---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-455436"
form_type: "8-K"
ticker: "MGX"
cik: "0001785279"
company_name: "Metagenomi Therapeutics, Inc."
filed_at: "2026-11-10T21:07:15+00:00"
generated_at: "2026-11-10T21:09:23.912873+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.78
calibrated_materiality_score: 0.78
confidence: "high"
source: SEC EDGAR
---

# Metagenomi wins FDA IND clearance for MGX-001 in hemophilia A; Q3 cash $101.7M runway into 2028

## Summary
- FDA cleared the IND for MGX-001; the INTEGR8 Phase 1/2 trial in adults with moderately severe to severe hemophilia A is planned to start in 1H 2027.
- Initial safety, tolerability and Factor VIII activity data are expected in 2H 2027; additional preclinical data will be presented at ASH on Dec. 14, 2026 (Abstract 952).
- Cash, cash equivalents and available-for-sale marketable securities were $101.7 million as of Sept. 30, 2026, with runway expected into 2028.
- Q3 R&D expense was $17.5 million vs. $25.3 million a year earlier; G&A was $6.9 million, including a $1.2 million one-time net litigation settlement, vs. $6.2 million.

## SEC filing metadata
- accession: 0001193125-26-455436
- form_type: 8-K
- ticker: MGX
- cik: 0001785279
- company_name: Metagenomi Therapeutics, Inc.
- filed_at: 2026-11-10T21:07:15+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.78
- calibrated_materiality_score: 0.78
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1785279/000119312526455436/0001193125-26-455436-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1785279/000119312526455436/mgx-20261110.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-455436
- JSON: https://secwatch.observer/filing/0001193125-26-455436.json
- Plain text: https://secwatch.observer/filing/0001193125-26-455436.txt

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