Cybin Reports Important Progress on Key Milestones and First Quarter Fiscal Year 2026 Financial Results

Executive Summary

• Cybin Inc. reported unaudited financial results for the first quarter ended June 30, 2025, reporting a net loss of $24.6 million and cash reserves of $118.7 million.
• The company received regulatory approvals for the EMBRACE study (Phase 3) from the European Medicines Agency and the UK MHRA, marking a key milestone in the PARADIGM program for CYB003.
• The company highlighted a recent $50 million financing agreement via convertible debentures and provided updates on the enrollment status of its CYB003 and CYB004 clinical programs.

Key Details

• Financial Results (Q1 2025):
  • Cash and cash equivalents: $118.7 million as of June 30, 2025.
  • Net loss: $24.6 million (compared to $10.8 million in the same period last year).
  • Cash-based operating expenses (R&D, G&A): $23.9 million (compared to $11.9 million in the same period last year).
  • Cash flows used in operating activities: $29.5 million (compared to $19.9 million in the same period last year).
• Financing:
  • Recent financing agreement for a US$50 million principal amount of convertible debentures to advance clinical pipeline programs.
• Regulatory & Clinical Milestones (CYB003 - MDD):
  • Received European and UK MHRA approval for the EMBRACE study, the second pivotal Phase 3 study within the PARADIGM program.
  • Received Clinical Trial Application (CTA) approval from the Irish Medicines Board for Ireland, Poland, and Greece.
  • EMBRACE study details: 12-week, randomized, double-blind, placebo-controlled study enrolling 330 participants across ~60 sites in the US, UK, Europe, and Australia.
  • EMBRACE design: Evaluates two doses of CYB003 (8 mg, 16 mg) three weeks apart vs. placebo in patients with moderate to severe MDD (MADRS≥24) with inadequate response to stable antidepressant therapy. Primary endpoint: change in MADRS from baseline six weeks after first dose.
  • APPROACH study (first pivotal Phase 3 study): Dosing ongoing; expected to enroll 220 patients across 45 US sites. Topline data expected in 2026.
  • EXTEND study: Long-term extension study for APPROACH; patient rollovers are ongoing.
  • Previous Phase 2 data for CYB003 in MDD showed durability of effect at 12 months: 100% of participants receiving two 16 mg doses were responders, and 71% were in remission. Mean change from baseline in MADRS was approximately -23 points.
• Clinical Updates (CYB004 - GAD):
  • Phase 2 study evaluating CYB004 for generalized anxiety disorder is expected to complete patient enrollment in August 2025.
• Corporate Changes:
  • Effective April 1, 2025, the company changed its presentation currency from Canadian dollars to United States dollars (USD).

Notable Quotes

• “With our recently announced funding agreement in place, we are well positioned to continue advancing our lead clinical programs, CYB003 and CYB004, through multiple inflection points,” said Doug Drysdale, Chief Executive Officer of Cybin. “Gaining European CTA approval and MHRA approval to commence EMBRACE in the UK has enabled us to expand our multinational Phase 3 PARADIGM program evaluating CYB003 for the potential adjunctive treatment of major depressive disorder.”
• “Cybin is in a strong position to advance our programs and continue our work to deliver innovative therapies to address some of the most challenging mental health disorders we face today and is helping to build momentum across the sector - both from a clinical and regulatory perspective,” concluded Drysdale.