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Date
Wednesday, Nov. 5, 2025 at 8:30 a.m. ET
Call participants
Chairman, Chief Executive Officer, and Co-Founder — Shankar Musunuri
Chief Accounting Officer — Ramesh Ramachandran
Chief Medical Officer — Huma Qamar
Senior Director, Investor Relations and Communications — Tiffany J. Hamilton
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Takeaways
Cash Balance -- $32.9 million as of September 30, 2025, with management stating this provides runway through 2026 after a $20 million financing in Q3 2025.
Operating Expenses -- $19.4 million for the quarter ended September 30, 2025, including $11.2 million for research and development and $8.2 million for general and administrative costs.
OCU400 Phase 3 Progress -- Nearing enrollment completion, with BLA and MAA submissions expected in 2026 and commercialization anticipated in 2027.
European Regulatory Alignment -- European Medicines Agency's CHMP confirmed acceptability of a single US-based trial for OCU410 SC submission, enabling timeline and budget efficiency.
South Korea Licensing Deal -- Exclusive agreement with Guangdong Pharmaceutical Company Limited for OCU400, valued at up to $7.5 million in upfront and development milestone payments, plus $1.5 million in sales milestones for every $15 million in sales in South Korea, and a 25% royalty on net sales in South Korea.
OCU410SD Clinical Results -- Twelve-month phase one data showed 48.2% lesion growth reduction and a six-letter visual acuity gain in treated eyes compared to untreated controls at twelve months; all treated eyes demonstrated stabilization or improvement in visual function.
OCU410 Market Potential -- OCU410 targets approximately two to three million atrophy patients in the US and Europe, with no approved GA treatments in Europe; twelve-month phase one data showed a 23% lesion growth reduction in treated eyes and a ten-letter gain or stabilization in vision for treated eyes at twelve months.
Manufacturing Capacity -- Ongoing process validation runs are on target, with all material suitable for commercialization and a Malvern, Pennsylvania facility planned to be ready by 2027 for US supply.
OCU200 Phase 1 Enrollment -- On track to complete enrollment by year-end 2025 with nine to twelve subjects; no serious adverse events related to the product reported thus far.
Pipeline BLA Timeline -- Management reiterated intent to file three biological licensing applications in the next three years.
Summary
Ocugen (OCGN 2.45%) reported $32.9 million in cash as of Q3 2025, bolstered by recent financing and expects operational runway through next year. The company announced strategic progress on its gene therapy platform, with OCU400 phase three trial close to enrollment completion and filings planned for US and EU regulatory agencies in 2026. European regulatory acceptance of a US-based trial design for OCU410 streamlines submission timelines in both regions. The new South Korean licensing agreement for OCU400 secures non-dilutive capital inflow and potential sales-based milestone revenues. Recent clinical data from OCU410SD indicated marked efficacy in lesion reduction and visual function enhancements for target diseases without approved therapies.
Management noted that only $1 million of the Guangdong Pharmaceutical upfront payment was included in reported cash as of September 30, 2025, with the remaining milestones still pending receipt.
Dr. Musunuri stated, "all the material we're making in support of the registration they can be commercialized. So we will have lots made, ready to go," underscoring readiness for commercial supply.
Plans are in place to gradually ramp US commercialization of OCU400 in 2026, with additional regional partnerships being pursued for ex-US launches.
Regulatory authorities in South Korea are expected to follow FDA approval for OCU400, potentially allowing rapid market entry after US authorization.
Phase two-three interim data readout for OCU410SD is scheduled for mid-2026, with only limited information expected to be made public.
Industry glossary
BLA (Biologics License Application): Formal FDA submission seeking approval to market a biological medical product in the United States.
MAA (Marketing Authorization Application): EU regulatory submission for approval of a new medicinal product in Europe.
CHMP: Committee for Medicinal Products for Human Use, the scientific body of the European Medicines Agency responsible for evaluation of medicines.
Process Validation (PPQ): Manufacturing runs conducted to confirm reproducibility and quality of biologic products at commercial scale.
GA (Geographic Atrophy): Advanced form of dry age-related macular degeneration marked by irreversible loss of retinal cells and vision.
DMC (Data Monitoring Committee): Independent group overseeing patient safety and data integrity during a clinical trial.
Subretinal Injection: Administration of therapeutics directly beneath the retina, frequently used for gene therapy delivery.
RMAT: Regenerative Medicine Advanced Therapy, an FDA designation for expedited development of eligible therapies.
Full Conference Call Transcript
Tiffany J. Hamilton: 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. Ramesh Ramachandran, our Chief Accounting Officer, is also on the call to provide a financial update for the quarter ended September 30, 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 2025. We encourage listeners to review the press release, which is available on our website at ocugen.com.
This call is being recorded, and a replay with the accompanying slide presentation will be available on the Investors section of the Ocugen website for approximately forty-five days. This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as predicts, believes, potential, proposed, estimates, anticipates, expects, plans, intends, may, could, might, will, should, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements include, but are not limited to, statements regarding our clinical development activities and related anticipated timelines.
Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission, the SEC, including the risk factors described in the section entitled Risk Factors. The quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation.
Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation. Finally, Ocugen's quarterly report on Form 10-Q covering 2025 will be filed today. I will now turn the call over to Dr. Musunuri.
Shankar Musunuri: Thank you, Tiffany. Thank you all for joining us today. I'm pleased to share an update on our modifier gene therapy platforms. We would like to recognize that in just over three years, we brought our lead candidate, OCU400, from initial phase one-two dosing to nearing phase three enrollment completion. The OCU410 ST phase two-three pivotal confirmatory trial is following close behind, and we're on track to complete enrollment in 2026, lining up for our planned biological licensing application (BLA) submission in 2027 for OCU410.
This rapid progress is somewhat unheard of in the industry and not only reinforces our commitment to file three BLAs in the next three years, but it also brings us closer to addressing the incredible unmet medical needs that exist for patients facing vision loss. When all three programs are moving along on schedule, we received additional positive news in the third quarter that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency confirmed the acceptability of a single US-based trial for submission of MAA in Europe for OCU410 SC. This alignment allows us to maintain the same timeline and budget efficiencies in Europe as we have with the OCU400 total trials.
To fund clinical trial progress, we continue to pursue opportunities to increase our working capital and in August closed the registered direct offering with Janice Henderson. The gross proceeds were approximately $20 million, which we anticipate to last through 2026. We will receive $30 million of additional gross proceeds if the warrants are exercised in full, extending into 2027. The OCU400 phase three limelight clinical trial remains on track for BLA and MAA submissions in 2026. It has only brought Retinitis Pigmentosa (RP) gene agnostic trial to address multiple genetic mutations with a single therapeutic approach. It's important to note that this is the largest known phase three orphan gene therapy trial.
There are approximately 300,000 people in the US and Europe combined living with RP, which affects more than 100 genes. Ocugen's gene agnostic approach has the potential to treat multiple gene mutations associated with RP with a single one-time subretinal injection. Currently, the only approved gene therapy for RP targets a single gene, RPE65, which accounts for one to two percent of the RP patient population. This product achieved peak sales of $52 million in 2023, with a patient population of approximately 2,000. We believe OCU400 has far greater commercial potential as it is intended to provide a therapeutic option for the remaining 98 to 99 percent of RP patients. We anticipate commercialization in 2027.
Process validation and manufacturing activities are progressing well in support of the BLA. Brand planning and market initiatives led by Abhi Gupta, our EVP of Commercial and Business Development, are scaling up as well. We will begin rolling submission of the OCU400 BLA in 2026 and release phase three top-line data in 2026 in line with our commitments. As we prepare for what will ultimately be a global rollout for OCU400, we are pursuing regional partnerships that preserve Ocugen's rights to larger geographies to maximize total patient reach while also generating returns for our shareholders. In September, we announced an exclusive licensing agreement with Guangdong Pharmaceutical Company Limited for the rights to OCU400 in South Korea.
Under the agreement, the company will receive up to $7.5 million in upfront and development milestone payments plus sales milestones of $1.5 million for every $15 million of sales in South Korea, projected to reach $180 million or more in the first ten years of commercialization. We will also earn a 25% royalty on net sales generated by Guangdong and will be responsible for manufacturing and supply of OCU400. There are an estimated 7,000 individuals in the Republic of Korea with RP, which represents approximately 7% of the US market. OCU400 provides the opportunity for our partner to help thousands of patients facing vision loss.
Upon regulatory approval of OCU400 in Korea, we believe Guangdong will become a leader in the field of optogenetic gene therapy in South Korea. Now, let's move on to OCU410 SD. OCU410SD has the potential to target over 1,200 pathogen mutations in the ABCA4 gene associated with Stargardt disease and other ABCA4-related retinopathies with a single one-time subretinal injection. As I mentioned earlier, enrollment in the phase two-three GUARDIN-three clinical trial is ahead of schedule. The strong response underscores the significant unmet medical need among target patients who currently have no approved treatment options available. Stargardt disease affects approximately 100,000 people in the US and Europe combined and approximately one million people globally.
With CHMP acceptance of US trial data for the MAA submission, we will maximize resources and streamline development efforts with the goal of bringing OCU410SD to patients in Europe sooner than originally anticipated. The twelve-month data from all available phase one subjects showed highly encouraging results with a 48.2% reduction in lesion growth and a meaningful one-line six-letter gain in visual acuity in available treated eyes compared with untreated eyes. All treated eyes also demonstrated stabilization or improvement in visual function, highlighting a consistent and tangible therapeutic benefit. Interim data from the ongoing phase two-three study is expected mid-2026, further advancing our goal of bringing OCU410SD to patients in need.
Finally, 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, which does not fully address the disease progression and underlying causes of vision loss. Currently approved treatment options require frequent intravitreal injections, about six to twelve doses per year, and are accompanied by various safety risks. For example, roughly 12% of patients develop wet AMD following treatment. With approximately two to three million atrophy patients in the US and Europe combined, OCU410 represents a significant market opportunity.
Current therapies have notable limitations, and there are no treatments approved for GA in Europe, as existing FDA-approved options fail to demonstrate meaningful functional outcomes. OCU410 is therefore well-positioned to address this critical unmet medical need. At twelve months, available subjects in the phase one study show a 23% reduction in lesion growth along with a two-line or 10-letter stabilization or gain in visual acuity in treated eyes. Preliminary results from six-month interim analysis demonstrated a 27% reduction in lesion growth and preservation of retinal tissue in the treated eyes compared to untreated control eyes. This reduction is over twice that observed with currently approved intravitreal therapies at six months.
Monthly and every other month pegcetacoplan injections showed only 13% and 12% reductions respectively, highlighting OCU410's potential to provide a significant and meaningful therapeutic benefit to patients with one-time treatment. In addition to the greater lesion reduction, a single subretinal injection of OCU410 demonstrates greater efficacy in preserving retinal tissue surrounding GA lesions compared with monthly and every other month pegcetacoplan treatments. We plan to provide full twelve-month data from the phase two study, including both structural and functional outcomes, in 2026 and anticipate initiating the phase three study next year. I will now turn the call over to Ramesh Ramachandran to provide an update on our financial results for the quarter ended September 30, 2025.
Ramesh Ramachandran: Thank you, Shankar. The company's cash, cash equivalents, and restricted cash totaled $32.9 million as of September 30, 2025, compared to $58.8 million as of December 31, 2024. With the recent $20 million financing in the third quarter, we believe our current cash position provides sufficient runway to operate through 2026. Total operating expenses for the three months ended September 30, 2025, were $19.4 million and included research and development expenses of $11.2 million and general and administrative expenses of $8.2 million. This compares to total operating expenses for the three months ended September 30, 2024, of $14.4 million that included research and development expenses of $8.1 million and general and administrative expenses of $6.3 million.
That concludes my update for the quarter. Tiffany, back to you.
Tiffany J. Hamilton: Thank you, Ramesh. We will now open the call for questions. Operator?
Operator: At this time, I would like to remind everyone, in order to ask a question, please press star, then the number one on your telephone keypad. Your first question comes from the line of Michael Okunewitch with Maxim Group. Please go ahead.
Michael Okunewitch: Hey, guys. Thank you very much for taking my questions today. Congratulations on all the progress. Thank you, Mike. So I guess to just start out, I'd like to ask a little bit about OCU400 and in particular the timing of the BLA completion. You mentioned that you're going to be starting that in 2026, a rolling BLA. But then how quickly do you believe that you can turn around the pivotal data over to the FDA and complete that filing?
Shankar Musunuri: As soon as it gets in. Think, I mean, we're nearing completion as we stated. And, so we will have resources ready to turn around in weeks.
Michael Okunewitch: Alright. It's great to hear. And then in terms of your manufacturing, are there any other items that you need to do to get ready for commercial manufacturing before you can start submitting that and start the rolling BLA process?
Shankar Musunuri: Yeah. Good question. Our PPQ, our process validation runs are doing very well. They're on target. In fact, all the material we're making in support of the registration they can be commercialized. So we will have lots made, ready to go.
Michael Okunewitch: Alright. Thank you. And then just one more for me, and I'll hop back into the queue. For OCU410 ST, with the upcoming interim readout, what endpoints are you expecting to release? Or is that going to be an internal DSMB review?
Shankar Musunuri: I mean, for endpoint for the phase two? Yes. It's already, in the clinical protocol. We're looking at lesion growth compared to untreated control group. We do have untreated control group. And, the secondary we're looking at visual acuity.
Michael Okunewitch: I'm specifically referring to the interim release that you're expecting mid-year 2026. Will that be publicly released or is that going to be internal?
Shankar Musunuri: That's a good point. Yeah. There'll be limited information publicly. The DMC looks at it, and then we'll be informing the agency. And, however, we will give some indications about the clinical trial.
Michael Okunewitch: Alright. Thank you very much. I appreciate the update. It looks like there's a lot to look forward to at Ocugen.
Shankar Musunuri: Thank you.
Operator: Your next question comes from the line of Boris Peaker with Titan Partners. Please go ahead.
Boris Peaker: Good morning. A couple of questions for me. Maybe let's start with the OCU400. Can you just remind us exactly what the statistical design of the Limelight Study is, what the assumptions were? And I'm just curious if you've had kind of recent discussion with the FDA to make sure that it's acceptable. I think this question comes in a context of what we've seen just recently with UniCure where it sounds like the FDA may have moved the goalpost a little bit in their gene therapy. I think we just want to get a sense to make sure that similar dynamic doesn't happen here.
Shankar Musunuri: Yeah. Good question. I'll start, then Huma will chime in. So first and foremost, I want to distinguish all our clinical trials, our phase two GA trials, we have a control arm within the study. Typically, FDA has been a tradition. Most of the clinical trials really look for control within the study, not using some external controls. Or, very rarely, natural history. So I think I really want to differentiate that from what you mentioned about UniCure. So we do have our OCU400, OCU410 ST, total trials including even 410GA clinical trial we have control untreated control subjects. The clinical trial. So that's what we're using to compare. Huma, go ahead on the clinical trial design.
Huma Qamar: Yeah, thank you, Shankar. So the clinical trial design is we have 150 subjects that we are planning to enroll for the study, 100 in the treatment and 50 in the control, 75 in the rhodopsin, and 75 in the gene agnostic arm with 50 being and 25 in the control. We have 97% power for this study. We have assumed 5-10% treatment effect in the treated and the untreated eyes. And there is a two into one randomization, which means there is, we are treating, both the eyes as they meet the inclusion exclusion criteria. With the worst eye being dosed first.
This is the only trial that is globally available with clinical and or genetic diagnosis of RP with syndromic and covering nonsyndromic forms.
Boris Peaker: Got it. Great. That's very helpful. And maybe a question on OCU200. You mentioned the milestone that we'll see completion of enrollment by the end of the year in phase one. Can you comment when we'll see the data and what would that initial data include?
Huma Qamar: Yeah. You can go ahead. Yes. So we are on track for our OCU200 enrollment for our phase one. Our periodic safety updates are there. There are no serious adverse events related to the product listed as of right now. Yes. The beginning of next year, we will be providing some more updates on the safety and efficacy of OCU200 as soon as it becomes available. But as this is a phase one first in human, there are no serious adverse events related to the investigation. Product reported as of right now.
Boris Peaker: And how many patients will you have in that initial update?
Huma Qamar: So we have a dose-ranging, dose-escalation portion of the study, so that would be almost nine to twelve subjects.
Boris Peaker: Great. Thank you very much for taking my questions.
Operator: Your next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Please go ahead.
Swayampakula Ramakanth: Thank you. Good morning, Shankar and team. So a couple of quick questions. The first one on OCU400. As you know, as you're nearing to the point where you're putting not only your application together but also thinking about commercialization, what sort of investments are you making within the commercial infrastructure so that you know, you're allocating appropriately within your budget for pre-commercial activities?
Shankar Musunuri: Yes. Let me start with that. Yeah. Good morning, RK. Thank you. Yeah. I think, I mean, based on the 2027 launch, next year, we will be ramping up slowly for US commercialization. Obviously, our goal is to look for partnerships, just like we announced one in South Korea, and other regional partnerships in Europe, Japan, elsewhere. But US, we are looking still into because it's a good market, and we have a good handle. We created a lot of these centers for excellence, which will be part of the commercialization for subretinal delivery. Therefore, we will have more information provided next year. But we'll slowly ramp up.
We'll be allocating, carefully limited budget starting with, but we are looking into other revenues to beef that up next year.
Swayampakula Ramakanth: Okay. And then on the AST, with the comment that it's reaching 50% enrollment on the Guardiome three trial, what's the cadence of enrollment there? Are you, and are you having, just trying to understand how the enrollment is going. Is there any geographic, are there any geographies where you know, you're seeing less of an enrollment? And if you know, what's how many patients you need to, you know, your screening so that, you know, you get the enrollment moving?
Huma Qamar: Thank you, Shankar. So, hi, RK. So this trial includes 51 subjects, 34 in the treatment, 17 in the control. We are almost 50% and above in our enrollment. We have completed that. And we are on track. So there are no geographical restrictions here. Actually, I would say, this is basically the disease of the pediatric population. And we are covering early to late stages of Stargardt, also three years of age and above. That's why we are pretty confident we are going to meet the enrollment goals. In fact, we do have almost, you know, half of we have enrolled more than that in the screening queue. So we are on track for completion of our enrollment.
But there are no restrictions. There are almost 15 centers that we have equally covered across in the US, and all of them have, you know, the screening metrics for those patients as well. So we are on track.
Swayampakula Ramakanth: Shankar, if I may, can I ask one quick one? On OCU400 itself? You know, are there, having looked at the data from the earlier studies and the patient characteristics, have you folks identified any of the patients? Obviously, there are some who are high responders and some who are non-responders. In general, how are you thinking about what the real potential is for OCU400? And, you know, what could your commercial strategy be? So that, you know, you try to get the highest adoption that you could get.
Shankar Musunuri: Yeah. So, RK, I mean, our design clearly outlines based on this strong scientific basis, we're targeting entire RP. From early stage to advanced pediatric to adult. And that's the coverage. And, I mean, we are including in our phase three clinical trial all major components of RP. I mean, that means some of the mutations with high prevalence, oligodopsin, or XLRP, crushers, and PDE6B. All those mutations are included with good representation. So our goal is to look at the data holistically, get the broad indication. So that we provide the treatment potentially for all RP patients. Not restricted to specific genotype.
Swayampakula Ramakanth: Thank you. So the market will be wide open.
Shankar Musunuri: Yeah. Go ahead.
Huma Qamar: Okay. Please go ahead.
Swayampakula Ramakanth: No. No. Thanks. That's what I said. Thanks for taking my questions. Thanks. Yeah. Yep.
Operator: Your next question comes from the line of Robert LeBoyer with NOBLE Capital. Please go ahead.
Robert LeBoyer: Good morning. Just as a follow-up from some of the previous questions, my understanding of OCU400 is that it's a regulatory gene that affects the entire gene network downstream with restoring homeostasis. So early stage, late stage, child, adult, specific mutations really wouldn't matter because it's affecting the whole downstream pathway that leads to blindness. So, please let me know if that is the correct way to think about it.
Shankar Musunuri: Yeah. Absolutely, Robert. You stated it.
Robert LeBoyer: Okay. And, secondly, the OCU410 in GA is also ongoing. And could you just go over some of the endpoints and what to expect in that trial?
Huma Qamar: Yes. Hi, Robert. So we have completed our ARMADA enrollment, phase one slash The Phase I was a typical dose-ranging, dose-escalation three plus three design, nine subjects there. And also we had phase two where we had a high dose, medium dose, and a control, which means that we enrolled 17 subjects in high dose, seventeen in the medium dose, and 17 in the control. Also in terms of the endpoints in phase two-three, which is important, the cytographic atrophy lesion growth reduction from baseline and also looking at, you know, low luminance visual acuity over the period of time as well, which is function.
We have been consistently releasing the data on that and we are on track for following up those patients till early part of next year.
Shankar Musunuri: So that's a one-year time point, Robert, to clarify. Hello? Our GA trial is a one-year trial.
Robert LeBoyer: Okay. Great. Thank you very much for that detail.
Shankar Musunuri: Welcome.
Operator: Your next question comes from the line of Elamor Pirros with Lucid Capital Markets. Please go ahead.
Elamor Pirros: Yes. Good morning. So Shankar, you talked about OCU410 ST and your agreement. No. I think it yes. OCU410 ST. Your agreement with the European agent that the US trial would be sufficient. Do you have a similar agreement related to the RP program as well?
Shankar Musunuri: Yes. Yeah. Have similar agreement with CHMP. But EMA. Okay. I'm not the program too. Yeah.
Elamor Pirros: Okay. And what would be the regulatory path in South Korea for OCU400?
Shankar Musunuri: Yeah. The currently, it looks like, South Korea and the rest of the world typically for orphan gene therapies. They're following FDA closely. Once you get FDA approval, based on the FDA approval, you get approvals in those countries.
Elamor Pirros: Got it. Most of these countries don't need any additional clinical trials.
Shankar Musunuri: Yeah. I understand. And one housekeeping question. How much of the $7.5 million or up to $7.5 million that you received from Guangdong is included in the cash balance that you reported?
Shankar Musunuri: The $7.5 million is not included in the cash one at this point in time. It is going to be in the future. So that's not part of our cash burn at this point in time.
Elamor Pirros: And could they project some into the fourth quarter in terms of the initial payment?
Shankar Musunuri: The $1 million which we received from Guangdong, that is already in the cash projection, but nothing more than that.
Elamor Pirros: Okay. $1 million. Okay. And lastly, could you talk about your manufacturing capacity, Shankar? Especially when we think about much larger indications such as OCU410 for geographic atrophy.
Shankar Musunuri: Yeah. The manufacturing capacity, we have an ex-US partner with plenty of capacity. And the goal is to, I mean, we have our own facility in our backyard in Malvern, Pennsylvania. And that facility will be ready. Our plan is to get that ready by 2027. And when we get the first approval, it's called, prior to close supplement with the US FDA. We have to add the site. Our goal in the future is to produce all US supply from our US manufacturing site.
Elamor Pirros: But you mentioned also that you have an ex-US partner as well, manufacturing partner?
Shankar Musunuri: That's right. Yeah. Currently. Yeah. And we have plenty of capacity. Global capacity.
Elamor Pirros: Okay. Thank you so much.
Operator: Final question comes from the line of Daniil V. Gataulin with Chardan. Please go ahead.
Daniil V. Gataulin: Yes. Hi. Good morning, guys. Thank you for taking my questions. I have a couple here. First, on OCU400. The trial, as we know, we have two arms, one with rhodopsin mutations, one with RP, gene agnostic mutations. For the gene agnostic arm, can are you disclosing how many different mutations are included there? And in terms of the enrollment, did one arm see a more robust enrollment than the other?
Huma Qamar: Thank you. Thanks for the question. So actually, an assessor-blinded study. So at this point, we cannot disclose gene agnostic means that all the major mutations will be covered, which is more than 95% geographically. Look at it in the US and globally. So we are going to cover that in the gene agnostic and on all forms of rhodopsin are going to be in the rhodopsin arm. So that is the first one. And yes, there is a robust enrollment randomization that we are proceeding with. As we stated, clinical and or genetic diagnosis, syndromic as well as nonsyndromic forms.
Daniil V. Gataulin: Okay. Got it. In terms of prep for BLA filing for OCU400, what are the outstanding CMC or what is the outstanding CMC work that needs to be completed before you file?
Shankar Musunuri: Yeah. With the RMAT designation, Daniil, we have the opportunity to initiate rolling submission. As we stated. In the first half of next year. And, so you can submit nonclinical and CMC sections. So as far as CMC is concerned, we have to complete our process validation runs. Drug substance and drug product. And it's progressing really well. And we're on target. So those sections will be submitted before we submit the clinical section. That will be the last one. Late next year. So somewhere in the middle of next year, somewhere, we'll be submitting the manufacturing section. We'll start with nonclinical. Followed by CMC, followed by clinical.
Daniil V. Gataulin: Okay. Got it. Understand. And one last question, for LCA. Is that on hold for now, or is that completely off or out of your pipeline, or what are your plans for LCA?
Shankar Musunuri: Yeah. That's a, from a market perspective, Daniil, it's very small. What we'll do is, that's right now, it's not in our plan. Obviously, once the RP gets into the market, we can always look into that for Phase four.
Daniil V. Gataulin: Okay. Got it. Alright. Thank you very much for taking my questions.
Operator: This concludes the Q&A portion. I will now turn the call back over to Chairman, CEO, and Co-Founder, Dr. Shankar Musunuri. Please go ahead.
Shankar Musunuri: Thank you, operator. The third quarter was marked with important clinical progress, strategic business development, and essential financing accomplishments. We're poised to close 2025 on a strong note and look forward to early 2026 catalysts that will further advance Ocugen's position as a biotechnology leader in gene therapy for blindness disease. Have a great day. Thank you.
Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.