Seelos Therapeutics Provides Update on Pipeline Developments and Corporate Highlights
March 28 2019 - 5:00PM
- First patient with Sanfilippo Syndrome expected to be
dosed with Trehalose in an open-label phase IIb trial in 2Q 2019
–
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
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