CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company, announced findings from a study indicating that its new vaccine candidate TNX-801 is significantly less virulent compared to traditional vaccinia smallpox vaccines. This comes in response to the World Health Organization's declaration of a public health emergency of international concern due to the spread of new Clade Ib Mpox.
The study, published in the peer-reviewed journal mSphere, presents data suggesting that TNX-801 could be a promising candidate for controlling the ongoing Mpox public health emergencies. The recent outbreak of Clade Ib Mpox has been reported in 16 African countries as well as non-African countries including Sweden, Thailand, Singapore, India, Germany, and England.
The WHO's declaration on August 14, 2024, marked the second such emergency in two years following the Clade IIb mpox outbreak that began in 2022. The current Clade Ib outbreak has notably affected children in Africa and has been spread by adult travelers to other regions.
TNX-801 has previously shown efficacy in protecting animals from lethal challenge with Clade Ia monkeypox virus and is now reported to be well-tolerated in immune-compromised animal models, supporting its potential for human clinical development. The vaccine is based on a synthesized horsepox virus, believed to be closer to the original smallpox vaccine developed by Dr. Edward Jenner than the vaccinia viruses used in the 20th century.
In addition to the potential for TNX-801 to address mpox, Tonix is also advancing other candidates in its pipeline, including a treatment for fibromyalgia and a vaccine for COVID-19, among others. The company is working with global partners to develop manufacturing processes for its mpox vaccine and is planning a Phase I clinical study in Kenya.
Tonix's development of TNX-801 is part of a broader effort to provide new solutions for public health challenges. The company emphasizes the significance of TNX-801's attenuated profile and its potential to be distributed without the need for a costly supply chain. The information for this article is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
In other recent news, Tonix Pharmaceuticals has been making significant advancements in various areas. The clinical-stage biopharmaceutical company has presented promising preclinical data on its mpox vaccine candidate, TNX-801, indicating its potential to prevent mpox and control future epidemics. The company has also secured a Department of Defense contract worth up to $34 million for the development of its antiviral drug, TNX-4200, in collaboration with X-Chem, Inc.
Tonix has submitted a New Drug Application to the U.S. Food and Drug Administration for TNX-102 SL, a non-opioid treatment for fibromyalgia, based on two Phase 3 studies showing statistically significant results. Additionally, the company has been granted patents extending market exclusivity for its migraine treatments, Zembrace® SymTouch® and Tosymra®, until 2036 and 2030, respectively.
Noble Capital analysts have maintained an Outperform rating on Tonix's stock. These are some of the recent developments in Tonix's ongoing commitment to research, development, and financial strategies. The company expects a decision on approval for TNX-102 SL in 2025.
InvestingPro Insights
As Tonix Pharmaceuticals (NASDAQ:TNXP) advances its promising vaccine candidate TNX-801, investors should be aware of some key financial metrics and insights provided by InvestingPro.
According to InvestingPro data, Tonix's market capitalization stands at $25.89 million, reflecting its status as a small-cap biopharmaceutical company. The company's revenue for the last twelve months as of Q2 2024 was $12.46 million, with a gross profit of $2.69 million and a gross profit margin of 21.59%.
However, it's important to note that Tonix is currently operating at a loss, with an adjusted operating income of -$95.19 million for the same period. This aligns with an InvestingPro Tip indicating that the company is "quickly burning through cash." This is not uncommon for biopharmaceutical companies in the development stage, as they often invest heavily in research and clinical trials before generating significant revenue.
Another InvestingPro Tip suggests that "analysts do not anticipate the company will be profitable this year." This information is crucial for investors considering the long-term potential of Tonix's pipeline, including TNX-801 and other candidates mentioned in the article.
The stock's performance has been challenging, with InvestingPro data showing a one-year price total return of -99.03% as of the latest available data. This significant decline underscores the volatility and risks associated with investing in early-stage biopharmaceutical companies.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. In fact, there are 8 more InvestingPro Tips available for Tonix Pharmaceuticals, which could provide valuable context for understanding the company's financial position and market performance as it continues to develop its vaccine candidates and other treatments.
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