Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced the signing of a Purchase and Sale Agreement to acquire
an approximately 48,000 square foot research and development
(R&D) facility in Frederick, MD to support Tonix’s expanding
infectious disease pipeline, including TNX-1800, a live replicating
viral vaccine designed to protect against COVID-19, TNX-801, a live
vaccine designed to protect against smallpox and monkeypox, and
TNX-3500, a small molecule antiviral to inhibit replication of
SARS-CoV-2.
Tonix agreed to purchase the R&D facility
from Southern Research, a research collaboration partner for
TNX-1800 and TNX-801 development. The facility currently operates
at biosafety level 2 (BSL-2) containment. Pending transfer and
approval of relevant permits, Tonix expects the transaction to
close and the facility to be operational in the fourth quarter of
2021. Southern Research plans to consolidate its research
activities at its Birmingham, AL campus. Tonix and Southern
Research plan to continue those aspects of their collaboration on
the development of vaccines and antivirals that are ongoing at the
Birmingham, AL campus.
“The Fredrick facility will be a major expansion
of our R&D capabilities,” stated Seth Lederman, M.D., President
and Chief Executive Officer of Tonix. “We believe this facility
will ensure adequate resources and capacity to support and grow our
pipeline of vaccines and antiviral therapeutics. In addition, we
view control of in-house facilities as a strategic capability to
ensure the speed and efficiency with which we can develop vaccines
and antiviral products in the future against known, emerging or
novel pathogens.”
Dr. Lederman continued, “While COVID-19 has the
appearance of being controlled in certain geographic centers,
reports of increasing infections in both unvaccinated and
vaccinated individuals, primarily related to new variants, have led
to new mask mandates and restrictions in parts of the U.S. as well
as new lockdowns and other restrictions in Europe and elsewhere.
These concerning trends point to an urgent need for more robust
vaccine technology and better overall preparedness. The COVID-19
pandemic revealed weaknesses in the U.S. domestic capability to
conduct infectious disease R&D and produce vaccines and
therapeutics, particularly in the setting of an interrupted global
supply chain. We believe our planned capabilities at the Frederick
facility will provide greatly needed domestic resources. The
facility is ideally located in Maryland’s ’biotech corridor’, which
is rich in highly skilled talent, and is also close to the center
of the U.S. biodefense research community.”
Josh Carpenter, PhD, Chief Executive Officer of
Southern Research stated, “We are delighted that Tonix will be
acquiring the Frederick research campus. This is another chapter in
a robust partnership that will be made even stronger. We have
enjoyed partnering with Tonix on TNX-1800 and TNX-801 vaccine
projects and look forward to continued collaboration on these
projects, as well as TNX-3500 with work performed at our Birmingham
campus.”
Tonix’s Fredrick R&D facility will
complement its Advanced Development Center (ADC) being constructed
in New Bedford, MA and the Commercial Manufacturing Center (CMC)
that Tonix is planning in Hamilton, MT. The ADC will house
laboratories dedicated to process analytical development and pilot
manufacturing of its vaccine candidates. The CMC is expected to
support commercial scale manufacturing of vaccine products.
Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
small molecules and biologics to treat and prevent human disease
and alleviate suffering. Tonix’s portfolio is primarily composed of
central nervous system (CNS) and immunology product candidates. The
Company’s CNS portfolio includes both small molecules and biologics
to treat pain, neurologic, psychiatric and addiction conditions.
Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3
development for the management of fibromyalgia. Tonix’s immunology
portfolio includes vaccines to prevent infectious diseases and
biologics to address immunosuppression, cancer, and autoimmune
diseases. Tonix’s lead vaccine candidate, TNX-18002, is a live
replicating vaccine based on the horsepox viral vector platform to
protect against COVID-19, primarily by eliciting a T cell response.
Tonix reported positive efficacy data from animal studies of
TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox
virus vaccine for percutaneous administration, is in development to
protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is
a small molecule antiviral drug in the pre-IND stage of
development.
1TNX-102 SL is an investigational new drug and
has not been approved for any indication.2TNX-1800 and TNX-801 are
investigational new biologics and have not been approved for any
indication.3TNX-3500 is an investigational new drug at the pre-IND
stage of development and has not been approved for any
indication.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
About Southern Research
Founded in 1941, Southern Research (SR) is an
independent, 501(c)(3) nonprofit affiliated with the University of
Alabama at Birmingham. SR is an applied scientific research
organization with more than 400 scientists and engineers working
across four divisions: CRO services, Drug Discovery, Energy
Storage, and Engineering. SR has supported the pharmaceutical,
biotechnology, defense, aerospace, environmental, and energy
industries. SR works on behalf of the National Institutes of
Health, the U.S. Department of Defense, the U.S. Department of
Energy, NASA and other major aerospace firms, utility companies,
and other external academic, industry and government agencies. SR
pursues entrepreneurial and collaborative initiatives to develop
and maintain a pipeline of intellectual property and innovative
technologies that positively impact real-world problems. SR has
numerous ongoing drug discovery programs, which encompass drug
discovery programs to combat various forms of cancer, Alzheimer’s,
schizophrenia, opioid use disorder, human immunodeficiency virus,
disease, Parkinson’s, tuberculosis, influenza, and others. SR’s
strong history, which includes nearly 80 years of successful
collaborations to solve complex problems, has led to the discovery
of seven FDA-approved cancer drugs—a number rivaling any other U.S.
research institute. Furthermore, experts at SR are well-equipped to
assist with the challenging landscapes of drug design and
development technologies and market viability. SR is headquartered
in Birmingham, Alabama.
Further information about SR can be found at
https://southernresearch.org
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimate,” “expect,” and “intend,” among
others. These forward-looking statements are based on Tonix's
current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to
differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, the
development of R&D facilities, risks related to failure to
obtain FDA clearances or approvals and noncompliance with FDA
regulations; delays and uncertainties caused by the global COVID-19
pandemic; risks related to the timing and progress of clinical
development of our product candidates; our need for additional
financing; uncertainties of patent protection and litigation;
uncertainties of government or third party payor reimbursement;
limited research and development efforts and dependence upon third
parties; and substantial competition. As with any pharmaceutical
under development, there are significant risks in the development,
regulatory approval, and commercialization of new products. Tonix
does not undertake an obligation to update or revise any
forward-looking statement. Investors should read the risk factors
set forth in the Annual Report on Form 10-K for the year ended
December 31, 2020, as filed with the Securities and Exchange
Commission (the “SEC”) on March 15, 2021, and periodic reports
filed with the SEC on or after the date thereof. All Tonix's
forward-looking statements are expressly qualified by all such risk
factors and other cautionary statements. The information set forth
herein speaks only as of the date thereof.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo
(investors)Westwicke/ICRpeter.vozzo@westwicke.com(443) 213-0505
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