Ocugen — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the three months ended September 30, 2026, was $1.951 million, an increase from $1.752 million in the same period in 2025.
• Total revenue for the nine months ended September 30, 2026, was $4.973 million, compared to $4.606 million in the same period in 2025.
• Total operating expenses for the three months ended September 30, 2026, were $19.704 million, up from $19.377 million in the prior year period; this included R&D expenses of $12.5 million (vs. $11.1 million) and G&A expenses of $7.2 million (vs. $8.2 million).
• Total operating expenses for the nine months ended September 30, 2026, were $57.008 million, up from $50.527 million in the prior year period.
• Net loss for the three months ended September 30, 2026, was $3.598 million, or $(0.01) per share, compared to a net loss of $20.051 million, or $(0.07) per share, in the prior year period.
• Net loss for the nine months ended September 30, 2026, was $47.653 million, or $(0.14) per share, compared to a net loss of $50.140 million, or $(0.17) per share, in the prior year period.
• Cash, cash equivalents, restricted cash, and short-term investments totaled $84.6 million as of September 30, 2026, providing an expected runway into 2028.
• As of September 30, 2026, the company held $24.632 million in cash and cash equivalents and $59.625 million in short-term investments.
• Total liabilities increased to $125.742 million as of September 30, 2026, from $55.682 million as of December 31, 2025, driven by the addition of $83.117 million in convertible notes and a $17.146 million derivative liability.
• Stockholders' equity (deficit) was $(17.681) million as of September 30, 2026, compared to $(12.166) million as of December 31, 2025.
• There were 339.3 million shares of common stock outstanding as of September 30, 2026.

Guidance and Future Outlook:

• OCU400 is expected to be the first Phase 3 study to read out in the first quarter of 2027.
• Top-line data from the 140-patient Phase 3 liMeliGhT trial for OCU400 are expected in the first quarter of 2027, followed by a planned Biologics License Application (BLA) submission.
• Topline data from the Phase 2/3 pivotal confirmatory trial for OCU410ST (Stargardt disease) are anticipated in the second quarter of 2027, with a planned BLA submission to follow.
• The company aims to achieve full LARTA approval in The Bahamas and potential patient enrollment for OCU400 as early as year-end 2026.
• The company expects to maintain a disciplined approach while advancing toward anticipated regulatory submissions and broader patient access opportunities.

Business Segments and Product Lines:

• OCU400 (Retinitis Pigmentosa): Received Provisional Approval and Priority Designation from the Longevity and Regenerative Therapies (LARTA) Board of The Bahamas; executed an agreement with local partner Global Alliance for Regenerative Medicine (GARM) to manage patient care; site readiness is progressing; completed Process Performance Qualification (PPQ) batches to support the BLA and commercial launch supply.
• OCU400 Licensing: Executed an exclusive OCU400 license agreement for the Middle East and North Africa (MENA) with Roots Pharmaceutical, eligible for up to $4 million in combined upfront and initial development milestone payments, up to $255 million in potential sales milestones, and a 22% royalty on net sales; this follows a prior agreement with Kwangdong Pharmaceutical in South Korea.
• OCU410ST (Stargardt disease): Advancing toward a Phase 2/3 pivotal confirmatory trial (N=63 subjects) with data anticipated in Q2 2027.
• OCU410 (Geographic Atrophy): Initiated dosing in the ArMaDa3 Phase 3 trial, a 240-subject global study randomizing patients 2:1 to a single subretinal injection of OCU410 or untreated control across the U.S., Canada, and Europe; presented 12-month Phase 2 ArMaDa2 results at three scientific conferences, including two podium presentations at AAO 2026.
• Corporate: Named Jolanda Crombach General Manager of the newly established European affiliate in Amsterdam to support OCU410 Phase 3 development, upcoming marketing authorization submissions, and potential commercialization in Europe.

Other Key Points:

• The company is executing a strategy of advancing three late-stage modifier gene therapy programs and leveraging strategic partnerships to expand global reach.
• The OCU400 license with Roots Pharmaceutical includes a manufacturing obligation for Ocugen to supply commercial product.
• The company reported a $16.562 million gain from the change in fair value of derivative liability for the three months ended September 30, 2026.
• The company reported an $8.886 million interest expense for the nine months ended September 30, 2026, compared to $3.856 million in the prior year period.
• A $2.383 million loss on extinguishment of debt was recorded for the nine months ended September 30, 2026.