Tonix vaccine aligns with WHO mpox criteria By Investing.com

CHATHAM, N.J. – Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a biopharmaceutical company, announced alignment between the World Health Organization’s (WHO) target profile for mpox vaccines and its own vaccine candidate, TNX-801. The WHO’s criteria, released during the Mpox Research and Innovation Scientific Conference on August 29-30, 2024, specify the need for a single-dose vaccine that provides durable protection and is stable at ambient temperature.

Tonix’s CEO, Dr. Seth Lederman, highlighted that TNX-801, a live attenuated horsepox vaccine, matches these specifications. Animal studies have shown that TNX-801 can protect against lethal Clade I monkeypox virus and potentially block forward transmission, a critical feature for controlling the disease’s spread. The vaccine is designed for easy administration and does not require an ultra-cold supply chain, which is beneficial for distribution in developing regions.

The urgency for effective vaccines has been underscored by the WHO’s declaration on August 14, 2024, that the rise of mpox in Africa represents a public health emergency of international concern. The current outbreak is attributed to the Clade I monkeypox virus, which has a higher case fatality rate than the Clade IIb strain involved in the 2022 outbreak.

Tonix has also announced a collaboration with Bilthoven Biologics to develop manufacturing processes for the vaccine. The company’s portfolio includes TNX-102 SL for fibromyalgia management, which is on track for a New Drug Application submission to the FDA in October 2024, and a broad-spectrum antiviral agent, TNX-4200, under a contract with the U.S. Department of Defense.

TNX-801 is part of Tonix’s broader effort to address infectious diseases, alongside other candidates for central nervous system disorders and immunology. All product development candidates, including TNX-801, are investigational and have not yet been approved for any indication.

This article is based on a press release statement from Tonix Pharmaceuticals Holding Corp.

In other recent news, Tonix Pharmaceuticals has made significant strides in its research and financial strategies. The company’s TNX-801 vaccine has shown promising preclinical data in protecting animals from a lethal monkeypox challenge, potentially offering a single-dose regimen with long-lasting T cell immunity. Tonix has also advanced its TNX-1800 for COVID-19, slated for inclusion in clinical trials by the U.S. National Institutes of Health’s Project NextGen.

On the financial front, Tonix has initiated a share repurchase program, authorizing the buyback of up to $10 million of its outstanding common stock. Additionally, the company 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:).

In terms of research, Tonix reported positive results from its Phase 3 RESILIENT study of TNX-102 SL for the treatment of fibromyalgia and initiated a Phase 2 trial to assess the efficacy of TNX-102 SL for reducing the severity of acute stress reaction. The company also announced a public offering of approximately 7.1 million shares, expected to raise $4 million before deducting fees and expenses.

In analyst notes, 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 most recent developments at Tonix Pharmaceuticals.

InvestingPro Insights

In the biopharmaceutical industry, where Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) operates, financial health and market performance are as crucial as scientific breakthroughs. As Tonix aligns its vaccine candidate with WHO criteria for mpox vaccines, it’s pertinent to consider the company’s financial metrics and market indicators to understand its position in the competitive landscape.

According to InvestingPro data, Tonix’s market capitalization stands at a modest $3.45 million, reflecting the size and scale of the company within the pharmaceutical sector. With a Price / Book multiple of 0.08 as of the last twelve months ending Q2 2024, the stock is trading at a low valuation relative to its book value, which could suggest that the market is undervaluing the company’s assets or that investors are cautious about the company’s future prospects.

InvestingPro Tips highlight that Tonix operates with a significant debt burden and is quickly burning through cash, which are important considerations for potential investors. These factors, coupled with a Price Total Return of -99.47% over the past year, paint a picture of a company that may be facing financial challenges. Moreover, the stock’s volatility is evident in its price movements, which have been quite volatile in recent times.

For investors seeking more detailed analysis, InvestingPro offers additional tips, including insights on the company’s profitability, analyst expectations, and stock performance over various timeframes. For instance, analysts do not anticipate that Tonix will be profitable this year, and the stock has fared poorly over the last month. These insights, along with others, are available on InvestingPro’s platform, which lists a total of 15 tips for Tonix Pharmaceuticals Holding Corp.

As Tonix Pharmaceuticals continues to develop its vaccine candidates and other pharmaceutical products, monitoring these financial and market metrics will be critical for investors to assess the company’s viability and potential for growth in the challenging biopharmaceutical industry.

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