Mr. Michael Frank reports

REVIVE THERAPEUTICS PROVIDES UPDATE ON PSILOCYBIN CLINICAL STUDY FOR METHAMPHETAMINE USE DISORDER

Revive Therapeutics Ltd. has provided an update on the company's clinical study (NCT05322954) evaluating the safety and feasibility of oral psilocybin as a potential treatment for methamphetamine use disorder conducted under an investigator-initiated IND (investigational new drug) at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy.

The study has enrolled nearly 50 per cent of its intended study sample, with initial efficacy being encouraging. The clinical data generated from the study may provide proprietary and valuable information on the safety, efficacy and dosing of oral psilocybin to support a potential pivotal clinical study and commercial initiatives in countries, such as Australia, where psilocybin can be available to licensed psychiatrists to prescribe for certain conditions. In addition, the company will have exclusive access to key intellectual property from this study to support commercial and development initiatives, including future clinical studies for its proposed novel delivery of psilocybin by a proprietary microneedle patch under its research collaboration agreement with Pharmather Holdings Ltd. for neuropsychiatric disorders.

Methamphetamine use disorder is a chronic relapsing condition associated with substantial mental, physical and social harms and increasing rates of mortality. Contingency management and psychotherapy interventions are the mainstays of treatment but are modestly effective with high relapse rates, while pharmacological treatments have shown little to no efficacy. At present, there are no approved medications to treat methamphetamine use disorder. Psilocybin-assisted psychotherapy is emerging as a promising treatment for a range of difficult-to-treat conditions, including substance use disorders; however, no studies have yet been published looking at psilocybin-assisted psychotherapy in the treatment of methamphetamine use disorder.

About Revive Therapeutics Ltd.

Revive Therapeutics is a life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures and rare disorders. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the Food and Drug Administration, such as emergency use authorization, orphan drug, fast-track and breakthrough therapy designations. Currently, the company is exploring the use of bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of psilocybin-based therapeutics through various programs.

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