SLS-005 Study on the HEALEY ALS Platform is Expected to Complete Enrollment this Quarter; Top-Line Data Readout Expected Mid-2023

Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced dosing of the first patient in an open-label basket study of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) in Australia.   

Seelos plans to conduct this 24-week, open-label basket study (ACTRN: 12621001755820) in Australia to evaluate the effectiveness of SLS-005 on disease progression and severity, as well as its safety and tolerability, in participants with ALS, spinocerebellar ataxia and Huntington's disease.

"Seelos would like to thank our partners in Australia for their hard work in helping us initiate this basket study. We hope to gain valuable insights into the activity of SLS-005 in several devastating neurodegenerative diseases and the open-label design provides a degree of transparency not possible in a blinded study," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "Today we are also very excited to share that the registrational study in the HEALEY platform trial is actively enrolling and at its current pace of enrollment, we currently expect it to be fully enrolled by the end of this quarter."

If you are a person with ALS (PALS) or caregiver of someone with ALS (CALS) and would like more information, please visit: https://seelostherapeutics.com/patients-and-caregivers/

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.  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 Amyotrophic Lateral Sclerosis (ALS)

According to the National Institute of Neurological Disorders and Stroke, amyotrophic lateral sclerosis (ALS) is a group of rare neurological diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement. In ALS, both the upper motor neurons and the lower motor neurons degenerate or die and stop sending messages to the muscles. Unable to function, the muscles gradually weaken, start to twitch (called fasciculations), and waste away (called atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. The disease is progressive, meaning the symptoms get worse over time. The majority of ALS cases (90 percent or more) are considered sporadic. This means the disease seems to occur at random with no clearly associated risk factors and no family history of the disease. Although family members of people with sporadic ALS are at an increased risk for the disease, the overall risk is very low, and most will not develop ALS.

Most people with ALS eventually die from respiratory failure, usually within 3 to 5 years from when the symptoms first appear. However, about 10 percent of people with ALS survive for 10 or more years. Currently, there is no cure for ALS and no effective treatment to halt or reverse, the progression of the 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 Seelos' open-label basket study of SLS-005 for the treatment of ALS, including SLS-005's prospects and potential insights from the open-label basket study, as well as statements regarding Seelos' registrational study in the HEALY platform trial and the pace of enrollment and anticipated timing for completing enrollment in the trial. 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, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials, 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 a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, 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 Ave., 2^nd Fl.
New York, NY 10022
(646) 293-2136
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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
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