December 16, 2024

Awakn Enters Into Binding Letter of Intent for Acquisition of Awakn by Graft Polymer (UK) plc

TORONTO, CANADA, December 16, 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, is pleased to announce that it has entered into a binding letter of intent (the "LOI") dated December 15, 2024, with Graft Polymer (UK) PLC (“Graft”), pursuant to which Graft would acquire all of the issued and outstanding common shares (the "Common Shares") in the capital of the Company, all outstanding restricted share units (the "RSUs") in the capital of the Company, and all outstanding deferred share units (the "DSUs") in the capital of the Company, to be carried out by way of a statutory plan of arrangement in British Columbia (the "Proposed Transaction").

Graft is biotechnology company incorporated in the United Kingdom with its ordinary shares listed on the London Stock Exchange under the symbol “GPL”,and is currently focused on developing intellectual property and co-developing therapeutics for mental health and substance use disorders. Anthony Tennyson, the Chief Executive Officer and a director of Awakn, was also appointed as Graft’s part-time Chief Executive Officer and to its board of directors in May 2024.

Under the terms of the LOI, each Awakn shareholder will receive 46.67 ordinary shares in the capital of Graft (the “Consideration Shares”) (each, a "Graft Share") for each one (1) Common Share held. Holders of RSUs and DSUs will receive 46.67 Graft Shares for each one (1) DSU and one (1) RSU, respectfully. All issued and outstanding Common Share purchase warrants (each, a "Warrant") shall be converted into or exchanged for new ordinary share purchase warrants (each, a "Graft Warrant") with adjustments to: (i) the number of Graft Shares issued upon exercise of the Warrants; and (ii) the exercise price, such that the Warrant holder will be entitled to receive upon exercise of the Graft Warrants that number of Graft Shares at such exercise price that the holder would have been entitled to receive had it exercised the Warrants immediately prior to the closing of the Proposed Transaction. It is intended that Awakn will seek consent from holders of outstanding stock options to cancel such options.

The number of Consideration Shares, based on the latest valuation of Graft on the LSE, is 2,074,378,592, resulting in a total acquisition price of $8,890,194, using an exchange rate of 0.56 GBP:CAD.  This results in the Company’s Common Shares being valued at $0.20 per Common Share, which is a 110.54% premium to the closing share price of Awakn’s Common Shares on the Canadian Securities Exchange on December 13, 2024 and a 88.69% premium to a 90-day VWAP.

“This proposed acquisition by Graft Polymer marks a significant milestone for Awakn Life Sciences and our mission to provide breakthrough therapeutics for substance use and other mental health disorders.  We have had a significant portion of our operations in the UK for the entire life of our business and following completion of the Proposed Transaction, Awakn will have access to the UK’s deep pool of liquidity as well as the international investor base positioned in London. We believe this transaction will create long-term value for our shareholders and provide new opportunities for growth and collaboration.” stated George Scorsis, Chairman of the Board of Directors and Special Committee.

Dennis Purcell, Chairman of Graft Polymer, commented: “This proposed acquisition marks an important milestone for Graft Polymer as we broaden our focus to address the pressing global challenges of addiction and mental health disorders. Awakn’s advanced research and clinical programs offer the potential to develop more effective and accessible treatments for these critical areas of need. We believe this strategic move will not only drive value for our shareholders but also contribute meaningfully to improving the lives of millions impacted by these conditions.”

The LOI has been unanimously approved by the respective boards of Awakn and Graft. The board of directors of Awakn (the "Awakn Board") formed a special committee of independent directors (the "Special Committee") to, among other things, oversee the negotiations of the terms of the LOI, as Anthony Tennyson is the Chief Executive Officer of both Awakn and Graft.

The Special Committee, following its review of the terms and conditions of the LOI and, in consideration of a number of factors including the premium to be received by shareholders of Awakn, opportunities for the business of Awakn upon completion of the Proposed Transaction, the alternatives available to Awakn, and the conditions to close the Proposed Transaction (including a due diligence review to the satisfaction of Awakn), unanimously recommended that the Awakn Board approve the LOI. After receiving the recommendation of the Special Committee and advice from its advisors, the Awakn Board, with Mr. Tennyson recusing himself from the vote, has unanimously approved, the execution of the LOI. As Mr. Tennyson has recused himself from Awakn Board discussions and the vote approving the LOI, Awakn expects that the Proposed Transaction will be considered an arms-length transaction.

Prior to executing the definitive transaction agreement in connection with the Proposed Transaction, the Special Committee intends to procure a fairness opinion regarding the consideration to be received by shareholders of Awakn pursuant to the Proposed Transaction.  

The Proposed Transaction is deemed to be a Fundamental Change (as defined in the policies of the Canadian Securities Exchange (the "CSE") and the trading of the Common Shares shall remain halted until the completion of the Proposed Transaction in accordance with CSE Policy 8.

Completion of the Proposed Transaction, which must occur by June 15, 2025 (the "Long Stop Date"), is subject to customary conditions including, but not limited to: (i) satisfactory due diligence completed by both parties; (ii) approval of the boards of directors of both parties; (iii) court approval of the plan of arrangement; (iv) the Company and Graft entering into a definitive agreement; (v) the approval of shareholders of the Company for Proposed Transaction and shareholders of Graft to issue the Consideration Shares; (vi) receipt of all required third party consents, including approval by the CSE and the United Kingdom Financial Conduct Authority;  and (vii) Graft completing a financing of no less than eighteen months working capital (the "Concurrent Financing").

Following completion of the Proposed Transaction, the Common Shares will be delisted from the CSE and Awakn will apply to cease to be a reporting issuer in Canada.

The LOI includes customary termination provisions, including the provision that if Proposed Transaction does not close by the Long Stop Date, the LOI will automatically be terminated.

About Graft

Graft Polymer (LON:GPL), is UK incorporated LSE listed innovative biotechnology company focused on developing intellectual property and co-developing therapeutics for mental health and substance use disorders. Its therapeutic priorities include trauma-related mental health disorders such as PTSD, which affects approximately 13 million adults in the U.S. and 20 million across the US, UK, and key EU markets. The company emphasises growth through strategic collaborations, joint ventures, and acquisitions.

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:

Jonathan Held, CFO, Awakn Life Sciences

jonathanh@awaknlifesciences.com

416-270-9566

December 11, 2024

Awakn Announces Promising Results from Aminoindane New Chemical Entity Pre-Clinical Program

Toronto, Canada – December 11, 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, today announces initial results from a preclinical study of its co-lead aminoindane series (AW21003) conducted by the University of Nottingham. This program focuses on new therapeutic options for trauma-related mental health disorders, particularly Post-Traumatic Stress Disorder (PTSD).

Aminoindanes are a class of compounds being explored in pre-clinical models by Awakn for their ability to promote pro-social behavior with a potentially improved safety profile compared to existing options under investigation for PTSD. Pro-social behavior, which includes actions that foster trust, empathy, and social bonding, is increasingly recognized as a key factor in addressing PTSD. Enhancing these behaviors could help individuals with PTSD overcome feelings of isolation, rebuild interpersonal relationships, and engage more effectively in therapeutic interventions.

Study Highlights:

  • Social Interaction and Information Transfer: AW21003 demonstrated the ability to enhance the speed at which observer animals consumed a demonstrated (correct) versus novel (incorrect) flavored diet, suggesting a positive impact on social transfer and retention of information.
  • Behavioral Safety Indicators: Unlike MDMA, the test standard, which is known to cause stereotyped behaviors such as flat body posture and lateral head weaving in similar studies, no such behaviors were observed in AW21003-treated animals. This suggests a favorable safety profile for AW21003.
  • Unique Observations: Test-standard treated animals unexpectedly showed a preference for the correct diet, suggesting baseline pro-social tendencies in the experimental design. AW21003-treated animals displayed complex outcomes in food intake preferences, warranting further analysis.

The study, announced on October 15, 2024, was led by Dr. Madeleine King, Assistant Professor in the School of Life Sciences in the Faculty of Medicine & Health Sciences at the University of Nottingham.

Awakn’s aminoindane NCE program, developed in collaboration with Graft Polymer (UK) Plc, is designed to address significant unmet medical needs, including PTSD, which affects approximately 13 million adults in the U.S. and 20 million individuals across the U.S., UK, and Europe.

Next Steps

Based on these promising early results, Awakn will expand its aminoindane program to synthesize a further range of aminoindane compounds in collaboration with Concept Life Sciences. These compounds will be screened against serotonin, dopamine, and norepinephrine release. Additional preclinical behavioral studies with the University of Nottingham are also planned to further explore and validate the therapeutic potential of this class of compounds.

Dr. Madeleine King of the University of Nottingham commented “These findings appear extremely promising for the aminoindane new chemical entities. AW21003 showed positive effects on social transfer of information, without any of the additional unwanted behaviors induced MDMA. I am excited to continue our collaboration with Awakn as they move to the next phase of their pre-clinical program”.

Professor David Nutt, Chief Research Officer of Awakn, commented: "These findings represent an important milestone in our aminoindane program. The ability to develop compounds that combine therapeutic efficacy with improved safety has transformative potential for treating PTSD and other trauma-related conditions."

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 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.

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.tennyson@awaknlifesciences.com

416-270-9566

October 22, 2024

Awakn Announces Opening of Four Additional Awkn-001 Phase 3 Trial Sites

Toronto, Canada – October 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, announces the opening of four additional clinical trial sites: University Hospitals Sussex NHS Foundation Trust; South London and Maudsley NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust; and University Hospitals Plymouth NHS Trust. This brings the total active trial sites to seven 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 at the University of Exeter.

The Phase 3 trial aims to evaluate the efficacy 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.

Anthony Tennyson, CEO, Awakn, commented: “The expansion of trial sites marks a significant milestone in our mission to address the pressing need for innovative treatments for AUD. We are confident that AWKN-001, has the potential to change the standard of care for individuals suffering from severe alcohol use disorder in the UK, offering them a novel, more effective treatment pathway.”

Prof. David Nutt, Chief Research Officer of Awakn, added: “The opening of these additional sites accelerates our ability to gather robust clinical data, essential for bringing this groundbreaking treatment to more patients. With the support of the UK’s leading research institutions, we are well-positioned to demonstrate the effectiveness of AWKN-001.”

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.

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 Heavy Drinking Days versus placebo.

A phase 3 clinical trial (“MORE KARE”) is being run by the University of Exeter. 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 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 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.

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

About the 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 The National Institute for Health and Care Research (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.

About the Medical Research Council

The UKRI Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers’ money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed.

Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation. 

www.mrc.ukri.org

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

October 15, 2024

Awakn Partners with the University of Nottingham for In Vivo Testing of Aminoindane New Chemical Entity Pre-Clinical Program

Toronto, Canada – October 15, 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, announces a new research partnership with the University of Nottingham, UK. This collaboration focuses on evaluating Awakn’s co-lead aminoindane series and its potential to enhance social cognition and pro-social behaviors.

The study will be led by Dr Madeleine King, Assistant Professor in the School of Life Sciences in the Faculty of Medicine & Health Sciences at the University of Nottingham, a globally recognized institution for its cutting-edge neuroscience research. Dr King, an expert in behavioral neuroscience with over 20 years of experience, is renowned for her contributions to translational research in psychiatric disorders. The study will use the Social Transmission of Food Preferences (STFP) test in rodent models. Conducted over a two-month period, the preclinical trials will explore varying dosages, with results expected by the end of 2024.

Awakn’s aminoindane NCE program, developed in collaboration with Graft Polymer (UK) Plc, focuses on creating new therapeutic options for trauma-related mental health disorders, particularly PTSD. PTSD affects approximately 13 million adults in the U.S. and 20 million individuals across the U.S., UK, and Europe. This partnership, originally announced on July 18, 2024, builds on Awakn's commitment to addressing these urgent medical needs.

This progress follows Awakn's recent partnership with Eurofins Discovery for in vitro pharmacology testing of the same aminoindane series. The selection of Eurofins marked a critical milestone, and this next phase with the University of Nottingham underscores Awakn's rapid advancements in developing next-generation treatments for mental health disorders.

Anthony Tennyson, CEO of Awakn Life Sciences, stated: “This is a pivotal step forward in our Aminoindane NCE program. We believe this novel aminoindane has the potential to revolutionize mental health treatment, offering a safer alternative for trauma-related mental health disorders such as PTSD. Our collaboration with the University of Nottingham reinforces our commitment to advancing science-backed, life-changing therapies.”

Dr King, from the School of Life Sciences at the University of Nottingham added: “I'm delighted that Awakn Life Sciences have chosen to collaborate with the University of Nottingham.  I'm excited to be involved in this research, which has real potential to improve patient health.”

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 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.

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

About the University of Nottingham

Ranked 32 in Europe and 16th in the UK by the QS World University Rankings: Europe 2024, the University of Nottingham is a founding member of Russell Group of research-intensive universities. Studying at the University of Nottingham is a life-changing experience, and we pride ourselves on unlocking the potential of our students. We have a pioneering spirit, expressed in the vision of our founder Sir Jesse Boot, which has seen us lead the way in establishing campuses in China and Malaysia - part of a globally connected network of education, research and industrial engagement. 

Nottingham was crowned Sports University of the Year by The Times and Sunday Times Good University Guide 2024 – the third time is has been given the honour since 2018 – and by the Daily Mail University Guide 2024

The University is among the best universities in the UK for the strength of our research, positioned seventh for research power in the UK according to REF 2021. The birthplace of discoveries such as MRI and ibuprofen, our innovations transform lives and tackle global problems such as sustainable food supplies, ending modern slavery, developing greener transport, and reducing reliance on fossil fuels. 

The University is a major employer and industry partner - locally and globally - and our graduates are the second most targeted by the UK's top employers, according to The Graduate Market in 2022 report by High Fliers Research.

We lead the Universities for Nottingham initiative, in partnership with Nottingham Trent University, a pioneering collaboration between the city’s two world-class institutions to improve levels of prosperity, opportunity, sustainability, health and wellbeing for residents in the city and region we are proud to call home.

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

October 4, 2024

Awakn Selects Eurofins Discovery for Pharmacology Testing in New Chemical Entity Pre-Clinical Program

Toronto, Canada – October, 04, 2024 – Awakn Life Sciences Corp. (CSE: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics for substance use and mental health disorders, with a near-term focus on Alcohol Use Disorder (“AUD”), today announced the selection of Eurofins Discovery to conduct initial pharmacology testing for its co-lead aminoindane series as part of Awakn's New Chemical Entity (NCE) pre-clinical program.

Eurofins Discovery, an industry-leading provider of products and services for drug discovery research, will play a pivotal role in advancing Awakn’s pre-clinical research efforts. This testing phase marks a critical milestone in the Company’s mission to develop next-generation therapeutics, with the potential to revolutionize treatments for addiction and mental health conditions.

Awakn’s NCE program is being developed in partnership with Graft Polymer (UK) Plc (“Graft”), an innovative biotechnology company that specializes in co-developing therapeutics for mental health disorders. This collaboration, initially announced on July 18, 2024, 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, UK and key European markets.

Today’s announcement follows Awakn’s recent program update from August 28, 2024, and reflects the continued progress and momentum of the NCE program. The initiation of pharmacology testing with Eurofins Discovery underscores Awakn’s commitment to advancing its therapeutic pipeline rapidly and efficiently.

Prof. David Nutt, Awakn’s Chief Research Officer, commented, “The selection of Eurofins Discovery for this crucial stage of pharmacology testing is a significant step forward in our pre-clinical program. We are confident that this collaboration will accelerate our path to delivering groundbreaking treatments for mental health and addiction disorders.”

Anthony Tennyson, CEO of Awakn, added, “Our partnership with Eurofins Discovery is a testament to the progress we’re making in developing innovative solutions for AUD and other mental health challenges. We are excited about the potential impact our NCE program could have for patients in need across North America and beyond.”

.

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 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.

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

About Eurofins Discovery
Eurofins Discovery supports drug discovery research with over 23,000 products and services developed in 40+ years of industry leadership. Benefit from the strength of our solutions that revolutionize your drug discovery.

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

September 18, 2024

Awakn Announces Upsizing and Closing of Tranche of Private Placement Financing

TORONTO, CANADA, September 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, further to its press releases dated April 3, 2024, April 17, 2024, June 4, 2024 and July 31, 2024, it has determined to increase the size of its previously announced non-brokered private placement financing (the “Offering”) from up to $1,000,000 to up to $2,000,000. Additionally, Awakn is pleased to announce the closing of a fourth tranche of the Offering through the issuance of an additional 857,143 units (the "Units") at a price of $0.46 per Unit for additional gross proceeds of $394,286 for a combined total of $1,117,142. 

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 substance use and mental health disorders. Awakn has a near-term focus on AUD, 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.

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.tennyson@awaknlifesciences.com

416-270-9566

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)

Sign Up for Newsletter

Awakn_logo_corp

MAIN OFFICE
Awakn Life Sciences Corp
301-217 Queen St. W
Toronto, Ontario M5V 0R2
Canada

© 2023 Awakn Life Sciences Corp      |      Privacy Policy      |      Disclaimer

// ABOUT US SUB NAV // THERAPEUTIC FOCUS SUB NAV // R&D SUB NAV
Back to top Arrow