Opus Genetics (IRD) Q4 2025 earnings summary

Executive summary

• Achieved positive early safety and efficacy data in BEST1 gene therapy program, with further data expected mid-2026.

• FDA PDUFA date set for October 2026 for Phentolamine Ophthalmic Solution 0.75% in presbyopia.

• Secured new funding, extending cash runway into 2028.

• Multiple clinical and preclinical programs advancing, including LCA5 and MERTK gene therapies.

Financial highlights

• Cash and cash equivalents of $45.1 million as of December 31, 2025; $25 million raised post-year-end, totaling $70.1 million in available cash.

• License and collaborations revenue was $14.2 million for 2025, up from $11.0 million in 2024, driven by Viatris collaboration.

• R&D expenses increased to $30.8 million from $26.9 million year-over-year, mainly due to higher clinical and professional costs.

• G&A expenses rose to $22.0 million from $18.2 million, reflecting higher legal, payroll, and public company costs.

• Net loss narrowed to $49.6 million ($0.80/share) from $57.5 million ($2.15/share) in 2024, primarily due to the absence of a $28 million acquired IPR&D charge.

Outlook and guidance

• Cash resources expected to fund operations into the first half of 2028, excluding potential warrant or milestone proceeds.

• Three-month results from full Cohort 1 of BEST1 trial expected mid-2026; LCA5 pivotal trial dosing planned for H2 2026.

• Topline results from LYNX-3 Phase 3 trial in keratorefractive patients expected in H1 2026.