Numinus Wellness Comments on FDA Advisory Committee Meeting for Investigational MDMA-Assisted Therapy for PTSD

Rhea-AI Summary

On June 7, 2024, Numinus Wellness commented on the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) meeting on June 4, 2024, which reviewed Lykos Therapeutics' new drug application for MDMA-assisted therapy for PTSD. The PDAC voted against recommending approval, with 2 of 11 members supporting MDMA's effectiveness and 1 member acknowledging its benefits outweighing risks. The FDA is expected to decide in August 2024, with historical data showing a 33% approval rate for drugs not recommended by PDAC. Numinus remains optimistic and continues to focus on other clinical treatments like Spravato and ketamine, aiming to achieve profitability with current operations.

Positive

• Numinus focuses on innovative mental health treatments.
• Numinus' US clinic network has delivered over 43,600 treatments.
• Positive results from Lykos' Phase 3 MDMA trial show potential.
• Numinus has a strong pipeline with three psychedelic compounds in Phase 3 trials and 34 in Phase 2.
• Numinus clinics have treated several patients with MDMA and psilocybin in Canada.
• Cedar Clinical Research has conducted research with four psychedelic medicines over 2.5 years.
• Numinus has a comprehensive practitioner training program for multiple medications.

Negative

• PDAC voted against recommending approval of MDMA for PTSD.
• Only 2 of 11 committee members supported MDMA's effectiveness.
• FDA approval is uncertain with historical approval at 33% for non-recommended drugs.
• Potential delays in MDMA-assisted therapy availability due to PDAC's decision.

VANCOUVER, BC, June 7, 2024 /PRNewswire/ - 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 results of June 4, 2024 meeting of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"). The independent committee reviewed Lykos Therapeutics' new drug application for MDMA (midomafetamine capsules) used in combination with psychological intervention for individuals with post-traumatic stress disorder ("PTSD"). The PDAC voted against recommending approval of MDMA for PTSD in a majority decision where 2 of 11 found that the available data demonstrates MDMA's effectiveness in PTSD patients, and one committee member found that the benefits of MDMA outweigh its risks for treating PTSD patients based on available data. The FDA is expected to decide on Lykos' new drug application in August this year and is not bound by the PDAC's guidance.  Advisory committees, like PDAC, make non-binding recommendations to the FDA.  Historically, between 2010 and 2021, the FDA approved subject treatments in 97% of cases where the committee recommended approval and in 33% of cases where the committee recommended against approval.¹  There can be no assurance as to the FDA's decision with respect to Lykos' MDMA new drug application.

Payton Nyquvest, Numinus Founder and CEO, commented on the decision: "While the decision of the PDAC was not the preferred outcome for many in the mental health care community, considering the dire need for an effective treatment for the millions impacted by PTSD, we understand the PDAC was acting in the best interests of patient safety and quality care. Based on the positive results from Lykos' Phase 3 trial, which focused on adult patients, we are optimistic that once the PDAC's specific concerns are addressed, MDMA-assisted therapy will be made available."

"Moreover, with three psychedelic compounds in the Phase 3 clinical trial stage and a further 34 at the Phase 2² stage, the pipeline of potential mental health treatments remains strong. We are active with the developers of several of these emerging treatments and are contributing to the identification, safe administration and, ultimately, healing of individuals. For Numinus, we will continue optimizing our clinic network to increase efficiencies, build visibility, and provide excellent care.  Numinus continues to execute its previously announced plan to achieve profitability with our existing operations, which were and continue not to be dependent on commercialization of new therapies such as MDMA."

Pending the approval of new medications for the treatment of mental health conditions, Spravato^® (esketamine), and ketamine continue to be available to practitioners. The Numinus US clinic network has delivered over 43,600 such treatments to patients. Through the auspices of Health Canada's Special Access Program, Numinus clinics have also treated several patients with MDMA and psilocybin in Canada. Through Cedar Clinical Research, Numinus has conducted clinical research involving four psychedelic medicines administered through different modalities involving 50 subjects over the past 2.5 years. At the same time, our comprehensive practitioner training program prepares the Numinus team and trainees to treat patients across multiple medications and modalities, including ketamine and MDMA.

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1 Daval  CJR, Teng  TW, Russo  M, Kesselheim  AS.  Association of advisory committee votes with US Food and Drug Administration decision-making on prescription drugs, 2010-2021. JAMA Health Forum. 2023;4(7):e231718. Abstract available at https://jamanetwork.com/journals/jama-health-forum/fullarticle/2807050

2 Psychedelic Alpha, "Psychedelics Drug Development Tracker"

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 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, 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 use of psychedelic compounds by regulatory authorities; safety and efficacy of psychedelic-assisted therapy; acceptance, uptake and commercialization of psychedelic-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 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.

FAQ

What was the outcome of the PDAC meeting on June 4, 2024, for MDMA-assisted therapy?

The PDAC voted against recommending approval of MDMA for PTSD.

How did the PDAC vote on MDMA's effectiveness for PTSD?

2 of 11 committee members supported MDMA's effectiveness, and 1 acknowledged its benefits outweighing risks.

When is the FDA expected to decide on the MDMA new drug application?

The FDA is expected to make a decision in August 2024.

What is the historical approval rate for drugs not recommended by PDAC?

The historical approval rate for such drugs is 33%.

What other treatments does Numinus currently offer?

Numinus currently offers treatments like Spravato (esketamine) and ketamine.

How many treatments has the Numinus US clinic network delivered?

The Numinus US clinic network has delivered over 43,600 treatments.

What is Numinus' strategy following the PDAC decision?

Numinus is optimizing its clinic network and focusing on profitability with existing operations.