Annual Impact Report

Message from the Executive Director

Dear Supporters and Collaborators,  

As we reflect on 2024, I am filled with gratitude for the strides we have made together in advancing Usona’s mission to revolutionize mental health through research and innovation. This year, our efforts have resonated across every area of focus—from clinical trials to educational outreach and the strengthening of our global collaborations. Each milestone brings us closer to providing safe, effective, and accessible treatments to those in need. 

Our shared accomplishments are driven by the unwavering dedication of our community. Thanks to your support, we have advanced to Phase 3 of our psilocybin study and laid the groundwork for Phase 2 of our 5-MeO-DMT program. Together, we have broadened the reach of our educational initiatives, engaging with leadership and faculty at the forefront of scaling for future delivery of care, and reinforced our commitment to the highest standards of safety, efficacy, and integrity. 

Looking ahead, the promise of our work continues to inspire and energize us. With your partnership, we are building on this momentum—pioneering new frontiers in psychedelic science and therapeutic care. Your belief in our mission helps to fuel the transformative potential of this journey, as we strive to create a future where mental health care is not just accessible for all but also contributes to the flourishing of humanity and our planet.    

Thank you for your continued support, your trust in our vision, and your role in this collective effort to create life-changing opportunities for healing and growth. Together, we are shaping a brighter, more compassionate future.

With deep gratitude,  

2024 Highlights

  • Initiated Phase 3 Study of Psilocybin for Major Depressive Disorder:
    Launched Phase 3 of our psilocybin study, uAspire (PSIL301), with expanded site activations across the U.S. and on-going engagement with the European Medicines Agency (EMA) to align with global regulatory standards, advancing progress toward regulatory submission. The study emphasizes collaboration with Veterans Affairs (VA) sites and specific initiatives focused on ensuring a diverse and representative participant population. 

  • Advanced the 5-MeO-DMT Program:
    Completed preparations for the Phase 2 efficacy study, including protocol development, Investigator’s Brochure (IB), and trial launch planned for mid-2025. 

  • Expanded the Investigational Drug Supply Program:
    Supported seven new research institutions and delivered to Singapore and Japan as new regulatory jurisdictions for this program.

  • Enhanced Education Programs:
    Hosted over 300 participants at ten educational events for immersive programs, workshops, and practitioner training, in partnership with leading educational institutions to support the understanding and preparation of leadership and practitioners for future delivery of care.

  • Strengthened Quality Assurance Capabilities:
    Enhanced the vendor audit system, refined the digital document control platform, and introduced specialized training modules to maintain accepted best practices in quality and compliance.

  • Broadened Global Outreach and Partnerships:
    Increased engagement with thought leaders and communities to foster support for psychedelic research and equitable access to emerging therapies. This included support of additional scholarships promoting diversity, cultural humility, and equitable access in psychedelic sciences.