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NEW YORK - Hoth Therapeutics, Inc. (NASDAQ:HOTH), a micro-cap biotech company with a market capitalization of $17.3 million, announced Tuesday it has engaged ICON Clinical Research Limited to expand its Phase II clinical trial for HT-001 into European Union countries. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet.
The biopharmaceutical company is seeking additional regulatory approval for the trial from potentially three EU countries in the coming months, according to a company press release. The trial is currently enrolling patients at multiple sites in the United States. The company’s stock has shown remarkable momentum, with a year-to-date return of over 75%, though analysts note the company is not expected to be profitable this year.
HT-001 is being developed to treat skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients. The Phase 2a study aims to investigate the efficacy, safety, and tolerability of topical HT-001 for this condition.
Robb Knie, CEO of Hoth Therapeutics, said the expansion serves two purposes: completing enrollment of the Phase II trial and establishing groundwork for a potential global Phase III trial.
The company indicated that ICON was selected based on its previous clinical trial management experience and interest in novel therapies.
Hoth Therapeutics describes itself as a clinical-stage biopharmaceutical company focused on developing treatments to improve patient quality of life. The company is currently in early-stage pharmaceutical research and development.
The expansion into European clinical sites represents part of the company’s international clinical development strategy for HT-001, as stated in the press release. With analyst price targets of $5.00, significantly above the current trading price of $1.31, investors following this development can access detailed valuation metrics through InvestingPro.
In other recent news, Hoth Therapeutics, Inc. has announced a Cooperative Research and Development Agreement with the U.S. Department of Veterans Affairs and the Foundation for Atlanta Veterans Education and Research. This collaboration aims to evaluate GDNF as a potential therapy for obesity and fatty liver disease, with studies to be conducted at the Atlanta VA Medical Center. Additionally, Hoth Therapeutics has formed a 50/50 joint venture with Silo Pharma, Inc. to further develop an obesity treatment technology licensed from the U.S. Department of Veterans Affairs. This therapeutic platform, based on GDNF, targets conditions such as non-alcoholic fatty liver disease, type 2 diabetes, and central obesity. In another development, Hoth Therapeutics reported positive results from its Phase 2a clinical trial for HT-001, a treatment for skin toxicities caused by cancer drugs. The trial results showed that HT-001 met at least one primary efficacy endpoint in 100% of the patients, indicating significant clinical dermatologic improvement. Over 65% of patients experienced reductions in pain and itching, and none required dose reduction or discontinuation of their cancer treatment.
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