Processa Pharmaceuticals Announces FDA Clears Its Investigational New Drug Application For Phase 2 Trial Of VT-7208 In Chronic Spontaneous Urticaria

Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical-stage pharmaceutical company developing VT-7208, a Bruton's tyrosine kinase (BTK) inhibitor therapy for immune-mediated diseases, today announced continued execution following its acquisition of Vidya Therapeutics ("Vidya"). Progress includes U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) application for a Phase 2 study of VT-7208 in chronic spontaneous urticaria (CSU), expansion of the pipeline through a research collaboration with Generian Pharmaceuticals, and the appointment of Sheila Gujrathi, M.D., as Executive Chair of the Board of Directors.

Processa is advancing VT-7208, a next-generation, CNS-penetrant, once-daily oral BTK inhibitor, across three Phase 2 proof-of-concept programs, including CSU, food allergy and relapsing multiple sclerosis. These programs provide multiple opportunities to evaluate VT-7208 across distinct immune-mediated diseases. The acquisition was accompanied by an approximately $200 million private placement from leading institutional healthcare investors. The Company expects its current cash resources to support operations into the second half of 2029.