Tonix Pharmaceuticals Added to the Nasdaq Biotechnology Index

Rhea-AI Summary

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced its addition to the Nasdaq Biotechnology Index, effective December 20, 2021. The Index tracks biotechnology and pharmaceutical securities listed on Nasdaq. Tonix focuses on developing therapeutics for various conditions, including COVID-19 related products and CNS disorders. Key candidates in their portfolio include TNX-102 SL, TNX-1300, and TNX-1800. However, the company faces risks such as regulatory delays and the need for further financing, which could impact development timelines.

Positive

• Inclusion in the Nasdaq Biotechnology Index, which may enhance visibility and credibility.
• Diverse portfolio with a focus on immunology and CNS products, addressing significant health issues.

Negative

• Dependence on FDA approvals poses regulatory risks.
• Potential delays due to the ongoing COVID-19 pandemic.
• Need for additional financing could impact operations and development.

CHATHAM, N.J., Dec. 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 visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

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.

CONTACTS

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

FAQ

What is the significance of Tonix Pharmaceuticals being added to the Nasdaq Biotechnology Index?

Being added to the Nasdaq Biotechnology Index may enhance Tonix's visibility among investors and improve stock liquidity.

When will Tonix Pharmaceuticals be officially part of the Nasdaq Biotechnology Index?

Tonix Pharmaceuticals will be added to the Nasdaq Biotechnology Index effective December 20, 2021.

What are the key products in Tonix Pharmaceuticals' pipeline?

Tonix's key products include TNX-102 SL for fibromyalgia, TNX-1300 for cocaine intoxication, and TNX-1800 as a COVID-19 vaccine.

What potential risks does Tonix Pharmaceuticals face in its operations?

Tonix faces risks including regulatory approval delays, need for financing, and substantial competition in the biopharmaceutical market.

How does Tonix Pharmaceuticals plan to address COVID-19?

Tonix is developing several COVID-19 related products, including vaccines and treatments for Long COVID.