Novel Therapy Corp Captures More of US Licensing Market, First EU Segment

In a pair of announcements this week, Awakn Life Sciences Corp. (AWKN:NEO; AWKNF:OTCQB) revealed new partnership agreements that will expand its footholds in the U.S. and Europe.

Awakn is a biotechnology company developing therapeutics to treat addiction, with a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 285 million people globally for which the current standard of care is inadequate.

The company aims to provide breakthrough therapeutics to addiction sufferers in desperate need by commercializing the results of its various R&D pipelines exploring the therapeutic benefits of different compounds.

The Catalyst: Expanded US Franchising and First European Licensee

Awakn has been using a two-pronged approach to bring its therapies to market. The first involves setting up its own clinics in various European markets, including London, Bristol, and Oslo.

At the same time, the company has been licensing its ‘Kare' methodology, which combines proprietary drug formulations with standardized therapeutic approaches to provide real-world assistance to patients in need. This methodology is being licensed wholesale to pre-existing clinics worldwide.

Awakn Kare is a proprietary treatment protocol developed and validated in a Phase 2 a/b trial. The trial delivered 86% abstinence over the six months post-treatment versus 2% pre-trial. This efficacy is significantly better than the current standard of care for AUD, which has an approximate 25% abstinence rate over a similar timeframe.

This week, Awakn announced its fourth licensing agreement in the U.S. and its first wholesale contract in Europe. The U.S. agreement is with Ken Starr MD Wellness Group, an addiction treatment facility in California, and represents the first licensing partnership Awakn has signed with a dedicated addiction treatment provider.

Awakn will provide access to and training on its proprietary therapeutics packages, and under the terms of the agreement, Ken Starr MD Wellness Group will pay Awakn a fee and a revenue share per treatment.

"With Awakn's guidance and leadership," Ken Starr MD continues, "I think we'd be able to take our program to the next level."

Kevin Lorenz, Awakn’s Head of U.S. Commercial Development, says, "We are excited to partner with Ken Starr and his team, who are seasoned veterans in the addiction treatment industry.

California has approximately 40 million people living there, and unfortunately, the rates of AUD are very high. Ken and his team are — geographically and professionally — perfectly placed to help so many of these people."

Dr. Starr explains that his group "is already committed to providing substance abuse patients with leading and innovative therapies. Our program has been at the forefront of ketamine and NAD+ treatments for both wellness and recovery for years."

"With Awakn's guidance and leadership," he continues, "I think we'd be able to take our program to the next level. Especially as other psychedelic treatments come downstream, our relationship with Awaken will allow us to be an earlier adopter of novel therapies."

Additionally, Awakn announced that it had signed its first licensing partnership agreement in Europe with a healthcare consortium currently operating in stealth mode (and listed in the press release as simply "Portuguese Partner"). The agreement will support the Portuguese Partner’s strategy to launch a new chain of medical-psychedelic clinics in Portugal, with the first location in Lisbon.

Awakn CEO Anthony Tennyson commented that Awakn is "very pleased to expand our Licencing Partnership business by geography, into Portugal, and by scope into anxiety, depression, eating disorders, and PTSD. We are also delighted to work with our new partners in Portugal who are deeply experienced in and knowledgeable of the Portuguese mental health treatment and wellness sectors."

"With Awakn being the first chain of psychedelic clinics in Europe, we have a wealth of knowledge to help accelerate the development and execution of their strategy," Tennyson explains. "Importantly, this partnership will allow many people in Portugal to access new, more effective treatment options which are not currently available."

Why This Sector? The Future of Drug-Assisted Therapy

The use of psychedelics in mental health and addiction recovery has recently enjoyed a renaissance, exemplified by a lengthy segment on  Last Week Tonight with John Oliver. In this 21-minute in-depth report, Oliver does a deep dive into the wide efficacy of psychedelic treatments and some of the issues facing the still-nascent industry.

"Sixty percent [reduction] immediately," the host explained, talking about one soldier's experience treating PTSD symptoms with managed psychedelic care. "It is not often you see those kinds of results after your first therapy session."

Dr. Starr concurs. "MDMA has now proven to be helpful with PTSD. Ketamine has proven to be helpful with addiction. The future is bright. Psychedelic medications, when used appropriately, can help patients authentically connect with themselves and help ignite behaviors that result in life they don't feel they need to escape from."

Why This Company? Multi-Revenue Stream Model, Multiple Therapies.

By developing retail and wholesale sales channels, Awakn has uniquely positioned itself at a nexus where it can generate funds for ongoing research in all market conditions. The decision not to focus solely on its own branded clinics has opened the company’s products up to a much larger market.

"When I learned they were bringing the alcohol use disorder research with ketamine to market, I reached out," Dr. Starr explains. "We were already in that space, but with a very limited geographic reach as we're in a small coastal town, I think our partnership with Awakn will accelerate our success as well as our patients’ success."

Why Now?

With Phase II trials in the UK complete, and multiple self-branded clinics across Europe, Awakn already seemed to be maturing into a regular-revenue company.

The additional profit streams associated with white-label agreements in both Europe and the U.S. cement the company’s position as a leader in the psychedelic treatment field. 

Ownership and Share Structure

Awakn’s management owns 21.22% of the company’s 35,602,993 fully-diluted structure, which consists of 28,799,011 common shares, 4,722,064 warrants, 1,996,746 outstanding options, and 35,172 DSUs.

Co-founder and Head of Psychedelic Medicine Dr. Ben Sessa owns the most, at 7.74%, with 2.23 million shares. Co-founder and chair George Scorsis is next at 1.84%, with 0.53 million shares. Nonexecutive Director Steve Page is at 0.24% with 0.07 million shares. Co-founder and CEO Anthony Tennyson is at 0.08%, with 0.02 million shares, and the other non-executive director, Professor John Papastergiou, is at 0.03%, with 0.01 million shares.

OrbiMed Advisors LLC files as an insider, with an 8.35% equity stake (2,403,550 regular shares) and 989,583 warrants at US$0.68, while other warrants are all US$1.20 and higher.

According to Reuters, 18.27% of shares are held by institutions and strategic investors, 8.35% by investment managers, and 9.93% by individual investors.

The company is covered by a myriad of analysts, including Andrew Partheniou of Stifel and Patrick Trucchio of H.C. Wainwright & Co. The company has also been reviewed by Jason McCarthy of Maxim Group and technical analyst Clive Maund of Clivemaund.com. You can see more in the data box above.

Other institutional investors of note include Iter Investments, Palo Santo, Negev Capital, Neo Kuma, TD Veen, JLS, and Ambria. The company’s market cap is US$ 7,354,000.

Disclosures:

1) Owen Ferguson wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. They members of their household own securities of the following companies mentioned in the article: None. They or members of their household are paid by the following companies mentioned in this article: None.

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