Tonix Pharmaceutical Holding Corp (TNXP), a biopharmaceutical company, on Monday released its first-quarter financial results, provided business updates on its commercial products, and progress across its drug pipeline.
The company is currently developing a diverse pipeline of drugs to treat diseases of the central nervous system (CNS), infectious diseases, autoimmune disorders, cancers, and rare diseases.
Q1 2026:
The company recorded a net revenue of $6.88 million, higher than the $2.43 million reported a year ago. This included revenues from sales of TONMYA equaling $3.7 million.
Research and development expenses (R&D) were $18.21 million, compared to $7.44 million in the previous year.
Tonix recorded a net loss of $40.19 million, or $2.93 per share, in Q1 2026, while net income was $16.83 million, or $2.84 per share, in the same period of 2025.
Cash, cash equivalents, and marketable securities held by the company on March 31, 2026, amounted to $185.47 million.
Additionally, the company raised $22.60 million in proceeds using its at-the-market (ATM) facility.
Commercial Products:
TONMYA (cyclobenzaprine hydochloride) is a sublingual, centrally acting, non-opioid analgesic that was approved by the U.S. Food and Drug Administration (FDA) for the treatment of fibromyalgia in adults in August 2025.
Supported by two double-blind, randomized, placebo-controlled Phase 3 trials conducted with nearly 1000 patients, the drug is the first prescription medicine for fibromyalgia approved in over 15 years. The company saw over 5,400 prescriptions for TONMYA filled for 3,588 unique patients in the first quarter, bringing the total number of prescriptions filled to 11,016 since its launch in November 2025. In May 2026, Tonix secured commercial payer coverage with its first managed care partnership agreement with a leading GPO, which will provide access for approximately 35 million U.S. patients.
Pipeline Highlights:
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is being advanced for the treatment of major depressive disorder (MDD) in adults. An investigational new drug (IND) application was cleared by the FDA in November 2025. The Phase 2 HORIZON trial evaluating TNX-102 SL as a first-line monotherapy for adults with MDD is expected to begin enrollment in mid-2026.
TNX-102 SL is also being explored for the treatment of acute stress disorder (ASD) and acute stress reaction (ASR) in the Phase 2 Optimizing Acute Stress Reaction Interventions (OASIS) study funded by the U.S. Department of Defense. Topline results are anticipated in the second half of 2026.
TNX-1300 (double-mutant cocaine esterase) has been granted a breakthrough therapy designation by the FDA for the treatment of cocaine intoxication. The Phase 2a study was completed, and the company plans to align with the FDA on the clinical design of the next part of Phase 2.
TNX-1900 (intranasal potentiated oxytocin) is being assessed for the treatment of CNS disorders in Phase 1 and Phase 2 trials. The Phase 2 investigator-initiated trials will evaluate TNX-1900 in treating binge-eating disorder, adolescent obesity, bone health in autism and arginine vasopressin deficiency. The first dosing in the Phase 1 investigator-initiated trial on healthy female volunteers was completed in March 2026.
TNX-4800 (anti-OspA monoclonal antibody) was developed as a seasonal prevention of Lyme disease, which currently has no approved vaccines or prophylactics. Positive data from a Phase 1 trial were presented in March, and an adaptive Phase 2 field study is planned by the company, pending a Type C meeting with the FDA in Q3 of 2026.
TNX-801 is a vaccine consisting of attenuated recombinant horsepox virus and live pre-clinical orthopoxvirus, developed for the prevention of smallpox and mpox. The vaccine is expected to enter a Phase 1 trial in 2027, pending an IND clearance from the FDA.
TNX-4200 is a small molecule, broad-spectrum anti-viral targeting CD45 for the treatment of high-lethality viral infections. In the first quarter of 2026, the company received clearance to enter the next budgetary and developmental phase.
TNX-1500 is a third-generation anti-CD04L humanized monoclonal antibody developed for the prophylaxis of kidney transplant rejection and for treating autoimmune disorders. A Phase 2 study is planned for initiation by mid-2026, pending an IND clearance by the FDA.
TNX-2900 (intranasal potentiated oxytocin) is being evaluated for the treatment of Prader-Wili syndrome, with a Phase 2 trial initiation planned for Q1 2027. The treatment was previously granted an orphan drug and rare pediatric disease designation and may be granted a priority review voucher upon approval.
TNX-1700 is a TFF2-albumin fusion protein currently in preclinical development for the treatment of gastric and colorectal cancer. TNX-4700 is a human anti-BTLA monoclonal antibody also in preclinical development for immuno-oncology indications.
TNXP closed Monday at $14.11, up 0.14%. In the pre-market, the stock is trading at $13.17, down 6.69%.
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Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.