Seelos Therapeutics Announces Mid-Year 2021 Business and Clinical Update

NEW YORK, Aug. 9, 2021 /PRNewswire/ -- 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 its mid-year 2021 business and clinical update.

"In the first half of 2021, the Seelos team continued to execute at a very high level. Part 1 of the SLS-002 study demonstrated rapid antidepressant and anti-suicidal effects with a well-tolerated safety profile. We have begun the placebo-controlled Part 2 of this registration directed study and plan to enroll in up to 30 sites," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "The SLS-005 IV trehalose program's pivotal study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, plans to commence dosing patients in the third quarter as well. We have begun additional in vivo studies with our gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression targeting Parkinson's disease, and we continue to evaluate additional indications for both SLS-002 and SLS-005."

In the first half of 2021, Seelos achieved several major clinical and financial milestones and continued to make progress on its multiple clinical stage development programs.

Seelos Business Update

As of the end of Q2, Seelos had $87.2mm of cash. It currently has no outstanding debt.

In January, Seelos raised $33.5 million in net proceeds in an offering of common stock. The company raised an additional $65 million in net proceeds in another offering of common stock. Proceeds were used for the full repayment of Seelos' prior convertible promissory notes and the remainder is for general corporate purposes and to advance the development of its product candidates.

Also in January, Seelos was selected as one of 17 companies included in the world's first psychedelic Exchange Traded Fund (ETF), the Horizons Psychedelic Stock Index Fund, which trades on Canada's NEO exchange and, in June, Seelos was included in the Defiance Next Gen Altered Experience ETF, the first U.S. listed Exchange Traded Fund (ETF) focused on psychedelics, which began trading on May 28^th.

In February, Seelos announced an amendment of its agreement with Vyera Pharmaceuticals AG for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash 9% of the royalties payable on any future net sales of SLS-002.

In April, Seelos announced a Strategic Device Partnership with AptarGroup, Inc. for the co-exclusive use and supply of Aptar Pharma's Bidose (BDS) Liquid System device for SLS-002 in the investigational development programs for the treatment of suicidality, depression, and Post-Traumatic Stress Disorder (PTSD) and under the terms of the agreement, Seelos has certain rights to add other undisclosed indications to the Strategic Device Partnership.

Seelos was added to the Russell 2000^®, Russell 3000^®, and Russell Microcap^® Indexes at the end of June, as part of the 2021 Russell US Indexes Reconstitution.

Seelos Clinical Update

SLS-002 (intranasal racemic ketamine)

• Data for Part 1, the open-label cohort, of the registration directed study for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder demonstrated a significant treatment effect plus a well-tolerated safety profile.
• In early July, dosing of Part 2, the double-blind, placebo-controlled cohort of the study commenced. A super-majority of the trial sites are in various stages of onboarding.
• On June 15^th, Seelos completed a Type C meeting with the FDA to discuss the regulatory pathway for the SLS-002 program.

SLS-005 (IV trehalose)

• Seelos was issued a patent from the Australian Patent Office covering the parenteral administration of SLS-005  in multiple neurodegenerative indications.
• A Notice of Allowance was received from the Japanese Patent Office covering the parenteral administration of SLS-005 in treating oculopharyngeal muscular dystrophy (OPMD).
• SLS-005 received European Orphan Drug designation for ALS.
• In the third quarter, Seelos is expected to commence dosing of a pivotal Phase IIb/III trial in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital at several dozen trial sites across the U.S.

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

• In vivo data was released in early July demonstrating down-regulation of SNCA mRNA and protein-expression from a study of SLS-004 in an in-vivo rodent model utilizing CRISPR-dCas9 gene therapy technology.
• Additional studies have commenced to explore efficacy of SLS-004 in the induced Parkinsonism in an in vivo rodent model.

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

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 enrollment in Seelos' Part 2 of the SLS-002 registration directed study focused on patients with major depressive disorder (the "SLS-002 Study"), and the planned dosing of patients in the SLS-005 IV trehalose program's pivotal study in ALS (with SLS-002 Study, collectively, the "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, or continuing the 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 the Studies are not replicated, or the risk that the clinical results from the SLS-002 Study are materially different from the topline clinical results of Part I of the SLS-002 Study), 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
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

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