Awakn Life Sciences Provides a Business and Corporate Update

Phase III Trial to Cost approximately CA$3.75 million with Awakn’s contribution expected to be approximately CA$1.25 million, Marks First Psychedelic Phase III Trial Ever to Receive Government Funding

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced today that the National Institute for Health and Care Research (NIHR), a UK government agency, has approved grant funding for 66% of the costs of Awakn’s Phase III clinical trial exploring the use of ketamine-assisted therapy for the treatment of AUD. The trial is currently forecast to cost approximately CA$3.75 million in total, with Awakn funding approximately CA$1.25 million of that.

The funding will support Awakn’s lead clinical development program, Project Kestrel, which aims to deliver clear Intellectual Property (IP) and marketing authorization/regulatory approval for ketamine-assisted therapy to treat AUD in the UK and the US.

The Phase III trial is expected be the largest ketamine-assisted therapy clinical trial to date and the only Phase III psychedelic clinical trial to receive government funding. Awakn will partner with the University of Exeter (UoE) and the UK’s National Health Service (NHS) to deliver the landmark trial. It is planned to be conducted across seven sites in the UK, with the treatment being administered within the NHS infrastructure. The trial is currently designed to include 280 patients and they will be followed up over the course of six to 12 months. The trial will also pilot bespoke ongoing peer support groups post-treatment.

The trial, which is targeted to be a pivotal trial, follows on from the ground-breaking results of Awakn’s Phase II a/b trial announced in January 2022, which resulted in AUD participants experiencing on average 86% abstinence at six-months post treatment versus 2% pre-trial. The Phase III trial will focus on establishing further definitive evidence of the efficacy of ketamine-assisted therapy for the treatment of AUD and to move towards the novel treatment being licensed for this indication. Awakn, UoE and the NHS will be working with the UK Department of Health and Social Care and other key stakeholders throughout the trial to facilitate the swift uptake within the NHS post trial, should the results be positive.

The Phase III trial will be led by Professor Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy and Professor of Psychopharmacology at the University of Exeter.

Professor Morgan commented: “It is a true honour to lead the team that will deliver this research. The trial represents a huge leap forward in the treatment of AUD. I know this will be a great source of hope for the patients we work with, their families and friends. The financial commitment by the UK Government emphasises the promise of this treatment and the scientific…