Ocugen, Inc.

Good morning and welcome to Ocugen's third quarter 2025 financial results and business update. Please note that this call is being recorded at this time. All participant lines are in a 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, Ocugen's head of corporate communications. You may begin.

Thank you, operator. Good morning, everyone. Joining me on today's call and webcast is Dr. Shankar Musunuri, OccuGen's chairman, CEO, and co-founder, who will provide a business update and an overview of our clinical and operational progress. Ramesh Ramachandran, our chief accounting officer, is also on the call to provide a financial update for the quarter-ended September 30th, 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 third quarter of 2025. We encourage listeners to review the press release, which is available on our website at Occugen.com. This call is being recorded, and a replay with the accompanying slide presentation will be available on the investor section of the Occugen website for approximately 45 days. This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may in some cases use terms such as predicts, believes, potentials, proposed, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should, or other words that convey uncertainty of future events or outcomes. to identify these forward-looking statements. Such statements include, but are not limited to, statements regarding our clinical development activity and related anticipated timelines. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission, the SEC, including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation. Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation. Finally, Ogden's Court of the Report on Form 10-Q, covering the third quarter of 2025, will be filed today. I will now turn the call over to Dr. Musuneri.

Thank you, Tiffany. Thank you all for joining us today. I'm pleased to share an update on our modified gene therapy platform, and would like to recognize that in just over three years, we brought our lead candidate, OQ400, from initial Phase I-II dosing to nearing Phase 3 enrollment completion. The RQ4-10ST Phase 2-3 pivotal confirmatory trial is following close behind, and we're on track to complete enrollment in the first quarter of 2026, lining up for our planned biological licensing application BLA submission in the first half of 2027 for RQ4-10ST. This rapid progress is somewhat unheard of in industry. and not only reinforces our commitment to file three BLAs in the next three years, but it also brings us closer to addressing the incredible unmet medical needs that exist for patients facing vision loss. While all three programs are moving along on schedule, we received additional positive news in the third quarter that the Committee for Medicinal Products for Human Use, THMP, of the European Medicines Agency confirmed the acceptability of a single U.S.-based trial for submission of MAA in Europe for OCU410ST. This alignment allows us to maintain the same timeline and project efficiencies in Europe as we have with the OCU400 total trials. To fund total trial progress, we continue to pursue opportunities to increase our working capital And in August, closed the registered direct offering to Janice Henderson. The gross proceeds were approximately 20 million, which we anticipate will extend our runway through the second quarter of 2026. And we will receive 30 million of additional gross proceeds if the warrants are exercised in full, extending our runway into 27. The OCU 400 Phase III Limelight Clinical Trial remains on track. for BLA and MAI submissions in 2026. This is the only broad retinitis pigmentosa RP gene agnostic trial to address multiple genetic mutations with a single therapeutic approach. And it's important to note that this is the largest known phase three orphan gene therapy trial. There are approximately 300,000 people in the US and Europe combined living with RP. which affects more than 100 genes. Opigen's gene agnostic approach has the potential to treat multiple gene mutations associated with RP with a single, one-time subretinal injection. Currently, the only approved gene therapy for RP targets a single gene, RP65, which accounts for 1 to 2% of RP patient population. This product achieved peak sales of 52 million in 2023, with a patient population of approximately 2,000. We believe Aukey 400 has far greater commercial potential as it is intended to provide a therapeutic option for the remaining 98 to 99% of RP patients. We anticipate commercialization in 2027. Process validation and manufacturing activities are progressing well in support of the BLA. Brand planning and market initiatives led by Abhi Gupta, our EVP of commercial and business development are scaling up as well. We will begin rolling submission of the RQ400 BLA in the first half of 2026 and release phase three top line data in the fourth quarter of 2026 in line with our commitments. As we prepare for what will ultimately be a global rollout for RQ400 by pursuing regional partnerships that preserve Ocugen's rights to larger geographies to maximize total patient reach while also generating return for our shareholders. In September, we announced an exclusive licensing agreement with Kwong Dong Pharmaceutical Company Limited for the rights to Ocu400 in South Korea. Under the agreement, the company will receive up to $7.5 million in upfront and development milestone payments, plus sales milestones of $1.5 million for every $15 million of sales in South Korea, projected to reach 180 million or more in the first 10 years of commercialization. We will also earn a 25% royalty on net sales generated by Kwong Dong and will be responsible for manufacturing and supplying Accu 400. There are an estimated 7,000 individuals in the Republic of Korea with RP, which represents approximately 7% of the U.S. market. OQ400 provides the opportunity for our partner to help thousands of patients facing vision loss. Upon regulatory approval of OQ400 in Korea, we believe Hwang Dong will become a leader in the field of ophthalmic gene therapy in South Korea. Now, let's move on to Ocuportin ST. Ocuportin ST has the potential to target all 1200 pathogens mutations in the ABCA4 gene associated with Stargardt disease and other ABCA4 related retinopathies with a single one-time subretinal injection. As I mentioned earlier, Enrollment in the Phase 2-3 Guardian 3 clinical trial is ahead of schedule. The strong response underscores the significant unmet medical needs among Stargardt patients who currently have no approved treatment options available. Stargardt disease affects approximately 100,000 people in the US and Europe combined, and approximately 1 million people globally. With CHMP acceptance of US trial data, for the NAA submission will maximize resources and streamline development efforts with the goal of bringing Occu410-ST to patients in Europe sooner than originally anticipated. The 12-month data from all available Phase 1 subjects showed highly encouraging results with a 48.2% reduction in lesion growth and a meaningful online six-letter gain in visual equity in available treated eyes compared with untreated eyes. All treated eyes also demonstrated stabilization or improvement in visual function, highlighting a consistent and tangible therapeutic benefit. Interim data from ongoing Phase 2-3 study is expected mid-2026, further advancing our goal of bringing RQ410ST to patients in need. Finally, Ocu410 is specifically designed to address multiple pathways implicated in the pathogenesis of dry edulated macular degeneration and offers a promising advantage for current treatment options that target only one pathway, the complement system, which does not fully address the disease progression and underlying causes of vision loss. Currently approved treatment options require frequent intraorbital injections. about six to 12 doses per year and are accompanied by various safety risks. For example, roughly 12% of patients developed with AMD following treatment. With approximately two to three million geography atrophy patients in the U.S. and Europe combined, Ocu410 represents a significant market opportunity. Current therapies have notable limitations. and there are no treatments approved for GA in Europe, as existing FDA-approved options fail to demonstrate meaningful functional outcomes. OCU410 is therefore well-positioned to address this critical medical need. At 12 months, available subjects in the Phase 1 study showed a 23% reduction in lesion growth, along with a two-line or 10-letter stabilization or GAID with visual equity in treated eyes. Preliminary results from six-month interim analysis demonstrated a 27% reduction in lesion growth and preservation of retinal tissue in the treated eyes when compared to untreated controlled eyes. This reduction is or twice that observed with currently approved intravitreal therapies at six months monthly and every other month PEC Cytocoplan injections, which showed only 13% and 12% reductions, respectively, highlighting Ocu410's potential to provide a significant and meaningful therapeutic benefit to patients with a one-time treatment. In addition to the greater lesion production, a single subretinal injection of Ocu410 demonstrates greater efficacy in preserving retinal tissue surrounding GA lesions compared with monthly and every other month type statistical plan treatments. We plan to provide full 12-month data from the phase two study, including both structural and functional outcomes in the first quarter of 2026 and anticipate initiating the phase three study next year. I will now turn the call over to Ramesh Ramachandran to provide an update on our financial results for the quarter ended September 30th, 2025.