Awakn Life Sciences Signs Agreement with a Leading Drug Development Company to Deepen IP Moat for Its Lead Program

Awakn Life Sciences Signs Agreement with a Leading Drug Development Company to Deepen IP Moat for Its Lead Program

Agreement Provides 12-Month Exclusive Period to Agree in-Licensing Deal for Proprietary Formulation of Ketamine

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 it has signed a twelve month option agreement with a leading drug development, manufacturing, and delivery systems company to in-license a proprietary formulation and route of administration for ketamine. The formulation and route of administration will be optimized for commercialization and has the potential to deepen the intellectual property (IP) moat for Awakn's lead clinical development program Project Kestrel, which targets AUD.

AUD is a chronic disease with a poor current standard of care. AUD affects 400 million1 people globally with an approximate 25% abstinence rate within 12 months of treatment2. Despite this poor efficacy, the AUD treatment market in Awakn's two core territories of the U.S. & U.K. is significant. The U.S. AUD treatment market is valued at CA$45 billion3, while the U.K. state spends more than CA$5.5 billion a year4 on AUD related illness.

Awakn's Phase II b clinical trial, which was part of Project Kestrel, delivered 86% abstinence at 6 months post treatment compared to the standard 25% abstinence rate. Awakn is now progressing this program into Phase III in the U.K. Awakn also signed a Memorandum of Understanding with the U.K. public healthcare system, the NHS, in December 2021 to establish a partnership to assess NHS organizational readiness for ketamine-assisted therapy and to collaborate on how to accelerate the on-label use of ketamine-assisted therapy to treat AUD within the NHS' existing infrastructure.

The proprietary formulation of ketamine and optimized route of administration in scope for this agreement has the potential to provide the best possible patient experience and outcomes in addition to deepening Awakn's IP moat. Awakn is planning for the new formulation to be evaluated in its Phase III clinical trial.

Anthony Tennyson, Awakn's CEO commented, "We are very happy to sign this agreement which is a key milestone in our strategy to bring our proprietary ketamine-assisted therapy for the treatment of AUD to market and to be able to help such a large cohort of people who are in such desperate need of an effective treatment and unfortunately do not currently have one."

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a revenue-generating biotechnology company researching, developing, and commercialising therapeutics to treat substance and behavioral addictions. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 400m people globally for which the current standard of care is inadequate. Our goal is to provide effective 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 | Facebook | www.AwaknClinics.com

About Project Kestrel

Project Kestrel is the lead clinical development program of Awakn Life Sciences. Project Kestrel is supported by Awakn's Phase II a/b 'KARE' clinical trial which examined ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD). The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial which means that study participants went from being sober on average 7 days a year to being sober on average 314 days a year. Awakn is planning to initiate a Phase III trial in the UK in 2022 and plans to seek regulatory approval in the UK and the US in due course.

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:
America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com

Rest of World:
Gordo Whittaker, CMO, Awakn Life Sciences
gordo@awaknlifesciences.com

___________________________

1: Global Burden of Alcohol Use Disorders and Alcohol Liver Disease. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6966598
2: "Treatment rates for alcohol use disorders: a systematic review and meta-analysis" by Tesfa Mekonen
3: www.researchnester.com/reports/alcohol-use-disorder-treatment-market/3804
4: www.england.nhs.uk/2019/01/nhs-long-term-plan-will-help-problem-drinkers-and-smokers

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/134738

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Awakn Life Sciences' Phase III Trial to Be Delivered in the UK National Health Service

Awakn Life Sciences' Phase III Trial to Be Delivered in the UK National Health Service

Phase III trial confirmed to cost CA$3.75 million, with a UK Government agency funding 66% of this cost

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), announces that its Phase III clinical trial exploring the use of ketamine-assisted therapy for the treatment of severe AUD will be delivered across seven NHS sites in the UK. The trial has also been approved for grant funding for 66% of the costs by the National Institute for Health and Care Research (NIHR), a UK government agency. It is currently forecast the trial will cost approximately CA$3.75 million in total, with Awakn funding approximately CA$1.25 million of that.

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(PRNewsfoto/Seelos Therapeutics, Inc.)

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At the effective time of the reverse split, every 8 issued and outstanding shares of the Company's common stock will be converted automatically into one share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. The reverse stock split will reduce the number of authorized shares of the Company's common stock from 400,000,000 shares to 50,000,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result of fractional shares. In addition, the reverse stock split will apply to the Company's common stock issuable upon the exercise of the Company's outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company's equity incentive plans, as applicable.

The reverse stock split will reduce the number of issued and outstanding shares of the Company's common stock from approximately 17.4 million to approximately 2.2 million.

About Seelos Therapeutics:

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

Forward-Looking Statements:

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the reverse stock split and the timing thereof, the potential impact of the reverse split on the bid price of the Company's common stock, the potential for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market and the expected number of shares of common stock to be outstanding following the reverse stock split. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties involved include those associated with general economic and market conditions, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information

Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-announces-1-for-8-reverse-stock-split-302144966.html

SOURCE Seelos Therapeutics, Inc.

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