IRD

#3307
Opus Genetics, Inc. - Common Stock
3.6 9 USD
-0.04%
Market Price
Sektor: Gesundheitswesen
Basis: USD
Gewinnwährung: USD
Tagesspanne
3.69
3.69
Jahresspanne
2.82
5.81
Tagesänderung
-4.16%
Monatliche Änderung
-4.16%
6 month change
-9.56%
Jahresänderung
-0.81%
Vorheriger Schlusskurs
3.8 5
Open
3.6 9
Tief
3.6 9
Hoch
3.6 9
Volumen
59
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Financials

Übersicht Finanzbericht Statistik Documents

2026

Current report, Q3 FY2026
Opus Genetics, Inc. current report, Q3 FY2026
8-K
Quarterly report, Q2 FY2026
Opus Genetics, Inc. quarterly report, Q2 FY2026
10-Q
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Quarterly report, Q1 FY2026
Opus Genetics, Inc. quarterly report, Q1 FY2026
10-Q

Opus Genetics, Inc. current report, Q4 FY2025

Full document

Business Context and Reporting Period

Opus Genetics, Inc. (Nasdaq: IRD) filed a Form 8-K on November 6, 2025, reporting two significant corporate events: a registered direct offering and a regulatory milestone for its lead gene therapy candidate.

Key Financial Metrics

  • Capital Raise: Announced a $23 million registered direct offering.
  • Liquidity Outlook: Management expects cash resources, including proceeds from the offering, to fund operations into the second half of 2027.
  • Revenue and Profit: The filing does not provide specific revenue, profit, or cash flow figures for the current period.
  • Debt: No specific debt figures are disclosed in this filing.

Material Changes and Operational Updates

  • Regulatory Milestone: Successfully completed a Type B Regenerative Medicine Advanced Therapy (RMAT) meeting with the FDA regarding OPGx-LCA5, a gene therapy for Leber congenital amaurosis (LCA) caused by LCA5 mutations.
  • Clinical Progress: Six late-stage participants in the Phase 1/2 trial have been treated, all showing clinically meaningful vision improvements.
  • Phase 3 Design: The FDA provided feedback supporting a single-arm, 12-month Phase 3 study with an adaptive design, potentially enrolling as few as eight participants.
  • Rare Disease Pathway: The company plans to submit an application under the FDA's Rare Disease Evidence Principles (RDEP) review process, citing a patient population of fewer than 1,000 individuals.

Guidance, Outlook, and Risks

  • Timeline: Dosing for the Phase 3 trial is anticipated in the second half of 2026, with topline data expected approximately one year later.
  • Study Methodology: The Phase 3 trial will include a run-in period to evaluate natural history, serving as a control. Efficacy will be measured via visual acuity, full-field stimulus testing, microperimetry, and the Multi-Luminance Orientation and Mobility Test (MLoMT).
  • Risks: Forward-looking statements are subject to risks regarding the consummation of the offering, market conditions, and the satisfaction of closing conditions. Actual results may differ materially from expectations.

Investor Verification Checklist

  • Confirm the final closing terms and actual proceeds of the $23 million registered direct offering.
  • Verify the specific FDA feedback received during the Type B RMAT meeting regarding Chemistry, Manufacturing, and Controls (CMC).
  • Monitor the enrollment progress for the Phase 3 run-in period and the timeline for validated clinical drug supply.
  • Review the company's eligibility confirmation for the Rare Disease Evidence Principles (RDEP) process.
  • Assess the impact of the offering on share dilution and the updated cash runway into late 2027.