Tonix Pharmaceuticals Announces Oral Presentation at the American College of Rheumatology Convergence 2021

Rhea-AI Summary

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the acceptance of an oral presentation at the ACR Convergence 2021, scheduled for November 6, 2021. The presentation will focus on TNX-102 SL, highlighting positive results from a Phase 3 trial for fibromyalgia treatment. The company's pipeline also includes candidates for COVID-19, such as TNX-1800, slated for Phase 1 studies in early 2022, and TNX-3500, which is in pre-IND development. Tonix aims to address various health challenges, particularly in immunology and CNS disorders.

Positive

• Acceptance of oral presentation at ACR Convergence 2021 regarding TNX-102 SL for fibromyalgia, indicating strong clinical results.
• Positive results from the Phase 3 RELIEF Study, enhancing credibility and potential marketability of TNX-102 SL.
• Active development pipeline, including TNX-1800 for COVID-19 with reported positive animal studies, planned human trials in 2022.

Negative

• None.

CHATHAM, N.J., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announces the acceptance and details of an oral presentation at the American College of Rheumatology (ACR) Convergence 2021. The ACR Convergence 2021 is being held virtually November 5-9, 2021. A copy of the presentation will be made available under the IR Events tab of the Investors section of the Tonix website following the presentation at www.tonixpharma.com. The oral presentation details are as follows:

Title		TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Trial
Abstract No.		0477
Presn ID		1815778
Date		November 6, 2021
Time		11:45 a.m. – 12:00 p.m. ET

About 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 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 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 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-2100, 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.

¹TNX-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. 

²TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

³TNX-102 SL is an investigational new drug and has not been approved for any indication.

⁴TNX-2100 is an investigational new biologic 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, the 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 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, an ICR Company
peter.vozzo@westwicke.com
(443) 213-0505

 

FAQ

What is the focus of the TNX-102 SL oral presentation at ACR Convergence 2021?

The presentation will focus on the positive results from a Phase 3 randomized trial for the treatment of fibromyalgia.

When will the TNX-102 SL presentation take place?

The presentation is scheduled for November 6, 2021, from 11:45 a.m. to 12:00 p.m. ET.

What other products is Tonix Pharmaceuticals developing?

Tonix is developing several candidates, including TNX-1800 for COVID-19 and TNX-3500 in pre-IND development.

Where can I find more information about TNXP's developments?

More information can be found on Tonix Pharmaceuticals' website under the Investors section.