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Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering

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Tonix Pharmaceuticals has closed a $4.0 million public offering, issuing 2,833,900 shares of common stock and pre-funded warrants for 4,228,158 shares. Each share was priced at $0.57, while the pre-funded warrants were priced at $0.569 with an exercise price of $0.001. Gross proceeds are earmarked for working capital, corporate purposes, NDA preparations for Tonmya™ for fibromyalgia, and debt servicing. The offering was executed with Dawson James Securities as the sole placement agent. The prospectus was filed with the SEC and is accessible online.

Positive
  • Tonix raised $4.0 million in gross proceeds.
  • Funds will support NDA preparations for Tonmya™ for fibromyalgia.
Negative
  • Share dilution from issuing 2,833,900 new shares and 4,228,158 pre-funded warrants.

Tonix Pharmaceuticals' recent $4.0 million public offering brings several key considerations for investors. The funds raised will be utilized for working capital and general corporate purposes, including the preparation of a new drug application (NDA) for their Tonmya™ product candidate. Importantly, these proceeds will also help manage existing indebtedness, which can stabilize the company's financial position.

Given that Tonmya™ already has two statistically significant Phase 3 studies, the potential submission of an NDA in the second half of 2024 represents a pivotal moment for the company. Success in this application could provide a significant boost to Tonix's valuation, but the inherent risks of FDA approval processes should not be overlooked.

It's noteworthy that the offering priced at $0.57 per share is quite low, which may dilute current share value. However, this is somewhat mitigated by the immediate exercisability of the pre-funded warrants at a nominal exercise price of $0.001, suggesting confidence in the company's future prospects.

Short-term, the offering stabilizes liquidity, but long-term success hinges on regulatory milestones and commercial viability of their drugs. Investors should monitor the FDA submission timeline closely and assess the market potential for Tonmya™ in treating fibromyalgia.

Tonix Pharmaceuticals' focus on developing treatments for central nervous system (CNS) disorders positions it in a high-need sector. The upcoming NDA for Tonmya™ in fibromyalgia, an area with significant unmet medical need, is particularly promising. However, it is important to understand that while the Phase 3 trials show statistical significance, regulatory approval is not guaranteed and often involves additional hurdles such as manufacturing validation and post-approval studies.

Additionally, Tonix's diverse pipeline with candidates like TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection highlights their strategic approach to addressing a range of medical challenges. This breadth can be both a strength and a risk, as spreading resources thin across multiple projects may delay milestones.

For retail investors, it's important to consider the broader implications of the company's research focus. Successful approval of any one of these drugs could drive substantial revenue, given the niche but underserved markets. On the flip side, the specialized nature of their treatments means longer development cycles and substantial investment before any return is realized.

Overall, Tonix's strategy seems well-aligned with emerging medical needs, but investors should be prepared for the long haul, with a focus on milestone tracking and regulatory updates.

CHATHAM, N.J., June 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 2,833,900 shares of its common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569 per pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance.

The gross proceeds of the offering are $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. acted as the sole placement agent for the offering.

Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent.

This offering was 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 was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were 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.

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 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 was the offering price for Tonix Pharmaceuticals' new shares?

The offering price was $0.57 per share of common stock.

How many pre-funded warrants did Tonix Pharmaceuticals issue in the offering?

Tonix issued pre-funded warrants to purchase up to 4,228,158 shares.

What will Tonix Pharmaceuticals use the proceeds from the public offering for?

The proceeds will be used for working capital, corporate purposes, NDA preparations for Tonmya™, and debt servicing.

Who acted as the placement agent for Tonix Pharmaceuticals' public offering?

Dawson James Securities acted as the sole placement agent.

What is the exercise price for the pre-funded warrants issued by Tonix Pharmaceuticals?

The exercise price for the pre-funded warrants is $0.001 per share.

Tonix Pharmaceuticals Holding Corp.

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