Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement

Rhea-AI Summary

On March 3, 2021, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced it has regained compliance with Nasdaq's minimum bid price requirement. The company confirmed its shares closed above $1.00 for 20 consecutive business days, satisfying the listing criteria. Tonix focuses on developing treatments for CNS and immunology conditions, with its lead candidate TNX-102 SL in mid-Phase 3 trials for fibromyalgia. The company expects interim data from another Phase 3 trial, RALLY, in Q3 2021, and efficacy data for its COVID-19 vaccine candidate, TNX-1800, in Q1 2021.

Positive

• Regained compliance with Nasdaq's minimum bid price requirement, closing above $1.00 for 20 consecutive business days.
• Lead candidate TNX-102 SL is in mid-Phase 3 development for fibromyalgia, with positive trial data reported.
• Expectations for interim data from the RALLY Phase 3 trial in Q3 2021.
• Lead vaccine candidate TNX-1800 aims to elicit a T cell response against COVID-19, with efficacy data expected soon.

Negative

• Dependence on future FDA clearances and potential delays in clinical development due to COVID-19.

CHATHAM, N.J., March 04, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market. On March 3, 2021, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a closing bid price at or above $1.00 per share for a minimum of 20 consecutive business days, Tonix’s stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(a)(1), and the matter is now closed.

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 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, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 2021² and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix’s lead vaccine candidate, TNX-1800³, 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 expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801³, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

¹TNX-102 SL is an investigational new drug and has not been approved for any indication.
²Pending submission and agreement from FDA on statistical analysis plan.
³TNX-1800 and TNX-801 are investigational new biologics and have 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 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, 2019, as filed with the Securities and Exchange Commission (the “SEC”) on March 24, 2020, 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)
Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

FAQ

What is Tonix Pharmaceuticals' stock symbol?

Tonix Pharmaceuticals is traded under the stock symbol TNXP.

When did Tonix Pharmaceuticals regain compliance with Nasdaq listing requirements?

Tonix Pharmaceuticals regained compliance on March 3, 2021.

What is TNX-102 SL?

TNX-102 SL is Tonix's lead candidate in mid-Phase 3 development for managing fibromyalgia.

What data is Tonix Pharmaceuticals expecting from its Phase 3 trials?

Tonix expects interim data from the RALLY trial in Q3 2021 and topline data in Q4 2021.

What is the purpose of the TNX-1800 vaccine?

TNX-1800 is a vaccine candidate aimed at protecting against COVID-19.