This article has been disseminated on behalf of Helus Pharma and may include paid advertising.
Helus Pharma(TM) (NASDAQ: HELP) (Cboe CA: HELP) provided updates on its lead drug candidates, HLP003 and HLP004, during an investor presentation held Oct. 21, 2026. The company reaffirmed that topline results from its APPROACH Phase 3 study of HLP003 as an adjunctive treatment for major depressive disorder (“MDD”) remain on track for the fourth quarter of 2026. Enrollment of 223 participants in APPROACH was completed in July, while enrollment continues in EMBRACE, the second pivotal Phase 3 study. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”), and Helus Pharma expects to submit a New Drug Application in 2028.
The company also outlined plans to initiate a Phase 2 study of HLP004 as a potential monotherapy for generalized anxiety disorder (“GAD”) in the first quarter of 2027. The randomized, double-blind, placebo-controlled study is expected to enroll approximately 144 adults to evaluate two 30 mg administrations of HLP004 against placebo, with primary and key secondary efficacy assessments at weeks six and 12, respectively. Helus Pharma said the advancement of both programs represents an important period as it works toward regulatory approval and potential commercialization.
To view the full press release, visit https://ibn.fm/ahWlS
About Helus Pharma
Helus Pharma(TM), the commercial operating name of Cybin Inc., founded in 2019 (the “Company”), 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. For Company updates and to learn more about Helus Pharma, visit www.helus.com or follow the team on X, LinkedIn, YouTube and Instagram. Helus Pharma(TM) is a trademark of Cybin Corp.
NOTE TO INVESTORS: The latest news and updates relating to HELP are available in the company’s newsroom at https://ibn.fm/HELP
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