Seelos Therapeutics Provides Second Quarter 2023 Clinical Update

- Seelos expects to release top-line data in its registration directed study of SLS-002 (Intranasal Racemic Ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD) in the third quarter of 2023.

- Seelos expects to release top-line data from its registrational Phase II/III trial of SLS-005 in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform in the fourth quarter of 2023.

- Seelos has been selected to present a poster of an in vivo study in a non-human primate model for the treatment of Alzheimer's disease at Neuroscience 2023, the Society for Neuroscience's annual meeting, to be held in November.

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- 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 provided its clinical update for the second quarter ended June 30, 2023.

On July 24, 2023, the Company received a letter from The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that it regained compliance with Nasdaq Listing Rule 5500(a)(2), as required by the Nasdaq Hearings Panel and the Company's compliance plan previously provided to Nasdaq. The letter further noted that the Nasdaq Hearings Panel determined to continue the listing of the Company's common stock.

Seelos Clinical Update

SLS-002 (intranasal racemic ketamine)

• Seelos announced the close of enrollment of the registration directed, double-blind, placebo-controlled study for ASIB in adults with MDD on June 22, 2023. Dosing and patient follow up has been completed, with data collection and evaluation ongoing.
   
• Top-line data from this study is expected to be released in the third quarter of 2023.

SLS-005 (IV trehalose)

• In April 2023, the first patient was dosed in an Expanded Access Program funded by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) under the Accelerating Access to Critical Therapies for ALS (ACT for ALS) for ALS patients who do not qualify for existing clinical trials.
   
• Top-line data from its registrational Phase II/III trial in ALS as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital is expected to be released in the fourth quarter of 2023.

SLS-009 (dysproteolyzer)

• Seelos presented a poster on SLS-009 at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting, held on May 16-20, 2023, in Los Angeles, California titled: SLS-009 Clears Only Mutant Huntingtin Aggregates in a Severe Huntington's Disease Mice Model.
  
  
• Seelos is currently evaluating SLS-009, along with SLS-005, in in vivo models of Alzheimer's disease.
  
  
• Seelos has been selected to present a poster at Neuroscience 2023 on November 11-15, 2023 in Washington, D.C. of an in vivo non-human primate study for treatment in Alzheimer's disease.

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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.

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

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 Seelos' business strategy, plans and objectives for future operations, Seelos' ability to complete clinical studies for its product candidates, Seelos' ability to efficiently execute its clinical and pre-clinical programs and Seelos' expectations around timing for releasing top-line data for its clinical trials. 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 successfully executing its preclinical and clinical studies, or continuing, completing or initiating its studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from its studies are not replicated), the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of Seelos' business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and 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, 2nd Floor
New York, NY 10022
(646) 293-2136
[email protected]
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
[email protected]

SOURCE Seelos Therapeutics, Inc.