Helus Pharma, formerly Cybin, outlined its late-stage psychedelic drug pipeline at the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit on September 23, 2026. The company, led by CEO Michael Halstead (joined in August 2024) and Chief Medical Officer Amir Inamdar, highlighted HLP-003—a deuterated psilocin formulation—as its lead candidate in Phase III development for adjunctive treatment of major depressive disorder (MDD). At the time of presentation, Helus Pharma’s stock traded at $18.56, down 4.13% from its prior close of $19.36, within its 52-week range of $5.30 to $20.88. The company maintains a strong financial position, with a current ratio of 10.97, indicating more cash than debt on its balance sheet, though it did not disclose revenue, earnings, or cash flow figures during the presentation.
HLP-003 is designed to bypass the metabolic step required by psilocybin, improving stability, delivery efficiency, and reducing drug burden. Preclinical and Phase II data suggest it achieves higher peak plasma concentrations and greater brain penetration than psilocybin. In a Phase II trial, the compound demonstrated a 13-point placebo-adjusted improvement on the MADRS scale at week 3 after a single dose, with a secondary dose adding an additional 5.5 points. Long-term extension data indicated sustained effects lasting up to 12 months post-treatment.
The Phase III APPROACH trial, comparing 16 mg of HLP-003 to placebo, is structured as two doses administered three weeks apart. The primary endpoint is assessed at 6 weeks, with a secondary durability assessment at 12 weeks. The trial targets patients with moderate to severe MDD who have inadequately responded to stable antidepressant therapy, with a MADRS score of at least 24. Background SSRIs and SNRIs are permitted, while MAOIs, tricyclics, antipsychotics, and mood stabilizers are excluded.
In addition to HLP-003, Helus Pharma is advancing HLP-004—a deuterated DMT candidate—in Phase II for generalized anxiety disorder (GAD), and HLP-005, an early-stage library program, is expected to yield a lead candidate by 2027. Top-line results from the HLP-003 Phase III trial are anticipated in Q4 2024, with an anticipated New Drug Application filing for HLP-003 by 2028.
Halstead emphasized the adjunctive nature of the trial, stating that HLP-003 is intended to complement, rather than replace, standard antidepressant therapy. Inamdar noted the trial’s simplicity, a design preference for Phase III studies, particularly in psychiatric indications. The company’s focus on improving psilocin’s stability and reducing drug load reflects broader industry efforts to optimize psychedelic drug development.
Helus Pharma’s pipeline positions it as a key player in the emerging field of psychedelic-assisted psychotherapy, with HLP-003 as the most advanced candidate to date. The upcoming Phase III results will be critical in determining its potential regulatory path and commercial viability in treating depression.
