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Numinus walks back claims made in press releases

Numinus blamed its public relations firm for embellishing claims in the press releases.
The post Numinus walks back claims made in press releases appeared…



Nearly two months after sending out press releases that crowed about the company’s advancements, Numinus Wellness Inc. (OTC: NUMIF) walked back those claims and blamed its public relations firm for the mistake.

Numinus released a statement after the markets closed on Friday, June 7, saying, “The releases were inadvertently disseminated by a public relations firm contracted by the company and represent information that was previously disseminated by the company. The company apologizes for any confusion.”

First error

The first error noted by Numinus related to a partnership between Numinus and Cybin (NYSE American: CYBN) (Cboe CA: CYBN) announced in a press release dated April 17 titled “Numinus and Cybin Embark on a Groundbreaking Journey: Pioneering Phase 3 Trials for Major Depressive Disorder.”

Cybin did indeed engage Cedar Clinical Research to provide clinical research services, and its Murray, Utah, location will be one of 15 U.S. research sites for Cybin’s Phase 3 multinational clinical trial of CYB003. However, the release claimed that Numinus’ Chief Science Officer Dr. Paul Thielking would be the principal investigator. In reality, Thielking is the site principal investigator for the CCR site, not the trial’s principal investigator.

Numinus made the claim again in a May 30 press release, which said, “The Phase 3 trial, set to begin enrollment in mid-2024, will delve deeper into CYB003’s safety and efficacy. Under the leadership of Dr. Paul Thielking, Numinus’s Chief Science Officer and the trial’s Principal Investigator, the study aims to further explore CYB003’s potential to address a critical unmet need in mental health care.”

Numinus clarified that it has no direct or indirect ownership interest in CYB003 and that any CYB003 research is the property of its sponsor, Cybin.

Second Error

Numinus also got ahead of itself by telling investors that it planned to launch a Numinus Network community pilot, which will be made available to its current therapists and other practitioners, alumni of its training program, and former therapists and other practitioners, including those who join the Canadian Centre for Psychedelic Healing when it launches. That press release, dated April 15, was titled “Numinus Wellness Provides Corporate Update.”

Numinus now says that it and CCPH have only agreed in principle to collaborate on the development of training content for the Numinus learning platform. However, Numinus insists that definitive terms of this collaboration will be determined in a subsequent agreement.

The new press release went on to explain that the planned community pilot program and Numinus Network do not provide access to medical infrastructure for the therapeutic administration of ketamine and other psychedelic drugs within Canada’s regulatory framework, which may be through a program such as CCPH’s co-op program.

It also added that there can be no assurance that a subscription-based model of the Numinus Network will be rolled out in Canada or the U.S.

MDMA pivot

In April, Numinus told investors it was going to ease away from the Canadian market and instead focus on the U.S. market and in particular on the drug MDMA. Numinus had high hopes that the FDA would give a positive nod to Lykos MDMA drug; instead, the FDA Advisory panel voted against the drug.

“While the decision of the (Psychopharmacologic Drugs Advisory Committee) 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,” Payton Nyquvest, Numinus founder and CEO, said about the decision.

“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,” he added.

The post Numinus walks back claims made in press releases appeared first on Green Market Report.

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