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Cybin Inc. Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

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Transcript

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Pete StavropoulosBiotech Analyst

Welcome to the Cantor Global Healthcare Conference. I'm Pete Stavropoulos, biotech analyst with Cantor. With us, we have Helus, a company I cover. Please introduce Michael Halstead, CEO, and Amir Inamdar.

Amir InamdarChief Medical Officer

Did I butcher it? Absolutely correct.

Pete StavropoulosBiotech Analyst

CMO. Let's start off with the introduction of yourselves, followed by a snapshot of the company, and touch on the milestones that will shape the company over the next 6-12 months.

Michael HalsteadCEO

Sure. Thank you, Pete, and thank you everyone for joining us today. Certainly very excited to talk to you about Helus Pharma. Michael Halstead, recently joined the company as the Chief Executive Officer in early August. A quick bit about my background. Been in and around industry for about 25 years. Started way back in the early days as an M&A lawyer. Spent a little less than a decade with Warner Chilcott Specialty Pharma Company. Then moved over to Intra-Cellular Therapies, a CNS-focused company. Was there for, I guess, 12 years. The company was acquired by Johnson & Johnson in 2025. I was the President of ITCI at that point. Then moved over to Helus Pharma, which I'm really excited to tell you about. Just a snapshot of Helus, and we'll get into some details here, I think, as we go. A mental health-focused company, a platform of programs.

Michael HalsteadCEO

We're developing novel serotonergic agonists for the treatment of various mental health indications. Our late-stage program is our 003 program. That's deuterated psilocin. We're developing that for adjunctive major depressive disorder. It's in phase III. Really excited about that program and the indication. Hopefully, we'll get a chance to talk about that in a few moments as well. Anticipating our first phase III study to read out in the fourth quarter of this year, so exciting near-term catalyst. Our 004 program is a DMT compound in phase II development for generalized anxiety disorder. We're in the process of finalizing the trial design for our next clinical trial in that program. We'll be communicating the details on that out very soon, so please stay tuned.

Michael HalsteadCEO

Our earlier stage programs, 005, we have a library of interesting compounds that I believe have application and real potential in a number of mental health-related treatment areas. The lead compound in that program we would expect to move forward in 2027. Underneath that platform, I would be remiss not to mention we do have a very broad intellectual property portfolio that the team has done a very nice job building over the years. We'll continue to build. In terms of the 004 program and the 003 program, would expect to have patent protection out to at least 2041, so a nice runway there in terms of the development. Of course, long-term commercialization. With that, I'll ask my Chief Medical Officer to introduce himself.

Amir InamdarChief Medical Officer

Thank you, Michael. Morning, everyone. Great to be here. Amir Inamdar, Chief Medical Officer. My background is in psychiatry. I trained as a psychiatrist and then went on to train in pharmaceutical medicine as well. Started working at, actually, a clinical research site. I've been a study coordinator, I've been an investigator for clinical trials. Really, my pharma career started at GSK. I've been in the industry for over 25 years now. I've worked in all phases of development, starting from identifying targets, candidate selection, first time in human studies, early clinical development, to launching a product in the market as well. The last compound I was part of launching was LATUDA, which now is a blockbuster drug, when I was working at Takeda.

Amir InamdarChief Medical Officer

Moved from GSK to Takeda based out of the London office, spent some time there, and then moved on to AstraZeneca working there for a few years before Cybin, now Helus, came calling. I've been here at Helus for just under 5 years now. I look after the medical governance and the clinical development of our programs. Happy to be here. All right.

Pete StavropoulosBiotech Analyst

Michael, you recently joined Helus, as you just mentioned, as CEO. You were at Intra-Cellular Therapies when it was acquired by Johnson & Johnson for almost $15 billion. What were some of the key drivers for your decision to join Helus? You stated some of the obvious, but we want to hear about the non-obvious ones.

Michael HalsteadCEO

Sure. It was really, I think, a fortunate position following the transaction with Johnson & Johnson that I could really spend significant time being selective, really doing full due diligence process on what the company was that I wanted to join next. Really wanted that to be somewhere where we had a high probability of success, of really making an impact. Have spent obviously over a decade in the CNS space with a focus on depression. Personal connections to the mental health space as well, as so many of us do. Really wanted to find a company in the mental health space. Got connected with the Helus founders, that was a great initial connection. They're very passionate about the mental health space, and that actually tracks through across the company. Every employee, they're motivated to be here. Really nice initial connection, built on that.

Michael HalsteadCEO

Then, of course, did, I think, a pretty standard due diligence process on the company. Looked at the company's assets, which I just outlined, the platform that Helus has and the supporting IP. But then also looked at the probability of success, obviously focusing on our CYB003 program, given it is such a near-term significant catalyst. Really dug into not only the phase II data that Amir and his team put together, the accomplishments there, as well as the phase III trial design and how the team has executed on that to get comfortable. I really thought that this was a program that does have a real likelihood of success. Then also evaluated the team. You have a lot of connections in the space, of course, being in it as long as I have in the depression space that is.

Michael HalsteadCEO

Really checked out the team to ensure that this was an experienced, competent team that I would work well with over the near and then the longer term. Really got excited about the broad platform and the impact that I really do think that this company has the potential to make in such an important space. You put all that together, I decided that this was the place to invest my most important commodities, my time, my energy, and made the leap. I'll say, we're 6 weeks in here. Every day has validated all of that diligence that I did up front and really excited about the potential of Helus, both in the near term and then in the longer term, given the breadth of these programs and what I really think they have the potential to do in the mental health space.

Pete StavropoulosBiotech Analyst

All right. Thank you very much for that overview. You are developing CYB003 for major depressive disorder. For those that may be new to the story, just sort of walk them through what it is exactly.

Michael HalsteadCEO

Why deuterated psilocin? Sure. Our compound for the CYB003 program, deuterated psilocin.

Michael HalsteadCEO

You start with the parent molecule, the prodrug, psilocybin. That then needs to be metabolized in the body into psilocin to the active metabolite. We take that active metabolite. We deuterate it. There are a number of benefits, we believe, in connection with that deuteration. The efficiency of delivery, the reduced drug load, and then the reduced variability. All of that we believe beneficial to supporting some of the really impressive data that we have seen so far and as the program moves forward. Maybe, Amir, if you want to speak just briefly to what we have seen with some of our earlier studies.

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