Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today an amendment of the agreement with Vyera Pharmaceuticals AG (“Vyera”) for the development of SLS-002 (intranasal racemic ketamine)
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NEW YORK, Feb. 18, 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, announced today an amendment of the agreement with Vyera Pharmaceuticals AG ("Vyera") for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash a significant portion of the royalties payable on any future net sales of SLS-002.
On March 6, 2018, Seelos entered into an asset purchase agreement with Vyera, currently known as Phoenixus AG, to acquire the assets and liabilities of Vyera's intranasal racemic ketamine program, which Seelos now calls SLS-002. As additional consideration to certain upfront cash and equity payments and success-based milestone payments contemplated under the prior agreement, Seelos agreed to pay a mid-teens percentage royalty on any future net sales of SLS-002. Under this amendment, for additional cash payments, Seelos has agreed to repurchase 9% of the future royalties and reduce its royalty obligations to a mid-single digit percentage on any future net sales of SLS-002. "We believe this repurchase of a significant portion of royalties due on SLS-002 has the potential to return meaningful future value to Seelos stockholders, assuming we are successful in the clinical development, FDA approval process, and commercialization of the intranasal ketamine program," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "The current study of SLS-002 is dosing patients with major depressive disorder who are at imminent risk of suicide. We plan to further evaluate ketamine in front-line major depression and other related indications." Seelos has begun dosing patients in Part A of its Proof-of-Concept study, which is a 16-patient, open-label cohort, using 90mg of SLS-002 in patients who are imminently suicidal. Part A of the Proof-of-Concept study precedes Part B, which is a registrational double blind placebo-controlled trial. 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. About SLS-002 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) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's Disease, other psychiatric and movement disorders plus orphan diseases. 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 Seelos' ability to repurchase future royalties under the asset purchase agreement with Vyera, the ability of the royalty repurchase to return meaningful future value to Seelos stockholders, Seelos' ability to succeed in the clinical development, FDA approval process and commercialization of its intranasal ketamine program (SLS-002), Seelos' plans to evaluate ketamine in front-line major depression and other related indications, the design of the Proof of Concept study, the expected timing for commencing Part B of the Proof of Concept study and the potential for ketamine to be a rapid, effective treatment for refractory depression and suicidality. 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 to Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, including the Proof of Concept study of SLS-002, 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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