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Tonix Pharmaceuticals Announces Pricing of $4.0 Million Public Offering

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Tonix Pharmaceuticals announced the pricing of a $4.0 million public offering. The offering includes 3,753,558 shares of common stock or pre-funded warrants at $1.065 per share. Gross proceeds will be approximately $4.0 million, with net proceeds used for working capital, corporate purposes, and preparing a new drug application for its Tonmya™ product. Closing is expected around June 13, 2024. Dawson James Securities will act as the sole placement agent. The offering is under an effective shelf registration statement filed with the SEC.

Positive
  • Gross proceeds of $4.0 million from the public offering.
  • Intended use of net proceeds for working capital and preparing a new drug application, which could drive future growth.
  • Dawson James Securities acting as the placement agent adds credibility.
  • Tonix has completed two statistically significant Phase 3 studies for its Tonmya™ product for fibromyalgia.
  • Tonix's diversified portfolio includes therapies for CNS disorders, immunology, rare diseases, and infectious diseases.
Negative
  • Dilution of existing shares due to the public offering.
  • Offering price of $1.065 per share may be seen as undervaluing the company.
  • Net proceeds are subject to deduction of placement agent fees and other expenses.
  • Tonmya™ has not yet been approved for any indication.

Insights

The public offering of $4.0 million by Tonix Pharmaceuticals is a notable event for investors. This move is essential for raising the necessary funds to continue their drug development pipeline, particularly their Tonmya™ product candidate for fibromyalgia. The offering price of $1.065 per share shows a strategic decision to attract new investors while ensuring sufficient capital inflow.

One key point to consider is the pricing of the shares. At a price close to $1 per share, Tonix is trying to balance between dilution and securing adequate funds. This price can be a reflection of the company's current market valuation and investor perception.

For retail investors, the short-term impact may involve share price volatility due to the dilution effect. However, in the long-term, if the funds are used effectively for advancing the drug pipeline, particularly Tonmya™, this could result in significant value creation.

It's important to monitor how the company allocates this capital, particularly towards the preparation of the New Drug Application (NDA) for Tonmya™. Successful FDA approval can be a game-changer, potentially driving the stock price substantially higher.

Tonix’s decision to use the proceeds from the offering for working capital and general corporate purposes, including debt repayment, points to a need for financial stabilization and operational flexibility. This strategy helps ensure that the company can meet its short-term obligations while continuing to invest in its development pipeline.

The focus on preparing the NDA for Tonmya™ indicates a strategic push towards regulatory milestones that can significantly impact the stock price. The successful completion of two Phase 3 trials suggests progress and potential for future market entry.

Investors should also consider the competitive landscape for fibromyalgia treatments. If Tonmya™ can demonstrate superior efficacy or safety, it might carve out a significant market share, further enhancing Tonix’s market positioning.

The biopharmaceutical landscape for CNS disorders, including fibromyalgia, is highly competitive and scientifically challenging. The funds raised will support critical stages like NDA submission, which is a rigorous process involving extensive data and regulatory scrutiny.

Tonix’s diversified pipeline, including treatments for acute stress reaction and cocaine intoxication, indicates a robust strategic approach towards addressing unmet medical needs. The Breakthrough Therapy designation for TNX-1300 is particularly noteworthy, as it can expedite the development and review process.

From a scientific standpoint, the successful progression of Tonmya™ through Phase 3 trials is promising. However, the next critical phase involves navigating the FDA approval process, which will be pivotal for its market entry and subsequent impact on revenue streams.

CHATHAM, N.J., June 12, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of 3,753,558 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $1.065 per share (or $1.064 per pre-funded warrant in lieu thereof). The closing of the public offering is expected to take place on or about June 13, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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 including those relating to the completion of the public offering, the satisfaction of customary closing conditions, the intended use of proceeds from the public offering and other statements that are predictive in nature. 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 purpose of Tonix Pharmaceuticals' $4.0 million public offering?

The proceeds will be used for working capital, general corporate purposes, and preparing a new drug application for Tonmya™.

When is the closing date for Tonix Pharmaceuticals' public offering?

The closing is expected to take place on or about June 13, 2024.

How many shares are being offered by Tonix Pharmaceuticals in the public offering?

Tonix is offering 3,753,558 shares of its common stock or pre-funded warrants.

What is the offering price for Tonix Pharmaceuticals' public offering?

The offering price is $1.065 per share or $1.064 per pre-funded warrant.

What is the stock symbol for Tonix Pharmaceuticals?

The stock symbol is TNXP.

Tonix Pharmaceuticals Holding Corp.

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Biotechnology
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CHATHAM