Numinus to Host Extension of MAPS-Sponsored MDMA-Assisted Therapy for PTSD Trials

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Numinus Wellness has announced the management of two new clinics in Montreal and Vancouver for hosting the MAPS PBC study on MDMA-assisted therapy for PTSD. This study, titled MAPPUSX, aims to evaluate the safety and efficacy of MDMA therapy. Numinus’s clinics comply with Health Canada regulations and will provide necessary therapy during the trial. Previous studies showed promising results, with 88% of participants experiencing symptom relief. The initiative is part of expanding treatment options for PTSD and enhancing collaboration with MAPS.

Numinus will manage two new clinics in Montreal and Vancouver to host trials.

VANCOUVER, BC, Nov. 10, 2021 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV: NUMI), a leader in psychedelics-focused mental healthcare, is pleased to announce that it has secured two new Canadian psychedelic clinics that will host the Canadian sites of the MAPS Public Benefit Corporation (MAPS PBC) study "A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX)."

In addition to managing the two new clinics, which are fully compliant with Health Canada regulations and ready to provide MDMA-assisted therapy as part of the trial, Numinus will host the Montreal and Vancouver sites in MAPPUSX, which will continue to study the safety and efficacy of MDMA in treating severe PTSD, under the leadership of MAPS PBC as study organizer. Numinus will also financially support costs relating to therapists who deliver the therapeutic intervention in Numinus clinics during the trial.

"We are honored to host the Canadian sites of the MAPPUSX trial as we continue to examine the important findings around MDMA-assisted therapy for PTSD," said Dr. Joe Flanders, VP, Psychology, Numinus and therapist for the Montreal site of the trial. "Our clinical and research teams are well positioned to implement MAPS' research and, ultimately, to work with MAPS on the translation of research findings into mainstream clinical practice. We are excited about this study in both BC and Quebec and look forward to how the MAPPUSX study supports expanded collaboration in the future."

To date, 25 Numinus-affiliated therapists have gone through MAPS' training program for delivery of MDMA-assisted therapy and a number of these therapists will have roles in the trial. The trial will be open to eligible participants who were previously enrolled in the placebo arm of the parent study (MAPP1) or who were not able to receive treatment due to COVID-19 restrictions.

"We are happy to work with a trusted ally to quickly complete the extension trial at the Canadian sites" said Rick Doblin, Ph.D. the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS).  "As we get closer to our goal of making MDMA-assisted therapy a reality, it is critical that we work with clinics who will advance making this treatment widely accessible in real-world settings."

To accomplish this next step in the MAPPUSX study, Numinus has assumed the leases of two new clinics, the Vancouver and Montreal psychedelic-assisted psychotherapy clinics that were previously used to conduct MAPS PBC's earlier study "A multi-site phase 3 study of MDMA-assisted psychotherapy for PTSD (MAPP1)." In that trial, 88% of participants experienced a clinically meaningful reduction in symptoms and 67% no longer qualified for a PTSD diagnosis. The highly statistically significant results and excellent safety record suggest MDMA-assisted therapy will be an effective treatment for severe, chronic PTSD

Payton Nyquvest, CEO, Numinus, added, "We are thrilled that our two new locations, which are purpose-developed for psychedelic-assisted therapy, regulatorily compliant and leading in industry standards, can be used to help advance this crucial work on psychedelic medicine. We look forward to deepening our collaboration with MAPS while expanding the resources and solutions available to those suffering from PTSD."

Securing the Canadian sites will further allow Numinus to expand its clinical activities in Quebec and BC, including its ketamine-assisted psychotherapy program, which is available in both provinces.

NOTE  
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by Health Canada or the U.S. Food and Drug Administration (FDA), does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.

About Numinus
Numinus Wellness (TSXV: 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.

About MAPS
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since its founding, MAPS has raised over $130 million for psychedelic and marijuana research and education and has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator. Learn more at maps.org 

ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization. Learn more at www.mapspublicbenefit.org

Forward-looking statements
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are "forward-looking statements". Forward-looking statements can be identified by the use of words such as "expects", "does not expect", "is expected", "intends", "anticipates", "does not anticipate", "believes" or variations of these words, expressions or statements, that certain actions, events or results "may", "could", "would", "might" or "will be" taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company's facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company's limited operating and profitability track record; dependence on management; the Company's need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company's efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws. 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

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SOURCE Numinus Wellness Inc.

FAQ

What is the purpose of the MAPPUSX study hosted by Numinus?

The MAPPUSX study aims to evaluate the safety and efficacy of MDMA-assisted psychotherapy for treating PTSD at Numinus clinics in Montreal and Vancouver.

When was the announcement about the new clinics made?

The announcement was made on November 10, 2021.

Which locations have new clinics for the MAPPUSX study?

The new clinics are located in Montreal and Vancouver.

What previous study's participants are eligible for the MAPPUSX trial?

Eligible participants are those who were previously enrolled in the placebo arm of the parent study (MAPP1) or who could not receive treatment due to COVID-19 restrictions.

What significant results did the earlier MAPP1 study show?

The MAPP1 study indicated that 88% of participants experienced a meaningful reduction in PTSD symptoms, and 67% no longer qualified for a PTSD diagnosis.