"In the second half of 2021, we continued to accomplish several significant milestones and continued to execute in the face of one of the most difficult environments for publicly-traded biotech companies that I've seen in my career," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "We began the placebo-controlled Part 2 of the registration directed study of SLS-002 and plan to enroll in over 30 sites. The SLS-005 IV trehalose program's registrational study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, commenced dosing participants in February 2022 and our IND was accepted to study SLS-005 in spinocerebellar ataxia and its Phase IIb/III pivotal study should begin dosing in Q2 2022. We have begun additional in vivo studies with our Parkinson's disease focused gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression. We look forward to continuing to provide meaningful updates on the current state of progress on all of our programs as well as additional initiatives."
Seelos Clinical Update
SLS-002 (intranasal racemic ketamine)
- In July, Seelos began dosing patients in Part 2 of the registration directed, double-blind, placebo-controlled cohort in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
- In June, based on feedback from a Type C meeting with the FDA, Seelos is planning to expand the size of the trial and number of sites now that this trial has been labeled registration directed.
- In October, Seelos presented a poster titled "A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide", at the 2021 IASR/AFSP International Summit on Suicide Research Virtual Conference. SLS-002 demonstrated rapid, robust and sustained reductions on the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression of Severity for Suicidal Ideation and Behavior, the Patient Global Impression of severity for Suicidal Ideation and Behavior, and the Sheehan-Suicidality Tracking Scale. Additionally, the group mean met the MADRS remission criteria initially on day 6 after only 2 doses of SLS-002.
SLS-005 (IV Trehalose)
- In November, the FDA accepted Seelos' Investigational New Drug (IND) application to study SLS-005 for the treatment of spinocerebellar ataxia (SCA). Seelos plans to initiate a Phase IIb/III registrational study in the first half of 2022.
- The FDA granted the program Fast Track designation in the U.S. for SCA, and SLS-005 has previously received Orphan Drug designation for spinocerebellar ataxia type 3 (SCA3) from the FDA and from the European Medicines Agency in the EU.
- Also in November, Seelos was an Emerald Sponsor of the 4th Annual ALS ONE Research Symposium where Dr. Mehra presented an update of the program.
- In February 2022, Seelos commenced dosing of the first participants in a registrational Phase II/III trial in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital at several dozen trial sites across the U.S.
SLS-004 and SLS-007 (Parkinson's disease gene therapy programs)
- In early July, Seelos released in vivo data demonstrating down-regulation of SNCA mRNA and protein-expression from a study of SLS-004 in an in-vivo rodent model utilizing CRISPR-dCas9 gene therapy technology.
- Additional studies have commenced to explore efficacy of SLS-004 in the induced Parkinsonism in an in-vivo rodent model.
- Seelos was issued a patent covering the composition of matter for SLS-007, a potentially disease-modifying gene therapy focused on intracellular alpha-synuclein (α-synuclein) aggregation in Parkinson's disease (PD).
Seelos Business Update
- In the second half of 2021, Seelos achieved several major clinical and financial milestones and continued to make progress on its multiple clinical stage development programs.
- As of year-end 2021, Seelos had $78.7mm of cash.
- Between August and December, Seelos presented at 8 investor conferences, multiple fireside chat format video calls for investors and 2 industry events for the scientific community.
- In September, Seelos announced the promotions of Michael Golembiewski to Chief Financial Officer and Anthony Marciano to Chief Communications Officer.
- Also in September, Seelos appointed Margaret Dalesandro, Ph.D., an accomplished biopharmaceutical executive with over 30 years of experience in drug development and commercialization, to its Board of Directors.
- In October, Seelos was the platinum level sponsor of the American Foundation for Suicide Prevention's Out of the Darkness Westchester County Walk in Mamaroneck, NY.
- In November and December, Seelos raised $20.2 million in a private placement of senior secured convertible notes. Seelos will use the proceeds for general corporate purposes and to advance the development of its product candidates.
- Also in November, Seelos acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Europe Ltd for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX™.
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 its product candidates, Seelos' ability to efficiently execute clinical and pre-clinical programs, opening additional trial sites for screening and dosing for the pivotal SLS-002 registration directed study (the "SLS-002 Study"), Seelos' plan to initiate the SLS-005 Phase IIb/III registrational study for the treatment of SCA (with SLS-002 Study, the "Studies"). These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, or continuing or initiating the Studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Studies are not replicated, or the risk that the clinical results from the SLS-002 Study are materially different from the topline clinical results of Part I of the SLS-002 Study), 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 most recent 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. (Nasdaq: SEEL)
300 Park Avenue, 2nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com
SOURCE Seelos Therapeutics, Inc.