Seelos Therapeutics Announces Year End 2020 Business Update
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NEW YORK, Jan. 6, 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 year end 2020 business update.
"This past year marked the most significant 12 months in Seelos Therapeutics' history despite being an otherwise challenging year due to the COVID-19 pandemic. We completed our safety trial for the intranasal ketamine program and began opening centers for our pivotal trial for Acute Suicidal Ideation and Behavior in patients with major depressive disorder. The trehalose program's pivotal study in ALS was accepted into the HEALEY ALS Platform Trial at Harvard and we began our first in vivo studies of SLS-004 and SLS-007, our gene therapy Parkinson's programs. Seelos received additional patents around the world, orphan drug designations in the US and Europe for various programs plus a Rare Pediatric Disease Designation for SLS-005," remarked Raj Mehra Ph.D., Chairman and CEO of Seelos. "We look forward to 2021 as we embark on clinical studies in two unmet needs, namely imminent suicidality and ALS. We have expanded the Seelos team by adding several experienced industry veterans as full-time Seelos employees to efficiently execute clinical and preclinical programs." Seelos Team Update Over the past six months, Seelos expanded its team with the hiring of four full-time employees and the addition of a consultant to aid in the development of key programs. In addition, Tim Whitaker, MD will now serve as Chief Medical Officer (CMO) for Seelos, formerly serving as Head of Research and Development, and Warren W. Wasiewski, M.D., F.A.A.P. will now serve as Senior Neuro Advisor. Jessica Kardish, Kimberly Farrand, Lucas Pilipski and Manira Rayamajhi, have all accepted full-time positions at Seelos as follows:
David M. Biondi, DO, FAAN has also joined Seelos as a consultant with an extensive background in medical practices and the pharmaceutical industry. Dr. Biondi served as a neurologist in the United States Navy and later in community and academic practice settings. He held medical affairs and clinical development roles at Janssen Pharmaceuticals, Johnson & Johnson, and Alder Biopharmaceuticals. He most recently served as Executive Director for Clinical Programs at Cohen Veterans Bioscience and currently sits on their Board of Directors. Dr. Biondi holds a Bachelor of Science in Pharmacy from Long Island University, a Doctor of Osteopathic Medicine from The University of New England and served his Neurology Residency at the US National Naval Medical Center in Bethesda, MD. Seelos Business Update In 2020, Seelos Therapeutics achieved several major milestones and continued to make progress on its multiple clinical stage development programs. SLS-002 (intranasal racemic ketamine)
SLS-005 (IV trehalose)
SLS-004 and SLS-007 (Parkinson's disease gene therapy programs)
Upcoming Catalysts SLS-002 (intranasal racemic ketamine)
SLS-005 (IV trehalose)
SLS-004 and SLS-007 (Parkinson's disease gene therapy programs)
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' ability to complete clinical studies for product candidates for imminent suicidality and ALS, Seelos' ability to efficiently execute clinical and pre-clinical programs, the hiring of certain employees and consultants, including their ability to aid in the development of key programs, the safety profile of SLS-002, the final safety data of SLS-002, the potential pivotal proof of concept study for SLS-002, opening additional trial sites for screening and dosing for the pivotal proof of concept study for SLS-002, the commencement of the pivotal Phase IIb/III trial of SLS-005 for ALS in the HEALEY ALS Platform Trial, the expected timing for preclinical data regarding the delivery and target engagement of SLS-007, and the expected timing for preclinical data for SLS-004. These statements are based on Seelos' 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 with 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 its product candidates, the risk that prior test 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 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:
SOURCE Seelos Therapeutics, Inc. |
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Company Codes: NASDAQ-NMS:SEEL |
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