Numinus Wellness Comments on FDA Decision on New Drug Application for MDMA-Assisted Therapy for PTSD

VANCOUVER, BC, Aug. 12, 2024 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a leader in mental health care specializing in innovative and evidence-based treatments, comments on the U.S. Food and Drug Administration's ("FDA") decision to not approve Lykos Therapeutics' new drug application for MDMA (midomafetamine capsules) used in combination with psychological intervention for individuals with post-traumatic stress disorder ("PTSD"). According to a news release issued by Lykos Therapeutics, the FDA has requested that an additional Phase 3 study be conducted to study the safety and efficacy of MDMA further.

"While this is a blow to all the incredibly positive and encouraging work that has been done to advance safe access to psychedelic therapy, which MAPS and Lykos have led the charge for, we remain unwavering and committed to doing all we can to make these important therapies available for all those suffering who need it most," said Payton Nyquvest, Numinus Founder and CEO. "We're confident that further study will continue to show the efficacy of MDMA, and with many psychedelic compounds at the late stages of research, the pipeline of treatments to address severe conditions remains strong."

"For Numinus, we will continue to execute on our previously announced plan to achieve profitability with our existing operations, which were and continue not to be dependent on the commercialization of new therapies," Mr. Nyquvest added.

Spravato^® (esketamine) and ketamine continue to be available to practitioners to treat mental health conditions, and Numinus Wellness clinics have delivered over 43,600 such treatments to patients. The clinics have built an optimized business model with best-in-class patient care, including a call center and expertise in reimbursed billing. The company is working to leverage its leadership into an offering available to mental health professionals across the U.S. Through Cedar Clinical Research, Numinus has conducted clinical research involving four psychedelic medicines administered through different modalities involving over 50 subjects over the past 2.5 years. At the same time, its comprehensive practitioner training program prepares the Numinus team and trainees to treat patients across multiple medications and modalities, including ketamine and MDMA.

"The FDA decision demonstrates the high level of scrutiny that psychedelic compounds receive and the continuing requirement for comprehensive, rigorous research as some of these investigational products move through late-stage clinical trials," said Dr. Paul Theilking, Numinus Chief Science and Medical Officer. "We're proud of our clinical trials work with major psychedelic drug developers and will continue to be a committed research partner as more compounds are advanced."

Letter of intent with MedBright AI
Numinus also announces that it has terminated the letter of intent previously announced on June 20, 2024, to acquire MedBright AI Investments Inc.

About Numinus

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 of 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, and Instagram.

Forward-looking statements

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 the results of further research into MDMA, if any, the FDA and other regulators' decisions in respect of MDMA and other psychedelic medications, restrictions that may be placed on the use of psychedelic compounds by regulatory authorities; safety and efficacy of psychedelic-assisted therapy; acceptance, uptake and commercialization of psychedelic-assisted therapy, if any; dependence on obtaining regulatory approvals, 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.

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SOURCE Numinus Wellness Inc.

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