Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Pharmaceuticals Announces Ribbon-Cutting Ceremony for its Infectious Disease R&D Center in Maryland
R&D Capabilities Expected to Support U.S. Pandemic Preparedness with Accelerated Discovery and Development of Vaccines and Antivirals
Against COVID-19 and Other Infectious Diseases
R&D Center is Operational with a Dedicated Staff of Scientists and Technicians
N.J., October 15, 2021 - Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical
company, today announced it will hold a ribbon-cutting ceremony at the Company's approximately 48,000 square foot research and
development center (RDC) in Frederick, Md. on October 18, 2021 at 12:00 p.m. ET. The RDC is expected to support the Company's expanding
infectious disease pipeline. This includes providing internal capacity to discover and develop vaccines and antivirals intended to support
U.S. pandemic preparedness.
Senator for Maryland Ben Cardin and U. S. Congressman David Trone representing Maryland's 6th Congressional District,
are expected to speak at the event. Also expected to attend the event are Maryland Department of Commerce Secretary Kelly Schulz, Frederick
County Executive Jan Gardner, and the Mayor of Frederick, Md., Michael O'Connor. Seth Lederman, M.D., President and Chief Executive
Officer of Tonix and Anthony Macaluso, PhD, Executive Vice President, Strategic Development of Tonix will make comments.
economy is an innovation economy, making Tonix and Frederick a great match," said U.S. Senator Ben Cardin, a member of the Senate
Finance Committee. "I applaud the decision to bring nearly 50,000 square feet of R&D space to Frederick and have no doubt that
the highly skilled local workforce will achieve great things there."
Pharmaceuticals does great work in the biopharmaceutical space and, equally important, brings high-paying jobs to our community"
said Congressman Trone. "We welcome Tonix to Maryland's 6th District and look forward to its positive impact in
at Tonix are excited to achieve this significant milestone in our efforts toward supporting and growing our pipeline of vaccines and
antiviral therapeutics," stated Dr. Lederman. "We believe that this strategy will enable Tonix to develop vaccines and therapeutics
to address the current COVID-19 pandemic, and to be prepared to efficiently combat potential novel or emerging pathogens, termed Disease
X', that could impact society in the future. We believe that the recombinant pox virus platform technology underlying TNX-1800
and TNX-801, coupled with our capabilities at the RDC and our Advanced Development Center (ADC) for manufacturing, will be rapidly deployable
for addressing Disease X, with simplified distribution and administration, relative to modified mRNA-based vaccines. Our goal is to be
able to design and test new recombinant pox virus vaccines against novel pathogens within the 100 days of recognition of a potential
emerging pandemic threat, consistent with the criteria1,2 recently set forth by the White House Office of Science and Technology
RDC main building was constructed as a biosafety level (BSL)-3 facility but has been operating at BSL-2. Tonix plans to make appropriate
upgrades and seek certification for BSL-3 so that research may be conducted on live SARS-CoV-2- and other pathogens.
RDC in Frederick, Md. will complement Tonix's ADC being constructed in New Bedford, Mass., and its Commercial Manufacturing Center
(CMC) planned in Hamilton, Mont. The ADC will house laboratories dedicated to process analytical development and pilot manufacturing
of the Company's vaccine candidates for clinical trials. The CMC is expected to support commercial scale manufacturing of vaccine
Pharmaceuticals Holding Corp.
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 immunology and central nervous
system (CNS) product candidates. Tonix's immunology portfolio includes a COVID-19 platform of product candidates to prevent and
treat COVID-19, to treat Long COVID as well as to detect functional T cell immunity to COVID-19. Tonix's lead vaccine candidate
for COVID-19, TNX-18001, is a live replicating vaccine based on Tonix's recombinant pox vaccine (RPV) 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 and expects to start a Phase 1 study in humans in the first half of 2022. TNX-35002 (sangivamycin)
is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-Investigational New Drug (IND) stage of development. TNX-102
SL3 (cyclobenzaprine HCl sublingual tablets) is a small molecule drug being developed to treat Long COVID, a chronic
condition, and is also in the pre-IND stage. Finally, Tonix is developing TNX-21004, an in vivo diagnostic
to measure the presence of functional T cell immunity to COVID-19. Tonix intends to initiate a first-in-human clinical study of TNX-21004 in
the fourth quarter of 2021, pending IND clearance. Tonix's immunology portfolio also includes biologics to address immunosuppression,
cancer, and autoimmune diseases. 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 SL3, is in mid-Phase 3 development for the
management of fibromyalgia.
is an investigational new biologic and has not been approved for any indication. TNX-1800 is based on TNX-801, live horsepox
virus vaccine for percutaneous administration, which is in development to protect against smallpox and monkeypox. TNX-801 is an investigational
new biologic and has not been approved for any indication.
is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
SL is an investigational new drug and has not been approved for any indication.
is an investigational new biologic and has not been approved for any indication.
press release and further information about Tonix can be found at www.tonixpharma.com.
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 risks related to the operation of research and manufacturing 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.