Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) provided detailed updates on Monday concerning the clinical development of TNX-4800, a long-acting human monoclonal antibody designed to target the outer surface protein A (OspA) of Borrelia burgdorferi, the bacterial agent responsible for Lyme disease in humans. TNX-4800, previously referred to as mAb 2217LS, is being formulated for an annual prophylactic use, administered as a single subcutaneous injection in the spring. This treatment aims to offer protection throughout the entire tick-active season across the United States, spanning the spring to fall months.
Currently, there are no U.S. Food and Drug Administration (FDA)-approved vaccines or therapeutic options available to prevent Lyme disease, highlighting a significant unmet medical need and a potential market opportunity for Tonix's novel antibody.
Seth Lederman, Chief Executive Officer of Tonix Pharmaceuticals, elaborated on forthcoming regulatory plans by stating, “We intend to engage with the FDA in 2026 to evaluate pathways for Phase 2 and Phase 3 development programs.” He further noted that the company considers employing a controlled human infection model (CHIM) using Borrelia-infected ticks to simulate natural infection as a promising strategy for demonstrating TNX-4800’s efficacy in support of regulatory approval.
Tonix is advancing efforts to develop investigational product material under Good Manufacturing Practices (GMP), with the objective of making it available for testing by early 2027, coinciding with planned regulatory discussions and study conduct timelines.
In light of Lyme disease’s epidemiology, Tonix highlighted that approximately 70 million individuals residing, working, or vacationing in endemic regions of the United States could potentially benefit from a pre-exposure prophylactic like TNX-4800, given the absence of approved preventive options.
Alongside the clinical update, Tonix announced completion of a securities purchase agreement with Point72 Asset Management, entailing the sale of 615,025 shares at $16.26 per share and pre-funded warrants to acquire an additional 615,025 shares at a closely matched warrant price of $16.259. This transaction generated gross proceeds totaling roughly $20 million.
The funds raised are earmarked for various corporate purposes, encompassing support for the commercialization of Tonix's existing marketed products, advancing the pipeline including TNX-4800 development, as well as covering general working capital and other corporate expenses.
Market response to the announcement was positively tempered, with Tonix’s share price demonstrating a modest gain of 0.80%, trading at $16.39 at the time of reporting.
This latest update on TNX-4800 and the concurrent capital raise reflect Tonix Pharmaceuticals' focused approach to addressing Lyme disease prevention through innovative biologic therapies, as well as sustaining financial resources to underpin development and operational activities.