GlycoMimetics, Inc.
Q3 2019 Earnings Call Transcript

Published: 9 Nov 2019

[Operator:]

Good morning, and thank you for joining the GlycoMimetics call. I would now like to turn the call over to Shari Annes of the Investor Relations Group at GlycoMimetics. Ma’am, please go ahead.

[Shari Annes:]

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.

[Rachel King:]

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 results in children. I’d like to focus your attention on two 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.

[Brian Hahn:]

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 was primarily the result of expenses relating to the company’s Phase 3 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 non-cash 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.

[Rachel King:]

Thank you, Brian. With two 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.

[Operator:]

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

[Nirav Shelat:]

Hi. Good morning, everyone. This is Nirav on for Daniel. 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?

[Helen Thackray:]

Sure. Good morning. 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.

[Nirav Shelat:]

Got it. Thank you. 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?

[Rachel King:]

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

[Nirav Shelat:]

I see. Thank you. That’s very helpful. Thank you for taking my question.

[Operator:]

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

[Lyla Youssef:]

Good morning. Thank you for taking our question. 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? Thank you.

[Rachel King:]

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 2 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 the 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 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.

[Lyla Youssef:]

Great. Thank you very much.

[Operator:]

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

[Stephen Willey:]

Yes. Good morning, thanks for taking the questions. Good morning, Rachel. 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?

[Rachel King:]

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

[Stephen Willey:]

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 six months relative to lows. So just kind of wondering if you can somehow connect the dots on that disconnect?

[Rachel King:]

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?

[Helen Thackray:]

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 will 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 maybe 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 transplants and that we think is reflected in the far extended overall survival median for that group.

[Stephen Willey:]

Okay. That’s helpful. Thank you very much.

[Operator:]

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

[Ed White:]

Hi, thanks for taking my question. 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?

[Rachel King:]

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 two things

[Ed White:]

Okay, great. Thanks, Rachel. 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?

[Rachel King:]

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 clinical trial stack up, 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, Helen, do you want to add anything to that?

[Helen Thackray:]

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.

[Ed White:]

Okay. Great. And then just the last question. With the rivipansel data and then the – recently, the HOVON trial, you 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? Thanks.

[Brian Hahn:]

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 2021 about $4 million a month. So you add cash well into 2022 at this point on what we have currently planned.

[Ed White:]

Great. Thanks, Brian.

[Rachel King:]

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.

[Operator:]

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

[Rachel King:]

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

[Operator:]

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.