Good afternoon, everyone. I'm Samantha Kulkarni, a senior biotechnology analyst with Canaccord Genuity, and it's my pleasure to have Helis with us today. The ticker is HELP, and they really are in the business of helping people with the products that they have in the pipeline. For Helis, this is a momentous event because this is the first event for the new CEO, Michael Halstead, who joined the company recently, and he already knows everything about the company anyway. So we're going to do our best to ask him questions that are thoughtful. I'll turn it over to Michael in a minute or so, but just to give you a bit of background, we are on the cusp of phase three data from HLP003 as an adjunct treatment for major depressive disorder that's coming in the calendar fourth quarter of this year. There is a due traded version of psilocin and it has a durability profile that not too many people have seen in terms of other products that are out there in trials right now. With that, I'll turn it over to Michael for a few minutes just to give a bit of a background on what attracted him to the company and how he sees what Healus can do in the larger scheme of things as they play in the mental health therapeutic space.

Thank you, Saman. Thank you for taking the time. And thank you all of you. Very, very excited to be here. And I'm very excited about Healus Pharma. I have been the CEO of Healus Pharma for eight days now, but certainly spent a lot of time in advance of that getting to know the company, the founders, the board, and throughout that whole process, continue to get more and more excited about the potential that Helis has to truly impact mental health. For those of you that are not familiar, Helis is focused on novel serotonergic agonists for the treatment of various mental health conditions. As Sumant said, we have a late stage program in adjunctive major depressive disorder. That's HOP003. Folks focus on that, given it is late stage. We do have, we're expecting top line results from our first phase three trial in the fourth quarter of this year. But I always like to focus folks on the broader platform. We also have the OO4 program, a distinct molecule in phase two for the treatment of generalized anxiety disorder. And then in addition, there is the OO5 platform program that the company hasn't talked a lot about yet, given its earlier stage, but a lot of promising compounds there for potential treatments in a number of therapeutic areas related to mental health. So maybe turning to your question, sort of why Helis? What excited me about the company? Maybe a little background because it's relevant. I've been in and around industry for about 25 years now. Started out as a mergers and acquisitions lawyer, then moved over to industry, worked in specialty pharma, You know, commercial stage, multiple products, therapeutic areas, really the operational focus then shifted in 2014 to intracellular therapies, which a CNS company focused mental health, the depression space. We were about 20 people when I joined intracellular therapies, a very, very similar stage to Helis. We'd finished phase two, ongoing phase three programs, and then followed the spectrum from there in terms of multiple approved indications, built out the infrastructure, and some successful commercial launches, and ultimately in 2025, we were 1,000 folks. So really that full spectrum, a lot of the same journey that we're going to walk with Helis as we look to execute on the company's potential go forward. I had finished up with intracellular therapies, was acquired by Johnson & Johnson in 2025, gave me the, I think, very fortunate opportunity to be in the position to really be selective about what it was that I did next. was very thoughtful and diligent in evaluating where was the opportunity, the company, where I felt like that we could really make an impact in a space, mental health, that's very important to me. As I said, Interstellar Therapies was a CNS company. I also have, as I always say, unfortunately, given the prevalence of the disease state, I have personal connections to mental health And so many folks do, friends, family. And certainly with the folks at Healus, almost to a person, they are similarly passionate about mental health. It started with, got connected with the founder of Healus Pharma, Eric So. He's very passionate about the mental health space. we had a real connection and and it really really went from there we spent quite a bit of time determining the the fit making sure that from from both of our sides that we thought that that this was a partnership that would work long term that we shared a vision and and a focus and met in terms of the the board directors, the management team really, really validated that throughout. And that decision has continued to be validated with every person from the company I've met as I've gotten to know the organization and folks better. And I fully expect that will continue. But then just as I did my my diligence process and and evaluating i think in probably a similar way that that many folks do if if you're you're looking all right where where are we going to make this this real impact right so when you're looking at a company you look at that the potential of the assets you look at the likelihood of success obviously you can have the greatest drug candidates in the world if you can't get them to the finish line you're not going to make that impact with patients And then, of course, the team that you're going to be working with, that you want people that are, A, passionate about the mission, but then, of course, experienced, competent folks that are really going to be great to work with as we look to realize this potential. And as I ran through all of those pieces, Sumat, and I can, of course, get into some more detail, all of those checked out. I got conviction, I believe, and I made, for me, the most significant investment, my time, my energy in joining the company. So here we are at Healus.

That's great. Thanks for that background. And I'm glad you brought up the fit that you have with the board. We also have a co-founder and a board member, Paul Glavine, in the audience here, so thanks for being here. Just on that, could you expand a little bit on what are some of the factors that you considered when you thought you achieved a fit with the company from a board perspective? That's one of the questions we get from investors and some of the history that the company's had with management in the past.

Sure. And as I said, it really starts first with that shared vision about where do we want this company to get to? Passion about really helping patients changing, transforming the treatment paradigm in mental health. There are 300 million folks worldwide suffering from depression. I probably don't need to quote the daily suicide statistics. There's just so, so important. And so having that shared focus, that shared goal to really impact mental health, that's the foundation that you start from. And then obviously, then you look to how do you view things executionally? How do you view building the company over time? And there was just a lot of common ground there that I think long term is really going to help us as we look to execute on on all this potential that I think Hillis has.

So with this class of molecules, there's a bunch of approaches. There's some molecules, there are several molecules in trials. Many of them, you know, target some form of depression. Are there lots of nuances within the indications within depression? Sure. Yours is one of the few, if not the only program right now that is going after adjunctive treatment of major depressive disorder. What made the company choose adjunctive treatment versus monotherapy versus going after treatment resistant depression, all those kinds of things.

I was very excited about the company's choice for adjunctive major depressive disorder. If you look at the way psychiatrists treat these disease states in the real world, if you look at the spectrum with depression, you have about a third of patients respond to standard of care. So that's your SSRIs, your SNRIs. About two-thirds of the patients don't have an optimal response. Now, they may get some benefit, but they need additional therapy. And this is the adjunctive space, or 21 million folks in the United States suffering from MDD. So on the spectrum, getting that adjunctive stage before they move to treatment-resistant depression, multiple failures on other medications, that you're accessing that large patient population, that doctors are able to, they don't have to take these patients off of their background therapy. so they stay on standard of care that you're not starting over again as you would in this switch situation here you're you're adding therapy on less disruptive for the for the for the patient hopefully you're you're you're achieving that improved result and I think it just fits very well in in terms of how this of how this disease is treated and and we're on the spectrum that we're focused. Really pleased with it.

So you've lived through the intracellular experience. That's one of the companies I still miss covering, by the way. And you had adjunctive treatment of major depressive disorder there as well. In this case, what would you consider a clinically meaningful difference? And is there a higher bar for a product like yours that happens to have different characteristics in terms of psychedelic experience?

Right. So I would focus on three pieces. There's, of course, the efficacy component. There's the durability of the treatment. And then there's the side effect profile. Growing up in the antipsychotic space, antipsychotics are, of course, some of them are approved for adjunctive MDD. They do provide some relief. They do have a side effect profile. I'm sure people are aware of the burdens there. Here, the potential with O3, right? You look at what was meaningful in the adjunctive space previously on the Madras depression scale, which is the measurement that people use in terms of severity of depression and the improvements in depression, if you saw a two- to four-point improvement on an adjunctive basis, so again, you're adding on to standard of care, folks are potentially already getting some relief, you saw two to four points of improvement on the Madras scale. Absolutely, that's a drug. It's currently in the marketplace. If you saw four to five points of improvement, that is a strong product candidate. And when I was doing my diligence, digging through the phase two results at Helis, really my jaw dropped. I had to do a double take and check that I was reading correctly. They saw 13 to 14 points of improvement on the Madras scale, again, as an adjunctive therapy. That was after three weeks, one dose. The side effect profile, no drug-related serious adverse events. The adverse events that they did see, mild to moderate, and largely transitory, resolving on the day of treatment. So strong side effect profile there. And finally, the durability that they saw in their phase two ran out to 12 months. So this is the way that phase two is designed. Primary endpoint was three weeks, first dose. That's where you got the 13 to 14 points of improvement that I referenced. Subsequent to that primary, there was a second dose. They saw an additional five points of improvement on the Madras scale. And again, that durability, the remitter-responder rates, 100% response north of 70% remission, just really, really powerful results. Now, all of us that are familiar with drug development, of course, this is a Phase II study that has to translate into the larger population in Phase III. but I'm really excited about this kind of a starting point as you look to the potential outcome in phase three. It certainly gives me confidence in a successful outcome.

So Healus as an organization is one of the pioneers of the two doors in induction in this space. You're kind of the new guy in the company, so how do you view that and how much of an important factor is that in the largest scheme of things?

I think it was a critical factor in achieving the durability, obviously the magnitude of effect, but then the durability. I think that adding that in as part of the primary in the phase three design, just absolutely the right approach. Overall, if I could just take a minute to talk about the phase three, I don't think we've talked about that. I was very pleased with the way the team has designed the phase three trial, the way they're executing on the phase three trial. Obviously, this event, we're expecting top-line data in the fourth quarter. As here we sit in August, just announced that we completed enrollment. I this wasn't a situation where I could come in and rework anything fix anything I had to be comfortable that the way the house had been built it was it was it was a solid approach and obviously I got conviction and belief on on on that but the the phase three design they tracked very well to the to the approach they used in phase two sometimes you see folks complicating their phase threes adding on multiple endpoints etc you can run into some issues there here again did did an excellent job of of of following the design and and as i said incorporating that two dose approach into the into the primary and then also clinical trial execution it's just it's just critical you you design the best plan but then if you're a contract research organization that's administering the trial for you. If at the site level, it's not being executed, certainly it can run into issues there. Helis has been very hands-on and down to the site level, ensuring that this clinical trial design is playing out in terms of clinical conduct. So again, across the board, very, very pleased.

So with Helis' product candidates, there is a point of differentiation that your product candidates are deuterated. That means they could be eligible for true composition of matter patents, which the classical psychedelic molecules that have been around for a long time may not be eligible for. How much of a factor was that? And how would you kind of position that as something that might have attracted someone like you who's lived through some patent battles in the past in other organizations, how much of a factor was that for you?

I would perhaps speak more broadly in terms of the intellectual property because it obviously is critical. If you want to make an impact with patients, you need that foundation to sustain your product. Given how long some of these compounds have been around, IP perhaps isn't as prevalent as folks might expect. Here, Healus has done really an excellent job building out a broad patent portfolio, not only with respect to the O03 program, but really across that platform, O04, O05, that I referred to. It's a real, it's a solid foundation. So really like the IP setup, the job that they've done across, in terms of patents going to the composition, your method of treatment, your formulation. It's a nice portfolio. It's a broad portfolio, pleased with where we're starting from there. In terms of the due duration, you referenced IP, but of course, the patient benefit is really critical. And there really are benefits to the deuteration in terms of being able, the drug load is less. So psilocybin, the parent, is inactive. The psilocin is the active metabolite. And so they've deuterated psilocin. And you really do get, as I said, the benefits of the lower drug load. Stability, less variance in terms of PK, PD. So just across, we get some real benefits there that we'll look to capitalize as we move forward in development.

So I'll switch to a bit of a bigger picture question. You're one of the few CEOs in this sliver of neuro that has been there, done that twice over in terms of companies that have coincidentally become part of someone else, when you look at helis as an organization clearly you're building this for the future but what does your profile as an organization the types of products you have differentiation all that mean from a from potential for strategic partnerships or buyouts and other things that we cannot predict sure and and what i always what i always focus people on and and certainly as an organization we're going to focus on is execution what what is it that we can control what's our goal here.

Our goal here is to impact positively, significantly, the mental health space. We need to focus on execution. There's the near-term execution, obviously, with our first phase three expected to read out in Q4. Then there will be all of the subsequent execution in terms of that infrastructure build-out, expanding our other clinical programs, progressing those, looking to become a fully integrated commercial company, there's a lot to be done. Thankfully, I've lived through that at a very granular level over the last decade plus with intracellular. So hopefully, I can bring some efficiencies with those learnings. But it's really that execution focus that I would point folks to. Got it.

So these are neuropsychiatric products. We typically, in the past, you know, in classes of molecules that were not similar to yours, we have seen highly challenging clinical trial situations play out. And this class of molecules has been very different. So as you evaluated your opportunity to join Healus, I guess I flipped the question and say, what was the key risk that you saw in your minds other than the sheer vagary of a neuropsychiatric trial? What do you think was the key risk in being associated with Healus?

Well, I think there have been a number of positive developments that I think have addressed a number of the risks in this space. The general progress positivity around this space, right? You have a supportive administration. You have a constructive FDA. Recently, FDA issued new guidelines, the pathway to approval. We're very pleased with those guidelines and how they line up well with our ongoing clinical programs. You also look at the broader interest in this space. You now have larger pharmaceutical companies that are focused on this space, getting into this space. Obviously, they've done their diligence on all of the pieces that there is a patient benefit here. It's very real. There is a pathway to approval. There is a commercial proposition from both, obviously, with the psychiatrists, with the payers, and then the commercial infrastructure that this is all real and it's achievable. And I think all of that is very positive. So if you'd asked me a year ago, what are the risks around this space, we've certainly seen that progress, which is great. And then Healist specific, I think I've probably touched on the key areas that I focused on that really the Healist team has done a great job of addressing in terms of good clinical trial design, obviously a great starting point with the phase two results that we have, and really the quality of the team. I probably haven't I haven't focused on that as much as I should because it's it's critical. I certainly did a significant amount of diligence to make sure that this was a competent experienced team that I was starting with and they absolutely are and and and as importantly that this group is passionate about about what they're doing you know you put all that together and you have to feel really good.

So given we are ahead of a major data set we've spent most of our time talking about adjunctive treatment of major depressive disorder, but Helis is more than just that. You have another product for generalized anxiety disorder. You have other products waiting in the wings. Can you talk quickly about that in the last minute or so we have left?

Sure. As I said, this really is a platform with broad IP to support it. This isn't a one product company. That was, of course, very, very important to me as we look to the impact we can make with patients in the mental health space, 004, that's our Generalized Anxiety Disorder Program, GAD. There we have completed a phase two. We are in the process of designing the next trial in that program. We think that program has real promise. Expect to continue it. Expect to roll out more details in terms of next steps in the very near future on that. So more to come. Again, people focus on the upcoming phase three, but there's really a lot here that I've gotten very excited about. And hopefully I'm able to convey that enthusiasm because it's just so important what the company is looking to achieve here.

Great. We're looking forward to that. And thanks for being here.

Thank you very much.