NEW YORK, Aug. 9, 2021 /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 announced its mid-year 2021
business and clinical update.
"In the first half of 2021, the Seelos team continued to execute
at a very high level. Part 1 of the SLS-002 study demonstrated
rapid antidepressant and anti-suicidal effects with a
well-tolerated safety profile. We have begun the placebo-controlled
Part 2 of this registration directed study and plan to enroll in up
to 30 sites," said Raj Mehra Ph.D., Chairman and CEO
of Seelos. "The SLS-005 IV trehalose program's pivotal study
in ALS, which was accepted into the HEALEY ALS Platform Trial at
Harvard, plans to commence dosing
patients in the third quarter as well. We have begun additional in
vivo studies with our gene therapy program SLS-004 after
demonstrating its capability of reducing alpha-synuclein expression
targeting Parkinson's disease, and we continue to evaluate
additional indications for both SLS-002 and SLS-005."
In the first half of 2021, Seelos achieved several major
clinical and financial milestones and continued to make progress on
its multiple clinical stage development programs.
Seelos Business Update
As of the end of Q2, Seelos had $87.2mm of cash. It currently has no outstanding
In January, Seelos raised $33.5
million in net proceeds in an offering of common stock. The
company raised an additional $65
million in net proceeds in another offering of common stock.
Proceeds were used for the full repayment of Seelos' prior
convertible promissory notes and the remainder is for general
corporate purposes and to advance the development of its product
Also in January, Seelos was selected as one of 17 companies
included in the world's first psychedelic Exchange Traded Fund
(ETF), the Horizons Psychedelic Stock Index Fund, which trades
on Canada's NEO exchange and, in June, Seelos was
included in the Defiance Next Gen Altered Experience ETF, the
first U.S. listed Exchange Traded Fund (ETF) focused on
psychedelics, which began trading on May 28th.
In February, Seelos announced an amendment of its agreement with
Vyera Pharmaceuticals AG for the development of SLS-002 (intranasal
racemic ketamine) to repurchase in cash 9% of the royalties payable
on any future net sales of SLS-002.
In April, Seelos announced a Strategic Device Partnership with
AptarGroup, Inc. for the co-exclusive use and supply of Aptar
Pharma's Bidose (BDS) Liquid System device for SLS-002 in the
investigational development programs for the treatment of
suicidality, depression, and Post-Traumatic Stress Disorder (PTSD)
and under the terms of the agreement, Seelos has certain rights to
add other undisclosed indications to the Strategic Device
Seelos was added to the Russell
2000®, Russell 3000®, and
Russell Microcap® Indexes at the end of June, as
part of the 2021 Russell US Indexes Reconstitution.
Seelos Clinical Update
SLS-002 (intranasal racemic ketamine)
- Data for Part 1, the open-label cohort, of the registration
directed study for Acute Suicidal Ideation and Behavior in
patients with Major Depressive Disorder demonstrated a significant
treatment effect plus a well-tolerated safety profile.
- In early July, dosing of Part 2, the double-blind,
placebo-controlled cohort of the study commenced. A super-majority
of the trial sites are in various stages of onboarding.
- On June 15th, Seelos
completed a Type C meeting with the FDA to discuss the regulatory
pathway for the SLS-002 program.
SLS-005 (IV trehalose)
- Seelos was issued a patent from the Australian Patent Office
covering the parenteral administration of SLS-005 in multiple
- A Notice of Allowance was received from the Japanese Patent
Office covering the parenteral administration of SLS-005 in
treating oculopharyngeal muscular dystrophy (OPMD).
- SLS-005 received European Orphan Drug designation for ALS.
- In the third quarter, Seelos is expected to commence dosing of
a pivotal Phase IIb/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 (Parkinson's disease gene therapy programs)
- In vivo data was released in early July 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
If you or a loved one are having thoughts of suicide, please
seek immediate medical help, go to your nearest emergency room, or
call the National Suicide Prevention Lifeline at
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 enrollment in Seelos' Part 2 of the SLS-002
registration directed study focused on patients with major
depressive disorder (the "SLS-002 Study"), and the planned dosing
of patients in the SLS-005 IV trehalose program's pivotal study in
ALS (with SLS-002 Study, collectively, 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 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.
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
View original content to download
SOURCE Seelos Therapeutics, Inc.