NOTE 1 – BUSINESS 

Tonix Pharmaceuticals Holding Corp. (“Tonix” or the “Company”), through its wholly owned subsidiary Tonix Pharmaceuticals, Inc. (“Tonix Sub”), and its wholly owned commercial subsidiary, Tonix Medicines, Inc. (“Tonix Medicines”), is a fully-integrated, commercial-stage biotechnology company with marketed products and a pipeline of development candidates.

Tonix’s marketed products include Tonmya^TM (cyclobenzaprine HCl sublingual tablets), a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, for which the Company received approval in August 2025 by the U.S. Food and Drug Administration (“FDA”). Fibromyalgia is a chronic pain condition that affects millions of adults, the majority of whom are women. Tonmya is the first new prescription medicine for fibromyalgia approved by the FDA in more than 15 years. Tonix expects to launch Tonmya in the U.S. before the end of November 2025. Tonix also markets two treatments for acute migraine in adults, Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray).

Tonix’s development pipeline is focused on central nervous system (“CNS”) disorders, immunology, immuno-oncology, rare disease and infectious disease. Within CNS, TNX-102 SL is being studied to treat acute stress reaction and acute stress disorder under an Investigator -Initiated Investigational New Drug Application (“IND”) at the University of North Carolina in the OASIS Phase 2 study funded by the U.S. Department of Defense (“DoD”). TNX-102 SL is also in development for major depressive disorder, with the Company expecting to initiate a potential pivotal Phase 2 study by mid-year 2026, contingent on IND clearance by the FDA. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a dimeric Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of kidney transplant rejection and the treatment of autoimmune diseases. In collaboration with Massachusetts General Hospital (“MGH”), an open-label Phase 2 study of TNX-1500 is planned to initiate in the first half of 2026 to evaluate safety and activity in five kidney transplant recipients, contingent on FDA clearance of an investigator-initiated IND and approval by the institutional review board (“IRB”). Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and for which the Company plans to initiate a Phase 2 study in the second half of 2026. Tonix’s infectious disease portfolio includes TNX-801 (recombinant horsepox, live virus vaccine), a vaccine in development for prevention of mpox and smallpox. Tonix is also developing TNX-4800 (anti-OspA mAb), a long-acting monoclonal antibody for the seasonal prevention of Lyme Disease, and expects to initiate an adaptive Phase 2/3 study in 2027. TNX-4800 was licensed from the University of Massachusetts Chan Medical School in 2025. Finally, TNX-4200, for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (“DTRA”) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art research and development facility in Frederick, Maryland.   

The consolidated financial statements include the accounts of Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiaries, Tonix Sub, Krele LLC, Tonix Pharmaceuticals (Canada), Inc., Tonix Medicines, Jenner Institute LLC, Tonix R&D Center LLC, Tonix Pharma Holdings Limited and Tonix Pharma Limited (collectively, the “Company” or “Tonix”). All intercompany balances and transactions have been eliminated in consolidation.

Liquidity

The accompanying financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered recurring losses from operations and negative cash flows from operating activities. At September 30, 2025, the Company had working capital of approximately $187.0 million. At September 30, 2025, the Company had an accumulated deficit of approximately $807.8 million. The Company held unrestricted cash and cash equivalents of approximately $190.1 million as of September 30, 2025.

The Company believes that its cash resources at September 30, 2025, and the net proceeds of $34.7 million that it received from the sale of equity in the fourth quarter of 2025 (See Note 18), will meet its planned operating and capital expenditure requirements into the first quarter of 2027.

The Company continues to face significant challenges and uncertainties and must successfully launch Tonmya and obtain additional funding through public and private financing and collaborative arrangements with strategic partners to increase the funds available to fund operations. However, the Company may not be able to raise capital on terms acceptable to the Company, or at all. Without the successful product launch of Tonmya and obtaining additional funds, the Company may be forced to delay, scale back or eliminate some or all of its research and development activities or other operations, and potentially delay product development in an effort to maintain sufficient funds to continue operations. If any of these events occurs, the Company’s ability to achieve development and commercialization goals will be adversely affected and the Company may be forced to cease operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.