After Seeing 86% Success Rate in Phase 2, Biotech Co. Moves to Phase 3 for AUD Treatment

The Canadian-based biotechnology company Awakn Life Sciences Corp. (NEO:AWKN; OTCQB:AWKNF; FSE:954) has applied for a Clinical Trial Application (CTA) for its flagship treatment for Severe Alcohol Use Disorder (SAUD), according to a press release put out by the company.

Awakn reports that it is working with the University of Exeter and the UK's National Institute of Health and Care Research and will put forward GBP£800,000 for the study, with unspecified amounts being contributed by the other two organizations.

The AWKN-P001 program seeks to treat SAUD through the application of "an N-methyl-D-aspartate receptor-modulating drug (ketamine) used in combination with psycho-social support to treat SAUD," reported the press release.

Awakn reported that the results of Phase 2 of clinical trials achieved, after six months of treatment with the drug, a success rate of 86%, as opposed to 2% compared to normal treatments.

The AWKN-P001 received an Innovation Passport from the UK, which allows the program accelerated access to the licensing process, the company said.

According to Anthony Tennyson, the CEO of Awakn, "We are pleased to be working with our partners in the NIHR, MRC, and the University of Exeter on this program as we together progress AWKN-P001 closer to potentially treating the first participant in the Phase 3 trial."

A Change in Attitudes 

According to Marijuana Moment, the FDA and the Congressional Psychedelics Caucus have made significant moves toward greenlighting psychedelics for clinical treatment. The agency released a guide for clinical trials involving these substances in July, The Marijuana Moment reported.

In late July, Technical Analyst Clive Maund commented on the company, which he rated as "an attractive investment here and not unduly speculative at this level."

The agency has indicated that it may be starting to thaw on psychedelics recently in relation to mental health, with Rep. Lou Correa and Rep. Jack Bergman commenting, "As our country continues to suffer tragic rates of suicide and opioid overdose deaths . . . it is critical that policymakers such as those in our caucus pursue additional pragmatic measures."

Australia has also begun to look increasingly friendly toward psychedelics in clinical settings, according to Stockhead. Stockhead reports that the Australian government has changed its stance on MDMA and psilocybin, allowing them to be prescribed to patients with PTSD and depression.

An Attractive Investment

In late July, Technical Analyst Clive Maund commented on the company, which he rated as "an attractive investment here and not unduly speculative at this level."

According to Maund, "AWKN Life Sciences Corp. has been advancing toward its goals to develop psychedelic therapeutics protocols . . . its stock has been in a severe bear market from early last year that has erased more than 90% of its value, so it is believed to have a lot of upside potential from here."

According to Awakn's investor presentation, potentially significant catalysts are on the horizon, including the possibility of the FDA's approval of MDMA as a treatment for certain mental health conditions. 

Awakn also reports that it has a number of other programs with important events on the horizon, including the AWKN-P001 program, which expects to see a "possible initial efficacy readout" in 2025 and expects the results of clinical trials to be released in 2027.

Ownership and Share Structure

Reuters provided a breakdown of the company's share structure. Management and insiders own 7.9% of the company. Anthony Tennyson owns 4.37% of the company with 1.53 million shares, George Scorsis owns 3.23% with 1.13 million shares, Stephen Robert Page owns 0.19% with 0.07 million shares, and John Papastergiou owns 0.11% with 0.04 million shares.

As for institutions, OrbiMed Advisors, LLC owns 6.86% of the company with 2.40 million shares.

Awakn reports that OrbiMed is a strategic investor.

The company reports no potential sellers, but has identified a group of current financing warrants valued at CA$0.68, and stated that the rest of the warrants are valued at CA$1.20.

According to Reuters, there are 35.04 million shares outstanding and 32.27 million free-float traded shares. The company has a market cap of CA$6.62 million. It trades in the 52-week period between CA$0.18 and CA$3.35.

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