secwatch.observer — SEC 8-K summary
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Issuer:     Genprex, Inc. (GNPX)
CIK:        0001595248
Form:       8-K
Filed at:   2025-01-23T23:59:59+00:00
Accession:  0001437749-25-001630
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Genprex doses first patient in Phase 2 expansion of Acclaim-3 trial for Reqorsa + Tecentriq in ES-SCLC
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- Phase 2 expansion will enroll ~50 patients at 10-15 U.S. sites; primary endpoint is 18-week progression-free survival rate.
- Recommended Phase 2 dose of Reqorsa set at 0.12 mg/kg (highest Phase 1 dose), no dose-limiting toxicities observed.
- Interim analysis planned after first 25 patients reach 18 weeks of follow-up; enrollment of initial 25 expected in H2 2025.
- Acclaim-3 holds FDA Fast Track and Orphan Drug Designations for this extensive-stage small cell lung cancer indication.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1595248/000143774925001630/0001437749-25-001630-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1595248/000143774925001630/gnpx20241220_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-001630

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