CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), in collaboration with Netherlands-based Bilthoven Biologicals (BBio), has announced the advancement of TNX-801, a vaccine candidate for mpox. This live virus vaccine, currently in pre-clinical development, aims to prevent mpox and smallpox, diseases which have recently posed significant public health challenges.
The World Health Organization (WHO) declared the spread of mpox in African countries a public health emergency of international concern on August 14, 2024. The current outbreak, attributed to the Clade 1 monkeypox virus, has shown a mortality rate of up to 10% in certain regions. This follows a global outbreak from Clade 2 in 2022, which affected over 90,000 individuals worldwide, including in non-endemic areas like Europe and the U.S.
TNX-801 is based on horsepox technology, which could potentially serve as a platform for vaccines against other infectious diseases. Preclinical studies have demonstrated that the vaccine provides immune protection with better tolerability compared to older vaccinia virus-based vaccines. It has shown efficacy in non-human primates, preventing clinical disease and reducing virus shedding, which suggests it may help block transmission of the virus.
The collaboration between Tonix and BBio, a global vaccine producer, is part of a strategic response to improve pandemic preparedness. BBio has been recognized by the European Union for its 'ever warm' vaccine manufacturing capabilities, designed to be ready in the event of a pandemic.
Tonix's CEO, Seth Lederman, M.D., emphasized the potential of TNX-801 to be rapidly scaled up for manufacturing and distributed without the need for an ultra-cold supply chain. The single-dose administration approach of TNX-801 is anticipated to enhance vaccine acceptance and coverage compared to the current two-dose regimens.
Tonix has engaged with the U.S. Food and Drug Administration (FDA) regarding the development of TNX-801 and is planning to enter Phase 1/2 clinical studies. The company also highlighted the importance of having an affordable, effective single-dose vaccine to address the pandemic potential of mpox.
This news is based on a press release statement from Tonix Pharmaceuticals Holding Corp. and reflects the ongoing efforts to address global health emergencies through collaborative vaccine development.
In other recent news, Tonix Pharmaceuticals has been making strides in various areas. The biopharmaceutical company has initiated a Phase 2 trial for TNX-1300, a potential treatment for acute cocaine intoxication. The company has also advanced its TNX-801 vaccine candidate in response to the World Health Organization's declaration of the mpox outbreak as a public health emergency.
Tonix has also reported positive results from its Phase 3 RESILIENT study for its investigational drug, TNX-102 SL, aimed at managing fibromyalgia. Additionally, the company has entered into a sales agreement with A.G.P./Alliance Global Partners (NYSE:GLP), allowing the sale of up to $50 million of its common stock over time.
In financial developments, Tonix has announced a public offering of approximately 7.1 million shares, which is expected to raise $4 million before deducting fees and expenses. Analyst firm Noble Capital has maintained an Outperform rating on Tonix's stock, but lowered the target to $1.50 from the previous $10.00. These developments reflect recent advancements in both the research and financial endeavors of Tonix Pharmaceuticals.
InvestingPro Insights
As Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) progresses with its promising vaccine candidate TNX-801, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro, the stock is currently in oversold territory based on the RSI (Relative Strength Index), which could indicate a potential rebound or at least stabilization in the near term.
However, InvestingPro Tips suggest caution, as Tonix is quickly burning through cash, and analysts do not anticipate the company will be profitable this year. These factors are critical for investors to consider, especially when evaluating the company's ability to fund ongoing research and development efforts for TNX-801 without significant financial strain.
From a data perspective, Tonix's market cap stands at a modest 7.48M USD, reflecting the company's small size in the pharmaceutical industry. The stock's price movements have been quite volatile, with a striking 93.95% drop over the last three months, a trend that underscores the high-risk nature of investing in biotech firms. Moreover, with a Price / Book ratio of 0.18 as of the last twelve months leading up to Q2 2024, the company's stock is trading at a level that suggests its assets are potentially undervalued, which could attract value-oriented investors.
For those interested in deeper analysis, InvestingPro offers additional insights and tips on Tonix Pharmaceuticals Holding Corp., which can be found at: https://www.investing.com/pro/TNXP. With 15 more InvestingPro Tips available, investors have access to a comprehensive view of the company's financial standing and market performance.
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