---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-040675"
form_type: "8-K"
ticker: "IRD"
cik: "0001228627"
company_name: "Opus Genetics, Inc."
filed_at: "2025-11-06T23:59:59+00:00"
generated_at: "2026-05-16T23:23:14.069266+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Opus Genetics raises $23M in direct offering and secures FDA guidance for LCA5 gene therapy trial

## Summary
- $23M registered direct offering led by Perceptive Advisors and Balyasny Asset Management; closes Nov 7, 2025.
- Offering: 3.83M shares at $2.09/sh and pre-funded warrants for 7.18M shares at $2.0899.
- FDA RMAT meeting provides guidance on registration strategy; Phase 3 design adaptive, as few as 8 participants.
- Phase 1/2 data: all 6 late-stage participants achieved clinically meaningful vision improvements.
- First participant enrolled in run-in; dosing H2 2026, topline ~1 year later; cash runway into H2 2027.

## SEC filing metadata
- accession: 0001140361-25-040675
- form_type: 8-K
- ticker: IRD
- cik: 0001228627
- company_name: Opus Genetics, Inc.
- filed_at: 2025-11-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1228627/000114036125040675/0001140361-25-040675-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1228627/000114036125040675/ny20058362x4_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-040675
- JSON: https://secwatch.observer/filing/0001140361-25-040675.json
- Plain text: https://secwatch.observer/filing/0001140361-25-040675.txt

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