Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel Amid Commercial Expansion

Tonix Pharmaceuticals Holding Corp. has appointed Irina Ishak as General Counsel effective December 8, 2025, bringing extensive legal experience to support the biotechnology company's commercial expansion and pipeline development. Ishak, who previously served as Senior Counsel at Lowenstein Sandler LLP where she advised Tonix on financings, licensing, strategic transactions, commercial agreements and governance matters, will now lead the company's legal, corporate governance and compliance functions internally.

The appointment comes during what CEO Seth Lederman described as a pivotal period for Tonix, which recently launched TONMYA, the first FDA-approved fibromyalgia therapy in more than 15 years. Lederman emphasized that Ishak's corporate and transactional experience will be instrumental as the company commercializes products, advances its pipeline and executes long-term strategy. Ishak previously held senior legal roles at Savient Pharmaceuticals, where she contributed to the development and launch of KRYSTEXXA, providing her with valuable experience in bringing pharmaceutical products to market.

Tonix Pharmaceuticals represents a fully-integrated biotechnology company with both marketed products and a diverse development portfolio. Beyond TONMYA for fibromyalgia, the company markets two treatments for acute migraine in adults: Zembrace SymTouch and Tosymra. The company's development pipeline focuses on central nervous system disorders, immunology, immuno-oncology, rare disease and infectious disease, with several candidates in various stages of development. TNX-102 SL, the same compound as TONMYA, is being developed for acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense.

The company's immunology portfolio includes TNX-1500, a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft rejection and treatment of autoimmune diseases. In rare diseases, TNX-2900, intranasal oxytocin potentiated with magnesium, is in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. The infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, and TNX-4800, a Phase 2-ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease.

Tonix also has a contract with the U.S. Department of Defense's Defense Threat Reduction Agency for up to $34 million over five years for TNX-4200, a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve medical readiness of military personnel. The company owns and operates a state-of-the-art infectious disease research facility in Frederick, Maryland, supporting its research and development efforts across multiple therapeutic areas.

Ishak's appointment as General Counsel represents a strategic move to strengthen Tonix's legal infrastructure as the company navigates the complexities of commercializing multiple products while advancing a broad development portfolio. Her experience with both Tonix and previous pharmaceutical companies positions her to address the legal challenges associated with product launches, regulatory compliance, intellectual property protection, and strategic partnerships. The timing of this appointment coincides with Tonix's transition from a development-focused company to one with commercial products in the market, requiring enhanced legal oversight for commercial operations, marketing compliance, and potential business development activities.