Pipeline Progress Is Encouraging, Focus Remains On Tonmya's Fibromyalgia Launch

研报英文原文证据摘录

Pipeline Progress Is Encouraging, Focus Remains On Tonmya's Fibromyalgia Launch

TD Cowen Tonix Pharmaceuticals

Global Research June 29, 2026

Regardless, poor public sentiment, hesitancy from HCPs towards LYMErix given lack of clear

recommendations, and lower efficacy in Year 1 resulted in modest uptake, eventually leading

to SmithKlein Beecham's decision to ultimately discontinue LYMErix. Specifically, LYMErix was

considered for ages 15-70 years old with target candidates that live/work in areas with high

rates of Lyme disease – competitor Valneva notes the expansion of endemic areas since 2002 is

meaningful.

For reference, periodical publications referring to the announcement report that 100K doses of

LYMErix were sold in 1999, with ~1.4MM doses distributed in 2001, however the safety concerns

led to GSK projecting the sale of 10K doses in 2002. PasteurMérieux-Connaught did not pursue

licensure following the failure of SmithKlein Beecham's commercial efforts for LYMErix. Given all

these dynamics, our consultants indicate the importance of higher initial efficacy outcomes as

key for patient adoption.

TNX-4800 Should Provide Strong Passive Immunity Against Lyme Disease

TNX-4800 is a B. burgdorferi anti-OspA half-life extended mAb being developed for seasonal

prevention of Lyme disease. In comparison to traditional vaccine approaches which induce

active immunity, Tonix indicates their approach for passive immunity should provide rapid,

lasting, and predictable protective effects in a broad population (i.e., both immunocompetent,

and immunocompromised patients). Based on the pre-clinical and Phase I data, Tonix expects

onset of immunity starting two days following initial dose administration, with PK suggesting

potential for efficacy lasting four months.