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Material updates from SEC filings (8-K, 10-Q, 10-K) ranked by impact, with no firehose noise.
Other Events. On June 8, 2026, the Company announced it entered into an agreement with a GPO, effective June 1, 2026, that provides coverage to approximately 17 million U.S. commercially insured individuals, with standard utilization management criteria, for TONMYA. To date, TONMYA is available under Medicaid in most states, representing approximately 75 million Medicaid beneficiaries. Forward-Looking Statements This Current Report on Form 8-K contains certain forward-looking statements withi…
Other Events. On May 27, 2026, the Company announced the publication of the Manuscript, which reports findings from a single-center, first-in-human, Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study in 26 healthy adult volunteers of the Company’s TNX-1500 product candidate, a monoclonal antibody in development for the prevention of organ transplant rejection and the treatment of autoimmune diseases. Participants were enrolled across three ascending…
Other Events. On May 15, 2026 , the Company presented the following analysis of pharmacokinetic data from the Phase 1 trial for TNX-4800 at the Global Lyme Alliance in connection with the proposed adaptive Phase 2 field study for TNX-4800, planned for the first half of 2027, pending agreement by the U.S. Food and Drug Administration: • Simulation of a two-dose regimen (350 mg subcutaneous administration on Day 1 and 56 Days) of TNX-4800 were presented that predict mean serum levels for partic…
Results of Operations and Financial Condition. On May 11, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced its operating results for the quarter ended March 31, 2026. A copy of the press release that discusses these matters is filed as Exhibit 99.01 to, and incorporated by reference in, this report.
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. (e) On May 7, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) held its annual meeting of shareholders (“Annual Meeting”). At the Annual Meeting, the shareholders of the Company approved the Company’s 2026 Stock Incentive Plan (the “Plan”) in accordance with the voting results set forth below under
Other Events. On May 6, 2026 , the Company announced it entered into an agreement with a GPO, effective May 1, 2026, that provides coverage to approximately 35 million U.S. commercially insured individuals, with standard utilization management criteria, for TONMYA. To date, TONMYA is covered under Medicaid in 38 states, representing approximately 55 million Medicaid beneficiaries. Forward-Looking Statements This Current Report on Form 8-K contains certain forward-looking statements within the…
Results of Operations and Financial Condition. Tonix Pharmaceuticals Holding Corp. (the “Company”) is disclosing selected preliminary operating results for the quarter ended March 31, 2026, and certain preliminary financial condition information as of April 30, 2026, as set forth below: · The Company ended the quarter with approximately $185.5 million in cash and cash equivalents. As of April 30, 2026, the Company had 15,540,801 shares of common stock outstanding. · The Company’s net cash use…
Other Events. On April 29, 2026, the Company announced program updates on its TNX-4800 product candidate for protection against Lyme disease, and presented TNX-4800 Phase 1 data at the 4 th Annual Ticks and Tickborne Diseases Symposium. The Company plans to initiate an adaptive Phase 2 field study of TNX-4800 in the first half of 2027, pending FDA agreement. The field study is intended to test a fixed subcutaneous (“SC”) two-dose regimen of TNX-4800, with the first dose administered in the Sp…
Other Events. On April 21, 2026 , the Company’s collaborators at Columbia University presented an oral presentation on the Company’s preclinical TNX-1700 program at the AACR entitled TFF2 Deficiency Amplifies IL-1β–Driven Inflammation and Promotes Aging-Associated Gastric Tumor Progression , which reviewed the results of a preclinical study comparing TFF2-expressing epithelial cells in the stomachs of aged and young mice, which were observed to be reduced in aged mice, with corresponding redu…
Other Events. On March 31, 2026, the Company announced program updates on its TNX-4800 product candidate for protection against Lyme disease, including the announcement that Phase 1 data of TNX-4800 was presented by Mark S. Klempner, MD, professor of medicine at UMass Chan Medical School, an inventor of TNX-4800 and principal investigator of the study, on March 30, 2026, at the World Vaccine Congress Washington 2026. The Company also announced its strategy for a Phase 2 field study of TNX-480…
Other Events. On March 26, 2026, the Company announced that the first participant was dosed in a Phase 1 investigator-initiated study to evaluate the effect of TNX-1900 on trigeminal nerve-mediated vasodilation of the forehead using capsaicin and electrical stimulation, a model for trigeminal neurovascular reactivity, in healthy female human volunteers. Dr. Antoinette Maassen van den Brink, Professor of Neurovascular Pharmacology, Erasmus University Medical Center, is the principal investigat…
Changes in Registrant’s Certifying Accountant. (a) Dismissal of Independent Registered Public Accounting Firm On March 16, 2026, Tonix Pharmaceuticals Holding Corp. (the “ Company ”) dismissed EisnerAmper LLP (“ EisnerAmper ”) as the Company’s independent registered public accounting firm. The Company notified EisnerAmper of its dismissal on March 16, 2026 (the “ Notice Date ”). The decision to dismiss EisnerAmper was approved by the Audit Committee of the Company’s Board of Directors. The di…
of this Current Report on Form 8-K, including Exhibit 99.01 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the United States Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Other Events. On March 10. 2026, the Company announced two oral presentations on TONMYA TM at the ICCF. The first presentation, “Cyclobenzaprine HCl Sublingual Tablets (CBP SL) Provide Rapid Pain Relief in Adults with Fibromyalgia” , presented data on the RESILIENT trial, a 14-week, randomized, placebo-controlled Phase 3 study evaluating 457 adults with fibromyalgia. A post hoc mixed-model repeated-measures analysis demonstrated that TONMYA produced a rapid reduction in pain, with improvement…
Results of Operations and Financial Condition. Tonix Pharmaceuticals Holding Corp. (the “Company”) is disclosing selected preliminary operating results for the year and quarter ended December 31, 2025, and certain preliminary financial condition information as of January 30, 2026, as set forth below: · The Company ended the year with approximately $207.6 million in cash and cash equivalents. As of January 30, 2026, the Company had 12,793,952 shares of common stock outstanding. · The Company’s…
Entry into a Material Definitive Agreement. On December 29, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with a single institutional investor (the “Purchaser”). Pursuant to the Purchase Agreement, the Company agreed to issue and sell to the Purchaser in a registered direct offering (the “Offering”): (i) 615,025 shares (the “Shares”) of the Company’s common stock, $0.001 par value per share (the “Common Stock”…
Other Events. On December 29, 2025, the Company announced that it plans to meet with the U.S. Food and Drug Administration (“FDA”) in 2026 to explore Phase 2/3 development options for TNX-4800. The Company believes that a controlled human infection model study using Borrelia -infected ticks that mimic natural infection would be a potential path to demonstrating TNX 4800 efficacy for potential FDA approval, and that it may have investigational product produced under Good Manufacturing Practice…
Other Events. On December 16, 2025, the Company announced that it licensed exclusive worldwide rights to TNX-4900 (formerly known as PW507), a highly selective small-molecule Sigma-1 receptor (“S1R”) antagonist with demonstrated analgesic activity in multiple animal models of neuropathic pain, from Rutgers University. TNX-4900 showed analgesic efficacy in multiple pain models and a safety profile supporting its potential as a non-opioid approach to treating neuropathic pain. TNX-4900 was crea…
Other Events. On December 9, 2025, the Company announced the appointment of Irina Ishak as General Counsel, effective immediately. Forward-Looking Statements This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical trials, clinic…
Other Events. On November 24, 2025, the Company announced that the FDA cleared the IND application to support clinical development of TNX-102 SL 5.6 mg for the treatment of MDD in adults. The pharmacological profile of TNX-102 SL is designed to target the disruptive sleep often associated with MDD. The potentially pivotal Phase 2 HORIZON study is a 6-week, randomized, double-blind, placebo-controlled trial of TNX-102 SL as a first line monotherapy in adults with MDD. The Company expects appro…
Entry into a Material Definitive Agreement. On November 21, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) amended its Sales Agreement with A.G.P./Alliance Global Partners, dated as of June 11, 2025 (as amended, the “Sales Agreement”), to allow for an increase to the maximum aggregate offering price of shares issuable under the Sales Agreement (the “Amendment”). The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to t…
Other Events. On November 18, 2025, Tonix Pharmaceuticals Holding Corp.’s (the “Company”) Board of Directors approved an increase to its share repurchase program pursuant to which the Company may repurchase up to an additional $25.0 million in value of its outstanding common stock, bringing total authorized shares under the program to $35 million. Forward-Looking Statements This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Sec…
Other Events. On November 17, 2025, the Company announced that TONMYA TM is commercially available at pharmacies by prescription in the United States. Forward-Looking Statements This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, cli…
Results of Operations and Financial Condition On November 10, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced its operating results for the quarter ended September 30, 2025. A copy of the press release that discusses these matters is filed as Exhibit 99.01 to, and incorporated by reference in, this report.
Results of Operations and Financial Condition. Tonix Pharmaceuticals Holding Corp. (the “Company”) is disclosing selected preliminary operating results for the quarter ended September 30, 2025, and certain preliminary financial condition information as of October 24, 2025, as set forth below: · The Company ended the quarter with approximately $190.1 million in cash and cash equivalents. As of October 24, 2025, the Company had 11,475,491 shares of common stock outstanding. · The Company’s net…
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