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Good morning. Welcome to Ocugen first quarter 2026 financial results and business update. All participants' lines are currently in listen-only mode. Following the speaker commentary, there will be a question-and-answer session. I will now turn the call over to Tiffany Hamilton, Ocugen Head of Corporate Communications. You may now begin.

Thank you, operator. Good morning, everyone. Joining me on today's call and webcast is Dr. Shankar Musunuri, Ocugen's Chairman, CEO and Co-founder, who will provide a business update and an overview of our clinical and operational progress. Rita Johnson-Greene, our Chief Financial Officer, is also on the call to provide a financial update for the quarter ended March 31st, 2026. Dr. Huma Qamar, Chief Medical Officer, will be available to answer questions following the presentation. This morning, we issued a press release covering our business and operational highlights for the first quarter 2026. We encourage listeners to review the press release, which is available on our website at ocugen.com. A replay of this call, along with the accompanying slide presentation, will be available on the investors section of the Ocugen 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 pipelines, commercialization strategy and financial information, and our anticipated cash runway. These statements reflect management's current expectations and are inherently subject to risks, uncertainties and assumptions that may cause actual results to differ materially from those expressed or implied. We encourage you to review our filings with the Securities and Exchange Commission, including the risk factors detailed therein, for a more comprehensive understanding of these potential risks. Finally, Ocugen's quarterly report on Form 10-Q, covering the first quarter of 2026, will be filed today. I will now turn the call over to Dr. Musunuri.

Thank you, Tiffany, and good morning, everyone. Before I walk through the quarter, I want to discuss the $115 million offering of convertible senior notes that we announced yesterday. With the recent offering, the company is expected to have cash equivalents and restricted cash of $112.1 million at closing, which includes the Avenue debt payoff. The company will use the remaining net proceeds for general corporate purposes and expects to extend cash runway into 2028. The offering is expected to close on May 7, 2026, subject to customary closing conditions, and includes an option to retire the debt with a cash payment. If the remaining Jones Henderson warrants are exercised, the company will receive an additional $15 million in gross proceeds, increasing expected cash equivalent and restricted cash to $127.1 million.

I would like to step back because Ocugen's potential is worth putting into context. For more than a a decade, gene therapy and ophthalmology has been confined to a single gene, a single mutation, and a single small patient population. Our modified gene therapy platform takes a fundamentally different approach. Rather than targeting individual mutations, it is designed to address the root cause of complex retinal diseases by modulating master regulators, nuclear hormone receptors that govern entire gene networks. The platform is gene-agnostic, inherently multifactorial, and designed to deliver durable benefit from a single one-time subretinal injection. What this means in practice is that Ocugen is not building three separate drugs. We're advancing one platform across three late-stage programs, each targeting a major cause of blindness for which patients today have either no approved treatment whatsoever or therapies that demand chronic injections and carry meaningful safety burdens.

retinitis pigmentosa or RP, Stargardt disease, and geographic atrophy or GA together affect approximately three million people across the United States and Europe, a combined patient population and a commercial opportunity far larger than anything currently served by approved gene therapies in ophthalmology. Across our pipeline, spanning phase I through phase III, we have treated more than 250 patients across multiple doses and indications, and we have not observed a drug-related serious adverse events. In our most recent readout, OCU410 demonstrated approximately twice the treatment benefit over currently approved therapies in GA, delivered at one-time injection. We remain on track to file three BLAs over next three years by 2028, and first of those, OCU400 for RP, will begin rolling submission in the third quarter of this year.

This positions the first half of 2027 as a catalyst-rich window for Ocugen with phase III top-line data for OCU400, phase II/III data for OCU410ST, and BLA submissions all expected to converge over a short period. In the first months of 2026, we completed enrollment in two of our late-stage programs, delivered positive phase II top-line data in a third, and are diligently working toward initiating our first BLA submission later this year. Let me walk you through how each program is advancing. Starting with OCU400 for RP, the phase III liMeliGhT clinical trial is the only broad gene-agnostic RP trial and the largest known phase III orphan gene therapy trial in the field. Approximately 300,000 people in the U.S. and Europe are living with RP, which is caused by mutations in more than 100 genes.

The only approved gene therapy for RP today targets a single gene, RPE65, which accounts for just 1%-2% of all RP cases. OCU400 is designed to provide a therapeutic option for the remaining 98%-99% of RP patients, and that is a fundamentally different commercial opportunity. Enrollment in liMeliGhT is now complete, with 140 patients randomized two to one across the RHO and gene-agnostic arms, covering over 25 genetic mutations associated with early to advanced stage RP, including pediatrics. The breadth of population is intended to validate the gene-agnostic mechanism of action of our novel modifier gene therapy platform. The primary endpoint is 12-month change in visual function assessed by luminance dependent navigation assessment, or LDNA. We plan to initiate the rolling BLA submission for OCU400 in the third quarter of 2026 and complete BLA submission by the second quarter of 2027.

Phase III top-line data is expected in the first quarter of 2027, with a potential FDA approval targeted for the fourth quarter of 2027. On the manufacturing side, process performance qualifications, PPQ batches completion is on track for the second quarter of 2026. Brand planning and marketing initiatives led by Abhi Gupta, our EVP of Commercial and Business Development, continue to scale in preparation for launch. OCU400 continues to demonstrate encouraging long-term durability with the three-year data supporting sustained improvement in visual function compared with untreated eyes. In phase I/II study, the treatment effect was maintained over time across evaluable subjects, with the clinically meaningful mean changes in LLVA observed at years one, two, and three in both the multiple mutation and RHO subgroups. Importantly, these results suggest the benefit is not limited to a single genetic subtype, reinforcing the program's gene-agnostic mechanism of action.

From a safety perspective, OCU400 continues to show a favorable profile with no serious adverse events reported as being related to treatment. At the three-year time point, 88% of treated evaluable subjects demonstrated either improvement or preservation in visual function relative to untreated eyes, highlighting both the durability and consistency of the response. Taken together, these data support the potential for OCU400 to deliver sustained clinical benefit over time in retinitis pigmentosa while maintaining a strong safety profile. Turning to OCU410ST for Stargardt disease. Stargardt disease is a pediatric-onset retinal disorder affecting approximately 100,000 patients in the U.S. and Europe and roughly one million globally. There are no approved therapies available for these patients today. OCU410ST is designed to address over 1,200 pathogenic mutations in the ABCA4 gene with a single one-time treatment.

On April 1st, we announced the completion of enrollment and dosing in phase II/III GARDian3 pivotal confirmatory trial, enrolling 63 participants in less than nine months, well ahead of the originally planned timeline. That pace reflects both the depth of unmet need in Stargardt disease and the exceptional engagement of our investigators and patient community. The interim analysis is planned for third quarter of 2026, with the phase II/III data expected in the second quarter of 2027, and BLA submission to follow by mid-2027. OCU410ST continues to demonstrate a favorable safety and tolerability profile, with no product-related serious adverse events reported to date. Turning now to OCU410 for GA. Late-stage dry age-related macular degeneration, GA represents our largest commercial opportunity, with approximately two million-three million patients in the United States and Europe combined. There are currently no approved treatments for GA in Europe.

In the United States, approved therapies require six to 12 intravitreal injections per year indefinitely, carry meaningful safety risks, including conversion to wet AMD in roughly 12% of treated patients, and face real-world dropout rates of nearly 40%. GA is a multifactorial disease driven by four distinct pathways that contribute to the progressive degeneration of the macula, lipid deposits, drusen, chronic inflammation, oxidative stress, and complement activation. The currently approved therapies in the U.S. address only one of these four pathways, the complement system, which is partly why they have been unable to demonstrate meaningful functional outcomes for patients. OCU410 operates differently. By delivering RORA, a nuclear hormone receptor that acts as a master regulator of retinal homeostasis, OCU410 is designed to address all four disease pathways simultaneously with a single subretinal injection, has the potential to redefine the standard of care in this indication.

In March, we reported positive top-line 12-month data from our phase II ArMaDa clinical trial. The study enrolled 51 patients aged 50 years and older with the GA lesions in the foveal or non-foveal region, randomized 1:1:1 to receive a single subretinal administration of OCU410 at the medium dose, high dose, or no treatment in the control group. The optimal dose, which is the medium dose, demonstrated a 31% reduction in lesion growth relative to control at 12 months, with a P value of less than 0.05. To put this in context, currently approved intravitreal therapies have shown approximately 15% reduction at 12 months for avacincaptad pegol and 22% reduction at 24 months for pegcetacoplan. OCU410, administered as a single one-time injection, has shown the potential for an approximately two-fold treatment benefit relative to approved therapies that require continuous chronic dosing regimens.

Across the treated population, 55% of treated subjects demonstrated a 30% or greater reduction in lesion size relative to control. We also observed a 27% slower rate of ellipsoid zone loss, which is structural biomarker that correlates with preservation of photoreceptor integrity and visual function. On safety, OCU410 continues to demonstrate a safe and tolerable profile with no serious adverse events, no adverse events of special interest related to OCU410 reported to date. We are now incorporating these results into an optimized phase III trial design, including a targeted GA lesion size window and an adaptive design powered at greater than 95%. We are now on track to meet with FDA and EMA to align on the phase III study design and reach regulatory agreement by the third quarter of 2026, with potential BLA filing by 2028.

As a one-time treatment for life, OCU410 has the potential to eliminate the chronic treatment burden and patient fatigue associated with currently approved therapies and to offer a lasting solution for the two million to three million patients in the U.S. and Europe living with GA. Let me briefly update you on other programs. For OCU200, we completed phase I clinical trial enrollment in the first quarter of 2026, and no serious adverse events or adverse events related to OCU200 have been reported to date. On OCU500, our first-in-class inhaled mucosal COVID-19 vaccine candidate designed to be administered via inhalation and intranasal delivery, NIAID intends to initiate the OCU500 phase I clinical trial in the second quarter of 2026. Today, we want to highlight the meaningful progress across our retinal gene therapy pipeline and the important milestones we expect over the next several quarters.

For OCU400 in retinitis pigmentosa, we remain on track to begin a rolling BLA submission in 2026, with phase III top-line data expected in 2027, and the potential for BLA and launch thereafter. For OCU410ST in Stargardt disease, we have completed dosing ahead of schedule in our pivotal phase II/III GARDian3 trial, with interim analysis expected in the third quarter of 2026 and top-line results anticipated in the second quarter of 2027, followed by a planned BLA submission. For OCU410 in geographic atrophy, we continue to advance toward phase III development following encouraging phase II data, with the program expected to move through phase III enrollment toward BLA submission by 2028. Taken together, these milestones reflect a disciplined multi-program strategy designed to create value through a series of increasingly important clinical and regulatory readouts.

I'll now turn the call over to Rita to provide an update on our financial results for the quarter ended March 31, 2026. Rita?

Thank you, Shankar. Good morning, everyone. Total operating expenses for the three months ended March 31st, 2026, were $19.4 million and included research and development expenses of $11.3 million and general and administrative expenses of $8.1 million, compared to total operating expenses for the three months ended March 31st, 2025, of $16 million that included research and development expenses of $9.5 million and general and administrative expenses of $6.5 million. Ocugen reported a $0.06 net loss per common share for the three months ended March 31st, 2026, compared to a $0.05 net loss per common share for the three months ended March 31st, 2025.

The company's cash equivalents and restricted cash totaled $32.2 million as of March 31st, 2026, compared to $18.9 million as of March 31st, 2025. The company received $37.5 million in gross proceeds, inclusive of $15 million due to exercised warrants in the first quarter of 2026. With the recent offering, the company is expected to have cash equivalents, and restricted cash of $112.1 million at closing, which includes the avenue debt payoff and expects to extend cash runway into 2028. The company had 338.3 million shares of common stock outstanding as of March 31st, 2026. That concludes my financial update. Shankar, back to you.

Thank you, Rita. The first quarter of 2026 was a quarter defined by execution. We delivered positive 12-month phase II data for OCU410 in GA, completed enrollment and dosing in the GARDian3 trial well ahead of schedule, and continued advancing OCU400 towards its rolling BLA submission earlier this year. Looking ahead, the remainder of 2026 is poised to be consequential with multiple meaningful inflection points. We expect interim outcome analysis from GARDian3 in the third quarter, regulatory alignment with FDA and EMA on the OCU410 phase III design in the third quarter and the initiation of our first BLA submission for OCU400 also in the third quarter. Each of these milestones bring us a step closer to delivering on our commitment of three BLAs by 2028.

I want to thank our employees, investigators and patients who have trusted us with their participation and our shareholders for continued belief in our mission to advance cures for blindness. We'll now open the call for questions. Operator?

At this time, I would like to remind everyone in order to ask a question, please press star then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Your first questions comes from the line of Leland Gershell from Oppenheimer. Please go ahead.

Hey, Ocugen team. This is Jason on for Leland. It seems like it's gearing up to be an exciting year for OCU400 and the retinitis pigmentosa. With that, could you give us a sense of what's being submitted for the rolling BLA versus the full BLA next year? How also are you thinking about the pre-commercialization activities going into 2027 launch? Thank you.

Yeah. Yep. The rolling submission, as we stated, will start with non-clinical section module. Also we're completing our PPQ lots from CMC manufacturing perspective. That module will also be submitted this year. Next year, as soon as the top-line results come in within weeks after that, the final clinical module will be submitted, and that will trigger a PDUFA date of six months clock. Expected to get the approval in the fourth quarter and launch. From commercial perspective, there are multiple things we are doing. As we mentioned before, we're working on one thing on the pricing with the government CMS. Second step is, of course, as a company, we have established very standard way of treating these patients with our surgery procedure, which we use in clinical trials, to minimize any risk to the patient.

We want to really identify the centers for excellence where our gene therapy can be administered. That's what we're working on as the second step. The third step is, of course, getting up for sales and marketing and really commercial plans. I think we're working on the strategy. Typically you start that work year before. Later part of the year, getting into the early next year, that's when we'll start bulk of the commercial work.

Sounds great. Thank you again.

Your next questions comes from the line of Michael Okunewitch from Maxim Group. Please go ahead.

Hey there. Thank you for taking my questions today. Good morning, everyone. Congrats on all the great progress you've been making.

Thank you.

I guess just to start off, I'd like to see, given how quickly the Stargardt program has been moving, how close together are you expecting an RP and a Stargardt approval could occur? Then are there any additional commercial considerations you're evaluating with the possibility that you will be kind of ramping both of these launches contemporaneously?

No, good question. I mean, if everything goes according to the plan, they could be within six months of each other. Obviously, from launch or commercial perspective, again, we're targeting the same centers for excellence for gene therapy administration. The same surgeons are going to administer for administering for RP. In fact, actually, it helps us as a company, economies of scale and how we are setting it up for RP, and that'll always help with Stargardt disease. When Stargardt, you know, is going to come later within six months, we should be in a great shape, from commercial perspective and launch perspective.

All right. How much overlap is there between the liMeliGhT and the GARDian3 studies? Are they largely at the same centers or if you take them combined, do they reach a broader swath of the overall market?

Go ahead, Huma.

Good morning. This is Huma Qamar. I'm gonna take this question. Good question. Both represent inherited retinal diseases, of course, retinitis pigmentosa. You know, we have almost the same centers. There is a single subretinal injection. There is an overlap. However, there is no approved product for Stargardt, and we do have a huge unmet medical need in terms of RP as well. The centers are almost the same, and also, as Shankar has mentioned, centers for excellence. There is an increased demand for as we have now closed the enrollment for both the programs to go as fast as we could per the protocol. You know, there will be some overlap, but there are quite a few more centers that we have identified as well.

The current clinical centers, Michael, just to answer, close it out, are not good enough for commercial. They're good, but we need a lot more for commercialization.

Yeah. Of course. Thank you very much. I appreciate the additional clarity. Once again, congrats on all the progress.

Thank you.

Your next questions comes from the line of Robert LeBoyer from Noble Capital Markets. Please go ahead.

Good morning, and congratulations on all of the progress that you've been making. My question has to do with the marketing and your mentions of centers of excellence. My understanding was that the product is something that can be administered by any ophthalmologist and anyone who treats patients and is very easy to fit into the current practice. I was wondering about the centers of excellence and how you're gonna launch the product, if it's going to be a broad launch or focused on specific areas or treatment centers in the marketplace?

Yeah. I mean, good question. I mean, obviously, this vitrectomy, it's not a big surgery. I think any of our 2,400 trained, well-trained retinal surgeons in our country can do that. However, you know, it's a one-and-done treatment. It's a one-time administration for life. We want to make sure whatever centers that are going to participate in the commercial and that they get trained on the same surgical manual we have been using in the clinical trials, which has been worked successfully. That's the goal. I mean, once again, I just want to clarify, this is not a, you know, complex surgery, and any of those surgeons, the 2,400 smart retinal surgeons can do this. As a company, we just want to make sure we train a group of people.

I mean, whatever centers we need for commercialization, it could be 100, it could be 200, we want to make sure those centers are very well-trained, and so they follow the same procedure across the board for consistency and patient safety.

Okay. You know, just my understanding was that anyone who's a retinal surgeon can administer OCU400 without any special training. Is that correct or, you know, just what is the difference between the clinical trial and actual practice?

I can answer that, Robert. Good to hear from you. Yes, it's a vitrectomy, which is pretty common. It's part of standard of care. This is not a new treatment or anything that they have not done. What Shankar is mentioning here is actually every product has its specifications. When we are launching the centers of excellence, that would be the main centers that could further train down the next few centers, like down there. The initial launch, definitely we have all across. They're covering majority of the centers. This is not a new treatment, new procedure, or single subretinal injection that we are giving. However, when we define centers of excellence, that's always like the initial ones that take the burden off, like, you know, for the first launch and then go towards the next.

Yes, you do not need any special training. This is pretty much standard of care. We have vitreoretinal surgeons that are pretty good in doing this. The only difference is this. There is, of course, with any product, you come up with the guidelines, and that's what they have to do.

Robert, I think this is the first time remember, we're not talking about going after 500 patients or 1,000 patients. We're going to go after hundreds of thousands of patients with our therapies. There is a whole payer system and how you direct the patients. It's a new paradigm Ocugen has to establish. It's nothing like anybody has done before. I just wanted to make it very clear in gene therapy space.

Yes. Okay. That's a very good point. Okay, thank you.

Your next questions comes from the line of Whitney Ijem from Canaccord Genuity. Please go ahead.

Hey, guys. Congrats on all the progress this quarter. First question, I guess headed into the interim for the Stargardt study in the third quarter, can you remind us, first of all, the powering of that study? Like, what was assumed, what should we all be expecting to see in that readout? Sorry, third part of this question is just what is the range of outcomes based on that data for the study moving forward?

Yeah. I think, Whitney, this is outcome analysis. It's not really giving any interim analysis like we expect in our primary endpoint and secondary endpoint analysis. This is done under strict guidance of data monitoring committee. Why do you do adaptive design? To minimize any further risk to phase III clinical trial. In phase III clinical trial, we have a true control arm, untreated arm, which will be compared with the treatment arm. The DMC looks at predictive analytics and see that study is designed for 12 months. At eight months, when 50% of the patients have completed, they're going to look at it, compared to control arm. Are we going to meet the success? If there is nothing to be changed, you continue. That's outcome number one. No changes.

Top line results come out in the second quarter of next year. BLA will be filed few weeks after that, and then the clock starts for PDUFA date. The outcome number two, I mean, we did recruit additional patients in the trial. I mean, obviously, anticipation of dropouts and all that. If the analytics show you need to increase number by a certain number, we have to again recruit. I mean, that may have, you know, that means you have to monitor those patients for additional one year. That has impact on the Top line results in the filing. During that timeframe, we're also, based on the discussions we had in the agency in the past, we have two options. Either you increase the size and we can also look into adding an additional time point.

From 12 months, you also can add 16 months time point. You can also look into predictive analytics and see if you're going to meet the criteria of making a success if you extend it to 16 months. Those are the two options we have. Obviously, the DMC with the blinded staff at Ocugen, they're going to look at it carefully and present this option to agency and get the buy-in from FDA, which they have recommended these two options in the past. Once the outcome is finalized with the agency's concurrence, we're going to let the markets know. Just to sum it up, one of the outcomes is there's no change. We're on track. Everything is looking good. Another outcome is, there is some delay, but the delay also minimizes any risk to the clinical trial we're adjusting.

There's a delay of, you know, six months. Those are the outcomes we'll discuss with the market.

Got it. Okay, that's really helpful. Going back to the powering question, what Have you disclosed the powering of the study on the primary endpoint?

Go ahead, Huma.

Yes. Yes. Basically, we have for the Stargardt disease, 51 subjects, 34 treatment, 17 control. Adaptive design would be for 24, 16 treatment, eight control. Yes, it's adequately powered around 90% or more. We are going to look at the powering once again once the adaptive, you know, analysis interim outcome is going to be there. However, we are sufficiently powered keeping in mind the prevalence as well as the no approved product right now in market. The interim outcome would be either sample size re-estimation or no.

Got it. Okay. That's helpful. Then, just to double-check, in terms of the range of outcomes, there's no, I guess, upside scenario, right? Just to make sure we're fully thinking through all the scenarios. Best case scenario is things are on track. There's not, like a best case, oh, we're gonna end early or something like that, right?

Yeah, that's right. Yeah, I think unless Whitney, if you look at many products which got approvals under, you know, some of them got approvals with 30 patients, right? With orphan diseases. Obviously, with the, as Huma stated, it's 50% reaching eight months. Eight months, I think we have to be also be practical. If it's a one year, it's a different story. For gene therapies, for us, modified genes to start working, you know, minimum you need, like six months to show something. At one year timeframe, you really reach the effect size and everything else. Obviously, again, the data will tell, and we'll wait. For orphan diseases, you're right.

If there's a significant unmet medical need, sometimes in the interim, if you really hit it out of the park, agencies will consider that. I also want to be practical about it. I think eight months is for adjustment. Typically it's good to look at it one year. One year itself, if you look at all our clinical trials compared to, you know, other things going on in the industry across all our three programs, we are doing one-year trials compared to anybody out there. Most of the people do two-year trials because we're able to show effect size, treatment effect, and benefit in one year.

Mm-hmm. Yep. That makes perfect sense. Okay. Then just moving on, a cash question. What does the new guidance into 2028 assume in terms of GA phase III spend?

Yeah. It's included within the GA. The GA phase III spend is included in the new cash runway into Q1 or into 2028. Yeah, we do anticipate being able to cover the expenses for that trial.

Okay. Got it. I guess could you, I know the conversations with the agency are ongoing, but what was assumed in terms of size of that study just for cash reasons or any design characteristics you can talk about at this point, just for, again, from a cash estimation perspective?

It's a 300 patients global trial in U.S., EU, and Canada together. Most of the patients or majority will be in the U.S. because we have the existing centers. It's a two-to-one ratio. 200 in treatment and 100 in untreated control. It's powered at over 95%.

Okay. Got it.

for the primary endpoint. 92% for EZ, ellipsoid zone, secondary endpoint. It has adaptive design. At 150 patients reach one year, we can take a look.

Got it. Okay. Perfect. That's it for me. Thanks so much.

Your next questions comes from the line of Ramakanth Swayampakula from H.C. Wainwright. Please go ahead.

Thank you. This is RK from H.C. Wainwright. Good morning, Shankar and team. A lot of my questions have been answered, but I have a couple of them. On the OCU400, you know, where you're planning for to start the rolling BLA in third quarter, can you confirm your PPQ runs would be completed, you know, in time, like by end of second quarter or so that you can initiate your rolling BLA?

Yeah, absolutely. We're on target to complete them this quarter.

Okay, perfect.

That, yeah, and support the rolling data submission.

Okay, great. Rita, in terms of expenses, you know, we have seen G&A and R&D expenses go up this quarter, which is understandable. How should we think about this going forward, especially into 2027, as you're preparing, you know, for commercialization? Relatedly, you know, on the BD side of things, what progress has been made, especially for OCU400 and OCU410, in terms of ex-U.S. licensing?

Yeah. Thank you for your questions. First of all, just to kind of address the, you know, the spend that you're seeing, you have to consider part of it is due to timing, and then also related to, you know, us exceeding some of our programmatic milestones, right? If you're looking at, you know, OCU410ST and OCU410 GA, we accelerated those timelines. When you think about, you know, us completing our enrollment for OCU400 and OCU410ST, the completion of that enrollment in Q1 will now enable us to kind of ramp down the clinical spend going into the balance of the, of the year.

We feel really confidently about, you know, the anticipated spend that we have in 2026 and going into 2027. We're, you know, averaging around $50 million-$60 million per year from a spend perspective, which is why we believe that our cash runway is into 2028. Going to the business development, we are, you know, actively evaluating various BD deals for ex-U.S. for both OCU400 and OCU410ST.

You know, we have term sheets that we're looking at, so you know, there's a lot of work going on, just as Shankar said, that Abhi is doing, who leads our business development team, to ensure that, you know, we are evaluating those alternatives and then making the best decision for Ocugen and for our shareholders. Lastly, from a commercialization perspective for OCU410 GA, we are still looking to commercialize that with a partner. Although, you know, as we talked about the spend associated with the clinical trials, we, you know, we have that incorporated into our runway.

Thank you. One last question. Shankar, I know in the past we have talked a little bit about payers and how to get payers agreed to the pricing that you would come up with. Any commentary, you know, especially from recent conversations from your payers as you're getting closer, you know, to commercialization, especially with the price tag that you're thinking for some of your drugs?

I mean, obviously, there is a publication in RETINA, I mean, that talks about potential pharmacoeconomic model, justifying $1 million-$2 million, somewhere in the range, price tag. Also, there is a publication from The New England Journal of Medicine. This is again, we're happy to state, CMS and CMMI, they're looking into, you know, what is the next iteration of sickle cell model they created. The publication clearly goes into payer time and subscription models, which can help with the budgetary constraints we have, how can we work? Everything is very creative, RK, as I mentioned before, from launch, you know, I mean, treatment centers to, and how the CMMI is looking. I'm very pleased to say it's, obviously these are one-time treatments, right?

We need to think about some creative ways, how can we work with payers, and make sure, especially if CMS, the government is spending a lot of money for orphan diseases or diseases like GA, which will have most of the patients are above 60, and they're going to get a bigger chunk of economy and budget from CMS. We need to really think into all those options, how we can provide market access to more patients and who need them. That NEJM article coming out of CMS is a good one. It goes into, okay, if the price tag is high, you pay over time. Because if you say your therapy is one-time treatment for life, you stand by it. Those are very good models coming out.

I mean, it's a very creative thinking. We are aligned with that strategy.

Perfect. Thank you. Thanks for taking all my questions.

Your next questions comes from the line of Daniil Gataulin from Chardan. Please go ahead.

Yes. Hi, good morning, guys. Thank you for taking my question. I have a more general question on EZ Preservation. It appears to be emerging as an important endpoint. Wanted to ask, in your conversations with the regulators, what would you say their most recent position is on the importance of EZ Preservation? Two, are there any differences in how U.S. and EU regulators are thinking about EZ Preservation? Thank you.

Daniil, good question. We just submitted our meeting request to both FDA and EMA. Obviously, I will let you know by early third quarter the input and alignment with them. I mean, obviously you saw GA trial, what we publicly stated. Our primary endpoint is lesion because that's an approved endpoint in two commercial products in the U.S. The secondary endpoint is we're proposing is ellipsoid zone because it correlates to visual function. We believe that should satisfy them, EU regulators. Obviously, we're going to wait until we complete all the meetings, everything buttoned up and aligned, then we'll let the markets know.

Got it. Thank you.

That will conclude our question and answer session. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Good morning, and welcome to Ocugen, Inc.'s Fourth Quarter and Full Year 2025 Financial Results and Business Update. All participant lines are currently in listen-only mode. Following the speakers' commentary, there will be a question-and-answer session. I will now turn the call over to Tiffany Hamilton, Ocugen, Inc.'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 Musunuri, Ocugen, Inc.'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 12/31/2025. Dr. Huma Qamar, Chief Medical Officer, will be available to answer questions following the presentation. 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 ocugen.com. A replay of this call, along with the accompanying slide presentation, will be available on the Investors section of the Ocugen, Inc. website at investors.ocugen.com. 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 and 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 the Securities and Exchange Commission, including the risk factors detailed therein, for a more comprehensive understanding of these potential risks. Finally, Ocugen, Inc.'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. Musunuri.

Thank you, Tiffany. And thank you all for joining us today. I am pleased to share an update on what was a transformative year for Ocugen, Inc. Considerable development across all of our modifier gene therapy programs, including licensing and financing agreements to strengthen our financial position and meaningful appointments to our leadership team, made 2025 a year of real momentum for Ocugen, Inc. We are now poised to leverage upcoming catalysts and advance the business as we near the first half of our three BLA filings. I am proud of what this team has accomplished, and I am confident that with the full range of experience in retinitis pigmentosa, which I will refer to as RP going forward. It is important to note that the Phase 3 Limelight clinical trial is the only broad RP gene-agnostic trial, and the largest known Phase 3 orphan gene therapy trial. Approximately 300,000 people in the U.S. and Europe are living with RP, which is caused by mutations in more than 100 genes. OCU400 is designed as a modifier gene therapy utilizing NR2E3, a central transcriptional regulator of retina-specific pathways, to address multiple genetic mutations with a single one-time treatment. The only approved gene therapy approach for RP today targets a single gene, RPE65, which accounts for just 1% to 2% of the total RP patient population. We believe OCU400 has significantly wider commercial potential, as it is intended to provide a therapeutic option for 98% to 99% of all RP patients. I am pleased to report that enrollment is now complete for the OCU400 Phase 3 Limelight trial. As a one-year clinical trial, top-line data will be available in 2027. These data are anticipated to support the Biologics License Application (BLA) filing for OCU400 and potential approval in 2027. The Limelight clinical trial enrolled 140 patients who were randomized 2:1 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: USH2A, XLRP, and PDE6B. The target population included patients with early- to late-stage disease among a broad RP population, including pediatrics. The primary endpoint is 12-month change in visual function assessed by LDNA (luminance-dependent navigation assessment), with improvement in lux level from baseline to 12 months. We also released positive long-term three-year Phase 1/2 data for OCU400 that build on our prior two-year results. The data demonstrate a sustained, clinically meaningful approximately two-line LLVA gain, reinforcing durable gene-agnostic benefit. OCU400 maintained a favorable durability, safety, and tolerability profile, with no new treatment-related serious adverse events or adverse events of interest emerging. With enrollment complete and these strong long-term data in hand, we are on track to begin the rolling BLA submission in 2026. Process validation and manufacturing activities are progressing well in support of the timeline, and planning and marketing initiatives are scaling up as well. We anticipate commercialization in 2027 in line with our commitments. As we prepare for what will ultimately be the global rollout of OCU400, we are pursuing regional partnerships that preserve Ocugen, Inc.'s rights to larger geographies while also generating near-term value for our shareholders. In 2025, we executed our first regional licensing agreement with QuanDan Pharmaceutical Company Limited for the exclusive Korean rights to OCU400. With upfront fees and near-term development milestone payments along with royalties, this was a valuable collaboration for Ocugen, Inc. and a critical step in the company's business development strategy. There are an estimated 7,000 individuals in the Republic of Korea with RP, equal to approximately 7% of the addressable U.S. RP market. This approach allows us to maximize total patient reach while retaining full commercial rights in the U.S. and Europe. Now let us move on to OCU410ST for Stargardt disease. OCU410ST holds the potential to target over 1,200 pathogenic mutations in the ABCA4 gene associated with Stargardt disease and other ABCA4-related retinopathies with a single one-time treatment. Stargardt disease affects approximately 100,000 patients in the U.S. and Europe combined, and approximately 1,000,000 people globally, with no approved treatment options available. The Phase 2/3 Guardian-3 pivotal confirmatory trial remains ahead of schedule. We anticipate top-line Phase 2/3 data in 2027, followed by the BLA submission. In January, we announced the peer-reviewed publication of our Phase 1 Guardian trial results in Nature Eye, which supports a favorable safety, tolerability, and efficacy profile of OCU410ST and its potential to provide clinically meaningful functional and structural benefits in Stargardt patients. This independent validation further strengthens the scientific foundation supporting the ongoing pivotal trial. Importantly, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency confirmed that data from our single U.S.-based trial can also support an EMA application. This alignment allows us to maintain the same timeline and budget efficiencies in Europe as we have with the OCU400 hurdle trial, streamlining our development efforts and bringing OCU410ST to patients in Europe sooner than originally anticipated. The program has also received Rare Pediatric Disease designation, further strengthening its regulatory positioning. I would like to explain ellipsoid zone (EZ) analysis in greater detail, as this is now an exploratory endpoint for both the Guardian-3 and ARMADA clinical trials. The ellipsoid zone is a hyperreflective band representing photoreceptor inner and outer layer segmentation. It indicates photoreceptor health and is a biomarker for photoreceptor structural integrity and metabolic health. EZ disruption precedes RPE loss and visible atrophy in geographic atrophy and Stargardt disease. EZ measurement is important because it provides early and sensitive detection. EZ changes occur before visible RPE atrophy expansion in GA and Stargardt progression. It also enables earlier intervention and more sensitive treatment effect detection in GA and Stargardt. Finally, EZ correlates to earlier functional therapeutic benefit, with an effect as early as one year compared to other measures such as visual acuity, with clinically meaningful effect at two years or more. Since all of our clinical trials aim to demonstrate benefit at one year, and we are targeting significant unmet medical needs, EZ is a relevant measure to show functional outcome in these trials. As EZ analysis has been established as a clinically relevant endpoint for dry AMD clinical trials, it was critical to incorporate this measure for both our Stargardt and GA trials. As shown in this bar graph, change from baseline at 12 months in treated fellow eyes across doses, excluding two subjects lost to follow-up and one subject with retinal detachment, demonstrated a mean of approximately 16% in lesion reduction in available treated eyes relative to untreated eyes. Specifically, 50% of OCU410ST-treated eyes achieved EZ preservation exceeding expected disease decline or atrophy progression at 12 months. This change-from-baseline structural preservation on spectral-domain OCT, quantified as approximately 16% lesion reduction in ellipsoid zone integrity, highlights meaningful photoreceptor protection and functional therapeutic benefit in Stargardt disease, underscoring the key differentiator of modifier gene therapy. Now let us turn to OCU410 in GA secondary to late-stage dry AMD. With approximately 2 million to 3 million GA patients in the U.S. and Europe combined, OCU410 represents a significant market opportunity. OCU410 is specifically designed to address multiple pathways implicated in the pathogenesis of dry age-related macular degeneration and offers a promising advantage over current treatment options that target only one pathway, the complement system. Currently approved treatment options require frequent intravitreal injections, about 6 to 12 doses per year, and are accompanied by various safety risks. For example, roughly 12% of patients develop wet AMD following treatment. There are no treatments approved for GA in Europe, and existing FDA-approved options have failed to demonstrate meaningful functional outcomes. OCU410 is therefore well-positioned to address this critical unmet need. In January, we announced positive preliminary 12-month data from approximately 50% of patients evaluated to date in the Phase 2 ARMADA clinical trial evaluating OCU410. The key findings were compelling. We observed a 46% reduction in lesion growth at 12 months across the medium- and high-dose groups combined versus control, with statistical significance at p = 0.015 in a cohort of 23 patients. We also saw a 50% responder rate, with patients achieving greater than 50% lesion size reduction versus control. To put this in context, currently marketed products have demonstrated only a 22% lesion reduction in two years. So at one year, OCU410 is already delivering more than double the benefit seen with existing therapies in twice the time. A subgroup analysis of patients with baseline lesion size of 7.5 mm² or greater, representing advanced atrophy, demonstrated a 57% reduction in lesion growth for the medium dose and a 56% reduction for the high dose compared with control. This suggests OCU410 may be even more effective in patients with substantial disease burden. The dataset also included encouraging 12-month Phase 1 findings, where OCU410-treated eyes demonstrated 60% slower loss of the ellipsoid zone, or EZ, compared to untreated fellow eyes. The 60% reduction in EZ loss rate indicates that OCU410 treatment is substantially slowing the rate of photoreceptor degeneration compared to the natural history observed in the untreated fellow eyes. We look forward to reporting the complete dataset from the OCU410 Phase 2 ARMADA trial this month and anticipate initiating Phase 3 in 2026. Let me also provide a brief update on our other programs. For OCU200, no serious adverse events or adverse events related to OCU200 have been reported to date across the Phase 1 dose-escalation cohorts, and trial enrollment is expected to be completed in 2026. Regarding our enhanced vaccine candidate, OCU500, NIAID intends to initiate the Phase 1 clinical trial in 2026. Finally, we created Arthroselix as a wholly owned subsidiary for our regenerative cell therapy assets, including NeoCart, with the goal to be independent through financing that will maximize value for Ocugen, Inc. shareholders and patients. We will provide further details as the process progresses. Across the portfolio, 2026 represents multiple defined inflection points. These include completion of enrollment for OCU410ST in early 2026, full Phase 2 data for OCU410 this month, interim pivotal data for OCU410ST in the third quarter, initiation of Phase 3 for OCU410 in 2026, and start of rolling BLA submission for OCU400 in the third quarter. Each of these milestones builds towards longer-term regulatory and commercialization objectives, and reinforces our commitment to file three BLAs in the next three years. Operationally, we also strengthened our executive leadership team with several appointments, including Abhi Gupta to Executive Vice President, Commercial and Business Development, bringing more than 20 years of experience across commercial strategy, gene therapy, and corporate development in the biopharmaceutical industry. Recently, Rita Johnson Green was named Chief Financial Officer. Rita's experience in financial strategy and capital planning supports our continued focus on disciplined resource allocation as our programs advance toward late-stage development and potential commercialization. And just this week, Paul Halsted joined us as Executive Vice President, Operations. Paul has more than 20 years of leadership experience in biologics and cell and gene therapy technical operations. He joins from Bristol Myers Squibb where, for over 16 years, he held leadership roles in manufacturing, launch, scale-up, and orchestration of reliable global supply chains, with a CAR T focus for the last five years. He will lead operations to strengthen execution and support the company's transition toward regulatory approvals and commercialization. I will now turn the call over to Rita Johnson Green to provide an update on our financial results for the quarter and full year ended 12/31/2025. Rita?

Thank you, Shankar. I am thrilled to join the Ocugen, Inc. team and support the company through its imminent transition into a commercial enterprise. Starting with our fourth quarter results, research and development expenses for the three months ended 12/31/2025 were $10,700,000 compared to $8,300,000 for the three months ended 12/31/2024. General and administrative expenses for the three months ended 12/31/2025 were $6,100,000 compared to $6,300,000 for the three months ended 12/31/2024. Ocugen, Inc. reported a $0.06 net loss per common share for the three months ended 12/31/2025 compared to a $0.50 net loss per common share for the three months ended 12/31/2024. For the full year ended 12/31/2025, research and development expenses were $39,800,000 compared to $32,100,000 for the full year ended 12/31/2024. General and administrative expenses were $27,600,000 compared to $26,700,000 for the prior year. Ocugen, Inc. reported a $0.23 net loss per common share for the year ended 12/31/2025 compared to a $0.20 net loss per common share for the year ended 12/31/2024. Our current cash and cash equivalents extend our runway into 2026. This includes the recent raise of $22,500,000 through an underwritten registered direct offering of common stock led by RTW Investments. In addition, if the $30,000,000 in warrants from the prior Janus Henderson raise are exercised in full, it will extend cash runway into 2027. That concludes my financial update. Shankar, back to you.

Thank you, Rita. We will now open for questions. Operator?

If you would like to ask a question, please press star and the number 1 on your telephone keypad to raise your hand and enter the queue. If you would like to withdraw your question or your question has been answered, please press star and the number 1 again. We will take our first question from Michael Okunewitch from Maxim Group. Please go ahead.

Hey, guys. Thank you so much for taking my question today. Congrats on all the great progress you have made. I guess to start off, given it is a 12-month primary endpoint for the Limelight study, how confident are you in the ability to turn around the data from when you hit on that top-line endpoint to actually releasing the top-line data within first quarter 2027?

Thank you for the question. We are very confident that we will be able to hit our timeline.

Alright. And then just for that endpoint, could you remind us of some of the modifications that you made for that particular navigation assessment course and why you decided to go with it as a primary metric for RP?

In terms of the mobility test that we are using, proprietary to Ocugen, Inc., that is luminance-dependent navigation assessment (LDNA). It is the mobility test that was approved as the primary endpoint for Luxturna; that was called MLMT at that time. That was only designed for RPE65 mutation that covers only 1% to 2% of the RP landscape. This is a very sensitive and specific test. As you can see, this is the broad RP indication trial, covering all clinical syndromic, nonsyndromic, all the genetic mutations that cause RP are included. So this has uniform lux levels and intensity and lux levels from 0 to 9, and that has the ability to capture the change in real time, which is from the baseline up to 52 weeks. This was also aligned with FDA, a validated test, as well as this was approved by FDA, and the only test that can capture the real change with functional outcome, demonstrating the functional outcome in these mutations. We are the only trial globally that is covering the majority of the gene-agnostic mutations as we have covered this morning in one of our slides as well. Thank you.

Thank you. That is certainly very helpful. And then last one before I jump back into the queue. For the Stargardt program, it is looking like there could be an approval from another company for a chronic therapy by the time you file for OCU410ST. So I wanted to know how this might impact the opportunity or pricing potential and if there is any reason that OCU410ST could not be complementary with other therapies as they come to market.

I will take that. There are other therapies out there. Obviously, what we have shown—if you look at the data we published in Eye—in one year, again, I want to restate all our trials were able to show treatment benefit in one year, unlike other trials out there of two years or more. The data we showed in one year are compelling. It looks superior. Our goal is to show functional benefit. With the gene therapy, we are targeting the major pathways, which are complex in Stargardt and GA. With our modifier gene, we also have the ability to reset the homeostasis and create a healthy environment for retinal cells to survive. That is very important. We are not just trying to slow down the disease progression. Our genes have the ability to control the internal network, so there is a big difference. Also, this is one-and-done. If you have a one-and-done therapy, this will set the standard of care. We are not worried about other therapies if they come to the market first. It is good—those therapies will educate the market and create market education. We may be behind them, but it is okay, because we believe we are going to set the standard of care for Stargardt patients globally. Huma?

Yes, I would like to add that this is the trial that we are also having the population three years of age and above versus the other trials that are very limited in the age population. Also, the inclusion/exclusion criteria are very globally representative. Other than that, OCU410ST is targeting early to advanced cases of Stargardt disease. If you look at the comparison, the safety, tolerability, and efficacy that we have seen in terms of lesion growth reduction and also the functional and structural outcomes have been trending in the right direction and are promising from the clinical standpoint as well.

Thank you. It is certainly an exciting time for the space. I am looking forward to any further updates that you have.

Thank you.

Thank you. Our next question comes from the line of Boris Peaker from TD Cowen. Please go ahead.

Boris? Mr. Peaker, you might be on mute.

Apologies—just came off mute. So for the RP OCU400 rolling BLA, when would we get the FDA feedback on your CMC part of the filing?

Typically, the CMC will be filed this year. Obviously, FDA has the right to request comments before, or they will wait for the entire BLA to be filed. Even though they are internally reviewing, you may not expect anything before the actual final clinical module is filed.

Got it. And, speaking of the FDA, have you discussed the ellipsoid zone as an endpoint with the Agency? I am just curious what their thoughts are about it as maybe a secondary endpoint. Is it something that could be incorporated into a label claim? Would that make any kind of a difference from the commercial perspective? Just general thoughts on that endpoint.

Ellipsoid zone—obviously, as we stated before, in all our clinical trials we are trying to show benefit because the diseases we are targeting have significant unmet medical needs. More delays and doing longer trials will take not only the resources from our perspective; it is not doing benefit to the patients. If you are able to show a benefit using primary endpoints we picked, which are acceptable, the EZ will be a secondary and some other analyses just to further support that we are demonstrating a good functional outcome or related to functional outcome. That is important. If you do longer trials, like two or three years, sure, we can look into multiple options. From FDA's perspective, they really focus on the primary endpoint. If you hit the primary endpoint, you will get the approval. If you hit the secondary, yes, you can include it in the product insert and the label. However, remember, in all our clinical trials, we have an obligation to continue them for five years for safety monitoring. That means one-year data are needed for filing. After that—second year, third year, fourth year, fifth year—we monitor the patients. We will continue to monitor them with these secondary endpoints. At any point the data are supportive, we can always add it to the label. From FDA's perspective, you have to hit the primary endpoint to get the product approved. Secondary is not necessary for approval. If you hit it, it is good; you can put it in the label.

Got it. But I just want to understand also, have you spoken to docs—what is the commercial value? Let us say you could get an ellipsoid zone label claim—not the primary endpoint, but still mention this positive in the label. Would that really make a difference? Is this something that the docs actually care about, or is it just kind of scientifically nice and it raises curiosity more than anything else?

Boris, this is Huma. So in terms of your question, with FDA alignment, yes, all the protocols are approved with exploratory secondary endpoints. In terms of EZ, it is the new hot topic for the clinicians in terms of functional outcomes and structural integrity for photoreceptors and retinal pigment epithelium. This is where FDA is leaning a lot based on these particular conditions such as Stargardt disease and geographic atrophy secondary to age-related macular degeneration. In fact, there has been buy-in and consensus from the IRD physicians as well as the geographic atrophy AMD surgeons as well. There is a real benefit to it, not only from the structural perspective but also from functional. This is now being taken not only nationally in the U.S., but also in Europe as well. Of course, there is clinical meaningfulness in terms of functional outcome for EZ. That is what we are seeing that could have potential meaning when we are going to file our claim commercially.

Also, for geographic atrophy, Phase 3 has not started. That is why we are going to look at the entire Phase 2 dataset this month, and then we are going to propose the endpoints with FDA and EMA. We do have an opportunity to introduce EZ as a secondary endpoint if the data are trending the way we anticipate.

Great. Thank you very much for taking my questions.

Thank you.

Thank you.

Our next question comes from the line of Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.

Thank you. Good morning, Shankar, Rita, and Huma. A couple of questions from me. Looking into the OCU410 program, in the Phase 2 study, the medium dose showed a 54% reduction versus the high dose, which showed a 36% reduction. I am trying to understand, as you go into your Phase 3 study, what is going to impact your decision for dose selection? Also, do you think that between these doses you are actually seeing some sort of a plateau effect in the transgene expression?

Good morning. The data we released—obviously, the high dose had fewer numbers in there. I would wait until we get the complete dataset this month to make an inference. From the Agency's perspective, if the lower dose is showing equal or better effect, you would take that into Phase 3. That is standard practice. I suggest we wait. Typically, for our genes—and what we have seen in our RP studies too—these genes require a threshold. Once you hit the threshold, we did not see any dose response. We are going to evaluate carefully once we get the full dataset.

Thanks for that. In the subpopulation where the baseline lesions were greater than or equal to 7.5 mm², you saw a 57% reduction in lesion growth. As you get into the Phase 3 study, would you have any restrictions in terms of the size of the lesions, or do you plan to use the same criteria as in Phase 2, which was all comers?

That is a good question. This is why we do Phase 2. We are going to carefully evaluate. We go from 2.5 to 22 mm², and we are going to evaluate and see. On the lower side, as you know, analytically, you will have more variability. Of course, we are going to look at where the average patients fall, even though in the larger trials people have done with a lot of data. We are going to look at all those metrics and see what is the right group to go into Phase 3.

Alright. The last question from me is on the OCU410ST program, where you are expecting to get the enrollment done this quarter and put up some interim data in Q3. In that dataset, what are we really looking for which can give us some indication of how the 2027 BLA filing is going to go, especially signals on either the structural side of things or on the functional side of things? What do you weigh more, and how should we be thinking when the data come out?

In terms of the masked interim analysis that is coming later part of the year, it will be for 24 subjects—16 treatment and 8 in the control. This is the adaptive design; that is a unique approach we have taken. The data points we are going to present, as we have presented this morning as well, are the primary endpoint—the lesion growth reduction—as well as structural and functional outcomes, which include visual acuity. We are also looking into the ellipsoid zone, which is the functional outcome that is very unique, and that data were very well received from the Stargardt perspective that we recently presented at one of the conferences as well. We are going to look at all of that, and, of course, safety and tolerability will be there as well. As of right now, it is trending in the right direction. This is what we are looking to release as masked interim analysis for those subjects later part of the year.

Perfect. Thank you very much. Thanks for taking all my questions.

Our next question comes from the line of Elemer Piros from EF Hutton. Please go ahead.

Good morning. I would like to ask a question about the primary measure of visual function in the RP study. What would be a clinically meaningful improvement? Where do you draw the threshold toward that?

Thanks for your question. As we said, it is a change in lux level improvement from baseline. There are a lot of mutations we are looking into. LDNA—luminance-dependent navigation assessment—is a validated protocol. That is what we are aiming for, and that is what our analysis is going to be based on. As I said earlier as well, there is a lot of heterogeneity with clinical diagnoses, and syndromic and nonsyndromic forms. The clinical meaningfulness is greater than or equal to one lux level.

As Huma has stated, we validated this course during Phase 3 with real patients, and the course looks very robust. Based on our KOL input, they are extremely happy with this.

Thank you. What are some of the secondary endpoints that you would also look at to support that primary?

The secondary endpoints are visual acuity, low-luminance visual acuity, and patient-reported outcome scores. We will be looking into these, and that is very well agreed and aligned with the FDA.

One last question. Are both eyes treated? Could you remind us?

Yes, that is correct. Yes, if both eyes meet the inclusion/exclusion criteria, both eyes are treated. It is a 2:1 randomization, a single subretinal injection, and the control group will have a crossover after one year.

And then—

The study is the worst-eye for analytic analysis per SAP. So you would compare the worst eye to the control group.

The worst eye in that group.

Yes. The study eye is compared to the control group.

Thank you so much.

Thank you.

Our next question comes from the line of Daniil Gataulin from Chardan. Please go ahead.

Hi. This is Steven on for Daniil. Thanks for taking my question. For dry AMD, you mentioned a 50% responder rate. Were there any underlying characteristics that made a patient more likely to be a responder?

Are you talking about OCU410 GA? Yes. In terms of the responder rate, we have the inclusion/exclusion criteria, which were very uniform across the groups. Baseline characteristics included the mean age—we were looking at GA diagnosed at a certain age, with the mean in the mid-70s. We were also looking at the lesion size, which is pretty much well-versed with the OAKS and DERBY trials that Apellis got approval on—7.5 mm² was the mean, up to 8.03. In terms of the baseline characteristics, the responders responded on the medium dose as well as on the high dose. There was not really any other unique criterion that we would cite at this point until we get our final clinical study report. At this point, it seems like it was uniform across all dose groups.

Got it. Thank you.

Thank you. This concludes the Q&A portion.

I will now turn the call back over to Chairman, CEO, and Co-Founder, Dr. Shankar Musunuri.

Thank you, Operator. 2025 was marked by important clinical progress, strategic business development, and essential financing accomplishments across the organization. We are entering 2026 with strong momentum and a clear line of sight to multiple catalysts that will further advance Ocugen, Inc.'s position as a biotechnology leader in gene therapy for blindness diseases. We expect to deliver full Phase 2 data for OCU410 this month, complete enrollment for OCU410ST, initiate Phase 3 for OCU410 in geographic atrophy, and begin a rolling BLA submission for OCU400. I want to thank our employees, investigators, patients, and shareholders for their continued support. We look forward to updating you on our progress. Have a great day. The meeting is now concluded.

Thank you all for joining. You may now disconnect.