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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.
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H.C. Wainwright – Biotech "On Tap" 2025 summary25 Sep, 2025

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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Frequently asked questions

Ocugen, Inc., a clinical-stage biopharmaceutical company, focuses on the development of gene therapies to cure blindness diseases. The company's lead product candidate is OCUL-001, an adeno-associated virus vector-based gene therapy for the treatment of wet age-related macular degeneration. The company is also engaged in the discovery, design, development and clinical trial advancement of additional AAV and complementary non-AAV gene therapies for retinal diseases, including EIPAO-203 and EPAC1. The company is headquartered in Malvern, Pennsylvania.

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