Tonix Pharmaceuticals (NASDAQ:TNXP) CEO Seth Lederman told attendees at the Cantor Healthcare Conference that the company’s near-term focus is the commercial launch of TONMYA, its FDA-approved treatment for fibromyalgia in adults, while it advances development programs in Lyme disease prevention and transplant rejection.
Lederman described Tonix as a fully integrated biotechnology company that took TONMYA from development through FDA approval and launch. He said the company also has several Phase II or Phase II-ready programs, including TNX-4800, a long-acting monoclonal antibody intended to prevent Lyme disease, and TNX-1500, an anti-CD40 ligand antibody program for transplant rejection and autoimmune conditions.
TONMYA launch and payer access
Tonix has secured contracts with two of the three major pharmacy benefit manager group purchasing organizations on the commercial side, according to Lederman, as well as one of the three major managed Medicare organizations. He said the managed Medicare contract is expected to take effect in January 2027, when the company expects to have approximately 46% of Americans covered.
Lederman said broader access could be a potential driver of an inflection point in sales, though he said he could not predict when that would occur. He noted that commercial coverage takes time to filter through sub-plans and that regular Medicare coverage is not expected until Oct. 1, 2027. Tonix estimates Medicare could represent about 30% of its market, he said.
The company is using a data-driven approach to target prescribers with a history of diagnosing fibromyalgia and prescribing treatments for the condition, rather than concentrating solely on rheumatologists. Lederman said about 40% of current prescribers are rheumatologists, followed by primary-care providers at roughly 30% and pain-anesthesia specialists at about 20%, with some prescriptions also coming from neurologists and psychiatrists.
Fibromyalgia positioning
Lederman said fibromyalgia remains poorly understood by many healthcare providers despite its prevalence. He estimated there are approximately 3 million diagnosed and treated fibromyalgia patients and another 7 million who have not yet been diagnosed.
He cited updated 2016 diagnostic criteria stating that fibromyalgia is not a diagnosis of exclusion and can be diagnosed alongside other conditions with similar symptoms. He also pointed to the removal of tender points from diagnostic criteria and the recognition of nociplastic pain by the International Association for the Study of Pain in 2017. Lederman called fibromyalgia the prototype of nociplastic pain.
TONMYA differs mechanistically from older FDA-approved fibromyalgia therapies, Lederman said, because it targets disturbed sleep associated with the condition. He said the other approved products—Lyrica, Cymbalta and Savella—were approved between 2007 and 2009 and include two serotonin-norepinephrine reuptake inhibitors and one gabapentinoid.
Lederman said Tonix has not conducted head-to-head studies against those therapies and that cross-trial comparisons are difficult because the studies used different diagnostic standards and approaches to missing data. However, he said he believes TONMYA has potential tolerability advantages.
In three Phase III studies, the most common adverse event associated with TONMYA was an oral sensation described by patients in different ways, including tongue numbness or abnormal taste, Lederman said. He said feedback from prescribers and key opinion leaders suggests the tolerability profile has not been a significant barrier to treatment initiation or continuation, though he said it remains too early to provide quantitative data on refills and persistence.
Lyme disease prevention study planned
Lederman said Tonix recently met with the FDA regarding TNX-4800 and expects to begin a Phase II study early next year. The long-acting antibody is designed to prevent Lyme disease infection by killing Borrelia bacteria in the midgut of a tick after the tick feeds on a treated person.
The planned study is expected to enroll 3,300 participants and compare clinical Lyme disease cases in the treatment and placebo groups over a six-month surveillance period. The company expects to dose participants once early in the Lyme season and again three months later. The trial is planned to span two Lyme seasons, although enrollment could extend into a third season if a specified number of cases is not observed after the second season.
Lederman said TNX-4800 may provide protection within two days based on the earliest measurement of the antibody in the bloodstream. He contrasted that anticipated timing with vaccines, which he said can require months of immunization before protection develops.
Tonix is focusing on site selection and enrollment strategies intended to increase Lyme disease event rates. Lederman said the company plans for its trial demographics to reflect populations at greater risk, including people age 60 and older and individuals involved in activities that increase tick exposure. He noted that 87 million Americans live, work or travel in Lyme-endemic areas.
Additional pipeline and financial position
Lederman also highlighted TNX-1500, which has received the provisional international nonproprietary name mostiprubart. The program is Phase II-ready and is expected to begin in kidney transplantation to prevent rejection, with Massachusetts General Hospital. Lederman said Tonix views transplantation as an entry point into broader autoimmune applications.
At the end of the second quarter, Tonix had $176 million in cash and no debt, Lederman said. The company has stated that its cash runway extends into the second quarter of 2027.
About Tonix Pharmaceuticals (NASDAQ:TNXP)
Tonix Pharmaceuticals is a clinical-stage biotechnology company focused on developing therapeutics for central nervous system disorders, immunology and rare diseases. The company’s pipeline includes small-molecule and biologic product candidates designed to address conditions such as fibromyalgia, post-traumatic stress disorder (PTSD) and other chronic pain syndromes, as well as vaccines for potential viral and biothreat agents.
Among Tonix’s lead programs is TNX-102 SL, a sublingual formulation of cyclobenzaprine being evaluated for the treatment of fibromyalgia and PTSD.
