Numinus Wellness Remarks on FDA Meeting for MDMA-Assisted PTSD Therapy

In an announcement made on June 7, 2024, Numinus Wellness Inc. ("Numinus" or the "Company"), a pioneer in mental health care with a focus on innovative and evidence-based treatments, commented on the recent decision of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"). The independent committee reviewed a new drug application submitted by Lykos Therapeutics for MDMA (midomafetamine capsules) to be used alongside psychological intervention for patients suffering from post-traumatic stress disorder ("PTSD").

The PDAC ultimately decided against recommending the approval of MDMA for treating PTSD. Out of 11 committee members, only two acknowledged that the current data demonstrated the effectiveness of MDMA for PTSD patients. Additionally, just one committee member believed that the benefits of MDMA outweighed its risks based on the available data. The FDA is expected to make a final decision regarding Lykos' application by August this year, although it is not obligated to follow PDAC's guidance. Historically, the FDA has approved treatments about 97% of the time when PDAC recommended approval and 33% of the time when PDAC recommended against it.

Payton Nyquvest, Founder and CEO of Numinus, expressed understanding and optimism despite the PDAC's decision. He acknowledged that while the decision was disappointing for many in the mental health community, it was made in the best interests of patient safety and quality care. Nyquvest remains hopeful that, following the addressing of PDAC's specific concerns, MDMA-assisted therapy will eventually become available, pointing out the promising results from Lykos' Phase 3 trials.

Furthermore, Nyquvest highlighted the robust pipeline for potential mental health treatments, noting that there are three psychedelic compounds currently in Phase 3 clinical trials and another 34 in Phase 2 trials. Numinus is actively collaborating with developers of these emerging treatments, contributing to the identification, safe administration, and healing of individuals. Nyquvest emphasized that Numinus would continue to optimize its clinic network to increase efficiency, build visibility, and provide excellent care. The company remains committed to achieving profitability with its existing operations, independent of the commercialization of new therapies such as MDMA.

While awaiting the approval of new medications for mental health conditions, practitioners still have access to treatments like Spravato® (esketamine) and ketamine. Numinus' U.S. clinic network has already administered over 43,600 such treatments. Additionally, Numinus clinics in Canada have treated several patients with MDMA and psilocybin under Health Canada's Special Access Program. Through Cedar Clinical Research, Numinus has conducted clinical research involving four psychedelic medicines over the past 2.5 years, involving 50 subjects in various modalities.

Numinus also runs a comprehensive practitioner training program, preparing its team and trainees to treat patients with a range of medications, including ketamine and MDMA. The company is at the forefront of integrating psychedelic-assisted therapies into mainstream clinical practice, focusing on healing rather than merely managing symptoms of conditions such as depression, anxiety, trauma, pain, and substance use.

Numinus Wellness Inc. is dedicated to helping people heal through innovative mental health care and safe, evidence-based psychedelic-assisted therapies. The company is committed to transforming mental health treatment, and its efforts are setting the foundation for a healthier society.