Tonix Pharmaceuticals (NASDAQ:TNXP) said sales of its fibromyalgia treatment TONMYA rose 37% in the third quarter, as the company expanded insurance access and increased its sales force.
Chief Executive Seth Lederman told biopharma analyst Vamil Divan at the Guggenheim Healthcare Innovation Conference that the product’s launch was on track. Tonix reported $15 million in net sales for the quarter, up from $11 million in the second quarter, while total prescriptions grew 27%.
Lederman said TONMYA had access to 53% of covered lives in the United States, with Divan putting the figure at 166 million people. Tonix secured access with two of the three largest commercial payers in the second quarter and two of the three largest managed Medicare payers in the third quarter, according to Lederman.
Access and prescribing
Tonix is seeking agreements with the remaining major payers and smaller plans, Lederman said, though he declined to predict how much additional coverage the company would obtain. He said contracts typically require patients to try one or two other medicines first, but Tonix does not view those requirements as a major obstacle because many diagnosed patients have already tried existing treatments.
The company added 50 sales representatives over the summer, bringing its field force to 150 as of Sept. 1. Lederman said the enlarged team is focused on both increasing the number of prescribers and generating more prescriptions per prescriber. Rheumatologists are the largest group of prescribers, he said.
Lederman also said Tonix expects its gross-to-net figure to be 50% or more favorable at a steady state, although he did not know whether that would occur in the product’s second or third year. He noted that the figure can fluctuate early in a launch and that the absence of rebates before contracts are in place had helped make it favorable so far.
Depression study and Lyme disease program
Tonix is also studying the same drug, known as TNX-102 SL in development, for major depressive disorder. The potential pivotal Phase II HORIZON study began enrolling patients in June. Lederman said the company was generally pleased with its progress but could not yet provide a timeline for top-line results because enrollment had not reached a steady state.
Lederman said the depression program aims to improve sleep quality and pointed to signals on depression measures in earlier fibromyalgia and post-traumatic stress disorder studies. He cautioned that Tonix had not prospectively enrolled patients with major depressive disorder and assessed their depression in those studies. TNX-102 SL is not approved for depression.
For Lyme disease prevention, Tonix plans to start a field study of its experimental antibody TNX-4800 in 2027. The trial will enroll adults age 18 and older and measure whether the treatment reduces the number of Lyme disease cases, Lederman said. The planned regimen calls for two doses three months apart.
Lederman said the company believes one dose could provide protective antibody levels for three months, based on serum levels, and that animal challenge studies suggested a rapid onset of protection. He emphasized that the product remains in development. If results and reviews are favorable, top-line data could arrive in the first half of 2029 and approval could potentially come in 2031, he said.
Transplant research and cash
Tonix also plans an investigator-initiated study of TNX-1500, an antibody targeting CD40 ligand, in kidney transplant rejection. Lederman said kidney transplantation would provide a stringent test of the drug’s potency and could open the door to research in other immunological conditions if results meet the company’s expectations. He said his comparisons with competing products were not based on head-to-head studies.
Tonix reported $163 million in cash at the end of the third quarter and had no debt, Lederman said.
About Tonix Pharmaceuticals (NASDAQ:TNXP)
Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company focused on developing therapies for conditions involving the central nervous system, immunology and infectious diseases. The company’s research programs are designed to address disorders with significant unmet medical needs, including chronic pain, neuropsychiatric conditions and infectious diseases. Tonix’s pipeline has included TNX-102 SL, an investigational sublingual formulation of cyclobenzaprine being studied for fibromyalgia and other pain-related conditions.
