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Seelos Therapeutics Provides Update on Pipeline Developments and Corporate Highlights

─ Scheduled to Meet with FDA to Design Proof-of-Concept Study in Suicidality-PTSD

─ Appoints Warren W. Wasiewski, MD as Chief Scientific Officer

─ Seelos to Webcast Presentation at the Jefferies 2019 Healthcare Conference

NEW YORK, June 06, 2019 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (SEEL), a clinical-stage biopharmaceutical company provided an update on recent pipeline developments and corporate highlights.

“Seelos will be meeting with FDA to design and initiate a Proof-of-Concept (PoC) study in patients with post-traumatic stress disorder (PTSD) at imminent risk of suicide,” said Raj Mehra, PhD, Chairman, Founder, and CEO of Seelos. “This study is in addition to our already scheduled PK/PD and DDI studies.”

Recent Corporate Highlights

  • Warren W. Wasiewski, M.D., F.A.A.P. has joined Seelos Therapeutics, Inc. as Chief Scientific Officer
    • Dr. Wasiewski brings over 35 years' of experience to Seelos including those spent as a practicing physician, focused on pediatric neurology, as well as his extensive clinical and regulatory experience at companies involved in the neurology, pediatric and orphan disease space
    • Dr. Wasiewski has worked previously at Alexion Pharmaceuticals, AstraZeneca LP and Bioblast Pharma Ltd., Inc, among others

Update on Pipeline Development

Seelos will webcast its presentation at the Jefferies 2019 Healthcare Conference at 8am (ET) on Friday, June 7th. Investors can access this presentation using this link: http://wsw.com/webcast/jeff118/seel

  • SLS-002 (intranasal racemic ketamine)
    • Seelos is seeking guidance from the FDA in a scheduled Type C meeting (face to face) over the summer to design and initiate a PoC study in patients with Suicidality-PTSD
      • This study is in addition to our PK/PD and DDI study that is scheduled for dosing in healthy volunteers in late Q3   
      • The study plans to utilize the Sheehan-Suicidality Tracking Scale (S-STS) to measure the safety and efficacy of intranasal racemic ketamine 
      • In addition to the S-STS, and usual safety measures and scales, we intend to utilize the following "gold standard" in the assessment of PTSD:
        the PTSD Checklist for DSM-5 (PCL-5), the Clinically Administered PTSD Scale (CAPS) to measure symptoms of PTSD, and the Montgomery-Åsberg Depression Rating Scale (MADRS) to stratify and to measure the severity of possible co-morbid depression symptoms
  • SLS-005 (trehalose)
    • Dr. Wasiewski will lead our collaboration with Team Sanfilippo Foundation (TSF), to advance SLS-005 (trehalose) program in Sanfilippo syndrome patients and will spearhead the trehalose program in oculopharyngeal muscular dystrophy (OPMD)
    • This study has now been expanded to be a combined Phase 2b/3, multicenter, enriched enrollment, case controlled withdrawal trial which will determine the safety and tolerability of Trehalose IV in Sanfilippo A and B patients along with efficacy based on well-known biomarkers, functional outcomes, neuro-cognitive assessments and quality of life measurements
    • TSF and Seelos previously announced on May 21st the decision to expand inclusion of Sanfilippo type C and D patients as well as type A and B patients who do not meet the trial entry criteria into a separate expanded patient access study

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 disorders. The Company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York.

For more information, please visit our website: http://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 our expectations regarding the expected timing for dosing the first patient with Sanfilippo Syndrome with Trehalose, expectations regarding the initiation of a phase I study with intranasal racemic ketamine in Suicidality-PTSD and expectations regarding proof of concept for target engagement for peptide-based approach targeting the NACore in Parkinson’s Disease. These statements are based on the company’s current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos’ business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies and not gaining marketing approvals for our product candidates, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund our development plans and ongoing operations, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its 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. (SEEL)
300 Park Ave., 14th Fl
New York, NY 10022
(646) 293-2136