Tonix Pharmaceuticals

The company's predecessors were Tamandare Explorations Inc. which had been formed in 2007 as a mining wildcat vehicle focused on land in Nevada and the shares of which were traded over the counter, and L & L Technologies, LLC, which had been formed in 1996 by Seth Lederman and Donald Landry to repurpose drugs for CNS development. L&L had formed Janus Pharmaceuticals, Inc., which later became Vela Pharmaceuticals, Inc. to develop some of its inventions, and Vela returned those assets to L&L in 2006. L&L placed them in a subsidiary called Krele Pharmaceuticals, Inc., and that subsidiary and Tamandare Explorations Inc. performed a reverse merger in October 2011; the new entity was renamed Tonix Pharmaceuticals Holding Corp. and Lederman was named CEO. It was listed on the NASDAQ exchange in 2013 under the symbol TNXP, and in December 2021 Tonix was added to the NASDAQ Biotechnology Index (Nasdaq:NBI). Tonix regained compliance for continued listing on The Nasdaq Capital Market in June 2022 by closing at a value of at least $1.00 per share for a time frame greater than or equal to 10 consecutive business days, criteria established by Nasdaq Listing Rule 5550(a)(2).

Ernest Mario, a scientist and former CEO of Glaxo Holdings Inc, served on the board of Tonix in the past.

Tonix finalized the purchase of a 40,000 square foot facility in Massachusetts in 2020 to house its new Advanced Development Center (ADC) for accelerated development and manufacturing of vaccines, including vaccines for COVID-19. This facility has been functional since June 2022. Tonix additionally purchased a 44-acre parcel of land in Hamilton, Montana at the end of 2020 for the construction of a vaccine production facility. In October 2021, Tonix announced the acquisition of a 48,000 square foot research and development center in Frederick, Maryland to support the Company's infectious disease pipeline. The facility was purchased from Southern Research, one of Tonix's collaborators on TNX-1800 and TNX-801 development.

Tonix licensed from University of Geneva, their technology for oxytocin-based treatments for treating insulin resistance, diabetes, and obesity allowing Tonix to expand its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes.

In March 2021, Tonix announced the issuance of a U.S. patent for compositions and uses of tianeptine oxalate salt, the active ingredient in TNX-601 CR. The patent provides Tonix with U.S. market exclusivity until December 2037 for claims directed to pharmaceutical compositions comprising crystalline tianeptine oxalate salts, to methods of using those compositions to treat various disorders, and to methods of producing oxalate salts.

Horsepox Platform, Monkeypox and Smallpox

In July 2017 the news division of the journal, Science, reported that Tonix had sponsored research and collaborating with scientists at the University of Alberta, David Evans and Ryan Noyce, and that the work had led to the generation of an extinct horsepox virus using synthetic biology—the lab had bought pieces of DNA from a reagent company and had built the horsepox genome with them. This invention was licensed to Tonix and Tonix announced that it intended to further develop it into a smallpox vaccine, TNX-801, which is a biodefense business model. The research was published in 2018. In December 2020, Tonix announced that independent researchers reported 99.7% colinear identity between a circa 1860 U.S. smallpox vaccine and horsepox virus. Tonix's TNX-801 is a preclinical horsepox-based live virus vaccine being developed as a potential vaccine to prevent smallpox and monkeypox. Tonix's TNX-801 is also the vector on which Tonix's COVID-19 experimental vaccine is based.

The United States Patent and Trademark Office (USTPO) issued Tonix Pharmaceuticals U.S. Patent No. 11, 345, 896, entitled "Synthetic Chimeric Poxviruses" in May 2022. This patent applies to synthetic horsepox virus, the basis for the Company's TNX-801 vaccine and Recombinant Pox Virus (PRV) platform, and is anticipated to grant Tonix with U.S. market exclusivity until 2037. Upon a global surge of Monkeypox cases, the Kenya Medical Research Institute (KE\MRI) and Tonix Pharmaceuticals announced a research collaboration to develop TNX-801 as a vaccine to protect against monkeypox and smallpox in July 2022. The Phase 1 clinical study is awaiting regulatory approval in Kenya.

In preclinical studies, TNX‑801—a single‑dose, recombinant horsepox live‑virus vaccine—demonstrated durable protection against mpox and rabbitpox in animal models, including those with compromised immune systems.

It is up to 100,000‑fold less virulent than live smallpox vaccine strains.