Opus Genetics Widens Loss as Gene Therapy Costs Rise

The Tip Desk · November 12, 2026 · 3 min read

Net loss reached $46.5 million, or $0.46 a share, as research and development spending climbed to $14.5 million in the third quarter.

Opus Genetics, Inc. (IRD), a clinical-stage biopharmaceutical company developing gene therapies for inherited retinal diseases, reported a net loss of $46.5 million, or $0.46 a share, for the quarter ended September 30, 2026, compared with a net loss of $17.5 million, or $0.25 a share, a year earlier.

The company said the larger loss was primarily due to a $19.1 million increase in the fair-value change on instruments measured at fair value, an $8.1 million increase in research and development expense, and $2.0 million lower license and collaborations revenue.

License and collaborations revenue totaled $1.1 million, down from $3.1 million in the year-ago quarter. Revenue in both periods came primarily from reimbursement of research and development services under the company’s collaboration with Viatris, Inc.

Research and development expenses were $14.5 million, up from $6.4 million a year earlier. The company said the increase was primarily attributable to higher manufacturing and clinical costs associated with its IRD programs, partially offset by lower clinical costs associated with the phentolamine ophthalmic solution 0.75% programs. Research and development expenses included $0.6 million in stock-based compensation, compared with $0.2 million a year earlier.

General and administrative expenses were $5.9 million, compared with $5.0 million a year earlier, which the company said was primarily attributable to higher employee compensation. Those expenses included $1.0 million in stock-based compensation, versus $0.6 million a year earlier.

Cash and cash equivalents were $89.0 million as of September 30, 2026. With current cash and potential future funding under a note purchase agreement with Oberland Capital Management, the company said its aggregate cash resources will fund operations into 2029.

The pipeline moved on several fronts in the quarter. The FDA approved phentolamine ophthalmic solution 0.75% (RYZUMVI) for presbyopia in adults, the second FDA-approved indication for the product, triggering a regulatory milestone payment from commercial partner Viatris.

For OPGx-BEST1, the company announced positive 3- and 6-month results from the low-dose Cohort 1 of the Phase 1/2 BIRD-1 trial, with a favorable safety profile and no serious adverse events or dose-limiting toxicities. All five participants showed clinically meaningful improvement in visual function, including retinal sensitivity improvement by microperimetry in 75% of evaluable participants, and four of five showed structural improvements. The company said it aligned with the FDA on a potential pivotal endpoint of at least 3 dB microperimetry improvement in at least five prespecified loci, in conjunction with a patient-reported outcome. Enrollment and dosing of 11 participants in the high-dose Cohort 2 was completed, with topline data, including 3-month Cohort 2 results and 6-month results for three Cohort 1 participants with Best vitelliform macular dystrophy, expected in the first quarter of 2027.

The OPGx-LCA5 registrational Phase 3 trial is fully enrolled with eight participants, and initiation of dosing is expected in the fourth quarter of 2026. Phase 1/2 data presented at Retina in Rio 2026 showed sustained improvements in visual acuity and light sensitivity in adults through 24 months and encouraging results in pediatric participants through six months.

The FDA cleared the investigational new drug application for OPGx-RDH12 for RDH12-associated Leber congenital amaurosis, with initiation of dosing in a Phase 1/2 trial expected in the fourth quarter of 2026.

Chief Executive Officer George Magrath said the company expects data from OPGx-BEST1 in the first quarter of 2027, followed by dosing in a potential pivotal Phase 3 trial anticipated to begin in the second half of 2027.

Opus Genetics recently added Andrew Murphy, Ph.D., as chief scientific officer, and Jamie Lynne Hart, M.S., M.P.H., as executive director of executive operations.