Conference Transcript - HELP 2026-11-09

Eddie Hickman, Analyst — Guggenheim

Back to the Guggenheim Healthcare Innovation Conference. My name is Eddie Hickman. I'm one of the biotech analysts here. I'm joined today by Helis Pharma CEO Michael Halstead. Michael, thank you so much for joining us. It's been a big year for the company, lots of changes, so maybe spend a few minutes introducing yourself and telling everyone here a little bit about the company.

Michael Halstead, CEO

Sure, sure, and thank you, Eddie, and thank you, everyone, for joining us today. I'm always excited to be here talking about Healus Pharma. The mission of the company is to improve the treatment of mental health conditions. We're currently developing novel serotonergic agonists for various mental health conditions. We have a platform of programs. Our OO3 program is deuterated psilocin for the adjunctive treatment of major depressive disorder. That's in phase three. We have an upcoming readout of our first phase three trial anticipated later this quarter. We also have a phase two program that is deuterated DMT in development for the treatment of generalized anxiety disorder. And then we have an earlier O5 program, which is a library of preclinical compounds. We think that there's potential there in a number of therapeutic areas looking to move the lead candidate forward in that program in 2027. So a lot going on with the company. I joined as the CEO in August of this year and really excited about both the team, all the work that's been done to date, and certainly looking forward to our readout later this quarter.

Eddie Hickman, Analyst — Guggenheim

Yeah, very exciting readout coming soon. Obviously, lots of talk on exactly when the data will come, but maybe let's step back a little bit and tell us about exactly who these patients are and what the design of the trial is and then sort of where you were when you finish enrollment and where you are in the database lock for when we should expect to see some numbers.

Michael Halstead, CEO

Sure. So importantly, this is for the adjunctive treatment of major depressive disorder. And maybe just a little bit about the disease state. MDD impacts approximately 22 million patients in the United States. Approximately 70% of those patients are on standard of care. So that's your SSRIs, your SNRIs. Of the patients on standard of care, approximately 66% are not getting adequate relief from standard of care. Often they're getting some benefit, but they need additional treatment. So the way clinicians approach these patients, they have sort of two options. One is to wash the patients off of standard of care. That can be a four- to six-week process, potential withdrawal there, and then start over with a monotherapy approach. Obviously, depression is a complicated disease state, so not every patient responds to monotherapy. So often, the way clinicians treat these patients is they continue them on standard of care, And then they add a treatment on adjunctively to hopefully move that patient down the path towards remission. To date, there are only five approved adjunctive treatment options. Those are the atypical antipsychotics, and they do have some efficacy but significant side effect burden. So, you know, as we look at our O03 program as an adjunctive treatment, really excited about the potential product characteristics that we could see here. Obviously, it has to play through in our upcoming phase three readout, but in phase two, saw really significant efficacy, saw durability off of two doses out to a year, and then also saw a very favorable tolerability profile, mild to moderate adverse events, primarily transitory on day of treatment, and you only have a few days of treatment. So really, really think that this has the potential to provide significant patient benefit and a great option for clinicians as they're looking to treat these patients following that adjunctive approach. And so, we completed enrollment in July. The process has been proceeding according to our plans. As I say, haven't provided any additional guidance other than we are on track for our expected data readout later this quarter. Certainly excited to get the data and excited to provide it out to the investors.

Eddie Hickman, Analyst — Guggenheim

What day in July? I may have gotten that question once or twice. So, yeah, I think a really important thing that you noted there that I want to just sort of zoom in on is the fact that these are adjunctive patients that are not required to fail a certain number of SSRIs. They're not washing off. These are patients that are on a current treatment that may be working for them. They're getting some benefit, but just not all. So as we think about that, not just from the patient perspective, from this upcoming trial, How should we think about what the placebo rate could be, these remission and response rates, as we compare them to something that might be in TRD or a much more sort of severe depression? Are those sort of easily comparable or sort of what's different about O3 in that sense?

Michael Halstead, CEO

So I think that is important perspective that people do need to keep in mind. This is an adjunctive trial. So as you said, every patient in the trial has to be on a stable dose of their antidepressant medications, has to have been stable dose for at least four weeks. And they remain on their background therapy throughout the trial. And then O03 is then administered to show an effect on top of that standard of care. So you need to look at this in the adjunctive setting. You're trying to show a benefit on top of for a patient that has already received, is already getting some benefit from standard of care often, as opposed to a monotherapy, Where the patient is washed off of their antidepressant and started over. Or the TRD patient population, which that is two or more failures on an antidepressant. Very challenging patient population there.

Eddie Hickman, Analyst — Guggenheim

So how does that treatment paradigm work currently when there are five antipsychotics approved for adjunctive, But there's also Spravato approved for TRD in these treatment centers. So how do physicians think about when to add on and when to change gears?

Michael Halstead, CEO

Right. And as I said, right now, their only indicated options are the antipsychotics that are indicated for adjunctive use. And then how we think about this in the case where if we were to be approved for the adjunctive treatment, you have the potential for a clinician to have the option of not only efficacy, but then also long-term durability and a safety tolerability profile that's very favorable. So if you have a patient that either is not responding to the antipsychotic that's being administered adjunctively, or that patient can't tolerate the side effects because, of course, the side effect burdens for the antipsychotics, very significant, weight gain, cardiometabolic, tardive dyskinesia, movement disorders, sexual dysfunction, these are significant side effects that really impact patient quality of life. So for a clinician to have the option of an adjunctive treatment with the characteristics that we hope will translate through in our Phase III program, we think could be very, very compelling, provide a significant patient benefit.

Eddie Hickman, Analyst — Guggenheim

And to confirm, that's the same patient population you looked at in phase two with this drug. And so, you know, remind us what other, if any, changes besides having a larger trial for phase three, like what is different about, you know, the phase three study from what you showed in phase two?

Michael Halstead, CEO

So significantly, the team really followed the trial design that worked in phase two, as I think I mentioned. So very significant efficacy results, durability as well out to a year. And the team followed that formula that worked in phase three. You always like to see that, keep it as consistent as possible. The one change that I would highlight that I view as a very positive change is in the phase two trial. It was one dose administered at study start. The primary endpoint was then measured at week three. After the primary endpoint, an additional dose in the phase two was administered and saw then durability, so an additional five points of improvement on terms of efficacy, but then also saw durability out to a year. So not surprisingly, perhaps, in the phase three, we incorporated the two doses into the primary endpoint. So in the phase three, patients are dosed at study start, again at three weeks, and then efficacy is measured at six weeks, and then there is a secondary endpoint at 12 weeks, no additional doses, but at 12 weeks, so you get that longer-term durability data.

Eddie Hickman, Analyst — Guggenheim

Yeah, and I think we've talked a lot about in the last six months or so about what a good expectation in a bar for success is, but I think you've sort of articulated this several times in the last month or so, that this four to five adjunctive bar is appropriate. But beyond that, how should we think about durability in terms of how to compare? Obviously, this isn't a daily oral pill like those types of competitors. So in reality, it might be competing with whether it's bravado or whether it's come 360 or one of the others. So how should we think about that difference in terms of patients needing to move to a whole other paradigm versus just another oral? Right.

Michael Halstead, CEO

And so, first, we do believe the relevant competitive set here is the antipsychotics. We believe labels are going to be very important in this space. And the only labeled drugs for the adjunctive treatment of MDD are the five antipsychotics. And so, but I do think you make an important point. You know, people, of course, focus on efficacy, rightly so, but when clinicians are making prescribing decisions, of course, they look at all of the things that impact the patient that go to not only efficacy, but then compliance, patient's quality of life. So that durability off of what, you know, in the phase two, it was two doses. We will talk a little bit about our long-term extension study when patients, you know, between the pivotals and the extension study could potentially have a total of five doses. But regardless, it's a small number of doses, and if you see that long-term durability, obviously that's very favorable from patient client's perspective. And then again, the tolerability going to the quality of life for the patient, very significant as the clinician is making prescribing decisions.

Eddie Hickman, Analyst — Guggenheim

I want to hone in on the tolerability piece, because I think oftentimes you talk about tolerability, but there's also safety, which are sort of two separate things in terms of... So what should we think about, you know, on the day of treatment, what kinds of sort of tolerability issues could sort of derail a good, great patient perspective? And then what is a safety concern that really might be super concerning for physicians thinking about moving a patient to something like this?

Michael Halstead, CEO

Right. And I think the takeaway so far, certainly what we saw in the phase two is, you know, the very favorable tolerability. And that these really were transitory, primarily transitory on day of treatment, and in terms of the specifics, the adverse events, mild to moderate, we're talking about nausea, headache, elevated blood pressure, but again, transitory primarily on the day of treatment, and you only have a few days of treatment. So, you know, certainly a favorable tolerability profile and from a clinician perspective and the experience in the clinic would be hopeful that that's a very, very positive backdrop.

Eddie Hickman, Analyst — Guggenheim

We talk about functional and blinding a lot, and we know you have a second phase three which you can talk about in terms of adding sort of a half dose or a lower dose, maybe not an ineffective dose, but to find a dose response. Anything we can learn from this study or we should expect in terms of what that placebo could look like in terms of? The functional and binding piece?

Michael Halstead, CEO

Sure, and placebo response has been a real challenge in drug development in the depression space for a very long time. We've seen between 10 and 12 points of placebo response. It's sort of what people expect with your traditional depression trial. In the psychedelic space, placebo response has been very well controlled. If you look at the late-stage trials, the larger late-stage trials, whether that's in MDD or TRD that our peers have done, you've seen between one and five points of placebo response. In our phase two, we saw approximately three points. So it's been relatively well controlled for the psychedelic space. These are, of course, intermittent, they're dosed intermittently, and you raise the point of functional unblinding. Obviously, FDA has provided guidance in terms of how it would like sponsors to deal with that, and as you mentioned, having a lower-dose active comparator in our EMBRACE trial, we do have three arms in that trial, so similar to approach. There is, of course, the 16-mig arm. There is the placebo arm, but then in EMBRACE, there is the 8-mig arm as well to serve as that active comparator, potentially show a dose response, and to further provide information in terms of functional unblinding. But again, overall, placebo response has been well controlled in the psychedelic space.

Eddie Hickman, Analyst — Guggenheim

On the safety piece, you know, I think, you know, there's, you know, competitor psilocybin, which is not psilocin, different compound, but maybe, you know, lumped together, you know, by many, and we don't need to get too into the biology here, but they obviously had some potential issue with with suicide ideation or suicidality. So how should we think about whether that should read through from molecule to molecule or whether that's just like a secondary effect of running a depression trial?

Michael Halstead, CEO

Yeah, and they're really, unfortunately, of course, suicidality is, in some respects, a feature of depression of the MDD population. So I don't think it surprises clinicians or FDA that, you know, occasionally do see suicidality in these trials. We obviously didn't see it in our phase two. And then our phase three trials, of course, have your standard safety data monitoring board that regularly evaluates any safety reports for signs of a signal. Obviously, we completed enrollment in the trial, and so we will proceed from there.

Eddie Hickman, Analyst — Guggenheim

Yeah, so we're looking forward in the coming weeks, days or weeks, to seeing those data. Beyond that, you obviously have breakthrough, so there's discussions with the FDA on what a package would look like, and you talked about embrace and then extend. So what does sort of your ideal NDA package look like for 003?

Michael Halstead, CEO

Right, and we, although everybody is, of course, focused on our first phase three approach and the anticipated readout this quarter, as I mentioned, we do have a full phase three program. Embrace is ongoing. I have not yet provided specific guidance as to when that will read out, but we'll look to when to get a little more enrollment information. We'll look to provide more precise timing in the near term on the timeline for EMBRACE, and then from both approach and EMBRACE, patients have the option to roll over into the long-term safety trial, extend, and that will be 52 weeks. It's a blinded trial, so getting the highest quality data we can there. Patients roll over, they can get up to three additional doses during that 52-week trial, so we'll get some very good durability data as well as information to inform prescribers on dosing, you know, how often, et cetera, and all that will form the basis for the For our NDA, which we've guided, we anticipate filing that in 2028. As you mentioned, we do have breakthrough therapy designation for the program, for the molecule, and so that would expect a rolling submission there. So also would anticipate approval in 2028 as well, but have the full standard program to support that.

Eddie Hickman, Analyst — Guggenheim

What do those discussions say about on the safety database? Obviously, it's unique in the sense that it's sort of an acute treatment, but you hope to be able to retreat and make it sort of a chronic treatment for certain patients. So is there a sort of a number of retreatments that they have to see or a number of a sort of safety database beyond the final treatment that they're looking for?

Michael Halstead, CEO

Yep. So our discussions with FDA obviously led us to the guidance that we've given in terms of a 2028 submission. But I would say that I view that long-term trial, the EXTEND trial, as very significant information for the clinician, right? So to be able to have that database, those results to inform prescribing decisions, I think is going to be very impactful beyond, obviously, what we need for the NDA package, but I think will be very helpful to clinicians as they move forward as well.

Eddie Hickman, Analyst — Guggenheim

You know, last few minutes here, I want to get into the second program, 004. You had some data, you know, earlier in the year, but sort of what, you know, how is that program sort of taking shape now that you have a plan for a phase two? What changes have you made? What is the sort of key focus or key thing that you need to show in phase two to move forward?

Michael Halstead, CEO

Right, so we did have a signal-finding study, and maybe I should start with OO4, as I mentioned earlier, is deuterated DMT, shorter-acting compound, that we did a phase two, done a number of phase one studies, and then a phase two signal-finding study in GAD. The results from that gave us confidence that we should move the program forward. We just, I think, at our investor day a couple weeks ago, provided details on the next phase to study, which is going to be a monotherapy study, 144 patients target. It'll be 30 mg of DMT In one arm, placebo in the other arm, and would anticipate initiating that trial in the first quarter of next year, and then once we get some enrollment information, then we'll provide people with guidance as to when we would expect that trial to read out.

Eddie Hickman, Analyst — Guggenheim

So why monotherapy here, and what is different about GAD from a standpoint versus adjunctive MDD?

Michael Halstead, CEO

Yeah, so MDD, there are 25 or 30 monotherapy treatments approved for MDD, and there's only the five atypical antipsychotics that are approved for adjunctive. I distinguish that from GAD. GAD, about 20 million people suffering from that in the United States. There's only five therapies approved for monotherapy. I think the last drug approval there was almost two decades ago, and there's just a significant unmet need there as a monotherapy. So we really think that our O4 program has real potential there.

Eddie Hickman, Analyst — Guggenheim

Yeah, and is there anything that you hear from KOLs about this type of population and how willing they are for like an intramuscular delivery, right? Because it's not an oral, it's not an intranasal or an inhaled version, it's a little bit more invasive. So I'm wondering if that's something that ever comes up in sort of thinking about this patient. I know if you have anxiety, it may be a needle in your...

Michael Halstead, CEO

So first is the significant unmet need, right? As I said, there's just a real need for safe, effective therapies. And remember, this is administered in a clinic. It is an IM administration, but again, would expect limited number of doses, so diminished burden from the patient perspective. And they've already elected to go to the clinic, so they get the IM injection and go through the treatment. So given the potential benefits, we think that this therapy has real potential in a patient population that really needs it where there just hasn't been any innovation in a long time.

Eddie Hickman, Analyst — Guggenheim

Yeah, no, I think we can see that in competitor market caps is that GAD is valued very highly. Final question is on the financial position. Obviously, finishing out of phase three, have a second one ongoing, and then this phase two started. So how will you capitalize and what should the burn rate look like in the next year?

Michael Halstead, CEO

Sure. So I think the last financials we filed, approximately $165 million on the balance sheet, and certainly capitalized through our near-term milestones, obviously the approach readout, and then our OO4 trial that were the initiation there, and have not provided long-term runway guidance yet. I expect to do that. I just needed to dig in a little more and get real confidence around the numbers so that whatever we do communicate, we can stand behind over the duration here, but certainly well capitalized over the near term.

Eddie Hickman, Analyst — Guggenheim

Awesome. Thank you so much for being here. That's all the time we have.

Michael Halstead, CEO

Appreciate it. Thank you.