Tonix Pharmaceuticals Highlights TONMYA Sales Surge, Lyme and Depression Pipeline

Tonix Pharmaceuticals NASDAQ: TNXP is focusing its near-term strategy on the commercial launch of TONMYA for fibromyalgia while advancing development programs in Lyme disease prevention and major depressive disorder, Chief Executive Officer Seth Lederman said during a Canaccord Genuity conference presentation.

Lederman said Tonix, founded in 2007, has developed into a fully integrated biopharmaceutical company with capabilities spanning research, development and commercialization. The company’s central priority for this year and next is expanding the launch of TONMYA, a sublingual and transmucosal formulation of cyclobenzaprine approved for fibromyalgia.

The company reported $11 million in net sales for TONMYA during the second quarter, approximately triple its first-quarter sales, according to Lederman. TONMYA launched in November, and the second quarter represented the product’s second full quarter on the market.

TONMYA Launch and Market Access

Lederman said TONMYA is designed to address disturbed sleep in fibromyalgia, an approach he characterized as different from existing treatments for the chronic pain condition. He cited the work of Harvey Moldofsky, whose research proposed that fibromyalgia may be associated with sleep disruption.

While cyclobenzaprine was previously studied in fibromyalgia, Lederman said Tonix developed a transmucosal formulation intended to reduce production of a metabolite that the company believes may have limited the durability of earlier oral cyclobenzaprine treatment effects.

The formulation uses a eutectic structure that combines cyclobenzaprine with a base despite their incompatibility in conventional formulations, Lederman said. He said the resulting tablet has demonstrated four years of stability.

Tonix’s U.S. and international patents covering the eutectic formulation extend through 2034, according to Lederman. He added that Sandoz challenged the patents in Europe, where Tonix prevailed in the patent interference case on all claims.

On commercial progress, Lederman said feedback from prescribers and patients has generally met company expectations. He said some patients do not respond, while others have reported benefits and a smaller but meaningful number have described the medicine as life-changing.

The company’s initial promotional focus has been on approximately 3 million patients who have already been diagnosed and treated for fibromyalgia. Lederman said many of these patients have used prior medications and remain dissatisfied with their treatment outcomes.

• Tonix has commercial contracts with two of the three major pharmacy benefit managers on the commercial side, Lederman said.
• The company has a managed Medicare contract with one of the three major pharmacy benefit managers.
• Tonix is expanding its sales force to 150 representatives from 100, with the new representatives expected to be fully deployed in September.

Lederman said the company has sought to balance demand generation with formulary access. He attributed progress with payers in part to TONMYA’s position as a non-opioid analgesic for chronic pain. The product’s label allows nightly use for months, years or decades, he said.

Lyme Disease Prevention Program

Tonix is also advancing TNX-4800, a long-acting monoclonal antibody being developed to prevent Lyme disease. The company licensed the program from UMass Chan Medical School last year, Lederman said.

TNX-4800 targets outer surface protein A, or OspA, on the Borrelia bacteria that cause Lyme disease. Lederman said OspA is a validated prevention target because it was targeted by the FDA-approved LYMErix vaccine, which was marketed from 1998 until 2002.

Lederman said a monoclonal antibody may offer advantages over a vaccine in Lyme prevention because OspA is typically hidden in a tick’s mid-gut and is not necessarily exposed in a way that prompts an antibody response after human infection. The company’s strategy is to provide a highly potent antibody that can be taken up by a feeding tick and act against the bacteria.

Tonix is manufacturing TNX-4800 this year and expects to begin clinical studies in 2027. Lederman said the company recently had a positive FDA meeting and anticipates initiating a Phase 2 field study in the first quarter, pending final protocol approval.

The planned trial is expected to enroll about 3,300 people in Lyme-endemic areas who participate in higher-risk activities such as hiking, golfing, gardening or landscaping. The study will compare clinical Lyme disease cases in participants receiving placebo with those receiving the antibody over two seasons. Lederman said the first season will place greater emphasis on safety work, while the second season is expected to enroll more participants.

Depression Study Underway

Tonix has also begun enrolling a Phase 2 study of TONMYA in major depressive disorder. Lederman described the program as a potential label-expansion opportunity.

He said TONMYA produced nominal P values on exploratory depression measures in two prior double-blind studies conducted in different indications. Those measures included the Montgomery-Åsberg Depression Rating Scale in one study and the Beck Depression Inventory in a fibromyalgia study.

Tonix expects to complete the major depressive disorder study by the end of 2027 and potentially report results in early 2028, Lederman said.

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.

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