20:49:37 EST Thu 05 Mar 2026
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Cybin Inc (2)
Symbol HELP
Shares Issued 57,364,294
Close 2026-03-05 C$ 7.70
Market Cap C$ 441,705,064
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Cybin talks HLP004 phase 2 study results

2026-03-05 17:00 ET - News Release

Mr. George Tziras reports

HELUS PHARMA ANNOUNCES TOPLINE RESULTS IN PHASE 2 SIGNAL DETECTION STUDY FOR HLP004 IN PATIENTS WITH GENERALIZED ANXIETY DISORDER

Cybin Inc., operating as Helus Pharma, has released top-line results from a phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate to severe generalized anxiety disorder (GAD) who remained symptomatic despite continuing SoC (standard-of-care) antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. GAD affects more than 20 million adults in the United States, and approximately half of patients treated for GAD fail to respond to initial first-line therapy. No adjunctive pharmacologic treatment for GAD has ever been approved. No new monotherapy has been approved in almost two decades.

In the phase 2 signal detection study, 36 patients were randomized two-to-one active-to-placebo to HLP004 20 milligrams or two milligrams and received two intramuscular doses three weeks apart. Patients were followed through week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening.

All study participants were already being treated and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment.

Key findings include:

  • Clinically meaningful efficacy: patients that received 20 milligrams HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4 points (p less than 0.0001) in the HAM-A from baseline at six weeks;
  • Efficacy in difficult-to-treat population: the study population consisted of moderate to severe patients who remained symptomatic despite continuing antidepressant or anxiolytic therapy;
  • Durable remission and robust response over time:
    • At six months, the pooled study population showed 67 per cent responders and 39 per cent remitters;
    • Participants randomized to both 20-milligram and two-milligram dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59 per cent meeting the criteria for response and 32 per cent for remission in the 20-milligram arm and a 30-per-cent responder and remitter rate in the two-milligram arm at week 6;
  • Commercially scalable clinic time: short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours, fitting within the treatment paradigm of existing interventional psychiatry clinics;
  • Well tolerated: favourable tolerability profile with no drug-related serious adverse events or suicidality-related safety signals.

"These phase 2 results support the continued development of HLP004, and I am encouraged by the magnitude of improvement observed over standard-of-care treatments, together with the rapid onset and short in-clinic treatment experience, for this patient population with limited options," noted Dr. Andrew Cutler, clinical professor of psychiatry at SUNY Upstate Medical University and senior adviser to Helus Pharma.

Michael Cola, chief executive officer of Helus Pharma, said: "Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments. We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients. The company's broad intellectual property portfolio has been leveraged once again to create what we feel are best-in-class products, and we are further excited to release the data on HLP003 targeted at major depressive disorder in the fourth quarter of 2026."

For additional information, please access the company's webcast, which is available on the company's investor relations website on the events and presentations page.

About HLP004

HLP004 is an investigational intramuscular deuterated serotonergic agonist designed to activate serotonin pathways believed to promote neuroplasticity. The program is being developed as a potential adjunctive treatment for patients with generalized anxiety disorder who remain symptomatic despite existing pharmacologic therapies.

About Cybin Inc.

Helus Pharma, the commercial operating name of Cybin, is a clinical-stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs (novel serotonergic agonists): synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The company's proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety and other mental health conditions.

With class-leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in phase 3 clinical development for the adjunctive treatment of major depressive disorder that has received breakthrough therapy designation from the U.S. Food and Drug Administration, and HLP004, also a proprietary NSA in phase 2 for generalized anxiety disorder. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs.

The company operates in Canada, the United States, the United Kingdom and Ireland.

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