Ocugen's 2026 Commercialization Plans and Gene Therapy Trials Advancements

Ocugen, a gene therapy company, announced three licensing applications and commercialization plans for 2026 while advancing its gene therapy trials. CEO Shankar Musunuri expressed enthusiasm about the progress of the company's modified gene therapy platform, with two candidates in late-stage trials and all three advancing through the clinic.

Ocugen, Inc. (NASDAQ: OCGN), a leading biotechnology company specializing in gene therapies for blindness diseases, has reported its second-quarter 2025 financial results and provided a business update. The company has made significant strides in its gene therapy trials and strategic partnerships, setting the stage for three Biologics License Application (BLA) filings by the end of 2026.

Financial Performance

Ocugen reported a net loss of $0.05 per share for the three months ended June 30, 2025, compared to a $0.06 net loss per share for the same period in 2024. Total operating expenses for the quarter were $15.2 million, including $8.4 million in research and development expenses and $6.8 million in general and administrative expenses. The company's cash, cash equivalents, and restricted cash totaled $27.3 million as of June 30, 2025, providing a cash runway into the first quarter of 2026 [1].

Clinical Trial Progress

Ocugen is actively advancing its gene therapy platform, with two candidates in late-stage trials. The company's OCU410ST Phase 2/3 GARDian3 pivotal confirmatory trial for Stargardt disease has been initiated, following FDA clearance in June. The trial builds upon encouraging results from the Phase 1 GARDian trial, which demonstrated significant improvements in visual acuity and lesion growth reduction. Additionally, the OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) remains on track for BLA and MAA submissions in 2026 [1].

Strategic Partnerships

Ocugen has signed a binding term sheet to negotiate and enter into a licensing agreement with a well-established leader in the pharmaceutical and healthcare sector in Korea for exclusive Korean rights to OCU400. This partnership is expected to generate upfront fees and milestone payments totaling up to $11 million. The company has also announced a reverse merger with OrthoCellix, a wholly-owned subsidiary, and Carisma Therapeutics, Inc., to create a Nasdaq-listed, late clinical-stage regenerative cell therapy company focused on orthopedic diseases [1].

Looking Ahead

CEO Shankar Musunuri expressed enthusiasm about the company's progress, stating, "We are securing strategic partnerships and evolving the business to support three successful BLA filings over the next three years." Ocugen's goal is to deliver paradigm-changing gene therapies to millions of people with blindness diseases [1].

Conference Call

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. The call will be open to all listeners and will include a question-and-answer session following the prepared remarks [1].

References

[1] https://www.globenewswire.com/news-release/2025/08/01/3125757/0/en/Ocugen-Provides-Business-Update-with-Second-Quarter-2025-Financial-Results.html