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spk05: Good morning, and thank you for joining the GlycoMimetics Investor and Analyst. On this note, this event is being recorded. Today's remarks will be followed by a question and answer session with the management team. Please dial in via telephone to participate. I would now like to turn the conference over to Christian Denning-Long, Company Counsel at GlycoMimetics. Please go ahead.
spk00: Good morning. Today we will review top-line results from our Phase III study of our lead drug candidate, upralesolin. A press release was issued this morning and is available on the company's website at glycomimetics.com. This call is being recorded, and 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 Investors section of the company's website. On the call today from Glycomimedics are Harit Samarjan, Chief Executive Officer, and Dr. Edwin Rock, Chief Medical Officer. Brian Hahn, the company's Chief Financial Officer, will also be available for the question and answer session. Today's call will include forward-looking statements based on our current expectations. Forward-looking statements may include, but are not limited to, statements about the company's product candidate, UproLessolan, and analysis of data from the company-sponsored Phase III clinical trial. the progress and timing of clinical trials being conducted by our collaborators, including expectations regarding data readout from those trials, planned or potential data presentation, regulatory and development plans and activities, and the company's cash burn and budget plan. Such statements represent management's judgment and intention as of today and involve assumptions, risks, and uncertainties. Glycomatics 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 through the Glycomimetics website. I'll now turn the call over to Haroud.
spk02: Thank you, Christian. Good morning, everyone. Earlier today, we announced top-line results from our pivotal Phase III study of buprenorphine or placebo in combination with MEK or FAI for the treatment of relapsed refractory acute myeloid leukemia. Unfortunately, the study did not achieve a statistical significant improvement in overall survival in the intent to treat population. Adverse events were consistent with known side effect profiles of the respective chemotherapies used in the study. While this is not the outcome we were hoping for, with data collected from 388 patients and an unprecedented follow-up of over three years, there will be important learnings from this study. We are diligently and rapidly evaluating the full data set with medical, statistical, and regulatory experts and we plan to share further updates as appropriate. We intend to present the comprehensive data analysis at an upcoming medical meeting and are developing a plan to discuss these data with the FDA given the significant unmet patient need. I want to take a moment to offer my sincerest gratitude to the investigators, trial sites, and most importantly, the patients and families for their dedication in this large, well-controlled randomized trial. I also want to thank the glycoemetics team for working tirelessly to develop Gupilatran and our investors for their support. We remain dedicated to exploring Gupilatran's potential in AML. As a reminder, the National Cancer Institute is sponsoring an ongoing Phase 2-3 trial evaluating Gupilatran in newly diagnosed older patients with AML who are fit for intensive chemotherapy. We look forward to sharing results from this trial when they become available. I will now turn the call over to Ed.
spk01: Thanks, Arut. As a reminder, this study enrolled a total of 388 patients with relapsed and refractory AML across 70 sites in nine countries and randomized them to upraleslan or placebo, with both treatment groups receiving investigator's choice of either MEK or FAI chemotherapy. All patients were randomized by November 2021 and the study had a low discontinuation rate of 3%. In June 2023, the FDA cleared addition of an optional time-based primary analysis to this Phase III randomized study of upralesolan, and the time-based analysis was triggered with a March 31 data cutoff. As Harut mentioned, Our phase three study did not meet its primary endpoint of achieving statistical significance in overall survival in the intent to treat population. Patients treated with buprenorphine had a median overall survival of 13 months compared to 12.3 months in the placebo arm. The control group median survival of over a year is unprecedented in a randomized trial of therapy for relapsed and refractory AML. Also, Adverse events in the uprolecelan arm were consistent with known side effect profiles of the respective chemotherapies. These features make this trial scientifically important, and we will analyze these data thoroughly with medical, statistical, and regulatory experts to understand these results and any lessons that could potentially benefit the AML population. We look forward to sharing results of our comprehensive analysis when available. I'll now turn it back to Harut.
spk02: Thanks, Ed. We remain committed to deepening our understanding of this study through rigorous analysis, and we look forward to sharing the full data set. We're also rapidly evaluating ways to reduce our cash burn as we complete the full analysis. In the coming weeks, we expect to report back to investors regarding a revised budget. Additionally, we will share our updated plans for Eucalyptus as soon as reasonably possible. I'd now like to open the lines to Q&A. Operator?
spk05: To ask a question, please press star keypad. To ask a question, again press star one. Your first question comes from Ed White with HC Wainwright. Please go ahead.
spk03: Good morning, everyone. So I just wanted to get your thoughts on why the study took so much longer to read out than you initially expected, and any thoughts on why, as you said, the median survival in the control group was unprecedented.
spk02: Yeah, thanks, Ed. I mean, so as a reminder for everyone, this trial had a primary endpoint of overall survival with a predetermined number to hit. The trial was taking longer because patients continued to live longer than what we anticipated. And given the 13 months of median overall survival in the urolateran arm, but also the 12 and a half months of median overall survival in the control arm, that is probably one of the highest control arms that we are aware of in a relapsed refractory setting. So that's what we know. Obviously, what's driving that? This is where we're now running a full-on analysis across this data-rich trial to really understand additional insights. And once we have those, we plan to share them at a subsequent medical conference and also to the market as soon as we can.
spk03: Okay, thanks, Faroud. And just a question on the other studies that are ongoing. Is there going to be any impact on the NCI study? Is there an ability there to take an interim look before the anticipated data readout? And then also, is there any impact to Epilomics study in China?
spk02: Yeah, probably the second question there about Epilomics is probably better off to Epilomics, our partners. We wouldn't be in a situation to comment on their trials in China. But regarding the NCI trial, As we have disclosed our last interactions in March, they still have not reached the EFS trigger at that time. And we are going to have additional conversations with the NCI team as part of our ongoing dialogue with them. And of course, in light of our data over here, we're going to have that conversation. It's an important thing to remember. It's a different line of therapy. It's a different backbone therapy, and it's a different endpoint. So, you know, those are important things to keep in mind is, yes, the broader area is both of them are under AML, but there are different lines, as I said, different combinations and different primary endpoints for the phase two. So we'll see once we see that data how that does, but we don't think there is a tremendous impact or read-through from from what we've seen over here, but we will know more once we actually see that data whenever that becomes available and they share it with us.
spk03: Okay, Haroun, my last question is just on 1687, if you can just address that study and your thoughts on a strategy going forward.
spk02: Yeah, 1687 is a very, you know, good asset. I mean, that is an asset that we have developed internally based on very key learnings from the previous generation, as you know, Ed. We've advanced it through IND. We've advanced it through a Phase IA. We do see that the drug candidate behaves as we want it to. Given that we're going to be looking at our financial situation and really revising a budget, it will be too early to say what else happens over there, but it's probably we're going to be looking at ways to conserve cash and really focus on deepening our understanding of what's going on with 301 and really work closely with regulatory partners, with clinical partners, and with statistical partners as a full full-fledged priority at this point.
spk03: Okay, Haru. Thanks for taking my questions. Thank you, Ed.
spk05: Your next question comes from the line of Tara Bankroft with TD Cowan. Please go ahead.
spk04: Hi. Good morning. Just one for me. So I'm wondering if you could discuss any subpopulations where it could be more effective? I know we won't know for sure until the full analysis, but if you had to postulate some potential outcomes, which types of patients do you think that this is most possible? Thanks.
spk02: Thank you, Tara, for the question. Yeah, I mean, to your point, this is only a few days. We're literally two or three days in. right, from when we got the data and we have an obligation to turn it around and communicate it. So what we're communicating is really the top line. And at the same time, really paying tribute to with 388 patients and one of the longest follow-ups, we are going to have multiple different looks at it. Obviously, you know, when it comes to subgroups, the study is not actually powered for subgroups. However, the design does include multiple stratification factors, such as age, disease status, backbone therapy. So it's really important for us to first conduct this comprehensive review of the full data set so that we can really understand, you know, what are the patients that we can help? Are there additional signals in there? Because ultimately, it's all under relapse and refractory AML patient groups, Tara. And as you know, those folks are in need of new therapies. So, you know, it's our real duty to really look into it and really understand what's going on on a subgroup level as well. And we are going to be conducting that as soon as possible.
spk04: Okay, great. And just one quick follow-up on that. So based on your engagements with the FDA, do you think the agency would be supportive of a potential filing in a more limited population?
spk02: Yeah, I wouldn't want to speculate or talk on behalf of the FDA at this point. It's just too early. But what I can say is we've had multiple very good conversations with the agency as we were developing this trial. There are things that they've asked us to put in, which we did. And at the end of the day, this is relapse and refractory ML. We do have fast track, breakthrough designation, orphan status for a reason. because we're aligned with the FDA that those patients, relapsed and refractory AML patients, need new therapy options. So we will do our part of deepening the understanding, having those conversations, reaching out both from a regulatory perspective, from a statistical perspective, but also from a clinical perspective, and make sure that we are really advancing our understanding and engaging with partners such as the FDA to further look at the data and based on what they see and if there is a path forward, then that would be, you know, obviously good news. But it would be too early to speculate at this point.
spk04: Okay, great. Thank you.
spk02: Thank you.
spk05: Your next question comes from the line of Noreen Quipria with Capital One Securities. Please go ahead.
spk06: Hi. Good morning. Thanks for taking my question and sorry to hear the news. I guess I just have really round one around MRD positive, negative patients. Do you know if MRD positive patients proceeded on to transplant or was it just MRD negative that went on to transplant? And are you able to comment on how many patients became MRD negative in the tumor arms?
spk02: Thank you, Noreen, for the question. Yeah, I mean, to your point, we have such a data-rich database with this patient, MRD negativity, transplant rates, subsequent therapies, different backbone therapies, different stages of disease, Noreen. So all these are being looked at by the team as we speak. And as we learn more and more about it, we're going to be compiling these insights and having conversations with the regulatory agencies such as the FDA. So stay tuned. We are committed to deepening this understanding given the rich database and given the high unmet medical needs.
spk06: Got it. That's it for me. Thanks.
spk02: Thank you, Noreen.
spk05: I want to go back over to Haroud for closing remarks.
spk02: Thank you, operator. Thank you, operator, and thank you for everyone for joining our call today. So stay tuned. We are committed to updating the market as soon as we can. Thank you very much for your attention.
spk05: This concludes today's conference call. Thank you for your participation, and you may now disconnect.
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