U.S . FDA clears IND for Phase 2 study of VT-7208 in chronic spontaneous urticaria; additional Phase 2 studies planned in food allergy and relapsing multiple sclerosis Company expands pipeline through research collaboration of a novel, oral macrocyclic peptide-based neonatal Fc receptor antagonist program from Generian Pharmaceuticals Sheila Gujrathi , M.D., appointed Executive Chair of Processa’s Board of Directors Cash runway expected to fund operations into the second half of 2029 VERO BEACH, FL , Oct. 29, 2026 (GLOBE NEWSWIRE) -- 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. “Since the Vidya transaction, we have made great progress in executing our strategy,” said Dr. Gujrathi . “The FDA clearance of the CSU IND is an exciting step toward advancing VT-7208 across three planned Phase 2 programs. At the same time, the Generian collaboration expands our pipeline around another high-value, clinically validated immune target. With funding in place to support these programs, our focus is on disciplined execution and generating the data needed to demonstrate the potential of the portfolio.” “Sheila has been an invaluable partner to the Board since the Vidya transaction, and her experience building biotechnology companies, advancing clinical programs and creating long-term value makes her well suited to lead the Board through this next phase,” said Justin Yorke , former Chair of the Processa Board of Directors. “We are pleased to have her step into the Executive Chair role as Processa advances its clinical strategy and broader pipeline.” FDA Clears IND for Phase 2 Study of VT-7208 in CSU The FDA has cleared the IND application for VT-7208 in CSU, enabling Processa to advance the program into a Phase 2 study in adults with moderate-to-severe disease. The planned multicenter, randomized, double-blind, placebo-controlled study is expected to enroll approximately 120 adults whose disease is not adequately controlled with H1 antihistamines. The study will evaluate VT-7208 versus placebo over 12 weeks and assess efficacy, safety, tolerability and pharmacologic activity. CSU is a chronic inflammatory disease characterized by recurrent hives, swelling or both without an identifiable external trigger and affects an estimated 1.6 to 2 million U.S . adults. Despite available therapies, a meaningful proportion of patients remain inadequately controlled, underscoring the need for additional treatment options. Pipeline Expansion Through Research Collaboration Processa also announced that it has entered into a research collaboration and exclusive option agreement with Generian Pharmaceuticals , a UPMC Enterprises portfolio company that emerged from the UPMC / University of Pittsburgh ecosystem for breakthrough science, to advance a novel oral macrocyclic peptide-based neonatal Fc receptor (FcRn) antagonist program, further expanding Processa’s immunology pipeline. The collaboration targets a clinically validated mechanism for treating IgG-mediated autoimmune diseases and supports the companies’ shared strategy of developing differentiated oral therapeutic alternatives to currently available injectable FcRn therapies. The program complements VT-7208 and reflects Processa’s broader strategy to selectively expand its pipeline around clinically validated immune targets, using capital-efficient structures that provide access to novel programs while preserving flexibility as the science matures. Sheila Gujrathi Appointed Executive Chair Dr. Gujrathi has been appointed Executive Chair of the Processa Board of Directors. She has served on the Board since Processa’s acquisition of Vidya in June 2026 , where she was founder and its executive chair. In this expanded role, she will support the management team on corporate strategy, capital allocation and organizational develo