Ocugen, Inc.

Good morning and welcome to Oxygen's fourth quarter and full year 2025 financial results and business update. All participant lines are currently in listen-only mode. Following the speaker's commentary, there will be a question and answer session. I will now turn the call over to Tiffany Hamilton, Oxygen's Head of Corporate Communications. You may begin.

Thank you, Operator, and good morning, everyone. Joining me on today's call and webcast is Dr. Shankar Musuneri, OccuGen's chairman, CEO, and co-founder, who will provide a business update and an overview of our clinical and operational progress. Rita Johnson-Green, our chief financial officer, is also on the call to provide a financial update for the quarter and full year ended December 31st, 2025. Dr. Huma Kumar, chief medical officer, will be available to answer questions following the presentations. This morning, we issued a press release detailing associated business and operational highlights for the fourth quarter and full year 2025. We encourage listeners to review the press release, which is available on our website at Occugen.com. A replay of this call, along with the accompanying slide presentation, will be available on the investor section of the Occugen website. Before we begin, please note that certain statements made during today's discussion may be forward-looking in nature. including those related to our clinical development pipeline, regulatory timelines, commercialization strategy, and financial information in our anticipated cash runway. These statements reflect management's current expectations and are inherently subject to risks, uncertainties, and assumptions that may cause actual outcomes to differ materially from those expressed or implied. We encourage you to review our filings with Securities and Exchange Commission, including the risk factors detailed therein. for a more comprehensive understanding of these potential risks. Finally, Octogen's annual report on Form 10-K covering the full year 2025 will be filed today. I will now turn the call over to Dr. Lucinari.

Thank you, Tiffany, and thank you all for joining us today. I'm pleased to share an update on what was a transformative year for Octogen. Considerable development across all of our modified gene therapy programs, including licensing, and financing agreements to strengthen our financial position, and meaningful appointments to our leadership team made in 2025 a year of real momentum for Opigen. We are now poised to leverage upcoming catalysts and advance business as we near the first of our three BLA filings. I'm proud of what this team has accomplished, and I'm confident that with the full venture of experienced leadership across the organization, we have the resources and the know-how to drive oxygen transition into a commercial stage company. Let me walk you through each program, starting with RQ400 and Regnitis pigmentosa, which I will refer to as RP going forward. It is important to note that the phase three limelight clinical trial is the only broad RP gene agnostic trial and the largest known phase three orphan gene therapy trial. Approximately 300,000 people in the U.S. and Europe are living with RP is caused by mutations in more than 100 genes. RQ400 is designed as a modified gene therapy utilizing MR2E3, a central transcriptional regulator of retina-specific pathways to address multiple genetic mutations with a single one-time treatment. The only approved gene therapy for RP today targets a single gene, RPE65, which accounts for just 1 to 2% of the total RP patient population. We believe OCU-400 has significantly wider commercial potential as it is intended to provide a therapeutic option for 98 to 99% of all RP patients. I'm pleased to report that enrollment is now complete for the OCU-400 Phase III Limelight Trial. As a one-year clinical trial, top-line data will be available in the first quarter of 2027. These data are anticipated to support the biologics license application, BLA, filing for RQ400 and potential approval in 2027. The limelight clinical trial enrolled 140 patients who were randomized two to one into the treatment group and untreated control group across mutations, including Rho and gene agnostic arms. The gene agnostic arm includes many genetic mutations, including those most prevalent.