Ocugen, Inc. ($OCGN)

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

Thank you, operator, and good morning, everyone. Joining me on today's call and webcast is Dr. Shankar Musunuri, Ocugen's Chairman, CEO and Co-Founder, who will provide a business update and an overview of our clinical and operational progress. Rita Johnson-Greene, our Chief Financial Officer, is also on the call to provide a financial update for the quarter ended March 31, 2026. Dr. Huma Qamar, Chief Medical Officer, will be available to answer questions following the presentation. This morning, we issued a press release covering our business and operational highlights for the first quarter 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. 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 pipeline, 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 first quarter of 2026 will be filed today. I will now turn the call over to Dr. Musunuri.

Thank you, Tiffany, and good morning, everyone. Before I walk through the quarter, I want to discuss the $115 million offering of convertible senior notes that we announced yesterday. With the recent offering, the company is expected to have cash, cash equivalents and restricted cash of $112.1 million at closing, which includes the Avenue debt payoff. The company will use the remaining net proceeds for general corporate purposes and expect to extend cash runway into 2028. The offering is expected to close on May 7, 2026, subject to customary closing conditions and includes an option to retire the debt with the cash payment. If the remaining Janus Henderson warrants are exercised, the company will receive an additional $15 million in gross proceeds, increasing expected cash, cash equivalent and restricted cash to $127.1 million. Now I would like 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 go on entire gene networks. The platform is gene agnostic, inherently multifactorial and designed to deliver durable benefit from a single onetime subretinal injection. What this means in practice is that Ocugen is not building 3 separate drugs, we're advancing 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 a 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 250 patients across multiple doses and indications, and we have not observed a drug-related serious adverse event. In our most recent readout, OCU410 demonstrated approximately twice the treatment benefit our currently approved therapies in GA delivered at onetime injection. We remain on track to file 3 BLAs over next 3 years by 2028. And first of those OCU400 for RP will begin rolling submission in the third quarter of this year. This positions the first half of 2027 as a catalyst-rich window for Ocugen with Phase III top line data for OCU400, top line Phase II/III data for OCU410ST and BLA submissions all expected to converge for a short period. In the first months of 2026, we completed enrolment in 2 of our late-stage programs, delivered positive Phase II top line data in the third and are diligently working towards initiating our first BLA submission later this year. Let me walk you through how each program is advancing. Starting with OCU400 for RP. The Phase III LiMeliGhT clinical trial is the only broad gene-agnostic RP trial and the largest known Phase III orphan gene therapy trial in the field. 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 just 1% to 2% of all RP cases. OCU400 is designed to provide a therapeutic option for the remaining 98% to 99% of RP patients, and there is a fundamentally different commercial opportunity. Enrolment in LiMeliGhT is now complete with 140 patients randomized 2:1 across the role and gene-agnostic arms covering over 25 genetic mutations associated with early to advanced stage RP, including pediatrics. The breadth of population is 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. We plan to initiate the rolling BLA submission for OCU400 in the third quarter of 2026 and complete BLA submission by the second quarter of 2027. Phase III top line data is expected in the first quarter of 2027 with a potential FDA approval targeted for the fourth quarter of 2027. On the manufacturing side, process performance qualifications, PPQ batches completion is on track for the second quarter of 2026 and brand planning and marketing initiatives led by Abhi Gupta, our EVP of Commercial and Business Development, continue to scale in preparation for launch. OCU400 continues to demonstrate encouraging long-term durability with the 3-year data supporting sustained improvement in visual function compared with untreated eyes. In the Phase I/II study, the treatment effect was maintained over time across evaluable subjects with a clinically meaningful mean changes in LLVA observed at years 1, 2 and 3 in both the multiple mutation and RHO subgroups. Importantly, these results suggest the benefit is not limited to a single genetic subtype, reinforcing the program's gene-agnostic mechanism of action. From a safety perspective, OCU400 continues to show a favorable profile with no serious adverse events reported as being related to treatment. At the 3-year time point, 88% of treated evaluable subjects demonstrated either improvement or preservation in visual function relative to untreated eyes, highlighting both the durability and consistency of the response. Taken together, these data support the potential for OCU400 to deliver sustained clinical benefit over time in retinitis pigmentosa while maintaining a strong safety profile. Turning to OCU410ST for Stargardt disease. Stargardt disease is a pediatrics onset retinal disorder affecting approximately 100,000 patients in the U.S. and Europe and roughly 1 million 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 onetime treatment. On April 1, we announced the completion of enrolment and dosing in our Phase II/III GARDian3 pivotal confirmatory trial enrolling 63 participants in less than 9 months, well ahead of the originally planned time line. That pace reflects both the depth of unmet need in Stargardt disease and the exceptional engagement of our investigators and patient community. The interim analysis is planned for the third quarter of 2026 with the top line Phase II/III data expected in the second quarter of 2027 and BLA submission to follow by mid-2027. OCU410STcontinues to demonstrate a favorable safety and tolerability profile with no product-related serious adverse events reported to date. Turning now to OCU410 for GA, late-stage dry age-related macular degeneration. GA represents our largest commercial opportunity with approximately 2 million to 3 million patients in the United States and Europe combined. There are currently no approved treatments for GA in Europe. In the United States, approved therapies require 6 to 12 intravitreal injections per year indefinitely, carry meaningful safety risks, including conversion to wet AMD in roughly 12% of treated patients and face real-world dropout rates of nearly 40%. GA is a multifactorial disease, driven by 4 distinct pathways that contribute to the progressive degeneration of the macula. Lipid deposits/Drusen, chronic inflammation, oxidative stress and complement activation. The currently approved therapies in the U.S. address only one 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. In March, we reported positive top line 12-month data from our Phase II ArMADa clinical trial. The study enrolled 51 patients aged 50 years and older with the GA lesions in the foveal or non-foveal lesion randomized 1:1 to receive a single subretinal administration of OCU410 at the medium dose, high dose or no treatment in the control group. The optimal dose, which is the medium dose demonstrated a 31% reduction in lesion growth relative to control at 12 months with a p-value of less than 0.05. To put this in context, currently approved intravitreal therapies have shown approximately 15% reduction at 12 months for Avacincaptad pegol and 22% reduction at 24 months for Pegcetacoplan OCU410 administered as a single onetime injection has shown the potential for an approximately twofold treatment benefit relative to approved therapies that require continuous chronic dosing regimens. Across the treated population, 55% of treated subjects demonstrated a 30% or greater reduction in lesion size relative to control. We also observed a 27% slower rate of ellipsoid zone loss, which is structural biomarker that correlates with the preservation of photoreceptor integrity and visual function. On safety, OCU410 continues to demonstrate a safe and tolerable profile with no serious adverse events, no adverse events of special interest related to OCU410 reported to date. We are now incorporating these results into an optimized Phase III trial design, including a targeted GA lesion size window and an adaptive design powered at greater than 95%. We are now on track to meet with FDA and EMA to align on the Phase III study design and reach regulatory agreement by the third quarter of 2026 with potential BLA filing by 2028. As a onetime treatment for life, OCU410 has the potential to eliminate the chronic treatment burden and patient fatigue associated with currently approved therapies and to offer a lasting solution for the 2 million to 3 million patients in the U.S. and Europe living with GA. Let me briefly update you on our programs. For OCU200, we completed Phase I clinical trial enrolment in the first quarter of 2026 and no serious adverse events or adverse events related to OCU200 have been reported to date. On OCU500, our first-in-class inhaled mucosal COVID-19 vaccine candidate designed to be administered via inhalation and intranasal delivery, NIAID intends to initiate the OCU500 Phase I clinical trial in the second quarter of 2026. Today, we want to highlight the meaningful progress across our retinal gene therapy pipeline and the important milestones we expect over the next several quarters. For OCU400 in retinitis pigmentosa, we remain on track to begin a rolling BLA submission in 2026 with Phase III top line data expected in 2027 and the potential for BLA and launch thereafter. For OCU410ST in Stargardt disease, we have completed dosing ahead of schedule in our pivotal Phase II/III GARDian3 trial with interim analysis expected in the third quarter of 2026 and top line results anticipated in the second quarter of 2027, followed by a planned BLA submission. For OCU410 in geographic atrophy, we continue to advance toward Phase III development following encouraging Phase II data with the program expected to move through Phase III enrolment toward BLA submission by 2028. Taken together, these milestones reflect a disciplined multi-program strategy designed to create value through a series of increasingly important clinical and regulatory readouts. I'll now turn the call over to Rita to provide an update on our financial results for the quarter ended March 31, 2026. Rita?

Thank you, Shankar. Good morning, everyone. Total operating expenses for the 3 months ended March 31, 2026, were $19.4 million and included research and development expenses of $11.3 million and general and administrative expenses of $8.1 million compared to total operating expenses for the 3 months ended March 31, 2025, of $16 million that included research and development expenses of $9.5 million and general and administrative expenses of $6.5 million. Ocugen reported a $0.06 net loss per common share for the 3 months ended March 31, 2026, compared to a $0.05 net loss per common share for the 3 months ended March 31, 2025. The company's cash, cash equivalents and restricted cash totaled $32.2 million as of March 31, 2026, compared to $18.9 million as of March 31, 2025. The company received $37.5 million in gross proceeds, inclusive of $15 million due to exercise warrants in the first quarter of 2026. With the recent offering, the company is expected to have cash, cash equivalents and restricted cash of $112.1 million at closing, which includes the Avenue debt payoff and expects to extend cash runway into 2028. The company had 338.3 million shares of common stock outstanding as of March 31, 2026. That concludes my financial update. Shankar, back to you.

Thank you, Rita. The first quarter of 2026 was a quarter defined by execution. We delivered positive 12-month Phase II data for OCU410 in GA, completed enrolment and dosing in the GARDian3 trial well ahead of schedule and continued advancing OCU400 towards its rolling BLA submission later this year. Looking ahead, the remainder of 2026 is poised to be consequential with multiple meaningful inflection points. We expect interim outcome analysis from GARDian3 in the third quarter, regulatory alignment with FDA and EMA on the OCU410 Phase III design in the third quarter and the initiation of our first BLA submission for OCU400 also in the third quarter. Each of these milestones bring us a step closer to delivering on our commitment of 3 BLAs by 2028. I want to thank our employees, investigators and patients who have trusted us with their participation and our shareholders for continued belief in our mission to advance cures for blindness. We'll now open the call for questions. Operator?

[Operator Instructions] Your first question comes from the line of Leland Gershell from Oppenheimer.

This is Jason on for Leland. It seems like it's gearing up to be an exciting year for OCU400 in the retinitis pigmentosa. And with that, could you give us a sense of what's being submitted for the rolling BLA versus the full BLA next year? And how are you thinking about the pre-commercialization activities going into 2027 launch?

Yes. So the rolling submission, as we stated, will start with nonclinical section module. And also, we're completing our PPQ lots from CMC manufacturing perspective. That module will also be submitted this year. And next year, as soon as the top line results come in within weeks after that, the final clinical module will be submitted, and that will trigger a PDUFA date of 6 months clock, expected to get the approval in the fourth quarter and launch. From a commercial perspective, there are multiple things we are doing, as we mentioned before, we're working on one thing on the pricing, the government, [ CMS ]. And second step is, of course, as a company, we have established very standard way of treating these patients with our surgery procedure, which we use in clinical trials to minimize any risk to the patients. So we want to really identify the centers for excellence where our gene therapy can be administered. So that's what we're working under the second step. And the third step is, of course, gearing up for sales and marketing and really commercial plans. I think we're working on the strategy. And typically, you start that work a year before. So later part of the year, getting into the early next year, that's when we'll start bulk of the commercial work.

Your next question comes from the line of Michael Okunewitch from Maxim Group.

Congrats on all the great progress you're making. I guess just to start off, I'd like to see, given how quickly the Stargardt program has been moving, how close together are you expecting an RP and a Stargardt approval could occur? And then are there any additional commercial considerations you're evaluating with the possibility that you will be kind of ramping both of these launches contemporaneously?

No, good question. I mean if everything goes according to the plan, they could be within 6 months of each of them. Obviously, from launch or commercial perspective, again, we're targeting the same centers for excellence for gene therapy administration. The same surgeons are going to administer for administering for RP. So in fact, actually, it helps us as a company, economies of scale and how we are setting it up for RP, and that will always help with Stargardt disease. So when Stargardt is going to come later within 6 months, we should be in a great shape from a commercial perspective and launch perspective.

All right. And then how much overlap is there between the LiMeliGhT and the GARDian studies? Are they largely at the same centers? Or if you take them combined, do they reach a broader swath of the overall market?

Go ahead, Huma.

This is Huma Qamar. I'm going to take this question. Good question. So both represent inherited retinal diseases, of course, Retinitis pigmentosa. We have almost the same centers. There is a single subretinal injection. There is an overlap. However, there is no approved product for Stargardt, and we do have a huge unmet medical need in terms of RP as well. So the centers are almost the same. And also, as Shankar has mentioned, centers for excellence. There is an increased demand for -- as we have now closed the enrolment for both the programs to go as fast as we could per the protocol. And there will be some overlap, but there are quite a few more centers that we have identified as well.

So the current clinical centers, Michael, just to answer, close it out, are not good enough for commercial. They're good. but we need a lot more for commercialization.

Your next question comes from the line of Robert LeBoyer from NOBLE Capital Markets.

Congratulations on all of the progress that you've been making. My question has to do with the marketing and you mentioned of centers for excellence. My understanding was that the product is something that can be administered by any ophthalmologist and anyone who treats patients and is very easy to fit into the current practice. So I was wondering about the centers of excellence and how you're going to launch the product, if it's going to be a broad launch or focused on specific areas or treatment centers in the marketplace.

Yes. I mean, good question. I mean, obviously, it's vitrectomy. It's not a big surgery. I think any of our 2,500 trained, well-trained retinal surgeons in our country can do that. However, it's a one-and-done treatment. It's a onetime administration for life. So we want to make sure whatever center they're going to participate in the commercial and that they get trained on the same surgical manual we've been using in the clinical trials, which has been worked successfully. So that's the goal. I mean, once again, I just want to clarify -- this is not a complex surgery. And any of those surgeons, the 2,500 smart retinal surgeons can do this. But as a company, we just want to make sure we train a group of people. I mean, whatever centers we need for commercialization, it could be 100, it could be 200. We want to make sure those centers are very well trained, and so they follow the same procedure across the board for consistency and patient safety.

And just my understanding was that anyone who is a retina surgeon can administer OCU400 without any special training. Is that correct? Or just what is the difference between the clinical trial and actual practice?

So I can answer that, Robert. Good to hear from you. So yes, it's a vitrectomy, which is pretty common as part of standard of care. This is not a new treatment or anything that they have not done. What Shankar is mentioning here is actually, every product has its specifications. So when we are launching the centers of excellence, that would be the main centers that could further train down the next few centers, like down there. So the initial launch, definitely, we have all across, they are covering majority of the centers. And this is not a new treatment, new procedure or single subretinal injection that we are giving. However, when we define centers of excellence, that's always like the initial ones that take the burden of like for the first launch and then go towards the next. So yes, you do not need any special training. This is pretty much standard of care, and we have vitro-retinal surgeons that are pretty good in doing this. The only difference is this there is, of course, with any product, you come up with the guidelines, and that's what they have to do.

And Robert, I think this is the first time, remember, we're not talking about going after 500 patients, 1,000 patients. We're going to go after hundreds of thousands of patients with our therapies. So there is the whole payer system and how you direct the patients. It's a new paradigm Ocugen has to establish. It's nothing like anybody has done before. I just wanted to make it very clear in gene therapy space.

Your next question comes from the line of Whitney Ijem from Canaccord Genuity.

Congrats on all the progress this quarter. First question, I guess, headed into the interim for the Stargardt study in the third quarter. Can you remind us, first of all, the powering of that study like what was assumed? And then what will -- what should we all be expecting to see in that readout? And then sorry, third part of this question is just what is the range of outcomes based on that data for the study moving forward?

Yes. I think Whitney -- so this is the outcome analysis. It's not really giving any interim analysis like we expect in our primary endpoint and secondary endpoint analysis. So this is done under strict guidance of data monitoring committee. So why do you do adapter design to minimize any further risk to Phase III clinical trial. In Phase III clinical trial, we have a true control arm, untreated arm, which will be compared with the treatment arm. And so the DMC looks at predictive analytics and see the study is designed for 12 months. And at 8 months and 50% of the patients have completed, they're going to look at it compared to control arm. Are we going to meet the success? And if there is nothing to be changed, you continue. That's outcome number one. No changes. Top line results come out in the second quarter of next year. BLA will be filed a few weeks after that and then the clock starts for a PDUFA date. The outcome number 2, I mean, we did recruit additional patients in the trial. I mean, obviously, anticipation of dropouts and all that. But if the analytics show you need to increase number by a certain number, we have to again recruit. I mean, that may have -- that means you have to monitor those patients for additional 1 year. So that has impact on the top line results in the filing. And during that timeframe, we're also based on the discussions we had in the agency in the past, we have 2 options, either you increase the size -- and we can also look into adding an additional time point from 12 months, you also can add 16 months' time point. You can also look into predictive analytics and see if you're going to meet the criteria of making a success if you extend it to 16 months. So those are the 2 options we have. Obviously, the [ DMC ] with a blinded staff Ocugen, they're going to look at it carefully and present these options to Agency and get the buy-in from FDA, which they have recommended these 2 options in the past. And then once the outcome is finalized by -- with the Agency's Congress, we're going to let the markets know. So just to sum it up, one of the outcomes is there's no change. We're on track. Everything is looking good. Another outcome is, yes, there is some delay, but the delay also minimizes any risk to the clinical trial. We're ingesting. So there's a delay of 6 months. So those are the outcomes we'll discuss with the market.

Got it. Okay. That's really helpful. And then going back to the powering question, what -- have you disclosed the powering of the study on the primary endpoint?

Yes. So basically, we have for the Stargardt disease, 51 subjects, 34 treatment 17 control and the adaptive design would be for 24, 16 treatment 8 control. And yes, it's adequately powered around 90% or more. And we are going to look at the powering once again once the adaptive analysis interim outcome is going to be there. However, we are sufficiently powered, keeping in mind the prevalence as well as the no approved product right now in market. So the interim outcome would be either sample size re-estimation or no.

Got it. Okay. That's helpful. And then just to double check, in terms of the range of outcomes, there's no, I guess, upside scenario, right, just to make sure we're fully thinking through all the scenarios. Best case scenario, things are on track. There's not like a best case, oh, we're going to end early or something like that, right?

Yes, that's right. Yes. I think -- I mean, unless -- yes, I mean, Whitney, if you look at many products which got approvals under -- some of them got approvals with 30 patients, right, with orphan diseases. I mean, obviously, with the -- as Huma stated, it's 50% reaching 8 months. Eight months, I think we have to be also be practical. I mean if it's a 1 year, it's a different story. But gene therapies for us, modified genes to start working, minimum, you need like 6 months to show something. And at 1-year timeframe, you really reach the effect side and everything else. So obviously, again, the data will tell and we'll wait. For orphan diseases, you're right, if there's a significant unmet medical need, even sometimes in the interim, if you really hit it out of the park, agencies will consider that. But I also want to be practical about it. I think 8 months is for adjustment. But typically, it's good to look at it 1 year. One year itself, if you look at all our clinical trials compared to other things going on in the industry across all our 3 programs, we are doing 1-year trials compared to anybody out there. Most of the people do 2-year trials because we are able to show effect size, treatment effect and benefit in 1 year.

Yes. That makes perfect sense. Okay. And then just moving on a cash question. What does the new guidance into 2028 assume in terms of GA Phase III spend?

Yes, it's included within the -- the GA Phase III spend is included in the new cash runway into Q1 or into 2028. So yes, we do anticipate being able to cover the expenses for that trial.

Okay. Got it. And I guess, could you -- I know the conversations with the Agency are ongoing, but what was assumed in terms of size of that study just for cash reasons or any design characteristics you can talk about at this point just for -- again, from a cash estimation perspective?

It's a 300-patient global trial in U.S., EU and Canada together. And most of the patients are -- majority will be in U.S. because we have the existing centers. And so it's 2:1 ratio, 200 in treatment and 100 in untreated control. It's powered at over 95% the primary endpoint and 92% for EZ Ellipsoid Zone secondary endpoint. And it has an adaptive design at 150 patients reach 1 year, we can take a look.

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

This is RK from H.C. Wainwright. A lot of my questions have been answered, but I have a couple of them. On the OCU400, where you're planning for -- to start the rolling BLA in third quarter, can you confirm your PPQ runs would be completed in time, like by end of second quarter or so, so that you can initiate your rolling BLA?

Yes, absolutely. We're on target to complete them this quarter. And can support the prelim submission.

Okay. Great. Rita, in terms of expenses, we have seen G&A and R&D expenses go up this quarter, which is understandable. But how should we think about this going forward, especially into 2027 as you're preparing for commercialization? And relatedly, on the BD side of things, what progress has been made, especially for 400 and 410 in terms of ex-U.S. licensing?

Yes. Thank you for your questions. So first of all, just to kind of address the spend that you're seeing, you have to consider, part of it is due to timing and then also related to us exceeding some of our programmatic milestones, right? So if you're looking at OCU410ST and OCU410 GA, we accelerated those timelines. And so when you think about us completing our enrolment for OCU400 and OCU410ST, the completion of that enrolment in Q1 will now enable us to kind of ramp down the clinical spend going into the balance of the year. So we feel really confidently about the anticipated spend that we had in 2026 going into 2027. And so we're averaging around $50 million to $60 million per year from a spend perspective, which is why we believe that our cash runway is into 2028. And then going to the business development, we are actively evaluating various BD deals for ex-U.S. for both OCU400 and OCU410ST. We have term sheets that we're looking at. So there's a lot of work going on just as Shankar said, that Abhi is doing, who leads our business development team, to ensure that we are evaluating those alternatives and then making the best decision for Ocugen and for our shareholders. And then lastly, from a commercialization perspective for OCU410GA, we are still looking to commercialize that with a partner, although as we talked about the spend associated with the clinical trials, we have that incorporated into our runway.

One last question. Shankar, I know in the past, we have talked a little bit about payers and how to get payers agree to the pricing that you would come up with. Any commentary, especially from recent conversations from your payers as you're getting closer to commercialization, especially with the price tag that you are thinking for some of your drugs?

Yes. I mean, obviously, we -- there is a publication in Retina, I mean, that talks about potential pharmacoeconomic model justifying $1 million to $2 million, somewhere in the range price tag. And also, there is a publication from New England Journal of Medicine. And this is, again, we're happy to state CMS and CMMI, they're looking into what is the next iteration of sickle cell model they created. And the publication clearly goes into pay-over-time and subscription models, which can help with the budgetary constraints we have, how can we work. So everything is very creative, RK, as I mentioned before, from launch and the treatment centers to and how the CMMI is looking. I'm very pleased to say it's obviously, these are onetime treatments, right? So we need to think about some creative ways, how can we work with payers and make sure, especially if CMS the government is spending a lot of money for orphan diseases or diseases like GA, which will have -- most of the patients are above 60, and you're going to get a bigger chunk of economy and the budget from CMS. So we need to really think into all those options, how we can provide market access to more patients and who need them. And then are there -- so that immediate article coming out of CMS is a good one. And it goes into, okay, if the price tag is high, you pay our time. Because if you say your therapy is onetime treatment for life, you stand by it. And so those are very good models coming out. I mean it's a very creative thinking, and we are aligned with that strategy.

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

I have a more general question on EZ preservation. It appears to be emerging as an important endpoint. So I wanted to ask in your conversations with regulators, what would you say their most recent position is on the importance of EZ preservation? And two, are there any differences in how U.S. and EU regulators are thinking about EZ preservation?

Daniel, good question. We just submitted our meeting request to both FDA and EMA. Obviously, I will let you know by early third quarter, the input and alignment with them. I mean, obviously, you saw GA trial, what we publicly stated. Our primary endpoint is lesion because that's an approved endpoint into commercial products in the U.S. And the secondary endpoint is we are proposing is ellipsoid zone because it correlates to visual function. We believe that should satisfy them, EU regulators. And obviously, we're going to wait until we complete all the meetings, everything buttoned up and aligned, then we'll let the markets know.

That will conclude our question-and-answer session. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.