secwatch.observer — SEC 8-K summary
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Issuer:     Processa Pharmaceuticals, Inc. (PCSA)
CIK:        0001533743
Form:       8-K
Filed at:   2024-08-28T23:59:59+00:00
Accession:  0001493152-24-034115
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Processa provides pipeline update, Q2 net loss $3.0M; Phase 2 NGC-Cap trial underway
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- FDA cleared IND for NGC-Cap Phase 2 in July 2024; multicenter trial in metastatic breast cancer initiated, initial data expected mid-2025.
- Net loss for Q2 2024 was $3.0M ($1.01 per share) vs $2.6M ($1.94 per share) in Q2 2023; per-share reflects 1-for-20 reverse split.
- Cash and cash equivalents $5.6M as of June 30, 2024; R&D expenses unchanged at $1.7M, G&A increased to $1.4M.
- Preclinical NGC-Iri study shows greater SN-38 accumulation in tumor vs non-cancer tissues compared to irinotecan and Onivyde.
- NGC-Cap Phase 1b data: 66.7% of patients had partial response or stable disease; progression-free survival 5-11 months.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1533743/000149315224034115/0001493152-24-034115-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1533743/000149315224034115/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-034115

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer