---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-045362"
form_type: "8-K"
ticker: "PCSA"
cik: "0001533743"
company_name: "Processa Pharmaceuticals, Inc."
filed_at: "2023-12-19T23:59:59+00:00"
generated_at: "2026-06-07T10:32:17.246263+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Processa Pharma: Phase 1b interim data show NGC-Cap improved safety with 10x higher 5-FU exposure than capecitabine

## Summary
- NGC-Cap doses: 75-225 mg twice daily vs capecitabine's 1600-2500 mg twice daily; 5-FU exposure up to 10x greater.
- Anabolite side effect profile similar to capecitabine; FBAL-related side effects (hand-foot syndrome) almost absent; FBAL exposure ~1% of capecitabine.
- FDA acknowledges NGC-Cap as a New Chemical Entity based on altered metabolism and distribution of 5-FU.
- Fireside chat scheduled Dec 20 at 4:30 PM ET to discuss data and corporate strategy; results require further studies.

## SEC filing metadata
- accession: 0001493152-23-045362
- form_type: 8-K
- ticker: PCSA
- cik: 0001533743
- company_name: Processa Pharmaceuticals, Inc.
- filed_at: 2023-12-19T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1533743/000149315223045362/0001493152-23-045362-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1533743/000149315223045362/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-045362
- JSON: https://secwatch.observer/filing/0001493152-23-045362.json
- Plain text: https://secwatch.observer/filing/0001493152-23-045362.txt

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