Earnings summaries and quarterly performance for Opus Genetics.
Research analysts covering Opus Genetics.
Recent press releases and 8-K filings for IRD.
Opus Genetics to Present at J.P. Morgan Healthcare Conference, Provides Pipeline and Financial Updates
IRD
New Projects/Investments
Guidance Update
- Opus Genetics, Inc. management will deliver a corporate presentation at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026.
- The company's OPGx-BEST1 Phase 1/2 trial dosed its first participant in Q4 2025, with initial data expected in Q1 2026 and 3-month results for Cohort 1 in mid-2026.
- For its OPGx-LCA5 program, positive Phase 1/2 safety and efficacy results were observed, and enrollment is ongoing in the run-in period for a planned adaptive Phase 3 trial.
- Opus Genetics reported pro-forma cash and equivalents of ~$54 million as of September 30, 2025, including $23 million raised in November 2025, providing an expected funding runway into H2 2027.
Jan 12, 2026, 2:00 PM
Opus Genetics Highlights 2025 Progress and Upcoming 2026 Catalysts
IRD
Guidance Update
New Projects/Investments
- Opus Genetics reported cash and cash equivalents of $30.8 million as of September 30, 2025, and subsequently raised $23.0 million in gross proceeds, resulting in a total cash position of over $50 million, which is expected to fund operations into the second half of 2027.
- The company anticipates announcing initial clinical data for OPGx-BEST1 in Q1 2026, with 3-month results from Cohort 1 expected in mid-2026.
- For OPGx-LCA5, dosing in the pivotal Phase 3 trial is expected in the second half of 2026.
- A Supplemental New Drug Application (sNDA) was submitted for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia, with an anticipated regulatory decision by the end of 2026.
Jan 8, 2026, 12:10 PM
Opus Genetics Announces Q3 2025 Financial Results and Pipeline Updates
IRD
Earnings
New Projects/Investments
Guidance Update
- Opus Genetics reported a net loss of $17.5 million, or $(0.25) per basic and diluted share, for the third quarter ended September 30, 2025.
- As of September 30, 2025, cash and cash equivalents were $30.8 million. Following the quarter, the company raised an additional $23.0 million in gross proceeds from an equity offering, extending its cash runway into the second half of 2027.
- The company announced positive 3-month pediatric and 18-month adult clinical data from its OPGx-LCA5 Phase 1/2 trial, and a successful FDA RMAT meeting provides potential for an accelerated regulatory pathway.
- The FDA accepted the Investigational New Drug (IND) application for OPGx-BEST1, with recruitment ongoing for its Phase 1/2 trial and initial data expected in the first quarter of 2026. Additionally, a Supplemental New Drug Application (sNDA) submission for Phentolamine Ophthalmic Solution 0.75% is planned by year-end 2025.
Nov 12, 2025, 12:07 PM
Opus Genetics Reports Positive Pediatric Data from OPGx-LCA5 Phase 1/2 Trial
IRD
- Opus Genetics announced positive three-month data from the pediatric cohort of its OPGx-LCA5 Phase 1/2 clinical trial for Leber congenital amaurosis type 5 (LCA5).
- The OPGx-LCA5 therapy was well tolerated in all six participants (three adults and three pediatric), with no ocular serious adverse events or dose-limiting toxicities observed.
- Pediatric participants demonstrated significant improvements in visual function, including a group average of a 0.3 logMAR improvement in visual acuity and greater than one log unit improvement in cone sensitivity.
- Durable improvements in visual acuity were sustained through 18 months in adult participants.
- The company expects to meet with the FDA in Q4 2025 to discuss the trial results and next steps for the LCA5 program.
Sep 30, 2025, 11:24 AM
Quarterly earnings call transcripts for Opus Genetics.
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