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Numinus Wellness Inc. (NUMIF) is a mental health care company dedicated to advancing traditional and innovative behavioral health treatments through safe, evidence-based psychedelic-assisted therapies. They aim to heal rather than manage symptoms of depression, anxiety, trauma, pain, and substance use. By leading the integration of psychedelic-assisted therapies into mainstream clinical practice, Numinus is pioneering a healthier society. Numinus helps individuals heal and be well by providing innovative mental health care and access to safe, evidence-based therapies.
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.
Numinus Wellness announced the results from its annual general meeting held on May 31, 2024. Approximately 15.68% of the company's common shares were represented at the meeting. Six nominees were elected as directors with significant majority votes: Payton Nyquvest (86.16%), Allen Morishita (76.45%), Larry Timlick (94.43%), Michael Tan (85.06%), Donna Wong (95.87%), and Donna Wilson (95.87%). All proposed resolutions, including setting the number of directors at six and appointing Davidson & Company LLP as auditors, were approved. Detailed voting results are available on SEDAR+.
Numinus Wellness has announced a strategic blueprint aimed at enhancing its presence in the U.S. and accelerating its path to profitability. The company plans to optimize costs and expand its network of wellness clinics and clinical research facilities. Key initiatives include a comprehensive membership program and a partnership with the Canadian Centre for Psychedelic Healing (Field Trip Health). This collaboration involves transitioning Numinus' Canadian therapists to Field Trip Health, closing clinics in Montreal, Toronto, and Vancouver, and leasing space for clinical trials at Field Trip Health's Vancouver clinic. The companies have also signed a 3-year training and marketing agreement to further their common interests. The plan emphasizes scalable growth, shareholder returns, and broader access to psychedelic-assisted therapies.
Numinus Wellness has announced its Cedar Clinical Research (CCR) site has been selected for Cybin's Phase 3 clinical trial of CYB003 for Major Depressive Disorder (MDD). The trial, set to begin enrollment mid-2024, follows promising Phase 2 results where 75% of participants achieved remission from depression symptoms. The U.S. FDA has granted breakthrough therapy designation for CYB003. The Murray, Utah location is among the 15 U.S. sites chosen for the study. Dr. Paul Thielking will lead the trial as Principal Investigator. This partnership aims to advance psychedelic-assisted therapy and address unmet needs in mental health care.
Numinus Wellness (TSX: NUMI, OTCQX: NUMIF), a mental health care company focused on psychedelic-assisted therapies, has received Health Canada approval for a new study. The trial will explore the feasibility of a group model for MDMA-assisted psychotherapy, aiming to determine the optimal number of therapists needed for group sessions. The study will involve trainee practitioners who will gain core competencies by observing seasoned therapists and experiencing MDMA in a therapeutic setting. This research aims to enhance the understanding of administering MDMA for severe mental disorders like PTSD.
Numinus Wellness Inc. announces a strategic plan to focus on U.S. operations for higher growth and profitability. The company is enhancing its wellness clinics and clinical research facilities, launching a membership program for healthcare professionals in psychedelic-assisted therapies, and collaborating with Field Trip Health. Numinus also entered into an agreement with Field Trip Health to transition Canadian clinic operations, aiming to optimize therapy and training expertise while maximizing shareholder returns.
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