Seelos expects to release top-line data in two registrational studies in 2023

NEW YORK, May 15, 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 a clinical update and reported its financial results for the first quarter ended March 31, 2023.

"2023 is the most important year in Seelos' history thus far. Our team has been diligently working to complete the registration directed study of our intranasal ketamine program, SLS-002, and we have notified our trial sites that enrollment will conclude by the end of June 2023. We expect to release top-line data in the third quarter of 2023. Our experienced team feels confident that the design and execution of this trial will allow SLS-002 to demonstrate its true potential of efficacy, safety, and tolerability in patients with MDD at imminent risk of suicide. We strongly believe that this therapeutic, if successful, may help the large number of people with suicidal ideation globally," said Raj Mehra, Ph.D., Chairman and CEO of Seelos.  "Additionally, with the completion of enrollment of the SLS-005 study in ALS, we look forward to the top line Phase II/III data in late 2023. Lastly, it is remarkable that our inventive R&D team has put forth our first internally created gene therapy program, SLS-009, focusing on one-time treatment of neurodegenerative disorders, such as Huntington's disease, by permanently activating the autophagy-lysosomal pathways."

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, call the Suicide and Crisis Lifeline at 988 or 1-800-273-8255 (TALK).

Seelos Clinical Update/Fiscal Year 2023 Outlook

SLS-002 (intranasal racemic ketamine)

• Seelos plans to complete enrollment of the registration directed, double-blind, placebo-controlled study in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD) by the end of June 2023.
• Top-line data from this study is expected to be released in the third quarter of 2023.

SLS-005 (IV trehalose)

• In February 2023, Seelos completed enrollment of its registrational Phase II/III trial in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital.
•  Top-line data from this study is expected to be released in the fourth quarter of 2023.
• In March 2023, Seelos announced it is temporarily pausing additional enrollment of patients in the SLS-005-302 study in spinocerebellar ataxia type 3 (SCA3). Patients already enrolled will continue in the study and data will continue to be collected in order to make decisions for resuming enrollment in the future. This temporary pause has been implemented as a business decision due to financial considerations, and is not based on any data related to safety or therapeutic effects.
• In April 2023, Seelos announced it has dosed the first patient in an Expanded Access Program (EAP) for patients with ALS who do not qualify for existing clinical trials and that the EAP will be fully funded by a grant from the NINDS under the ACT for ALS.

SLS-004 (Parkinson's disease gene therapy programs)

•  At the Annual Alzheimer's & Parkinson's Drug Development Summit in February 2023, Seelos presented a poster on quantitative increase in SNpc TH+ neuronal count and neuronal density compared to control hemisphere.

SLS-009 (dysproteolyzer)

• Seelos has been selected to present a poster on SLS-009 at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting, to be 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.

Overview of First Quarter (Q1) 2023 Financial Results:

Net revenue for Q1 2023 was $808,000, as compared to Q1 2022 net revenue of zero. Q1 2023 net revenue was primarily attributable to grant revenue earned from Mass General Brigham Research Management under the Expanded Access Program, which is funded by a grant from the national Institute of Neurological Disorders and Stroke (NINDS).

Research and development (R&D) expenses were $5.7 million for Q1 2023, as compared to $10.0 million in Q1 2022. This period-over-period decrease was primarily driven by the completion of enrollment of SLS-005 in ALS during Q1 2023 and reduced manufacturing costs in Q1 2023.

General and administrative (G&A) expenses were $4.1 million for Q1 2023, as compared to $4.0 million in Q1 2022.

Other expenses were ($4.5) million for Q1 2023, as compared to income of $9,000 in Q1 2022.  The loss is attributable to a $4.3 million loss on the issuance of common stock and warrants in March 2023 in a registered direct offering.

Net loss for Q1 2023 was ($13.4) million, or ($0.12) per basic and diluted share, compared to a net loss of ($14.0) million, or ($0.13) per basic and diluted share for the same period in 2022.

As of March 31, 2023, total cash and cash equivalents were $14.1 million, which was a decrease of $1.5 million compared to $15.5 million as of December 31, 2022.

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 any financial targets, business strategy, and plans and objectives for future operations, Seelos' ability to complete clinical studies for its product candidates, Seelos' ability to efficiently execute clinical and pre-clinical programs, Seelos' plans to complete enrollment for the SLS-002 registration directed study by the end of June 2023, Seelos' expectations around timing releasing top-line data for its clinical trials and Seelos' future plans to resume enrollment of patients in the SLS-005-302 study in SCA3 and statements regarding the potential efficacy, safety and tolerability of SLS-002. 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 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 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, 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
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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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