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Advancements in Modifier Gene Therapy:
- Ocugen's three modifier gene therapies are advancing through the clinic, with the goal of three biologics license application/market authorization application filings in the next three years.
- The therapies target diseases affecting large patient populations globally, offering potential cures for life by regulating gene networks and creating a healthy environment for retinal cells to survive.
Clinical Trial Progress and Approvals:
- Positive clinical data continues to support the multi-layered gene therapy approach, with dosing completed ahead of schedule in various trials.
- The EMA granted eligibility to submit an OCU400 MAA via a centralized procedure, underscoring the potential of the therapy to address serious unmet medical needs in Europe.
Financial Performance and Cash Runway:
- Research and development expenses increased to
$9.5 million in Q1 2025, compared to
$6.8 million in Q1 2024, reflecting investments in ongoing trials and development efforts.
- Total cash and restricted cash stood at
$38.1 million as of March 31, 2025, providing a cash runway into the first quarter of 2026.
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