Seelos Therapeutics Releases the Itinerary for its Research and Development Update Conference Call and Webcast to be Held on December 15, 2022

NEW YORK, Dec. 8, 2022 /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 released the itinerary for its research and development update conference call and webcast to be held on Thursday, December 15^th from 1pm to 3pm ET. 

Registration is available at https://lifescievents.com/event/seelos-therapeutics-kol-event/, and https://seelostherapeutics.com/registration-for-12-15-rd-update-webcast/.

Itinerary for the Research and Development Update Conference Call and Webcast

SLS-002 (intranasal racemic ketamine)

We will hear an update from Evan P. Cohen, MD, Medical Director and Chairman of Emergency Services at Montefiore St. Luke's Cornwall Hospital in Newburgh, New York since he participated in our Key Opinion Leader (KOL) call in April. He will share his experience treating psychiatric patients in his emergency department and in prescribing ketamine. Dr. Cohen will also share trends he has witnessed over the past several years treating imminently suicidal patients and potential new directives to address the current issues in the treatment of mental health. 

Raj Mehra, Ph.D., Chairman and CEO of Seelos, and Tim Whitaker, MD, Chief Medical Officer of Seelos, will provide an update of the ongoing registration directed study of SLS-002 in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

Michael Cozart, Managing Partner at LifeSci Consulting, will discuss recently completed market research of the potential unmet need and market opportunity for SLS-002 in China, Japan, and Korea.

SLS-005(trehalose injection, 90.5 mg/mL for intravenous infusion)

Raj Mehra, Ph.D. will provide an update of the ongoing registration directed studies of SLS-005 in amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA).

Jeffrey H. Kordower, Ph.D., Founding Director, ASU-Banner Neurodegenerative Disease Research Center (NDRC) at Arizona State University, will discuss recent developments Seelos has made with SLS-005 in Huntington's disease and Alzheimer's disease.

SLS-004 and SLS-007 (gene therapy approaches for Parkinson's disease)

Krishna Subramanian, Ph.D., Vice President, Non-Clinical Development and Translational Science at Seelos, will discuss recent data and Raj Mehra, Ph.D. will discuss next steps for the programs.

Evan P. Cohen, MD is Medical Director & Chairman of Emergency Services at Montefiore St. Luke's Cornwall Hospital in Newburgh, New York. Dr. Cohen is an emergency medicine physician serving the NYC area for more than 10 years. Dr. Cohen is Board Certified by the American Board of Emergency Medicine. He received his bachelor's degree of science from Syracuse University in 2003 and graduated from the State University of New York, Upstate Medical University in 2007. He completed his residency in Emergency Medicine at Cooper University Hospital in Camden, New Jersey in 2010 and has been in practice for 12 years. 

Jeffrey Kordower is the founding director of the ASU-Banner Neurodegenerative Disease Research Center and endowed chair as The Charlene and J. Orin Edson Distinguished Director at the Biodesign Institute at ASU. He has been a pioneer in the field of neural transplantation techniques and his pathbreaking investigations into the underpinnings of neurodegenerative disease have made him a leader in the field. Kordower's interests include the study of gene and stem cell therapies, disease pathogenesis including the morphological and molecular changes during the course of neurodegeneration, learning and memory, and aging. He has also been a pioneer in the field of neural transplantation techniques. He comes to ASU from the Rush University Medical Center in Chicago, where he was faculty member for more than 30 years. He received his Ph.D. from The City University of New York.

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 and in 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. Seelos looks to address an unmet need for a therapy to treat suicidality in the U.S. with SLS-002. 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 includes two parallel healthy volunteer studies (Phase I), 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 refractory depression and suicidality.

SLS-005 is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier and is thought to stabilize proteins and activate autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression. Activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic accumulation of storage material. In animal models of several diseases associated with abnormal cellular protein aggregation or storage of pathologic material, SLS-005 has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. SLS-005 has previously received Orphan Drug Designation for the treatment of SCA type 3 from the U.S. Food and Drug Administration and from the European Medicines Agency in the EU. SLS-005 is an investigational treatment and is not currently approved by any health authority for medicinal use.

SLS-004 is a novel epigenome-editing approach to modulate expression of SNCA gene mediated by modification of DNA-methylation. SLS-004 utilizes an all-in-one lentiviral vector harboring dCas9-DNA methyltransferase 3A (DNMT3A) to enrich DNA-methylation within CpGs island at the SNCA intron 1 region. The system resulted in a precise and fine-tuned downregulation (30%) of SNCA overexpression in hiPSC-derived dopaminergic neurons from a PD patient with the triplication of the SNCA locus (SNCA-Tri). Most importantly, the reduction of SNCA expression mediated by the developed system was sufficient to ameliorate disease related cellular phenotypes. The in vitro studies achieved several key milestones, including the establishment that DNA hypermethylation at SNCA intron 1 allows an effective and sufficient tight downregulation of SNCA expression levels and suggests the potential of this target sequence combined with the CRISPR-dCas9 technology as a novel epigenetic-based therapeutic approach for PD.

SLS-007 is a family of rationally designed peptide inhibitors that target the non-amyloid component core (NACore) of α-synuclein to inhibit protein aggregation in patients with PD. The overexpression of α-synuclein leads to the formation of α-synuclein aggregates which comprise Lewy bodies and Lewy neurites which are the hallmarks of the pathology in brains of patients with PD. Recent in vitro and cell culture research have shown that SLS-007 has the potential to stop the propagation and seeding of α-synuclein aggregates.

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), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

For more information, please visit our website: https://seelostherapeutics.com, the content of which is not incorporated herein by reference.

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 the topics expected to be discussed on the call, Seelos' ability to complete clinical studies for its product candidates, and Seelos' ability to efficiently execute clinical and pre-clinical programs. 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 clinical 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 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
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2^nd 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

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