes evaluated, we've identified several that are directly involved in the final glycosylation of the E-selectin ligand and that are highly statistically correlated with poor survival. The samples for this analysis come from a large retrospective independent database of over 1,000 patients. Here, for the first time in a large clinical setting, we demonstrate that E-selectin ligand is identified by unique glycogen signatures, was highly correlated with poor clinical outcomes in AML. This builds on our previously presented clinical and preclinical data, complements and confirms our work with a flow-based assay and opens up the possibility that RNA could be used to study E-selectin ligand in patients at highest risk for poor outcomes. This is very exciting and compelling.

The other key poster reports a new post-hoc look at the final Phase II dataset reported last year at ASH. The first author is Dr. Dan DeAngelo, the principal investigator for the Phase II and the ongoing Phase III trial in relapsed/refractory AML. If you recall, we previously reported that when treated with uproleselan, those patients we expected to do worse because of high levels of E-selectin ligand expression as measured by a flow-based assay, actually did much better than predicted. In the analysis you'll see at ASH, we dug deeper into the clinical characteristics of 22 patients who had high levels of E-selectin ligand expression. Using a validated index called the European Prognostic Index, or EPI, this new data reports that 72% of these patients had poor risk disease with an expected 1-year survival of less than 20%. However, in our trial, this group showed a 45% 1-year survival with median overall survival of 12.7 months.

Thus, by higher E-selectin expression -- higher E-selectin ligand expression or by EPI risk at baseline, the poor risk patients should have done worse clinically than the general population of relapsed/refractory AML patients. And yet in this trial, when treated with uproleselan, they did dramatically better than expected. This, we believe, is an important observation given the findings I just described on the glycogene signatures. And it's important as we think about targeting additional indications and patient populations. Separately, in other ASH posters, we'll present new preclinical work that reinforces our enthusiasm for the uproleselan opportunity. More specifically, we're building a data set that demonstrates the power of E-selectin in environment-mediated drug resistance. What I mean by environment-mediated drug resistance is this: there are intrinsic drivers of AML, like AML mutational status such as IDH3 mutations. There are also extrinsic factors that play a role in tumor cell resistance propagation metastatic spread. Our focus at GlycoMimetics is on the extrinsic factors, particularly those within the tumor microenvironment, and the data selected for presentation validates our efforts.

The new data expands our understanding of the role we believe E-selectin plays in the pathology of AML, namely in the tenacity of tumor cells in the bone marrow microenvironment and their survival. The Winkler abstracts also published yesterday, one of which was selected for oral presentation elaborates how blocking E-selectin favorably impacts multiple cancer survival pathways. Our work targeting E-selectin in AML complements our work targeting other extrinsic factors, such as CXCR4 and the Galectin. Together, this research represents a precision medicine focus on specific extrinsic factors within the tumor microenvironment that play critical roles in disease proliferation, progression and resistance. With an increasing number of relevant biomarkers being identified, we're in a stronger position than ever to exploit this opportunity.

I'll now discuss the third quarter's development. In the clinic, our highest priorities are the 2 AML registration trials. Our own trial is in the relapsed/refractory setting, and the NCI's trial is with newly diagnosed patient population fit for chemotherapy. Each is a stand-alone trial that if successful could support registration. The trials are running in parallel and together are building significant visibility for uproleselan. We believe this is helpful as investigators identify AML patients for whom uproleselan may improve outcomes. During the third quarter, we continued to add sites and patients in the company-sponsored relapsed/refractory trial. Enrollment in the NCI-sponsored trial also continued during the quarter. Enthusiasm for both trials remain strong.

Work is underway to initiate a clinical trial of 1359, a dual antagonist of E-selectin and CXCR4 in breast cancer patients with bone metastases. As you recall, this trial is a single center study being done at the Duke Cancer Institute, looking at a number of biomarkers of pharmacodynamic activity across a range of different dose levels. Its results will be used to inform a broader Phase II program in cancer.

Finally, I'd like to say a few words about our partnered program with Pfizer, rivipansel. As you know, on August 2, Pfizer announced that the Phase III study of rivipansel failed to meet its primary and key secondary endpoint. Pfizer publicly stated that they intended to present or publish the study's results either at a major medical meeting or in a peer-reviewed journal publication. Until that occurs, we're unable to provide any additional detail or comment on the results. While we were surprised and disappointed by the outcome, we do look forward to providing our perspective on the data once the full efficacy, safety, PK and biomarker data have been publicly presented by Pfizer.

In summary, we've made progress in our own programs and are looking forward to ASH. The data to be presented not only supports the role of E-selectin as a major extrinsic driver of chemoresistance in AML, it also reinforces the potential of uproleselan in disrupting E-selectin mediated interactions in the bone marrow. The posters add to a growing dataset and underscore our belief that uproleselan has the potential to augment deep clinical remissions and to prolong overall survival.

Moving forward, our operational focus on the uproleselan program continues. In addition, we were successful in the third quarter in reprioritizing our spend to conserve what we believe is a significant amount of cash. In clinical development, we are efficiently advancing our portfolio of investigational drugs. Our pipeline is robust with all programs stemming from the company specialized GlycoMimetics chemistry platform. Additionally, we have a stellar team in place to deliver results, and we're well financed to take the company into 2022 and through key readouts with the potential to create value inflections for our programs, first and foremost of which is uproleselan.

Let me now turn the call over to Brian, who will review our financials with you.

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Brian M. Hahn, GlycoMimetics, Inc. - Senior VP, CFO & Secretary [4]

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Thank you, Rachel. As of September 30, 2019, GlycoMimetics' cash and cash flow was $170.9 million as compared to $209.9 million as of December 31, 2018. The company's research and development expenses increased to $10.7 million for the quarter ended September 30, 2019, as compared to $9.7 million for the third quarter of 2018. This increase is primarily the result of expenses related to the company's Phase III clinical trial of uproleselan in relapsed or refractory AML patients and supporting the clinical trials of uproleselan conducted by or in collaboration with third parties.

The company's general and administrative expenses increased to $3.4 million for the quarter ended September 30, 2019, as compared to $2.8 million for the third quarter of 2018. The increase was due to higher patent, legal and noncash based -- stock-based compensation expenses.

In summary, GlycoMimetics is in an excellent financial position to carry out its planned initiatives and to advance its novel pipeline.

I'll now turn the call back over to Rachel.

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [5]

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Thank you, Brian. With 2 key registration trials in AML actively recruiting and a robust slate of data scheduled for presentation at ASH, we're excited about the remainder of 2019 and the year ahead.

With that, I'd like to open the call for your questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Your first question comes from the line of Danielle Brill of Piper Jaffray.

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Nirav Y. Shelat, Piper Jaffray Companies, Research Division - Research Analyst [2]

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This is Nirav on for Danielle. I just had a couple of questions. On the additional analysis that you'll be presenting at ASH for the Phase I AML study, I noticed that there were -- in the high E-selectin group, there was a slightly lower prevalence of primary refractory patients. So I was just wondering how that would have impacted -- in your thoughts, how that would impact the overall survival and response rates compared to the low E-selectin group?

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [3]

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Thank you. I'll turn that question over to Helen, our Chief Medical Officer.

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Helen M. Thackray, GlycoMimetics, Inc. - Senior VP of Clinical Development & Chief Medical Officer [4]

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Sure. So we look at that as a breakdown of the E-selectin ligand in the group that is high and the group that is low. There are a number of clinical characteristics in each of those groups that vary a little bit. We compare that to the total population in the aggregate as well. We would expect primary refractory disease to be a very high-risk characteristic. We would also expect early relapse -- short prior duration of remission to be a high-risk characteristic, and we look at the adverse risk cytogenetics and molecular profile as high-risk characteristics. So we don't report on all of those here in the abstract, and we will have more of those in the poster. But generally, the profile across the clinical risk characteristics where the high E-selectin ligand group is, in fact, high. And so I would not focus on one component of that to look at the -- to sort of focus on what that should say -- tell you about overall survival.

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Nirav Y. Shelat, Piper Jaffray Companies, Research Division - Research Analyst [5]

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Got it. And my second question was on the discontinuation of the collaboration with Haemato Oncology Foundation, just your thoughts on how will this impact spending? And what do you expect to see from this? And how does this impact your plans for developing uproleselan in AML overall?

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [6]

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Yes. So we haven't disclosed specifically what the spending commitment had been on HOVON. But I think that there are a couple of important points to make: one is that we wanted to focus on the pretrials that could drive to registration. And those are 2 studies, that's our study and the NCI trial. And so that's, I think, properly where we would have our operational focus. The other issue is that, in the setting in which the HOVON trial was planned, there have been a number of changes, particularly with the approval of venetoclax. That setting, as you may recall, was for the newly diagnosed patients who are unfit for intensive chemotherapy. So it's a setting where the standard of care is also evolving, and that was another factor that again made us decide that we wanted to focus our resources where we thought they could have the most impact in terms of the company's development. I will say there continues to be a lot of interest in the potential for using uproleselan in the newly diagnosed patients who are unfit for chemo setting. And so we continue to explore the potential to look at that setting, but with potentially a different study design.

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Operator [7]

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Your next question comes from the line of Ritu Baral of Cowen.

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Lyla Youssef, Cowen and Company, LLC, Research Division - Research Associate [8]

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This is Lyla on for Ritu. My question focuses on the GMI-1359 program. Could you remind me when we expect to see data from this program? And also if you're considering any other cancer populations aside from the breast cancer with bone metastases that this drug may be relevant for?

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [9]

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Sure. We're looking for data at the end of 2020 for that program. And as a reminder, this is a trial that's designed as a dose escalation study to help us to evaluate pharmacodynamic markers of that drug. From that study, then we would get information that would lead us into what you might consider to be a more traditional Phase II type study. There are a number of different cancers that we are considering as we look at the program as we contemplate developing this drug. If you recall, from our preclinical data, we've seen particularly exciting data, compelling data in settings where there is bone involvement in cancer. And that's occurred in settings where there's metastasis to bone, like breast cancer metastases as in this trial or prostate cancer metastases. We've published on both of those. We've also shared data on a cancer which is primary to bone, which is osteosarcoma. So there are a number of settings where we think we could take 1359 forward. We'll be looking at where we could find a targeted population where we think the drug would specifically be beneficial. And this trial, as I said, is one that would give us data on dose and some data on pharmacodynamics of the drug.

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Operator [10]

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Your next question comes from the line of Stephen Willey of Stifel.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [11]

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So just kind of curious as to how the communication arrangement is going to work out with NCI as it pertains to the trial in fit, newly diagnosed patients? And I guess, specifically, with respect to the event-free survival trigger after 262 patients are enrolled, is that something that you're going to have freedom to communicate? Or is that going to be kind of up to NCI just with respect to kind of how that interim gets disseminated to the public?

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [12]

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Yes, we would expect to have a coordinated communication with them. I think that's the simplest way to answer it.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [13]

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Okay. And then maybe just kind of following up on, I guess one of the prior questions with respect to high and low E-selectin ligand expression. I think you -- there's an attempt to talk a little bit about it in the abstract. But I guess I found it interesting that within the high E-selectin ligand group, and I understand that these are small patient numbers, but you had a smaller number of primary refractory patients and, I guess a greater number of patients who had actually been through an induction and into a response for, I guess greater than 6 months relative to lows. So just kind of wondering if you can somehow connect the dots on that disconnect for me?

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [14]

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Well, so let me make one comment and then I'll turn it back to Helen. One of the things -- one of the important disclosures in the abstract is that we look at this EPI risk, which is a measure that attempts to aggregate all of the risk factors and determine what the overall risk for the patient population is. And so while we did break out some of the specific demographics, I think focusing attention on this validated risk scoring that's commonly used, I think is a good way of capturing how you might expect that population to perform when taking into account all these various demographic specifics. Helen, do you want to add anything?

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Helen M. Thackray, GlycoMimetics, Inc. - Senior VP of Clinical Development & Chief Medical Officer [15]

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Yes, I would echo that there are ways of looking sort of at the aggregate risk and the EPI, as Rachel just said, is a very good way of doing that. The EPI risk across the groups is very high. And so the expected overall survival for these groups is quite low. I think the most remarkable factors to us, and there are multiple clinical characteristics set for the data that's available in this patient group and that will be presented at ASH. The thing that stands out the most to us is that no matter how you measure it and no matter how you compare this group, the expected overall survival would be quite low and it is instead dramatically longer than you would expect. And so regardless of what the individual components are that make up the high-risk nature for that population, they are doing remarkably well in this trial. We think that one of the major -- one of the most interesting potential benefits from uproleselan and E-selectin inhibition is the ability to get into remission and into a deeper remission, and that is a key factor of the ability to extend survival. And we think that, that may be what we're seeing reflected in this high E-selectin ligand group. This is a similarly high-risk group, but they are getting to remission, they are getting to deep remission, they are getting to transplant and that we think is reflected in the far extended overall survival median for that group.

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Operator [16]

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(Operator Instructions)

Your next question comes from the line of Ed White of H.C. Wainwright.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [17]

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Most of them were already asked, so maybe just on the company-sponsored trial. You had previously said that you expect the top line in the fourth quarter of next year, is that still true?

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [18]

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Yes. So we're continuing to drive the addition of sites and patients. We're also enrolling now in multiple countries, including multiple countries in Europe, we've got Australia, we've got U.S., Canada and multiple countries in Europe. So we are continuing to drive towards the objective of getting data by the end of 2020. And at this point, we're not revising any guidance. I would remind you though that the delivery of top line data depends on 2 things: it depends both on accrual and on the number of events, and so we continue to follow both of those. But at this time, we're not revising any guidance, and we're still driving toward top line data at the end of 2020.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [19]

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Great. And I know with the NCI, we just went over about how you're going to disseminate the interim data, but since the first patient was enrolled, I think it was in April, are you getting an idea of how enrollment is going there? And when we think -- are you getting an idea of when you think you can see that interim data from the first 250 patients?

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [20]

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Yes. So we're still not giving specific forecast for the top line data for that study. I will say interest is high in that trial. If you look at even the clinicaltrials.gov, there's a lot of sites. Sites are accruing. We have a great communication channel with the NCI, so we do know that they're accruing well. But we've not given yet public guidance on when we expect the top line data for that interim analysis. I will remind you though that it was targeted for after 250 patients are enrolled and that it's an EFS endpoint. So that's -- I think that's the general way that we're framing it now. And then, Helen, do you want to add anything to that?

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Helen M. Thackray, GlycoMimetics, Inc. - Senior VP of Clinical Development & Chief Medical Officer [21]

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No, I think it's 262 patients. So I think after 262 patients are enrolled is the point of assessment for an event-free survival in that trial.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [22]

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Okay. And then just the last question. With the rivipansel data and then the -- recently, the HOVON trial, you had briefly mentioned on cash, but I just wanted to know if you can give us a little guidance on your cash runway or maybe a cash burn rate going forward?

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Brian M. Hahn, GlycoMimetics, Inc. - Senior VP, CFO & Secretary [23]

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So Ed, so for the rest of this year, it's about $5 million a month. In 2020, we'll go up to just about $6 million a month of burn. And then as that trial winds down in '21, about $4 million a month. So we do have cash well into 2022 at this point on what we have currently planned.

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [24]

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Yes. So I would just add in response to a couple of the earlier questions, just to come back and emphasize a couple of points at the high level because I think the data that we're presenting at ASH is very exciting and really strongly supportive of our uproleselan program. The RNA data that I described increases our confidence in the E-selectin mechanism and its role in AML. The clinical data that we described increases our confidence in uproleselan. And so the combination of those data sets, I think is really strongly supportive of the program. And we very much look forward to the opportunity to discuss those in more detail at the meeting itself.

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Operator [25]

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Speakers, I am not showing any further questions at this time. I would like to turn the conference back to Rachel.

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Rachel K. King, GlycoMimetics, Inc. - President, CEO & Director [26]

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Great. Thank you, operator, and thanks, everyone, for your questions and for taking the time to listen to our call.

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Operator [27]

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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.