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

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 7 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

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

Source

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AWKN:CNX

Seelos Announces Second Postponement of its Annual Meeting of Stockholders

Seelos Therapeutics, Inc. (OTCQB: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its 2024 Annual Meeting of Stockholders (the "Annual Meeting"), which was previously postponed to Friday, October 25, 2024 from its originally scheduled date of Friday, September 27, 2024 has been further postponed. The Annual Meeting is now scheduled to be held virtually, via live webcast at www.virtualshareholdermeeting.comSEEL2024 on Monday, November 25, 2024 at 8:00 a.m., Eastern Time . The record date for the Annual Meeting, August 19, 2024 is unchanged and applies to the postponed Annual Meeting.

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Compass Pathways to Announce Third Quarter Financial Results on October 31, 2024

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the third quarter 2024 ending September 30, 2024, and provide an update on recent business developments, on October 31, 2024.

The management team will host a conference call at 8:00 am ET (12:00 pm UK) on October 31, 2024. To access the call, please register in advance here to obtain a local or toll-free phone number and your personal pin.

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Seelos Therapeutics Announces Notice of Delisting from Nasdaq and Transfer of Listing to Over-the-Counter Market

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that on October 14, 2024 Seelos Therapeutics, Inc. (the "Company") received notice that the Nasdaq Hearings Panel (the "Panel") had determined to delist the Company's common stock from The Nasdaq Stock Market LLC ("Nasdaq") due to the Company's failure to comply with the minimum stockholder's equity requirement under Nasdaq Listing Rule 5550(b)(1) (the "Equity Standard Rule"). As previously disclosed, the Panel had provided the Company until October 11, 2024 to regain compliance with the Equity Standard Rule.

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Seelos Announces Postponement of its Annual Meeting of Stockholders

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its 2024 Annual Meeting of Stockholders (the "Annual Meeting"), which was originally scheduled to be held on September 27, 2024 has been postponed. The Annual Meeting is now scheduled to be held virtually, via live webcast at www.virtualshareholdermeeting.comSEEL2024 on Friday, October 25, 2024 at 8:00 a.m., Eastern Time . The record date for the Annual Meeting August 19, 2024 is unchanged and applies to the postponed Annual Meeting.

The Annual Meeting has been postponed due to an anticipated lack of quorum, and to provide further time to solicit proxies from the Company's stockholders. Seelos' Board of Directors unanimously recommends that you vote FOR the Board of Director nominees and FOR all other proposals identified in the Company's proxy statement for the Annual Meeting. Stockholders who have already cast their votes do not need to take any action, unless they wish to change or revoke their prior proxy or voting instructions, and their votes will be counted at the postponed Annual Meeting. For stockholders who have not yet cast their votes, we urge them to vote their shares now, so they can be tabulated prior to the postponed Annual Meeting.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases.

For more information, please visit our website: https://seelostherapeutics.com , the content of which is not incorporated herein by reference.

IMPORTANT ADDITIONAL INFORMATION

Seelos has filed a definitive proxy statement with the Securities and Exchange Commission (the "SEC") on August 20, 2024 . STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED BY SEELOS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ANY SOLICITATION. Stockholders may obtain a free copy of the proxy statement and the other relevant materials, and any other documents filed by Seelos with the SEC, at the SEC's web site at http://www.sec.gov or on the "SEC Filings" section of Seelos' website at https://seelostherapeutics.com .

Participants in the Solicitation

Seelos, its directors and executive officers and other members of management and employees will be participants in the solicitation of proxies with respect to a solicitation by Seelos. Information about Seelos' executive officers and directors, including information regarding the direct or indirect interests, by security holdings or otherwise, is available in Seelos' definitive proxy statement for its Annual Meeting, which was filed with the SEC on August 20, 2024 . To the extent holdings by our directors and executive officers of Seelos securities reported in the proxy statement for the Annual Meeting have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC. These documents are or will be available free of charge at the SEC's website at http://www.sec.gov .

Forward-Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements related to Seelos for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not receiving stockholder approval of any of the proposals to be presented at the Annual Meeting, the risks related to raising capital to fund its development plans and ongoing operations and risks related to Seelos' current stock price, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023 , subsequent Quarterly Reports on Form 10-Q, including Seelos' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 ^nd Floor
New York , NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York , NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

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SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics Announces 1-for-16 Reverse Stock Split

Seelos Therapeutics, Inc. (Nasdaq: SEEL ) ("Seelos" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its Board of Directors approved a 1-for-16 reverse stock split of its outstanding shares of common stock, to be effective as of 12: 01 a.m. Eastern Time on Friday September 27, 2024.

The Company's common stock, par value $0.001 , will begin trading on a reverse stock split-adjusted basis at the opening of the market on Friday, September 27, 2024. Following the reverse stock split, the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "SEEL" with the new CUSIP number, 81577F 406. The reverse stock split is intended for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market. The reverse stock split was approved by the Company's Board of Directors pursuant to Section 78.207 of the Nevada Revised Statutes and was effectuated by the filing of a Certificate of Change with office of the Nevada Secretary of State.

At the effective time of the reverse split, every sixteen (16) issued and outstanding shares of the Company's common stock will be combined automatically into one (1) share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and any fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. The reverse stock split will reduce the number of authorized shares of the Company's common stock from 50,000,000 shares to 3,125,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result of the rounding of fractional shares. In addition, the reverse stock split will apply to the Company's common stock issuable upon the exercise of the Company's outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company's equity incentive plans, as applicable.

The reverse stock split will reduce the number of issued and outstanding shares of the Company's common stock from approximately 9.2 million to approximately 581 thousand.

About Seelos Therapeutics:
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

Forward-Looking Statements:
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the reverse stock split and the timing thereof, the potential impact of the reverse split on the bid price of the Company's common stock, the potential for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market and the expected number of shares of common stock to be outstanding following the reverse stock split. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties involved include those associated with general economic and market conditions, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL )
300 Park Avenue, 2 ^nd Floor
New York , NY 10022
(646) 293-2136
anthony.marciano@seelostx.com

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York , NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

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