Helus Pharma Inc. (HELP) September 2026 Conference Transcript

Hello, everyone. Good morning, and thank you for joining H.C. Wainwright's 28th Annual Global Investment Conference held on September 14 and 16, 2026. My name is Patrick Trucchio. I'm a senior healthcare analyst at H.C. Wainwright, and it's our pleasure to host you today. And it's my pleasure to welcome Healus' CEO, Michael Halston, as well as the CMO, Amir Amandar. For those who are unfamiliar, Healus is a neuropsychiatry company pioneering next-generation psychedelics and neuromodulators for mental health. Healus is currently conducting a phase three program evaluating its lead candidate, HLP3, a deuterated psilocin analog for adjunctive treatment of major depressive disorder, MDD, and top-line data is expected later this year in the fourth quarter. So maybe for those who are less familiar, maybe you could introduce us to Healus and where the company stands today.

Sure. Thank you, Patrick. Thank you, everyone, for joining us today. Michael Halstead, recently appointed CEO of Helis, I joined in August, very excited to talk about Helis Pharma today. In terms of the company, as you said, we are a mental health focused company, a platform, we have multiple programs, we're developing novel serotonergic agonists for the treatment of several different mental health indications, our late stage program, as you said, is our 003 program, that's deuterated psilocin, that we are in phase three development for the treatment of adjunctive major depressive disorder, MDD, really important indication. I'm sure we'll dig into that a little later in the talk. That is in phase three development. Our first phase three is expected to read out in the fourth quarter of this year. So a very near-term, important event. But also we have our 004 program that is the Moleculous DMT. It is in development for generalized anxiety disorder, GAD. We completed a phase two signal finding study earlier this year, currently finalizing the design of the next trial in that program. and we'll be rolling that information out very soon. And then also we have our earlier stage program, 005, that is a library of compounds that I think have real potential in a number of mental health indications. We'll be moving forward the lead candidate of that program expected in 2027. And underneath that platform, I think it's important to note there is a very strong IP foundation. The Hillis team has done a very nice job building out our IP portfolio, in particular around the O03 program, the O04 program, anticipated patent protection to run at least through 2041. So a very nice foundation as we look ahead to both development and then ultimately commercialization. So a lot going on at the company, both at the later stages, the middle stages, and the earlier stages, as I dug in, got very excited about the potential of the company and really looking forward to moving things ahead here in the near future.

That's really helpful. And maybe just as a follow-up, you can tell us a bit more, you know, joined recently in August. Maybe tell us a bit more about, you know, why Healus and why now? What attracted you to the company?

Sure, sure. And I've been in and around industry for about 25 years now, most recently at Intracellular Therapies that was acquired by Johnson & Johnson in 2025. And, you know, following that acquisition, I think I was in the fortunate position to be able to really take my time, do some significant diligence, wanted to make sure that wherever I, whatever company I joined, that there was the real potential to make a real impact, in particular, given my over a decade in CNS, and just a general focus on mental health, that got connected with the Helis Pharma a team. And it really just made a lot of sense from all perspectives. When you look at the passion to a person, starting with our chief medical officer, but our founders, all the folks in the company, really passionate about mental health and what we're trying to achieve here. And then looking more specifically in terms of the company's assets, their potential, as I said before, a platform here with late stage, mid stage, early stage, exactly what you'd like to see as you're looking towards building a company for the long term. Then also in particular the O3 program, the adjunctive MDD indication, I think that's very promising, exactly the right area of focus in the MDD space. And I can talk more specifics around why that is, I think, really, really a good indication here. But then very strong face to data, both from drug efficacy perspective, but also durability perspective, durability of effect, and then safety and tolerability. So the three key legs of the stool, as you think about product potential, most importantly from a patient benefit perspective, but also then from the clinician perspective as well as the commercial perspective. In terms of the phase three then, really like the way Amir designed the program, really like the way the program's been executed. Really think that there's a real probability of success here. Look forward to providing data in the fourth quarter. So excited about the setup, and it's a great team that I'm working with, experienced, competent people. So overall, it was just a very attractive opportunity to make that difference in the mental health space.

Great. Maybe we can dig a little bit more into HLP3 and kind of what's the differentiation of this compound? What's the advantage of deuteration? And maybe you can talk a little bit more about the phase two data, what you saw, and sort of what gives confidence going into the phase three.

Sure. And I'll let Amir, our chief medical officer, maybe take most of that as the primary architect. You know, deuterated psilocin, so that psilocybin is the parent molecule. It needs to be dephosphorylated in the body, which then gives you the active metabolite psilocin. We have deuterated psilocin, believe that that provides a number of benefits, including the reduced variability in our preclinical studies, as well as reduced drug load, efficiency of delivery. So a lot of positive characteristics as a result of the deuteration, we believe. But maybe Amir, a little bit on deuteration, but then also the face-tooth.

Yeah, absolutely. Thank you, Michael. So deuteration does stabilize the molecule. We know that psilocin traditionally has been unstable in solution, so deuteration helps. And because we have the active moiety and not the prodrug, that translates into some meaningful differences. And we do see those in our preclinical data. In the preclinical studies, what we've seen is that O3 very rapidly gets into the brain. and achieves concentrations that are about one and a half times higher in CMAX and two and a half times more than in AUC, which is exposure. Now, that translates clinically potentially in a way that we believe is necessary for demonstrating good therapeutic benefit. It gives patients the opportunity to get to a higher level of the drug in the plasma, and we know higher levels of drugs, drug in the plasma are associated with a threshold effect which results in therapeutic benefit. So, those are some of the advantages we see from deuterating the psilocin and using the active drug than the prodrug. Now, we've seen data in phase 2, we saw about 13 to 14 points at the two doses, 12 and 16 milligrams and that was after a single dose of o3 and at the three week time point and a second dose resulted in an incremental benefit of about five points what we've done in phase three is we've rolled that second dose into the primary endpoint in phase two it was the three week after a single dose in phase three our primary endpoint will be after the second dose so it'll be able to benefit from the incremental improvement and not just that we saw durability of data we saw out to a year north of 70 percent remission rates after two doses of 16 milligrams that of course needs to translate into phase three it's a phase two smaller study but that gives us a lot of confidence that there's a real drug there with a potential to meet a significant unmeting right great and then maybe you can walk us through the paradigm program for hlp3 um approach embrace and extend yeah absolutely so um the paradigm phase three pivotal program which will be the basis of our new drug application consists of two short-term studies and a long-term extension the two short-term studies that approach and embrace approach is a two-arm study comparing two administrations of the active 16 milligrams versus two administrations of the inactive placebo given three weeks apart with a primary endpoint at six weeks and a secondary endpoint at 12 weeks. That gives us some intermediate durability data. It's a randomized double-blind controlled study. Embrace is only different from approach in one respect, which is the introduction of an intermediate eight milligram dose, which gives us the opportunity to attempt to show a dose response in EMBRACE. And really, the combination of these two studies is consistent with what the agency has asked of sponsors in this space to do as part of their Phase III program. And patients from both those trials, Approach and EMBRACE, have the opportunity to roll over into the long-term extension, which remains blinded up until such point of time that a patient relapses and requires treatment. We've got criteria to do that, to give them treatment. And Extend follows them up out to a year. So trying to replicate or assess what we did in phase two, so we'll see the durability of effect out to a year, but also because there's an opportunity for retreatment, we'll be able to tell what the retreatment needs are, how many doses will be needed, if at all, and what the interval between those doses will be, which is what clinicians like me would like to see in the label, right?

And Patrick, I think it's important to emphasize for folks that aren't as familiar, of course, this is all administered adjunctively. So patients are on standard of care, your SSRIs, your SNRIs, and then OO3 is administered on top of that in these studies, which really fits in nicely in terms of how clinicians treat patients with depression in this space, again, going to the benefit of that adjunctive MDV indication.

Can you talk about some of the nuances of the phase two and phase three? You know, first, just the difference in terms of being an adjunctive treatment. What does that actually mean? What implication might that have for the phase three data?

And as well, you know, being an MDD rather than TRD, what are some of the key differences and then ultimately what is the product profile that's emerging what is the ideal product profile look like for hlp3 sure sure and and starting with with the mdd population so this is approximately 23 million people in the united states suffer from from mdd of that 23 million approximately at least 70% are on standard of care, your SSRIs, your SNRIs. Of that 70%, approximately two-thirds of those aren't getting optimal benefit relief of their depressive symptoms. But often they're getting some benefit. So you think then about a clinician treating a patient with depression. So they have the opportunity with adjunctive therapy, because, of course, it'll be tested clinically in connection with standard of care, to then add that on. So what you're doing is you're getting the advantage of whatever benefit people are getting from standard of care, but then moving them down that path towards hopefully remission with the addition of the adjunctive treatment. And think about that as opposed to, say, a monotherapy approach where the clinician has to wash the patient off of the standard of care, off of any drugs, start over effectively, see if that new monotherapy actually adds a benefit while the patient's been taken back to the beginning. So the adjunctive approach really, again, continues on that path. You're getting them before they get to treatment-resistant depression, which is about 3 million patients, at the end of the spectrum, multiple failures. And where you really see how adjunctive therapy plays out is with the atypical antipsychotics. They've been very successful, notwithstanding the side effect burden of the antipsychotics. I'm very familiar with this because it's cellular therapies. We, of course, developed CapLyda for adjunctive MDD. And there really is a significant side effect burden with the antipsychotics. So if adjunctively you can add on a therapy, you asked me about the product characteristics, a therapy that has the drug efficacy together with durability instead of daily dosing. You know, as Amir said, let's say this is four doses a year. We'll see how it plays out in the phase three and the long-term extension, but four doses a year. And then if you have a safety and tolerability profile that tracks along the lines of what we saw in the phase two, which is no severe AEs related to drug, and the adverse events, mild to moderate, that were transitory mostly on day one. And when I say mild to moderate, think headache, upset stomach, nausea, and high blood pressure. Again, transitory on day of treatment, as opposed to the antipsychotics, You know, we are looking at real severe, you know, cardiometabolic and sexual dysfunction. You know, the laundry list goes on. So those three key, the efficacy, the durability, and then the safety and tolerability would really be, you know, what we would hope would emerge out of our phase three. Again, really like where we're starting from in terms of the phase two data. And we'll be turning over that card hopefully very soon.

Right. Terrific. And so could you give us a little more specifics in terms of the timing of the data? Do we know when in the fourth quarter? And what data will you have at that point to present to us?

So in terms of timing at this point, all we've said is just fourth quarter. Obviously, we announced completion of enrollment at the end of July.

So certainly on track with that fourth quarter timeline in terms of the the top line data readout here do you want to um well it's pretty much what you'd expect with the six-week primary endpoint we'll also be sharing data from the 12-week secondary endpoint and then some top-line safety data as well have you discussed what the study is power to demonstrate we have not um it should be pretty standard you You know, you've got 220 patients in approach, about 110 per arm. When you look at some of the powering assumptions generally that have been published, it should be there or thereabouts.

So HLP3 has a breakthrough therapy designation, and there's been, you know, a number of initiatives from the administration, from the FDA that appear to be, you know, favorable towards psychedelic drug development. How are you going to leverage, you know, these different, or how are you planning to use those levers into, you know, your NDA filing? And is that, should we expect, when should we expect that NDA filing?

Sure. And so we've guided people to anticipated NDA filing in 2028. And as you said, given our compound has breakthrough therapy designation and the likely review cycle, we would also anticipate approval in in 2028 uh you you mentioned uh the the positivity in this space and i perhaps i i was remiss and not mentioning that earlier as i was looking at the company uh obviously great dynamics you're seeing uh a lot of a lot of good data in this space it's very clear this class of drugs provides a patient benefit obviously we need to get through all of need to get through FDA approval process, but really positive developments there, support from the administration, FDA being very constructive, and now we have guidelines from FDA so that everybody understands the path to approval. So really good overall momentum in terms of the phase as well can uh just pivoting over to hlp4 can you tell us a little bit more about hlp4 next steps for this program and and here i think the the buzzwords would be stay tuned uh as i said uh we uh we've done a a lot of work with with with this deuterate dmt compound uh there are a number of of promising early stage studies as well as then our signal finding study earlier this year in phase two and we are going we are finalizing that clinical trial design it's going to be rolled out to everyone uh very soon i definitely think the program has promise uh and and plan to and plan to move it forward but we'll we'll give you more details in the very near future and also i would say generalized anxiety disorder in general it's very important indication again large patient population there really haven't been significant advances new treatments in a very long time just a question on the infrastructure so where are we today with the interventional psychiatry infrastructure and where do you think we'll be you know presumably at some point when hlp3 hits the market right so there are approximately 8 000 uh clinics currently uh j and j spravato has done you know significant work in this area they're now i think up to a a $2 billion a year annual run rate, and certainly have done a great job building that infrastructure. You've also got some of the peers in this space that will be slightly ahead of us that will continue to build on that infrastructure. So I think there will be a lot there. Of course, there'll be work that we have to do. We'll be prepared for that. But a nice jumping off point in terms of what's already been done to date, and look forward to moving towards that commercialization process can you talk about the financial uh you know runway for the company and how does it see you through these catalysts sure uh we we have not provided our long-term cash runway uh guidance yet allow me a few more weeks to to really to dig in uh and and we'll be rolling out longer-term guidance uh um to folks uh but about 166 million in on the balance sheet as of June 30. Very comfortable in terms of that cut cash runway to get us through our near-term catalyst. And so in a good place currently, and as I say, we'll provide additional guidance soon.

Just as a final question, what do you think is the most common misunderstanding investors have about Keyless today?

You know, I really think it's fully appreciating the platform that we have obviously everybody is focused on oh three as rightly so uh given the given the the the very promising phase two data and given the the readout that we expect in in q4 but this really is more than a single drug candidate this is as i said before uh there's a full pipeline here late stage middle stage early stage with ip uh serving as a foundation of that platform. And really, there's a growth story from a lot of angles, and it's incumbent upon us to execute, execute, execute, which is what we'll be focused on in the year and longer term.

Right. Terrific. Well, I have to leave it there. Michael and Amir, thank you so much. Thanks to Gillis for joining us, and thanks to everyone for being our conference. Have a great rest of your day in conference.

Thank you. Thank you.