Awakn Life Sciences Provides Corporate Update.

Toronto, Ontario--(Newsfile Corp. - September 14, 2023) - Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (“Awakn”), a clinical-stage biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), shares a corporate update on recent progress. Awakn also announces the closing of the third tranche of its previously announced private placement.

Key recent corporate activity:

• Healthcare services exit completed and burn reduced: In June 2023 Awakn announced its intended exit from healthcare services to focus solely on Research and Development of therapeutics treating addiction. Awakn successfully completed its exit from the healthcare services in August 2023, which has significantly reduced Awakn’s burn.

• Clinical trial application (CTA) submitted for phase III of lead program AWKN-P001, with Awakn’s cost for the phase III capped at approximately GBP £800,000. In September 2023 Awakn submitted the CTA for a phase III clinical trial for its lead program AWKN-P001 for the treatment of Severe Alcohol Use Disorder (SAUD). The trial is being run by the University of Exeter, and a partnership between the UK National Institute of Health and Care Research (NIHR) and the UK Medical Research Council (MRC). The phase III trial will be a n=280, two-armed randomized placebo-controlled trial. It will be delivered in the UK across ten UK National Health Service (NHS) sites. Awakn will contribute approx. GBP £800,000 towards the costs of the trial, with the NIHR, MRC, and the University of Exeter contributing the balance of the costs.

Awakn and its partners are expecting feedback in the coming months on the CTA, and subject to ethical and regulatory approval, first trial participants will be treated in Q1 2024.

• Zydis®/MDMA feasibility study progressing. Awakn initiated a feasibility study in March 2023 for a proprietary formulation of MDMA using Catalent’s Zydis® orally disintegrating tablet (ODT) technology. The study is evaluating a variety of chemical parameters and several aspects of the Zydis® MDMA ODT.

Awakn and Catalent have completed two of the three planned manufacturing tests and are now progressing into the third manufacturing production run test.

• Awakn continues to expand its addiction and mental health treatment licensing partnership business. Awakn provides access to its proven proprietary ketamine-assisted therapy protocol for the treatment of Alcohol Use Disorder (AUD) and additional healthcare services intellectual property under license to substance use disorder and mental health treatment facilities. Awakn’s partner clinic network now includes clinics in New York and California, in the US; Ontario, in Canada; Oslo and Trondheim, in Norway, London, in UK and Lisbon, in Portugal.

Financing:

On April 26th, 2023, Awakn announced a non-brokered private placement financing for gross proceeds of up to $3,000,000, which was upsized to $4,000,000 on June 15, 2023 at a price of CAD$0.46 per unit (the “Offering”). Each unit is comprised of one common share in the capital of the Company (each, a “Common Share”) and three quarters (0.75) of one whole Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant entitles the holder thereof to acquire one Common Share at a price of $0.63 per Common Share for a period of five (5) years from the date of issuance. Gross proceeds from the Offering will be used to fund the company’s general working capital.

Today, Awakn has closed the third tranche of the Offering, issuing 1,667,858 Units for gross proceeds of $767,215 for this tranche and $2,734,663 in total for the Offering to date.

Closing of the Offering is subject to receipt of all necessary corporate and regulatory approvals, including the approval of NEO Exchange. All securities issued in connection with the Offering will be subject to a hold period of four months plus a day from the date of issuance and the resale rules of applicable securities legislation.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons as defined under applicable United States securities laws unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting approximately 37 million people in the US and key international markets and 285m people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels.

www.AwaknLifeSciences.com | Twitter | LinkedIn

Notice Regarding Forward-Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com

Media Enquiries:
Gordo Whittaker, CMO, Awakn Life Sciences
gordo@awaknlifesciences.com

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