NUMI Numinus Wellness Inc

• Study Results are widely regarded as the final step before MDMA-assisted therapy is reviewed by the FDA for wider patient access.
  
  
• Numinus continues to support greater access to these important therapies, through its growing psychedelic-assisted therapy practitioner training programs

VANCOUVER, BC, Sept. 19, 2023 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies congratulates the Multidisciplinary Association of Psychedelics Studies ("MAPS") on the results of their phase 3 results. These findings were published last week in the peer-reviewed medical journal, Nature Medicine.

As largely expected, the results of the confirmatory phase 3 study, named MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial indicated 71.2% of participants in the MDMA-AT group no longer met the criteria for PTSD after receiving three dosing sessions, together with therapy, delivered approximately one month apart – further underscoring the importance and potential effectiveness of MDMA for the treatment of PTSD.  Just as important, therapy alone the study showed substantial results, with 47.6% of the placebo group no longer meeting the PTSD criteria post-treatment after receiving therapy for approximately three months.

With its established clinic network, Numinus stands ready to offer MDMA-assisted therapy pending appropriate regulatory approvals. The company has already initiated a comprehensive practitioner training pathway to  train qualified professionals to meet the demand for MDMA-assisted therapy.

"This marks a milestone for both MAPS and the entire psychedelic-assisted therapy community," said Payton Nyquvest, Founder and CEO. "By further demonstrating the effectiveness of MDMA-assisted therapy for the treatment of PTSD, many in the industry view this as the final step before the treatment undergoes FDA review for approval and the promise of wider patient access."

Mr. Nyquvest continued: "At Numinus, we're well-positioned to welcome clients looking for relief from PTSD, and expect to be able to add MAPS's MDMA-assisted therapy protocol to our existing service offering within our clinic network following regulatory approval. We believe there is a significant number of people who can benefit from these important treatments. Moreover, for providers are eager to adopt this treatment modality to serve their clientele, Numinus offers those practitioners a pathway through its existing training program. With mental wellness clinics across North America  Numinus is taking a leading role in facilitating access to a growing list of psychedelic-assisted therapies."

This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of MDMA-assisted therapy ("MDMA-AT") compared to placebo, with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Participants were ethnoracially diverse, which is important because gender-diverse and transgender individuals, ethnoracial minorities, first responders, military personnel, veterans and victims of chronic sexual abuse have a disproportionately higher risk of developing PTSD due to disparities in trauma exposure. These diverse populations are historically underrepresented in clinical trials. Full text available at MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial | Nature Medicine.

To learn more about Numinus' practitioner training programs, please see: https://numinus.com/our-training-selection/

Numinus Wellness Inc. (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.

Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "seek", "anticipate", "believe", "plan", "estimate", "expect" and "intend" and statements that an event "may", "will", "should", "could" or "might" occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements, including approval of MDMA-assisted therapy for any indication or at all; restrictions that may be placed on use of MDMA by regulatory authorities; safety and efficacy of MDMA-assisted therapy; acceptance, uptake and commercialization of MDMA-assisted therapy;  the effect, if any, of having obtained certification on any particular trainee or such trainee's business or profile; and other risks that are set forth in our annual information form dated December 12, 2022 and available on SEDAR at www.sedar.com. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. Numinus does not undertake any obligation to update forward-looking statements even if circumstances or management's estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.

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SOURCE Numinus Wellness Inc.