Ocugen, Inc. (OCGN) 2025 Q4 法說會逐字稿

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.

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 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 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 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's annual report on Form 10k 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'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 a leadership team made in 2025 a year of real momentum for Ocugen.

We are now poised to leverage upcoming catalysts and advance the business as we near the first of our 3 BLA filings. I'm proud of what this team has accomplished, and I'm confident that with a full bunch 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 RQ 400 and 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 US and Europe are living with RP. It is caused by mutations in more than 100 genes. RQ-400 is designed as a modifier gene therapy utilizing MR2E3. A central transcriptional regulator of retina specific pathways to address multiple genetic mutations with a single one-time treatment.

The only approved gene therapy for RP today targets a single gene, RPE65, which accounts for just 1-2% of the total RP patient population. We believe RP 400 has significantly wider commercial potential, as it is intended to provide a therapeutic option for 98% to 99% of all RP patients.

I'm pleased to report that enrolment is now complete for the RT 400 phase 3 line trial. As a one-year clinical trial, topline data will be available in the 1st quarter of 2027. These data are anticipated to support the biologics license application, BLA filing for RQ400 and potential approval in 2027. The limelight clinical trial enrolled 140 patients who randomized 2 to 1 into the treatment group and untreated control group across mutations, including Rowe and gene agnostic arms.

The gene agnostic arm includes many genetic mutations, including those most prevalent. Tulip cross. XRS, USHA, XLRP and PDE 6B. The target population included patients with early to late-stage disease among a broad RP population, including paediatrics. The primary endpoint is 12 months 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 12 data or 0.400 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 a no new treatment related serious adverse events or adverse events of interest emerged. With enrolment complete and these strong long-term data in hand, we're 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 timeline, and plan 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 of RK 400, we're 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 Company Limited for the exclusive Korean rights 0.400 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 US RP market. This approach allows us to maximize total patient reach while retaining full commercial rights in the US and Europe.

Now, let's move on to Acuf NSD for disease. Aquafor NFD 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 one-time treatment. Stargardt disease affects approximately 100,000 patients in the US and Europe combined and approximately 1 million people globally, with no approved treatment options available. The phase 2/3 GARDian3 total confirmatory trial remains ahead of schedule. We anticipate top-line phase 2/3 data in the second quarter of 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 independence validation further strengthens the scientific foundation supporting the ongoing [Pal] trial.

Importantly, the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency confirmed that data from our single US-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 this OCU400 total trial, streamlining our development efforts and bringing OCU410ST to patients in Europe sooner than originally anticipated.

The program has also received rare paediatric disease designation, further strengthening its regulatory positioning. I would like to explain ellipsoid zone, easy 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 line and is a biomarker for photoreceptor structural integrity and metabolic health. Easy disruption precedes RPE loss and visible atrophy and geographic atrophy and Stargardt disease.

EZ measurement is important because it provides early and sensitive detection. EZ changes occur before visible RP atrophy expansion in GA and start progression. It also enables earlier intervention and more sensitive treatment effect detection in GA and star block. Finally, EZ correlates to earlier functional therapeutic benefit with an effect as early as 1 year compared to other measures such as visual equity with clinically meaningful effect at 2 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 SA and GA trials.

As shown in this bar graph, change from baseline at 12 months in treated fellow eyes across doses, excluding two subjects last to follow-up and one subject with retinal detachment demonstrated 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 modified gene therapy.

Now, let's turn to OCU410 in GA secondary to late-stage AMD. With approximately 2 million to 3 million GA patients in the US and Europe combined, A410 represents a significant market opportunity. OCU410 is specifically designed to address multiple pathways implicated in the pathogenesis of triageated 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 intravital injections, about 6 to 12 doses per year, and are accompanied by various safety risks. For example, roughly 12% of patients develop We 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 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 controlled, with the 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 in two years. So, at one year, OCU410 is already delivering more than double the benefit seen with existing therapies at twice the time.

A subgroup analysis of patients with baseline GA size of 7.5 millimetre square or greater, representing advanced atrophy, demonstrated a 57% reduction in lesion growth in treated eyes 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 data set also included encouraging 12-month phase 1 findings where OCU410 treated eyes demonstrated 60% slower loss of the ellipsoid zone are easy compared to untreated fellow ice. 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 ice.

We look forward to reporting the complete data set 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 enrolment is expected to be completed in the 1st quarter of 2026.

Regarding our inhaled vaccine candidate OCU500, NIAID intends to initiate the Phase 1 clinical trial in the second quarter of 2026.

Finally, we created OrthoHelix 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 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 enrolment 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 OCU200 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 3 BLAs in the next 3 years. Operationally, we also strengthened our executive leadership team with the several appointments, including Abbi 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 Perreault, joined us as executive Vice President of operations. Paul has more than 20 years of leadership experience in biologics and cell and gene therapy technical operations. He joins from Bristol-Myers Square, where for over 16 years he held leadership roles in manufacturing, launch.

Scale up orchestration of reliable global supply chains with a CT focus for the last 5 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 Greene, to provide an update on our financial results for the quarter and full year ended December 31, 2025. Rita.

Thank you, Shankar. I am 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 three months ended December 31, 2025 were $10.7 million compared to $8.3 million for the three months ended December 31, 2024. General and administrative expenses for the three months ended December 31, 2025, were $6.1 million compared to $6.3 million for the three months ended December 31, 2024.

Ocugen reported a $0.06 net loss per common share for the three months ended December 31, 2025, compared to a $0.05 net loss per common share for the three months ended December 31, 2024.

For the full year ended December 30th, 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 Janice Henderson raids are exercised in full, it will extend cash runway into the second quarter of 2027.

That concludes my financial update. Shankar, back to you.

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

(Operator Instructions) Michael Okunewitch, Maxim Group LLC - Equity Analyst

Hey guys, thank you so much for taking my questions today. Congrats On all the great progress. You've made. I guess to start off just given that 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 end point to actually releasing the top-line data. Within 1st quarter 27.

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

Alright, and then just for that end point, 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 the primary metric for RP.

Okay, so, in terms of, the mobility test that we are using proprietary tool Ocugen, that's luminance dependent navigation assessment, it's the mobility test that was approved as the primary endpoint for Luxturna, that is, that was called MLMT at that time, that was only designed for RPE 65 nutrition, 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 clinical 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 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. Thank you.

Thank you. It's 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 OCU410ST. So, I wanted to know how this might impact the opportunity or pricing potential and if there's any reason that OCU410ST couldn't be complementary with other therapies as they come to market.

Yeah, I'll take that. So, there are other therapies out there. Obviously, what we have shown, if you look at the data we published in I, 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're targeting the major pathways which are complex in Stargar MGA with the ura gene, and also we have the 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, in our genes have ability to control the entire network. So there's 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.

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.

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

(Operator Instructions) Boris Peaker, Titan Partners - Analyst

So, for the RP 400 for the rolling BNA BLA, when would we get the FDA feedback on your CMC part of the filing?

Typically, the CMC will be, also we're planning to file this year. Obviously, I mean, FDA has, Write to, request comments before or they will wait for an entire section to be filed, even though they're 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'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 endpoint.

Yeah, ellipsoid zone, I mean, obviously, as we stated before, all our clinical trials. We're trying to show a benefit because the diseases we're 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 easy 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 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 end point. If you hit the primary point, 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 2nd year, 3rd year, 4th year, and 5th year, we monitor the patients. Even we'll continue to monitor them with the 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. You can put it on the label.

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 an ellipsoid zone label claim, obviously not the primary employment, 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 a curiosity more than anything else?

Yeah, go ahead,

Boris, this is Huma. So, in terms of your question, with MDA 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 Stargard 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 the US 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 could have a potential meaningful information when we are going to file our claim commercially.

And also geographic atrophy phase 3 didn't start at. That's why we're going to look at the entire phase 2 data set this month, and then we're going to propose the endpoints with FDA and EMA. So, we do have an opportunity to introduce EZ as a secondary endpoint if the data is trending the way we anticipate.

Great, thank you very much for taking my questions.

(Operator Instructions) Swayampakula Ramakanth, H C Wainwright & Co LLC (Pre-Merger) - Analyst

Thank you. Good morning, Shankar, Rita and Suma. Look, a couple of questions from me. Looking into the, OCU400 program, in the phase 2 study, the medium dose, showed a 54% reduction versus the high dose which showed a 36% reduction. In, so, I'm just trying to understand, when, as you go into your phase 3 study, how, 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?

Okay, good morning. Yeah, 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 an inference and obviously, agency's perspective, if, lower dose is showing equal or better effect, I mean you take that into phase 3, that's a standard practice. And so I suggest, 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 you get the threshold, we didn't see any dose response, so we're going to evaluate carefully once we get the full data set.

Okay, thanks for that. And then, in the subpopulation where the baseline lesions were greater than, equal to or greater than 7.5 mm square, you saw a 57% reduction in the lesion growth. So as you get into the phase three 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 the all comers?

That, that's a good question. Yes, this is why we do phase two, right? We're going to carefully evaluate and we go from what is it 2.5 to 22. And so we're going to evaluate and see because on the lower side, I mean, as 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 with 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 3.

All right. And then the last question from me is on the ST, OCU410ST program, where you're expecting to, get the enrolment 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, 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.

So, RK, good morning. Thanks for your question. So in terms of the mass 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 equity 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 yeah, 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 and this is what we are looking into, to release, mass interim analysis for those subjects, later part of the year.

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

(Operator Instructions) Elemer Piros, Lucid Capital Markets LLC - Equity Analyst

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

So, thanks for your question. So, basically, as we said that it's a change in lux level improvement from baseline, and as there's a lot of mutations we are looking into. Technically one lux level and, more because it's a validated, protocol, LD and aluminance dependent navigation assessment. That's what we are aiming for, and that's, what, our analysis is going to be based of. And, as I've said earlier as well, there's a lot of heterogeneity with clinical diagnosis syndromic non-syndromic forms. So, of course, the clinically meaningfulness is, greater than or equal to one lux level, depending on. Yes, greater than or equal to one.

And I think Elmer, as we, Huma has stated, we have validated this course during phase 3 with the real patients, and, the course looks very robust, and based on our KYL input, they're very extremely happy with this.

Yeah, thank you. And what are some of the secondary end points that you would also look at to support that primary?

Of course, the secondary endpoints are, of course, on the visual equity, low [luence] visual equity, and also, the patient reported outcome scores, they're looking into it, and that is actually very well, agreed and aligned upon with the FDA.

And one last question, are both eyes are treated, if you could remind us.

Yes, it can meet the inclusion exclusion criteria. Both the eyes are treated. It's a two into one, randomization, a single subretinal injection, and, the control group will have a crossover after one year.

And yeah, and the study is the worst type for, analytic analysis. It's sad.

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

Yeah, it's so in the study eye, yeah, study eye is compared to the control group, yeah.

yeah, thank you so much. Yeah, thank you, Shankar. Thanks, Huma.

(Operator Instructions) Daniil Gataulin, Chardan Capital Markets LLC - Analyst

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

Are you talking about the, 41G? Yes. So, in terms of that, the responder rate, by the way, we have the inclusion exposure criteria, which was very well uniform, across the groups, and, it was, not the baseline characteristics were that the, there was a mean age, that we were looking into. And, of course, the GA gets diagnosed at a certain age, but of course, 70, in the mid 70s was the main age. We were also looking at, the lesion size, which actually is pretty much, well versed with the Oaks and Derby trials, and Apple has got approval on it was 7.5 millimetres, that was the main 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 seemed like it was uniform across all, those 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 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 2 data for OCU-410 this month, complete enrolment for OCU410ST, initiate phase 3 for OCU-410 in geographic atrophy, and begin a rolling VLA 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 has now concluded. Thank you all for joining. You may now disconnect.