August 28, 2024

Awakn Announces Key Progress in Pre-clinical Program

Toronto, Canada, August 28, 2024Awakn Life Sciences Corp. (CSE: AWKN, OTCQB: AWKNF), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, is pleased to provide an update on the progress of its pre-clinical program being executed as part of a commercial collaboration with Graft Polymer (UK) Plc (LON: GPL) (“Graft Polymer”), an innovative healthcare industry services company.

The collaboration focuses on developing a new class of therapeutics for the potential treatment of trauma-related mental health disorders, such as Post-Traumatic Stress Disorder (“PTSD”), which affects approximately 13 million adults in the U.S. and 20 million collectively in the US and other key international markets.

Recent progress includes:

  • Lead chemical series identified: Two chemical series have been identified as co-leads for further development. These series represent a promising new class of compounds with the potential to improve treatment options for trauma-related mental health disorders such as PTSD. The selection of these co-lead candidates is a pivotal step in the drug development process.
  • Synthesis pathways defined: Thesynthesis pathways for these compounds successfully established. This achievement is crucial, as it enables efficient and scalable production of the drug candidates, which will be essential as the collaboration moves towards more advanced pharmacological testing.
  • Charnwood Discovery selected as synthesis partner: Awakn has selected Charnwood Discovery, a respected UK-based provider of drug discovery services, as its synthesis partner. The selection of Charnwood Discovery, known for its technical expertise, ensures that the synthesis process will be conducted to a high standard.
  • New provisional patent filed: On 27 August 2024, Awakn filed a provisional patent application with the US Patent and Trademark Office, covering a new class of aminoindane chemical entities and their derivatives. This provisional patent has been incorporated into the scope of the commercial collaboration agreement between the Company and Awakn. This filing strengthens the intellectual property portfolio underpinning the Graft Polymer-Awakn collaboration, further reinforcing the Company’s competitive edge in the biopharmaceutical market.

Anthony Tennyson, CEO of Awakn Life Sciences, commented: “We are making great strides in our collaboration with Graft Polymer as we move closer to developing a new class of therapeutics to tackle PTSD and other trauma-related conditions. These advancements represent a major step forward in our mission to deliver more effective solutions for those suffering from mental health disorders.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders. Awakn has a near-term focus on AUD , a condition affecting approximately 29 millionadults in the US and approximately 40 million in the US and key European markets 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 commercialising our R&D pipeline across multiple channels.

www.awaknlifesciences.com | LinkedIn | X (formerly Twitter) 

About Graft Polymer (UK) Plc

Graft Polymer Plc is an innovative healthcare services company dedicated to helping biopharmaceutical companies specializing in central nervous system disorders enhance the effectiveness of their therapeutics.

www.graftpolymer.co.uk | LinkedIn | X (formerly Twitter) 

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@awaknlifesciences.com

416-270-9566

August 9, 2024

Awakn Announces First Patient Screened in Phase 3 Clinical Trial of AWKN-001 for Severe Alcohol Use Disorder

Toronto, Canada, August 9, 2024 - Awakn Life Sciences Corp. (CSE: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn” or the “Company”), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, with a near-term focus on Alcohol Use Disorder (“AUD”), announces that the first patient has been screened in the landmark ‘MORE-KARE’ Phase 3 trial of AWKN-001 for severe AUD.

AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support for severe AUD.

The MORE-KARE study, or the Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse, is co-funded by a partnership between the UK’s Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), and Awakn Life Sciences Corp. It is managed by the Exeter Clinical Trials Unit.

The Phase 3 trial aims to evaluate the effectiveness of a single treatment cycle of AWKN-001. Participants will be randomly allocated into a trial arm, receiving different doses of ketamine infusion along with psycho-social support sessions from a trial therapist. The specific dose and type of psychological support for each participant will be randomly assigned by a computer. Both participants and the research team will be blinded to the assigned dose/support.

The primary endpoint is the reduction in heavy drinking days (HDD) over a six-month period post-treatment. Secondary endpoints include continuous abstinence and the percentage of HDD at the six-month follow-up. The effectiveness of the treatment will be assessed using drink diaries and daily self-administered breathalyser tests, with follow-up visits at three and six months.

This study is the largest of its kind investigating ketamine-assisted therapy for AUD. The total trial cost is estimated at £2.4 million / CAD 4.2 million, with Awakn contributing £0.8 million / CAD 1.4 million. The trial is being conducted at eight National Health Service (NHS) sites across the UK.

Trial lead Professor Celia Morgan, from the University of Exeter, said: “More than half a million UK adults have serious alcohol problems that require help, yet only one in five of those get treatment. Current treatments have low success rates - we know that three out of four people who quit alcohol will be back drinking heavily after a year. This new trial is helping to fill the gap in the urgent search for new treatments. We’re excited that the NIHR and Awakn Life Sciences have funded this study, which is the largest study of ketamine combined with psychological therapy to take place anywhere in the world.” 

Awakn's Chief Scientific Officer, Professor David Nutt, added: "This trial could potentially revolutionize the treatment landscape for severe AUD, offering hope to those who currently have limited options. We're excited to see the impact of combining ketamine with structured psychological support."

About AWKN-001

AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support in the UK market only.

A phase 2 trial was successfully completed with efficacy proven, achieving 86% abstinence on average over the 6 months post-treatment versus 2% pre-trial and a 50% reduction in HDD versus placebo.

A phase 3 clinical trial (“MORE KARE”) is being run by the University of Exeter with participant recruitment due to start in Q3 2024. This trial is co-funded by the Efficacy and Mechanism Evaluation (EME) Programme - a partnership between the UK’s National Institute for Health Research (NIHR) and the Medical Research Council (MRC) - and Awakn Life Sciences Corp.

About Alcohol Use Disorder

AUD is a chronic, relapsing brain health disorder characterised by compulsive alcohol use, loss of control over drinking, and negative emotional states when not using alcohol. AUD affects approximately 29[1] millionadults in the US and approximately 40 million[2,3,4,5,6] in the US and key European markets. Despite this high prevalence treatment success rates are very low with up to 75% of patients with AUD returning to harmful drinking within 12 months of treatment[7]. This creates a significant unmet medical need and a substantial public health concern, with enormous economic cost of approximately $249 billion in the US[8], rising to approximately US$472 billion[9,10,11,12,13] when including key European markets.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders. Awakn has a near-term focus on AUD , a condition affecting approximately 29 million[1] adults in the US and approximately 40 million[2,3,4,5,6] in the US and key European markets 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 commercialising our R&D pipeline across multiple channels.

www.awaknlifesciences.com | LinkedIn | X (formerly Twitter) 

About University of Exeter

The University of Exeter is the sponsor of this clinical trial with overall trial management, data management and statistical analysis provided in collaboration with the Exeter Clinical Trials Unit (University of Exeter).  At the University of Exeter, we combine teaching excellence and high levels of student satisfaction with world class research at our campuses in Exeter and Cornwall. We are a member of the Russell Group of leading research-intensive universities.

About NIHR

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

  • Funding high quality, timely research that benefits the NHS, public health and social care;
  • Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
  • Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
  • Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
  • Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
  • Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.

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@awaknlifesciences.com

416-270-9566

Sources

  1. US Substance Abuse and Mental Health Services (SAMHSA), 2022 National Survey on Drug Use and Health
  2. UK The National Institute for Health and Care Excellence (NICE) - Alcohol-use disorders diagnosis, assessment and management of harmful drinking (high-risk drinking) and alcohol dependence
  3. Jahrbuch Sucht 2020 der Deutschen Hauptstelle für Suchtfragen
  4. Inserm. Reducing the harm associated with alcohol consumption. Summary and recommendations. Collection Expertise collective. Montrouge: EDP Sciences, 2022.
  5. Istituto Superiore di Sanità EpiCentro
  6. Monografía. Alcohol 2021: Consumo y Consecuencias
  7. Mekonen, T., Chan, G. C. K., Connor, J., Hall, W., Hides, L. and Leung, J. (2021) 'Treatment rates for alcohol use disorders: a systematic review and meta-analysis'
  8. Sacks JJ, Gonzales KR, Bouchery EE, Tomedi LE, Brewer RD. 2010 National and State Costs of Excessive Alcohol Consumption.
  9. Lister, G. et al (2006), Comparing the Societal Impacts of Common Health Risks. National Social Marketing Centre.
  10. DHS Jahrbuch Sucht 2020 der Deutschen Hauptstelle für Suchtfragen (DHS)
  11. Le Cout Social des Drogues: Estimation en France. Le Cout Social des Drogues: Estimation en France
  12. OECD: Preventing Harmful Alcohol Use: Italy
  13. Alcohol consumption in Spain and its economic cost: A mathematical modeling approach. Francisco-José Santonja, Emilio Sánchez, María Rubio, José-Luis Morera

July 31, 2024

Awakn Life Sciences Announces Closing of Tranche of Private Placement and Warrant Extension

TORONTO, CANADA, July 31, 2024 – Awakn Life Sciences Corp. (CSE: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn” or the “Company”) a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, with a near-term focus on Alcohol Use Disorder (“AUD”), is pleased to announce that, further to its press releases dated April 3, 2024, April 17, 2024, and June 4, 2024 it has closed a third tranche of its previously announced non-brokered private placement (the “Offering”) through the issuance of an additional 428,571 units (the "Units") at a price of $0.46 per Unit for additional gross proceeds of $197,143.

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.

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. 

In addition to this, the Company has also elected to extend the expiry date of 5,610,920 common share purchase warrants, each warrant with an exercise price of $0.68.  The following warrants have been extended:

  • 1,933,654 warrants issued on September 14, 2022, with an initial expiry date of September 14, 2024, has been extend to September 14, 2027.
  • 3,677,266 warrants issued on November 16, 2022, with an initial expiry date of November 16, 2026 have been extended to November 16, 2027.

A total of 85,000 Warrants are held by parties considered to be "related parties" of the Company. Therefore, the Warrant Amendment constitutes a "related party transaction" as contemplated by Multilateral Instrument 61-101 Protection of Minority Shareholders in Special Transactions. However, the exemptions from formal valuation and minority approval requirements provided for by these guidelines can be relied upon as the fair market value of the Warrants held by insiders does not exceed 25% of the market capitalization of the Company.

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

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders. Awakn has a near-term focus on Alcohol Use Disorder, a condition affecting approximately 29 millionadults in the US and approximately 40 million in the US and key European markets 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 commercialising our R&D pipeline across multiple channels. 

www.awaknlifesciences.com | LinkedIn | X (formerly Twitter) 

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@awaknlifesciences.com

416-270-9566

July 23, 2024

Awakn Life Sciences Provides Update on Aminoindane New Chemical Entity Patent Portfolio

Toronto, Ontario- (July 22, 2024) - Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, with a near-term focus on Alcohol Use Disorder ("AUD"), is pleased to provide details of the status of the intellectual property ("IP") portfolio for its aminoindane new chemical entity ("NCE") series program (the "Aminoindane NCEs") being developed in commercial collaboration with Graft Polymer (UK) Plc (LSE: GPL) ("Graft"). Details of the commercial collaboration agreement with Graft were announced on July 18, 2024.

The Aminoindane NCEs

The Aminoindane NCEs are novel small molecule empathogens that promote the release of serotonin, dopamine, and noradrenaline while blocking their reuptake. These compounds have potential in trauma-related mental health disorders such as post-traumatic stress disorder ("PTSD"), which affects approximately 13 million[1] adults in the U.S. and 20 million[2,3,4] in key international markets.

Patent Status in the U.S. and Key International Markets

In 2021 Awakn filed provisional patent applications covering the Aminoindane NCEs, their pharmaceutical compositions, and innovative treatment methods for substance use and mental health disorders. The patent portfolio is now progressing well across multiple jurisdictions:

  • United States: The fast-tracked U.S. application, facilitated by the Patent Prosecution Highway ("PPH"), is under examination. Positive evaluations from the International Searching Authority ("ISA") suggest a promising path to a granted U.S. patent.
  • Europe: The European application is pending, with substantive examination expected to begin soon. European patent counsel is optimistic about securing a granted patent, particularly for claims deemed novel and inventive by the European Patent Office ("EPO") examiner.
  • Canada: The Canadian application, pending examination, also holds strong prospects for a granted patent. The examination process in Canada can be expedited using the PPH, enhancing IP protection efficiency.

IP Protection Progress to Date

In May 2021, Awakn initiated its IP protection strategy for the Aminoindane NCEs by filing two provisional patent applications. These applications cover the Aminoindane NCEs, their pharmaceutical compositions, and innovative methods for treating substance use disorders and mental health disorders. This foundational step laid the groundwork for subsequent advancements in IP protection.

In May 2022, Awakn filed a Patent Cooperation Treaty ("PCT") application, claiming the benefit of priority to both provisional applications.

In August 2022, an examiner from the EPO, acting as the ISA, issued a search report and written opinion, confirming the pharmaceutical composition and method of use claims for all of Awakn's lead compounds to be both novel and inventive.

In November 2022, the PCT application published as WO2022/238507A1.

In November 2023, the International Preliminary Report on Patentability was received and Awakn entered the PCT into national phase in the US and Canada, and in December, into European regional phase.

In April 2024, a petition to accept the U.S. application onto the PPH was granted based on the novel and inventive claims deemed allowable in the PCT written opinion, indicating a likely U.S. patent grant.

Prof. David Nutt, Awakn's Chief Scientific Officer, commented, "These advancements in our patent portfolio are a testament to the innovative potential of our Aminoindane NCEs. We are committed to progressing these compounds through the development pipeline to address the substantial unmet needs in mental health and addiction treatment."

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders. Awakn has a near-term focus on Alcohol Use Disorder, a condition affecting approximately 29 million adults in the US and approximately 40 million in the US and key European markets 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 commercialising our R&D pipeline across multiple channels.

awaknlifesciences.com | LinkedIn | X (formerly Twitter)

About Graft Polymer (UK) Plc

Graft Polymer (UK) Plc (LSE: GPL) is an innovative developer of biopolymer drug delivery systems dedicated to assisting biopharmaceutical companies in enhancing the effectiveness of their therapeutics. Our proprietary patented platform, a bioabsorbable self-nanoemulsifying drug delivery system (SNEDDS), represents a cutting-edge solution in drug delivery technology. By integrating active pharmaceutical ingredients (APIs) into our novel, patented delivery systems, we enable clients to improve the bioavailability, pharmacokinetics, and stability of their therapeutics.

www.graftpolymer.co.uk | LinkedIn | X (formerly Twitter)

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@awaknlifesciences.com

Sources

  1. US VA National Center for PTSD. US Department of Veterans Affairs.
  2. UK National Health Service (NHS), Adult Psychiatric Morbidity Survey: Survey of Mental Health and Wellbeing, England, 2014.
  3. Maercker, A., Forstmeier, S., Wagner, B. et al. Posttraumatische Belastungsstörungen in Deutschland. Nervenarzt 79, 577-586 (2008).
  4. Nemeroff, Charles B., and others, 'Trauma and PTSD in Europe', in Charles B. Nemeroff, and Charles Marmar (eds), Post-Traumatic Stress Disorder (New York, 2018; online edn, Oxford Academic, 1 Sept. 2018)

July 18, 2024

Awakn Announces Collaboration Agreement with Graft Polymer (UK) Plc

TORONTO, CANADA, July 18, 2024 – Awakn Life Sciences Corp. (CSE: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn” or the “Company”), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, with a near-term focus on Alcohol Use Disorder (“AUD”), is pleased to announce that it has entered into a commercial collaboration agreement dated July 17, 2024 (the “Collaboration Agreement”) with Graft Polymer (UK) Plc (LON: GPL) (“Graft”), an innovative biopolymer drug delivery systems development company. The collaboration is focused on developing Awakn’s novel aminoindane new chemical entity series programme (the “Aminoindane NCEs”) which have potential in trauma-related mental health disorders, developed as part of Awakn’s previous new chemic entity research program.

The collaboration involves the joint development and potential commercialization of the Aminoindane NCEs, with an initial phase focused on completing certain pre-clinical research activities. The Aminoindane NCEs are novel small molecule empathogens with potential applications in trauma related mental health disorders such as post-traumatic stress disorder (“PTSD”), which affects approximately 13 million[1] adults in the US and approximately 20 million[2,3,4] in the US and other key international markets.

The NCE program will be led by Awakn’s Chief Scientific Officer, the globally renowned neuroscientist and psychiatrist, Prof. David Nutt.

Under the Collaboration Agreement, Graft will initially contribute £300,000 and expertise in novel drug delivery systems to potentially enhance the bioavailability and improve the pharmacokinetics of the Aminoindane NCEs. Awakn will contribute intellectual property, relevant small molecule development expertise, and management resources. Future funding of the collaboration is intended to be split equally between Awakn and Graft, and Awakn has agreed to grant Graft a royalty of initially 40% of the future net income generated by the Aminoindane NCEs, such royalty to be adjusted based on the actual proportional split between the parties of future funding.

Nicholas Nelson, Chairman of Graft Polymer (UK) Plc, commented: "We are pleased to partner with Awakn on this innovative program. This collaboration aligns perfectly with our mission to leverage our proprietary drug delivery systems to enhance therapeutic treatments' effectiveness. We believe our contribution and expertise will significantly aid the success of Awakn’s research program, potentially making a substantial positive impact on the treatment of trauma-related mental health disorders."

Prof. David Nutt, CSO of Awakn, commented: "This collaboration with Graft is a significant step forward for our new chemical entity program. Graft’s expertise in drug delivery systems will be invaluable as we advance our research. We are confident that this partnership will accelerate the development of new therapeutic options for addiction and mental health, areas in desperate need of innovative solutions."

Awakn’s CEO, Mr. Anthony Tennyson, also serves as CEO of Graft. To mitigate any potential conflict of interest, Awakn formed a special committee of independent members of the board of directors who have reviewed and approved the Collaboration Agreement.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting approximately 29 million[5] adults in the US and approximately 40 million[6,7,8,9,10] in the US and key European markets for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction and mental health sufferers in desperate need and our strategy is focused on commercialising our R&D pipeline across multiple channels.

www.awaknlifesciences.com | LinkedIn | X (formerly Twitter) 

About Graft Polymer (UK) Plc

Graft Polymer (UK) Plc (LSE: GPL) is an innovative developer of biopolymer drug delivery systems dedicated to assisting biopharmaceutical companies in enhancing the effectiveness of its therapeutics. Its proprietary patented platform, a bioabsorbable self-nanoemulsifying drug delivery system (SNEDDS), represents a cutting-edge solution in drug delivery technology. By integrating active pharmaceutical ingredients (APIs) into novel, patented delivery systems, Graft can enable clients to improve the bioavailability, pharmacokinetics, and stability of therapeutics.

www.graftpolymer.co.uk | LinkedIn | X (formerly Twitter) 

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@awaknlifesciences.com

  1. US VA National Center for PTSD. US Department of Veterans Affairs.
  2. UK National Health Service (NHS), Adult Psychiatric Morbidity Survey: Survey of Mental Health and Wellbeing, England, 2014.
  3. Maercker, A., Forstmeier, S., Wagner, B. et al. Posttraumatische Belastungsstörungen in Deutschland. Nervenarzt 79, 577–586 (2008).
  4. Nemeroff, Charles B., and others, 'Trauma and PTSD in Europe', in Charles B. Nemeroff, and Charles Marmar (eds), Post-Traumatic Stress Disorder (New York, 2018; online edn, Oxford Academic, 1 Sept. 2018)
  5. US Substance Abuse and Mental Health Services (SAMHSA), 2022 National Survey on Drug Use and Health
  6. UK The National Institute for Health and Care Excellence (NICE) - Alcohol-use disorders diagnosis, assessment and management of harmful drinking (high-risk drinking) and alcohol dependence
  7. Jahrbuch Sucht 2020 der Deutschen Hauptstelle für Suchtfragen
  8. Inserm. Reducing the harm associated with alcohol consumption. Summary and recommendations. Collection Expertise collective. Montrouge: EDP Sciences, 2022.
  9. Istituto Superiore di Sanità EpiCentro
  10. Monografía. Alcohol 2021: Consumo y Consecuencias

June 4, 2024

Awakn Life Sciences Announces Closing of Tranche of Private Placement

TORONTO, CANADA, June 4, 2024 – Awakn Life Sciences Corp. (CSE: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn” or the “Company”) a clinical-stage biotechnology company developing medication-assisted treatments for addiction with a near-term focus on Alcohol Use Disorder, is pleased to announce that, further to its press releases dated April 3, 2024, and April 17, 2024, it has closed a second tranche (the “Second Tranche”) of its previously announced non-brokered private placement (the “Offering”) through the issuance of an additional 857,142 units (the "Units") at a price of $0.46 per Unit for additional gross proceeds of $394,285.

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.

All securities issued in connection with the Offering will be subject to a hold period of four months plus a day from the date of issuance and the resale rules of applicable securities legislation. 

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

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting addiction. Awakn has a near-term focus on Alcohol Use Disorder, a condition affecting 40 million people in the US and key international markets and 285m people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. 

www.awaknlifesciences.com  |  Twitter  | LinkedIn 

Notice Regarding Forward-Looking Information

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

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: 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

416-270-9566

May 7, 2024

Awakn Life Sciences Discusses Filing of Financial Statements

Toronto, Ontario--(Newsfile Corp. - May 2, 2024) - Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing medication-assisted treatments for addiction with a near-term focus on Alcohol Use Disorder (AUD), announces that, it intends to file its audited annual financial statements and MD&A for the financial year ended January 31, 2024 (the "Financial Statements") by May 30, 2024, in line with the standard timeline applicable to venture issuers.

As previously disclosed in its press release dated February 12, 2024, on such date the Company delisted its common shares from Cboe Canada ("Cboe") and listed them on the Canadian Securities Exchange ("CSE"). The change of stock exchange resulted in the Company continuing as a venture issuer under applicable Canadian securities law, and the Company prepared its audit for the financial year ended January 31, 2024 based on the filing deadline applicable to venture issuers, being 120 days from the financial year end. However, the Company has been alerted that, since the listing on the CSE occurred twelve days following the end of the financial year, that technically the Financial Statements remain subject to the filing deadline for non-venture issuers, being 90 days from the financial year end. As a result of this condensed timeline, the Company has been notified by the Ontario Securities Commission that it is late filing the Financial Statements and that it intends to commence the process of issuing a cease-trade order against the Company if the Financial Statements are not filed by 3:00p.m. (EST) on May 7, 2024.

The audit is being carried out by the Company's auditor MNP LLP, and the Company expects that the audit will be completed and the Financial Statements filed by May 30, 2024. If a cease trade order is issued against the Company, it will be revoked when the Financial Statements are filed.

Considering the foregoing factors, the Company has made an application with th applicable securities regulators under National Policy 12-203 - Cease Trade Orders for Continuous Disclosure Defaults ("NP 12-203") requesting that a management cease trade order be imposed in respect of the anticipated late filing rather than an issuer cease trade order. The issuance of a management cease trade order does not affect the ability of persons who have not been directors, officers, or insiders of the Company to trade in their securities. In the event that the MCTO application is rejected by the Ontario Securities Commission, the Company expects that a full cease trade order will be issued by the Ontario Securities Commission sometime shortly after May 7, 2024.

The Company confirms that it will satisfy the provisions of the alternative information guidelines under NP 12-2023 by issuing by-weekly default status reports in the form of news releases for so long as it remains in default of the filing requirements to file the Financial Statements and MD&A within the prescribed period of time. The Company confirms that there is no other material information relating to its affairs that has not been generally disclosed.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 40 million people in the US and key international markets and 285m people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels.

www.awaknlifesciences.com | Twitter | LinkedIn

Notice Regarding Forward-Looking Information

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

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: 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.sedarplus.ca. 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
416-270-9566

April 19, 2024

Awakn Life Sciences Announces Closing of Tranche of Private Placement

TORONTO, CANADA, April 17, 2024 – Awakn Life Sciences Corp. (CSE: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn” or the “Company”) a clinical-stage biotechnology company developing medication-assisted treatments for addiction with a near-term focus on Alcohol Use Disorder (AUD), is pleased to announce that, further to its press release dated April 3, 2024, it has closed a first tranche (the “First Tranche”) of its previously announced non-brokered private placement (the “Offering”) through the issuance of an additional 285,714 units (the "Units") at a price of $0.46 per Unit for additional gross proceeds of $131,428.

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.

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

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

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 40 million people in the US and key international markets and 285m people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. 

www.awaknlifesciences.com  |  Twitter  |  LinkedIn 

Notice Regarding Forward-Looking Information

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

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: 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

416-270-9566

April 3, 2024

Awakn Life Sciences Announces Launch of Licensing Partnership with Oklahoma Based Clinic  

TORONTO, CANADA, April 03, 2024 – Awakn Life Sciences Corp. (CSE: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn” or the “Company”) a clinical-stage biotechnology company developing medication-assisted treatments for addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the launch of an additional Licensing Partnership agreement in North America. The agreement is with RivusWellness and Research Institute (“Rivus”), based in Oklahoma City. This is the first Licensing Partnership Awakn has in the U.S. southern states, opening up a whole new population and geographic region to the Awakn Kare 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.

Under the terms of the license agreement, signed May 18, 2023, and launched April, 2024, Awakn provides access to its proprietary therapeutics and training to the Rivus practitioners, and in return, Rivus will pay Awakn an annual fee and a revenue share per treatment.

The U.S. alcohol and substance addiction treatment industry is significant in size with 14,000+ treatment facilities across the country[1], with direct medical costs in the region of US30bn per annum[2] but with relatively poor treatment success rates. Awakn aims to improve the performance of the addiction industry by providing its license partners and clinic operators with access to an efficient and more effective treatment option under license.

Anthony Tennyson, Awakn CEO commented “We are excited to partner with Rivus and their excellent team, there is shared ethos and vision between the two organizations which is important. Being able to provide a whole new cohort of people in Oklahoma with a new more effective treatment option whilst they are in desperate need, is what drives us.”

Dr. Lane Peyton commented The Rivus Wellness and Research Institute has consistently served the Oklahoma City mental health community with innovative treatments, interventions, and preventions, and we feel that this partnership with Awakn Kare will benefit our patients tremendously. Rivus will continue to be at the forefront of the mental health industry as we continue to provide outstanding care to those in need. 

Financing:

On April 26th, 2023, and while listed on the CBOE Canada, Awakn announced a non-brokered private placement financing for gross proceeds of up to $3,000,000, which was upsized to $4,000,000 on June 15, 2023 at a price of CAD$0.46 per unit (the “Offering”). Each unit is comprised of one common share in the capital of the Company (each, a “Common Share”) and three quarters (0.75) of one whole Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant entitles the holder thereof to acquire one Common Share at a price of $0.63 per Common Share for a period of five (5) years from the date of issuance. On December 15, 2023 Awakn announced the closing of the fourth tranche of this financing for $230,000 and $2,964,663 in total.

On February 12, 2024 Awakn announced the listing of its common shares on the Canadian Securities Exchange (“CSE”) and delisting of its common shares from the Cboe Canada (“Cboe”). However, Awakn continues to receive funds under the terms of the previously announced non-brokered financing, and as such Awakn is pleased to today announce a new non-brokered financing on the CSE for gross proceeds of up to $1,000,000 at a price of CAD$0.46 per unit (the “Offering”). Each unit is comprised of one common share in the capital of the Company (each, a “Common Share”) and three quarters (0.75) of one whole Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant entitles the holder thereof to acquire one Common Share at a price of $0.63 per Common Share for a period of five (5) years from the date of issuance.

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

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

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 40 million people in the US and key international markets and 285m people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. 

www.awaknlifesciences.com  |  Twitter  |  LinkedIn 

About Rivus Wellness and Research Institute

Rivus Wellness and Research Institute is a team of medical and scientific professionals who are united by a passion for individual and community health. Rivus is led by Dr. Lane Peyton, a board certified psychiatrist who works with adults, adolescents, and the elderly in a psychotherapy-based clinic in Northwest Oklahoma City.

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

416-270-9566


[1] National Survey Of Substance Abuse Treatment Services (N-SSATS): 2020, Data On Substance Abuse Treatment Facilities

[2] Projections of National Expenditures for Treatment of Mental and Substance Use Disorders, 2010-2020

February 12, 2024

Awakn Announces Listing on the Canadian Securities Exchange

Toronto, Canada – February 12, 2024 - Awakn Life Sciences Corp. (Cboe CA: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a clinical-stage biotechnology company developing medication-assisted treatments for addiction with a near-term focus on Alcohol Use Disorder (“AUD”), is pleased to announce that it has received approval to have the common shares ("Common Shares") of the Company listed on the Canadian Securities Exchange (the "CSE") under the symbol "AWKN" at the opening of markets on February 13, 2024. Further to the Company’s press release dated November 10, 2023, the Company will no longer trade on Cboe Canada (”Cboe”) effective close of trading on February 12, 2024. No action is required by shareholders in connection with this change of listing.

Management is pleased about the listing of the Common Shares on the CSE and the opportunities it provides to its investors, as the Company continues the ongoing development of its business operations. In addition, the Company expects that being listed on a junior stock exchange will help reduce the regulatory compliance costs for the Company and allow it to preserve capital while it continues to undertake its growth process and path towards financial self-sustainability.

About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing medication-assisted treatments for addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting approximately 51 million people in the US and key European markets and 285 million people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. 

www.AwaknLifeSciences.com | Twitter | LinkedIn 
 

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

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

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

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


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

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