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DATE

Thursday, Aug. 6, 2026 at 8:30 a.m. ET

CALL PARTICIPANTS

  • Chairman, Chief Executive Officer, and Co-Founder - Shankar Musunuri
  • Chief Financial Officer - Rita Johnson-Greene
  • Executive Vice President of Commercial and Business Development - Abhi Gupta
  • Chief Medical Officer - Mohamed Genead
  • Head of Communications - Chris Clark

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TAKEAWAYS

  • Cash, Cash Equivalents, and Restricted Cash -- $100.4 million as of June 30, 2026, compared to $32.2 million as of March 31, 2026.
  • Cash Runway -- Extended into 2028 following the closing of a $130 million convertible notes financing.
  • Net Loss Per Common Share -- $0.07 for the three months ended June 30, 2026, compared to $0.05 for the prior-year period.
  • Operating Expenses -- $17.9 million in the second quarter of 2026, reflecting an increase from $15.2 million in the prior-year quarter.
  • Research and Development Expenses -- $10.7 million in the quarter ended June 30, 2026, compared to $8.4 million in the same period last year.
  • General and Administrative Expenses -- $7.2 million in the second quarter of 2026, compared to $6.8 million in the prior-year period.
  • Convertible Senior Notes Financing -- $130 million aggregate principal amount at a 6.75% interest rate, providing net proceeds of $112.5 million.
  • Debt Retirement -- $32.7 million of note proceeds used to retire the Avenue Capital loan, which carried a 12.25% interest rate.
  • Collaborative Arrangement Revenue -- $1.5 million in the second quarter of 2026, compared to $1.4 million in the second quarter of 2025.
  • OCU410 Phase III Enrollment Target -- 237 subjects for the ArMaDa3 global registrational trial for geographic atrophy.
  • OCU410 Phase II Efficacy -- 31% reduction in geographic atrophy lesion growth at the optimal dose within the target patient population.
  • OCU410 Ellipsoid Zone Preservation -- 27% in the target patient population during Phase II clinical trials.
  • OCU410 Clinical Timeline -- Phase III initiation planned for September 2026, with Biologics License Application and Marketing Authorization Application filings targeted for 2028.
  • OCU410ST Enrollment -- 63 subjects completed in the Phase II/III GARDian3 trial for Stargardt disease.
  • OCU410ST Clinical Milestones -- Interim outcome decision expected in the third quarter of 2026, with topline data anticipated in the second quarter of 2027.
  • OCU400 Phase III Enrollment -- 140 patients randomized in the liMeliGhT trial for retinitis pigmentosa.
  • OCU400 Clinical Timeline -- Topline Phase III data expected in the first quarter of 2027, supporting a potential approval in the fourth quarter of 2027.
  • MENA Licensing Agreement -- Binding term sheet for OCU400 includes up to $255 million in sales milestones and a 22% royalty on net sales.
  • Shares Outstanding -- 339 million shares of common stock as of June 30, 2026.
  • Common Stock Authorization -- Special meeting planned for September 2026 to increase authorized shares to support potential future equity raises.
  • Stargardt Disease Market Size -- Approximately 100,000 patients in the United States and Europe, with no currently approved therapies.
  • Geographic Atrophy Market Size -- Approximately 2 million to 3 million people across the United States and Europe.
  • Retinitis Pigmentosa Market Size -- Approximately 300,000 people across the United States and Europe.
  • Janus Henderson Warrants -- 10 million warrants at a $1.50 strike price could provide $15 million in proceeds.

SUMMARY

Ocugen, Inc. (OCGN -2.86%) reported a transition toward late-stage clinical development across three core gene therapy programs. Management stated that recent financing has supported the retirement of high-interest debt and the progression of Phase III trials. The company remains on track for three Biologics License Application filings by 2028, with the first potential approval for retinitis pigmentosa anticipated in late 2027. Operational focus has shifted to establishing commercial infrastructure and global licensing partnerships, including a recent agreement for distribution in the Middle East and North Africa.

  • CEO Musunuri stated the company's modified gene therapy platform is designed to "address the root cause of complex retinal diseases by modulating master regulators."
  • Management reported that its subretinal injection approach is gene-agnostic, allowing it to target broad patient populations identified by multiple gene mutations.
  • CFO Johnson-Greene noted that the company is evaluating the potential sale of its Rare Pediatric Disease Priority Review Voucher for OCU410ST, which could yield $100 million to $200 million.
  • Management noted that the OCU400 program has EMA alignment, meaning the current U.S. clinical trial data is expected to support global regulatory approvals.
  • The company is scaling commercial readiness by evaluating "specialized centers of excellence with expertise in subretinal surgical procedures" to support future treatment delivery.
  • CEO Musunuri stated that the Phase III ArMaDa3 trial for geographic atrophy is powered at 95% for its primary endpoint following positive results from earlier studies.

INDUSTRY GLOSSARY

  • Biologics License Application (BLA): A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
  • EMA: European Medicines Agency, the regulatory body for medicines in the European Union.
  • Geographic Atrophy (GA): An advanced form of dry age-related macular degeneration that leads to the loss of retinal cells.
  • PPQ: Process Performance Qualification, a stage in manufacturing that confirms a process is capable of reproducible commercial manufacturing.
  • RMAT Designation: Regenerative Medicine Advanced Therapy designation, which provides intensive FDA guidance and eligibility for priority review.
  • RORA: Related Orphan Receptor Alpha, a master regulator nuclear hormone receptor that governs gene networks to maintain retinal health.
  • RP: Retinitis pigmentosa, a group of rare genetic disorders that involve a breakdown and loss of cells in the retina.

Full Conference Call Transcript

Operator: Good morning, and welcome to Ocugen's Second Quarter 2026 Financial Results and Business Update. [Operator Instructions] I will now turn the call over to Chris Clark, Ocugen's Head of Communications. You may begin.

Chris Clark: 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 ended June 30, 2026; Abhi Gupta, Executive Vice President of Commercial and Business Development; and Dr. Mohamed Genead, who joined Ocugen as Chief Medical Officer in June, will be available to answer questions following the presentation. This morning we issued a press release covering our business and operational highlights for the second quarter of 2026.

We encourage listeners to review the press release, which is available on our website at ocugen.com. A replay of this call, along with the accompanying slide presentation, will be available on the Investors section of the Ocugen website. Please note that certain statements made during today's discussion may be forward-looking in nature, including those related to our clinical development pipeline, regulatory time lines, commercialization strategy, and financial information, and our anticipated cash runway. These statements reflect management's current expectations and are inherently subject to risks, uncertainties, and assumptions that may cause actual results to differ materially from those expressed or implied.

We encourage you to review our filings with the Securities and Exchange Commission, including the risk factors detailed therein, for a more comprehensive understanding of these potential risks. Finally, Ocugen's quarterly report on Form 10-Q covering the second quarter of 2026 will be filed today. I will now turn the call over to Dr. Musunuri.

Shankar Musunuri: Thank you, Chris, and good morning, everyone. The second quarter was a defining one for Ocugen. The FDA cleared our Phase 3 trial for OCU410 to initiate dosing in geographic atrophy patients and granted RMAT designation for the program. We signed a binding term sheet with Roots Pharmaceutical to negotiate an exclusive license for OCU400 in retinitis pigmentosa across the Middle East and North Africa, MENA region. And from the closing of $130 million convertible notes financing, we extended our cash runway into 2028, now able to support all 3 of our late-stage programs. Before I walk through the quarter, I want to step back, because Ocugen's potential is worth putting into context.

For more than a decade, gene therapy in ophthalmology has been confined to a single gene, a single mutation and a single small patient population. Our modified gene therapy platform takes a fundamentally different approach. Rather than targeting individual mutations, it is designed to address the root cause of complex retinal diseases by modulating master regulators, nuclear hormone receptors that govern multiple gene networks. The platform is gene-agnostic, inherently multifactorial, and designed to deliver a durable benefit from a single, one-time subretinal injection. What this means in practice is that Ocugen is not building 3 separate drugs.

We're advancing 1 platform across 3 late-stage programs, each targeting a major cause of blindness for which patients today have either no approved treatment whatsoever or therapies that demand chronic injections and carry meaningful safety burdens. Retinitis pigmentosa, or RP, Stargardt disease and geographic atrophy, or GA, together affect approximately 3 million people across the United States and Europe, a combined patient population, and the commercial opportunity far larger than anything currently served by approved gene therapies in ophthalmology. Across our pipeline, spanning Phase I through Phase III, we have treated more than 325 patients, including EAP through multiple doses and indications, and we have not observed a drug-related serious adverse event.

We remain on track to file 3 BLAs by 2028. This positions the first half of 2027 as a catalyst-rich window for Ocugen with the top line data for OCU400 and OCU410ST and our planned BLA submissions following over a short period. Let me walk you through how each program is advancing. Then I will hand over the call to Rita for financials. Starting with OCU410 for GA, a secondary to dry age-related macular degeneration or dry AMD. GA represents our largest commercial opportunity with approximately 2 million to 3 million patients in the U.S. and Europe combined. There are currently no approved treatments for GA in Europe.

Current approved therapies in the U.S. target only one complement pathway and require frequent intravitreal injections, which has been associated with treatment discontinuation in clinical practice. GA is a multifactorial disease driven by 4 distinct pathways that contribute to the progressive degeneration of the macula, drusen, inflammation, oxidative stress and complement RORA activation. The currently approved therapies in the U.S. address only 1 of these 4 pathways, the complement system, which is partly why they have been unable to demonstrate meaningful functional outcomes for patients. OCU410 operates differently by delivering RORA, a nuclear hormone receptor that acts as a master regulator of retinal homeostasis.

OCU410 is designed to address all 4 disease pathways simultaneously with a single subretinal injection, has the potential to redefine the standard of care in this indication. We recently received FDA clearance for OCU410 Phase III registrational trial for GA. The trial, ArMaDa3, is planned to be a global study of approximately 237 subjects, using an adaptive design powered at 95% for the primary endpoint, with the BLA and Marketing Authorization Application filings targeted for 2028. We plan to initiate Phase III by September 2026. This design is anchored by positive 12-month data from our Phase II ArMaDa trial.

At the optimal dose, OCU410 delivered a statistically significant 31% reduction in GA lesion growth within the patient population of lesion size 2.5 millimeter square and 17.5 millimeter square. The criteria to be used in our Phase III pivotal trials versus control, approximately twice the benefit of approved complement inhibitors and from a single injection. We also saw a 27% preservation of the ellipsoid zone within the same patient population and no drug-related serious adverse events reported to date. Importantly, these Phase II data help support the FDA's decision to grant RMAT designation for OCU410. Turning to OCU410ST for Stargardt disease.

Stargardt is a pediatric onset retinal disorder affecting approximately 100,000 patients in the U.S. and Europe, and roughly 1 million people globally. There are no approved therapies available for these patients today. OCU410ST is designed to address over 1,200 pathogenic mutations in the ABCA4 gene with a single one-time treatment. On April 1, we announced the completion of enrollment and dosing in our Phase II/III GARDian3 pivotal confirmatory trial, enrolling 63 participants. We expect the interim outcome decision for the first 50% of subjects at 8 months in the third quarter of 2026 and top line Phase II/III data in the second quarter of 2027 with our BLA submission to follow mid-2027. Moving to OCU400 for RP.

The Phase III liMeliGhT trial is the first and largest genetic medicine registration trial for broad RP, spanning more than 30 genetic mutations. Approximately 300,000 people in the U.S. and Europe are living with RP, which is caused by mutations in more than 100 genes. The only approved gene therapy for RP today targets a single gene, RPE65, which accounts for less than 2% of all RP cases. OCU400 is designed to provide a therapeutic option for all RP patients and that is a fundamentally different commercial opportunity.

Enrollment in the liMeliGhT is complete with 140 patients randomized 2:1 treated versus control across the RHO and gene-agnostic arms spanning more than 30 genetic mutations associated with early to late-stage RP, including pediatrics. The breadth of the population intended to validate the gene-agnostic mechanism of action of our novel modifier gene therapy platform. The primary endpoint is 12-month change in visual function assessed by Luminance Dependent Navigation Assessment, or LDNA. Subjects are followed for 1 year post-dosing for the primary endpoint analysis. Top line Phase III data is expected in the first quarter of 2027, advancing OCU400 to a potential approval in the fourth quarter of 2027.

FDA feedback confirmed that the path to rolling BLA submission remains tied to top line data expected in the first quarter of 2027. On the manufacturing side, our Process Performance Qualification, PPQ, batches are complete, supporting BLA and commercial launch supplies. Brand planning and marketing initiatives led by Abhi Gupta, our EVP of Commercial and Business Development, continue to scale in preparation for launch. We also advanced our global commercialization strategy for OCU400 during the quarter. In July, we signed a binding term sheet with Roots Pharmaceutical and its strategic partner, Al-Dhow International Holding, for exclusive rights to OCU400 in the Middle East and North Africa.

We are active on the BD front to find other global partners for regional commercialization partnerships where RP is most prevalent. Here is a snapshot of the market opportunity across all 3 late-stage development programs. While OCU410 for GA represents our largest commercial opportunity, we believe all 3 programs have the potential to generate significant revenue while addressing areas of substantial unmet medical need. As we continue advancing our pipeline, we're also building the foundational commercial capabilities to support future global access. Our efforts are focused on 5 key areas. First, we're in discussions with CMS and peers to establish early market access and reimbursement strategies.

Second, we continue to identify and evaluate specialized centers of excellence with expertise in subretinal surgical procedures that could support future treatment delivery. Third, we are mapping the patient journey from diagnosis through treatment and long-term follow-up with the goal of facilitating a seamless experience for patients, caregivers, and healthcare providers. Fourth, we are assessing manufacturing, supply chain, and distribution requirements to help ensure operational readiness. Finally, we are beginning to build out our commercial infrastructure, including our marketing and sales capabilities as we ramp up for launch. With that, I'll turn the call over to Rita for the financial update. Rita?

Rita Johnson-Greene: Thank you, Shankar. Good morning, everyone. Total operating expenses for the 3 months ended June 30, 2026, were $17.9 million, and included research and development expenses of $10.7 million, and general and administrative expenses of $7.2 million. This compares to total operating expenses for the 3 months ended June 30, 2025, of $15.2 million, which included research and development expenses of $8.4 million and general and administrative expenses of $6.8 million. Total operating expenses for the 6 months ended June 30, 2026, were $37.3 million and included research and development expenses of $21.9 million, and general and administrative expenses of $15.4 million.

This compares to the total operating expenses for the 6 months ended June 30, 2025, of $31.2 million, which included research and development expenses of $17.9 million, and general and administrative expenses of $13.2 million. Ocugen reported a $0.07 net loss per common share for the 3 months ended June 30, 2026, compared to a $0.05 net loss per common share for the 3 months ended June 30, 2025. On our capital position, following the closing of the $130 million convertible notes financing, the company's cash, cash equivalents, and restricted cash totaled $100.4 million as of June 30, 2026, extending our cash runway into 2028. The company has 339 million shares of common stock outstanding as of June 30, 2026.

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

Shankar Musunuri: Thank you, Rita. The second quarter was a quarter of execution. The remainder of 2026 is poised to be impactful. We expect the OCU410ST interim outcome decision in the third quarter, and we expect to initiate the OCU410 Phase III trial in this quarter. Looking to 2027, we expect top line data from both OCU400 and OCU410ST in the first half of the year, followed by our planned BLA submissions. Each of these milestones brings us a step closer to delivering on our commitment to 3 BLAs by 2028, offering potentially life-altering improvement to patients coping with blindness-causing diseases.

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

Operator: [Operator Instructions] Our first question comes from the line of Michael Okunewitch with Maxim Group.

Michael Okunewitch: Congrats on all the great progress. So, I wanted to ask, you now have a handful of international partnerships, which makes OCU400 a truly international program at this point. So I just wanted to see if you could share the regulatory plans in particular for ex-U.S. jurisdictions, what's required there, and how those time lines could vary versus your BLA path?

Shankar Musunuri: Michael, what we have with OCU400, we got alignment from EMA in addition to FDA with the same -- the single trial we're doing in the U.S. is good for approvals. And across the globe for orphan gene therapies, typically they get approval based on U.S. approval. So everything will be linked to our U.S. FDA approval in MENA and other regions.

Michael Okunewitch: All right. And then I wanted to see also if you could just highlight some of the key differences in the trial design between ArMaDa3 and the Phase II ArMaDa trial?

Shankar Musunuri: I will let our CMO, Dr. Genead, answer that.

Mohamed Genead: Thank you, Michael. Regarding ArMaDa3, which is our global Phase III trial for GA, which we just got the approval from FDA, just recently to be initiated this quarter. The Phase III trial designed for ArMaDa3 will be one treatment arm with OCU410 versus a control will be 2:1 randomization allocation and that data will follow each subject up to 12 months. And this is where we're going to be looking at the primary efficacy endpoint plus other key functional endpoint. The ArMaDa1, the earlier Phase I/II GA trials was similar on the efficacy. So we should expect similar outcome here. We're going to look -- the numbers obviously is different.

We're going to be enrolling in ArMaDa3 close to 237 subjects in 2:1 allocation. It's going to be global. We're going to go ex-U.S. We're going to go to Europe and other territorial parts in the world. But the primary endpoint will be very similar, so we should expect to see similar trend what we saw from ArMaDa1, the Phase I/IIa GA trial.

Michael Okunewitch: All right. And then just one last one from me before I hop back into the queue. So it looks like in Stargardt, there is a chance that we'll have an approved therapy sometime around when you'll be completing your own BLA filing. So it will be a chronic therapy versus a one-time. But I wanted to ask how important the pricing on other therapies, since we don't have any pricing comps, would be to inform your own pricing strategy and if there's any way that we can think about how to translate pricing between a chronic ongoing therapy and a one-time therapy?

Shankar Musunuri: Yes. Good question, Michael. I think the way you look at it is our treatments are one-and-done treatments potentially. So that will have a different pricing structure than ongoing chronic therapies. Number two, everything will be dictated by data. And if you have a safe one-time treatment, I think our gene therapies, once again, we're still collecting data, as you can see in some of the patients in RP, and as they approach like second year, third year, they're improving further.

So the current therapies, if the oral therapy comes to the market, what patients -- providers are going to look for is that a therapy just reducing the degeneration of the disease or in some patients, is it stalling it, is it has potential to reverse it in some patients. At least, with our modified gene therapy in some of the patients we're seeing all those trends. So that could be a big differentiating factor. And also as you know, Stargardt impacts a lot of pediatric patients. And the current clinical trial they're conducting focuses on 12 plus. And our clinical trial focuses on 3 plus. So there are a lot of differentiators.

So whenever we come for pricing, because of the differentiated disruptive technology platform we have, and obviously everybody will focus on safety, efficacy, and one-and-done treatment, there'll be more compliant for anyone. So I think all those factors will be rolled in. So I don't think we'll be truly comparing any pricing what the -- other chronic therapies are doing. If you have a me-too products, the answer is yes. But if you have truly a definitively disruptive technology, which is completely different, it'll come -- we can price it on its own merits.

Operator: Our next question comes from the line of Whitney Ijem with Canaccord Genuity.

Whitney Ijem: My congrats on all the progress as well. Just to keep going on the Stargardt discussion, Shankar, since you mentioned it, can you talk about a little bit more, I guess, around the TPP here and the potential to show kind of reversal of disease and improvement in visual acuity. Is that something that is reasonable to expect given the duration of follow-up in the ongoing Phase II/III study? And I guess if so, is there anything that was done in terms of entry criteria to maybe enrich for that outcome as far as patient baseline characteristics?

Shankar Musunuri: I will ask Dr. Genead to talk about -- a little bit about baseline characteristics, then I'll answer the other question.

Mohamed Genead: Thank you, Shankar. Whitney, yes, happy to answer. So our population was definitely broader than other competitors. Just to highlight, first, we included patients from early to late-stage Stargardt disease. That's number one. And as Shankar just mentioned, too, we included subjects are younger than, young adults. We included, subject, 3-plus years of age. So that's a very broad population. As you know, for Stargardt, the earlier the better, especially if it's a progressive retina generation disease. The lesion size, we also included in our trial, the Phase II/III GARDian trial, was more broader than what we saw with others. And our lesion size will include smaller lesion, also larger lesion.

So we have a broad spectrum, and that's also going to be aligned with our early, late-stage strategy for the disease. We already included some of the subjects in our Phase II/III trials. So we will be excited to see the data. In addition to the gene mutation, specifically, we include all the variants and all the other specific mutations included in the ABCA4-related retinopathy. So it includes Stargardt and others as well. So this is also on the disease indication. It's overall. Based on your point about the functional, I think this is going to be a critical.

So we saw from our Phase I data that we just published at the Eye Nature early in the year, we saw a very clear structure -- slowing in the structure progression in those patients. And also we saw functional benefit in those patients. And as you remember, as you know, in Stargardt disease, the first target is to hold that progression, to stop losing more retinal structure and function, which we achieved in our prior trial. The second goal, which will be the upside here and the ultimate goal to reverse that tide, try to improve on the disease outcome. And we saw that in our Phase I/II. We saw some of the patients did improve in visual function.

The gain was 6 letters close to 1 line between the treated versus the untreated eyes. So we felt also very excited about the functional gain in the patient population. So that's kind of where we think the big differentiation, the broader application of our molecule.

Shankar Musunuri: Whitney, just to clarify, the primary endpoint, because it's a 1-year trial, it's not a 2-year trial, it's still a lesion. Then there are secondary visual function we'll be monitoring. In addition to that, at the time of filing, we continue to monitor our early-stage Phase I patients, and so we'll have long-term data in those patients still.

Whitney Ijem: Got it. Really helpful. And then just last question, and maybe Rita, this one is for you. Just -- can you help us understand how you're thinking about cash given the exciting progress with the GA study and the ability to start that study in September. I think you said, if there is a need to kind of pull levers to extend the cash runway further, how should we think about maybe the startup of GA versus commercial prep for RP or Stargardt, and just kind of how you guys are thinking about those different levers if needed?

Rita Johnson-Greene: Yes. Thank you, Whitney. So, first of all, I mean, our primary goal is to make sure that we are minimizing shareholder dilution, but evaluating our opportunities in order to raise capital, just as you said, in order to bring these novel products to patients. So, just first of all, we have cash runway into 2028. And so I just want to remind everyone of that, which gives us the confidence to execute our clinical state -- our late-stage products that we have, and then progress to BLA submission for both OCU410 and OCU410ST in 2027, with the potential to commercialize OCU400 by the end of the year in 2027. We do have some additional levers that we can pull.

One, we have the PRV for OCU410ST given the RPD designation that we have. And so, of course, we have the ability to sell that for somewhere between $100 to $200, even prior to approval. And that's something that we are evaluating. We also have various business development deals that we are looking at from a globalization perspective. We're looking at ex-U.S. for both OCU400, OCU410ST, and even GA, right, just depending upon what that term sheet looks like. So always looking for potential deals that we can make in order to again, just minimize that dilution. We also have the Janus Henderson warrants, right?

There's another 10 million warrants at $1.50 strike price, which could bring in another $15 million, and those warrants expire in August of 2027. And then, of course, we anticipate a special meeting in September of this year in order to increase authorized shares, which will give us the ability to raise additional equity if we decide to do so. So again, just looking at both non-dilutive as well as dilutive options in order to make sure that we are able to bring these amazing and novel products to patients as well as looking at maximizing shareholder value.

Operator: Our next question comes from the line of Charles Wallace with H.C. Wainwright.

Charles Wallace: This is Charles from H.C. Wainwright, on for RK. Maybe a question on ArMaDa3 design. So it seems like based on the prior -- based on the prior earnings call, the study has been a little bit resized. I think previously you said it would be about 300 patients and now it's 237 patients. So I was just curious if this was something the FDA specifically asked for or if this was something you proposed? And then also if the assumptions change based on effect size, variability, dropout, or the narrower lesion size compared to the Phase II?

Shankar Musunuri: Yes, Dr. Genead?

Mohamed Genead: Thank you, Charles. Yes, we had a discussion with the agency, the FDA. So all this being aligned and discussed with the FDA. But to answer your question specifically, it was based on the sample size estimation and also the power calculation we did. So the estimate you're citing, the 300, was based on estimate. But when we saw the effect site based on our ArMaDa1, the Phase I/II trial, as we discussed today, we saw the 31% reduction in the median dose, the optimal dose, which is the one we are taking forward. When we did our calculation based on that, we saw the 237 total population to be enrolled will give us 95% power in our pivotal trial.

All these pieces have been discussed with the agency. Obviously, it's based on the rate of change, the slope analysis for the primary efficacy. So, the effect size based on what we saw from earlier trial was very positive and was strong enough that we end up with 237. 2:1 randomization, as we mentioned earlier, 158 in the treatment arm and 79 in the control arm. So all this has been discussed and aligned, and as we announced today, we got the clearance from the FDA to initiate our Phase III trial in the next few weeks.

Charles Wallace: Very helpful. And then I guess for -- on the rolling submission. So I think originally the guidance was to submit in the third quarter. And now I believe it's the first quarter after the liMeliGhT data. And, I think -- I guess my question is, what kind of changed between submitting the non-clinical module earlier compared to after the top line data of the liMeLight?

Shankar Musunuri: Charles, I think from our perspective, we're ready. I mean, I think we are doing very well with our PPQs as we've mentioned. There are a lot of gene therapy companies stuck with CMC. We're ahead of the game. We used to commercial scale lots in our Phase III. We completed our PPQs on time. We got non-clinical and PPQ are done, so we have CMC non-clinical ready to go. I mean, obviously, this is where we have to work with agency when they're comfortable. And that's the time line they gave us, and we're going to be fine with that.

The reason is, I just want to clarify, it's good to have rolling submission that gives a head start for agency, okay? It's for their own benefit. And if they want to wait until next year, I mean, we are ready to file it as soon as the top line comes for the pre-BLA meeting. We may still give them a head start of maybe a month or 2 months before we drop the clinical section. So however, I just want to clarify, until the final BLA is completed with the clinical section, the PDUFA date, the accelerated clock of 6 months doesn't start. I just want to clarify that.

So once again, this is a collaboration between the sponsor and the agency. In this case, of course, we respect their decision, whatever they are, because they have a lot of programs and a lot of workload, whatever the reasons are, we are fine with it. I think we're ready from our perspective, and we will work with them closely in collaborative way. And whenever we have a top line, we'll be ready to file it.

Charles Wallace: Great, very helpful.

Shankar Musunuri: So it doesn't change any -- yes, filing clock, as we mentioned before, second quarter, complete the BLA filing, anticipated approval in fourth quarter, 6 months accelerated clock.

Operator: [Operator Instructions] Our next question comes from the line of Robert LeBoyer with NOBLE Capital Markets.

Robert LeBoyer: Congratulations on the progress. Just to follow up on that last question, my understanding was that the BLA submission will be completed in early 2027 when the clinical module is filed, that's when you get the PDUFA date and the approval launches based on that. But you also have rolling submission and have the option of filing the CMC and the other non-clinical modules before that. Is that still your plan?

Shankar Musunuri: Yes, Robert, absolutely. Because based on agency's suggestion and recommendation, as soon as the top line comes out, we'll have a pre-BLA meeting. Right after that, we can file the 2 modules, non-clinical and CMC modules. So that will still give them a head start. And as soon as the clinical module is done when you file it, the PDUFA date starts. So that's basically our plan is to file that in second quarter, so 6 months' clock should be fourth quarter, approval clock.

Operator: And at this time, we have no further questions. I would like to turn the call back over to the Ocugen team for closing remarks.

Shankar Musunuri: Thank you all for attending today's webcast. Really appreciate all our investors, shareholders, patients, providers. Thank you.

Operator: This concludes today's conference call. You may now disconnect. Have a good day.