Opus Genetics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents totaled $89.0 million as of September 30, 2026, compared to $45.1 million as of December 31, 2025.
• License and collaborations revenue was $1.1 million for the quarter ended September 30, 2026, a decrease from $3.1 million in the same period in 2025.
• Research and development expenses were $14.5 million for the quarter, an increase from $6.4 million in the prior year period.
• General and administrative expenses were $5.9 million for the quarter, an increase from $5.0 million in the prior year period.
• Net loss for the quarter was $46.5 million, or ($0.46) per share, compared to a net loss of $17.5 million, or ($0.25) per share, in the same period in 2025.
• The increase in net loss was driven by a $19.1 million increase in fair value changes in instruments measured at fair value, an $8.1 million increase in R&D expenses, and a $2.0 million decrease in license and collaborations revenue.
• Long-term debt on the balance sheet was $34.5 million as of September 30, 2026, compared to zero as of December 31, 2025.
• Total assets were $95.3 million as of September 30, 2026, compared to $50.2 million as of December 31, 2025.
• Total stockholders' equity was $38.4 million as of September 30, 2026, compared to $15.3 million as of December 31, 2025.

Guidance and Future Outlook:

• The Company expects its cash runway to extend into 2029, supporting multiple clinical inflection points and opportunities for priority review vouchers.
• Topline data for OPGx-BEST1 Cohort 2 is expected in Q1 2027.
• Dosing for a potential pivotal Phase 3 trial for OPGx-BEST1 is anticipated to begin in the second half of 2027.
• Initiation of dosing for the OPGx-LCA5 registrational Phase 3 trial is expected in Q4 2026.
• Initiation of dosing for the OPGx-RDH12 Phase 1/2 trial is planned for Q4 2026.
• Future funding is anticipated under a note purchase agreement with Oberland Capital Management.

Business Segments and Product Lines:

• OPGx-BEST1: Positive 3- and 6-month results were announced for the low-dose Cohort 1 of the BIRD-1 Phase 1/2 trial, showing a favorable safety profile with no serious adverse events or dose-limiting toxicities. All five participants demonstrated clinically meaningful improvement in visual function, with retinal sensitivity improvement in 75% of evaluable participants and structural improvements in four of five. The trial is aligned with the FDA on a potential pivotal endpoint of ≥3 dB microperimetry improvement in ≥5 prespecified loci. Cohort 2 enrollment and dosing are complete with 11 participants.
• OPGx-LCA5: The registrational Phase 3 trial is fully enrolled with 8 participants. 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.
• OPGx-RDH12: Received FDA clearance of the Investigational New Drug (IND) application for RDH12-associated Leber congenital amaurosis.
• Phentolamine Ophthalmic Solution 0.75% (RYZUMVI®): Received FDA approval of the supplemental New Drug Application (sNDA) for the treatment of presbyopia, triggering a regulatory milestone payment from commercial partner Viatris Inc.
• The Company's pipeline includes seven AAV-based programs, with additional candidates targeting MERTK, RHO, CNGB1, and NMNAT1.

Market and Competitive Landscape:

• The Company operates in the clinical-stage biopharmaceutical sector developing gene therapies for inherited retinal diseases (IRDs).
• The approval of RYZUMVI® for presbyopia marks the second FDA-approved indication for the product.

Risks and Challenges:

• Forward-looking statements regarding clinical development, results, regulatory interactions, and cash runway are subject to risks and uncertainties that could cause actual results to differ materially.
• Specific risks include factors described in the Company's most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2026.

Management Commentary and Tone:

• CEO George Magrath, M.D., described the last several months as a period of "tremendous advancement" for the gene therapy programs.
• Management highlighted the alignment with the FDA on potential pivotal endpoints and the over-enrollment of Cohort 2 for OPGx-BEST1.
• Dr. Magrath noted that the FDA approval of RYZUMVI® demonstrates the capabilities of the clinical and regulatory teams.
• The Company recently added Andrew Murphy, Ph.D., as Chief Scientific Officer, and Jamie Lynne Hart, M.S., M.P.H., as Executive Director, Executive Operations.

Other Key Points:

• A regulatory milestone payment was triggered from Viatris Inc. following the FDA approval of RYZUMVI® for presbyopia.
• The Company has a note purchase agreement with Oberland Capital Management that may provide future funding.
• Data presentations were delivered at Euretina Innovation Spotlight, Euretina 2026, and Retina in Rio 2026.
• Stock-based compensation expense for the quarter was $0.6 million for R&D and $1.0 million for G&A, compared to $0.2 million and $0.6 million, respectively, in the prior year period.