Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel Amid Key Commercialization Phase

Tonix Pharmaceuticals Holding Corp. has appointed Irina Ishak as General Counsel effective December 8, 2025, positioning the biotechnology company with strengthened legal leadership during a critical commercialization period. 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. Her appointment comes as Tonix markets TONMYA, the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years, representing a significant advancement for millions of adults affected by this chronic pain condition.

The importance of this appointment extends beyond routine corporate governance, as Ishak brings specific experience from her previous senior legal roles at Savient Pharmaceuticals where she contributed to the development and launch of KRYSTEXXA. This background in pharmaceutical commercialization is particularly relevant as Tonix expands its marketed portfolio, which also includes two treatments for acute migraine in adults: Zembrace SymTouch and Tosymra. CEO Seth Lederman emphasized that Ishak's corporate and transactional experience will support Tonix as it commercializes products, advances its pipeline and executes long-term strategy, indicating the company's transition from development to commercial operations requires specialized legal expertise.

Ishak's appointment signals Tonix's preparation for increased regulatory and commercial complexity as the company manages multiple development programs across central nervous system disorders, immunology, immuno-oncology, rare disease and infectious disease. The company's development portfolio includes TNX-102 SL being developed to treat 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, as detailed in the company's newsroom at https://ibn.fm/TNXP. Additionally, Tonix is advancing TNX-1500, a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand for prevention of allograft rejection and treatment of autoimmune diseases, along with TNX-2900 for Prader-Willi syndrome expected to start a potential pivotal Phase 2 study in 2026.

The broader implications for the biotechnology industry involve how companies strategically build legal teams during transition periods from research to commercialization. Ishak noted she is honored to join Tonix during a pivotal period following the launch of the fibromyalgia therapy, suggesting the timing aligns with increased regulatory requirements and partnership negotiations typical of commercial-stage biotech companies. For investors, this appointment represents Tonix's commitment to strengthening corporate infrastructure as it manages multiple revenue streams from marketed products while advancing a diverse pipeline, including infectious disease candidates like TNX-801 for mpox and smallpox and TNX-4800 for seasonal prevention of Lyme disease.

Tonix's infectious disease research capabilities are supported by a state-of-the-art facility in Frederick, Maryland, and government contracts including one with the U.S. DoD's Defense Threat Reduction Agency for up to $34 million over five years for TNX-4200, a small molecule broad-spectrum antiviral agent. The full press release detailing Ishak's appointment and Tonix's current operations is available at https://ibn.fm/UH3pO. As biotechnology companies increasingly navigate complex regulatory environments while managing both commercial products and investigational candidates, strategic legal appointments like Ishak's become critical for ensuring compliance, protecting intellectual property, and facilitating strategic transactions that drive long-term growth in the competitive pharmaceutical landscape.