Tonix Pharmaceuticals Holding Corp. Announces Upcoming Investor Presentations at January Conferences

Tonix Pharmaceuticals announces investor presentations at January conferences, highlighting its CNS disorder treatments and pipeline developments.

Quiver AI Summary

Tonix Pharmaceuticals Holding Corp. announced that its management, led by CEO Seth Lederman, will present and meet with investors at two upcoming January conferences: the 8th Annual Neuroscience Innovation Forum and the 2025 Biotech Showcase, both in San Francisco. Lederman is scheduled to lead a company presentation and participate in a panel discussion on neuropsychiatric treatments. The company is focused on developing therapies for central nervous system disorders, with its lead candidate, TNX-102 SL, aiming for FDA approval for fibromyalgia by August 2025. Tonix is also advancing several other projects, including treatments for cocaine intoxication, organ transplant rejection, autoimmune diseases, and infectious diseases. They have a contract with the U.S. Department of Defense for the development of antiviral agents and market two migraine treatment products. The company's presentations will be available for replay on their website.

Potential Positives

• Tonix Pharmaceuticals is scheduled to participate in prominent investor conferences, enhancing visibility and engagement with potential investors.
• The company is advancing its lead product candidate, TNX-102 SL, for fibromyalgia with an upcoming PDUFA goal date of August 15, 2025, signifying potential for market approval.
• Tonix has received Fast Track designation from the FDA for TNX-102 SL, which may facilitate expedited development and review processes.
• The announcement of a significant contract with the U.S. Department of Defense for up to $34 million for antiviral development underscores confidence in Tonix's research capabilities and aligns with public health priorities.

Potential Negatives

• The press release heavily emphasizes the company's development pipeline without disclosing any assurances or recent successes in obtaining FDA approvals, which may lead to investor skepticism about future outcomes.
• There is a strong focus on forward-looking statements, indicating the presence of significant risks the company faces, such as potential failures in obtaining FDA clearances or successful marketing of products.
• The company acknowledges a need for additional financing, which could imply financial instability or reliance on external funding to continue operations and product development.

FAQ

What conferences will Tonix Pharmaceuticals be attending in January 2025?

Tonix will present at the Neuroscience Innovation Forum and the 2025 Biotech Showcase in San Francisco.

Who will represent Tonix Pharmaceuticals at these events?

Seth Lederman, M.D., President and CEO of Tonix Pharmaceuticals, will be the representative at the conferences.

How can investors schedule meetings with Tonix management?

Investors can arrange meetings by contacting the respective conference coordinators during the events.

What is the NDA status for TNX-102 SL?

TNX-102 SL has an NDA submitted for fibromyalgia, with a PDUFA date set for August 15, 2025.

What is the focus of Tonix Pharmaceuticals' development portfolio?

The development portfolio focuses on central nervous system disorders, pain management, and immunology-related treatments.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$TNXP Hedge Fund Activity

We have seen 0 institutional investors add shares of $TNXP stock to their portfolio, and 2 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

• ROSALIND ADVISORS, INC. removed 28,154 shares (-100.0%) from their portfolio in Q3 2024
• TWIN LAKES CAPITAL MANAGEMENT, LLC removed 1 shares (-100.0%) from their portfolio in Q3 2024

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

Full Release

CHATHAM, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Tonix management will present and host investor meetings at the following January investor conferences:

8



^th



Annual Neuroscience Innovation Forum by Sachs Associates

Investors interested in arranging a meeting with the Company's management during these conferences should contact the respective conference coordinators. Replays of both webcasts of the Company’s presentations at the Neuroscience Innovation Forum and the 2025 Biotech Showcase will be available under the

IR Events

tab of the Tonix website at

www.tonixpharma.com

following each presentation.

Tonix Pharmaceuticals Holding Corp.



^*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing approval. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. 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; their efficacy and safety have not been established and have 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 Healthcare



peter.vozzo@icrhealthcare.com



(443) 213-0505

Media Contact

Ray Jordan


Putnam Insights



ray@putnaminsights.com





(949) 245-5432

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.