Cybin Inc. Common Stock TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit

Good morning, everyone. Welcome to the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry virtual summit. I'm covering analyst, Ritu Baral, and I will be hosting today with my colleague, Managing Director Joseph Thome, across a number of our neuropsych companies under coverage, some not under coverage, and we will be featuring a private company showcase panel later today as well. To start off the day, we have one of my most frequent inbounds and covered company, Helus Pharma, formerly known as Cybin Inc. With us from Helus, we have new CEO, Michael Halstead, and Chief Medical Officer, Amir Inamdar. Welcome, Michael. Welcome, Amir. Thank you so much for the time this morning.

Thank you, Ritu, really appreciate you making the time and everyone joining us today. As you said, I am the new CEO here. I joined in early August. Very excited about Helus Pharma, the potential we have with a number of different programs to really significantly impact an area of great importance, and that's the mental health treatment paradigm. Maybe before we really get started, Ritu, I'll just give people just a real high-level overview of the company.

That would be great. For those that aren't as familiar.

Helus Pharma is developing novel serotonergic agonists for the treatment of several different mental health areas. We have really a platform is how I think about the number of programs that we have ongoing. Our late stage HLP-003 program, that is deuterated psilocin is the molecule. It is in phase III development for adjunctive MDD, and hopefully we'll get a chance to discuss that indication. I just think it was an incredible choice by the company to move forward in the adjunctive MDD space in terms of potential patient benefit. We are on track towards our expected readout in the fourth quarter of our first phase III trial in that program, and then of course, have the full phase III program that is ongoing, supporting that with an anticipated NDA filing in 2028.

Importantly, we also have a number of other programs, both mid-stage and then early stage. HLP-004, which is deuterated DMT, is in phase II development for generalized anxiety disorder, another very important indication. Hopefully we will have a chance to talk about that. I do think that is a very important program. We also have our library of earlier stage compounds, our HLP-005 program, that I really think has potential in a number of therapeutic areas related to mental health. We anticipate that we will be moving the lead candidate forward out of that program in 2027. Importantly, underlying that platform is a really nice broad IP foundation. Intellectual property, obviously critical, and the Helus Pharma team has done a very nice job of developing the intellectual property portfolio to support, obviously, the clinical development and then long-term commercialization.

Again, very pleased with the platform we have, the potential, and number of programs that the company has, and obviously excited about our upcoming phase III readout in adjunctive MDD.

Before the end of the year. Thank you for going over that, especially the IP portion, which hopefully we will dig into later. We will have chance to go over HLP-004. Let us start with HLP-003, as you mentioned, deuterated psilocin. How does that differ from the active psilocybin that others are developing?

Sure, and I will let, in just a minute, our Chief Medical Officer, Amir Inamdar, walk you through a bit of the detail around what we have seen in preclinical studies and other areas. Just high level, so psilocybin, the parent molecule, inactive, has to be dephosphorylated in the body to psilocin, the active metabolite. Our compound is deuterated psilocin. We believe that that provides several benefits as you think about the drug development process, improved stability, efficiency of delivery, and also importantly, reduced drug load. So can get the similar effects as the parent with a reduced drug load of the deuterated psilocin. Maybe, Amir, just a minute if you want to talk about what we have seen.

Yeah in terms of studies that we've done.

Absolutely. Thank you, Michael. We do believe that deuteration of psilocin results in real tangible benefits. We've seen this in our preclinical studies where we saw that deuterated psilocin gets into the brain about twice as fast compared to psilocin from psilocybin, and it achieves higher exposures in the brain compared to psilocybin. We think this is clinically important, and we've seen that with 16 mgs of HLP-003 compared to what is typically given in efficacy studies of psilocybin, which is 25 milligrams. HLP-003 delivers a Cmax, the peak plasma concentration, that's about 1.5 times higher than 25 mgs of psilocybin, and AUC or exposure, which is about 2.5 times higher. We think this is clinically relevant. I can speak a little bit about that in a bit. We also believe and know that deuteration shifts the metabolism.

The breaking down of the drug in the body changes because of deuteration, and it does so in clinically meaningful ways, such that the risk of relevant drug-drug interactions, we believe, becomes very low. Happy to talk about the clinical implications of what we think deuteration does.

Great. Yes. We're going to move next to the study that we'll be reading out probably in November, we estimate. The phase III APPROACH adjunct MDD study. Could you guys walk us through the design, the inclusion criteria, and including, because it is adjunct, what background medications are allowed, are prohibited, and then we're going to go into the treatment effect and expectations.

Sure. Amir, as the architect of the study, it would be great if you could provide some details there.

Yeah. What you really are saying, it is going to be my fault whatever happens in the study, right?