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Tonix Pharmaceuticals Holding Corp. reported that the U.S. FDA has cleared its Investigational New Drug application for TNX-102 SL 5.6 mg, enabling clinical development for treating major depressive disorder (MDD) in adults. The company plans a potentially pivotal Phase 2 HORIZON study, a 6-week, randomized, double-blind, placebo-controlled trial of TNX-102 SL as first-line monotherapy in about 360 adults across approximately 30 U.S. sites. The primary goal is to measure change in Montgomery-Asberg Depression Rating Scale-II scores at Week 6, with additional measures of overall clinical impression, anxiety, and sleep disturbance, and enrollment is planned to begin in mid-year 2026.
Tonix Pharmaceuticals (TNXP) is updating its at-the-market common stock offering program under its existing Sales Agreement with A.G.P./Alliance Global Partners. The company is now offering up to an aggregate of $400,000,000 of its common stock under this program.
Under the prior prospectus, Tonix had registered up to $150,000,000 and sold 3,882,223 shares of common stock for an aggregate purchase price of $103.1 million. Following this prospectus supplement dated November 21, 2025, Tonix may sell up to an additional $296.9 million of common stock under the Sales Agreement.
Tonix Pharmaceuticals Holding Corp. reported that on November 21, 2025 it amended its Sales Agreement with A.G.P./Alliance Global Partners. The amendment increases the maximum aggregate offering price of the company’s common shares that may be issued under the agreement from $150,000,000 to $400,000,000, giving Tonix a larger authorized capacity to sell stock through this program as needed over time. The company also filed a legal opinion on the validity of the shares issuable under the Sales Agreement as an exhibit.
Tonix Pharmaceuticals Holding Corp. reported that its Board of Directors approved an increase to its share repurchase program, authorizing the Company to buy back up to an additional $25.0 million of its outstanding common stock. This brings the total amount authorized for repurchases under the program to $35 million.
The decision signals that the Company is willing to allocate a meaningful amount of capital to repurchasing its own shares, which can reduce the number of shares in the market over time and may support shareholder value, depending on execution and future business needs.
Tonix Pharmaceuticals Holding Corp. (TNXP) reported that its product TONMYA, a cyclobenzaprine HCl sublingual tablet, is now commercially available at pharmacies in the United States by prescription. This marks the move of TONMYA from development into the commercial marketplace, allowing eligible patients to obtain the drug through standard retail pharmacy channels.
The company released this information via a press release furnished as an exhibit, and emphasized that the disclosure includes forward-looking statements about its broader product development plans, regulatory timelines and market opportunities, which remain subject to various risks and uncertainties.
Tonix Pharmaceuticals (TNXP) reported Q3 2025 results. Product revenue was $3.29 million, up from $2.82 million a year ago. Operating loss was $33.07 million and net loss to common stockholders was $32.01 million, or $3.59 per share. Selling, general and administrative expenses were $25.70 million versus $7.71 million last year, and research and development was $9.29 million versus $9.11 million.
As of September 30, 2025, cash and cash equivalents were $190.06 million and total assets were $252.44 million. The company eliminated its term loan, reducing debt to zero from $4.67 million at December 31, 2024. Year‑to‑date, net cash provided by financing activities was $155.39 million, including $170.99 million of proceeds from sales of common stock and warrants.
Tonix received FDA approval for Tonmya in August 2025 and expects a U.S. launch before the end of November 2025. Management states current cash plus $34.7 million of Q4 2025 equity proceeds are expected to fund operations into the first quarter of 2027. Shares outstanding were 11,776,542 as of November 10, 2025.
Tonix Pharmaceuticals Holding Corp. filed a current report to disclose that it announced its operating results for the quarter ended September 30, 2025.
The company explains that these quarterly results are described in a press release dated November 10, 2025, which is attached as Exhibit 99.01 and incorporated by reference. The report is signed on behalf of the company by Chief Financial Officer Bradley Saenger.
Tonix Pharmaceuticals (TNXP) filed an 8-K with preliminary updates. The company believes its cash at September 30, 2025, plus $29.3 million of net proceeds from equity offerings in the fourth quarter of 2025, will cover planned operating and capital needs into the first quarter of 2027.
Management emphasized these are unaudited, preliminary estimates subject to completion of closing procedures and potential adjustments. The independent auditor has not audited, reviewed, or compiled this information. Tonix currently expects to file its Form 10-Q for the quarter ended September 30, 2025, on or about November 10, 2025.
The company also expects to commence the U.S. commercial launch of Tonmya for the treatment of fibromyalgia in adults by the end of November 2025.
Tonix Pharmaceuticals (TNXP) announced the first patient was dosed in the investigator-initiated FOCUS study at Massachusetts General Hospital in adults with arginine-vasopressin deficiency (AVP-D).
The randomized, double-blind, placebo-controlled crossover pilot will evaluate single-dose intranasal potentiated oxytocin at two doses: 6 IU (TNX-2900) and 24 IU (TNX-1900). The study will assess markers of anxiety, depression, and socioemotional functioning, with an exploratory two-week replacement period to observe mental health outcomes.
Tonix Pharmaceuticals Holding Corp. filed an 8-K to share an updated investor presentation and outline upcoming clinical plans. The company intends to start a Phase 2 trial in 2026 of its TNX-102 SL product candidate, already approved for fibromyalgia, for treating major depressive disorder. Tonix also plans an adaptive Phase 2/3 study in 2027 of TNX-4800 for the seasonal prevention of Lyme disease. The presentation is furnished as Exhibit 99.01 and is not deemed filed for liability purposes under U.S. securities laws.