On April 11, 2022 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported an amendment of the agreement with Phoenixus AG, formerly known as Vyera Pharmaceuticals AG ("Vyera"), for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash and stock the remaining royalties payable on any future net sales of SLS-002, all future success and commercial based milestones and the change of control fee in the event SLS-002 is acquired (Press release, Apricus Biosciences, APR 11, 2022, View Source [SID1234611975]).

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On March 6, 2018, Seelos entered into an asset purchase agreement (the "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. In February 2021, Seelos amended the asset purchase agreement, for three additional cash payments, agreeing 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. Seelos completed those payments in February, June, and September of 2021. Under the amendment entered into on April 8, 2022, for additional cash and stock payments due by April 2022, July 2022 and January 2023, the parties have agreed to terminate in full all contingent payment obligations to Vyera and its related entities under the Purchase Agreement, effective upon the payment and issuance of all cash and stock payments.

"We believe this repurchase of the remaining financial obligations owed or that may become payable on SLS-002 has the potential to return meaningful future value to Seelos’ stockholders, assuming we are successful in the clinical development, regulatory approval processes, and commercialization of the intranasal ketamine program," said Raj Mehra, Ph.D., Chairman and CEO of Seelos.

"This amendment removes all future royalties due to Vyera, nearly $100 million of potential future milestones and a change of control fee in the event this program were to be acquired as a standalone transaction or as part of a larger transaction," said Michael Golembiewski, CFO of Seelos.

About SLS-002

SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment

of Acute Suicidal Ideation and Behavior in Major Depressive Disorder or Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 looks to address an unmet need for a therapy to treat suicidality in the U.S. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I) and is being followed by pivotal registration studies after meeting with the FDA. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for depression and suicidality.