Cybin Inc. (HELP) Discusses Phase II Results for HLP004 in Generalized Anxiety Disorder Prepared Remarks Transcript

SA Transcripts158.85K FollowersFollow5ShareSaveCommentsPlay Earnings CallPlay Earnings Call Cybin Inc. (HELP) Discusses Phase II Results for HLP004 in Generalized Anxiety Disorder March 5, 2026 7:30 AM EST Company Participants Michael Cola - Chief Executive Officer Presentation Michael ColaChief Executive Officer Good morning, everyone, and thank you for taking the time today. I'm Mike Cola, CEO of Helus, and we're here today to discuss the results from our most recent Phase II signal finding study in generalized anxiety disorder. Just a quick platform overview. As many of you know, we have two proprietary clinical programs, 003 and 004 in major depressive disorder and GAD with positive Phase II data. Our lead program, 003 has been granted FDA breakthrough therapy status and is in Phase III for adjunctive treatment of MDD. We have a differentiated platform with potential to expand in additional indications affecting a lot of people in the United States with a very high unmet need. We also benefit from strong IP with over 350 filed patents, 100 of which are already granted. As I mentioned, our pipeline consists of 2 late-stage clinical development programs in 003 and 004. Importantly, we have a major catalyst upcoming in Q4 this year with the approach top line data, our first Phase III trial in MDD. Today, we'll discuss our top line data in 004 in generalized anxiety disorder. So let's get right into the 004 data. We believe we have an emerging best-in-class profile with 004. We're going to walk you through data from the Phase I in healthy volunteers and also the Phase II results in patients with moderate to severe GAD. We've had a very good outcome in both studies. In the Phase II, we show a clinically meaningful 10-point reduction in HAM-A at 6 weeks, and we see that quite rapidly by day 2. Importantly, it's really