Ocugen Shares Q3 2024 Financial Results and Business Update

Ocugen, Inc., a biotechnology firm specializing in the development and commercialization of innovative gene and cell therapies, biologics, and vaccines, recently unveiled its financial results for the third quarter of 2024. The company also provided updates on its ongoing business ventures. Chairman, CEO, and Co-founder, Dr. Shankar Musunuri, expressed optimism regarding the advancements in Ocugen's gene therapy programs and the significant clinical and regulatory achievements during the quarter. Of particular note was the expansion of the OCU400 Phase 3 liMeliGhT clinical trial into Canada, which he described as a substantial milestone.

OCU400, which is in Phase 3 clinical development, aims to provide a one-time treatment for retinitis pigmentosa (RP). The expanded access program (EAP) for adult RP patients allows the inclusion of patients from the U.S., Canada, and Europe, thereby broadening the potential reach of this therapy. The trial's expansion into Canada is expected to enhance the prospects for broader commercialization across North America and Europe. OCU400's development is progressing well, with an expected completion of enrollment by the first half of 2025.

OCU410, another of Ocugen's therapies, is currently in Phase 2 of the Phase 1/2 ArMaDa clinical trial. This therapy targets geographic atrophy (GA), a severe form of dry age-related macular degeneration (dAMD), affecting millions in the U.S. and EU. Unlike current GA treatments, which require multiple annual injections, OCU410 offers a potential single subretinal injection solution by addressing all four pathways linked with dAMD pathophysiology. The Data and Safety Monitoring Board (DSMB) has approved the enrollment for the second phase of the Phase 1/2 clinical trial for OCU410ST, which is undergoing trials for Stargardt disease.

In addition to its clinical trials, Ocugen participated in several conferences during the third quarter, sharing updates on its clinical-stage modifier gene therapies. This included presentations at the Cell & Gene Meeting on the Mesa, hosted by the Alliance for Regenerative Medicine. Dr. Musunuri emphasized the importance of educating stakeholders about the company's innovative gene-agnostic modifier gene therapy platform. This platform leverages master gene regulators to reset the functional network of the retina, offering potential treatments for multiple disease mutations with a single therapy.

Ocugen's primary focus remains on advancing its gene therapy programs. However, the company is also pursuing funding opportunities to ensure the reach of its innovative platforms to the patients who need them. The company secured $30 million in debt financing and $35 million in equity financing in the third quarter, extending its cash runway into the first quarter of 2026. As of September 30, 2024, Ocugen's cash and restricted cash totaled $39.0 million, compared to $39.5 million at the end of 2023. Operating expenses for the three months ended September 30, 2024, were $14.4 million, down from $16.1 million in the same period in 2023, reflecting $8.1 million in research and development expenses and $6.3 million in general and administrative expenses.

Ocugen is scheduled to host a conference call and webcast at 8:30 a.m. ET to discuss these financial results and recent business highlights. This session will feature a question-and-answer segment with the company's senior management team. The call will be open to all interested listeners, and a replay will be available for 45 days on the Ocugen investor site.

Overall, Ocugen continues to make significant strides in the field of gene therapy, with promising clinical trials and a robust pipeline. The company remains focused on its mission to develop and deliver transformative therapies that address unmet medical needs and improve patient outcomes worldwide.