June 9, 2023

Awakn Life Sciences to Focus Solely on Research And Development of Therapeutics Targeting Addiction

Term Sheet Signed to License Healthcare Intellectual Property to UK Healthcare Consortium Exclusively in the UK Market

Strategic Review of Norwegian Healthcare Clinics Business Unit Initiated

TORONTO, CANADA, June 9, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”) a biotechnology company developing therapeutics targeting addiction, with a near term focus on Alcohol Use Disorder, announces today its intention to exit healthcare services to focus solely on research and development (“R&D”) of therapeutics to treat addiction and licensing of its intellectual property.

As part of this process, Awakn:

  • Has signed a non-binding term sheet to exclusively license selected elements of its healthcare services intellectual property (“IP”), within the UK, and to a non-exclusive license for Awakn Kare, also within the UK, with a consortium consisting of a private UK investment company and a large UK 3rd sector addiction and mental health treatment provider, for an upfront fee and a revenue share.
  • Has initiated a strategic review of its Norwegian healthcare clinics business unit, Awakn Oslo AS, which consists of two clinics, one in Oslo and one in Trondheim. Awakn Oslo AS generated its highest monthly revenue to date during May 2023, driven by the opening of its Trondheim clinic in March 2023, and its new Oslo clinic in May 2023. As part of the strategic review, Awakn is seeking potential purchasers of Awakn Oslo AS.
  • Is initiating a restructuring of its UK healthcare clinics business unit, in which Awakn’s UK entities are expected to enter into administration or liquidation.

Awakn is undertaking these steps to focus capital currently available and to be received from the closing of future tranches of its private placement financing announced on April 26, 2023 solely on its R&D programs and its IP licensing activities.

Awakn will continue to execute its R&D strategy. Awakn’s focus will be on efficiently progressing forward its clinical and pre-clinical stage pipelines, including AWKN-P001, its Phase III lead clinical development program, targeting Severe Alcohol Use Disorder, which is majority funded by the UK Department of Health and is expected to start in the second half of 2023. AWKN-P001 has received 66% government funding for the cost of the trial and the backing of the UK National Health Service who will be running the trial across ten of its locations, resulting in Awakn’s cost of the study being approximately GBP£800,000.

The scientific and research team at Awakn, which includes world-renowned Prof. David Nutt, Chief Research Officer, Prof. Celia Morgan, Head of ketamine-assisted therapy and Shaun McNulty, Chief Scientific Officer, are among some of the most experienced industry leaders and will continue to spearhead the progression of Awakn’s research pipeline.

Anthony Tennyson, Awakn CEO commented “Streamlining our operations and increasing our focus on the advancement of our pipeline, both from a resource and financial perspective, is something that is necessary, and we believe will have a positive impact for Awakn and our shareholders, to try to maximize the long-term value of each business. At the same time, the actions taken in the UK are deeply regrettable and not the route we had hoped for, however, critically they provide the best outcome for continuity of care for existing clients and continuity of employment for a majority of the Awakn Clinics UK team.”

Awakn has also agreed to issue 2,700,000 share purchase warrants to a consultant of the Company.  The warrants shall be exercisable at $0.63, for a period of five years from the date of issuance. The issuance of these warrants have been approved by the exchange.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics targeting addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

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: 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.

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

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

April 28, 2023

Awakn Life Sciences Reports Q4 2023 And Annual Results

Annual Revenue Increased by 534%

TORONTO, CANADA, April 28, 2023 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced todayit is reporting its financial results and business highlights for the three and twelve months ended January 31, 2023. All results are reported under International Financial Reporting Standards ("IFRS") and in Canadian dollars, unless otherwise specified.

Anthony Tennyson, Awakn CEO commented “Awakn made significant progress during the last fiscal year. With safety and efficacy established we are progressing our lead program, AWKN-P001, which targets Severe AUD, into phase III. The majority of the costs for this trial are being paid by the UK state, resulting in this phase III, potentially definitive trial, costing Awakn only $1.25m. Additionally, we partnered with a European pharma company to assess repurposing (S)-ketamine into a licenced treatment for addiction, and we are also working with Catalent on a feasibility study of MDMA, leveraging Catalent’s proprietary Zydis® Oral Disintegrating Tablet (ODT) fast dissolve technology, to investigate the possibility of shortening MDMA therapy sessions.

“Our clinics delivered strong revenue growth over the same time period with a 534% year on year increase in revenue and looking forward to the current fiscal year we are targeting a further increase in revenue from our clinics and partnerships.”

4Q22 Business and Operational Updates, Including Subsequent Updates:

  • U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted Awakn an Innovation Passport as part of the Innovative Licensing and Access Pathway (ILAP) for its proprietary ketamine-assisted therapy for the treatment of Severe Alcohol Use Disorder. ILAP aims to accelerate time to market, similar to the FDA’s fast-track program in the United States.
  • Awakn signs collaboration agreement with University of Exeter for upcoming phase III trial (n=280), which will assess ketamine-assisted therapy for the treatment of Severe Alcohol Use Disorder. The total cost of trial to Awakn will be approximately $1.25m.
  • Awakn initiated an investigative study to establish the dissociative effect of a proprietary and patent pending formulation of (S)-ketamine and optimized route of administration to support commercialization in due course.
  • Awakn initiated a feasibility study for MDMA using Catalent’s Zydis® orally disintegrating tablet (ODT) technology. Due to the faster onset of effects of Zydis technology, there is the possibility to shorten therapy sessions, and, through pre-gastric absorption & bypassing of the first-pass metabolism, there is potential to enhance pharmacokinetics.
  • Awakn’s phase III trial to be delivered in the UK’s National Health Services (NHS). The trial has also been approved for grant funding for 66% of the costs by the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC), both UK government agencies.
  • Awakn announces location for larger Oslo clinic. The move to the new Oslo premises is the first stage of Awakn’s Nordic expansion plans. The new location will be a 6-treatment room clinic situated near the center of Oslo and will replace the existing clinic. 
  • Awakn announces the opening of its fourth clinic. Awakn Clinics Trondheim is its second clinic in Norway with a further two clinics already based in the UK.

4Q22 Key Corporate Highlights and Developments, Including Subsequent Developments:

Key Financial Highlights:

  • Achieved 12-month revenue of $1,495,343 for year ended January 31, 2023, was which was a 534% increase year on year. 4Q23 revenue was $471,813 compared to 4Q22 revenue of $204,300, a 131% increase quarter over quarter. 4Q23 also achieved a 10% growth rate on 3Q22 with an increase in revenue from $430,504 to $471,813.
  • Revenue during the 12-month period was was predominantly generated from the provision of ketamine-assisted therapy at the London, Oslo, and Bristol clinics.
  • As of January 31, 2023, the Company had approximately $550,866 in cash.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

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

April 26, 2023

Awakn Life Sciences Announces Private Placement

TORONTO, CANADA, April 26, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (the "Company"), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), is pleased to announce a non-brokered private placement financing for gross proceeds of up to $3,000,000 through the issuance of up to 6,521,739 units in the capital of the Company (the “Units”) at a price of $0.46 per Unit (the “Offering”), and that the Company has closed the first tranche of the Offering issuing 2,392,858 Units for gross proceeds of $1,100,715.

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.

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 biotechnology company developing therapeutics to treat addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

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.

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

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

April 18, 2023

Awakn Life Sciences Signs Collaboration Agreement With University of Exeter for Upcoming Phase III Trial

Phase III Trial will Assess Ketamine-Assisted Therapy for The Treatment of Severe Alcohol Use Disorder

TORONTO, CANADA, 18 April, 2023 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces that it has signed a collaboration agreement with the University of Exeter (UoE) putting in place a framework for the upcoming Phase III trial exploring the use of ketamine-assisted therapy to treat Severe AUD. The agreement formalizes the design, budget and Awakn's contribution to the cost of the trial.

The trial will be a Phase III, 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 GBP £800,000 towards the costs of the trial, with the National Institute for Health and Care Research (NIHR), the Medical Research Council (MRC), and the University of Exeter contributing the balance of the costs.

The trial will be the largest ketamine-assisted psychological therapy clinical trial to date and the only Phase III psychedelic clinical trial to receive government funding. If the results of the Phase III are positive, Awakn plans in due course to apply for marketing authorization for ketamine-assisted therapy to treat severe AUD.

Professor Celia Morgan, Professor of Psychopharmacology at UoE and Awakn’s Head of Ketamine-Assisted Therapy will lead the trial, which follows on from the impressive results of the Phase II a/b trial announced in January 2022, which resulted in participants experiencing on average 86% abstinence at six-months post treatment, versus 2% pre-trial.

In February 2023 Awakn received an Innovation passport as part of the Innovative Licensing and Access Pathway (ILAP) from the Medicine’s Health and Regulatory Authority (MHRA) the UK regulatory body, which aims to accelerate time to market for research programs, much like the FDA’s fast track designation. ILAP will allow Awakn a working collaboration with access to specialist advice from the MHRA and its partners, including the National Institute of Health and Care Excellence (NICE).

Anthony Tennyson Awakn CEO added “We are delighted to formalize an even stronger working collaboration and agreement with the University of Exeter particularly when this gives such a clear roadmap for our Phase III. We have been working side by side for several years now and they are a world leading institute for research and a partner we are very happy to work with. We share the same vision of providing a new more effective treatment for AUD available to the millions of people who are in such desperate need for it.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

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

April 12, 2023

Awakn Life Sciences Increases Ownership of Awakn Bristol to 100% and Provides Corporate Update

TORONTO, CANADA, April 12, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), is today providing a corporate update.

  • Dr. Ben Sessa has resigned from his role as Head of Psychedelic Medicine at Awakn and will leave the business effective April 13. As a result of Dr. Sessa leaving Awakn, Dr. Sessa has agreed to transfer his 49% stake of Awakn Bristol Limited, which operates Awakn Clinics Bristol, to Awakn Life Sciences Inc., a wholly owned subsidiary of Awakn, resulting in Awakn Life Sciences Inc. holding a 100% interest in the Bristol operation.
  • Nushama Inc., a licensing partner of Awakn based in Manhattan, New York, has treated its first clients with Awakn’s novel treatment for Alcohol Use Disorder, Awakn Kare, marking the first people in North America to receive the treatment.
  • Awakn has completed the filing of three Patent Cooperation Treaty (PCT) applications for its New Chemical Entity program. As a result, and pursuant to the Intellectual Property Transfer Agreement among Awakn, Awakn Life Sciences Inc. and Equasy Enterprises Ltd. dated March 8, 2021, as amended, an additional 70,000 common shares of Awakn are issuable to Prof. David Nutt.
  • On March 1st, 2023, Awakn opened ‘Awakn Clinics Trondheim’, Awakn’s fourth clinic and its second clinic in Norway. Awakn Clinics Trondheim is the first ketamine-assisted therapy clinic in the region. In accordance with the terms of the Share Exchange Agreement among Awakn Axonklinikken AS (“Axon”) and its shareholders dated September 15, 2021, the opening of an additional clinic in Norway has triggered an obligation of Awakn to issue an additional aggregate of 100,000 common shares of Awakn to the former shareholders of Axon.

Awakn CEO, Anthony Tennyson commented: “We thank Dr. Sessa for his contribution to Awakn and wish him well in the future. We are happy to hit another milestone in our licensing partnerships business with the first clients to be treated with Awakn Kare in North America. On the clinics side of the business, we are delighted to open our fourth clinic, and second in Norway; we have a dedicated and industry-leading team in Norway making huge progress.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

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.

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

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

February 28, 2023

Awakn Life Sciences Signs its Fourth Licensing Partnership Agreement in North America, And First in California

Partnership is Awakn’s first with a dedicated addiction treatment clinic, Ken Starr MD Wellness Group

TORONTO, CANADA, Feb 28, 2023 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today it has signed its fourth Licensing Partnership agreement in North America. The agreement is with Ken Starr MD Wellness Group an addiction treatment facility in California. This is the first Licensing Partnership Awakn has signed with a dedicated addiction treatment provider.

Awakn will provide access to, and training for its proprietary therapeutics package ‘Awakn Kare’ to Ken Starr practitioners. Under the terms of the agreement Ken Starr MD Wellness Group will pay Awakn a fee and a revenue share per treatment.

Awakn Kare is a proprietary treatment protocol  developed and validated in a Phase II 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.

The U.S. alcohol and substance addiction treatment industry is significant in size with 14,000+ treatment facilities across the country. Traditional AUD rehabilitation facilities range in cost nationally from US$20,000 to US$65,000 per month, generating more than $35bn in revenue, even with their low efficacy rates. Awakn aims to improve performance of the addiction industry by providing clinic operators with access to an efficient and more effective treatment option under license.

Kevin Lorenz, Awakn’s Head of U.S. Commercial Development commented “We are excited to partner with Ken Starr and his team, who are seasoned veterans in the addiction treatment industry. California is home to nearly 40 million people and unfortunately the rates of AUD are very high. With their experience, skill, and caring support for those struggling with AUD, Dr. Starr and his team are well positioned geographically to make Awakn’s breakthrough AUD treatment available to help many Californians who need it.  From Awakn’s perspective expanding our U.S. reach to the west coast and to include such an important market as California is another major milestone for our program, but most importantly we can offer this new more effective treatment to a whole new cohort of people who are in such desperate need.”

Ken Starr comment “We are excited to partner with Awakn. For years we’ve been the leader in delivering both traditional and alternative therapies for those suffering with addiction. Both ketamine and IV NAD+ have shown tremendous promise in the addiction medicine space. With Awakn’s support and leadership we’ll be able to help change even more lives.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

About Ken Starr MD Wellness Group

The Ken Starr MD Wellness Group has been a fixture on the Central California Coast since 2011. Lead by Dr. Starr, a board-certified physician in Addiction Medicine, the clinic is both a state licensed and CARF accredited treatment facility. Patients arrive from all over the United States to receive treatments not previously available anywhere. The clinic is the longest running and most experienced provider of NAD+ on the West Coast and has been providing ketamine services for the last four years. By offering innovative detox solutions combined with intensive outpatient counselling services we can more completely address patients at different points in the recovery process.

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

February 21, 2023

Awakn Life Sciences Signs its First Licensing Partnership Agreement in Europe

Awakn Will License its Protocols for Treating Addiction and Mental Health to a Healthcare Consortium to Help Accelerate Their Development of a Chain of Clinics in Portugal

TORONTO, CANADA, Feb 21, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a biotechnology company developing 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 Europe with a healthcare consortium currently operating in stealth-mode (“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 will provide the Portuguese Partner with an exclusive licence for use of its clinical protocols for the treatment of AUD, Anxiety, Depression, Eating Disorders and PTSD in Portugal for a period of 10 years. Awakn will train the Portuguese Partner’s clinicians in the delivery of these protocols and will provide ongoing strategic, operational, risk management, and marketing support.

Portugal has a population of 10 million people and is a member of the European Union, Unfortunately, like many of its European counterparts it has a relatively high lifetime prevalence of mental health conditions, in the region of 20% to 30%. These conditions include addiction, anxiety, depression, eating disorders and PTSD, conditions that Awakn’s protocols treat and that will be licensed to the Portuguese Partner.

Anthony Tennyson, Awakn CEO commented “We are 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. Importantly, this partnership will allow many people in Portugal to access new more effective treatment options which are not currently available."

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

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

February 14, 2023

Awakn Life Sciences Announces The Opening of Its Fourth Clinic

Awakn Clinics Trondheim is its second clinic in Norway

TORONTO, CANADA, Feb 14, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today that Awakn Clinics Trondheim is now open and will begin treating clients next week. This will be the second Awakn clinic operating in Norway with a further two clinics already based in the UK.

Awakn Clinics Trondheim is a 3-treatment room clinic situated in the center of Trondheim. The new clinic is part of the second stage of Awakn’s Nordic expansion plans, following on from last November’s announcement of a move to a larger premises for its Oslo clinic, which is scheduled for Q2 2023.

Awakn’s Nordic expansion is being led by its Regional Director of the Nordics, Dr. Lowan Stewart a renowned figure in the Nordic medical community. He was responsible for the adoption of ketamine therapy into the public healthcare system in Norway.

There has been a groundswell of support for ketamine to be more broadly adopted as a treatment for mental health conditions in Norway. Lars Lien, leader of the Norwegian Psychiatric Association, wrote an editorial in Norway’s most popular paper urging the health department tospeed up the process in the last few weeks.

Anthony Tennyson, Awakn's CEO commented, "We are delighted to open our second clinic in Norway and our fourth clinic overall. Our goal as a company is to provide our breakthrough therapeutics to the vast number of people who are in desperate need of a new and more effective treatment option. Our new clinic in Trondheim does exactly this and allows us to provide these treatments to a whole new cohort of people in central Norway.”

The Trondheim clinic will be led by Dr. Ingrid Castberg, a prominent and well-respected psychiatrist in Norway.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

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

February 9, 2023

Awakn Life Sciences Initiates Feasibility Study For MDMA Using Catalent’s Zydis® Orally Disintegrating Tablet (ODT) Technology

TORONTO, CANADA, February 9, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), today announced it has initiated a feasibility study of MDMA leveraging Catalent’s proprietary Zydis® ODT fast dissolve technology.

Zydis ODT is a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, allowing for dosing with no water required. When formulated appropriately, the technology affords the potential for better pre-gastric absorption, a more efficient delivery, rapid onset of effects, an enhanced patient experience and compliance.

The study is focused on establishing the feasibility of using Catalent’s Zydis ODT technology for the formulation and delivery of MDMA. A variety of chemical parameters are presently being evaluated to access preliminary formulations and, if proven to be feasible, a viable production formulation will be developed. The ultimate aims of the study are to optimise the delivery of MDMA to minimise the amount of drug required to deliver efficacy, minimise variability in absorption, and to increase the overall speed of onset.

Due to the faster onset of effects of Zydis ODT technology, there is the possibility to shorten therapy sessions and, through pre-gastric absorption and bypassing of the first-pass metabolism, there is potential to enhance pharmacokinetics.

Shaun McNulty, Awakn’s CSO, commented on the news, “Catalent is a world leader in the field of formulation and their Zydis ODT technology is the gold standard for rapid, safe, and consistent delivery of drugs to patients. The Zydis platform offers the potential to minimise both MDMA dose and the duration of therapy sessions. This study has the potential to demonstrate that Zydis ODT technology can provide an ideal MDMA formulation option both for patients and for health care providers.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

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.

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

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

February 7, 2023

Awakn Life Sciences Granted Fast-Track Designation From UK Regulator For Ketamine-Assisted Therapy For Alcohol Use Disorder

Designation Aims to Accelerate Time to Market

TORONTO, CANADA, February 7, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted Awakn an Innovation Passport as part of the Innovative Licensing and Access Pathway (ILAP) for its proprietary ketamine-assisted therapy for the treatment of Severe Alcohol Use Disorder. 

Alcohol use disorders affect 285 million people globally, of these circa. 25% or 70m people suffer with Severe Alcohol Use Disorder.

ILAP aims to accelerate time to market, facilitating patient access. Similar to the FDA’s fast-track program in the United States, the U.K.’s MHRA Innovation Passport provides Awakn with access to specialist advice from the MHRA and its partners, including the National Institute of Health and Care Excellence (NICE). Throughout the therapeutic development process this has the potential to enable a more efficient, and ultimately a faster route to marketing authorization.

The ILAP provides a single integrated platform for sustained collaborative working among the MHRA, several key bodies and the therapeutics developer, allowing for earlier engagement, enhanced coordination and monitoring of important product development activities culminating in market authorisation. This also has the potential to allow the National Health Service (NHS) to adopt potential treatments faster and ultimately enable quicker patient access to these potential medicines. Under the ILAP, Awakn will have access to a toolkit to support all stages of the design, development, and approvals process, as well as identify key areas for future agency engagement.

Anthony Tennyson Awakn CEO commented “Ensuring our therapeutics reach people who need them most is our key priority as a company. Having an innovation passport gives us the opportunity working with the regulators to find the most efficient pathway to marketing authorization and ultimately and most importantly to those people who desperately need it. We are very grateful to the MHRA and its partners for identifying the vast potential in our treatment.

Professor Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy added “The award of Innovation Passport status validates development of our highly innovative therapeutic approach of using ketamine-assisted psychotherapy to treat severe alcohol use disorder and our desire to bring this therapeutic approach to patients as rapidly as possible. This will enable us to build optimally on the excellent phase II proof of concept study as we work in partnership towards marketing authorization.  We look forward to working closely with the MHRA, NICE and partners to accelerate our planned phase 3 clinical trial, to be undertaken in collaboration with the NIHR, MRC, NHS, and Exeter University.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 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  |  Facebook | www.AwaknClinics.com

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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