Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical firm centered on the event of therapies for central nervous system issues and uncommon illnesses, introduced right this moment an modification of the settlement with Phoenixus AG, previously referred to as Vyera Prescribed drugs AG (“Vyera”), for the event of SLS-002 (intranasal racemic ketamine) to repurchase in money and inventory the remaining royalties payable on any future web gross sales of SLS-002, all future success and business primarily based milestones and the change of management price within the occasion SLS-002 is acquired.
On March 6, 2018 , Seelos entered into an asset buy settlement (the “Buy Settlement”) with Vyera, at the moment referred to as Phoenixus AG, to accumulate the property and liabilities of Vyera’s intranasal racemic ketamine program, which Seelos now calls SLS-002. As further consideration to sure upfront money and fairness funds and success-based milestone funds contemplated beneath the prior settlement, Seelos agreed to pay a mid-teens proportion royalty on any future web gross sales of SLS-002. In February 2021 , Seelos amended the asset buy settlement, for 3 extra money funds, agreeing to repurchase 9% of the longer term royalties and scale back its royalty obligations to a mid-single digit proportion on any future web gross sales of SLS-002. Seelos accomplished these funds in February, June, and September of 2021. Beneath the modification entered into on April 8, 2022 , for extra money and inventory funds due by April 2022 , July 2022 and January 2023 , the events have agreed to terminate in full all contingent fee obligations to Vyera and its associated entities beneath the Buy Settlement, efficient upon the fee and issuance of all money and inventory funds.
“We imagine this repurchase of the remaining monetary obligations owed or that will turn into payable on SLS-002 has the potential to return significant future worth to Seelos’ stockholders, assuming we’re profitable within the scientific growth, regulatory approval processes, and commercialization of the intranasal ketamine program,” mentioned Raj Mehra, Ph.D., Chairman and CEO of Seelos.
“This modification removes all future royalties attributable to Vyera, practically $100 million of potential future milestones and a change of management price within the occasion this program have been to be acquired as a standalone transaction or as half of a bigger transaction,” mentioned Michael Golembiewski , CFO of Seelos.
About SLS-002
SLS-002 is intranasal racemic ketamine with two investigational new drug purposes for the therapy of Acute Suicidal Ideation and Habits in Main Depressive Dysfunction or Put up-Traumatic Stress Dysfunction. SLS-002 was initially derived from a Javelin Prescribed drugs, Inc./Hospira, Inc. program with 16 scientific research involving roughly 500 topics. SLS-002 seems to be to handle an unmet want for a remedy to deal with suicidality within the U.S. Historically, anti-depressants have been used on this setting however lots of the current therapies are identified to contribute to an elevated danger of suicidal ideas in some circumstances, and if they’re efficient, it usually takes weeks for the total therapeutic impact to be manifested. The scientific growth program for SLS-002 included two parallel wholesome volunteer research (Section I) and is being adopted by pivotal registration research after assembly with the FDA. Primarily based on info gathered from the databases of the Company for Healthcare Analysis and High quality, there have been greater than 1,000,000 visits to emergency rooms for suicide makes an attempt in 2019 within the U.S. alone. Experimental research recommend ketamine has the potential to be a speedy, efficient therapy for despair and suicidality.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical firm centered on the event and development of novel therapeutics to handle unmet medical wants for the advantage of sufferers with central nervous system (CNS) issues and different uncommon illnesses. The Firm’s strong portfolio consists of a number of late-stage scientific property focusing on indications together with Acute Suicidal Ideation and Habits (ASIB) in Main Depressive Dysfunction (MDD) or Put up-Traumatic Stress Dysfunction (PTSD), amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia (SCA), Sanfilippo syndrome, Parkinson’s Illness, different psychiatric and motion issues plus orphan illnesses.
For extra info, please go to our web site: http://seelostherapeutics.com , the content material of which isn’t included herein by reference.
Ahead Trying Statements
Statements made on this press launch, which aren’t historic in nature, represent forward-looking statements for functions of the protected harbor offered by the Non-public Securities Litigation Reform Act of 1995. These statements embody, amongst others, these relating to the flexibility of the royalty repurchase to return significant future worth to Seelos stockholders, and Seelos’ capability to reach the scientific growth, regulatory approval processes and commercialization of its intranasal ketamine program (SLS-002). These statements are primarily based on Seelos’ present expectations and beliefs and are topic to a variety of components and uncertainties that would trigger precise outcomes to vary materially from these described within the forward-looking statements. Dangers related to Seelos’ enterprise embody, however are usually not restricted to, the chance of not efficiently executing its preclinical and scientific research, and never gaining advertising approvals for its product candidates, the chance that prior scientific outcomes might not be replicated in future research and trials, the dangers that scientific examine outcomes could not meet all or any endpoints of a scientific examine and that any information generated from such research could not help a regulatory submission or approval, the dangers related to the implementation of a brand new enterprise technique, the dangers associated to elevating capital to fund its growth plans and ongoing operations, dangers associated to Seelos’ present inventory value, dangers associated to the worldwide impression of COVID-19, in addition to different components expressed in Seelos’ periodic filings with the U.S. Securities and Trade Fee, together with its Annual Report on Type 10-Okay and Quarterly Studies on Type 10-Q. Though we imagine that the expectations mirrored in our forward-looking statements are affordable, we have no idea whether or not our expectations will show right. You might be cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date hereof, even when subsequently made out there by us on our web site or in any other case. We don’t undertake any obligation to replace, amend or make clear these forward-looking statements, whether or not because of new info, future occasions or in any other case, besides as could also be required beneath relevant securities legal guidelines.
Contact Data
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 nd Ground
New York, NY 10022
(646) 293-2136
[email protected]
www.seelostherapeutics.com
https://twitter.com/seelostx
https://www.linkedin.com/firm/seelos
Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West fifty fifth St., Suite 3401
New York, NY 10019
(617) 308-4306
[email protected]
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