Mr. Eric So reports

HELUS PHARMA PROVIDES UPDATE ON APPROACH PHASE 3 TRIAL ENROLLMENT PROGRESS

Cybin Inc.'s (Helus Pharma Corp.) enrolment in the Approach phase 3 clinical trial of HLP003 for the adjunctive treatment of major depressive disorder (MDD) is progressing as planned and has surpassed 86-per-cent enrolment.

• Approach phase 3 clinical trial of HLP003 for the adjunctive treatment of major depressive disorder (MDD) is progressing as planned and has surpassed 86-per-cent enrolment;
• Phase 2 HLP003 data demonstrated long-term efficacy with approximately 23-point reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score compared with baseline at 12 months after two 16-milligram doses of HLP003 three weeks apart;
• Previously reported phase 2 HLP003 results showed response and remission rates of 75 per cent at week 18 and by the 12-month mark, response and remission rates improved to 100 per cent and 71 per cent, respectively;
• Previously granted breakthrough therapy designation for HLP003 by the Food and Drug Administration;
• Company remains on track for top-line data readout in Q4 2026.

The Approach trial is one of the company's phase 3 studies evaluating HLP003, Helus Pharma's lead proprietary NSA, which has received breakthrough therapy designation from the U.S. Food and Drug Administration.

"We are pleased with the continued progress of the Approach study as we surpass 86-per-cent enrolment," said Eric So, interim chief executive officer of Helus Pharma. "This milestone underscores the execution of our clinical program and brings us closer to the anticipated top-line data readout in the fourth quarter of 2026. We remain focused on advancing HLP003 as a potential transformative treatment option for patients living with MDD."

The Approach study is evaluating the efficacy and safety of HLP003 as an adjunctive treatment in patients with MDD. The trial is part of the company's broader phase 3 Paradigm program, which also includes the Embrace study and the Extend long-term extension study, supporting the continued advancement of HLP003 toward potential commercialization.

In previous reported phase 2 data, HLP003 demonstrated long-term efficacy with approximately 23-point reduction in Montgomery-Asberg Depression Rating Scale score compared with baseline at 12 months after two 16 mg doses of HLP003 three weeks apart. Phase 2 HLP003 results showed response and remission rates of 75 per cent at week 18 and by the 12-month mark, response and remission rates improved to 100 per cent and 71 per cent, respectively.

About Cybin Inc. (Helus Pharma)

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 a portfolio of investigational NSAs.

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

We seek Safe Harbor.