Helus Pharma reports news on clinical-stage pharmaceutical development for novel serotonergic agonists in mental health. Recurring updates cover HLP003 for major depressive disorder, HLP004 for generalized anxiety disorder, clinical and regulatory disclosures, research collaborations, and medical or scientific leadership.
Company news also includes governance changes, executive and advisory appointments, shareholder voting matters, capital-structure disclosure, operating and financial results, and participation in healthcare and life-sciences forums tied to the company's depression and anxiety pipeline.
Helus Pharma (HELP) announced that co-founders Eric So and Paul Glavine have stepped down from executive and consulting roles, retaining board seats. So served as President and Executive Chairman, while Glavine served as Chief Growth Officer.
Board member Mark Lawson was appointed independent Chair, effective immediately. The board also named So Chairman Emeritus, an honorary title. Helus Pharma continues to anticipate reporting topline data in Q4 2026 from its Phase 3 APPROACH pivotal study of HLP003 in major depressive disorder.
Helus Pharma (HELP) reiterated that its HLP003 APPROACH Phase 3 topline data readout remains on track for Q4 2026. HLP003 is being developed as an adjunctive treatment, added to existing antidepressant therapy, for major depressive disorder. APPROACH completed enrollment of 223 participants in July 2026; enrollment continues in EMBRACE, the second pivotal study. Eligible participants may enter EXTEND to assess longer-term safety, durability of effect and redosing. HLP003 has FDA Breakthrough Therapy Designation, making it eligible for expedited review; the company expects an FDA marketing application in 2028.
Helus expects to initiate its next HLP004 Phase 2 study in Q1 2027 for generalized anxiety disorder. The program has shifted from adjunctive treatment to monotherapy, or treatment on its own. The planned study will test two 30 mg administrations against inactive placebo.
Helus Pharma (HELP) announced the appointment of Dr. Suresh Durgam, a former member of its Scientific Advisory Board, to its Board of Directors.
Durgam brings more than two decades of experience in central nervous system drug development. He most recently served as Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies and helped secure FDA approvals for CAPLYTA across multiple indications. His board responsibilities will include corporate governance and long-term strategic oversight. The appointment is subject to Cboe Canada approval.
Helus Pharma (HELP) will host an investor presentation on October 21, 2026, covering its depression and anxiety drug development programs.
The webcast starts at 9:00 a.m. EDT. Topics include HLP003, in Phase 3 development as an added treatment for major depressive disorder, and HLP004, in Phase 2 development for generalized anxiety disorder. Experts will discuss the treatment landscape, followed by questions and answers with executive leadership.
Helus Pharma (HELP) completed its legal name change from Cybin to Helus Pharma, effective October 1, 2026. Shareholders approved the change at the annual and special meeting on September 22, 2026, following adoption of the Helus Pharma business name on January 5, 2026.
Common shares will continue trading on the Nasdaq Global Market and Cboe Canada under HELP. The company said the change reflects its anticipated transformation from clinical-stage discovery and development to a commercial-ready pharmaceutical company.
Helus Pharma (HELP) reported the results of its annual and special shareholder meeting held on September 22, 2026, where all management proposals were approved.
Shareholders representing 46,452,598 common shares, or 63.58% of outstanding shares as of the record date, were present in person or by proxy. Zeifmans LLP was appointed auditor until the next annual meeting, with 99.207% of votes cast in favour. A special resolution setting the board at eight directors passed with 99.326% support, and a special resolution to change the company’s legal name from “Cybin Inc.” to “Helus Pharma Inc.” passed with 99.315% support. The legal name change will take effect on October 1, 2026. All eight director nominees were elected for the ensuing year.
Helus remains a clinical-stage company developing proprietary serotonergic agonists, including Phase 3 candidate HLP003 for major depressive disorder and Phase 2 candidate HLP004 for generalized anxiety disorder.
Helus Pharma (HELP) announced that CEO Michael Halstead will participate in a fireside chat at the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit, a virtual event on September 23, 2026.
The webcasted session is scheduled for Wednesday, September 23, 2026 at 9:00 a.m. EDT and will be available live online. Registration for the webcast is accessible through the provided event link. A replay of the fireside chat will later be posted on the Events & Presentations page of Helus Pharma’s investor relations website.
Helus Pharma (HELP) presented four posters on its investigational oral deuterated psilocin analog HLP003 for major depressive disorder (MDD) at Psych Congress 2026, held September 15–19, 2026, in New Orleans.
Three posters extend findings from a completed Phase 1/2a randomized, double-blind study of HLP003 as an adjunctive MDD therapy, including 12‑month efficacy data, and explore effects on MADRS item scores, anhedonia, psychedelic experience assessment, and expanded safety. A fourth poster provides a trial‑in‑progress overview of PARADIGM, the ongoing Phase 3 clinical program evaluating the efficacy and safety of HLP003 as an adjunctive treatment for MDD.
Helus Pharma (HELP)/b) announced that CEO Michael Halstead will participate in a fireside chat at the Morgan Stanley 24th Annual Global Healthcare Conference in New York City. The session will be webcast live on Wednesday, September 16, 2026 at 8:30 a.m. EDT. A replay of the webcast will later be available on the Events & Presentations page of Helus Pharma’s investor relations website.
Helus Pharma (HELP) will participate in the H.C. Wainwright 28th Annual Global Investment Conference in New York City from September 14-16, 2026. CEO Michael Halstead is scheduled for a fireside chat on Monday, September 14, 2026 at 9:00 a.m. EDT, which will be webcast live. Registration is available via the provided webcast link, and a replay will be posted on the Events & Presentations page of Helus Pharma’s investor relations website.