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CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a clinical-stage biopharmaceutical company with a market capitalization of $263 million, announced Monday that its experimental mpox vaccine candidate TNX-801 has demonstrated protection against lethal monkeypox challenges in preclinical animal studies. The company’s stock has shown strong momentum, delivering a 23% return over the past six months, according to InvestingPro data.
The company reported that a single dose of TNX-801, a recombinant horsepox virus live vaccine, provided durable protection in animals and was well tolerated even in immunocompromised subjects without evidence of spreading to blood or tissues at high doses. InvestingPro analysis shows Tonix maintains a healthy balance sheet with more cash than debt and a strong current ratio of 12.3, providing financial flexibility for its research programs.
Sina Bavari, Executive Vice President of Infectious Disease Research and Development at Tonix, will present these findings at the Vaccine Congress 2025 in Vienna on July 10. The presentation will detail the safety, immunogenicity, and efficacy data collected to date.
TNX-801 is designed as a minimally replicative, attenuated live virus vaccine that generates both humoral and cellular immunity after a single dose. The company noted that the vaccine candidate also serves as a platform that can potentially deliver multiple protective antigens against various viral pathogens.
The vaccine development comes amid ongoing global concerns about mpox, formerly known as monkeypox, which has caused outbreaks in multiple countries in recent years.
Tonix’s infectious disease portfolio also includes TNX-4200, for which the company has a contract with the U.S. Department of Defense’s Defense Threat Reduction Agency worth up to $34 million over five years.
Separately, Tonix is awaiting an FDA decision on its fibromyalgia treatment candidate TNX-102 SL, with a PDUFA date of August 15, 2025.
The information is based on a company press release statement.
In other recent news, Tonix Pharmaceuticals Holding Corp. has reported promising data on its experimental cancer treatment, mTNX-1700, in animal models. The study, published in Cancer Cell, indicates that the combination of mTNX-1700 with an anti-PD1 antibody improves survival and reduces metastases in gastric cancer models. Additionally, Tonix has announced a significant move to raise up to $225 million through two separate stock offerings. These offerings involve agreements with A.G.P./Alliance Global Partners and Lincoln Park Capital Fund, aiming to bolster the company’s financial position.
Furthermore, Tonix has initiated a Phase 2 clinical trial for TNX-102 SL, a treatment targeting acute stress reactions, with support from the University of North Carolina and a $3 million grant from the U.S. Department of Defense. The trial seeks to enroll 180 participants who have experienced traumatic events. In vaccine development, Tonix shared positive preclinical results for its TNX-801 vaccine, designed to protect against mpox and smallpox, at the World Vaccine Congress.
The company also held its annual shareholder meeting, where seven key proposals were approved, including the election of eight board members and the ratification of EisnerAmper LLP as the accounting firm for 2025. An amendment to increase shares available for awards under the 2020 Stock Incentive Plan was also approved. These developments reflect Tonix’s ongoing efforts in research, financial strategy, and corporate governance.
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