secwatch.observer — SEC 8-K summary
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Issuer:     Telomir Pharmaceuticals, Inc. (TELO)
CIK:        0001971532
Form:       8-K
Filed at:   2026-04-30T23:59:59+00:00
Accession:  0001493152-26-019773
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA clears IND for Telomir-Zn in advanced triple-negative breast cancer; Phase 1/2 trial planned for 1H 2026
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- FDA cleared IND for lead candidate Telomir-Zn in advanced/metastatic triple-negative breast cancer.
- Phase 1/2 trial to enroll ~76 patients; Phase 1 dose-escalation, Phase 2 primary endpoint ORR.
- Planned initiation in first half of 2026 at a leading US academic medical center.
- Preclinical data included pharmacology, toxicology, PK, and biomarker analyses.
- Translational biomarker program to assess epigenetic modulation and telomere dynamics.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1971532/000149315226019773/0001493152-26-019773-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1971532/000149315226019773/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-019773

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