Ocugen, Inc. (OCGN) Q4 FY2025 Earnings Call Transcript & Summary

March 4, 2026

NasdaqCM US Health Care Biotechnology Earnings Calls 42 min

Earnings Call Speaker Segments

Operator

Operator
#1

Good morning, and welcome to Ocugen's Fourth Quarter and Full Year 2025 Financial Results and Business Update [Operator Instructions] I will now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications. You may begin.

Tiffany Hamilton

Executives
#2

Thank you, operator, and 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 his 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 and full year ended December 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 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 time lines, 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 Securities and Exchange Commission, including the risk factors detailed therein for a more comprehensive understanding of these potential risks. Finally, Ocugen'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.

Shankar Musunuri

Executives
#3

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 Ocugen. 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 Ocugen. We are now poised to leverage upcoming catalysts and advance business as we near the first half or 3 BLA filings. I'm proud of what this team has accomplished, and I'm confident that with a full bench of experienced leadership across the organization, we have the resources and the know-how to drive Ocugen's transition into a commercial stage company. Let me walk you through each program. Starting with OCU400 retinitis pigmentosa, which I will refer to as RP going forward. It is important to note that the Phase III liMeliGhT clinical trial is the only broad RP gene-agnostic trial and the largest known Phase III 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. OCU400 is designed as a modified gene therapy, utilizing NR2E3, a central transcriptional regulator of retina-specific pathways to address multiple genetic mutations with a single onetime 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 OCU400 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 OCU400 Phase III liMeliGhT trial as a 1-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 OCU400 and potential approval in 2027. The liMeliGhT clinical 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. TULP, Cross, XLRS, USHA, 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 3-year Phase I/II data for OCU400 that builds on our prior 2-year results. The data demonstrates sustained clinically meaningful approximately 2-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 emerged. With enrollment complete, and these strong long-term data in hand, we are on track to begin the rolling BLA submission in the third quarter of 2026. Process validation and manufacturing activities are progressing well in support of the time line and brand 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 global rollout to OCU400, we are pursuing regional partnerships that preserve Ocugen's right to larger geographies while also generating near-term value for our shareholders. In 2025, we executed our first regional licensing agreement with Kwangdong Pharmaceutical, Co., Ltd. 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 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 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's move on to our OCU410ST for Stargardt disease. OCU410ST holds the potential to target over 1,200 pathogenic mutations in the ABCA4 gene associated with the Stargardt disease and other ABCA4 related retinopathies with a single onetime treatment. Stargardt disease affects approximately 100,000 patients in the U.S. and Europe combined and approximately 1 million people globally with no approved treatment options available. The Phase II/III GARDian3 pivotal confirmatory trial remains ahead of schedule. We anticipate top line Phase II/III data in the second quarter of 2027, followed by the BLA submission. In January, we announced a peer-reviewed publication of our Phase I GARDian 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 ongoing pivotal trial. Importantly, the Committee for Medicinal Products for Human Use, CHMP of the European Medicines Agency confirm that data from our single U.S.-based trial can also support an EMA application. This alignment allows us to maintain the same time line and budget efficiencies in Europe as we have with this OCU400 pivotal 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 end point for both the GARDian3 and ArMaDa clinical trials. The ellipsoid zone is a hyperreflective band representing photoreceptor inner and outer layer segment function. It indicates photoreceptor health line and is a biomarker for photoreceptor structural integration 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 1 year compared to other measures such as visual acuity with clinically meaningful effect at 2 years or more. Since all of our clinical trials aim to demonstrate benefit at 1 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 untreated fellow eyes across doses, excluding 2 subjects lost to follow-up and 1 subject with retinal detachment, demonstrated a mean of 116% in lesion reduction in a valuable 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 116% lesion reduction and ellipsoid zone integrity highlights meaningful photoreceptor protection and functional therapeutic benefit in Stargardt disease underscoring the key differentiator of modifier gene therapy. Now let's turn to OCU410 in GA secondary to late-stage dry AMD. With approximately 2 million to 3 million GA 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 developed wet AMD following treatment. There are no treatment 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 II 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 of 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 at 2 years. So at 1 year, OCU410 is already delivering more than double the benefit seen with existing therapies at twice the time. The subgroup analysis of patients with baseline GA size of 7.5 millimeter square or greater, representing advanced atrophy, demonstrated a 57% reduction in lesion growth untreated eyes for the medium dose and a 56% reduction or the high dose compared with control. This suggests OCU410 may be even more effective in patients with substantial disease burden. The data set also included encouraging 12-month Phase I finding where OCU410 treated eye 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 data set from OCU410 Phase II ArMaDa trial this month and anticipate initiating Phase III 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 I dose escalation cohorts and trial enrollment is expected to be completed in the first quarter of 2026. Regarding our inhaled vaccine candidate OCU500, NIAID intends to initiate the Phase I clinical trial in the second quarter of 2026. Finally, we created OrthoCellix as a wholly owned subsidiary for our regenerative cell therapy asset, including NeoCart, with the goal to be independent through financing that will maximize value for Ocugen shareholders and patients. We will provide further details as the process progresses. Across the portfolio, 2026 represent multiple defined inflection points. These include completion of enrollment for OCU410ST in early 2026, full Phase II data for OCU410 this month, interim pivotal data for OCU410ST in the third quarter, initiation of Phase III for OCU410 in 2026 and start off rolling BLA submission for OCU400 in the third quarter. Each of these milestones build towards longer-term regulatory and commercialization objectives and reinforces our commitment to file 3 BLAs in the next 3 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-Greene 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 Staid 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, orchestration of reliable global supply chains with a CAR-T focus for the last 5 years. He will lead operations to strengthen execution and support the company's transition towards regulatory approvals and commercialization. I will now turn the call over to Rita Johnson-Greene to provide an update on our financial results for the quarter and full year ended December 31, 2025. Rita?

Rita Johnson-Greene

Executives
#4

Thank you, Shankar. I'm thrilled to join the Ocugen team and support the company through its imminent transitions into a commercial enterprise. Starting with our fourth quarter results, research and development expenses for the 3 months ended December 31, 2025, were $10.7 million compared to $8.3 million for the 3 months ended December 31, 2024. General and administrative expenses for the 3 months ended December 31, 2025, were $6.1 million compared to $6.3 million for the 3 months ended December 31, 2024. Ocugen reported a $0.06 net loss per common share for the 3 months ended December 31, 2025, compared to a $0.05 net loss per common share for the 3 months ended December 31, 2024. For the full year ended December 31, 2025, research and development expenses were $39.8 million compared to $32.1 million for the full year ended December 31, 2024. General and administrative expenses were $27.6 million compared to $26.7 million for the prior year. Ocugen reported a $0.23 net loss per common share for the year ended December 31, 2025, compared to a $0.20 net loss per common share for the year ended December 31, 2024. Our current cash and cash equivalents extend our runway into the fourth quarter of 2026. This includes the recent raise of $22.5 million through an underwritten registered direct offering of common stock led by RTW Investments. In addition, if the $30 million in warrants from the prior Janus Henderson raise are exercised in full, it will extend cash runway into the second quarter of 2027. That concludes my financial update. Shankar, back to you.

Shankar Musunuri

Executives
#5

Thank you, Rita. We'll now open the call for questions. Operator?

Operator

Operator
#6

And we will be taking our first question from Michael Okunewitch from Maxim Group.

Michael Okunewitch

Analysts
#7

Congrats on all the great progress you've made. I guess to start off, just 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 that -- from when you hit on that top line endpoint to actually releasing the top line data within first quarter of '27?

Shankar Musunuri

Executives
#8

Huma?

Huma Qamar

Executives
#9

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

Michael Okunewitch

Analysts
#10

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

Huma Qamar

Executives
#11

Okay. So in terms of the mobility test that we are using proprietary to Ocugen that's Luminance Dependent Navigation Assessment. It's 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 that this is the broad RP indication trial, covering all clinicals syndromic non-syndromic, 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. So this was also aligned with FDA. It's a validated test as well as this was approved by FDA and the only test that can capture the real change with functional outcome, improving the functional outcome or demonstrating the functional outcome in these mutations. And just to let you know, we are the only trial globally that is covering all the majority of the gene agnostic mutations as we have covered this morning in one of our slides as well.

Michael Okunewitch

Analysts
#12

Certainly very helpful. And then last one before I jump back into the queue. For the Stargardt program, it's looking like there could be an approval from another company for a chronic therapy by the time you file for 410ST. So I wanted to know how this might impact the opportunity or pricing potential? And if there's any reason that 410ST couldn't be complementary with other therapies as they come to market?

Shankar Musunuri

Executives
#13

Yes, I'll take that. So there are other therapies out there. Obviously, what we have shown, if you look at the data we published an Eye, in 1 year, again, I wanted to restate all our trials were able to show treatment benefit in 1 year, unlike other trials out there, 2 years or more. And so the data we showed in 1 year is compelling. It looks superior. And also, our goal is to show also functional benefit. With the gene therapy, we are targeting the major pathways, which are complex in Stargardt and GA with RORA gene and also, we have ability to reset the homeostasis and bring -- make sure we create a healthy environment for retinal cells to survive. That's a very important factor. We're not just trying to slow down the disease progression. We're working on the -- and our genes have ability to control the entire network. So there is a big difference. And also, this is one and done. And if you have a one and done therapy, this will set up the standard of care. So we're not worried about other therapies if they come to the market first, it's good. Those therapies will educate the market and they'll create a market education and everything else. We will come back and then we may be behind them, but it's okay because what we believe we are going to set the standard of care for Stargardt patients globally. Huma?

Huma Qamar

Executives
#14

Yes. I would like -- thank you, Shankar. Very well said. So that I would like to add that this is the trial that we are also having the population 3 years of age and above versus the other trials that are very limited in the age population. Also, the inclusion exclusion criteria is very globally representing. Other than that, this is the OCU410ST is targeting early to advanced cases of Stargardt disease. If you look at in the comparison, the safety and tolerability and efficacy that we have seen in terms of lesion growth reduction and also the functional and structural outcomes has been trending in the right direction and promising from the clinical standpoint as well.

Michael Okunewitch

Analysts
#15

Certainly an exciting time for the space. I'm looking forward to any further updates that you have.

Operator

Operator
#16

Our next question comes from the line of Boris Peaker from Titan Partners.

Shankar Musunuri

Executives
#17

Boris?

Boris Peaker

Analysts
#18

Can you hear me? Sorry. Perfect. So for the [ OCU400 ], so the rolling BLA, when would we get the FDA feedback on your CMC part of the filing?

Shankar Musunuri

Executives
#19

Typically, the CMC will be -- also we are planning to file this year. Obviously, I mean, FDA has right to request comments before or they will wait for entire section to be filed. Even though they're internally reviewing, you may not expect anything before that actual final clinal module is filed.

Boris Peaker

Analysts
#20

Got it. And speaking of the FDA, have you discussed the ellipsoid zone as an endpoint with the agency? I'm just curious what their thoughts about it as maybe kind of 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 kind of general thoughts on that end point.

Shankar Musunuri

Executives
#21

Yes. Ellipsoid zone, I mean, obviously, as we stated before, all our clinical trials, we're trying to show a benefit because the diseases we are targeting have significant unmet medical needs. So more delays and doing longer trial trials will take not only the resources from our perspective, it's not doing benefit to the patients. If you're able to show a benefit using primary endpoints, what we picked which are acceptable, obviously, the EZ will be a secondary and some other analysis just to support further that demonstrating -- this is showing a good functional outcome or related to functional outcome. That's important. So if you do a longer trials like 2 or 3 years, sure, we can look into multiple options. So obviously, the agency's perspective, from FDA's perspective, they really focus on primary endpoint. If you hit the primary endpoint, you'll get the approval. If you hit the secondary, yes, you can include it in the product insert and the label. And however, remember, all our clinical trials, we have obligation to continue them for 5 years for safety monitoring. And so that means 1-year data is needed for filing after that second year, third year, fourth year and fifth year, we monitor the patient. Even we'll continue to monitor them with these secondary endpoints. At any point, the data is looking at, we can always add it to the label. So from FDA's perspective, you have to hit the primary endpoint to get the product approved. Secondary is not necessary for approval. I mean if you hit it, it's good, they can put it in the label.

Boris Peaker

Analysts
#22

Got it. But I just want to understand also, have you spoken to docs like what's the commercial value. Let's say you could get on ellipsoid zone label claim, obviously, not the primary endpoint, but still mentioned as 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 curiosity more than anything else?

Shankar Musunuri

Executives
#23

Yes, go ahead, Huma.

Huma Qamar

Executives
#24

Boris, this is Huma. So in terms of your question, with FDA alignment, yes, all the protocols are approved with exploratory secondary endpoints. And yes, in terms of EZ, it's the new hot topic for the clinicians in terms of functional outcomes and structural integrity, for photoreceptor and retinal pigment epithelium. This is where actually 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 a buying in consensus from the IRD physicians as well as the geographic atrophy AMD surgeons as well. And there is a real benefit to it, not only from the structural perspective, but also from functional. But yes, this is now being taken not only nationally in U.S. but also from Europe as well. And of course, there is a clinically meaningfulness in terms of functional outcome for EZ. And that's what we are seeing that, that could have a potential meaningful information when we are going to file our claim commercially.

Shankar Musunuri

Executives
#25

And also geographic atrophy, Phase III didn't started that's why we're going to look at the entire Phase II data set this month. And then we are going to propose the endpoints with FDA and the EMA. So we do have an opportunity to introduce EZ as a secondary end point if the data is trending the way we anticipate.

Operator

Operator
#26

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

Swayampakula Ramakanth

Analysts
#27

A couple of questions from me. Looking into the OCU410 program in the Phase II study, the medium dose showed a 54% reduction versus the high dose, which showed a 36% reduction. So I'm just trying to understand when as you go into your Phase III study, what is going to impact your decision for dose selection? And also, do you think that between these doses, you're actually seeing some sort of a plateau effect in the transgene expression?

Shankar Musunuri

Executives
#28

RK, yes. I think the data we released, obviously, the high dose had less numbers in there. I would wait until we get the complete data set this month to make any inference. And obviously, agency's perspective, if lower dose is showing equal or a better effect, I mean, you would take that into Phase III, that's a standard practice. And so I suggest now we wait. Typically, what we look for in our genes and what we have seen in our RP studies too, typically, these genes require a threshold. Once again the threshold, we didn't see any dose response. So we're going to evaluate carefully once we get the full data set.

Swayampakula Ramakanth

Analysts
#29

Okay. And then in the subpopulation where the baseline lesions were greater than -- equal to or greater than 7.5 millimeter square, you saw a 57% reduction in the lesion growth. So as you get into the Phase III 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 II, which was the all-comers?

Shankar Musunuri

Executives
#30

That's a good question. Yes, this is why we do Phase II, right? We're going to carefully evaluate and we go from -- what is that 2.5 to 22. And so we're going to evaluate and see because on the lower side, I mean, as you know, analytically, you'll have more variability. Of course, we're going to look at where the average patients fall, even though in the large trials, people are done, we have a lot of data. And we're going to look at all those metrics and see what is the right group to go into the Phase III.

Swayampakula Ramakanth

Analysts
#31

All right. And then the last question from me is on the OCU410ST program where you're expecting to get the enrollment done this quarter and put up some interim data in Q3. In that data set, what are we really looking for, which can give us some indication of how the '27 BLA filing is going to go, especially, I'm thinking about the signals on either on the structural side of things or on the functional side of things? And where -- what do you weigh more? And how should we be thinking when the data comes out?

Huma Qamar

Executives
#32

So RK, thanks for your question. So in terms of the masked interim analysis that's coming later part of the year, will be for 24 subjects, 16 treatment and 8 in the control, and this is the adaptive design that's a unique approach we have taken. And what are the -- what kind of data points we're going to present as we have presented this morning as well, of course, the primary endpoint, the lesion growth production as well as structural as well as functional, which is the visual acuity and not -- last but not the least, of course, we are looking into the ellipsoid zone which is the functional outcome, which is very unique, and that data was very well received from Stargardt perspective that we have recently presented at one of the conferences as well. So yes, we are going to look 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, and this is what we are looking into, to release masked interim analysis for those subjects later part in the year.

Operator

Operator
#33

Our next question comes from the line of Elemer Piros from Lucid Capital Markets.

Elemer Piros

Analysts
#34

I'd like to ask a question about the primary measure, visual function in the RP study. What would be a clinically meaningful improvement? Where do you draw the threshold for that?

Huma Qamar

Executives
#35

So thanks for your question. So basically, as we said that it's a change in lux level improvement from baseline. And as you know, there is a lot of mutations we are looking into. Technically, one lux level and more because it's a validated protocol LDNA, Luminance Dependent Navigation Assessment. That's what we are aiming for, and that's what our analysis is going to be based off of. And as I've said earlier as well, there is a lot of heterogeneity with clinical diagnosis in rolling non-syndromic forms. So of course, the clinically meaningfulness is greater than or equal to 1 lux level...

Elemer Piros

Analysts
#36

I lux.

Huma Qamar

Executives
#37

Depending on -- yes. Greater than or equal to 1 lux.

Shankar Musunuri

Executives
#38

And I think Elemer, as we -- Huma has stated, we validated this course during Phase III with real patients and the course looks very robust. And based on our KOL input, they're very extremely happy with this.

Elemer Piros

Analysts
#39

And what are some of the secondary end points that you will also look at to support that primary?

Huma Qamar

Executives
#40

Of course, the secondary endpoints are, of course, on the visual acuity low luminance visual acuity and also the patient-reported outcome scores we will be looking into it. And that is actually very well agreed and aligned upon -- with the FDA.

Elemer Piros

Analysts
#41

And one last question. Are both eyes are treated, if you could remind us in the treatment...

Huma Qamar

Executives
#42

Yes, if it meets the inclusion/exclusion criteria both the eyes are treated. It's a 2-to-1 randomization, a single subretinal injection and the control group will have a crossover after 1 year.

Shankar Musunuri

Executives
#43

Yes. And the study eye is the worst eye for analytic analysis test set.

Elemer Piros

Analysts
#44

So you would compare diverse eye to the control group in diverse eye in that group.

Shankar Musunuri

Executives
#45

Yes. So there is a study eye -- yes, study eye is compared to the control group. Yes...

Operator

Operator
#46

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

Steven Klupt

Analysts
#47

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

Huma Qamar

Executives
#48

Are you talking about the 410 GA?

Steven Klupt

Analysts
#49

Yes.

Huma Qamar

Executives
#50

Yes. So in terms of that the responder rate, by the way, we have the inclusion/exclusion criteria, which was very well uniform across the groups. And it was not -- in the baseline characteristics were that there was a mean age that we were looking into. And of course, the GA gets diagnosed at a certain age but of course in the mid-70s was the mean age. We were also looking at the lesion size, which actually is pretty much well versed with the OAKS and DERBY trials and Apellis got approval on it was 7.5 millimeters square, that was the mean as well, up to 8.03. And in terms of the baseline characteristics, the responders basically responded on the medium dose as well as on the high dose as well. So there was not really any other unique criteria that we would say at this point till we get our final clinical study report at that point. But at this point, it seems like it was uniform across all dose groups.

Operator

Operator
#51

This concludes the Q&A portion. I will now turn the call back over to Chairman, CEO and Co-Founder, Dr. Shankar Musunuri.

Shankar Musunuri

Executives
#52

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 a strong momentum and a clear line of sight to multiple catalysts that will further advance Ocugen's position as a biotechnology leader in gene therapy for blindness diseases. We expect to deliver full Phase II data for OCU410 this month, complete enrollment for OCU410ST, initiate Phase III for OCU410 in geography atrophy and begin our 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.

Operator

Operator
#53

The meeting is now concluded. Thank you all for joining. You may now disconnect.

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