Ocugen, Inc. Q3 FY2024 earnings call

• Clinical and regulatory milestones achieved in Q3 2024 include Health Canada approval to initiate the OCU400 Phase 3 liMeliGhT Clinical Trial in Canada and U.S. FDA approval for an Expanded Access Program for OCU400 in treating adult RP patients.
• OCU400's pivotal Phase 3 liMeliGhT Clinical Trial is well underway, with enrollment expected to complete in H1 2025, BLA and MAA filing in H1 2026, and commercialization in 2027.
• OCU410 is advancing in Phase 2 ArMaDa clinical trial for dAMD's GA, with dosing ongoing and plan to complete dosing in early 2025; OCU410ST completed Phase 1 dosing in Phase 1/2 GARDian clinical trial with favorable safety profile, and DSMB approved enrollment for second phase.
• Closed $30 million debt financing from Avenue Capital Group, extending runway into Q1 2026.
• OCU200 Biologic Candidate: FDA cleared investigational drug application for Phase 1 clinical trial, plan to initiate Phase I trial this quarter.

As of September 30, 2024, Ocugen's cash and restricted cash totaled $39 million, compared to $39.5 million as of December 31, 2023. Total operating expenses for the three months ended September 30, 2024 were $14.4 million, including research and development expenses of $8.1 million and general and administrative expenses of $6.3 million. In comparison, total operating expenses for the three months ended September 30, 2023 were $16.1 million, with research and development expenses of $7 million and general and administrative expenses of $9.1 million.

• Debt financing extends runway into Q1 2026.
• Pivotal Phase 3 liMeliGhT Clinical Trial for OCU400 expected to complete enrollment in H1 2025, file BLA and MAA in H1 2026, and commercialize in 2027.
• OCU410 plans to complete dosing in early 2025 in Phase 2 ArMaDa clinical trial.
• OCU200 plans to initiate Phase I clinical trial this quarter.

• Forward-looking statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from current expectations.
• Risks and uncertainties are more fully described in Ocugen's periodic filings with the SEC, including risk factors in Risk Factors section of filings.

Q: At the upcoming clinical showcase, what to look for in GA data and gene agnosticism?

A: Huma Qamar states they will present preliminary safety and efficacy for GA, including efficacy endpoints like geographic atrophy lesion and functional/structural parameters. For gene agnosticism, details will be part of the showcase data.

Q: Regarding European GA opportunity and OCU410ST program, how is it planned?

A: Shankar Musunuri mentions they will start interactions with EU regulators this year, focusing on functional endpoints for GA. For OCU410ST, after Phase 1, they will pause to discuss with FDA about converting Phase 2 into a pivotal trial for orphan disease registration.