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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 Corp.


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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), today announces it has signed a drug development agreement with Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities.

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Awakn Life Sciences Signs Second Licensing Partnership Agreement and Expands Commercial Operations Into Canada

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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 today it has signed its first licensing partnership agreement in Canada with Wellbeings® Pain Management and Dependency Clinic (Wellbeings). The agreement will enable Ontario based Wellbeings®, who are focused on multi-disciplinary, evidence based, best-practice, patient centred care, to treat their patients with Awakn's proprietary ketamine-assisted therapy for the treatment of AUD as a co-morbidity for pain.

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 Revitalist Partners with Awakn Life Sciences as First Licensee in the United States to begin Redefining Treatment for Addiction, Recovery, and Relapse Prevention in the Psychedelic Space

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Awakn's proprietary ketamine-assisted therapy for the treatment of Alcohol Use Disorder was developed and validated in a Phase II a/b trial, with results announced in the American Journal of Psychiatry in January 2022. The trial delivered 86% abstinence over the six-month period post treatment versus 2% pre-trial and 25% in the current standard of care.

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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 today it has signed a licensing partnership agreement with Revitalist Lifestyle and Wellness Ltd. (CSE: CALM) (OTCQB: RVLWF) (FSE: 4DO) ("Revitalist"), one of the largest publicly listed U.S. based ketamine wellness-clinic chains. The agreement will enable Revitalist to treat clients with Awakn's proprietary ketamine-assisted therapy for the treatment of AUD.

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Nirvana Life Sciences Inc. Deuterates 7-Hydroxymitragynine to Create D7-h, an Analogue that May Improve Research and Formulations using Kratom Derivatives

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Nirvana Life Sciences Inc. (Nirvana or the "Company") (CSE: NIRV) a western Canadian based life sciences company aimed at developing psychedelic therapeutic medicines, including non-addictive chronic pain and relapse preventing products is pleased to report filing of a patent for D7-h.

Nirvana Life Sciences Inc. Logo (CNW Group/Nirvana Life Sciences Inc.)

Nirvana Life Sciences Inc. is pleased to announce it has recently filed a patent for the deuterated form of 7-hydroxymitragynine (D7-h), the active compound in kratom responsible for the opiate like effect the plant produces when ingested. Opioid use disorder and opioid addiction remain at epidemic levels in Canada , the US and worldwide.  In 2021, there were 7560 apparent opioid-related deaths in Canada , which is equivalent to 20 people dying each day, and was greater than the average number of Canadians killed daily in motor vehicle collisions. This number continues to grow, with the PHAC projecting as many as 2400 opioid-related deaths in each quarter of 2022.

The use of Kratom in Southeast Asia has been documented back for at least 150 years and is described both as having a stimulant effect for use in hard day labor when fresh leaves are chewed and an analgesic and relaxing effect if brewed into a tea. In the past decade or more, recognition and the use of kratom has grown in Canada , the United States , and the world at large. Although use has increased, there still remains a lack of research regarding kratom and the various different components within it that are active when taken. One important observation that has been made is that people who take kratom do not see the same respiratory decrease that is often the cause of death and overdose in people who take opiates. This is due to 7-hydroxymitragynine being a partial mu opioid agonist, unlike Fentanyl and oxycodone which are full mu opioid agonists and are known to have depressant effects on respiration.

With so many people affected by opioid use disorder, opioid addiction, and the risk of death from using these substances, research into alternative pain formulations is more than ever necessary. In order to create a medicine that has the potential to truly help people with addictions and those living with chronic pain, it is important to have a deep understanding of how these compounds work in the brain and body. Scientists and doctors have long used deuterated drugs to help track how a drug moves through the brain and body, in order to gain a better understanding of its mechanisms.

A deuterated drug is a small molecule medicinal product in which one or more of the hydrogen atoms contained in the drug molecule have been replaced by its heavier stable isotope deuterium. Because of the kinetic isotope effect, deuterium-containing drugs may have significantly lower rates of metabolism, and hence a longer half-life, as can be seen with Deutetrabenazine, a deuterated version of tetrabenazine, developed by Teva and approved by the FDA in 2017 for the treatment of chorea associated with Huntington's disease. Applications of the deuterium isotope effect have increased over time, and it is now applied extensively in mechanistic research focused on the metabolism of drugs, as well as with many other studies that focus on safety, efficacy, tolerability, bioavailability, and pharmacokinetics (PK).

Nirvana Life Sciences Inc. knows the importance of creating a deuterated form of 7-hydroxymitragynine (D7-h) in order to gain a better understanding of the mechanisms of this compound in the body, including knowledge about safety, bioavailability, efficacy, pharmacokinetics (PK) and more. It is our hope that researchers at Nirvana Life Sciences Inc. and elsewhere will be able to use D7-h to fill the gap in knowledge that exists about kratom, to then create safer and more effective alternatives to opiates for people struggling with addiction and chronic pain.

Robert August , lead chemist and Head of Innovation with Nirvana Life Sciences Inc., stated "With research in chronic pain and addiction, and developing treatments for these, being at the forefront of the mission of Nirvana Life Sciences Inc., we are hopeful to see how this development may change not just science, but the lives of many people." We couldn't agree more and are thrilled to add D7-h to our growing portfolio of novel compounds, formulations and processes focused on chronic pain, addiction and trauma.

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Forward Looking Statements

This news release contains certain forward-looking statements and forward-looking information (collectively referred to herein as "forward-looking statements") within the meaning of Canadian securities laws including, without limitation, statements with respect to the future investments by the Company. All statements other than statements of historical fact are forward-looking statements. Undue reliance should not be placed on forward-looking statements, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward-looking statements will not occur. Although the Company believes that the expectations reflected in the forward-looking statements contained in this press release, and the assumptions on which such forward-looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause the Company's actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.

SOURCE Nirvana Life Sciences Inc.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2022/22/c3080.html

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