Mr. Will Rascan reports

NOVA MENTIS ANNOUNCES PARTICIPANT SCREENING UNDERWAY IN CANADA'S FIRST PSILOCYBIN CLINICAL TRIAL FOR FRAGILE X SYNDROME

Nova Mentis Life Science Corp. has provided an update on its phase IIA clinical trial testing psilocybin for the treatment of fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).

The research team is continuing its recruitment efforts and has now begun prescreening a number of potential participants with an FXS diagnosis to determine if they are eligible to join the clinical trial. Through advertising efforts across Ontario, Canada, and connecting with ASD and FXS support groups, work is under way to create a registry of trial participants.

"A tremendous amount of groundwork has taken place since Nova received Health Canada approval to conduct a human trial testing the efficacy of psilocybin on adults diagnosed with fragile X. We are very eager to enroll our first participants in this groundbreaking study, which we anticipate will happen later in September," stated Will Rascan, Nova's president and chief executive officer.

The 28-day study will evaluate the safety and efficacy of Nova's proprietary microdose psilocybin formulation on adult patients diagnosed with FXS and is one of the first Health Canada approved studies allowing participants to take home psilocybin for dosing every other day. Nova has completed production of pharmaceutical-grade cGMP (current good manufacturing system) synthetic psilocybin 1.5-milligram microdose capsules that will be used in the study.

Nova and KGK Science have partnered to conduct the phase IIA clinical trial, which is being carried out at the KGK facility in London, Ont., Canada. This 10-person, open-label study will assess repetitive, oral low-dose psilocybin therapy for FXS. The company intends to confirm changes in behavioural symptoms with state-of-the-art diagnostic and therapeutic mRNA and serotonin biomarker technology, combined with machine learning artificial intelligence (AI).

The company anticipates treating the 10 participants in Q3 or Q4 2023 and having preliminary results ready early in 2024.

To express your interest in participating in this study, please complete this eligibility questionnaire.

If you have questions, e-mail participate@kgkscience.com or call 1-833-858-8359.

About Nova Mentis Life Science Corp.

Nova Mentis Life Science is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of fragile X syndrome (FXS).

Nova's goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.

We seek Safe Harbor.