Processa Pharmaceuticals (PCSA) investor relations material

Transaction overview

• Definitive merger agreement for a stock-for-stock transaction between Processa and Vidya, with Vidya equity holders receiving Processa common and preferred shares.

• $200 million PIPE investment led by prominent healthcare investors to fund the combined company.

• Pro forma cash runway expected to extend into H2 2029, supporting multiple clinical milestones.

• Shareholder vote on the merger anticipated in Q4 2026.

• Sheila Gujrathi joined the Board of Directors, strengthening leadership.

Lead asset and pipeline

• VT-7208 is a once-daily, oral BTK inhibitor targeting immune-mediated diseases, designed for improved efficacy and safety.

• Phase 2 trials planned for food allergy, chronic spontaneous urticaria (CSU), and relapsing multiple sclerosis (RMS), with data readouts expected 2027–2028.

• Parallel development in multiple indications offers near-term validation and long-term upside.

• Large addressable markets: >1.7M CSU, ~14M food allergy, ~1M RMS patients in the U.S.

• BTK inhibition validated in multiple autoimmune and inflammatory diseases.

Scientific rationale and preclinical data

• BTK is a central immune signaling node, modulating both adaptive and innate immune pathways.

• VT-7208 shows potent in vitro and in vivo activity, strong CNS penetration, and a clean metabolic profile.

• Low risk of liver toxicity and favorable safety margins demonstrated in preclinical studies.

• Predictable pharmacokinetics support low, once-daily oral dosing.

• Robust and sustained BTK target engagement observed at ≥5 mg/day.