---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-114833"
form_type: "8-K"
ticker: "PHGE"
cik: "0001739174"
company_name: "BiomX Inc."
filed_at: "2025-11-25T23:59:59+00:00"
generated_at: "2026-05-16T16:58:59.193272+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# BiomX reports FDA clinical hold continues; DMC recommends adjusted dosing for Phase 2b CF study

## Summary
- FDA continues evaluation of third-party nebulizer used in BX004 Phase 2b cystic fibrosis study; clinical hold remains.
- Independent Data Monitoring Committee recommends adjusted dosing regimen; company updating trial protocol accordingly.
- Topline results now expected in Q2 2026, pending availability of financial resources and other factors.
- Company working with third-party manufacturer to address FDA follow-up requests; expects to lift hold.

## SEC filing metadata
- accession: 0001213900-25-114833
- form_type: 8-K
- ticker: PHGE
- cik: 0001739174
- company_name: BiomX Inc.
- filed_at: 2025-11-25T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1739174/000121390025114833/0001213900-25-114833-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1739174/000121390025114833/ea0267116-8k_biomx.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-114833
- JSON: https://secwatch.observer/filing/0001213900-25-114833.json
- Plain text: https://secwatch.observer/filing/0001213900-25-114833.txt

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