Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Pharmaceuticals Added to the Nasdaq Biotechnology Index
CHATHAM, N.J., December 15, 2021 (GLOBE NEWSWIRE)
-- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced
that it has been added to the Nasdaq Biotechnology Index (Nasdaq: NBI) as part of the Nasdaq's annual reconstitution process. The
addition will become effective prior to market open on Monday, December 20, 2021.
The Index is designed to track the performance of
a set of securities listed on The Nasdaq Stock Market (Nasdaq ) that are classified as either Biotechnology
or Pharmaceutical according to the Industry Classification Benchmark (ICB). For more information about the Nasdaq Biotechnology Index
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company
focused on discovering, licensing, acquiring and developing therapeutics and diagnostics 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 COVID-19-related product candidates to prevent and treat COVID-19, to treat Long COVID as well as to detect
functional T cell immunity to SARS-CoV-2. 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 (cyclobenzaprine HCl sublingual
tablets), is in mid-Phase 3 development for the management of fibromyalgia. TNX-13002 is a biologic designed to treat cocaine
intoxication that is expected to start a Phase 2 trial before year end. Tonix's lead vaccine candidate for COVID-19, TNX-18003,
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 expects to start a Phase 1 study in humans in the second half of 2022. Tonix is also developing TNX-21004,
an in vivo diagnostic to measure the presence of functional T cell immunity to SARS-CoV-2 and intends to initiate a first-in-human
clinical study in the first quarter of 2022. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug
to treat acute COVID-19 and is in the pre-IND stage of development. Finally, TNX-102 SL is a small molecule drug being developed
to treat Long COVID, a chronic post-COVID condition, and is also in the pre-IND stage. Tonix expects to conduct a Phase 2 study in Long
COVID in the first half of 2022. Tonix's immunology portfolio also includes biologics to address immunosuppression, cancer, and
autoimmune diseases.
1TNX-102 SL is an investigational
new drug and has not been approved for any indication.
2TNX-1300 is an investigational
new biologic at the pre-IND stage of development and has not been approved for any indication.
3TNX-1800 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.
4TNX-2100 is an investigational
new biologic and has not been approved for any indication.
5TNX-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.
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, risks related to the 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.
Jessica Morris (corporate)
Tonix Pharmaceuticals
Olipriya Das, Ph.D. (media)
Peter Vozzo (investors)
Westwicke, an ICR Company