Seelos Therapeutics Announces Encouraging Data from an In Vivo Study of SLS-005 in an Aggressive Preclinical Model of Alzheimer's Disease

- Treatment with SLS-005 demonstrated a 46% reduction in tau protein and an 18% reduction in NfL biomarker from baseline values within six months  

- Seelos has been selected to present these data at Neuroscience 2023 to be held on November 11-15, 2023 in Washington, D.C. 

NEW YORK, Sept. 27, 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 announced encouraging preclinical data from an in vivo study of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) in an aggressive Alzheimer's disease non-human primate model. Seelos has been selected to present a poster of these data at Neuroscience 2023 to be held on November 11-15, 2023 in Washington, D.C.

In this study, the overexpression of tau in older non-human primates (NHPs) was utilized through bilateral AAV induced tauopathy. NHPs in this study were administered either SLS-005 weekly, a single administration of SLS-009 or control. The NHPs receiving SLS-005 demonstrated a 46% reduction in tau protein and an 18% reduction in NfL (neurofilament light chain) protein biomarker from baseline values in a preliminary analysis. NfL is a non-specific biomarker for several neurodegenerative conditions, including Alzheimer's disease, multiple sclerosis, and amyotrophic lateral sclerosis (ALS).

"We believe these data from the SLS-005 cohort are highly encouraging and supports SLS-005 as an active drug that targets key biomarkers, including both a broad-based non-specific CNS biomarker like NfL reduction, and a target-specific biomarker such as tau reduction, within six months. These biomarkers are key emerging targets for reduction to treat Alzheimer's disease and tauopathies," said Krishna Subramanian, Ph.D., Vice President, Non-Clinical Development and Translational Science at Seelos. "We are also currently completing the analysis of the SLS-009 cohort where the initial results appear promising and expect to release that full dataset when available at a future scientific meeting."

Additionally, top-line data from the SLS-005 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.

About SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion)

SLS-005 is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier and is thought to stabilize proteins and activate autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression. The activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic accumulation of storage material. In animal models of several diseases associated with abnormal cellular protein aggregation or storage of pathologic material, SLS-005 has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. SLS-005 is an investigational treatment and is not currently approved by any health authority for medicinal use.

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 the in vivo study of SLS-005, statements regarding SLS-005's and SLS-009's prospects and potential and statements regarding the timing to release data from the SLS-009 and SLS-005 preclinical studies. 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, not being able to move forward with the development of SLS-005 or SLS-009, and not gaining marketing approvals for SLS-005, SLS-009 and/or its other product candidates; the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the results from the prior studies of SLS-005 or SLS-009 may not be replicated or may be materially different from the results of the preclinical data from the in vivo study of SLS-005 and/or SLS-009); 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; the 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, 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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