Cybin Inc. (HELP) Earnings Call Transcript & Summary

Well, good morning, everyone. Thank you for joining me today for this fire site chat with the CEO of Helus Pharma, Michael Halstead. Let me quickly read the Morgan Stanley research disclaimer. So for important disclosures, please see the Morgan Stanley research disclosure website at www.morganstan.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. Michael, thank you much for joining us this early in the morning. And before we get into the details, perhaps you can give us a bit of background on Helus Pharma and where the company is today.

Sure. And thank you, [ Rebecca ]. Thank you, everyone, for joining us today. Certainly excited to talk about Helus Pharma. I'm Michael Halstead, the new CEO of Helus. I joined in early August. Helus Pharma is developing treatments for several mental health indications. We're developing novel serotonergic agonist. Our lead program, our first Phase III readout, expected in the fourth quarter of this year, is the molecule is deuterated psilocin. It is for the -- in development for the treatment of adjunctive major depressive disorder, MDD. Very excited about that program, that indication and particular, hopefully, we'll get into that as we progress. Mid-stage program, we have as well is our 004 program. That is deuterated DMT, the molecule, and that is for the treatment of generalized anxiety disorder, very, very important indication there with a real unmet need. We, at the beginning of this year, completed a Phase II signal-finding study. We've told everyone that we're finalizing the clinical trial design for the next study in that program this quarter, and we'll be rolling details of that out very soon. And then the earlier stage program in the platform, and I'd like to emphasize, this is a platform late stage, mid-stage and early stage. is our 005 program, which is a library of compounds. Preclinical, we're going to be -- but I think have real potential in a number of mental health-related indications. We're going to be expecting to move the lead molecule in that program forward in 2027. So a lot going on. Obviously, a big near-term catalyst with the expected Phase III data in Q4, but just really, really excited about the potential that the company has to make a real positive impact in the treatment of mental health.

And so you mentioned you joined in early August, not that long ago. What would it that drew you to Helus Pharma?

Sure, sure. And I've been in and around the industry for about 25 years. Most recently, I was with [ intracellular therapies ], CNS-focused company, had developed antipsychotics for the treatment of adjunctive MDD. That was acquired by Johnson & Johnson in 2025. So I was in the fortunate position then of having the opportunity to be very thoughtful, selective what it was I wanted to do next. Saw the opportunity with Helus to make an impact in, again, a very, very important area, right, mental health, all the real unmet need, and the company is doing just some really great work. I did, I would say, a very similar diligence exercise to what investors do when they look at a company. So I looked at the potential of these assets, the likelihood of success. Obviously, you can have the greatest assets. But if you can't get them to the finish line, then you can't do what -- our real mission, what we really want to do make that real patient impact to provide that patient benefit. And then looked at the quality of the team that we have at Helus. All of those things checked out for me and especially as I look at the Phase III program in adjunctive MDD, and really the platform that the company has, the strong IP underneath to support long-term development, long-term commercialization, I just think the real potential with the company. And so I decided this was a place to devote my time and my energy.

And so you've had a month to get your feet under the table and get equated with the company. What are your first -- like, what are your priorities now going forward?

3 words, and they're all the name: execution, execution, execution. Obviously, we need to read our data out in Q4 with our late-stage Phase III program in adjunctive MDD. But then continuing with that focus on execution, both from the clinical development perspective, not only with our 003 program, but the other programs I referenced in the platform. And then also in parallel with that, all of the infrastructure build the unit and appropriate, scalable pace, so that we are prepared as we hopefully achieve these various clinical milestones to then support ultimately successful commercial launch.

Did that make sense? So HLP003, it's being advanced and tested as an adjunctive MDD treatment. What's the rationale for going after the adjunctive route and why not go after a bigger indication like TRD, for example?

Actually, adjunctive MDD is the broadest indication. And I should have said it upfront as I was evaluating the company, I really like the choice that they made, obviously, predated knee of focusing on the adjunctive MDD space. So if you think about the major depressive disorder population, there's approximately 23 million people suffering from MDD in the United States. Of that 23 million, approximately 70% are on standard of care. So that's your SSRIs or SNRIs. Of that 70%, approximately 2/3 aren't getting optimal benefit from standard of care and very, very high numbers. And the way in terms of how clinicians approach treating depressed patients, adjunctively, you have the option. So you have someone, they're not the optimal benefit on standard of care, but hopefully, they may be getting some benefit, right? And so you have the opportunity adjunctively to add a therapy on. You don't have to wash the patient off of their off of drug, if you would have restarted with a monotherapy, and that's 6-week process, and then you're giving them a monotherapy, and different patients react differently. So really starting over. Adjunctively, you continue on that path to remission. You're adding on to standard of care, hopefully, providing that incremental benefit that the patient needs to get them to remission and you're getting them importantly before they get to treatment-resistant depression, which is the end of the spectrum, that's multiple failures on other therapies. That population is about 3 million or so patients. So we're really focused on that broad swap and really helping these patients continue that journey towards remission. I think it's a great indication. You're able to access that broad patient population and again, really help them continue that journey to remission, hopefully.

So capturing them a little bit early and actually keeping them functional and living...

And it really fits with how clinicians approach treating these patients in the real world in their practices.

Makes a lot of sense. And perhaps you could spend a couple of minutes just walking us through the design of the HLP003 PARADIGME study?

Sure. And PARADIGME program, I was probably the right way to characterize it. It's -- and it is a full Phase III program, as you would expect. We have the 2 pivotal trials. The 1 that I was referencing that we anticipate will read out in the fourth quarter of this year is our APPROACH trial. We recently, end of July, announced completion of enrollment, so that's 223 patients, I think, if I remember the number correctly. It's a 2-arm study, 16 mgs of deuterated psilocin and then placebo. The primary endpoint is at 6 weeks, patients get 2 doses of the active, 1 at study start, 1 at week 3, then you major efficacy at week 6. This is on the MADRS, the applicable depression scale. Then, as a secondary endpoint, you're measuring again at week 12, show your durability of effect. And then there's also our the second Phase III, second pivotal. That is our EMBRACE study. That is a 3-arm study, a target of 330 patients. That is 16 mg an intermediate dose of 8 mgs and then placebo as well. And then, of course, we have a long-term extension study Study these patients have the opportunity to roll over from the 2 pivotals, long-term efficacy data over the course of the year. So that full package that you would expect to support an NDA filing. We've guided to anticipated NDA filing in 2028. We have Breakthrough Therapy designation from FDA for this molecule. And then with the rolling submission process, we would also then anticipate if all goes well, approval than in 2028 as well.

Okay. And so there are the 3 in MDD, you just like the company is developing it as an adjunctive therapy rather than mono therapy. You've already touched on some of the reasons why like not having to have that long washout period to making sure patients don't start to get to remission. But as a fresh pair of eyes coming into the company, do you think that's the right strategy?