November 13, 2025 — Cybin Inc., a clinical-stage neuropsychiatry company, reported its unaudited financial results for the second quarter ended September 30, 2025, and recent business highlights.
According to Eric So, Interim Chief Executive Officer of Cybin, the company is pleased with the strong demand for its recently completed financing, and the participation of notable institutional investors underscores confidence in the strength of its science and the potential of its therapeutic candidates.
So added that the financing enables the company to maintain strong momentum as it advances its Phase 2 and Phase 3 clinical trials toward key data readouts in 2026 and work to deliver clinical outcomes and transformative therapies to patients in need.
So also mentioned that the company is focused on a disciplined execution strategy and building a strong foundation leading up to critical clinical milestones in 2026, and the recent financing enables the company to advance its late-stage programs, prepare for commercialization and retire inefficient capital structures.
Recent Business and Pipeline Highlights include:
- Completed enrollment in its Phase 2 study evaluating CYB004, a proprietary deuterated dimethyltryptamine (“DMT”) program, for the treatment of GAD.
- Continues to progress CYB003 through the Phase 3 APPROACH and EXTEND studies. Dosing is currently ongoing in the first pivotal study, APPROACH, which is expected to enroll 220 patients across 45 U.S. clinical sites. Patient rollovers continue into EXTEND, the long-term extension study.
- Received approval in Australia to conduct the EMBRACE® study, the second Phase 3 study within the PARADIGM program evaluating CYB003, for the adjunctive treatment of MDD. This approval follows other recent regulatory decisions which granted approval to initiate the EMBRACE study in the United States, Ireland, Poland, Greece and the United Kingdom.
- The Board of Directors formed a committee to conduct a formal search for a Chief Executive Officer to guide the Company through its next phase of growth and clinical advancement.
- Growing intellectual property portfolio with 100+ granted patents and 250+ pending applications providing protection around lead programs, CYB003 and CYB004, until at least 2041.
Upcoming Key Milestones and Catalysts:
- CYB003 Phase 3 PARADIGM Program in MDD:
- APPROACH™ Study: Dosing is ongoing with expected enrollment of 220 participants across 45 clinical sites in the U.S. Topline data expected in Q4 2026.
- EMBRACE™ Study: Initiation of enrollment expected in Q4 2025, targeting 330 participants with moderate to severe MDD. EMBRACE has been granted approval to initiate in the United States, Australia, Ireland, Poland, Greece, and the United Kingdom.
- EXTEND Long-Term Extension Study: Patient rollovers are underway, providing long-term safety and durability data.
- CYB004 Phase 2 Program in GAD:
- Successfully completed enrollment in Phase 2 study. Topline data expected in Q1 2026.
- Differentiated delivery: Intramuscular delivery mechanisms optimized for clinical and commercial scalability
Second-Quarter Financial Highlights:
- Cash totaled US$83.8 million as of September 30, 2025.
- The Company’s cash position as at September 30, 2025 after giving effect to the net proceeds of the Registered Direct Offering is US$248 million, but before adjustment for post quarter events and repayment of the remaining balance outstanding under the Company’s convertible debentures and early repayment fees for a total cash repayment of approximately US$22.8 million.
- Net loss was US$33.7 million for the quarter ended September 30, 2025, compared to a net loss of US$41.9 million in the same period last year.
- Cash-based operating expenses consisting of research, general, and administrative costs totaled US$28.5 million for the quarter ended September 30, 2025, compared to US$18.2 million, in the same period last year.
- Cash flows used in operating activities were US$34.5 million for the quarter ended September 30, 2025, compared to US$19.1 million in the same period last year.
Cybin is a late-stage neuropsychiatry company committed to revolutionizing mental healthcare. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder.
Cybin is operational in Canada, the United States, the United Kingdom and Ireland.
Contact:
Investor Relations
info@cybin.com
Source: Cybin Inc.
