Cybin's phase 2a data published in Nature Medicine

Executive Summary

• Cybin Inc. (operating as Helus Pharma) announced the publication in Nature Medicine of Phase 2a trial results for SPL026 in patients with moderate-to-severe major depressive disorder (MDD).
• The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in depressive symptoms at two weeks compared to placebo, with effects observed as early as one week and sustained for up to three months.
• The findings support the therapeutic potential of short-acting serotonergic agonists and inform the development of HLP004, with top-line Phase 2 data for generalized anxiety disorder (GAD) expected in Q1 2026.

Key Details

• Publication: Results published in Nature Medicine regarding a randomized, placebo-controlled Phase 2a trial of SPL026.
• Primary Endpoint: SPL026 demonstrated a mean difference of -7.35 in Montgomery-Asberg Depression Rating Scale (MADRS) scores versus placebo at two weeks (95% CI: -13.62 to -1.08; p = 0.023).
• Onset and Durability: Antidepressant treatment effects were observed within one week (mean difference: -10.75; p = 0.002) and were sustained for up to three months, with effects lasting up to six months in some participants.
• Response and Remission Rates (Week 2):
  • Response rates (≥50% MADRS reduction): 35% for SPL026 vs. 12% for placebo.
  • Remission rates (MADRS ≤10): 29% for SPL026 vs. 12% for placebo.
• Safety Profile: The treatment was generally well-tolerated with no treatment-related serious adverse events reported.
• Study Design:
  • Enrolled 34 participants (mean age 32.8 years) with moderate-to-severe MDD.
  • Participants received a single 21.5-milligram intravenous dose of SPL026 over 10 minutes or placebo, combined with supportive psychotherapy.
  • Stage 2 was an open-label extension where all participants could receive a second dose two weeks later.
• Strategic Implications:
  • Helus Pharma is not advancing intravenous SPL026 in its current form.
  • Insights inform the HLP004 development program; HLP004 is a proprietary non-deuterated analog of SPL026 designed to optimize pharmacology, consistency, and scalability for GAD.
  • Top-line data for the Phase 2 study of HLP004 in GAD is expected in Q1 2026.
• Regulatory Context: The release constitutes a designated news release for the company's prospectus supplement dated Dec. 30, 2025, to its short-form base shelf prospectus dated Sept. 17, 2025, as amended on Dec. 19, 2025.

Notable Quotes

• Dr. David Erritzoe, Lead Investigator: "We have shown that a single dose of SPL026 is safe, effective and durable, with treatment effects comparable to other promising interventional treatments often requiring much longer treatment sessions... these data show the promise of DMT as a potentially more cost-effective treatment for clinical depression than related serotonergic agonists with longer psychoactive action due to the shorter dosing sessions."
• Michael Cola, CEO of Helus Pharma: "This publication represents an important validation of short-acting serotonergic agonists as a clinically meaningful approach in mental health treatments... The findings provide clinical proof of concept for short-acting serotonergic modulation and further support our conviction that our novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility."