Nextbigone
6 months ago
Tonix Pharmaceuticals Announces Issuance of EU Patent Covering Intranasal Potentiated Oxytocin (TNX-1900) for the Treatment of Pain
New patent expected to expire in 2036
Proof of concept data from Phase 2 study for prevention of migraine headache expected in early December 2023
CHATHAM, N.J., October 4, 2023 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that the European Patent Office (EPO) issued European Patent No. 3242676 to the Company on October 4, 2023. The patent, entitled “Magnesium-Containing Oxytocin Formulations and Methods of Use”, claims methods and compositions for treating pain, including migraine headaches, using intranasal magnesium-containing oxytocin formulations. This patent, excluding possible patent term extensions, is expected to provide Tonix with market exclusivity in the member states of the European Patent Office until 2036. The U.S. Patent and Trademark Office (USPTO) has previously issued U.S. Patents No. 9,629,894 and 11,389,473 which are expected to provide market exclusivity in the U.S. until 2036.
In August 2023, Tonix announced it completed enrollment in its proof-of-concept Phase 2 PREVENTION study of TNX-1900 (intranasal potentiated oxytocin) for the prevention of migraine headache in chronic migraineurs with a total of 88 patients enrolled. The Company expects topline results from this trial in early December 2023.
“We believe this European patent combined with the U.S. issuance provides a strong patent position for TNX-1900 as we move forward in clinical development for the treatment of chronic migraine,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “With a differentiated formulation including magnesium, which Tonix has shown to potentiate the action of oxytocin at oxytocin receptors in animal models, we believe TNX-1900 has the potential to help those chronic migraine sufferers by engaging and stimulating oxytocin receptors in the trigeminal ganglia. By expanding our patent coverage in Europe, we are ensuring the IP protection of this unique approach.”
In addition to Tonix’s patents that protect certain uses including treating migraine, Tonix has licensed patents from INSERM, the French national health and medical research institute, that claim methods of treating feeding disorders with onset during neonatal development, specifically Prader Willi syndrome and non-organic failure to thrive (NOFTT), using oxytocin (EP 2575853, US8853158 and US9125862) and licensed patents from University of Geneva that claim methods of treating insulin resistance using oxytocin (US9101569 and EP2571511).
About Migraine
Migraine is a neurological condition that manifests in throbbing headache, often on one side of the head, that lasts at least four hours. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light, strong smells, and loud noises.1 Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.2 In the U.S., approximately 39 million Americans suffer from migraines and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month).2
Nextbigone
8 months ago
Tonix Pharmaceuticals Announces Pricing of $7 Million Public Offering
2023-07-27 21:31 ET - News Release
CHATHAM, N.J., July 27, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced it has entered into a securities purchase agreement for the purchase and sale of 7,000,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 7,000,000 shares of common stock in a public offering at a combined offering price of $1.00 per share (or common stock equivalents in lieu thereof) and accompanying warrant. The warrants have an exercise price of $1.00 per share, will become exercisable commencing the date of issuance, and will expire five years following the issuance date. The closing of the public offering is expected to take place on or about August 1, 2023, subject to the satisfaction of customary closing conditions.
The gross proceeds of the offering will be approximately $7 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, the build out of the Company’s manufacturing and research and development facilities, and the acquisition or licensing of approved products and products in development.
A.G.P./Alliance Global Partners is acting as lead placement agent for the offering.
Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-placement agent for the offering.
This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-254975) 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 final prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.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 biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, nearing complete enrollment in a potentially registration-enabling study, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is nearing complete enrollment with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes 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. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.
* Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Tonix Medicines has contracted to acquire the Zembrace SymTouch and Tosymra registered trademarks. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc.