As psychedelic-assisted therapies move closer to mainstream psychiatric care, Cybin, a clinical-stage biopharmaceutical company, continues to push the boundaries of innovation in mental health. The company recently announced a strategic partnership with Osmind, a leader in point-of-care software and real-world data for interventional psychiatry. This partnership, along with new Strategic Partnership Agreements (SPAs) to support its multinational Phase 3 program (Paradigm) for CYB003, represents a significant step forward in Cybin’s mission to deliver scalable, accessible treatments for major depressive disorder (MDD).

Cybin just announced a partnership with Osmind. How does this collaboration specifically support your commercial strategy for CYB003 and beyond?

The partnership with Osmind, a leading provider of point-of-care software and real-world data for interventional psychiatry, enhances Cybin’s commercial strategy by leveraging its extensive clinic network. This collaboration ensures CYB003, Cybin’s leading psychedelic-based treatment for major depressive disorder (MDD), will be well-positioned for market access, streamlining pharmacy fulfillment, patient engagement, and reimbursement pathways while supporting physician adoption across interventional psychiatry clinics.

With Osmind’s network covering more than 800 clinics, what kind of reach do you anticipate for CYB003 once approved—and how quickly could it be scaled?

With Osmind’s network of 800+ clinics, its established infrastructure can enhance adoption among its interventional psychiatry providers. Early engagement with clinicians and payers will also support scalability and physician uptake.

You’ve engaged 18 clinical sites so far for the Paradigm program, with plans for approximately 45 sites for Approach, the first key study. What has been your biggest challenge in expanding this network, and how are these Strategic Partnership Agreements helping?

Every clinical site comes with a significant amount of operational and logistical complexity. While we have scaled to meet the added complexity each additional site provides, our ability to address the logistics has a direct impact on participant recruitment rates. This complexity is not borne solely by Cybin—the sites also need to work within the unique requirements of psychedelic trials. The Strategic Partnership Agreements, which are designed to streamline operations and logistics for clinical sites, enable us to provide resources that expedite a site’s time from engagement to enrollment.

The Phase 2 results were impressive—71% of patients experienced remission for up to 12 months after just two doses. How do you see this data impacting physician and payer attitudes toward psychedelic-based therapies?

The Phase 2 results, which showed a 71% remission rate for up to 12 months following two doses of CYB003 (16 mg), reinforce its potential as a breakthrough therapy. If we see similar efficacy data in our pivotal trials and gain FDA approval, we expect physicians and payers would consider earlier integration of CYB003 into psychiatric care. CYB003 could have the potential to simultaneously improve patient outcomes while presenting significant opportunities for healthcare savings, such as through reduced hospitalizations.

You’ve described CYB003 as an adjunctive treatment for MDD. Can you clarify how it integrates with existing care pathways and standard treatments for depression?

CYB003 is designed as an adjunctive treatment for major depressive disorder (MDD), complementing existing therapies. It integrates seamlessly into psychiatric care by enhancing treatment efficacy while maintaining compatibility with standard antidepressant regimens. Notably, when we started our CYB003 Phase 2 adjunctive treatment trial, scientific thinking of the time suggested it was best to remove participants from any medications that could target the same receptor pathways. We were fortunate to choose—based on our own research—to pursue an adjunctive therapy. Our Phase 2 data, along with other recent third-party studies, show there is likely value in keeping patients on their existing therapy going into treatment.

The second Phase 3 trial, Embrace, is expected to begin in mid-2025. What distinguishes it from Approach, and what will it aim to prove or reinforce?

Embrace, the second Phase 3 trial for CYB003, will build on Approach by further validating CYB003’s efficacy and safety. Approach is a 220-person study with an active and a placebo arm. Embrace is a larger, 330-person study with active, placebo, and intermediate dose arms. The Embrace intermediate dose provides 8 mg of CYB003, while the active dose provides 16 mg.
The US FDA recognizes the unique challenges in designing studies for psychedelic therapies, including dose optimization and expectancy bias (where participants’ prior experiences or beliefs influence their response to treatment). An intermediate dose arm helps mitigate expectancy bias by introducing a treatment where participants may experience some psychedelic effects but not the full intensity of a high dose. This maintains blinding integrity and provides valuable insights into dose-response relationships.

How are you preparing for regulatory approval and reimbursement pathways, especially given the novel nature of psychedelic-based treatments?

Cybin is fortunate to have been granted Breakthrough Therapy designation by the US FDA for its CYB003 program. This designation enhances our opportunity to work collaboratively with the FDA as we navigate the regulatory process.
Because reimbursement will be a key driver of access, we are also working proactively with stakeholders across the care continuum—from payers to providers—to optimize delivery models. As data becomes available, Cybin will leverage health economics and outcomes research to support reimbursement strategy by demonstrating clinical value, cost-effectiveness, and real-world impact.

Do you believe real-world data from Osmind’s platform will play a role in accelerating adoption post-approval? If so, how?

Yes. Real-world data from Osmind’s platform will be instrumental in supporting physician confidence, payer decisions, and broader adoption. Demonstrating treatment effectiveness in clinical settings helps bridge the gap between clinical trial results and real-world outcomes, providing the evidence base needed for both reimbursement and physician uptake.

As more psychedelic-based companies enter the clinical stage, what do you think sets Cybin apart in terms of science, execution, or patient-centric strategy?

Our science is certainly unique. Rather than delivering naturally occurring compounds, we’ve focused on creating novel molecules and optimizing proprietary formulations that improve critical drug characteristics. This innovation enables better pharmacokinetics, greater consistency, and improved patient experience—all of which are central to our patient-first strategy and scalable model for integration into modern mental healthcare.

Looking ahead, what are the biggest hurdles to bringing psychedelic therapies into mainstream psychiatric care—and how is Cybin planning to overcome them?

Mainstreaming psychedelic therapies will require addressing regulatory complexity, educating healthcare providers, and engaging payers with robust data to support reimbursement. Cybin is tackling these challenges head-on with strategic partnerships, proactive payer engagement, and a strong regulatory strategy supported by the FDA’s Breakthrough Therapy designation. If approved, we believe CYB003 could become an accessible, scalable, and cost-effective solution within today’s psychiatric care models.