Full Transcript: Ocugen Q1 2026 Earnings Call

Ocugen (OCGN) reported first-quarter financial results on Tuesday. The transcript from the company's first-quarter earnings call has been provided below.

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Summary

Ocugen Inc (OCGN) announced a $115 million offering of convertible senior notes, expected to close on May 7, 2026, enhancing cash reserves to $112.1 million and extending cash runway into 2028.

The company is advancing its gene therapy platform across three late-stage programs targeting retinitis pigmentosa, Stargardt disease, and geographic atrophy, with plans to file three BLAs by 2028.

Financially, Ocugen Inc (OCGN) reported an increase in operating expenses to $19.4 million for Q1 2026, with a net loss of $0.06 per share, and cash equivalents of $32.2 million as of March 31, 2026.

Notable progress includes completing enrollment in late-stage programs, positive phase 2 data for OCU410 in geographic atrophy, and preparations for a rolling BLA submission for OCU400 in the third quarter of 2026.

Management emphasized strategic partnerships for commercialization, especially for OCU410GA, and is exploring creative pricing models with payers to facilitate market access.

Full Transcript

OPERATOR

Good morning and welcome to Ocugen Inc's (OCGN) first quarter 2026 financial results 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.

Tiffany Hamilton (Head of Corporate Communications)

Thank you Operator and good morning everyone. Joining me on today's call and webcast is Dr. Shankar Muhsinuri, Ocugen Inc's (OCGN) 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 Investors section of the Ocugen (OCGN) 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, Ocugen Inc's (OCGN) quarterly report on Form 10Q covering the first quarter of 2026 will be filed today. I will now turn the call over to Dr. Moosunuri.

Shankar Muhsinuri

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 off 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 in gross proceeds, increasing expected cash, cash equivalent and restricted cash to $127.1 million. Now I would like to step back because Ocugen Inc's (OCGN) 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 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 with modulating master regulators, nuclear hormone receptors that govern entire gene networks. The platform is gene agnostic, inherently multifactorial and designed to deliver durable benefit from a single one time subretinal injection. What this means in practice is that oxygen is not building three separate drugs. We're 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 are therapies that demand chronic injections and carry meaningful safety burdens. Retinas 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 one through phase three, 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, OCU410 demonstrated approximately twice the treatment benefit over currently approved therapies in GA delivered a one time injection. We remain on track to file 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 Ocugen Inc (OCGN) with phase three top line data for AQ400 top line phase two three data for AQ410ST and BLA submissions, all expected to converge over a short period. In the first months of 2026 we completed enrollment in two of our late stage programs, delivered positive phase to top line data in the 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 RPE. The Phase 3 Limelight Clinical Trial is the only broad gene agnostic RP trial and the largest known phase three orphan gene therapy trial in the field. Approximately 300,000 people in the US and Europe are living with RP, which is caused by mutations in more than 100 genes. The only approved gene therapy for RPE today targets a single gene RPE65 which accounts for just 1 to 2% of all RPE cases. RQ400 is designed to provide a therapeutic option for the remaining 98 to 99% of RPE 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 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 and assessed by luminance dependent navigation assessment or LDNA (Luminance Dependent Navigation Assessment). 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 three 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 batches completion is on track for the second quarter of 2026 and brand planning and marketing initiatives led by Abhigupta, our EVP of commercial and business development continue 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 for action. 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% 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 OCU 400 to deliver sustained clinical benefit over time in retina's pigmentosa while maintaining a strong safety profile. Turning to OCU410SD for Stargardt disease Stargardt Disease is a pediatric onset retinal disorder affecting approximately 100,000 patients in the US and Europe and roughly 1 million globally. There are no approved therapies available for these patients today. OCU410ST is designed to address over 1200 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 23 Guardian 3 pivotal confirmatory trial, enrolling 63 participants in in less than nine months, well ahead 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 III data expected in the second quarter of 2027 and BLA submission to follow by mid 2027. OCU 410ST continues to demonstrate a favorable safety and tolerability profile with the 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 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 intrauterial injections per year, indefinitely carry meaningful safety risks, including conversion to Vit AMD in roughly 12% of treated patients and face real world dropout rates of nearly 40%. 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 US 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 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 2 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 receive a single subretinal administration of OCU 410 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 intrautereal therapies have shown approximately 15% reduction at 12 months for avanthicopigal and 22% reduction at 24 months for Pancytico Plan OCU 410 administered as a single on time injection. As 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% 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 preservation of photoreceptor integrity and visual function. On safety, OQ410 continues to demonstrate a safe and tolerable profile with no serious adverse events. No adverse events of special interest related to OC410 reported to date. We are now incorporating these results into an optimized Phase three trial design including a targeted GA lesion size window and an adapter design powered at greater than 95%. We are now on track to meet with FDA and EMA to align on the phase three 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, AQ410 has a potential to eliminate the chronic treatment burden and patient fatigue associated with currently approved therapies and to offer a lasting solution for the 2 to 3 million patients in the U.S. and Europe living with GA. Let me briefly update you on other programs for OCU 200. We completed Phase 1 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. NIAID intends to initiate the RQ500 phase 1 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 three top line data expected in 2027 and the potential for BLA and launch thereafter for OCU 4, 10, ST and Stargard disease. We have completed dosing ahead of schedule in our pivotal Phase III 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 OQ410 in 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 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 Johnson Green (Chief Financial Officer)

Rita thank you Shankar Good morning everyone. Total operating Expenses for the three 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 three months ended March 31st, 2025 of $16 million that included research and development expenses of $9.5 million and general and administrative expenses of $6.5 million. Ocugen (OCGN) 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 3 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.

Shankar Muhsinuri

Thank you, Rita. The first quarter of 2026 was a quarter defined by execution. We delivered positive 12 month phase two data for OCU410. NGA completed enrollment and dosing in the Guardian 3 Trial well ahead of schedule and continued advancing AKI400 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 3 in the third quarter. Regulatory alignment with FDA and EMA on the RQ410 Phase 3 design in the third quarter and the initiation of our first BLA submission for RQ400 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.

OPERATOR

At this time I would like to remind everyone in order to ask a question please press star then the number one on your telephone keypad. We will pause for just a moment to compile the Q and A roster. Your first question comes from the line of Leland Gershel from Oppenheimer.

Jason

Please go ahead. Hey Ockagen team, this is Jason on for Leland. Seems like it's gearing up to be an exciting year for Auky 400 and the retinitis pigmentosa. 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 commercial commercialization activities going into 2027 launch?

Shankar Muhsinuri

Thank you. Yeah. Yep. So the rolling submission as we stated will start with non clinical section module and also we're completing our PPQ last 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 PDUFA 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 we're working on one thing on the pricing, the government and 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 patient. So we want to really identify the centers for excellence where our gene therapy can be administrated. So that's what we're working on. That's 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.

Jason

Sounds great. Thank you again.

Michael Arkanovich (Equity Analyst)

Your next question comes from the line of Michael Arkanovich from Maxim Group. Please go ahead. Hello. 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 Stargardt program has been moving, how closely 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?

Shankar Muhsinuri

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 commercial perspective and launch perspective.

Michael Arkanovich (Equity Analyst)

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, do they reach a broader swath of the overall market?

Huma Gamar

Go ahead. Huma. Good morning. This is Huma Gamar. 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 Stargard. 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 enrollment 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.

Shankar Muhsinuri

So the current clinical centers. Michael, just answer. Close it out. Are not good enough for commercial. They're good, but we need a lot more for commercialization. Of course.

Michael Arkanovich (Equity Analyst)

Thank you very much. I appreciate the additional clarity and once again, congrats on all the progress.

Shankar Muhsinuri

Thank you.

OPERATOR

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

Robert Lebuyer (Equity Analyst)

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. And is very easy to fit into the current practice. So I was quick 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.

Shankar Muhsinuri

Yeah, I mean, good question. I mean, obviously this Vitrectomy, it's not a big surgery. I think any of our 2500 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 have 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 with 2500 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.

Robert Lebuyer (Equity Analyst)

And you know, 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?

Huma Gamar

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're 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 off like further 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 vitreoretinal 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.

Shankar Muhsinuri

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 Inc (OCGN) has to establish. It's nothing like anybody has done before. I just wanted to make it very clear in gene therapy space.

Robert Lebuyer (Equity Analyst)

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

OPERATOR

Your next question comes from the line of Whitney Ije from Kanacord Genuity.

Whitney Ije (Equity Analyst)

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?

Shankar Muhsinuri

Yeah, 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 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 8 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 PDF date. The outcome number two, I mean we did recruit additional patients in the trial. I mean obviously ants patient 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 time frame. 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 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 two options we have. Obviously the DMC with a blinded staff at Ocugen Inc (OCGN), 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 two options in the past. And then once the outcome is finalized by with 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 adjusting so there's a delay of six months. So those are the outcomes we'll discuss with the market.

Whitney Ije (Equity Analyst)

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?

Huma Gamar

Go ahead. Yes, yes. So basically we have for the Stargardt disease, 51 subjects, 34 treatment 17 control and adaptive design would be for 24, 16 treatment 8 control, 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. Or no.

Whitney Ije (Equity Analyst)

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?

Shankar Muhsinuri

Yeah, that's right. Yeah, I think, I mean unless. Unless. Yeah, 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 human stated at 50% reaching 8 months. 8 months. I think we have to be also be practical. I mean if it's a one year it's a different story. For gene therapies for us modified genes still start working, you know minimum, you need like six months to show something and at one year time frame you really reach the effect size and everything else. So obviously again the data will tell and will wait for orphan diseases. You're right. If there's a significant unmet medical need Even though 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 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 in 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.

Rita Johnson Green (Chief Financial Officer)

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.

Whitney Ije (Equity Analyst)

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

Shankar Muhsinuri

a 300 patients global trial in US EU and Canada together. And most of the patients or majority will be in us because we have the existing centers. And so it's 2 to 1 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.

Whitney Ije (Equity Analyst)

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

OPERATOR

Your next question comes from the line of Ramakant swayam pakula from H.C. wainwright. Please go ahead.

Ramakant swayam pakula

Thank you. This is RK from H.C. wAINWRIGHT. Good morning, Shankar and team. A lot of my questions have been answered, but I have a couple of them on the AQIA 400 where you're planning 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 that you can initiate your rolling bla?

Shankar Muhsinuri

Yeah, absolutely. We're on target to complete them this quarter. Okay, perfect. And support the rolling Bailey submission.

Rita Johnson Green (Chief Financial Officer)

Okay, great. Rita, in terms of expenses, you know, we have seen GNA 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,

Ramakant swayam pakula

on the BD side of things, what progress has been made, especially for 404. 10 in terms of ex US licensing?

Rita Johnson Green (Chief Financial Officer)

Yeah, thank you for your question. 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 OC410ST and OCU410GA, we accelerated those timelines. And so when you think about 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 the the anticipated spend that we have in 2026 going into 2027. And so we're averaging around 50 to 60 million dollars 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 X US for both AQ400 and AQ4 OciFor 10st. 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. 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.

Ramakant swayam pakula

Thank you. One last question, Shankar. I know in the past we have talked a little bit about

Shankar Muhsinuri

payers and how to get payers agreed to the pricing that you would come up with. Jenny, 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?

Ramakant swayam pakula

Yeah, I mean obviously there is a publication in Retina that talks about potential pharmacoeconomic model justifying 1 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, 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 rk as I mentioned before from launch treatment centers to and how the CMMI is looking I'm very pleased to say 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 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 energy article coming out of CMS is a good one and it goes into okay, if the price tag is high, you pay over 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.

OPERATOR

Thank you. Thanks for taking all my questions. Your next question comes from the line of Daniel Ghataulin from Chargent.

Daniel Ghataulin (Equity Analyst)

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 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 US and EU regulators are thinking about easy preservation?

Shankar Muhsinuri

Thank you Daniel. Good question. We just submitted our meeting request 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 US. 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 let the markets know. Got it. Thank you.

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