Ocugen, Inc. Q1 FY2025 earnings call

• Progress on modifier gene therapy platform with three gene therapies advancing in clinic, aiming for three BLA/MAA filings in next three years. - OCU400: Two-year safety and efficacy data from Phase 1/2 trial supports gene agnostic mechanism, Phase 3 trial to enroll 150 participants, open to all eligible RP patients. - OCU410ST: Aligned with FDA for Phase 2/3 pivotal trial, dosing complete in Phase 2 portion of ArMaDa trial for GA, interim results expected fall 2025. - OCU200: First patient dosed in Phase 1 trial for diabetic macular edema, planning to complete Phase 1 in second half of 2025. - OCU500: Investigational new drug application in effect, NIAID to initiate Phase 1 trial in Q2 2025.

Research and development expenses for the quarter ended March 31, 2025 were $9.5 million compared to $6.8 million for the first quarter of 2024. General and administrative expenses for the quarter ended March 31, 2025 were $6.5 million compared to $6.4 million during the same period in 2024. Net loss was approximately $15.3 million or $0.05 net loss per share for the quarter ended March 31, 2025, compared to a net loss of approximately $11.9 million or $0.05 net loss per share for the first quarter of 2024. Cash and restricted cash totaled $38.1 million as of March 31, 2025, compared to $58.8 million as of December 31, 2024.

• Aim to file three BLA/MAA in next three years. - OCU400 Phase 3 trial on track, process validations to complete this year for BLA submission. - OCU410ST Phase 2/3 pivotal trial to start in 2026, BLA submission in 2028. - OCU200 Phase 1 trial to complete in second half of 2025, provide clinical update then. - OCU500 Phase 1 trial to initiate in Q2 2025.

Forward-looking statements subject to risks and uncertainties, detailed in SEC filings including risk factors in quarterly and annual reports.

Q: Regarding liMeliGhT study enrollment and filing targets, A: Huma Qamar said on track for first half 2025 enrollment, BLA submission a year from now.

Q: On manufacturing capabilities for OCU400, A: Shankar Musunuri and Arun Upadhyay discussed process validations this year, plan to bring manufacturing in house.

Q: Timeline for OCU200 program update, A: Shankar Musunuri said Phase 1 to complete late 2025, provide data then.

Q: Europe regulation for OCU400, A: Shankar Musunuri and Arun Upadhyay discussed EMA eligibility for OCU400 MAA submission, in negotiations with EMA.

Q: Influenza trial with NIAID, A: Arun Upadhyay said on track, no impact from agency changes, Phase 1 to initiate in Q2 2025.

Q: liMeliGhT study interim look and randomization, A: Huma Qamar said no interim look, randomization 2:1; Shankar Musunuri clarified OCU410 Phase 2 has 1:1:1 randomization.

Q: OCU400 for RP filing in Europe, A: Huma Qamar said US data sufficient for EU approval, no additional trials needed.