Conference Transcript - HELP 2026-06-04

Andrew Tsai, Analyst — Jefferies

All right, we're going to get started with our next session. I'm Andrew Tsai, Senior Biotech Analyst at Jefferies, and thanks for tuning in. It's my pleasure to have Eric Soh, Interim CEO of Helis joining me. Welcome, Eric.

Eric Soh, CEO

Thank you, Andrew. Thanks for having me.

Andrew Tsai, Analyst — Jefferies

So why don't you give us an introduction about Helis? What are you working on? What are you trying to achieve? And the milestones over the next six to 12 months would be helpful.

Eric Soh, CEO

Sure. So Healus Pharma is what we call a novel serotonergic agonist company that's focused on mental health. Colloquially, folks have referred to it as the psychedelic space. I don't necessarily think that that's fair or 100% applicable to us because what we do that is different from some of our peers is we actually modify these compounds through deuteration amongst other techniques to try and change the metabolic profile of these compounds to give what we hope is benefits like better brain penetration, durability, impact on the duration of the treatment time. So we have two programs for example our first is in major depressive disorder that is a big milestone coming up in Q4 of this year where we read out our top line phase three, our first phase three on that, which we expect to be quite transformative as far as value for the company. There we're using a deuterated psilocin molecule, psilocin being obviously the dephosphorylated form of psilocybin, but we've seen some incredible results there that have translated into, you you know, longer durability, incredible remission rates north of 71% even after 12 months. What we do with our second compound, which is focused on generalized anxiety disorder, is something called deuterated DMT. We use deuteration in that scenario to actually extend the duration of therapy for that molecule. Some may know of DMT as the active ingredient in ayahuasca. You might have seen some, you know, videos of ceremonies where people take it and they start vomiting and have a bad reaction. That's because the plasma spike that they experience is a bit extreme for them. And so through deuterating of that compound, what we're able to do is extend the window to about 90 minutes, smooth out that plasma curve, and have them have a better experience while not taking away from the therapeutic aspects. So, you know, that's a phase two program. But as it relates to kind of near-term and longer-term milestones over the next 12 to 24 months, we obviously expect top-line Phase III on the 03 MDD program, which has breakthrough therapy designation. And we also expect to submit NDA on that by 2028. And obviously we'll continue the 04 programs a bit early stage still, but I think shows some tremendous promise as a short-acting compound in the space great thank you for that overview so

Andrew Tsai, Analyst — Jefferies

um maybe a high level maybe talk about how the regulatory environment in the space has evolved over the years and for you at your company what was what has your own experience been like with

Eric Soh, CEO

FDA so far the experiences with FDA have been phenomenal we were able to get breakthrough therapy designation as I mentioned under the Biden administration that was further you know continued under the Trump administration and the access that we have at FDA is absolutely amazing they've been very instrumental in helping us design and architect what they want to see out of these trials and been very responsive to us I think furthermore what's what's quite interesting about the current climate is obviously we know the the voucher program the priority voucher program came into play by the white house a couple weeks back helis was one of three companies that were called out in the white house press release specifically which i thought was was great and i think that's definitely shown a changing of the times at least it appears to stigma. And looking at these compounds, obviously, there had been a long history, you know, in stigma around the war on drugs. I think we've definitely seen progress and changes there. And I can tell you that interest in this space, even by big pharma, has, you know, escalated considerably since that announcement. And I do think that it's really ultimately motivated by wanting to change and transform outcomes for patients i think you know there are those who would believe that it was simply a political move i like to remind folks that that program is about companies that had achieved breakthrough therapy designation that had large unmet needs that had you know companies with decent data and safety profiles and it's really about changing and shortening the administrative review of those companies post-data. And although Helos was called out at the time in that announcement, I do think it was probably premature for us if we had gotten a voucher, because you do only have two years to use it and have two phase threes in that time. So I do think that that would be nice to have when we announce our top line phase three. But if anything, I do think it signals further underlying desires by FDA and the administration to really look at patient outcomes, which goes very well with the philosophies for Healus. The company is called Healus Pharma. It's not called Treat Us Pharma. So we are ultimately engaged in transforming outcomes for patients.

Andrew Tsai, Analyst — Jefferies

Thanks. And I think investors have also felt more comfortable on the commercial side of things to commercialization with Spravato possibly being a nice proof point, doing $2 billion run rate right now. But going back to the psychedelic space, Compass could actually be approved soon. What can you leverage from the Spravato infrastructure? What can you leverage from Compass's build-out? Anything that you envision?

Eric Soh, CEO

Yeah, so I think obviously Spravato's doing tremendous things. I like to remind folks that they got to a slow start because they got started during the pandemic, obviously. But, you know, a $2 billion run rate, that's a blockbuster right now. I think some distinctions and opportunities as it relates to Spravato. And just so you know, one of the folks that helped architect their rollout has actually joined our company as an advisor as well. And I think they gave us some great insights on learnings and advantages that we may have. So, yes, there are a lot of interventional psychiatry clinics that they're currently utilizing. I think they have penetration in about 5,000 or 6,000, about 8,000 that exist across the United States right now. And patients are obviously opting for it. There's REMS programs and reimbursement around it. Spravato is something that scores something around the range of foreign change on the Madras point separation from baseline. fine, but it is a substance that you've got to take, you know, 30 to 50 times a year depending on the patient. So not a tremendous amount of durability. I do remind folks that this is for treatment-resistant depression, but the commercial success definitely tells us there's an appetite to use that drug, and it is significantly above the current standard of care. Furthermore, as it relates to the reimbursement, and if you actually look at the $2 billion number, that works out to around, you know, 40,000, 50,000 patients that they're currently helping. In an indication like TRD, where you're looking at almost 3 million people who suffer from that, to be objective, I think we could and should be doing better. And so what are some of the barriers that we've learned from Spivato that help it or stop it from helping more people. I think it's the redosing regiment there. And so clinics are now inundated with patients that they're constantly redosing as opposed to treating new patients. And therein lies the opportunity and an opportunity for Compass to step in. So although Compass, through its phase three, and just so you know, we wish Compass all the best of luck and hope that they get through get approved and help set the stage for this space I think that even at you know 3.6 or 3.8 depending on the study that they're showing as far as separation is concerned I do think the fact that there is hopefully more durability we haven't seen evidence of a lot of tremendous durability but we have seen signs that it is better than Spravato I think that that represents a difference that patients are willing to try and that doctors are willing to prescribe for. Now how does that set the stage for us? In our phase two we saw at our primary endpoint north of 13 points of separation from from Madras we saw long-term durability over 12 months that saw the score and separation reach almost 23 points which is unprecedented. Now that being said of course we're major depressive disorder, which obviously is a 23 million roughly million American addressable market size in the United States. And so we think that there's a larger market there. But furthermore, I think with that degree of separation, even if we were to experience a halving of our results, not saying that we will, but even if we did, like Compass saw translating their phase two to phase three, we'd still be the best drug on the market by quite a bit. And where I think our real advantage is, is we know that on two doses, at least in our phase two data, that we have durability of effect to past or around 12 months. And what we have done as it relates to conversations with those clinics, those same clinics that are currently offering Spravato, is they're telling us that if our drug does what we think it does, that even if they didn't have the infrastructure, they'd be willing to invest in it. to offer our drug because what they feel is that, one, on just two doses they could obviously treat more patients and see more patients, which is very important, and second of all, with that level of durability and not having to constantly re-dose patients, they'd be making more money. So it's very useful for folks that are offering your product to be incentivized to do so. And I think one thing that Helis has always tried to do is be sensitive to the needs of patients, providers, and payers. And so on the patient side, death efficacy, durability, definitely doing better for patients there and their outcomes. But for providers, obviously the dosing regimen, the durability are strong. But we also want to highlight the fact that we are one of the only adjunctive therapies that will be coming to market. So currently Compass and and others are monotherapy what is the impact of adjunctive so one of the benefits of the modifications that we've done to the compound is we've seen far fewer drug drug interactions and what does that mean it means that it's safer to administer with background medication one thing that we talk about at heal us is the fact that we like to test our drugs in the real world and ultimately if you're dealing with severely depressed patients we feel that it's unlikely that they wouldn't be on background medication. And so when you think about doctors and patients and safety, a doctor may realize that perhaps antidepressants are not necessarily helping their patients a lot. At least they're not doing themselves harm. And so what is the impact potentially of titrating a patient off of drug and washing them out for three weeks, or sorry, three months going to do. With ours, they don't need to ask the question. It's very low friction. They can say that there's good data behind this. It seems that the patient would experience an acute and transformative effect. So we feel that it's a lot easier to offer that. And from a commercialization perspective, I think that gives us a major advantage. A second advantage that we have over some of our peers is our intellectual property. So having north of 350 patent filings, of which over 100 have been granted, we have a definitive lock on dominant IP in the sector. And that allows us, and how does that translate? It allows us to commercialize for a much longer period of time than the seven-year marketing exclusivity that some of our peers will get. So we will have over double the period of time to commercialize. and we're good on those until at least 2041 before any patent restoration on those periods. So I think the commercial landscape, Spravato has shown us that there is an opportunity and I think Compass will show us that they can take advantage of that and I feel that we will compete very well in that space.

Andrew Tsai, Analyst — Jefferies

Very clear. Thank you. And so phase three data in Q4, I think it's a primary endpoint should be six weeks long. It is two upfront dosing. that's a little bit different from phase two, where it was a single dose out to week three as the primary endpoint. So like, my question is, two doses should ensure and maximize the chances of getting efficacy, not only at week six, but out to week 12 and even longer, like you said earlier.

Eric Soh, CEO

Yeah, we feel so. So there will be a single dose on day one, 60 milligrams, and then a second dose on day 21. We feel that to a certain extent, these drugs have a certain threshold effect. We feel that At 16 milligrams, we have a potent drug, especially with the modifications that have made to it. And we feel that giving that second dose really reinforces the durability. And obviously, these patients remain on background medications as well, so there's no interruption there. But what we saw in durability was extraordinary, nothing short of extraordinary, and we hope to see similar results translate in the Phase 3. And even if it wasn't as long as 12 months, we have reason to believe that obviously it'll last past the primary and secondary endpoints for quite a while after that.

Andrew Tsai, Analyst — Jefferies

And so one more time, 12-week long study, you've guided to Q4. I guess if I did my math correctly, I think you need to maybe complete enrollment, I don't know, by September, August time? Are you on track to complete enrollment?

Eric Soh, CEO

We are definitely on track to complete enrollment, and I love doing the math. My parents would be proud of me doing math as well. I can tell you that we're very pleased. In fact, May was a banner month. We actually exceeded our forecast in May for patient recruitment. We've set ourselves up well for June with number of patients in screening, and when we look at the traditional pass rate on those patients, I can say that we're doing well and expect to have a banner June. So we are very confident in delivering on time.

Andrew Tsai, Analyst — Jefferies

Great. And like you mentioned, you know, phase two almost is bound, the effect size is bound to degrade. Phase three is almost all the time bound to degrade from phase two, yet I know you showed a very strong effect size from phase two. But how did you power the study exactly?

Eric Soh, CEO

So we haven't formally disclosed our powering assumptions. I didn't necessarily say invariably there will be a degrade in the results. I'd say that even if there was one, we were starting from a very good position. But that said, even though we haven't disclosed our powering assumptions, I think we can all do some math, 220 patients, 110 inner placebo, 110 active. You can probably establish from that and extrapolate the effect size that we're going for. But let's just say we're sufficiently powered and maybe even a little overpowered.

Andrew Tsai, Analyst — Jefferies

Okay, very good. And when I look at your placebo arm from phase two, it was maybe around two, three-point reduction. In MDD, I typically think placebo behaves maybe closer to 9 or 10, but maybe you would talk us through why you think that was the case, and where do you think the phase 3 placebo could trend instead of minus 2, minus 3, for instance?

Eric Soh, CEO

So, I mean, I think there's some distinctions, and I think psychedelic trials in general have not been strangers to those types of placebo responses. I think the one thing that you get from patients who are taking a daily dose of an antidepressant, for example, they have that certain expectation placebo effect that, you know, they're continually taking something, so there should be an effect. I don't think we necessarily see that here because you're, you know, you're taking two doses and they're sufficiently separated by three weeks. In fact, the curve that we saw in placebo response was kind of the ideal one. So an initial view that something was happening, and then past the three-week point, it drifted back to where it was at baseline, whereas we saw significant separation on the active arm. So I don't have reason to necessarily believe that things will be different this time around. And as it relates to the placebo effect, it's kind of interesting. I can tell you that even patients who are not on active allege that they have an experience on visual animal scale, et cetera. So if anything, I think that that's behaving the way exactly how you want to see it.

Andrew Tsai, Analyst — Jefferies

And when you top line the data in Q4, would you consider sharing a cut of the open label extension that follows week 12 just to help us elucidate what the durability after two off-front doses could look like, or if not, when would you consider sharing open label extension data?

Eric Soh, CEO

So that is a point, and I saw your piece this morning, you know, that is a point of discussion for us and FDA. There are those who believe perhaps that we are a blinded long-term extension as opposed to an open label. Let's just say that we're maybe a little premature on that now as we get closer to data um and at least you know past recruitment uh we may um be able to share more but obviously we want to do that in consultation with fda and and you know but obviously we're always excited to share more if we can but we want to be respectful of the blinding and the powering of

Andrew Tsai, Analyst — Jefferies

the study okay and then remind us um on safety uh what you saw in phase two anything to note and For instance, did you see signs of suicidal ideation at all in Phase 2?

Eric Soh, CEO

Yeah, so we did not see any of that in Phase 2. It was extraordinarily safe and well-tolerated. You know, any AEs at all, which, you know, related to, let's say, blood pressure, which, you know, might have increased, not to the point of a brisk walk, let's say, all subsided after treatment. So, you know, that said, suicidal ideation is not an uncommon thing to MDD or TRD trials. I think COMPAS has dealt with that to a certain extent. But we don't expect to see anything, you know, terrible in this trial and would expect these to continue to be well tolerated and safe in patients.

Andrew Tsai, Analyst — Jefferies

And then what is the total monitoring time for your program? and I believe compass psilocybin is around six hours I'm just curious how

Eric Soh, CEO

long I mean obviously as a really trial design we are on the side of caution as it relates to monitoring I think this will change you know in the universe of practice I can tell you we reach peak effects you know about 90 minutes and then there's two-hour monitoring post that but you know in a four to six hour window I think is not unreasonable and we'll see that at least in the phase three. Subject obviously to modification, you know, in practice. But I do think that FDA is receptive in some of the suggestions that they've had as it relates to monitoring and session monitors. It's probably guided by some other experiences like with potentially some other companies like Lycos, for example, that are not applicable in our situation.

Andrew Tsai, Analyst — Jefferies

I see, I see. And so can you describe the treatment journey for the patient that day? Is there any preparation involved before they dose, integration after they dose? I ask because other companies might be employing that.

Eric Soh, CEO

Yeah, so we want to make it very clear that we have measured drug effect here. So we're not doing any form of psychotherapy or psychedelic talk therapy or anything like that. However, we have our program Embark, which is done to, you know, ensure that the patient is prepared for the experience, not unlike, you know, what an oncologist would tell somebody before they're going, you know, for chemotherapy. But there is no active therapy during the session. It's an experience where they wear a blindfold and have headphones on. So it is a, you know, internal experience to the patient.

Andrew Tsai, Analyst — Jefferies

Great. And so the second phase three also has started. When is the data, in your view?

Eric Soh, CEO

Yeah, so we launched that earlier this year and that continues to recruit as well and do well. Like I said, we've guided to NDA submission in 2028 and approval in 2028 because we also have rolling review by virtue of our breakthrough therapy designation. The precise timing of the of the end of the second phase three. It kind of depends on recruitment, et cetera, but we are still maintaining target on 2028 NDA approval.

Andrew Tsai, Analyst — Jefferies

Okay. Thank you. And so in the second phase three, it's actually two drug arms versus placebo, 16 and eight. Do you expect eight to do something in between?

Eric Soh, CEO

Yeah. So just to be clear, in that third study, or sorry, that second phase three study, we We have three arms, placebo, 8 milligrams, 16 milligrams. The trial wasn't designed to power to show separation between 8 and 16, but what the purpose around that behind is to kind of address FDA's, I'll say, inherent desire to give as low a dose as humanly possible. Now we obviously know that this is safe and tolerable at 16 mg. I think, if anything, if the eight shows some degree of efficacy, that that simply gives doctors more options, potentially, to prescribe a range, potentially, on the label. So we'll see what happens there. But I think, obviously, the key is that first phase three where we see or hope to see significant separation and material separation from baseline, which I think, obviously, sets up our thesis around how we believe this drug is a good one and better than most.

Andrew Tsai, Analyst — Jefferies

Okay. And speaking of the label, should your compound be approved, what do you think is the dosing protocol going to read? What are you hoping? Dose two times up front, retreat as needed after 12 weeks, or is there something different?

Eric Soh, CEO

I mean, obviously that is still premature. We'll see, you know, we haven't even completed the first phase three yet, so we'll have to to see what FDA says about that as well and what we see there, but what we hope would be something along the lines of adjunctive MDD and two-dose, you know, either 8 to 16 or 16 and 16, and, you know, we'll see what the durability shows us in the studies and what other particular label claims we could make.

Andrew Tsai, Analyst — Jefferies

And then in terms of the staffing requirement in your clinical studies, can you describe how many people are monitoring are they monitoring in person can they monitor remotely and will that be different in the real world yeah so again we've we've

Eric Soh, CEO

done this in accordance with with FDA guidelines to you know for a phase three study so we have two monitors one in person one remote again perhaps some of This was guided by what we saw in some other companies' trials. But at least that's what we currently have in place. Could that change in practice in the future? Absolutely. I think given the fact that this is, like I said, a kind of inward experience, doesn't require any talk therapy during, it would be possible to potentially monitor several patients simultaneously. and it could very well transform how care is deployed but I often tell people that what's important is patient outcomes and you know there's a difference between health span and lifespan over the last 20 years we've probably figured out ways to to make people live longer at least stop them from dying we haven't necessarily explored ways to improve their quality of life And that's ultimately what we want to do here. And if that means a paradigm-shifting drug or treatment, and that necessitates, you know, a paradigm-shifting change in how we deliver that care, it's ultimately the outcomes that we're guided by and what we're motivated to achieve.

Andrew Tsai, Analyst — Jefferies

And have you, by chance, done some payer work around this, your program? I mean, there's the drug reimbursement and the monitoring reimbursement. And on the monitoring side, what is your kind of best understanding on reimbursement? Will payers reimburse for the entire four to six hours for your program and why?

Eric Soh, CEO

So I think, you know, obviously CPT, you know, codes exist already. We've seen them used in Spravato. I think they currently contemplate at least one hour of initial coverage. I think I see a paradigm where you'd see a stacking of those potentially to reimburse for the whole session. Obviously what we've seen in the case of Spravato is that it's reimbursed and they have a number like up to, like I said, 30 to 50 treatments a year and that two hours is reimbursed. I don't see a reason why a therapy and drug that ultimately involves less patient time in the chair over the course of a year wouldn't be similarly reimbursed, but obviously we'll see what happens with FDA, and we have folks like Compass, as you say, and like I said, we appreciate everything they do because they kind of paved the way, and then we can take advantage of the learnings there to access the market as quickly as we can.

Andrew Tsai, Analyst — Jefferies

Okay, great. And then maybe one question on your other program, HELP 004, in your data-rated GMT program that reported phase two data earlier this year. What are the next steps for this exactly, or is all your focus going to be an MDD in the meantime kind of

Eric Soh, CEO

Yeah, so, you know, clearly our focus here is the 003 program and that data readout in Q4 which we feel will be a transformative event for the company but HELP 004 is a great compound and we feel that it could very well be one of the greatest short acting compounds out there what we saw in our phase 2 was obviously signs of efficacy and durability do we have to do more work on the dosing side of things? Absolutely but what we want to do is be responsible about the capital that we have and be responsible to shareholders and they expect us to deliver and execute on O3, which includes embrace as well as approach. So obviously we don't want to, you know, skip a step or a beat on the second phase three. That said, it is responsible for us to also examine the O4 program and what can be done there. And I can tell you with that scientific advisory committee and board that we have and all the smart people that we have at our disposal, that we will be examining a design to bring that forward as well in a fiscally responsible way while also at the same time respecting the timelines and the ability to capitalize on the market. So also say that you will be hearing from us soon on that. Maybe that's a teaser for a movie or something like that. The best is yet to come. but I think we have a great year ahead of us especially with with O3 as well as potentially some further insights on O4. Okay well thank you Eric for sharing

Andrew Tsai, Analyst — Jefferies

all the updates and best of luck on the data readout later this year. Thank you

Eric Soh, CEO

so much Andrew it's been a real pleasure being here.