Tonix Pharmaceuticals Q2 2024 Financial Results and Highlights

Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company with a focus on central nervous system (CNS) disorders, recently shared its financial results for the second quarter ending June 30, 2024, alongside a series of operational highlights.

CEO Seth Lederman, M.D., emphasized the progress made in advancing the New Drug Application (NDA) for their candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablets). This medication targets fibromyalgia, a chronic condition characterized by widespread pain and fatigue. The FDA granted TNX-102 SL Fast Track designation in July 2024, a status that could speed up its review process due to the serious nature of fibromyalgia and the unmet medical need it addresses. Tonix anticipates submitting the NDA in the latter half of 2024, with potential FDA approval in 2025.

Additionally, developments in the broader pipeline were outlined, including the company's work on TNX-4200, a broad-spectrum antiviral program backed by a $34 million contract from the U.S. Department of Defense (DoD). This program aims to develop antiviral drugs to enhance the medical readiness of military personnel.

Key developments in Tonix’s CNS pipeline include:

1. TNX-102 SL for Fibromyalgia: Following successful pre-NDA meetings with the FDA, Tonix is on track for NDA submission. The drug has shown promising results in improving depressive symptoms and other fibromyalgia-related issues during clinical trials, with good tolerability.

2. TNX-102 SL for Stress Disorders: Plans for a Phase 2 trial to evaluate TNX-102 SL for Acute Stress Disorder (ASD) after motor vehicle accidents are in motion, supported by a $3 million DoD contract.

3. TNX-1300 for Cocaine Intoxication: A Phase 2 study is expected to begin in the third quarter of 2024. This biologic, designed to treat life-threatening cocaine intoxication, has been granted Breakthrough Therapy designation by the FDA.

4. TNX-1900 for Various Conditions: This small peptide is under investigation for several conditions, including adolescent obesity, binge eating disorder, and social anxiety disorder, across different clinical trials.

5. TNX-2900 for Prader-Willi Syndrome (PWS): With FDA's Rare Pediatric Disease designation, TNX-2900 is being developed to treat PWS, a genetic disorder causing cognitive and behavioral issues.

In the immunology pipeline, TNX-1500 is being developed to prevent organ transplant rejection and treat autoimmune diseases. This monoclonal antibody has shown favorable preclinical results and is proceeding to Phase 2 trials.

Tonix's infectious disease pipeline includes TNX-4200, TNX-3900, and TNX-4000, all aiming to develop broad-spectrum antiviral drugs. Notably, TNX-801, a vaccine based on horsepox virus, is under development to protect against mpox and smallpox. Preclinical data show that TNX-801 can protect non-human primates against lethal monkeypox virus challenges.

Financially, Tonix reported $2.2 million in net product revenue for the second quarter of 2024. Research and development expenses fell to $9.7 million from $22.0 million in the same period of 2023, reflecting a more capital-efficient strategy. However, the net loss for the quarter was $78.8 million, significantly impacted by non-cash asset impairment charges.

Tonix operates a state-of-the-art infectious disease research facility in Frederick, MD, and has a commercial subsidiary, Tonix Medicines, which markets migraine treatments Zembrace SymTouch and Tosymra.

Tonix is pushing forward with a comprehensive product development strategy, with significant advancements in CNS disorders, immunology, rare diseases, and infectious diseases, backed by a robust financial plan and strategic partnerships.

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