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Ocugen (OCGN) investor relations material
Ocugen H.C. Wainwright – Biotech "On Tap" 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Strategic pipeline and clinical development
Three gene therapy BLAs are planned within three years, starting in 2026, targeting retinitis pigmentosa, Stargardt disease, and geographic atrophy.
OCU400, the lead candidate for retinitis pigmentosa, is in phase 3 with a broad indication covering most mutations and aims for BLA submission in 2026.
OCU410ST for Stargardt disease and OCU410 for geographic atrophy are advancing, with adaptive trial designs and promising early data.
EMA has agreed to accept US clinical data for European submission, expediting potential market access.
The company’s modifier gene therapy platform targets cellular homeostasis, offering broad applicability across genetic mutations.
Clinical data and endpoints
OCU400 phase 3 trial uses a sensitive luminance-dependent navigation assessment as the primary endpoint, with secondary endpoints including low luminance visual acuity.
Prior trials show 24-month durability, safety, and statistically significant efficacy with no serious adverse events.
OCU410ST for Stargardt disease demonstrated a 48% lesion size reduction at 12 months in early to advanced cases, with a single subretinal injection.
OCU410 for geographic atrophy showed a 27% lesion reduction at six months, outperforming existing therapies in early data.
Both structural and functional endpoints are being pursued for regulatory approval.
Financial strategy and balance sheet
Divestment of the neocart asset through a reverse merger valued at $150 million allows focus on gene therapies and provides a significant balance sheet asset.
The company maintains a quarterly burn rate of $12 million, with a current cash runway of $50 million, recently extended by a $20 million investment and a potential $30 million option.
Runway is projected to extend into 2027, supporting ongoing clinical programs.
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