---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-003705"
form_type: "8-K"
ticker: "PCSA"
cik: "0001533743"
company_name: "Processa Pharmaceuticals, Inc."
filed_at: "2024-01-25T23:59:59+00:00"
generated_at: "2026-06-06T18:18:17.924599+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Processa completes Phase 1b of NGC-Cap; recommends two Phase 2 doses for advanced breast cancer

## Summary
- Phase 1b trial in 18 advanced GI cancer patients achieved 2-10x greater 5-FU exposure than FDA-approved capecitabine.
- Hand-foot-syndrome incidence only 6% (1 of 16) vs >50% for capecitabine; severe HFS 0% vs >10%.
- Myelosuppression at lower 150 mg BID dose: 33% overall, 0% severe vs 80% and 3% for capecitabine.
- Of 5 evaluable patients at highest doses, 80% had positive response (1 partial response, 3 stable disease).
- Phase 2 will target advanced/metastatic breast cancer using two selected dosing regimens.

## SEC filing metadata
- accession: 0001493152-24-003705
- form_type: 8-K
- ticker: PCSA
- cik: 0001533743
- company_name: Processa Pharmaceuticals, Inc.
- filed_at: 2024-01-25T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1533743/000149315224003705/0001493152-24-003705-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1533743/000149315224003705/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-003705
- JSON: https://secwatch.observer/filing/0001493152-24-003705.json
- Plain text: https://secwatch.observer/filing/0001493152-24-003705.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.