Numinus Wellness Comments on FDA Advisory Committee Meeting on Clinical Trials of MDMA-Assisted Therapy for PTSD

Vancouver, British Columbia, June 7, 2024 /PRNewswire/ — Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI) (OTCQX: NUMIF), a mental health care leader specializing in innovative, evidence-based treatments, today announced that it has announced June 4, 2024 At a meeting of the U.S. Food and Drug Administration’s (FDA) Psychopharmacological Drugs Advisory Committee (PDAC), an independent committee reviewed Lykos Therapeutics’ new drug application for MDMA (midomaphetamine capsules) used in combination with psychological interventions for patients with post-traumatic stress disorder (PTSD). The PDAC voted against recommending approval of MDMA for PTSD. Two of the eleven members determined that the available data indicate the effectiveness of MDMA for PTSD patients, and one committee member determined that based on the available data, the benefits of MDMA in treating patients with PTSD outweigh the risks. The FDA is expected to decide on Lykos’ new drug application this August and will not be bound by the PDAC’s guidance. Advisory committees, like the PDAC, make non-binding recommendations to the FDA. Historically, between 2010 and 2021, the FDA approved the subject treatment in 97% of cases where the committee recommended approval and approved the subject treatment in 33% of cases where the committee recommended against approval.¹ There can be no assurance regarding the FDA’s decision on Lykos’ MDMA new drug application.

Payton Nikvestfounder and CEO of Numinus, commented on the decision: “While PDAC’s decision was not the desired outcome for many in the mental health community, we understand that PDAC was doing what was best for patient safety and quality care, given the dire need for effective treatment for the millions of people affected by PTSD. Based on the positive results of Lykos’ Phase 3 trial focused on adult patients, we are optimistic that MDMA-assisted therapy will become available once PDAC’s specific concerns are resolved.”

“In addition, three psychedelic compounds are in Phase 3 clinical trials, and a further 34 compounds are in Phase 2 clinical trials.² “At this time, the pipeline of potential mental health treatments remains strong. We are actively working to develop several of these novel therapies to contribute to patient identification, safe administration, and ultimately a cure. Numinus will continue to optimize its clinic network with the aim of improving efficiencies, raising awareness, and providing superior care. Numinus will continue to execute on its previously announced plan to achieve profitability in its existing businesses that are not dependent on the commercialization of novel therapies such as MDMA.”

While awaiting approval of new drugs to treat psychiatric disorders, Spravato^® Esketamine and ketamine remain available to physicians. The Numinus U.S. Clinic network has provided such treatment to more than 43,600 patients. With the support of Health Canada’s Special Access Program, Numinus Clinics have treated several patients using MDMA and psilocybin. CanadaThrough Cedar Clinical Research, Numinus has been conducting clinical studies over the past two and a half years with 50 subjects across four psychedelic drugs administered in a variety of ways. At the same time, our comprehensive physician training program prepares the Numinus team and trainees to treat patients with multiple drugs and methods, including ketamine and MDMA.

About Numinus

Numinus Wellness Inc. (TSX: NUMI) helps people heal and get well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic drug therapy. The Numinus model, which includes psychedelic drug research and clinic care, is at the forefront of change to heal, rather than manage, the symptoms of depression, anxiety, trauma, pain and substance use. At Numinus, we are integrating psychedelic drug therapy into mainstream clinical practice, building the foundation for a healthier society.

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Forward-Looking Statements

Statements and other information contained in this press release concerning anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by words such as “seeks,” “anticipates,” “believes,” “plans,” “estimates,” “expects,” “intends,” and statements that events “may,” “should,” “might” or “might occur,” or other similar expressions. Forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those contained in the forward-looking statements, including the results of further research on MDMA (if any), decisions of the FDA and other regulatory agencies regarding MDMA and other hallucinogens, restrictions that regulatory agencies may impose on the use of hallucinogen compounds, the safety and effectiveness of hallucinogen-assisted therapies, the acceptance, adoption and commercialization of hallucinogen-assisted therapies, the effectiveness of advice provided by or future collaborations related thereto (if any), dependence on obtaining regulatory approvals, and other risks described in the Company’s Annual Information Form. November 29, 2023 Available on SEDAR Click here for details. Forward-looking statements are based on management’s expectations and opinions as of the date the statements are made. Numinus undertakes no obligation to update forward-looking statements if circumstances or management’s expectations or opinions should change, except as required by applicable law. Investors should not place undue reliance on forward-looking statements.

SOURCE Numinus Wellness Inc.