secwatch.observer — SEC 8-K summary
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Issuer:     Calidi Biotherapeutics, Inc. (CLDI)
CIK:        0001855485
Form:       8-K
Filed at:   2024-09-30T23:59:59+00:00
Accession:  0001493152-24-038718
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA clears IND for Calidi's CLD-101 Phase 1b/2 trial in high-grade glioma
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- FDA cleared Northwestern University's IND for CLD-101, a stem cell-based oncolytic virus therapy for high-grade glioma.
- Phase 1b/2 trial will evaluate safety/feasibility of multiple doses in newly diagnosed patients; expected to start Q1 2025.
- Prior Phase 1 trial showed median overall survival 18.4 months and no dose-limiting toxicity (Lancet Oncology 2021).
- Additional Phase 1 trial in recurrent high-grade glioma at City of Hope with interim data expected H1 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1855485/000149315224038718/0001493152-24-038718-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1855485/000149315224038718/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-038718

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