Mr. Eric So reports

HELUS PHARMA COMPLETES ENROLLMENT IN PHASE 3 APPROACH STUDY OF HLP003 IN ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER AHEAD OF SCHEDULE

Helus Pharma, the commercial operating name of Cybin Inc., has completed enrolment in its Approach phase 3 pivotal study of HLP003 in patients living with major depressive disorder.

Approach enrolled adults with moderate to severe MDD, who experience inadequate response despite a stable antidepressant regimen. Completion of enrolment represents an important milestone for Helus Pharma and advances the company toward the expected release of top-line data in the fourth quarter of 2026.

Current first-line antidepressant treatments are only effective in a small proportion of MDD patients. For those who do not achieve remission, Food and Drug Administration-approved adjunctive atypical anti-psychotics can provide modest benefit. However, their use is often limited by side effects such as weight gain, cardiometabolic dysfunction, movement disorders (such as tardive dyskinesia) and sedation, often resulting in treatment discontinuation. A novel adjunctive intermittent treatment such as HLP003 could potentially provide a more practical real-world solution.

"Completion of enrolment in Approach ahead of schedule demonstrates the focus and execution of our clinical team, investigators and study partners. We thank them and the trial participants for achieving this important milestone. We believe the pace of enrolment of participants reflects not only the efficiency of our clinical team, but also the strength of our screening and site selection processes. Despite rigorous eligibility requirements, we successfully enrolled participants with baseline disease severity aligned with that of our phase 2 study, reinforcing the quality and integrity of the phase 3 study population," said Eric So, interim chief executive officer of Helus Pharma. "With participant enrolment now complete, our focus turns to completing the study and preparing for top-line data in Q4 2026. We believe the durability, remission rates and overall profile demonstrated in our phase 2 study support the potential of HLP003 to meaningfully improve outcomes for patients living with MDD, and we look forward to advancing the program through the next stage of development and toward a potential FDA new drug application in 2028."

The milestone comes amid growing adoption of innovative, clinic-administered treatments for difficult-to-treat depression. Johnson & Johnson reported worldwide Spravato sales of $584-million (U.S.) in the second quarter of 2026, an increase of approximately 25 per cent from the first quarter of 2026 and 40.8 per cent from the second quarter of 2025, including $514-million (U.S.) in U.S. sales. While HLP003 and Spravato are distinct treatments with different mechanisms, clinical profiles and development pathways, Helus Pharma believes this continued growth provides further evidence of significant patient and provider demand for new approaches to treating depression and the increasing adoption of novel treatments in interventional psychiatry.

The Approach study and broader Paradigm program incorporate key considerations outlined in the FDA's recently finalized guidance. These include rigorous placebo-controlled evaluation, measures intended to support the interpretability of study results, assessment of clinical outcomes beyond the primary end point, defined safety monitoring, and the collection of longer-term safety, durability and redosing data through the Extend study.

"We have developed an industry-leading development engine, which we believe will not only continue to drive the Approach study to completion, but serve to accelerate Embrace and Extend studies, respectively," said Amir Inamdar, chief medical officer. "The Approach study and the Paradigm program in its entirety are designed to generate robust evidence across efficacy, durability, safety and tolerability. The early completion of enrolment in Approach brings us closer to determining whether HLP003 can provide a durable clinical benefit within a practical adjunctive treatment model for people with MDD."

Enrolment is continuing in Embrace, the second pivotal study in the phase 3 Paradigm program. Eligible participants from Approach and Embrace may also roll over into Extend, Helus Pharma's long-term extension study, which is designed to further evaluate safety, durability of clinical effect and the potential role of redosing.

Beyond its clinical development program, Helus Pharma has developed a broad intellectual property portfolio supporting its differentiated and proprietary NSA pipeline, with more than 350 patent applications filed and more than 100 patents granted worldwide.

About the Approach pivotal study:

• HLP003 is an investigational deuterated psilocin analogue that has received FDA breakthrough therapy designation, and Approach is the first pivotal trial to assess HLP003 as a potential adjunctive treatment for MDD.
• Approach has completed enrolment of 223 participants with moderate to severe MDD (MADRS greater than or equal to 24), who are on a stable dose of antidepressant medication but are responding inadequately.
• Participants were randomized one to one to receive HLP003 (16 milligrams) or placebo. Each study arm evaluates a two-dose regimen, with doses administered three weeks apart.
• The primary end point is change from baseline in MADRS at six weeks after the first dose compared with placebo.
• The key secondary end point is change from baseline in MADRS at 12 weeks, compared with placebo.
• Participants are eligible to roll over into Extend, the blinded long-term extension study with opportunity for redosing.
• Top-line data release will include both the primary and key secondary end points and is on track for fourth quarter 2026.

About Helus Pharma Corp.

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 MDD that has received breakthrough therapy designation from the U.S. Food and Drug Administration, and HLP004, also a proprietary NSA in phase 2 for GAD. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs.

The company operates in Canada, the United States, the United Kingdom and Ireland. Helus Pharma is a trademark of Helus Pharma Corp.

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