Tonix Pharmaceuticals (NASDAQ:TNXP) reported second-quarter 2026 net product revenue of approximately $13.5 million, led by $11 million in sales of fibromyalgia treatment Tonmya. The company said Tonmya sales rose 197% from the first quarter, its second full quarter of commercial sales following the product’s November launch.
Revenue also included approximately $2.5 million from migraine products Zembrace SymTouch and Tosymra, compared with $2 million in total product revenue in the prior-year period, when revenue consisted solely of the migraine products.
Tonmya Sales and Access Expansion
Tonix said Tonmya, a once-daily, non-opioid analgesic taken at bedtime, is the first FDA-approved medicine for adult fibromyalgia in more than 15 years. The company said it is initially targeting nearly 3 million diagnosed and treated patients within an estimated U.S. adult fibromyalgia population of more than 10 million.
During the second quarter, prescriptions totaled 12,592, up 100% sequentially. New patient prescriptions increased 36% from the first quarter, while refills rose 207%, according to Executive Vice President of Commercial Operations Thomas Englese.
Englese attributed the sales performance to growing interest from patients and prescribers, traction with the company’s targeted healthcare-provider list, and favorable early gross-to-net dynamics. He said the company expects gross-to-net results to continue fluctuating in the third and fourth quarters as additional payer coverage becomes active.
Tonix said Tonmya coverage across commercial insurance, managed Medicare and Medicaid currently represents about 136 million covered lives, or 43% of approximately 314 million U.S. covered lives. The company expects coverage to reach roughly 145 million lives, or 46%, when a managed Medicare group purchasing organization agreement takes effect on Jan. 1, 2027.
The company has signed commercial payer agreements with two group purchasing organizations covering 52 million lives, which became effective May 1 and June 1. Tonix expects downstream benefits from those agreements to begin materializing during the third and fourth quarters.
Following its market-access progress, Tonix is adding 50 sales representatives and expects them to be in the field by September. The field force is expected to total roughly 150 representatives, primarily working through a contract partner. Englese said the company is focusing initially on 25,000 healthcare providers responsible for approximately 70% of fibromyalgia treatment prescriptions.
Management said prior-authorization submissions and approvals have been favorable, while many patients have already received or are receiving multiple therapies for fibromyalgia. Englese said payers have generally required one or two steps through treatment options rather than mandating use of a specific product.
Pipeline Programs Advance
In June, Tonix randomized the first patient in HORIZON, a potentially pivotal Phase II study of TNX-102 SL as a first-line monotherapy for adults with major depressive disorder. The study is targeting enrollment of approximately 360 U.S. patients experiencing moderate-to-severe major depressive episodes.
Participants will receive either 5.6 milligrams of TNX-102 SL sublingually at bedtime or placebo. The primary endpoint is change from baseline in Montgomery-Åsberg Depression Rating Scale total score at week six. Secondary measures include global impression scores, anxiety ratings and sleep-quality measures.
Lederman said Tonix is evaluating the candidate for depression based on signals from prior company studies in fibromyalgia and post-traumatic stress disorder patients. The company also cited an investigator-initiated Phase II study, called OASIS, evaluating TNX-102 SL in acute stress disorder and acute stress reaction. Tonix expects top-line data from that study in mid-2027.
For TNX-4800, Tonix said it received final minutes from a Type C meeting with the FDA that supported key elements of a planned adaptive Phase II field study in Lyme disease prevention. Subject to agreement on the final protocol, the company expects to begin enrollment in the first quarter of 2027.
The planned randomized, placebo-controlled study is expected to enroll approximately 3,300 adults from Lyme-endemic U.S. areas who participate in activities that increase their exposure to deer ticks. Tonix expects the trial to span two seasons, with most participants enrolled in 2028. Enrollment could extend into 2029 if the Lyme disease attack rate is lower than planned.
The primary endpoint will assess prevention of Lyme disease through six months following the first dose, with prevention through three months as a key secondary endpoint. Lederman said the company believes a positive Phase II study could provide evidence of efficacy and potentially serve as a pivotal study supporting approval.
Expenses and Cash Position
Second-quarter cost of sales was approximately $700,000, compared with $3.3 million a year earlier. Chief Financial Officer Bradley Saenger said the decline primarily reflected product mix and a 2025 write-off of migraine products.
Research and development expense rose to approximately $19.4 million from $10.8 million in the prior-year quarter, driven by higher manufacturing and clinical costs related to pipeline prioritization and increased employee-related expenses. Selling, general and administrative expense increased to approximately $36 million from $16.2 million, reflecting sales and marketing investment behind Tonmya and the migraine portfolio, as well as higher employee and professional expenses.
Tonix ended June 30 with approximately $176.2 million in cash and cash equivalents, down from $207.6 million at the end of 2025. Saenger said the company expects its June 30 cash resources, together with net proceeds from equity offerings completed after quarter-end, to fund planned operating and capital expenditure requirements into early in 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.
