Hoth Therapeutics Reaches European Regulatory Milestone For HT-001 Clinical Program Targeting Cancer Patients Undergoing EGFR Inhibitor Therapies

• Positive EU regulatory conclusion achieved
• Oncology-focused clinical program
• Multi-country European trial footprint
• Clear line of sight to site activation and enrollment
• Near-term regulatory and operational catalysts

Positive CTIS Conclusion Positions Company for Near-Term Clinical Trial Initiation in Cancer Patients

NEW YORK, Jan. 15, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ:HOTH), a clinical-stage biopharmaceutical company developing therapies for serious and underserved conditions, today announced it has achieved a major European regulatory milestone for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies.

The Company received a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I. This determination confirms the scientific and regulatory acceptability of the trial design and investigational products. Hoth expects to activate clinical trial sites and initiate the study across multiple European countries.

In parallel, country-specific Part II regulatory decisions in Hungary, Spain, and Poland are expected by January 19, 2026, positioning the program for rapid, multi-national clinical execution.

The HT-001 program is being developed to address EGFRI-induced dermatologic toxicities, a common and often dose-limiting complication experienced by cancer patients undergoing treatment. These side effects can negatively impact quality of life, disrupt treatment schedules, and increase overall healthcare burden.

Hoth expects to activate sites, initiate patient enrollment, and advance the program into active clinical execution, representing a critical step toward validating a potential new supportive-care therapy for oncology patients.