Processa Pharmaceuticals (PCSA) Investor presentation summary

Strategic focus and approach

• Focuses on improving distribution and metabolism of proven anti-cancer agents to enhance efficacy and reduce side effects.

• Targets heavily used approved drugs where toxicity limits benefit, aiming to improve their therapeutic index.

• Employs a proprietary Regulatory Science Approach aligned with FDA's Project Optimus to optimize dosage regimens.

• Experienced team with a track record of over 30 FDA approvals using this approach.

Pipeline and clinical development

• Three anti-cancer NCEs: NGC-Cap (capecitabine), NGC-Gem (gemcitabine), and NGC-Iri (irinotecan), with two in clinical development and one near clinic-ready.

• NGC-Cap Phase 2 trial in advanced/metastatic breast cancer ongoing, with interim analysis expected 2H2025.

• NGC-Gem completed Phase 2a in pancreatic cancer; planning further FDA discussions for next trial phase.

• NGC-Iri in preclinical stage, showing promising tumor targeting and reduced side effects in animal models.

Clinical results and product profiles

• NGC-Cap demonstrated 5-10x greater exposure to active metabolite, better tolerability, and preliminary efficacy in refractory patients.

• NGC-Gem showed responses in patients resistant to standard gemcitabine, with improved metabolism and safety profile.

• NGC-Iri accumulates preferentially in tumors, maintains efficacy at lower doses, and animal data suggest fewer side effects compared to irinotecan.