Ocugen, Inc. Q1 FY2026 Earnings Call

Good morning and welcome to Oxygen First Quarter 2026, Financial Result and Business Update. All participants' line are currently in listen-only mode. Following the speaker commentary, there will be a question and answer session. I will now turn the call over to Tiffany Hamilton, Oxygen 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 Musanari, Ocugen's chairman, CEO, and co-founder, who will provide a business update and an overview of our clinical and operational progress. Rita Johnson-Green, our chief financial officer, is also on the call to provide a financial update for the quarter ended March 31, 2026. Dr. Huma Kumar, 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 Investor 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 pipelines, 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, Occitan'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. Musanari.

Thank you, Tiffany. Good morning, everyone. Before I walk through the quarter, I want to discuss the $115 million offering of convertible senior nodes 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 revenue debt payoff. The company will use the remaining net proceeds for general corporate purposes and expects 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 a cash payment. If the remaining Janus Henderson warrants are exercised, the company will receive an additional 15 million dollars in gross proceeds, increasing expected cash, cash equivalent, and restricted cash to $127.1 million. Now, I would like to step back because Occigen's potential is worth putting into context. For more than a decade, gene therapy and ophthalmology has been confined to a single gene, a single mutation, and a single small patient population. Our modifier 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 entire gene networks. The platform is gene agnostic, invariantly multifactorial, and designed to deliver durable benefit from a single, one-time subretinal injection. What this means in practice is that Ocigen is not building three separate drugs. We are advancing one platform across three 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. Ritonitis 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 and ophthalmology. Across our pipeline, spanning phase 1 through phase 3, we have treated more than 250 patients across multiple doses and indications, and we have not observed a drug-related serious adverse events. In our most recent readout, RQ410 demonstrated approximately twice the treatment benefit over currently approved therapies in GA, delivered a one-time injection. We remain on track to find three BLAs over next three years by 2028, and first of those, RQ400 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 oxygen with phase 3 top line data for ocu400 top line phase 2 3 data for ocu410 st and bla submissions all expected to converge for a short period in the first months of 2026 we completed enrollment in two of our late stage programs delivered positive Phase II top-line data in a third and are diligently working toward initiating our first BLA submission later this year. Let me walk you through how each program is advancing. Starting with RQ400 for ARP, the Phase III Limelight Clinical Trial is the only broad gene agnostic ARP 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, RP65, which accounts for just 1-2% of all RP cases. RQ400 is designed to provide a therapeutic option for the remaining 98 to 99% of RP patients, and that is a fundamentally different commercial opportunity. Enrollment in Limelight is now complete, with 140 patients randomized 2 to 1 across the row 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 RQ400 in the third quarter of 2026 and complete BLA submission by the second quarter of 2027. Phase 3 top-line data is expected in the first quarter of 2027 with the potential FDA approval targeted for the fourth quarter of 2027. On the manufacturing side, process performance qualifications, PPQ badges 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, continued to scale in preparation for launch. RQ400 continues to demonstrate encouraging long-term durability with the three-year data supporting sustained improvement in visual function compared with untreated eyes. In the Phase 1-2 study, the treatment effect was maintained over time across evaluable subjects with the clinically meaningful mean changes in LLVA observed at years 1, 2, and 3 in both the multiple mutation and row subgroups importantly these results suggest the benefit is not limited to a single genetic subtype reinforcing the program's gene agnostic mechanism fraction from a safety perspective rq400 continues to show a favorable profile with no serious adverse events reported as being related to treatment at the three-year time point 88 percent of treated valuable subjects demonstrated either improvement or preservation in visual function relative to untreated eyes, highlighting both durability and consistency of the response. Taken together, these data support the potential for RQ400 to deliver sustained clinical benefit over time in retinitis pigmentosa while maintaining a strong safety profile. Turning to RQ410ST for Stargardt disease. Sargaard disease is a pediatric 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, one-time treatment. On April 1st, we announced the completion of enrollment and dosing in our Phase 2-3 Guardian 3 pivotal confirmatory trial, enrolling 63 participants in less than nine months, well out of the originally planned timeline. 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 2-3 data expected in the second quarter of 2027 and BLA submission to follow by mid-2027. OCU-410-ST continues to demonstrate a favorable safety and tolerability profile with the no-product-related serious adverse events reported to date. Turning now to OCU-410 for GA. Late-stage, dry, age-related macular degeneration, GA represents our largest commercial opportunity with approximately 2 to 3 million patients in the United States and Europe combined. There are currently no approved treatments for GA in Europe. The United States approved therapies require 6 to 12 intra-utrial injections per year indefinitely, carry meaningful safety risks including conversion to with AMD in roughly 12% of treated patients and face real-world dropout rates of nearly 40 percent. GA is a multifactorial disease driven by four 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 four 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 four disease pathways simultaneously with a single subretinal injection as a 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 GA lesions in the foveal or non-foveal region, randomized 1 to 1 to 1 to receive a single subretinal administration of Ocu410 at a 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 intravetrial therapies are shown approximately 15% reduction at 12 months for Avanzico-Pegol and 22% reduction at 24 months for Pegsitco Plan Ocu410 administered as a single one-time injection has shown the potential for an approximately two-fold treatment benefit relative to approved therapies that require continuous chronic dosing regimens. Across the treated population, 55 percent of treated subjects demonstrated a 30 percent or greater reduction in lesion size relative to control. We also observed a 27 percent slower rate of ellipsoid zone loss, which is structural biomarker that correlates with the preservation of photoreceptor integrity and visual function. On safety, the OCU-410 continues to demonstrate a safe and tolerable profile with no serious adverse events, no adverse events of special interest related to OCU-410 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 one-time treatment for life, RQ410 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 two to three million patients in the US and Europe living with GA. Let me briefly update you on other programs. For OCU-200, we completed phase one clinical trial enrollment in the first quarter of 2026 and no serious adverse events or adverse events related to OCU-200 have been reported to date. On OCU-500, our first-in-class inhaled mucosal COVID-19 vaccine candidate designed to be administered via inhalation and intranasal delivery, NYAID intends to initiate the RQ500 phase one 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 RQ400 in retinitis pigmentosa, we remain on track to begin a rolling BLA submission in 2026 with phase 3 top-line data expected in 2027 and the potential for BLA and launch thereafter. For RQ410ST in Stargardt disease, we have completed dosing ahead of schedule in our pivotal phase 2-3 Guardian 3 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 OCU-410 and geographic atrophy, we continue to advance toward Phase 3 development, following encouraging Phase 2 data, with the program expected to move through Phase 3 enrollment toward BLA submission by 2028. Taken together, these milestones reflect a disciplined, multi-programmed strategy designed to create value through a series of increasingly important clinical and regulatory readouts. And 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 three months ended March 31, 2026 were $19.4 million and that 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 three 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 three months ended March 31st, 2026, compared to a $0.05 net loss per common share for the three months ended March 31st, 2025. The company's cash, cash equivalents, and restricted cash totaled $32.2 million as of March 31st, 2026, compared to $18.9 million as of March 31st, 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 ARCU-410 NGA, completed enrollment and dosing in the Guardian III trial well ahead of schedule, and continued advancing ARCU-400 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 Guardian III in the third quarter, regulatory alignment with FDA and EMA on the OCU-410 Phase III design in the third quarter, and the initiation of our first BLA submission for OCU-400, also in the third quarter. Each of these milestones bring us a step closer to delivering on our commitment of three 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 will now open the call for questions.

Operator?

At this time, I would like to remind everyone in order to ask a question, please press start then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Your first questions comes from the line of Leland Jerschel from Oppenheimer. Please go ahead.

Hey, Occugen team. This is Jason on through Leland.

It seems like it's gearing up to be an exciting year for Occy 400 and the red night, this 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 else are you thinking about the pre-commercialization activities going into 2027 launch. Thank you.

Yeah, yeah. So the rolling submission as we stated will start with non-clinical 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 top line results come in within weeks after that the final clinical module will be submitted and that will trigger a pdf data of six months clock expected to get the approval in the fourth quarter and launch from commercial perspective there are multiple things we are doing as we mentioned before um we're working on one thing on the pricing the government cms and second step is Of course, as a company, we have established a very standard way of treating these patients with our surgery procedure, which we use in clinical trials to minimize any risk to the So we want to really identify the Centers for Excellence, where our gene therapy can be administered. So that's what we're working on with the second step. And the third step is, of course, getting up for sales and marketing and really commercial plans. I think we're working on the strategy. And typically, you start that work 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.

Sounds right. Thank you again.

Your next question comes from the line of Michael Arkanovich from Maxim Group. Please go ahead.

Hey there. Thank you for taking my questions today.

Good morning, everyone, and congrats on all the great progress you've been making. Thank you.

I guess just to start off, I'd like to see, given how quickly the StarGuard program has been moving, how close together are you expecting an RP and a StarGuard 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? like?

No, good question. I mean, if everything goes according to the plan, they could be within six months of each other. 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 six 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 Guardian studies? Are they largely at the same centers, or if you take them combined, and do they reach a broader swath of the overall market?

Go ahead.

Good morning. This is Huma Kumar. I'm going to take this question. Good question. So both represent inherited retinal diseases, of course, retinitis, pigmentosa. You know, we have almost the same centers. There is a single subretinal injection. There is an overlap. However, there is no approved product for StarGuard, Stargard, and we do have a huge unmet medical need in terms of RPA 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 enrollment, for both the programs to go as fast as we could per the protocol. And, you know, 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.

Of course. Thank you very much. I appreciate the additional clarity.

And once again, congrats on all the progress.

Thank you.

Your next question comes from the line of Robert Leboyer from Noble Capital Markets. Please go ahead.

Good morning and congratulations on all of the progress that you've been making. My question has to do with the marketing and your mentions 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.

Yeah, I mean, good question. I mean, obviously, this 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, you know, it's a one-and-done treatment. It's a one-time 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. So, I mean, once again, I just want to clarify, this is not a complex surgery, and any of those surgeons with 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.

Okay, and just my understanding was that anyone who's a retina surgeon can administer OCU 400 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, 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 However, when we define centers of excellence, that's always like the initial ones that take the burden off, like, you know, 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 vitoretinal 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 or 1,000 patients. We're going to go after hundreds of thousands of patients with our therapies. So there is a whole payer system in how you direct the patients. It's a new paradigm oxygen has to establish. It's nothing like anybody has done before. I just wanted to and make it very clear in gene therapy space.

Yes, okay, that's a very good point. Okay, thank you.

Your next question comes from the line of Whitney Ije from KanaCore Genuity. Please go ahead.

Hey guys, 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 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?

Yeah, I think, Whitney, so this is outcome analysis.

It's not really giving any interim analysis like you 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 adaptive design to minimize any further risk to phase three clinical trial? In phase three 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 that study is designed for 12 months. And at eight months, when 50% of the patients are 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 second quarter of next year. BLA will be filed a few weeks after that, and then the clock starts for a pre-due for date. The outcome number two, 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 certain number, we have to, again, recruit, I mean, that may have, you know, that means you have to monitor those patients for additional one 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 two 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-month 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 two options we have. Obviously, the DMC with the blinded staff oxygen, they're going to look at it carefully and present this option to agency and get the buy-in from FDA, which they have recommended these two options in the past. And then once the outcome is finalized with the agency's concurrence, 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, yeah, there is some delay, but the delay also minimizes any risk to the clinical trial we're ingesting. So there's a delay of, you know, six 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, have you disclosed the powering of the study on the primary endpoint?

Go ahead, Yuma.

So basically we have, for the Straharka disease 51 subjects, 34 treatment, 17 control. And adaptive design would be for a 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 is things are on track. There's not like a best case, oh, we're going to end early or something like that, right?

Yeah, that's right.

Yeah, I think, I mean, unless, yeah, I mean, Whitney, if you look at many products which got approvals under, you know, some of them got approvals with 30 patients, right? So with orphan diseases i mean obviously um with the as huma stated it's 50 percent reaching eight months eight months i think we have to be able to be practical um i mean if it's a one year it's a different story for gene therapies for for us modified genes to start working you know minimum you need like six months to show something and at one year time frame you really reach the the effect size and everything else so obviously um again the data will tell and will wait for orphan diseases you're right if there's a significant unmet medical need even the sometimes at 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 eight months is for adjustment but typically it's good to look at it one year one year itself if you look at all our clinical trials compared to you know other things going on the industry across all our three programs we are doing one-year trials compared to anybody out there. Most of the people do two-year trials because we're able to show effect size, treatment effect, and benefit in one year.

Yep, 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 3 spend?

Yeah, it's included within the GA.

The GA Phase 3 spend is included in the new cash runway into Q1 or into 2028. So, yeah, 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 patients global trial. in the U.S., EU, and Canada together. And most of the patients, majority will be in the U.S. because we have the existing centers. And so it's two-to-one ratio, 200 in treatment and 100 in untreated control. It's powered at over 95% for the primary endpoint and 92% for easy ellipsoid zone, secondary endpoint. And it has an adaptive design at 150 patients reach one year. We can take a look.

Okay, perfect. That's it for me. Thanks so much.

Your next question comes from the line of Ramakant Swayampakula from HC Rainwright. Please go ahead.

Thank you. This is R.K. from HC Rainwright. Good morning, Shankar and team. A lot of my questions have been answered, but I have a couple of them. On the OCU400, you know, where you're planning to start the rolling BLA in third quarter, um can you confirm your ppq runs would be completed you know in time like by by end of second quarter or so so that you can initiate um your rolling bla yeah absolutely we're on target to complete them this quarter okay perfect and that yep and support the rolling beta submission Okay, great. Rita, in terms of expenses, you know, 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, you know, for commercialization? And relatedly, you know, on the BD side of things, what progress has been made, especially for 400 and 410 in terms of ex-US licensing?

Yeah, thank you for your questions. So, first of all, just to kind of address the, you know, the spend that you're seeing, you have to consider part of it is due to timing and then also related to, you know, us exceeding some of our programmatic milestones, right? So if you're looking at, you know, OCU-410ST and OCU-410GA, we accelerated those timelines. And so when you think about, you know, us completing our enrollment for OCU-400 and OCU-410ST, the completion of that enrollment 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, you know, the anticipated spend that we had in 2026 and going into 2027. And so, we're, you know, averaging around $50 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, you know, actively evaluating various BD deals for XUS for both Acu400 and Acu410ST. You know, we have term sheets that we're looking at. So, you know, there's a lot of work going on, just as Shankar said, that Avi is doing, who leads our business development team, to ensure that, you know, we are evaluating those alternatives and then making the best decision for AcuGen and for our shareholders. And then lastly, from a commercialization perspective for Acu410GA, we are still looking to commercialize that with a partner. Although, you know, as we talked about the spend associated with the clinical trials, we, you know, we have that incorporated into our runway.

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

Yeah, I mean, obviously, there is a publication in Retina, I mean, that talks about potential farmco-economic model justifying one to two million, somewhere in the range, price tag. And also there is a publication from the New England Journal of Medicine. And this is, again, we're happy to state CMS and CMMI, they're looking into, you know, 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 okay as i mentioned before from launch you know and the treatment centers too and how the cmmi is looking i'm very pleased to say it's obviously these are one-time 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 about 60, and they're going to get a bigger chunk of economy and 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 energy article coming out of CMS is a good one, and it goes into, okay, if the price tag is high, you pay your time. Because if you say your therapy is one-time 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.

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

Your next question comes from the line of Daniel Gataulin from Charjan. Please go ahead.

Yes. Hi. Good morning, guys. Thank you for taking my question. I have a more general question on easy preservation. It appears to be emerging as an important endpoint, so I wanted to ask in your conversations with the regulators, what would you say their most recent position is on the importance of easy preservation, and two, are there any differences in how U.S. and E.U. regulators are thinking about easy preservation?

Daniel, a 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. A primary endpoint is lesion because that's an approved endpoint in two commercial products in the U.S. And the secondary endpoint is we're 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 let the markets know.

Okay, thank you.

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.