Ocugen, Inc. reported a net loss of $54.05 million for the year ended December 31, 2024, a $9.02 million improvement compared to the $63.08 million net loss in 2023. Total revenue decreased from $6.04 million in 2023 to $4.06 million in 2024, primarily due to a decrease in collaborative arrangement revenue, which fell by $1.98 million. Operating expenses also decreased by $12.76 million, primarily driven by reductions in research and development and general and administrative expenses.

Significant changes compared to the previous fiscal year include the termination of the COVAXIN program, resulting in a $8.8 million decrease in research and development expenses. This decrease was partially offset by increased preclinical activities and GMP manufacturing for OCU500, leading to a $1.8 million increase in spending in this area. General and administrative expenses decreased by $5.3 million, mainly due to lower professional service fees and reduced headcount. The company's cash balance stood at $58.5 million as of December 31, 2024.

Strategic developments during the year included the initiation of a Phase 1 clinical trial for OCU500, a COVID-19 vaccine, with the National Institute of Allergy and Infectious Diseases (NIAID) intending to commence the trial in the second quarter of 2025. The company also announced positive two-year safety and efficacy data for OCU400, its lead product candidate for retinitis pigmentosa, and received positive opinions from the European Medicines Agency (EMA) for OCU400, OCU410, and OCU410ST Advanced Therapy Medicinal Product (ATMP) classification. Furthermore, Ocugen completed dosing in Phase 2 of the OCU410 ArMaDa clinical trial and reached alignment with the FDA to proceed with a Phase 2/3 pivotal trial for OCU410ST.

Key operational developments included the completion of renovations to a current Good Manufacturing Practice (cGMP) facility to support NeoCart manufacturing for a Phase 3 clinical trial. The company also reported that it had 95 employees as of February 24, 2025, with the majority located in the United States. In November 2024, Ocugen entered into a loan agreement with Avenue Capital Management for net proceeds of $29.2 million, and in July 2024, the company completed a public offering, receiving net proceeds of $34.7 million. The company's cash and cash equivalents are projected to fund operations into the first quarter of 2026.

Ocugen's outlook indicates a need for significant additional funding to support ongoing and planned clinical trials and other development activities. The company anticipates increased expenses in fiscal year 2025 compared to 2024 due to increased clinical activities and headcount. The company's continued operations are contingent upon securing additional funding, and the successful development, regulatory approval, and commercialization of its product candidates remain uncertain.

About Ocugen, Inc.

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