Numinus Wellness Inc. Congratulates Lykos Therapeutics on FDA Acceptance of New Drug Application for MDMA-Assisted Therapy for PTSD
Numinus Welcomes Psychedelic Pioneer, Rick Doblin, Ph.D., as Strategic Adviser
Updates Market on Closing of Previously Announced Bought Deal
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VANCOUVER, BC, Feb. 14, 2024 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI), a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, congratulates the Multidisciplinary Association for Psychedelic Studies ("MAPS") for incubating the research that led to the first new drug application to the USFDA, submitted by Lykos Therapeutics (formerly MAPS Public Benefit Corporation) on the acceptance of its new drug application to the U.S. Food and Drug Administration ("FDA") for MDMA (midomafetamine capsules) used in combination with psychological intervention for individuals with PTSD. 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 August 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, Numinus Founder and CEO. "Getting here was the result of over 20 years of clinical research that was begun by MAPS, the nonprofit 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 COO 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."
Numinus further proudly announced that Rick Doblin, Ph.D., 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 which support the efficacy and safety of MDMA-assisted therapy for PTSD.
"We are honored 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' mission to provide transformative and accessible care to individuals worldwide," said Payton Nyquvest.
"My hope in becoming an unpaid, non-exclusive Numinus Strategic Advisor 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. Rick Doblin.
Numinus also today provided an update regarding the previously announced bought deal for aggregate gross proceeds to the Company of $6,000,000 (the "Offering"). While MAPS remains a significant collaborator with Numinus in experiential training and other mission-critical areas of our business, including the addition of Rick Doblin as a strategic advisor 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 February 16, 2024.
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 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 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 effectiveness of any advice provided by a strategic advisor or future collaborations related thereto, if any; dependence on obtaining regulatory approvals and the possibility that the Offering does not close when expected, or at all, because conditions to closing are not satisfied on a timely basis, or because the underwriters exercise their termination rights; ability of Numinus to maintain or increase earnings; ability of Numinus to achieve or maintain profitability; the Company's need for additional financing and the effects of financial market conditions and other factors on the availability of capital; and other risks that are set forth in our annual information form dated November 29, 2023 and available on SEDAR at www.sedarplus.ca. 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.
SOURCE Numinus Wellness Inc.
Investor Contact: Craig MacPhail, [email protected]
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