3/4/2026

speaker
Operator
Conference Operator

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

speaker
Tiffany Hamilton
Head of Corporate Communications

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

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

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

speaker
Rho

CROSS, XLRS, USHA, XLRP, and PDE6B.

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

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-month. We also released positive long-term three-year Phase 1-2 data for OCU400 that builds on our prior two-year results. The data demonstrates 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 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 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 AQ400, we are pursuing regional partnerships that preserve AQGEN's right to larger geographies while also generating near-term value for our shareholders. In 2025, we executed our first regional licensing agreement with Guangdong Pharmaceutical Company Limited for the exclusive Korean rights AQ400 with upfront fees and near-term development milestone payments along with royalties. This was a valuable collaboration for Ocigen 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 Ocufortin ST, or Stargardt disease. Ocufortin ST 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 U.S. and Europe combined, and approximately 1 million 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 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-I, 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 ongoing total 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 this OQ400 Pertl trial, streamlining our development efforts and bringing Ocufort NST to patients in Europe sooner than originally anticipated. The program has also received great pediatric 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 Armora 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, angiographic atrophy, and stroke or disease. Easy measurement is important because it provides early and sensitive detection. EZ changes occur before visible RPE atrophy expansion in GA and StarGuard progression. It also enables earlier intervention and more sensitive treatment effect detection in GA and StarGuard. Finally, EZ correlates to earlier functional therapeutic benefit with an effect as early as one year compared to other measures such as visual equity 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, EASY is a relevant measure to show functional outcome in these trials. As EASY analysis has been established as a clinically relevant endpoint for dry AMD clinical trials, it was critical to incorporate this measure for both our SARGOT 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 a mean of 116% in lesion reduction in available treated eyes relative to untreated eyes. Specifically, 50% of OQ-410ST treated eyes achieved Easy 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 Sorghut disease, underscoring the key differentiator of modifier gene therapy. Now let's turn to Ocu410 and GA secondary to late stage dry AMD. With approximately two to three million GA patients in the US 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 intraventricular injections, about six 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 treatment approved for GA in Europe, and existing FDA-approved options have failed to demonstrate meaningful functional outcomes. OQ410 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 OQ410. 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 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% agent size reduction versus control. To put this in context, currently marketed products have demonstrated only a 22% lesion reduction at two years. So at one year, Ocuportin 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 millimeters squared 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 OQ410 may be even more effective in patients with substantial disease burden. The data set also included encouraging 12-month Phase I findings where OQ-410 treated eyes demonstrated 60% slower loss of the ellipsoid zone or easy compared to untreated fellow eyes. The 60% reduction in easy loss rate indicates that OQ-410 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 enrollment is expected to be completed in the first quarter of 2026. Regarding our inhaled vaccine candidate, RQ500, NIAID intends to initiate the Phase 1 clinical trial in the second quarter of 2026. Finally, we created OrthoCellix as a wholly-owned subsidiary for our regionally-reduced SELTAD-B assets, including Neocard, with the goal to be independent through financing that will maximize value for oxygen 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 acute 410ST in early 2026, full phase two data for acute 410 this month, interim total data for acute 410ST in the third quarter, Initiation of phase three for RQ410 in 2026 and start of rolling BLA submission for RQ400 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 the 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 State 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 Square, where for over 16 years, he's held leadership roles in manufacturing, launch, scale-up, 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 December 31st, 2025. Rita?

speaker
Rita Johnson-Green
Chief Financial Officer

Thank you, Sankar. 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 31st, 2025 were $10.7 million compared to $8.3 million for the three months ended December 31st, 2024. General and administrative expenses for the three months ended December 31st, 2025 were $6.1 million compared to $6.3 million for the three months ended December 31st, 2024. Ocugen reported a six cent net loss per common share for the three months ended December 31st, 2025 compared to a five cent net loss per common share for the three months ended December 31st, 2024. For the full year ended December 31st, 2025, research and development expenses were $39.8 million compared to $32.1 million for the full year ended December 31st, 2024. General and administrative expenses were $27.6 million compared to $26.7 million for the prior year. Oxygen reported a 23 cent net loss per common share for the year ended December 31st, 2025, compared to a 20 cent net loss per common share for the year ended December 31st, 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 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.

speaker
Rho

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

speaker
Operator
Conference Operator

If you'd like to ask a question, please press star and the number one on your telephone keypad to raise your hand and answer the queue. And if you'd like to withdraw your question or your question has been answered, please press star and the number one again. And we will be taking our first question from Michael Okunovic from Maxine Group.

speaker
Operator
Q&A Operator

Please go ahead.

speaker
Rho

Hey, guys. Thank you so much for taking my questions today. Congrats on all the great progress you've made.

speaker
Michael Okunovic
Analyst, Maxine Group

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 when you hit on that top-line endpoint to actually releasing the top-line data? within first quarter 27.

speaker
Dr. Huma Kumar
Chief Medical Officer

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

speaker
Michael Okunovic
Analyst, Maxine Group

All right, 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 a primary metric for RP?

speaker
Dr. Huma Kumar
Chief Medical Officer

Okay, so in terms of the mobility test that we are using proprietary to OCHIGEN, 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 one to two percent 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 zero to nine 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. Thank you.

speaker
Michael Okunovic
Analyst, Maxine Group

Thank you. That'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 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.

speaker
Rho

Yeah, I'll take that.

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

So 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 wanted to restate all our trials were able to show treatment benefit in one year, unlike other trials out there, two years or more. And so the data we showed in one 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 Stargardt and GA with the RORA gene. And also, we have ability to reset the homeostasis and bring, you know, 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, you know, 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, you know, behind them, but it's okay because what we believe, we are going to set the standard of care for Stargardt patients globally.

speaker
Dr. Huma Kumar
Chief Medical Officer

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 working 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 is very globally representing. Other than that, this is the Ocufortin ST 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.

speaker
Rho

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

speaker
Operator
Q&A Operator

Thank you. Thank you.

speaker
Rho

Our next question comes from the line of Boris Peker from Titan Partners. Please go ahead. Sorry.

speaker
Boris Peker
Analyst, Titan Partners

Perfect. So for the RP400, for the rolling BLA, when would we get the FDA feedback on your CMC part of the filing?

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

Typically, the CMC will be also planning to file this year. Obviously, I mean, FDA has right to, you know, 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 the actual final clinical module is filed.

speaker
Boris Peker
Analyst, Titan Partners

Got it. And, you know, speaking of PFDA, have you discussed the ellipsoid zone as an endpoint with the agency? I'm just curious what their thoughts about it as maybe, you know, 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.

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

Yeah. In Ipsos 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, you know, demonstrating this is showing a good functional outcome or related to functional outcome. That's important. So if you do longer trials, like two or three 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 five years for safety monitoring. And so that means one year data is needed for filing. After that, second year, third year, fourth year, and fifth 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. I mean, if you hit it, it's good. You can put it in the label.

speaker
Boris Peker
Analyst, Titan Partners

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, you know, obviously 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 a curiosity more than anything else?

speaker
Dr. Huma Kumar
Chief Medical Officer

Yeah, go ahead, Hilma. Boris, this is Hilma. 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 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 the U.S., but also from Europe as well. And of course, there is a clinically meaningfulness in terms of functional outcomes for EZ. And that's what we are seeing that, you know, that could have a potential meaningful information when we are going to file our claim commercially.

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

And also, geographic entropy phase three didn't start yet. That's why we're going to look at entire phase two 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.

speaker
Operator
Q&A Operator

Great. Thank you very much for taking my questions. Thank you. Thank you.

speaker
Rho

Our next question comes from Valenswayan Pakula Ramakant from HC Wainwright. Please go ahead. Thank you.

speaker
Valenswayan Pakula Ramakant
Analyst, HC Wainwright

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

speaker
Rho

Okay, good morning.

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

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 would take that into phase three. That's a standard practice. And so I suggest that 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 you get the threshold, we didn't see any dose response. So we're going to evaluate carefully. once you get the full data set.

speaker
Valenswayan Pakula Ramakant
Analyst, HC Wainwright

Okay, thanks for that. And then, you know, in the subpopulations where the baseline lesions were greater than, equal to or greater than seven and a half millimeters square, you saw a 57% reduction in the lesion growth. So as you get into the phase three study, you know, 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 two, which was the all comers?

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

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 in the lower side, I mean, as you know, analytically, you'll have more variability. Of course, we're going to look at you know, 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 three.

speaker
Valenswayan Pakula Ramakant
Analyst, HC Wainwright

All right. And then the last question from me is on the ST, OCU410 ST program, where, you know, you're expecting to get the enrollment done this quarter and put up some interim data. in Q3, in that data set, you know, 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 either on the structural side of things or on the functional side of things, and what do you weigh more, and how should we be thinking when the data comes out?

speaker
Dr. Huma Kumar
Chief Medical Officer

So, RK, good morning. 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 eight 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 reduction 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 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.

speaker
Valenswayan Pakula Ramakant
Analyst, HC Wainwright

Perfect.

speaker
Operator
Q&A Operator

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

speaker
Operator
Conference Operator

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

speaker
Elemer Piros
Analyst, Lucid Capital Markets

Yes, good morning. 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?

speaker
Dr. Huma Kumar
Chief Medical Officer

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, LG and Illuminance 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'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 lux.

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

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

speaker
Elemer Piros
Analyst, Lucid Capital Markets

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

speaker
Dr. Huma Kumar
Chief Medical Officer

So, of course, the secondary endpoints are, of course, on the visual equity, low-liveness visual equity, and also, you know, the patient-reported outcome scores. We will be looking into it. And that is actually very well, you know, agreed and aligned upon with the FTAs.

speaker
Elemer Piros
Analyst, Lucid Capital Markets

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

speaker
Dr. Huma Kumar
Chief Medical Officer

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

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

And the study is the worst type for analytic analysis, exactly.

speaker
Elemer Piros
Analyst, Lucid Capital Markets

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

speaker
Rho

Yeah. So the study eye, yeah.

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

Study eye is compared to the control group.

speaker
Rho

Yeah. Thank you so much.

speaker
Elemer Piros
Analyst, Lucid Capital Markets

Thank you, Shankar. Thanks, Huma.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Danil Gataoulin from Chardon.

speaker
Rho

Please go ahead.

speaker
Operator
Conference Operator

Hi, this is Steven . 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?

speaker
Dr. Huma Kumar
Chief Medical Officer

Are you talking about the 410 ? 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 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 Apple has got approval on it was 7.5 millimeters squared. That was the mean as well, up to 8.03 millimeters. And in terms of the baseline characteristics, the responders basically responded, you know, 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 until we get our final, you know, clinical study report at that point. But at this point, it seemed like it was uniform across all dose groups.

speaker
Operator
Conference Operator

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.

speaker
Dr. Shankar Musunuri
Chairman, CEO & Co-Founder

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 OccuGen'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 Ocu410-ST, initiate Phase III for Ocu410 in geographic 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.

speaker
Operator
Conference Operator

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

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