Seth Lederman
Analyst · TD Cowen. Your line is open
Thank you, Tom. Medical affairs is making headway with KOL engagements and education through conference symposia and data presentations. A key focus of our efforts has been on raising awareness among HCPs for the current fibromyalgia diagnostic criteria that state fibromyalgia is not a diagnosis of exclusion. The outdated conception that fibromyalgia was a diagnosis of exclusion created a barrier to diagnosis for two reasons. First, a diagnosis of exclusion was an unreasonable standard because no amount of lab tests or imaging can prove a negative. Second, the medical community now recognizes that fibromyalgia commonly occurs in the context of other conditions, including long COVID, chronic Lyme, systemic lupus, rheumatoid arthritis, and cancer. This means that these other diagnoses should not exclude the diagnosis of fibromyalgia. We believe broader understanding of the current diagnostic criteria could meaningfully grow the addressable fibromyalgia patient population and help patients get diagnosed and treated earlier in the course of their condition. It currently takes on average over 6 years for patients to be diagnosed with fibromyalgia. Moving on from medical affairs, I now want to update you on the pipeline. We are advancing our development pipeline. Today, I will focus on TNX-102 SL and TNX-4800. Moving to Slide 6, TNX-102 SL for the treatment of MDD could potentially serve as a label expansion for TONMYA. In June, we randomized the first patient in HORIZON, a potentially pivotal Phase II study evaluating TNX-102 SL as first-line monotherapy in adults with MDD. We are targeting the enrollment of approximately 360 patients in the U.S. Eligible participants must be 18 years of age or older, currently experiencing a moderate to severe major depressive episode. Participants are being randomized to receive TNX-102 SL 5.6 milligrams taken sublingually at bedtime or matching placebo. The primary endpoint of the study is the change from baseline in MADRS total score at week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep quality. We are evaluating TNX-102 SL for MDD based on initial signals observed in previous Tonix Phase II and III studies in which TNX-102 SL nominally improved depression symptoms in fibromyalgia patients and PTSD patients. TNX-102 SL was designed to target the disturbed sleep in fibromyalgia. If TNX-102 SL has effects on depression, then we believe targeting sleep would be a novel mechanism. Use of SSRIs and SNRIs for depression are frequently associated with treatment-emergent insomnia. Another TONMYA label extension is acute stress disorder and acute stress reaction. An investigator-initiated Phase II study called OASIS is enrolling at the University of North Carolina, funded by a United States Department of Defense grant to University of North Carolina, and for which we expect to report top-line data in mid-2027. Now, I'll move to Slide 7 to discuss TNX-4800, our long-acting monoclonal antibody for the treatment of Lyme disease -- for the prevention of Lyme disease. Positive FDA meeting minutes demonstrate alignment on the key elements of our adaptive Phase II study design and support study start in the first quarter of 2027. Currently, no FDA-approved vaccines or prophylactics for Lyme disease are available. We believe TNX-4800 could potentially change the prevention paradigm. It targets the outer surface protein A, or OspA, on the Lyme-causing Borrelia bacteria. One type of Borrelia, Borrelia burgdorferi, causes 99.9% of Lyme disease cases in the United States. TNX-4800 is designed to act in the midgut of the Borrelia-infected deer tick. If someone is treated with TNX-4800 before getting bitten by the tick, then the tick sucks 4800-containing blood into its midgut. TNX-4800 either kills or blocks the maturation of Borrelia burgdorferi in the midgut of infected deer ticks while they are sucking the victim's blood. This mechanism blocks transmission and infection. OspA is a validated target for antibodies. TNX-4800 is engineered for an extended half-life to provide a longer duration of protection after dosing relative to standard monoclonals. As a monoclonal antibody, we believe TNX-4800 has important advantages over vaccines, namely that it provides protection within 2 days after 1 dose, compared to a prior vaccine or a vaccine in development that takes 3 or 4 separate immunizations over at least 6 months to provide protection. Also, TNX-4800 does not require a host immune response like vaccines. That means it doesn't depend on the host's immune system, which is known to be less active in older people and people with certain conditions. After reporting Phase I data earlier this year and meeting with the FDA in early Q3, we now have a clear view of our planned Phase II study. Pending FDA agreement on the final study protocol, we plan to conduct a randomized, placebo-controlled, adaptive field study. We expect to enroll approximately 3,300 adult participants. These volunteers, age 18 and older, will be recruited from Lyme endemic areas in the U.S. and selected for their engagement in activities that increase their risk of deer tick bites. We expect this to be a 2-season study and expect to enroll the majority of participants in 2028. If the attack rate is lower than planned, enrollment could potentially extend into 2029. The primary efficacy endpoint will be Lyme disease prevention through 6 months after the first dose, and a key secondary efficacy endpoint will be prevention through 3 months. Although it is a Phase II study, we believe it has the potential to demonstrate efficacy. The primary safety objective will be to evaluate the safety and tolerability of TNX-4800 over a 52-week period after dosing. Participants in the planned adaptive Phase II field study will be randomized 1-to-1 to receive either placebo or TNX-4800 dosing 450 milligrams sub-Q in the spring, and another dose approximately 3 months later. Our focus in 2026 has been on manufacturing investigational product for TNX-4800, which is on track for delivery to study sites in the first quarter of 2027. With that, I will turn the call over to Bradley Saenger, our Chief Financial Officer, to review our financial results. Bradley?