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

February 6, 2024

Awakn’s Response to Dr. Sessa’s Medical Practitioner Tribunal

In relation to the recently announced upcoming General Medical Counsel (“GMC”) medical practitioners tribunal into Dr. Ben Sessa. The allegations made against Dr. Sessa relate solely to Dr. Sessa’s private practice work at Dr. Ben Sessa Ltd. This work was undertaken outside of Dr. Sessa’s Awakn contracted hours. Dr. Sessa tendered his resignation to Awakn prior to notifying Awakn management that the GMC had initiated an investigation into his conduct. Awakn had no prior knowledge of the allegations whatsoever. Awakn has supported, and will continue to support, GMC in their investigation when requested.

February 5, 2024

Awakn Life Sciences Announces Conditional Approval of CSE Listing

Toronto, Canada – February 5, 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, further to its press release dated November 10, 2023, that it has made an application and received conditional approval to list its common shares on the Canadian Securities Exchange (the "CSE") subject to fulfilling customary CSE requirements. The Company intends to delist its common shares from Cboe Canada and is working to ensure that trading of its common shares on the CSE will commence immediately following such delisting, with an effective date to be disclosed in due course. The Company’s trading symbol “AWKN” will remain the same.

Management is of the view that listing the common shares on the CSE will provide the Company continued liquidity for its shareholders and it will allow the Company to continue to reduce expenses due to the CSE's lower operating costs.

Financing:

On April 26th, 2023, 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. Gross proceeds from the Offering will be used to fund the company’s general working capital.

Today, Awakn has closed the fifth tranche of the Offering, issuing 142,857 Units for gross proceeds of $65,714 for this tranche and $3,030,377 in total for the Offering to date.

Closing of the Offering is subject to receipt of all necessary corporate and regulatory approvals, including the approval of Cboe. 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 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.

Enquiries:

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

January 24, 2024

Awakn Life Sciences Completes Successful Investigative Study to Establish Dissociative Effect of a Proprietary Sublingual S-ketamine Oral Thin Film Formulation in Harmful Drinkers

Awakn Designates Program AWKN-002 for Alcohol Use Disorders in the US Market

Toronto, Canada – January 24, 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 successfully completed an investigative study to establish the dissociative effect of a proprietary and patent pending S-ketamine formulation, administered sublingually via an oral thin film (“OTF”).

Today’s news builds on Awakn’s announcement on December 20, 2023 of a global licensing agreement with LTS Lohmann Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company. The agreement was for a proprietary and patent pending S-ketamine OTF, with global exclusivity in the treatment of Addiction, Anxiety Disorders, and Eating Disorders. LTS has successfully completed a Phase 1 (“Ph1”) clinical trial and filed patents in the US and key international markets of China, Europe, and Japan for the S-ketamine OTF. Under the terms of the license, Awakn has secured access to this Ph1 data and patents thereby ensuring strong intellectual property protection and potential to rapidly progress to late clinical stage trials.

The mechanistic study, comprising 28 people who were harmful drinkers, investigated the impact of a single dose of the S-ketamine OTF on dissociation and alcohol cravings. The S-ketamine OTF was well-tolerated by all participants, with no reports of serious adverse effects. The S-ketamine OTF exhibited significantly greater dissociative effects than placebo, which were of a magnitude observed with doses of intravenous racemic ketamine given in clinical treatment.  the S-ketamine OTF also demonstrated a statistically significant reduction in alcohol cravings in participants compared to placebo.

Following the successful completion of the investigative study and the signing of the license agreement with LTS, Awakn is pleased to designate this program AWKN-002, S-ketamine OTF plus manualized relapse prevention cognitive behavioural therapy (“CBT”)  for  AUD. AWKN-002 is focusing on the US market, with Awakn planning a pre-IND meeting with the U.S. Food and Drug Administration (“FDA”) during the first half of 2024.

AWKN-002 will be complimented by Awakn’s existing AWKN-001 program ,intravenous (“IV”) racemic ketamine plus manualized relapse prevention CBT  for  Severe AUD, which will now focus on the UK market only.

Prof. Celia Morgan, the principal Investigator on the study commented “The rapid onset and offset of action of AWKN-002 and the ease of clinical use that we observed in our investigative study, compared to IV ketamine has galvanized our view that this represents a way to dramatically widen access to ketamine treatment. AWKN-002 means that we may reach more of the patients that desperately need this life-saving addiction treatment”. 

The Company has granted a total of 496,666 deferred share units (“DSUs”) and 993,334  restricted share units (“RSUs“) to certain directors, officers, employees and consultants of the Company in accordance with the Company’s Omnibus Long-Term Incentive Plan. The RSUs will vest in two stages, with 50% vesting on the date that is one year from the date of grant, and the remaining 50% vesting on the date that is two years from the date of grant. Each DSU and, once vested, each RSU, represents the right to receive one common share of the Company.

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

December 20, 2023

Awakn Life Sciences Enters Global Licensing Agreement for Proprietary Sublingual S-Ketamine Formulation With LTS

Agreement Includes Exclusive Rights for Treatment of Addiction, Anxiety and Eating Disorders

Also Includes Access to Phase 1 Data and Patents Filed in US and Key International Markets

Toronto, Canada – December 20, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a clinical-stage biotechnology company developing Medication-Assisted Treatments to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces it has signed a global licensing agreement with LTS Lohmann Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company. The agreement is for a proprietary S-ketamine formulation, administered sublingually via an oral thin film (OTF). Awakn will have global exclusivity of its use in the treatment of Addiction, Anxiety Disorders, and Eating Disorders.

LTS has successfully completed a Phase 1 clinical trial and filed patents in the US and key international markets of China, Canada, Europe, and Japan for this novel formulation of S-ketamine. Under the terms of the Agreement Awakn has secured access to this Phase 1 data and exclusive global rights to the proprietary formulation for use in the above indications. Thereby ensuring strong intellectual property protection and potential to rapidly progress to late clinical stage trials.

The sublingual S-ketamine formulation signifies a remarkable potential advancement in addiction treatment. Its sublingual administration offers potentially a faster onset of action, more precise dosing, and reduced potential for adverse effects compared to conventional delivery methods. Safety, efficacy, and patient well-being are paramount in Awakn and LTS's commitment to transforming the treatment of addiction.

The licensing agreement includes terms related to milestone payments, royalties, and commercial manufacturing of the drug product by LTS.

Commenting on this agreement, Anthony Tennyson, CEO of Awakn, stated, "This exclusive global licensing agreement represents a significant milestone in our mission to provide innovative and effective treatments for addiction, while also providing scope for other mental health disorders. We are confident that LTS’ pioneering sublingual S-ketamine formulation will be a game-changer for those suffering from these conditions. We are excited to lead the way in this mental healthcare revolution."

“At LTS, we are unrelenting in our commitment to make life better for patients,” commented Bas van Buijtenen, CEO of LTS. “Under this agreement, we will deploy our full expertise and experience to the development and commercial manufacturing of this new therapeutic option in an area that fits perfectly with our strategic focus. The cooperation with Awakn is an opportunity to demonstrate once again how LTS creates commercial value at every stage: from product development to launch.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing Medication-Assisted Treatments targeting addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting approximately 50 million people in the US, UK, and EU4 markets, and 285m people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough treatments 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 LTS

We CARE. We CREATE. We DELIVER. The driving philosophy behind LTS. As a trusted technology partner for the pharmaceutical industry, we develop and manufacture innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) as well as wearable drug delivery devices (“OBDS”). LTS ́ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 40 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Microneedle Array Patches (“MAP”) for the transdermal delivery of small and large molecules, biological actives and vaccines. With its SorrelTM wearable drug delivery platform LTS offers patient friendly solutions for complex drugs delivery at home. Founded in 1984, LTS operates today from four sites: in Andernach, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA and Netanya, Israel. LTS also has a representative office in Shanghai, China.

Notice Regarding Forward-Looking Information

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

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

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

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

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

December 15, 2023

Awakn Life Sciences Provides Corporate Update

TORONTO, CANADA, December 15, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a clinical-stage biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), shares a corporate update on recent progress. Awakn also announces the closing of the fourth tranche of its previously announced private placement.

Key recent corporate activity:

  • Awakn received regulatory and ethical approval for phase III clinical trial: In November 2023 Awakn announced it has received clinical trial authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) and ethical approval from the Health Research Authority in the UK for a phase III clinical trial for its lead program AWKN-P001 for the treatment of Severe Alcohol Use Disorder (SAUD). This study is jointly funded by Awakn and the NIHR Efficacy and Mechanism Evaluation (EME) Programme (NIHR150193), an MRC and NIHR partnership.
  • Awakn completed MDMA Zydis® ODT feasibility study: In October 2023 Awakn announced it had completed a feasibility study for its proprietary formulation of MDMA using Catalent's Zydis® orally disintegrating tablet (ODT) technology. The study identified that MDMA is stable on Catalent's Zydis ODT technology and is suitable for pre-gastric absorption.
  • Awakn engaged Orphan Insight Ltd.: In October 2023 Awakn announced it has engaged Orphan Insight to develop and advance market access, pricing, and reimbursement for Awakn’s lead program AWKN-P001 which targets Severe Alcohol Use Disorder (SAUD), the most chronic type of AUD, a condition affecting approximately 17 million individuals in the United States and the key European markets of UK, Germany, France, Italy, and Spain.

Financing:

On April 26th, 2023, 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. Gross proceeds from the Offering will be used to fund the company’s general working capital.

Today, Awakn has closed the fourth tranche of the Offering, issuing 500,000 Units for gross proceeds of $230,000 for this tranche and $2,964,663 in total for the Offering to date.

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

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

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting approximately 37 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:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

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

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

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

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

November 15, 2023

Awakn Life Sciences Receives Regulatory and Ethical Approval For Phase III Clinical Trial of AWKN-P001

AWKN-P001 is a N-methyl-D-aspartate Receptor-Modulating Drug Used in Combination with Psycho-Social Support for the Treatment of Severe Alcohol Use Disorder

Toronto, Canada – November 15, 2023 - Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954), a clinical-stage biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today that it has received clinical trial authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) and ethical approval from the Health Research Authority in the UK for a phase III clinical trial for its lead program AWKN-P001 for the treatment of Severe Alcohol Use Disorder (SAUD).

SAUD, the most acute type of alcohol use disorder, affecting approximately 12.5 million people in the US and the key European markets of Germany, UK, France, Italy, and Spain.

AWKN-P001 is a novel combined therapeutic of a N-methyl-D-aspartate receptor-modulating drug (ketamine) used in combination with psycho-social support to treat SAUD. Results from AWKN-P001 phase II study were very positive, achieving 86% abstinence in the 6 months post treatments vs. 2% abstinence pre-trial, and 25% abstinence in current standard of care.

The trial is being funded by Awakn, The University of Exeter, and a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC). The phase III trial will be a n=280, two-armed randomized placebo-controlled trial. It will be delivered in the UK across ten UK National Health Service (NHS) sites. Awakn will contribute approx. GBP £800,000 towards the costs of the trial, with the NIHR, the MRC, and the University of Exeter contributing the balance of the costs.

The MHRA and Health Research Authority’s approval and continued support reflects their confidence in the rigorous research, ethical standards and promise of this trial. Enrollment for the phase III is due to start in Q1 2024.

Prof. Celia Morgan Head of Ketamine-Assisted Therapy at Awakn and Principal Investigator of the trial commented "We are thrilled to have received the green light to proceed with this landmark trial, which will be the largest and most rigorous study of ketamine-assisted therapy for Alcohol addiction to date. We believe that ketamine, when combined with psychological support, has the potential to offer a new treatment paradigm for millions of people who suffer from alcohol addiction, and another vote of confidence from these organizations is an amazing and critical step in the process."

Anthony Tennyson Awakn CEO commented “This regulatory and ethical approval is not only a testament to our commitment to scientific rigor and patient well-being, but also a pivotal step in our commercial journey. It opens new horizons for Awakn, as we move one step closer to delivering a potentially transformative therapy to the market. Our Phase 3 clinical trial represents a crucial bridge between cutting-edge science and a commercially viable solution for addressing severe alcohol use disorder."

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 approximately 51 million people in the US and key European 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 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.

Notice Regarding Forward-Looking Information

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

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

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

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

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

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

November 10, 2023

Awakn Life Sciences Announces Receipt of Notice of Non-Compliance With CBOE Exchange Continued Listing Requirements

Toronto, Canada - November 10, 2023 - Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) ("Awakn"), a clinical-stage biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today that it has received a notice (the "Notice") from Cboe Canada ("Cboe") indicating that Awakn is not in compliance with Section 3.01(3) of Cboe’s Listing Manual.  Awakn has 90 days to address the non-compliance.

The Notice has no immediate effect on the listing of Awakn’s common stock on Cboe, subject to Awakn's compliance with Cboe's continued listing requirements within 90 days.

The Notice does not affect the Company's day-to-day operations or its commitment to advancing groundbreaking psychedelic research and development. Awakn intends to provide updates when 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 approximately 51 million people in the US and key European 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:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

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

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

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

October 31, 2023

Awakn Life Sciences Engages Orphan Insight Ltd. To Advance Market Access, Pricing, And Reimbursement Strategies for AWKN-P001 Targeting Severe Alcohol Use Disorder

Toronto, Canada - October 31, 2023 - Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) ("Awakn"), a clinical-stage biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces it has engaged Orphan Insight Ltd ("Orphan Insight") to develop and advance market access, pricing, and reimbursement for Awakn’s lead program AWKN-P001. AWKN-P001 targets Severe Alcohol Use Disorder (SAUD), the most chronic type of AUD, a condition affecting approximately 17 million individuals in the United States and the key European markets of UK, Germany, France, Italy, and Spain.

Founded in 2007, Orphan Insight is a consultancy specializing in UK healthcare market access and pricing strategies. Orphan Insight has supported many organisations in achieving market access in the UK, leading to the successful introduction of therapeutics for the treatment of diseases with significant unmet clinical need. Orphan Insight also will play a pivotal role in due course in negotiations with the UK Department of Health to ensure that AWKN-P001 becomes accessible to those in need.

AWKN-P001 is a novel combined therapeutic of an N-methyl-D-aspartate receptor-modulating drug (ketamine) used in combination with psycho-social support to treat SAUD. Results from AWKN-P001 phase II study were very positive, achieving 86% abstinence in the 6 months post treatments vs. 2% abstinence pre-trial and a 50% reduction in Heavy Drinking Days (HDD) versus placebo.

In February 2023, Awakn announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) awarded an Innovation Passport to AWKN-P001. The Innovation Passport is the entry point for the MHRA’s Innovative Licensing and Access Pathway (ILAP), the UK’s version of the FDA break through designation. The goal of ILAP is to accelerate the time to market in the U.K.

In September 2023, Awakn announced that it had submitted the Clinical Trial Application (CTA) for a phase III trial of AWKN-P001 in the UK. The trial is being run by Awakn, The University of Exeter, and a partnership between the National Institute for Heath and Care Research (NIHR) and the Medical Research Council. The phase III trial will be an n=280, two-armed randomized placebo-controlled trial. It will be delivered in the UK across ten UK National Health Service (NHS) sites. Awakn will contribute approx. GBP £800,000 towards the costs of the trial, with the NIHR, the MRC, and the University of Exeter contributing the balance of the costs.

Anthony Tennyson, Awakn Life Sciences’ CEO commented, "Our commitment to developing innovative addiction treatments goes beyond scientific discovery. We are also focused on ensuring these treatments reach the patients who need them most, and that's where Orphan Insight plays a crucial role. Their experience and strategic guidance will be invaluable in driving revenue and maximizing our reach."

Mark Barrett, Managing Director, Orphan Insight commented “The introduction of a life-changing therapeutic approach to the treatment of SAUD is massively important, and the UK has a real opportunity to lead the way in implementing this meaningful intervention to reduce the burden of a globally devastating condition.”

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 approximately 51 million people in the US and key European 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 Orphan Insight

Founded in 2007, Orphan Insight has supported a number of organisations to navigate the market access landscape in the UK.  Successful negotiations across a range of therapeutic areas have led to the introduction of therapies, including the first ‘advanced therapeutic medicinal product’, into the UK market for the treatment of diseases with significant unmet clinical need.

About 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.

Notice Regarding Forward-Looking Information

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

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

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

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

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

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

October 4, 2023

Awakn Life Sciences Completes MDMA Zydis® ODT Feasibility Study

Study Confirms MDMA Is Stable on Zydis® ODT and Suitable for Pre-Gastric Absorption

TORONTO, CANADA, October 04, 2023 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a clinical stage biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), today announces it has completed a feasibility study for its proprietary formulation of MDMA using Catalent's Zydis® orally disintegrating tablet (ODT) technology.

The study, which was initiated in February 2023, evaluated a variety of chemical parameters and several aspects of MDMA on Catalent’s Zydis ODT technology. The aims of the feasibility study were to ascertain if MDMA is stable on Catalent's Zydis ODT technology and is suitable for pre-gastric absorption in order to optimize the delivery of MDMA and potentially address known pharmacokinetic challenges of MDMA in oral capsules for gastric absorption.

Awakn has completed the feasibility study and has identified that MDMA is stable on Catalent's Zydis ODT technology and is suitable for pre-gastric absorption.

The study was conducted at Catalent's Swindon, UK facility, where the company has extensive experience and expertise in developing and manufacturing ODT products using its patented Zydis technology.

Awakn will now proceed to testing its proprietary formulation of MDMA using Zydis ODT technology against oral capsule MDMA in vivo. Anthony Tennyson, Chief Executive Officer of Awakn, said “we look forward to the results, and my hope is the testing will demonstrate that MDMA on Catalent’s Zydis® ODT technology will improve the performance of MDMA and provide significant benefits to patients in the clinic compared to MDMA in oral capsules.”


"We are very pleased with how the feasibility study has progressed and has given us positive data around the stability and suitability of Catalent's Zydis technology for our novel MDMA formulation. This is an important part of our product development strategy, which aims to optimize the delivery of MDMA." said Prof David Nutt, Chief Research Officer of Awakn.


Zydis® is a registered trademark of R.P. Scherer Technologies, Inc., a wholly owned subsidiary of Catalent, Inc.

About Awakn Life Sciences

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

www.AwaknLifeSciences.com  |  Twitter  |  LinkedIn  

Notice Regarding Forward-Looking Information

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

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

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

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

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

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

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

Back to top Arrow