---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-007115"
form_type: "8-K"
ticker: "MTNB"
cik: "0001582554"
company_name: "Matinas BioPharma Holdings, Inc."
filed_at: "2024-02-20T23:59:59+00:00"
generated_at: "2026-06-05T23:05:07.226485+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA agrees on Phase 3 trial design for Matinas' MAT2203 in invasive aspergillosis

## Summary
- FDA agreed on design of single Phase 3 ORALTO trial for MAT2203 in invasive aspergillosis; primary endpoint all-cause mortality at day 42.
- Trial will enroll ~216 adults with limited treatment options; 2:1 randomization to oral MAT2203 vs continued AmBisome + SOC.
- Key secondary endpoint: superiority of MAT2203 over AmBisome for treatment-related toxicities leading to treatment changes.
- Enrollment expected to begin H2 2024, complete in ~24 months at ~65 sites across US, Europe, South America, Middle East, Asia Pacific.
- CEO says FDA alignment provides certainty to advance partnership discussions; product not yet approved.

## SEC filing metadata
- accession: 0001493152-24-007115
- form_type: 8-K
- ticker: MTNB
- cik: 0001582554
- company_name: Matinas BioPharma Holdings, Inc.
- filed_at: 2024-02-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1582554/000149315224007115/0001493152-24-007115-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1582554/000149315224007115/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-007115
- JSON: https://secwatch.observer/filing/0001493152-24-007115.json
- Plain text: https://secwatch.observer/filing/0001493152-24-007115.txt

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