- First patient with Sanfilippo Syndrome expected to be dosed with Trehalose in an open-label phase IIb trial in 2Q 2019 –

- Plan to initiate phase I study with intranasal racemic ketamine in Suicidality-PTSD in the summer of 2019–

- Proof of concept for Target Engagement for peptide-based approach targeting the NACore in Parkinson’s Disease expected to begin in 2Q 2019 –

- Management to share archived webcast of interview with the TD Ameritrade Network –

NEW YORK, March 28, 2019 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (NASDAQ: SEEL), a clinical-stage biopharmaceutical company provided an update on recent pipeline developments and corporate highlights.

“Seelos successfully transitioned into a publicly traded company on Nasdaq by completing its reverse merger with Apricus BioSciences, Inc. on January 24, 2019,” said Raj Mehra, PhD, Chairman, Founder, and CEO of Seelos. “Furthermore, in the short time span of two months since the merger, Seelos has acquired two exciting new programs: SLS-005, focused on orphan diseases in the CNS, and SLS-007, a family of peptidic inhibitors directed toward alpha-synuclein aggregates in Parkinson’s disease.”

Recent Corporate Highlights

  • The financials for FY 2018 primarily relate to the legacy company, Apricus BioSciences.
  • As of March 14, 2019, Seelos has approximately 18.4mm shares and 3.1mm warrants outstanding.
  • On January 24th, Seelos Therapeutics completed its merger with Apricus and began trading under the symbol “SEEL” on the NASDAQ. Seelos completed a capital raise in conjunction with the merger. Cash, cash equivalents and short-term investments for the combined company at the closing were approximately $18 million, prior to payment of transaction costs.
  • In February, Seelos acquired the worldwide development and commercial rights to Bioblast’s proprietary trehalose 90 mg/mL IV solution and all inventory of the drug. Seelos has named this program SLS-005.
  • In addition, in February, Seelos assumed a collaborative agreement with Team Sanfilippo Foundation (TSF), as part of the aforementioned acquisition.
  • In March, Seelos acquired a license to technology developed at UCLA that relates to a family of rationally-designed peptide inhibitors that target the aggregation of alpha-synuclein (α-synuclein). Seelos has named this program SLS-007.

Update on Pipeline Development

  • SLS-002 (intranasal racemic ketamine)
    • In line with our investigational new drug (IND) program, preparations are underway to initiate our phase I in the summer of 2019 to further evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interactions (DDI) of SLS-002 in patients with post-traumatic stress disorder (PTSD) at imminent suicide risk (suicidality).
    • Upon study completion and review of data, Seelos plans to request a post-Phase II meeting with the FDA to discuss trial design requirements for a pivotal study.
  • SLS-005 (trehalose)
    • TSF is finalizing the protocol for an up to 20 patient open-label phase IIb study in Sanfilippo syndrome that currently presents few therapeutic options for patients. Seelos will provide drug for the current 52-week study as well as an extension study and own all data upon the completion of the trial. Initial patient dosing is scheduled to begin in 2Q 2019.
  • SLS-007 (Peptidic inhibitors)
    • Seelos expects to begin to evaluate this peptide-based approach targeting the NACore (nonamyloid component core) in Parkinson’s disease (PD) in a proof of concept, in-vivo delivery of SLS-007 in a PD transgenic mice model in 2Q 2019.

Link to Archived Interview with TD Ameritrade Network

Chairman, Founder, and CEO Raj Mehra, PhD was interviewed in a live studio setting by Nicole Petallides of the TD Ameritrade Network on Monday, March 25th in NYC for the launch episode of her show “The Watch List.”

The archived webcast of this interview can be accessed at: https://tdameritradenetwork.com/video/rB4AoWmoG5SBabX3gpQB8Q

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 disorders. The Company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York.

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

Forward-Looking Statements

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements including, among others, statements regarding: the expected timing for dosing the first patient with Sanfilippo Syndrome expected to be dosed with Trehalose in an open-label phase IIb trial; expected timing for a phase I study in suicidality-PTSD; expected timing for a proof of concept for Target Engagement for peptide-based approach targeting the NACore in Parkinson’s Disease; prospects regarding trehalose; the Company’s collaboration with Team Sanfilippo Foundation (TSF) and the Company’s plans to request a post-Phase II meeting with the FDA to discuss trial design requirements for a pivotal study for suicidality-PTSD. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, 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. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; the Company may encounter delays or obstacles in successfully completing its clinical trials; the Company’s products may not be approved by regulatory agencies, the Company’s products may not be validated as it progresses further and its methods may not be accepted by the scientific community; the Company may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with the Company’s process; the Company’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; the Company’s patents may not be sufficient; the Company’s products may harm recipients; changes in legislation may adversely impact the Company; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc.
anthony.marciano@seelostx.com
www.seelostherapeutics.com