Processa Pharmaceuticals (PCSA) Investor presentation summary

Strategic focus and approach

• Developing next-generation chemotherapies by improving distribution and metabolism of proven anti-cancer agents to enhance efficacy and reduce side effects.

• Three anti-cancer candidates: two in clinical development and one near clinic-ready, all showing increased tumor concentration and reduced healthy tissue exposure.

• Proprietary Regulatory Science Approach aligns with FDA guidance, aiming to optimize dosage regimens and increase approval likelihood.

• Focus on modifying existing drugs (capecitabine, gemcitabine, irinotecan) to address toxicity and resistance, expanding use to broader patient populations.

• Large oncology market opportunity, with millions of new cancer cases annually and significant unmet needs in chemotherapy.

Pipeline and clinical progress

• NGC-Cap (capecitabine): Completed Phase 1b, IND cleared for Phase 2 in advanced/metastatic breast cancer; shows better tolerability and higher efficacy in refractory patients.

• NGC-Gem (gemcitabine): Oral formulation, Phase 2a completed in pancreatic cancer; improved metabolism and efficacy in resistant patients, with similar side-effect profile.

• NGC-Iri (irinotecan): Preclinical stage, demonstrates higher tumor drug concentration and lower toxicity in animal models, aiming for safer, more effective chemotherapy.

• All candidates have ongoing or planned regulatory interactions and clinical milestones through 2025.

Product profiles and intellectual property

• NGC-Cap: Increases cancer-killing metabolites, reduces side effects, patent protection until 2030–2044.

• NGC-Gem: Overcomes resistance via novel enzyme pathway, potential patent until 2036.

• NGC-Iri: Preferential tumor targeting, fewer side effects, potential patent until 2031.

• Additional partnering opportunities for non-oncology assets (PCS12852 for gastroparesis, PCS499 for rare nephropathies).