CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company, has announced a collaboration with X-Chem, Inc. to expedite the development of oral broad-spectrum antivirals, particularly their TNX-4200 program. This partnership leverages artificial intelligence (AI) and machine learning (ML) to enhance drug discovery processes.
Tonix's TNX-4200 aims to create host-directed antiviral drugs that boost the immune response across various viral families. The U.S. Department of Defense's Defense Threat Reduction Agency (DTRA) has awarded Tonix a contract up to $34 million to accelerate the TNX-4200 program, which includes funding an Investigational New Drug (IND) application and a Phase 1 clinical trial.
"We are excited to enter into this research collaboration with X-Chem," said Seth Lederman, M.D., CEO of Tonix Pharmaceuticals. He anticipates that the AI/ML technology will improve the drug candidates' properties and safety profiles. Erin Davis, Ph.D., CTO of X-Chem, also expressed enthusiasm for the partnership's potential impact on human health.
The TNX-4200 program focuses on developing oral CD45 phosphatase inhibitors, with the goal of reducing viral load and prompting an adaptive immune response. Tonix plans to build on its previous research on phosphatase inhibitors for therapeutic intervention against biothreat agents.
Tonix operates a research and development center in Maryland, equipped with Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) facilities, to support their antiviral programs.
In addition to TNX-4200, Tonix is preparing to submit a New Drug Application (NDA) to the FDA for another candidate, TNX-102 SL, intended for fibromyalgia management, which has completed two Phase 3 studies and received Fast Track designation.
This collaboration and the DTRA contract underscore Tonix's commitment to addressing biological threats and advancing public health. The information provided is based on a press release statement from Tonix Pharmaceuticals.
In other recent news, Tonix Pharmaceuticals has made significant strides in the development of its migraine treatment, Zembrace® SymTouch®, securing a patent that extends its market exclusivity until 2036. The company is also advancing its fibromyalgia treatment, TNX-102 SL, with a New Drug Application expected to be submitted by October 2024. Additionally, Tonix has been granted a new patent for its migraine nasal spray, Tosymra®, further enhancing its portfolio.
On the research front, Tonix's TNX-801 vaccine has demonstrated encouraging preclinical data, effectively protecting animals from a lethal monkeypox challenge. This aligns with the World Health Organization's criteria for mpox vaccines, highlighting the potential of TNX-801 in addressing this public health concern.
In financial developments, Tonix has initiated a share repurchase program, authorizing a buyback of up to $10 million of its outstanding common stock. The company has also 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).
Analysts from Noble Capital have maintained an Outperform rating on Tonix's stock, albeit with a lowered target. These recent developments underscore Tonix Pharmaceuticals' active pursuit of research, development, and financial strategies.
InvestingPro Insights
Tonix Pharmaceuticals' collaboration with X-Chem and the substantial DTRA contract highlight the company's potential in the antiviral drug development space. However, investors should be aware of some critical financial metrics and market performance indicators provided by InvestingPro.
As of the latest data, Tonix has a market capitalization of $20.14 million, reflecting its current market valuation. The company's revenue for the last twelve months as of Q2 2024 stands at $12.46 million, with a gross profit of $2.69 million and a gross profit margin of 21.59%. These figures suggest that while Tonix is generating revenue, it's operating at a loss, as evidenced by its adjusted operating income of -$95.19 million for the same period.
InvestingPro Tips highlight some concerns for potential investors. The company is "quickly burning through cash," which aligns with the negative operating income and the need for external funding like the DTRA contract. Additionally, analysts do not anticipate the company to be profitable this year, which is consistent with the current financial situation.
The stock's performance has been challenging, with InvestingPro data showing a significant price decline of 79.8% over the last three months and 99.2% over the past year. This volatility and downward trend are reflected in the InvestingPro Tip noting that "stock price movements are quite volatile."
For investors interested in a more comprehensive analysis, InvestingPro offers 8 additional tips that could provide deeper insights into Tonix Pharmaceuticals' financial health and market position.
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