Tonix Pharmaceuticals Awarded Up to $34 Million U.S. Department of Defense Contract for Accelerated Development of Broad-Spectrum Antiviral Program

Rhea-AI Summary

Tonix Pharmaceuticals has been awarded a contract by the Defense Threat Reduction Agency (DTRA) worth up to $34 million over five years. The contract aims to develop Tonix's broad-spectrum oral antiviral program, TNX-4200, to enhance the medical readiness of military personnel against biological threats.

The development will focus on optimizing a CD45 antagonist for broad-spectrum efficacy against various viral families, establishing necessary properties for an IND submission, and funding a Phase 1 clinical study. This initiative aligns with the Department of Defense's strategy to develop broad-spectrum antiviral drugs.

The funding will leverage Tonix's advanced research facilities, including BSL-3 and ABSL-3 labs, and prior work on phosphatase inhibitors. The program seeks to provide effective, low-dose antiviral protection with improved safety profiles.

Positive

• Tonix Pharmaceuticals awarded a $34 million contract by DTRA.
• The contract spans five years, providing significant funding for research.
• Focus on developing TNX-4200, a broad-spectrum oral antiviral agent.
• Supports the military's readiness against biological threats.
• Funding will support IND submission and Phase 1 clinical study.
• Utilizes advanced BSL-3 and ABSL-3 laboratory capabilities.

Negative

• None.

Biopharmaceutical Financial Analyst

The $34 million contract from the U.S. Department of Defense represents a significant financial boost for Tonix Pharmaceuticals. For retail investors, this can be interpreted as a strong validation from a reputable entity, underpinning the company's financial stability and its potential for future growth. Such funding also provides a substantial runway to advance the TNX-4200 program through its preclinical and early clinical phases, reducing the financial risk often associated with drug development.

From a financial perspective, investors should note that while the contract spans up to five years, the receipt of funds will be contingent on meeting specific milestones. This could smooth out the company's cash flow over the duration of the contract. However, it is important to consider that the development of broad-spectrum antiviral agents is inherently risky and costly. The company must demonstrate solid progress and favorable results to ensure continued funding.

The location of the company's research and development center in Maryland’s ‘I-270 biotech corridor’ also provides strategic advantages, as it places Tonix at the heart of the U.S. biodefense research community. This proximity could facilitate collaborative opportunities and access to additional resources.

Medical Research Analyst

The focus on developing a broad-spectrum antiviral, specifically targeting CD45, is quite innovative. The move away from a 'one bug, one drug' approach signifies a paradigm shift in antiviral research. By partially inhibiting CD45, Tonix aims to provide effective antiviral protection with lower plasma drug concentrations, thereby enhancing the drug's safety profile.

For investors, this distinction is important as it showcases the company's forward-thinking approach and scientific adaptability. The use of a Biosafety Level 3 (BSL-3) lab and Animal Biosafety Level 3 (ABSL-3) facility indicates that Tonix has the necessary infrastructure to handle high-risk pathogens, which is a positive sign for the project's feasibility.

However, it is important to recognize that early-stage drug development can encounter numerous hurdles, including regulatory challenges and potential setbacks in clinical trials. Investors should monitor the progress of preclinical evaluations and the submission of the Investigational New Drug (IND) application closely.

Defense Threat Reduction Agency (DTRA) contract is expected to advance development of Tonix’s broad-spectrum oral antiviral program TNX-4200 for medical countermeasures

CHATHAM, N.J., July 01, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced it has been awarded an Other Transaction Agreement (OTA) with a potential for up to $34 million over five years by the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense (DoD). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments.

Tonix’s program will focus on optimization and development of its TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug (IND) submission and to fund a first-in-human Phase 1 clinical study.

“Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. Joint Forces in the event biological weapons are introduced onto the battlefield,” said Seth Lederman, M.D., President, and Chief Executive Officer of Tonix. “The DoD announced in December 2022 that they are moving beyond a ‘one bug, one drug’ approach and are seeking broad-spectrum drugs since one cannot predict which or how many viruses may be deployed.¹ This funding provides important validation for our ongoing research and current in-house capabilities, and will enable Tonix to advance its antiviral discovery program.”

The $34 million five-year contract will help fund and accelerate the development of the Company’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix’s premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.

Tonix will utilize its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center (RDC) located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland’s ‘I-270 biotech corridor’ and is close to the center of the U.S. biodefense research community.

¹ “Approach for Research, Development, and Acquisition of Medical Countermeasure and Test Products.” 2022. Chemical and Biological Defense Program. U.S. Department of Defense. https://media.defense.gov/2023/Jan/10/2003142624/-1/-1/0/APPROACH-RDA-MCM-TEST-PRODUCTS.PDF (accessed March 5, 2024)

About Defense Threat Reduction Agency (DTRA)

The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD) is both a Defense Agency and Combat Support Agency with two distinct yet highly integrated roles countering Weapons of Mass Destruction (WMD) and emerging threats. Its origins stretch back to World War II and the Manhattan Project, but today the agency encompasses a wide variety of strategic and operational functions that deter, prevent, and ultimately prevail against these unique threats. DTRA enables the Department of Defense (DoD), the United States Government and international partners to counter and deter weapons of mass destruction (WMD) and emerging threats. DTRA provides cross-cutting solutions to enable the Department of Defense, the United States Government, and international partners to deter strategic attack against the United States and its allies; prevent, reduce, and counter WMD and emerging threats; and prevail against WMD-armed adversaries in crisis and conflict. DTRA’s continued effort to enhance the combat support mission also advances public health services by developing innovative technologies that protect against biological threats. For more information, visit www.dtra.mil.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya¹, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace^® SymTouch^® (sumatriptan injection) 3 mg and Tosymra^® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

¹Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of 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.

Investor Contact

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

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

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com  
(978) 360-3151

FAQ

What is the value of the contract awarded to Tonix Pharmaceuticals by the DTRA?

The contract awarded to Tonix Pharmaceuticals by the DTRA is valued at up to $34 million over five years.

What is the objective of the DTRA contract awarded to Tonix Pharmaceuticals?

The objective of the DTRA contract is to develop broad-spectrum antiviral agents to enhance the medical readiness of military personnel in biological threat environments.

Which antiviral program will Tonix Pharmaceuticals develop under the DTRA contract?

Tonix Pharmaceuticals will develop the TNX-4200 program, a broad-spectrum oral antiviral agent under the DTRA contract.

How will the $34 million contract support Tonix Pharmaceuticals' antiviral program?

The $34 million contract will support the optimization, preclinical evaluation, IND submission, and Phase 1 clinical study of Tonix Pharmaceuticals' TNX-4200 antiviral program.

What are the key research capabilities of Tonix Pharmaceuticals for the TNX-4200 program?

Tonix Pharmaceuticals will use its BSL-3 and ABSL-3 laboratory capabilities and expertise in phosphatase inhibitors for the TNX-4200 program.

What is the significance of the TNX-4200 program for military personnel?

The TNX-4200 program aims to provide broad-spectrum antiviral protection to improve the medical readiness of military personnel against biological threats.