CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a clinical-stage biopharmaceutical company, has presented new preclinical data on its mpox vaccine candidate, TNX-801, at the World Vaccine Congress-Europe. The data, unveiled in Barcelona, Spain, from October 28-31, 2024, suggest that TNX-801 is well-tolerated in immunocompromised animals and does not spread to blood or tissues, even at high doses.
TNX-801 is a live attenuated vaccine based on synthesized horsepox, designed to provide single-dose immune protection against monkeypox. The vaccine candidate aligns with the World Health Organization’s (WHO) preferred target product profile for mpox vaccines, which includes criteria such as single-dose administration, durable protection, and stability at ambient temperatures.
During the recent outbreak of clade I mpox, a public health emergency of international concern has been declared by the WHO. Cases have been reported in various countries, including Sweden, Thailand, Singapore, India, Germany, and England. Tonix's vaccine candidate has shown efficacy in protecting animals from lethal challenges with clade I monkeypox.
Tonix CEO Seth Lederman, M.D., highlighted the vaccine's strong tolerability and efficacy profiles, noting its potential to prevent mpox and control future epidemics. The company also mentioned a collaboration with Bilthoven Biologics to develop manufacturing processes for TNX-801.
The company’s broader portfolio includes TNX-1800, a candidate for protecting against COVID-19, and other therapeutics for pain management, CNS disorders, and public health challenges. Tonix's development pipeline focuses on addressing unmet medical needs, with various candidates in different stages of development.
The presented data are based on a press release statement from Tonix Pharmaceuticals Holding Corp. and reflect the company's ongoing efforts to combat infectious diseases through innovative vaccine development.
In other recent news, Tonix Pharmaceuticals has made significant strides in various areas. The biopharmaceutical company has 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. This funding will accelerate Tonix's antiviral program, which focuses on reducing viral load to prompt an adaptive immune response.
The company has also 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 in reducing widespread pain associated with the condition.
Tonix has been granted patents extending market exclusivity for its migraine treatments, Zembrace® SymTouch® and Tosymra®, until 2036 and 2030, respectively. Additionally, Tonix has initiated a share repurchase program, authorizing a buyback of up to $10 million of its outstanding common stock and expanded its maximum aggregate offering price under an existing Sales Agreement with A.G.P./Alliance Global Partners (NYSE:GLP).
Noble Capital analysts have maintained an Outperform rating on Tonix's stock. These developments are part of 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
While Tonix Pharmaceuticals (NASDAQ: TNXP) is making strides in vaccine development, particularly with its mpox vaccine candidate TNX-801, the company's financial health presents a complex picture. According to InvestingPro data, Tonix's market capitalization stands at a modest $25.95 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. However, the operating income was negative at -$95.19 million, indicating significant ongoing research and development expenses, which is common for clinical-stage biopharmaceutical companies.
InvestingPro Tips highlight that Tonix is "quickly burning through cash" and "not profitable over the last twelve months." This aligns with the company's focus on developing its pipeline, including TNX-801 and other candidates, which requires substantial investment before potential commercialization.
The stock's performance has been challenging, with InvestingPro data showing a -71.54% price return over the past three months. This volatility is not uncommon in the biotech sector, especially for companies awaiting key clinical or regulatory milestones.
For investors interested in a deeper analysis, InvestingPro offers 11 additional tips for Tonix Pharmaceuticals, providing a more comprehensive view of the company's financial situation and market position.
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