Mr. Payton Nyquvest reports

NUMINUS WELLNESS INC. CONGRATULATES LYKOS THERAPEUTICS ON FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR MDMA-ASSISTED THERAPY FOR PTSD

Numinus Wellness Inc. has congratulated the Multidisciplinary Association for Psychedelic Studies (MAPS) for incubating the research that led to the first new drug application to the U.S. Food and Drug Administration (FDA), submitted by Lykos Therapeutics (formerly MAPS Public Benefit Corp.), on the acceptance of its new drug application to the U.S. FDA for MDMA (3,4-methylenedioxymethamphetamine) (midomafetamine capsules) used in combination with psychological intervention for individuals with PTSD (posttraumatic stress disorder). The FDA has granted the application a priority review, which mandates the authority to take action within six months. A Prescription Drug User Fee Act (PDUFA) target action date of Aug. 11, 2024, has been set.

"This is an exciting development and, if approved, would be the first MDMA-assisted therapy available in the U.S. for the millions of Americans struggling with PTSD," said Payton Nyquvest, founder and chief executive officer of Numinus. "Getting here was the result of over 20 years of clinical research that was begun by MAPS, the non-profit organization that founded Lykos, and we are proud to have collaborated with them through participation in the clinical research at our Cedar clinical research facilities. There needs to be a dedicated focus on building the infrastructure to be able to administer MDMA-AT if the FDA approves. Numinus has been at the forefront of this effort through training and offering services that are sustainable and scalable while ensuring the highest-quality outcomes for clients. We look forward to actively supporting these efforts in the immediate future to continue to help meet the needs of over the 14 million people diagnosed with PTSD in the United States."

"Psychotherapy is a component of the proposed treatment, and, with our clinic network, practitioner training program and protocols we have developed in conjunction with our clinical research programs, we would like to be able to offer MDMA-assisted therapy as soon as regulators allow," added Michael Tan, president and chief operating officer of Numinus. "It's important to note that, in our Canadian clinics, we are currently treating patients with MDMA-assisted therapy on a limited scope under the current regulatory exceptions. The combination of our experience and infrastructure positions us to be a leading provider of psychedelic-assisted therapy."

Strategic adviser

Numinus further proudly announced that Dr. Rick Doblin, PhD, the founder and president of MAPS, is independently joining as an unpaid, non-exclusive strategic adviser of Numinus to help guide enhancements to and foster empirical validation of Numinus treatment modalities and training assets related to MDMA-assisted therapy. Numinus and Dr. Doblin share a common goal of ensuring broad access to treatment, focusing on inclusivity and making quality care accessible to all those seeking transformative therapeutic treatments. This appointment fortifies the company's commitment to training programs that support the efficacy and safety of MDMA-assisted therapy for PTSD.

"We are honoured to welcome Dr. Rick Doblin to Numinus as an unpaid strategic adviser. His wealth of experience and commitment to the advancement of psychedelic-assisted therapies align seamlessly with Numinus's mission to provide transformative and accessible care to individuals worldwide," said Mr. Nyquvest.

"My hope in becoming an unpaid, non-exclusive Numinus strategic adviser is to accelerate our collective mission to expand access to psychedelic-assisted therapies. I look forward to contributing to the evolution of MDMA-related training and care programs, ultimately advancing the standard of care in this transformative field," expressed Dr. Doblin.

Bought deal market update

Numinus has provided an update regarding the previously announced bought deal for aggregate gross proceeds to the company of $6-million. While MAPS remains a significant collaborator with Numinus in experiential training and other mission-critical areas of the company's business, including the addition of Dr. Doblin as a strategic adviser to Numinus, MAPS is not able to participate in the offering. Integrated V.C. is also not participating in the offering. The offering is expected to close on or about Feb. 16, 2024.

About Numinus Wellness Inc.

Numinus 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 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, the company is leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

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