Cybin Announces Major Clinical and Regulatory Milestones Alongside First Quarter Fiscal Year 2026 Financial Results
Cybin Inc. (NYSE American: CYBN) (Cboe Canada: CYBN), a clinical-stage breakthrough neuropsychiatry company focused on transforming mental health care through the development of next-generation psychedelic-based treatments, has released its unaudited financial results for the first quarter of fiscal year 2026, ended June 30, 2025. In parallel, the Company provided a comprehensive business update outlining its recent operational progress, regulatory achievements, and the next steps for its leading drug development programs.
Cybin, which has positioned itself as one of the leaders in the modern psychedelic medicine sector, continues to advance its flagship candidates—CYB003, a deuterated psilocin analog, and CYB004, a deuterated dimethyltryptamine (DMT) compound—through critical late-stage clinical milestones. With new funding secured and an expanding global trial footprint, the company is poised for what CEO Doug Drysdale calls “multiple inflection points” in the coming quarters.
CEO’s Perspective: Building on Momentum
Doug Drysdale, Chief Executive Officer of Cybin, emphasized the Company’s readiness to push forward with its clinical objectives, highlighting the significance of recent approvals in Europe and the United Kingdom.
“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,” Drysdale stated. “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.”
Drysdale noted that the ongoing PARADIGM program marks a step-change in scale from the Company’s previous Phase 2 efforts. While the earlier trial was more limited in size and scope, the combined Phase 3 studies under PARADIGM aim to enroll approximately 550 participants globally, significantly broadening the data set to assess efficacy and safety.
“Our Phase 3 studies will evaluate the potential clinical benefits of CYB003 in patients living with moderate to severe MDD, whose symptoms remain uncontrolled with existing antidepressant treatment,” Drysdale continued. “Meanwhile, our Phase 2 study of CYB004 in generalized anxiety disorder is on track to complete patient enrollment this month.”
Recent Business and Pipeline Highlights
Cybin’s update featured several major clinical and regulatory accomplishments achieved during the quarter:
- Regulatory Approvals for EMBRACE
The Company received European Clinical Trial Authorization (CTA) approval for EMBRACE, the second Phase 3 study in the PARADIGM program, from multiple regulatory bodies, including:- The Irish Medicines Board (covering Ireland, Poland, and Greece)The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
- Study Design for EMBRACE
EMBRACE is a 12-week, randomized, double-blind, placebo-controlled trial enrolling 330 participants diagnosed with moderate to severe MDD, defined by a MADRS score ≥24. All participants are on stable doses of antidepressant medication but have shown inadequate response.
The trial will test two doses of CYB003—8 mg and 16 mg—administered three weeks apart. The primary endpoint is the change in depressive symptoms as measured by the Montgomery–Åsberg Depression Rating Scale (MADRS) from baseline to six weeks after the first dose.
- Progress in APPROACH and EXTEND Studies
The APPROACH study is the first pivotal Phase 3 trial in the PARADIGM program and is currently dosing patients. It will enroll 220 participants across 45 clinical sites in the United States.
Additionally, participants from APPROACH have the option to enroll in EXTEND, the long-term extension study designed to assess the durability and sustainability of CYB003’s clinical effects over time.
CYB003 Program Overview: Deuterated Psilocin for MDD
CYB003 is Cybin’s most advanced clinical program and represents a modified form of psilocin—the active metabolite of psilocybin—engineered through deuteration to improve pharmacokinetic properties. The goal is to create a shorter, more predictable, and therapeutically optimized psychedelic-assisted therapy experience.
Notable Achievements to Date:
- Breakthrough Therapy Designation granted by the U.S. Food and Drug Administration for adjunctive treatment of MDD.
- Phase 2 Data Highlights:
- 100% of participants receiving two 16 mg doses achieved clinical response.
- 71% achieved remission.
- Mean MADRS score reduction was approximately -23 points after two doses.
- Benefits demonstrated durability at 12 months post-treatment.
Phase 3 PARADIGM Program:
- Two pivotal trials—APPROACH and EMBRACE—running concurrently.
- Combined target enrollment: ~550 participants.
- Topline results from APPROACH are expected in 2026, a potential inflection point for the program and the Company.
CYB004 Program Overview: Deuterated DMT for GAD
CYB004 is a proprietary deuterated version of DMT, optimized for administration and pharmacological control. While DMT is known for its intense but brief psychedelic effects, Cybin’s formulation is designed for therapeutic consistency and integration in clinical settings.
Phase 2 Trial Design:
- Randomized, double-blind format.
- Evaluates safety and efficacy in participants with generalized anxiety disorder (GAD).
- Allows inclusion of patients on concomitant antidepressant or anxiolytic therapy and those with comorbid depression.
- Patient enrollment is expected to conclude this month, setting the stage for data analysis in the coming quarters.
Strategic Financial Realignment: Currency Change
Effective April 1, 2025, Cybin transitioned its presentation currency from the Canadian dollar (CAD) to the United States dollar (USD).
This decision was driven by three primary factors:
- The majority of the Company’s cash-based expenses are denominated in USD.
- The change improves the alignment between financial reporting and operational reality.
- It enhances comparability with peer companies in the biotechnology and pharmaceutical sectors, most of which report in USD.
First Quarter Fiscal Year 2026 Financial Highlights
- Cash Position: $118.7 million as of June 30, 2025, providing significant operational runway.
- Net Loss: $24.6 million for Q1 FY2026, compared to $10.8 million in the same quarter last year.
The increase reflects higher R&D investments in late-stage clinical trials and expansion into multinational regulatory environments. - Cash-Based Operating Expenses: $23.9 million, up from $11.9 million in Q1 FY2025, largely due to clinical trial site activations, patient recruitment, and manufacturing scale-up.
- Cash Flows Used in Operating Activities: $29.5 million versus $19.9 million in the prior year period.
Industry Context: A Critical Time for Psychedelic Medicine
Cybin’s advances come at a pivotal moment for the psychedelic therapeutics industry. Regulatory agencies, including the U.S. FDA and European Medicines Agency, are increasingly receptive to well-designed clinical trials in this space. Breakthrough Therapy Designations for psilocybin- and MDMA-assisted therapies have accelerated timelines, and growing public and policy awareness is reducing stigma around psychedelic research.
MDD and GAD remain unmet medical needs despite the availability of numerous pharmacological and psychotherapeutic options. The World Health Organization estimates that more than 280 million people worldwide live with depression, and anxiety disorders affect hundreds of millions more. Many patients do not respond adequately to existing treatments, underscoring the urgent need for innovation.
By targeting adjunctive indications—patients already on antidepressants but still experiencing symptoms—Cybin is positioning itself for potentially faster adoption if approvals are granted. This approach could allow CYB003 and CYB004 to enter clinical practice as add-on treatments rather than replacements, reducing barriers to physician uptake.
Key Catalysts in 2025–2026
Cybin outlined several anticipated milestones over the next 12 months:
- Completion of CYB004 Phase 2 enrollment and subsequent topline data readout.
- Ongoing recruitment in APPROACH and EMBRACE Phase 3 trials for CYB003, with site activations expanding in both the U.S. and Europe.
- Interim updates from EXTEND on long-term treatment durability.
- Potential additional regulatory designations or expedited pathways in international markets.
CEO’s Closing Remarks
In wrapping up the quarterly update, Doug Drysdale emphasized the Company’s dual focus on scientific rigor and commercial readiness:
“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. Our progress is helping to build momentum across the sector—both from a clinical and regulatory perspective.”
With sufficient capital, advanced clinical programs, and multinational regulatory clearances, Cybin’s trajectory over the coming year will be closely watched by investors, clinicians, and patient advocacy groups alike.
About Cybin
Cybin Inc. is a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options. With a focus on precision psychedelic therapeutics, Cybin is dedicated to improving patient outcomes through rigorous science, regulatory engagement, and scalable delivery models.
