NOTE 1 – BUSINESS 

Tonix Pharmaceuticals (“Tonix” or the “Company”) is a fully integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system (“CNS”) disorders, infectious diseases, and immunology. The Company’s portfolio consists of commercial, development-stage and discovery programs.

TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), the Company’s flagship internally conceived and developed medicine, is the first new medicine for fibromyalgia in adults approved by the U.S. Food and Drug Administration (“FDA”) in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix received approval from the FDA for TONMYA for the treatment of fibromyalgia in adults in August 2025 and commercially launched TONMYA in November 2025. TONMYA is a centrally acting, non-opioid analgesic designed for bedtime administration and long-term use, for which the Company holds worldwide commercialization rights. Tonix’s commercial platform includes sales, marketing, market access, distribution, and patient support capabilities.

Tonix is advancing a diversified pipeline generated through internal discovery, in-licensing, acquisitions, and collaborations with academic and non-profit institutions. The Company’s pipeline addresses conditions that span CNS, infectious disease, immunology, and rare disease, with several programs in clinical and preclinical development.

Clinical Stage Pipeline

TONMYA’s proprietary cyclobenzaprine HCl sublingual tablet formulation is referred to as “TNX-102 SL” outside of the fibromyalgia indication. Tonix is exploring the utility of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in Phase 2 clinical trials for major depressive disorder (“MDD”) and acute stress disorder (“ASD”)/acute stress reaction (“ASR”). A potentially pivotal Phase 2 study of TNX-102 SL as a first-line monotherapy in adults with MDD, the HORIZON study, commenced in June 2026 and is currently enrolling.

TNX-102 SL is being developed to treat ASD/ASR under an investigator-initiated investigational new drug (“IND”) application at the University of North Carolina (“UNC”) in the ongoing OASIS study funded by a grant UNC received from the U.S. Department of Defense (“DoD”). Topline data from the OASIS study is expected to be reported mid-2027.

Tonix’s clinical-stage infectious disease portfolio includes TNX-4800, a human monoclonal antibody targeting Borrelia OspA, for the prevention of Lyme disease in the U.S., where no vaccines or prophylactics for Lyme disease are approved by the FDA. Tonix received positive, final minutes from the FDA following a Type C meeting in the third quarter of 2026. The minutes support the planned initiation of an adaptive Phase 2 field study in the first quarter of 2027. The Phase 2 study is expected to enroll in the 2027 and 2028 seasons, with the majority of participants enrolled in 2028, pending final FDA review and agreement on the study protocol. If the attack rate is lower than expected, the study could continue enrolling in 2029. TNX-4800 was licensed from UMass Chan Medical School.

Tonix’s clinical-stage immunology development portfolio includes TNX-1500 (provisional international nonproprietary name: mosdaprubart), which is a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of kidney transplant rejection and for the treatment of autoimmune diseases. A Phase 2, open-label, investigator-initiated study to prevent rejection in adult kidney transplant patients at Massachusetts General Hospital (“MGH”) is expected to begin in the first quarter of 2027.

Tonix’s clinical-stage CNS portfolio includes the biologic candidate TNX-1300 (double-mutant cocaine esterase), which is being developed for the treatment of cocaine intoxication. TNX-1300 has been granted Breakthrough Therapy designation by the FDA, and a Phase 2 study has been completed. Tonix met with the FDA in the fourth quarter of 2026 to discuss the clinical design of the next Phase 2 study but does not plan to initiate a study in the near term in order to prioritize its cash and resource allocation toward TONMYA and TNX-4800.

Tonix uses artificial intelligence (“AI”) and computational tools to support scientific research, drug development and corporate activities. The Company’s AI-assisted scientific analyses are subject to appropriate human review and, where relevant, experimental and clinical validation.

The Company is focused on supporting TONMYA’s commercial growth and the advancement of TNX-102 SL in MDD, TNX-4800 for Lyme disease prevention, and TNX-1500 in an investigator-initiated study to prevent kidney transplant rejection. 

Research Contract with the U.S. Department of Defense

Tonix is developing a pre-IND infectious disease program designated TNX-4200, which is a small molecule broad-spectrum antiviral agent targeting CD45 to improve the medical readiness of military personnel in biological threat environments. The TNX-4200 program is supported by a $34.1 million contract over five years from the U.S. DoD’s Defense Threat Reduction Agency (“DTRA”). Tonix owns and operates a state-of-the-art research facility in Frederick, Maryland that supports this research.

Our product candidates are investigational and have not been approved for the indications for which they are being developed.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are the property of their respective owners. Tonix is led by a management team with significant industry experience in drug development and commercialization.

Going Concern

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, 2026, the Company had working capital of approximately $150.1 million. At September 30, 2026, the Company had an accumulated deficit of approximately $988.8 million. The Company held cash and cash equivalents of approximately $162.8 million as of September 30, 2026. The Company believes that its cash resources at September 30, 2026, and the net proceeds of $1.5 million that it raised from equity offerings subsequent to September 30, 2026, will meet its planned operating and capital expenditure requirements into early third quarter of 2027, but will not extend to 12 months from the issuance of these financial statements. 

These factors raise substantial doubt about the Company’s ability to continue as a going concern. The Company continues to face significant challenges and uncertainties and must 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 additional funds, it may be forced to delay, scale back, or eliminate some 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, its ability to achieve development and commercialization goals would 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.