Tonix Pharmaceuticals Holding Corp. SEC Filings

Tonix Pharmaceuticals Holding Corp. entered into an agreement with a pharmacy benefit manager to provide TONMYA coverage for Medicare Part D beneficiaries, effective January 1, 2027. The agreement adds coverage for approximately 9 million Medicare lives, or 16% of about 55 million Medicare beneficiaries in the U.S.

Combined with two previously announced commercial coverage agreements and Medicaid availability in most states representing approximately 73 million lives, pharmacy coverage for TONMYA is expected to reach about 145 million covered lives on January 1, 2027, or 46% of 314 million covered lives. Tonix plans to expand its sales force by 50 representatives by mid–third quarter 2026, bringing the total to around 150 to support the product’s launch.

TONMYA, a 2.8 mg cyclobenzaprine HCl sublingual tablet, was approved by the FDA on August 15, 2025 for treatment of fibromyalgia in adults, with U.S. patent protection expected to provide market exclusivity until 2034. The disclosure also reiterates extensive safety, contraindication, and use-in-specific-populations information for TONMYA.

Tonix Pharmaceuticals Holding Corp. Chief Financial Officer Bradley Saenger reported a routine share acquisition through an employee stock plan. He obtained 1,453 shares of common stock at a price of $10.914 per share via the Tonix Pharmaceuticals Holding Corp. 2025 Employee Stock Purchase Plan.

Following this transaction, Saenger directly holds 2,154 shares of Tonix common stock. The transaction is coded as “J” (other acquisition or disposition), reflecting a compensation-related, plan-based purchase rather than an open-market trade, so it carries limited signaling value about his view of the stock.

Tonix Pharmaceuticals Holding Corp. announced that the first patient has been enrolled in HORIZON, a potentially pivotal Phase 2 trial of TNX-102 SL 5.6 mg as a first-line monotherapy for adults with major depressive disorder. The 6-week, randomized, double-blind, placebo-controlled study plans to enroll approximately 360 patients at about 30 U.S. sites, with a primary endpoint of change from baseline in the MADRS depression score at Week 6 and secondary measures including global impression, anxiety, and sleep quality. TNX-102 SL, a sublingual cyclobenzaprine tablet, is already FDA-approved as TONMYA for fibromyalgia in adults, and Tonix holds multiple U.S. patents expected to provide market exclusivity for TNX-102 SL until 2034, with method-of-use applications that could extend to 2044.

Tonix Pharmaceuticals Holding Corp. Schedule 13G shows Millennium Management LLC, Millennium Group Management LLC and Israel A. Englander report shared voting and dispositive power over 890,366 shares of Common Stock, representing 5.6% of the class, with the cover date 06/09/2026.

A Joint Filing Agreement dated June 12, 2026 is attached; the filing lists the filers' principal address as 399 Park Avenue, New York.

Tonix Pharmaceuticals Holding Corp. director Carolyn E. Taylor reported an open-market purchase of common stock. She bought 1,415 shares of Tonix common stock at an average price of $10.55 per share. After this transaction, she directly owns 1,833 shares of Tonix common stock.

Tonix Pharmaceuticals Holding Corp. director Richard Newcomb Stillwell reported an open-market purchase of 5,000 common shares. The shares were bought on June 8, 2026 at a weighted average price of $11.65 per share, with individual trade prices ranging from $11.63 to $11.65. Following this transaction, Stillwell directly holds 5,000 Tonix common shares.

Tonix Pharmaceuticals Holding Corp. Chief Executive Officer Seth Lederman reported an open-market purchase of common stock. On June 9, 2026, he bought 5,000 shares at a weighted average price of $11.79 per share in a series of trades priced between $11.735 and $11.883.

Following this purchase, Lederman directly owns 9,005 common shares. He also has indirect ownership of 1 share through Lederman & Co. and 20,001 shares through an IRA account, where he may be deemed a control person of the Lederman & Co. entity.

Tonix Pharmaceuticals entered an agreement with a second leading group purchasing organization effective June 1, 2026, expanding commercial payer coverage for TONMYA, its FDA-approved fibromyalgia treatment for adults. The new contract adds access for approximately 17 million U.S. commercially insured individuals with standard utilization management criteria.

Combined with a prior GPO deal, TONMYA now has commercial coverage for about 52 million U.S. lives, representing roughly 29% of an estimated 177 million commercial lives. TONMYA is also available under Medicaid in most states, covering approximately 75 million beneficiaries, and Tonix continues discussions with Medicare while supporting patients through its TONMYA Together savings program.

Tonix Pharmaceuticals Holding Corp. reported that Phase 1 clinical data for its investigational monoclonal antibody TNX-1500 were published in the Journal of Clinical Immunology. In a first-in-human study of 26 healthy adults, single intravenous doses of 3, 10, or 30 mg/kg were generally well tolerated, with no serious adverse events and only mild, transient aphthous ulcers deemed possibly related to TNX-1500.

TNX-1500 significantly suppressed T cell-dependent antibody responses to the KLH antigen, blocking primary responses at all doses and secondary responses at 10 and 30 mg/kg, with about a 70% reduction at 3 mg/kg versus placebo. Pharmacokinetic data showed dose-proportional exposure and terminal half-lives around 34–38 days, supporting monthly dosing. Tonix highlighted that a Phase 2 investigator-initiated study in kidney transplant recipients at Massachusetts General Hospital is expected to begin in the second half of 2026, pending FDA clearance of the IND.