Tonix Pharmaceut SEC Filings

Tonix Pharmaceuticals Holding Corp. reported Phase 1 results and next-step plans for TNX-4800, a long-acting monoclonal antibody being developed to prevent Lyme disease. The single-dose subcutaneous treatment is designed to offer about four months of protection for people in Lyme-endemic U.S. regions.

The Phase 1 trial enrolled 44 healthy adults, with 41 completing, and showed TNX-4800 was generally safe and well tolerated across doses from 0.5 to 10 mg/kg, with most side effects mild or moderate. Pharmacokinetic data showed rapid absorption, long half-life of roughly two to three months, and serum levels remaining measurable for up to 12 months.

Based on these data, Tonix plans a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study using a fixed 350 mg dose. The primary goal is to test whether TNX-4800 prevents the first occurrence of confirmed Lyme disease over the four months after dosing, with a key secondary endpoint at six months. The company expects GMP clinical material in early 2027 and aims to start Phase 2 in the first half of 2027, pending FDA clearance, with a potential controlled human infection model study in 2028.

Tonix Pharmaceuticals Holding Corp. is asking shareholders to approve several key items at its 2026 virtual annual meeting. Investors will vote on electing nine directors, ratifying PwC as the new independent auditor, authorizing a flexible reverse stock split, and adopting a new 2026 stock incentive plan.

The Board seeks authority to implement one or more reverse stock splits over two years, at ratios between 1:2 and 1:250, to help maintain Nasdaq listing standards tied to minimum bid price. Shareholders of record on March 19, 2026, when 13,405,401 common shares were outstanding, may vote online or by proxy.

Tonix Pharmaceuticals Holding Corp: The Vanguard Group filed an amendment stating it currently reports zero beneficial ownership of Tonix common stock. The filing explains an internal realignment effective January 12, 2026 that led certain Vanguard subsidiaries/divisions to report holdings separately and says Vanguard no longer is deemed to beneficially own securities reported by those entities. The filing lists Amount beneficially owned: 0 and Percent of class: 0%, and is signed by Ashley Grim on 03/27/2026.

Tonix Pharmaceuticals Holding Corp. is advancing its migraine pipeline with the first participant dosed in a Phase 1 investigator-initiated study of TNX-1900, an intranasal potentiated oxytocin candidate. The trial uses a trigeminal neurovascular reactivity model, measuring forehead blood flow responses to capsaicin and electrical stimulation in healthy female volunteers.

The study is led and sponsored by Professor Antoinette Maassen van den Brink at Erasmus University Medical Center under a collaborative research agreement. TNX-1900 targets oxytocin receptors in the trigeminal system to block CGRP release, offering a mechanism distinct from triptans and CGRP inhibitors and aiming at non-opioid treatment options for migraine and other craniofacial pain conditions.

The Board of Tonix Pharmaceuticals Holding Corp. has scheduled a virtual Annual Meeting for May 7, 2026 to vote on: election of nine directors; ratification of PwC as independent auditors; a proposal authorizing the Board to implement one or more reverse stock splits at ratios between 1:2 and 1:250; and approval of the 2026 Stock Incentive Plan. Only shareholders of record at the close of business on March 19, 2026 may vote. The company reported 13,405,401 shares of common stock outstanding as of the Record Date. The Board recommends a vote FOR all proposals, and preliminary voting results will be announced at the meeting with final results filed on Form 8-K.

Tonix Pharmaceuticals Holding Corp. Chief Executive Officer Seth Lederman bought 15,000 shares of common stock in an open-market transaction at $14.89 per share through an IRA account.

After this purchase, he held 15,001 shares indirectly via the IRA, 4,005 shares directly, and 1 share indirectly through Lederman & Co., where he may be deemed a control person.

Tonix Pharmaceuticals Holding Corp. changed its independent auditor, dismissing EisnerAmper LLP and appointing PricewaterhouseCoopers LLP for the 2026 audit, with Audit Committee approval. The company states the dismissal was not related to disagreements over accounting, disclosure, or audit scope.

EisnerAmper’s reports for 2024 and 2025 were clean except for an explanatory paragraph highlighting continuing losses and negative operating cash flows that raised substantial doubt about Tonix’s ability to continue as a going concern. Previously disclosed material weaknesses in internal control over financial reporting were remediated by year-end 2024 and did not require financial statement restatements.

Tonix Pharmaceuticals reported fourth quarter and full year 2025 results, highlighted by the November 17 U.S. launch of TONMYA for fibromyalgia. Net product revenue for 2025 was about $13.1M, up from $10.1M in 2024, including roughly $1.4M from TONMYA.

Cash and cash equivalents were approximately $207.6M as of December 31, 2025, compared with $98.8M a year earlier, helped by a $20.0M registered direct offering and ATM usage. The company posted a 2025 net loss available to common stockholders of about $124.0M, versus $130.0M in 2024.

Fourth quarter 2025 net product revenue was roughly $5.4M, up from $2.6M in the prior-year quarter, while the net loss available to common stockholders was $46.9M. Management cites ongoing investment in TONMYA commercialization and a broad CNS, infectious disease, immunology, and rare disease pipeline, and believes existing cash will fund operations into the first quarter of 2027.