GlycoMimetics, Inc.
Q1 2021 Earnings Call Transcript

Published: 3 May 2021

[Operator:]

Good morning and thank you for joining the GlycoMimetics Call. At this time, all participants are in listen-only mode. Following management’s remarks, we will hold a question-and-answer session. I would now like to turn the call over to Shari Annes of Investor Relations Group at GlycoMimetics. Please go ahead.

[Shari Annes:]

Good morning. Today, we will review our accomplishments and financial results for the period ended March 31, 2021. We will also update you on recent achievements. 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 on the Investor Relations section of the company’s website for 30 days.

[Rachel King:]

Thank you, Shari. This year is an important one for GlycoMimetics. Our primary operational focus is on advancing the two uproleselan registration programs in AML. Leading clinicians, academic centers, collaborative networks and regulatory agencies are working with us here in the U.S. and abroad as uproleselan continues to garner significant attention and interest. We believe the progress being made in both registration trials stands as testimony to the excitement around this program as do the breakthrough therapy designations granted by both the FDA and the Chinese Health Authority. GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML continued to enroll patients in the U.S., Australia and in Europe at a steady pace through the first quarter of this year. Our remaining number of sites continued to be activated in Europe and in the U.S. as we make a final push toward reaching our target enrollment numbers. Once again, we are confirming that we anticipate completion of enrollment of all 380 patients by the end of this year. In parallel, the NCI-sponsored Phase 2/3 registration trial that’s evaluating uproleselan in newly diagnosed older adults with AML also continues to accrue participants at a steady pace. Based on the information provided by the NCI to-date, we continue to anticipate that the trial will complete enrollment of the Phase 2 portion by year end, supporting a subsequent interim analysis of event-free survival, or EFS, in the trial’s initial 262 patients. Together, the GlycoMimetics and NCI-sponsored programs will constitute a large dataset of patients treated with uproleselan and intensive chemotherapy. If both are positive, we would anticipate filing for approval for treatment of patients in both settings.

[Brian Hahn:]

Thank you, Rachel. As of March 31, 2021, GlycoMimetics had cash and cash equivalents of $132.5 million as compared to $137 million as of December 31, 2020. The company’s research and development expenses decreased to $11.2 million for the quarter ended March 31, 2021, as compared to $12.7 million for the same period in 2020, primarily due to lower clinical asset development and manufacturing expenses related to uproleselan. The company’s general and administrative expenses decreased to $4.2 million for the quarter ended March 31, 2021, as compared to $4.4 million for the same period in 2020, primarily due to lower stock-based compensation expense. I would now like to turn the call back to Rachel.

[Rachel King:]

Thank you, Brian. Before I open the lines to Q&A, I would like to leave you with 2 takeaways. First, the momentum and excitement around uproleselan continues to build as we drive to complete enrollment of 2 pivotal trials. These are important milestones ahead. Second, in the interim, we look forward to sharing both news of newly initiating trials with independent investigators as well as progress in our expanding pipeline, underscoring the value of our unique GlycoMimetics platform. Operator, would you please open the lines for the Q&A session?

[Operator:]

Your first question comes from the line of Stephen Willey with Stifel.

[Stephen Willey:]

Yes. Good morning. Thanks for taking my questions.

[Rachel King:]

Good morning.

[Stephen Willey:]

Good morning. Rachel, I was just wondering if you can update us, I guess, on the number of sites that you intend to open across the U.S. and Europe for the relapsed/refractory study before year-end to kind of help you get to that goal. And can you just remind us how many sites are activated and open to-date?

[Rachel King:]

Yes. So you – so the sites are generally listed on clinicaltrials.gov. And I think we have right now around 60 sites open.

[Stephen Willey:]

Okay. And then just the number that you are hoping to activate before the end of this year?

[Rachel King:]

So, we are near the complete number of sites, actually. We have got a very robust network currently in place. We are continuing to activate a small number of sites, primarily in Europe and a couple in the U.S. But we are essentially at the full complement of sites today, as of today.

[Stephen Willey:]

Okay. And just with respect to 1359. I know we saw the data at AACR. And it sounds like you are evaluating indications in which to maybe move this asset forward. Can you maybe just talk a little bit about what those indications may be? Obviously, we saw this in the context of breast cancer, I would imagine that might be a priority. But can you just provide a little bit more color around what development options are at this point? And if you do move forward in breast cancer, is that also a hormone receptor positive patient population, would you expect to have this against background standard of care? Just any color there would be helpful.

[Rachel King:]

Sure. So, we are not yet in a position to describe the specific next plans. What will be important, though, is that whatever we choose is going to be a targeted and focused indication with – again, targeted and focused clinical trial. The preclinical data that we have presented has been actually fairly broad in the sense of looking at settings where there is bone involvement in the solid tumor case or in some cases, in liquid tumors, bone marrow involvement. We also have some very encouraging preclinical data in osteosarcoma. So, that’s generally the scope of indications that we are looking at. But again, we are – we think it’s going to be critical both from a strategic and an operational standpoint to find a setting where we can move forward in a targeted and focused way, and that’s going to be the same as we look through the potential indications that we could take 1359 into.

[Stephen Willey:]

Okay. Thanks for taking my questions.

[Rachel King:]

Sure.

[Operator:]

Your next question comes from the line of Zegbeh Jallah with ROTH Capital Partners.

[Zegbeh Jallah:]

Good morning guys and congrats on all the progress, particularly on the enrollment for upro. Just had a question about that program as well as it relates to Apollomics. I was just wondering when you think they might be starting that study after the bridging study?

[Rachel King:]

We expect that to start later this year.

[Zegbeh Jallah:]

Perfect. Okay. And then just again, just curious if there is any way for them to leverage some of the Phase 3 data that you are going to be generating as well for approval?

[Rachel King:]

Yes. So I can’t speak to their specific path forward for approval in China. I’ll leave that to Apollomics. But we do believe that the programs are complementary, and that we will be able to – that they would be able to leverage some of they would be able to leverage some the data in our study.

[Zegbeh Jallah:]

Thanks, Rachel. And then again, just a follow-up, I know you mentioned potential investigator sponsor studies for upro. I was just wondering how you plan to leverage those studies for later clinical development and then what indications maybe prioritizing?

[Rachel King:]

Sure. So I want to comment on the ISTs generally. And as we announce them as the year goes forward, we can address each one specifically. We’ve been really gratified in the uproleselan program with the support and the interest that we’ve received from many, many KOLs in the U.S. and outside the U.S. And I think you see that, of course, first, in the NCI trial, where there was a lot of enthusiasm for taking the program forward into the alliance network. But we’ve continued to see a number of investigators who have come to the company with very interesting proposals for expansion of use of uproleselan. So we’re very gratified by that. And we’re working with a small number of investigators to try to go forward in the most – what we believe are the most promising areas. So as those roll out, then we will announce them. But I think the general concept is to build on this investigator enthusiasm to broaden the use of the drug in these clinical trials, which potentially could give us opportunities as the program advances to continue to broaden the use ultimately in the commercial setting. So I would say stay tuned as these trials initiate one by one, we will announce them. And then we can speak specifically to each of those approaches as they come forward.

[Zegbeh Jallah:]

Thanks, Rachel. And then the last one here for me, just on 1757, I thought it was exciting, but a little bit different because you guys mentioned some solid tumor indications, which is a little different from what you’re currently doing. So just wondering how you’re thinking about that opportunity?

[Rachel King:]

Yes. So the galectins represented an entirely new opportunity for the company, and they are involved. We know from the basic preclinical science. We know that they are involved in fibrosis as well as in cancer. And we think we have a unique approach from a chemistry perspective to creation of a new set of compounds, which, as I indicated, are, we believe, more potent and more specific than other compounds that have been described by anyone else. So we’re continuing right now to explore the potential use of these compounds in a broad range of preclinical studies, and we’re also moving toward eventual selection of a clinical asset. So that program is early, but it’s quite exciting in terms of the potential applications. And so I think it’s too early to describe any specific indication for that. But we’re very encouraged by the biological activity, by the binding affinities, and as I said, the specificity that we’re seeing in these compounds. We think they are quite unique in the field.

[Zegbeh Jallah:]

Thank you. And actually just one last quick one here. So you do have a solid cash position. I think you guys have put it $132 million, but I was just curious with multiple programs now in preclinical and clinical development, I was just wondering what the cash run-rate might be?

[Rachel King:]

Yes. So it’s very important – well, go ahead – let me make one comment, and then I’ll turn it to Brian. I think it’s really important to recognize that we’re – our operations – our operational focus remains on uproleselan, and that’s the – that’s really where most of the spend is going and with the critical objective of getting the enrollment completed in these trials. But go ahead, Brian, as to runway.

[Brian Hahn:]

Let’s get on to that. Cash – current cash run rate gets us through the end of ‘22 right now.

[Zegbeh Jallah:]

Thanks, Brian. Again congrats on all the progress.

[Rachel King:]

Thank you. Thanks Zegbeh.

[Operator:]

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

[Steve Bersey:]

Hi. This is Steve Bersey on for Edward. Sorry. Did you say to the end of ‘23 for the cash runway?

[Brian Hahn:]

No, through the end of ‘22 right now. So we’ve got about $75 million of total expenses in ‘21, about $50 million in ‘22, so comfortably getting through the end of ‘22 for current cash.

[Steve Bersey:]

Alright. Thank you.

[Operator:]

Your next question comes from the line of Kelly Shi with Jefferies.

[Jason Bouvier:]

Hi, good morning. This is Jason Bouvier on for Kelly Shi and thanks for taking my questions. I just had two questions. One was from the development, a regulatory perspective, are there any material differences for breakthrough therapy designation between the FDA and the Chinese health agency? And then the other question was just if you had any specifics on the timing of a data readout following the interim analysis for the Phase 2 NCI study? Thanks.

[Rachel King:]

Sure. As far as the BTDs in China is concerned, I can’t speak to the specifics of the Chinese designation, but I believe it generally is consistent with what the FDA grants in terms of an opportunity to work more closely with the agency to try to expedite development of the compound there. And as far as data readout at the NCI, this actually is a question that applies both to day to read out at an tinted read out for our own trial, which is that two things have to happen. The trials have to complete enrollment and then a certain number of events has to occur to enable the locking of the database. And so I think as both trials progress more towards completion of enrollment, we will be able to give more specific guidance as to when we might expect the number of events to occur. But as of today, the NCI has not given specific guidance publicly as to when they expect the number of events to occur. But I think as they – again, as they complete enrollment that they may be able to provide some more guidance on that.

[Jason Bouvier:]

Alright. Great. Thank you.

[Rachel King:]

Sure.

[Operator:]

As there are no more questions in the queue, I’d like to turn the call back over to Ms. King.

[Rachel King:]

Well, thank you. Thank you very much for your questions and for your attention. And again, I want to emphasize our excitement around the uproleselan program as well as the expectation that we be able to announce ongoing progress with newly initiating trials as the year goes forward as well as some progress with our underlying pipeline. So thanks very much for your support of the company and your interest. We appreciate it.

[Operator:]

Thank you for your participation. This concludes today’s call. You may now disconnect.