Processa Pharmaceuticals (PCSA) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Strategic approach and industry context

• Focuses on improving existing chemotherapies by reducing toxicity and enhancing efficacy, rather than developing entirely new drugs.

• Utilizes a proprietary regulatory science approach, emphasizing early and frequent FDA communication, combined with Project Optimus guidelines for oncology.

• Oncology remains a major unmet need, with chemotherapy still foundational and projected to grow despite the rise of newer therapies.

• Team has over 30 regulatory approvals and significant experience in drug development and commercialization.

• Strategy is positioned as de-risked compared to high-failure-rate novel science programs.

Pipeline highlights and clinical progress

• Three anti-cancer drugs in development: two in phase II (NGC-Capecitabine and NGC-Gemcitabine), one preclinical (NGC-Irinotecan).

• NGC-Capecitabine phase II study underway, targeting advanced GI cancers, with interim data expected mid-next year.

• NGC-Gemcitabine completed phase II-A; meeting with FDA to finalize phase II-B trial design.

• NGC-Irinotecan in preclinical stage, showing promising tumor-targeting and reduced toxicity; IND-enabling studies ongoing.

• Patent protection for pipeline assets extends to at least 2044.

Key clinical data and differentiation

• NGC-Capecitabine shows 5x-10x higher tumor exposure to 5-FU and significantly reduced hand-foot syndrome incidence (6% vs. expected 50%).

• NGC-Gemcitabine overcomes resistance by targeting an alternative pathway, with 31% of late-stage patients achieving progression-free survival of 8+ weeks.

• NGC-Irinotecan achieves 200x higher tumor-to-muscle drug ratio and maintains efficacy at lower doses, potentially reducing BlackBox warning risks.

• All programs demonstrate improved tolerability and efficacy in early studies, supporting further development.

• Oral formulations and combination potential with other oral chemotherapies enhance patient convenience.