Skye Bioscience Inc Q1 2025 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: George Farmer - Scotiabank - Analyst : This is Chloe on for George. A couple from us. So, number one, in terms of preclinical data, what can we expect to see at ADA? And I believe you mentioned ECO next week. So, a little more detail around that would be helpful. Number two, so on Monlunabant, so we know that, well, Novo has said that they are planning on presenting their full Phase 2a data this year. So last September, when they had the data, so that had pretty bad negative read-through to your stock. Do you think by now; now that you have all this preclinical data out in public domain, I think by now, investors have kind of begun to grasp the difference between nimacimab and Monlunabant? And do you think this time around, the reaction will be more muted, if not positive on your stock? And I have a follow-up after that.

Question: George Farmer - Scotiabank - Analyst : Great. Super helpful. If I may squeeze in one last question. This is regarding regulatory interactions. So, you've talked about where you see nimacimab fitting into this obesity treatment paradigm, right, across different populations exposed refractory or nonresponders or incretins, for instance. So, have you had these conversations with FDA yet or plan to? And just walk us through for your plan there.

Question: Jay Olson - Oppenheimer - Analyst : Can you please remind us about your findings from the DIO model on body composition and how nimacimab may help preserve lean muscle mass in combination with GLP-1? And then I guess, looking ahead longer term, just how are you thinking about the magnitude of the commercial opportunity for nimacimab in combination with GLP-1 versus nimacimab monotherapy? And then I had a follow-up, if I could, please.

Question: Jay Olson - Oppenheimer - Analyst : Yes. Just how you're thinking about the relative magnitude of the commercial opportunity for the combination of nimacimab plus GLP-1 GIP versus the magnitude of the opportunity for nimacimab monotherapy?

Question: Jay Olson - Oppenheimer - Analyst : Okay. Great. That's super helpful. And if I could squeeze in one last follow-up question. Have you guys done any work on the co-formulation of

Question: Albert Lowe - Craig-Hallum - Analyst : Maybe the first one, I saw that there's some safety reviews that have not raised any concerns. I was just wondering if there are any other reviews planned? And would any severe or serious neuropsychiatric AEs be raised in these reports?

Question: Albert Lowe - Craig-Hallum - Analyst : So it sounds like the review board has some, I guess, discretion over, I guess, what warrant a concern. Is that right?

Question: Albert Lowe - Craig-Hallum - Analyst : Maybe one follow-up question. I just want to be sure I still kind of understand what's the expectations for would be a strong separation from placebo and Monotherapy at 26 weeks. Would this still be 8%?

Question: Albert Lowe - Craig-Hallum - Analyst : And if I could just squeeze in one last one. And I can see with this open-label extension for the 26 weeks, it looks like there may be some gaps in the treatment period. I was just wondering, I guess, if you have plans on how to interpret this data to, I guess, account for some variations here and potential weight changes during these gaps.

Question: Edward Tenthoff - Piper Sandler - Analyst : I wanted to get a sense. I know you guys extended the CBeyond study Phase 2a to 52 weeks. What is the incremental benefit from going from 26 weeks to 52 weeks, considering you still have the primary efficacy readout at 26 weeks? And then how does this impact potential timing for a Phase 2b start? Would you have to wait for the full 52-week data set for CBeyond? And just wanted to get a sense for how you're thinking about that.

Question: Edward Tenthoff - Piper Sandler - Analyst : So, do you think the Phase 2b would have to be a Monotherapy study? Or could this become?

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Based on some of these preclinical studies that you've conducted, the ones that are ongoing, I'm wondering if the way you're thinking about how the trial is powered. So, perhaps are you walking away with greater conviction in the percent that you've provided us with, or essentially if any of your parameters or thought process has changed? And outside of just the Monotherapy, same thing with the combination.

Question: Andy Hsieh - William Blair - Analyst : So maybe from the outside world, can you kind of talk us through some of the discussions that you will be having with the FDA in terms of the protocol amendment? Just what are some steps that you need? Do you need to have a meeting with the FDA, the kind of logistical part of that? And the second question I have, I just wanted to make sure, so Chris, you mentioned about all the preclinical data that really kind of accentuates the clinical differentiation of imatinib. So, was that also a part of the April 15 disclosure? I just want to see if there's any overlap? Or is there any new data that you disclosed today?

Question: Jonathan Wolleben - Citizens JMP - Analyst : Wondering if you guys have looked at blinded baseline data and specifically wondering if you have any concerns like we've seen with some of the incretins about reduced efficacy in larger individuals and also in Hispanic population, if there's anything in the demographics that caught your eye when you take a look at that.

Question: Jonathan Wolleben - Citizens JMP - Analyst : And how do you think about managing discontinuations in the combination arm? And are you allowing dose adjustments for patients on Semaglutide?