Cedar Clinical Research selected as clinical research site for Cybin';s Phase 3 Study of CYB003

Rhea-AI Summary

Numinus Wellness Inc. announces Cedar Clinical Research as a site for Cybin's Phase 3 trial of CYB003 for Major Depressive Disorder. In Phase 2, 75% of patients achieved remission from depression symptoms. The FDA granted CYB003 breakthrough therapy designation. Phase 3 enrollment starts mid-2024.

Positive

• Cedar Clinical Research selected as a site for Cybin's Phase 3 trial of CYB003 for Major Depressive Disorder.
• 75% of patients achieved remission from depression symptoms in Phase 2 of the trial.
• FDA granted CYB003 breakthrough therapy designation.
• Phase 3 trial enrollment to begin mid-2024.
• Dr. Paul Thielking to be the Principal Investigator at CCR's Murray, Utah location.

Negative

• None.

VANCOUVER, BC, April 17, 2024 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based novel therapies,  is proud to announce that its research site, Cedar Clinical Research ("CCR"), has been chosen as one of multiple sites for Cybin's Phase 3 pivotal, multinational clinical trial of CYB003 for the adjunctive treatment of Major Depressive Disorder ("MDD").

In its recently completed Phase 2 trial in participants with moderate to severe major depressive disorder, Cybin reported that at four months after dosing, 75% of patients receiving two 16mg doses of CYB003 achieved remission from depression symptoms. With the Phase 2 trial data, the U.S. Food and Drug Administration ("FDA") granted CYB003 breakthrough therapy designation, potentially shortening the drug development timeline.

The Phase 3 trial for CYB003 is planned to commence enrollment mid-2024 and focus on its safety and efficacy. CCR's Murray, Utah, location will be one of the 15 U.S. sites. Dr. Paul Thielking, Chief Science Officer of Numinus, will be the Principal Investigator.

"The Phase 2 results from the CYB003 trials were impressive and demonstrated the potential for treating a serious condition that affects over 20 million Americans," said Dr. Thielking. "We look forward to working with Cybin on the Phase 3 trials to add to the knowledge of CYB003's efficacy and address an important unmet need in patient care."

"With many drug candidates advancing to later stages of clinical trials, 2024 is turning out to be a critical year for psychedelic-assisted therapy," added Payton Nyquvest, Numinus Founder and CEO. "We are proud of our role in working with drug developers to facilitate the important research that will help move these candidates to FDA approval and, ultimately, patient care."

To learn more about enrolling in the CYB003 Phase 3 Trial, please visit this link.

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 challenges and uncertainties inherent in product and/or treatment development and in the psychedelics industry generally, availably of suitable subjects, the uncertainties of clinical success, the possibility of adverse events, and the timeline for the availability of the treatment under investigation; the laws, challenges and risks involved in the production of a psychedelics drug; and the uncertainty of the level of demand, uptake and/or insurance coverage for treatment other risks that are set forth in 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 is the Phase 3 trial about for NUMIF?

The Phase 3 trial is for CYB003, a treatment for Major Depressive Disorder.

What percentage of patients achieved remission in the Phase 2 trial for CYB003?

75% of patients receiving two 16mg doses of CYB003 achieved remission from depression symptoms.

When will Phase 3 trial enrollment start for CYB003?

Phase 3 trial enrollment for CYB003 is planned to commence mid-2024.

Who will be the Principal Investigator at CCR's Murray, Utah location for the Phase 3 trial?

Dr. Paul Thielking, Chief Science Officer of Numinus, will be the Principal Investigator.

What designation did the FDA grant to CYB003 based on Phase 2 trial data?

The FDA granted CYB003 breakthrough therapy designation based on Phase 2 trial data.