Cybin 3rd Annual Guggenheim Healthcare Innovation Conference

Sure. Thank you, Eddie, and thank you everyone for joining us today. Always excited to be here talking about Helus Pharma. The mission of the company is to improve the treatment of mental health conditions. We are currently developing novel serotonergic agonists for various mental health conditions. We have a platform of programs. Our 003 program is deuterated psilocin for the adjunctive treatment of major depressive disorder. That is in phase III. We have an upcoming readout of our first phase III trial anticipated in later this quarter. We also have a phase II program that is deuterated DMT in development for the treatment of generalized anxiety disorder. Then we have an earlier 005 program, which is a library of preclinical compounds. We think that there is potential there in a number of therapeutic areas, looking to move the lead candidate forward in that program in 2027.

A lot going on with the company. I joined as the CEO in August of this year, and really excited about both the team, all the work that has been done to date, and certainly looking forward to our readout later this quarter.

Sure. Importantly, this is for the adjunctive treatment of major depressive disorder. Maybe just a little bit about the disease state. MDD impacts approximately 22 million patients in the United States. Approximately 70% of those patients are on standard of care, so that's your SSRIs, your SNRIs. Of the patients on standard of care, approximately 66% are not getting adequate relief from standard of care. Often they're getting some benefit, but they need additional treatment. The way clinicians approach these patients, they have sort of two options. One is to wash the patients off of standard of care. That can be a four to six-week process, potential withdrawal there, and then start over with a monotherapy approach. Obviously, depression is a complicated disease state, so not every patient responds to monotherapy.

Often, the way clinicians treat these patients is they continue them on standard of care, and then they add a treatment on adjunctively to hopefully move that patient down the path towards remission. To date, there are only five approved adjunctive treatment options. Those are the atypical antipsychotics, and they do have some efficacy, but significant side effect burden. As we look at our 003 program as an adjunctive treatment, really excited about the potential product characteristics that we could see here. Obviously, has to play through in our upcoming phase III readout. But in phase II, saw really significant efficacy, saw durability off of two doses out to a year, and then also saw a very favorable tolerability profile, mild to moderate adverse events, primarily transitory on day of treatment, and you only have a few days of treatment.

Really think that this has the potential to provide significant patient benefit and a great option for clinicians as they're looking to treat these patients following that adjunctive approach. We completed enrollment in July. The process has been proceeding according to our plans. As I say, haven't provided any additional guidance other than we are on track for our expected data readout later this quarter. Certainly excited to get the data and excited to provide it out to the industry.

May have gotten that question once or twice.

I think that is important perspective that people do need to keep in mind. This is an adjunctive trial. As you said, every patient in the trial has to be on a stable dose of their antidepressant medications, has to have been stable dose for at least four weeks. They remain on their background therapy throughout the trial, and then 003 is then administered to show an effect on top of that standard of care. You need to look at this in the adjunctive setting. You're trying to show a benefit on top of, for a patient that has already received, is already getting some benefit from standard of care often, as opposed to a monotherapy where the patient is washed off of their antidepressant and started over.

Or the TRD patient population, which that is two or more failures on an antidepressant, very challenging patient population there.

Right. As I said, right now, their only indicated options are the atypical antipsychotics that are indicated for adjunctive use. How we think about this in the case where if we were to be approved for the adjunctive treatment, you have the potential for a clinician to have the option of not only efficacy, but then also long-term durability and a safety tolerability profile that's very favorable. If you have a patient that either is not responding to the atypical antipsychotic that's being administered adjunctively, or that patient can't tolerate the side effects because, of course, the side effect burdens for the atypical antipsychotics, very significant, weight gain, cardiometabolic, tardive dyskinesia, movement disorders, sexual dysfunction. These are significant side effects that really impact patient quality of life.