Tonix reports promising results for mpox vaccine TNX-801

CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a clinical-stage biopharmaceutical company with a market capitalization of $109.5 million, has announced positive preclinical data for its TNX-801 vaccine, which is in development to protect against mpox and smallpox. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 6.5x, indicating robust short-term financial stability. The data, presented at the World Vaccine Congress Washington 2025, showed that the vaccine provided durable six-month protection against a lethal rabbitpox virus challenge and protected immunocompromised animals from a lethal monkeypox clade IIa virus challenge.

TNX-801 is a single-dose, live virus vaccine that has demonstrated tolerability, with no spreading to blood or tissues, even at high doses. The vaccine is based on synthesized horsepox and is designed to be minimally replicative. According to Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, the vaccine has shown potential for providing protective immunity with a single dose and has been well tolerated in immunocompromised animals. While the company reported revenue growth of nearly 30% in the last twelve months, InvestingPro analysis indicates the company is quickly burning through cash, with negative free cash flow of $61 million.

The vaccine’s development is timely, given the recent mpox epidemics that have been declared Public Health Emergencies of International Concern by the World Health Organization. The company believes that TNX-801 could contribute significantly to preventing mpox and controlling future epidemics.

Tonix has also reported that the World Health Organization’s preferred target product profile for mpox vaccines aligns with the characteristics of TNX-801. This includes single-dose administration, durability of protection, and suitability for use in immunocompromised individuals.

The company is collaborating with the Kenya Medical Research Institute to seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya. Tonix aims to position TNX-801 as a global solution for mpox and smallpox prevention, citing its potential for scalable manufacturing and a durable T-cell immune response.

This report is based on a press release statement from Tonix Pharmaceuticals. The safety and efficacy of TNX-801 have not yet been established, and it has not been approved for any indication.

In other recent news, Tonix Pharmaceuticals Holding Corp. has made significant strides in its development efforts. The company announced a collaboration with Makana Therapeutics to explore the use of Tonix’s TNX-1500 in conjunction with genetically engineered pig organs for xenotransplantation. This partnership aims to address organ rejection in transplant patients and could lead to a reliable supply of organs. Furthermore, Tonix launched TONIX ONE, a digital platform designed to improve migraine management by integrating telehealth services and prescription fulfillment, in collaboration with partners like UpScript Telemedicine and Blink Health.

In another development, Noble Capital reaffirmed its Outperform rating and maintained a $70 price target on Tonix Pharmaceuticals. This comes after the U.S. FDA decided not to require an Advisory Committee Meeting for the approval of Tonix’s drug candidate TNX-102 SL, a treatment for fibromyalgia. This decision is seen as a positive indicator of a smooth review process, suggesting no significant concerns from the FDA. TNX-102 SL, which has been granted Fast Track designation, is on track for a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025.

These developments highlight Tonix Pharmaceuticals’ ongoing commitment to advancing its product pipeline, with potential implications for both the xenotransplantation and fibromyalgia treatment markets.

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