CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company, announced preclinical data showing that its TNX-801 vaccine effectively protected animals from a lethal challenge with monkeypox, also known as mpox. The findings were presented at a symposium hosted by the Department of Medical Microbiology & Immunology and the Li Ka Shing Institute of Virology.
The TNX-801 vaccine, a live virus vaccine for percutaneous administration, is based on synthesized horsepox. It is structurally closer to vaccinia vaccines used in the 19th century, which were effective against smallpox. The recent data suggests that TNX-801 is more tolerable than 20th-century vaccinia vaccines, with no evidence of spreading to blood or tissues in immunocompromised animals, even at high doses.
In contrast to the recently FDA-approved ACAM2000 and Jynneos vaccines for mpox, TNX-801 may offer a single-dose regimen with potential long-lasting T cell immunity, avoiding the need for multiple repeated doses. Additionally, its stability could eliminate the need for ultra-cold storage, facilitating its use in regions like Africa.
The preclinical study demonstrated that TNX-801 prevented clinical disease and lesions while reducing viral shedding in the mouth and lungs of animals challenged with clade I monkeypox virus. This strain has been associated with higher fatality rates and has recently been declared a Public Health Emergency of International Concern by the World Health Organization.
Tonix also highlighted the potential of TNX-801 to be manufactured economically at scale with standard shipping and storing requirements. The company is collaborating with Bilthoven Biologics for developing Good Manufacturing Practice (GMP) processes for TNX-801.
Moreover, Tonix is working on other applications of its horsepox vaccine platform, including TNX-1800 for COVID-19, which is set for inclusion in clinical trials by the U.S. National Institutes of Health's Project NextGen.
The company's efforts are in line with recommendations by the Bipartisan Commission on Biodefense and the U.S. National Academies of Science, emphasizing the importance of single-dose vaccines for effective epidemic control.
This report is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
In other recent news, Tonix Pharmaceuticals has announced a series of significant developments. The company has initiated a share repurchase program, authorizing the buyback of up to $10 million of its outstanding common stock. Additionally, Tonix has expanded its maximum aggregate offering price from $50 million to $150 million under an existing Sales Agreement with A.G.P./Alliance Global Partners (NYSE:GLP).
On the research front, Tonix has reported positive results from its Phase 3 RESILIENT study of TNX-102 SL for the treatment of fibromyalgia. The company has also initiated a Phase 2 trial to assess the efficacy of TNX-102 SL for reducing the severity of acute stress reaction. In collaboration with Netherlands-based Bilthoven Biologicals, Tonix has advanced TNX-801, a vaccine candidate for mpox, following the World Health Organization's declaration of the mpox outbreak in African countries as a public health emergency.
Financially, Tonix announced a public offering of approximately 7.1 million shares, expected to raise $4 million before deducting fees and expenses. The analyst firm Noble Capital has maintained an Outperform rating on Tonix's stock, albeit with a lowered target to $1.50 from the previous $10.00. These are the recent developments at Tonix Pharmaceuticals.
InvestingPro Insights
As Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) advances its vaccine development, including the promising TNX-801 for mpox, investors and market watchers are keeping a close eye on the company's financial health and stock performance. According to InvestingPro, Tonix operates with a significant debt burden and is quickly burning through cash, which are important considerations for stakeholders evaluating the company's long-term viability.
InvestingPro Data shows that Tonix has a market capitalization of approximately $3.14 million, reflecting a small-cap status that often comes with higher investment risk. The company's Price / Book ratio, as of the last twelve months leading up to Q2 2024, stands at a low 0.07, which might suggest that the stock is undervalued relative to its book value. However, the company's financials also reveal challenges, with an operating income margin of -764.06% for the same period, indicating significant operational losses relative to its revenue.
InvestingPro Tips highlight that the stock's price has fallen significantly over various time frames, including a -99.51% one-year price total return as of the end of 2024. This performance aligns with the Relative Strength Index (RSI) suggesting the stock is in oversold territory, which could interest contrarian investors or those looking for potential turnaround stories.
For those interested in further analysis and more comprehensive insights, InvestingPro offers additional tips on Tonix Pharmaceuticals, guiding investors through the complexities of biotech investing. With the biopharmaceutical landscape being notoriously volatile, these tips could be invaluable for making informed decisions.
For more detailed information and further insights, investors can explore the full range of InvestingPro Tips available for Tonix Pharmaceuticals at https://www.investing.com/pro/TNXP, which currently lists over 16 tips for the company.
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