Tonix Pharmaceuticals Announces Proposed Public Offering
Tonix Pharmaceuticals announced a proposed public offering of its common stock or pre-funded warrants. The proceeds will be used for working capital, general corporate purposes, including a new drug application for their product candidate Tonmya™, targeting fibromyalgia, and to address existing debt. Dawson James Securities is the sole placement agent. The offering is subject to market conditions and the terms remain unspecified. The offering is based on an effective shelf registration statement previously filed with the SEC. Investors are encouraged to read the entire prospectus supplement and accompanying documents for more information.
- Tonix will use proceeds to fund working capital and general corporate purposes, including the preparation of a new drug application for Tonmya™.
- The company aims to address fibromyalgia with Tonmya™, a product that has completed two statistically significant Phase 3 studies.
- Potential shareholder dilution due to the new stock issuance.
- The offering's success is uncertain and subject to market conditions.
- Proceeds may be used to satisfy existing debt, indicating financial obligations that need to be addressed.
Insights
Tonix Pharmaceuticals' announced public offering introduces a few important elements for investors to consider. Public offerings typically serve as a capital-raising activity. Tonix plans to use the proceeds for working capital and general corporate purposes, which often implies addressing financial health, enabling future growth, or managing existing debts.
Investors should evaluate the implied dilution of the shares as it affects shareholder value. The net proceeds are likely to be channeled into clinical development and preparation for the New Drug Application (NDA) for Tonmya™, which shows company prioritization on product pipeline advancement amidst financial restructuring.
Short-term impact might include stock price fluctuations due to market reaction. However, long-term benefit hinges on successful product development, regulatory approval and market acceptance of Tonmya™. The financial injection can potentially stabilize the firm’s operational activities and aid in pushing critical projects forward.
Understanding the strategic intent behind the offering requires an appreciation of the balance between short-term financial maneuvers and long-term growth prospects. This move could be seen positively by the market if interpreted as a step towards sustainable growth and innovation.
Tonmya™ is a key focus in Tonix's pipeline, particularly targeting fibromyalgia. The announcement highlights the significance of the two statistically significant Phase 3 studies. Success in these trials is a positive indicator for potential FDA approval, which would be a significant milestone.
Fibromyalgia, a chronic condition characterized by widespread pain, has a substantial market potential. Current treatments are limited, which creates an opportunity for a new entrant with proven efficacy. Investors should understand that while Tonmya™ shows promise, the path to full market approval is laden with regulatory scrutiny and requires substantial investment.
This public offering, therefore, serves a dual purpose: ensuring sufficient funds for the NDA process and potentially enhancing the company's market position in addressing an unmet medical need.
CHATHAM, N.J., July 08, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
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 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 prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, 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. 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
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