Cybin Inc. Common Stock Canaccord Genuity's 46th Annual Growth Conference
Review the key takeaways and the transcript of this earnings call.
- Helius Pharma is preparing for top-line phase three data from its HLP 003 adjunctive treatment for major depressive disorder in the fourth quarter of this year.
- HLP 003 is a deuterated version of psilocin with a notable durability profile and showed 13 to 14 points of improvement on the Madras depression scale in phase two after one dose, with no drug-related serious adverse events.
- The company also has a phase two program for generalized anxiety disorder (HLP 004) and an earlier-stage platform program (HLP 005) with promising compounds for mental health conditions.
- Enrollment for the phase three trial of HLP 003 has been completed, and the trial design closely follows the successful phase two approach, including a two-dose induction strategy.
- Helius has built a broad intellectual property portfolio around its deuterated molecules, including composition of matter, method of treatment, and formulation patents, providing a strong foundation for product exclusivity.
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Transcript
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Good afternoon, everyone. I'm Sumant Kulkarni, a Senior Biotechnology Analyst with Canaccord Genuity, and it's my pleasure to have Helus with us today. The ticker is HELB, and they really are in the business of helping people with the products that they have in the pipeline. For Helus, 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. 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 III data from HLP003 as an adjunct treatment for major depressive disorder. That's coming in the calendar fourth quarter of this year.
That is a deuterated 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 Helus can do in the larger scheme of things, as they play in the mental health therapeutic space.
Thank you, Sumant. Thank you for taking the time, and thank you, all of you. Very excited to be here, and I am very excited about Helus Pharma. I have been the CEO of Helus Pharma for 8 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, continued to get more and more excited about the potential that Helus has to truly impact mental health. For those of you that are not familiar, Helus 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 HLP003. Folks focus on that, given it is late stage. We're expecting top-line results from our first phase III trial in the fourth quarter of this year.
I always like to focus folks on the broader platform. We also have the HLP004 program, the distinct molecule in phase II for the treatment of generalized anxiety disorder. In addition, there is the HLP005 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, why Helus? 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, commercial stage, multiple products, therapeutic areas, really the operational focus.
Then shifted in 2013, 2014, excuse me, to Intra-Cellular Therapies, which CNS company focused mental health, the depression space. We were about 20 people when I joined Intra-Cellular Therapies at very similar stage to Helus. We'd finished phase II, ongoing phase III programs, and then followed the spectrum from there in terms of multiple approved indications, built out the infrastructure, and some successful commercial launches. 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 Helus, as we look to execute on the company's potential go forward. Finished up, Intra-Cellular 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.
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