Operator
Good morning, and welcome to Ocugen First Quarter 2026 Financial Results and Business Update. All participants' lines 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, Ocugen Head of Corporate Communications.
You may now begin.
Tiffany Hamilton
Thank you, operator, and good morning, everyone. Joining me on today's call and webcast is Dr.
Shankar Musunuri, Ocugen's Chairman, CEO, and Co-Founder, who will provide a business update and an overview of our clinical and operational progress. Rita Johnson-Greene, our Chief Financial Officer, is also on the call to provide a financial update for the quarter ended March 31st, 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 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'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.
Shankar Musunuri
Thank you, Tiffany, and good morning, everyone. Before I walk through the quarter, I want to discuss the 115, $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 expects to extend cash runway into 2028.
The offering is expected to close on May 7th, 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 equivalents, 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 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, inherently multifactorial, and designed to deliver durable benefit from a single, one-time subretinal injection. What this means in practice is that Ocugen 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 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 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, 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 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 3 top-line data for OCU400, top-line Phase 2/3 data for OCU410ST, 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 2 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 OCU400 for RP, the Phase 3 liMeliGhT clinical trial is the only broad, gene-agnostic RP trial and the largest known Phase 3 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 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 that is a fundamentally different commercial opportunity.
Enrollment in liMeliGhT is now complete with 140 patients randomized 2-to-1 across the RHO 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 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 batches completion is on track for the second quarter of 2026.
Brand planning and marketing initiatives led by Abby 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 1/2 study, the treatment effect was maintained over time across evaluable subjects, with 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 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 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 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 GARDian3 pivotal confirmatory trial, enrolling 63 participants in less than 9 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 2/3 data expected in the second quarter of 2027, and BLA submission to follow by mid-2027.
OCU410ST continues 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 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 four distinct pathways that contribute to the progressive degeneration of the macula: lipid deposits and 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-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 .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, one-time 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 3 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 3 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, 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 to 3 million patients in the US and Europe living with GA.
Let me briefly update you on other programs. For OCU200, we completed Phase 1 clinical trial enrollment 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 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 OCU400 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 OCU410ST in Stargardt disease, we have completed dosing ahead of schedule in our pivotal Phase 2/3 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 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 31st, 2026. Rita?
Rita Johnson-Greene
Thank you, Shankar. Good morning, everyone.
Total operating expenses for the three months ended March 31st, 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 reported a 6 cents net loss per common share for the three months ended March 31st, 2026, compared to a 5 cents 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 31st, 2026.
That concludes my financial update. Shankar, back to you.
Shankar Musunuri
Thank you, Rita. The first quarter of 2026 was a quarter defined by execution.
We delivered positive 12-month Phase 2 data for OCU410 in GA, completed enrollment 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 3 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 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'll 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&A roster.
Your first questions comes from the line of [Leland Gershell?] from [Oppenheimer?]
. Please go ahead.
Hey, Ocugen team. This is Jason on for Leland.
Seems like it's gearing up to be an exciting year for OCU400 in 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 commercialization activities going into a 2027 launch?
Thank you.
Shankar Musunuri
Yeah. Yep.
The rolling submission, as we stated, will start with non-clinical section module. Also, we're completing our PPQ lots from CMC manufacturing perspective.
That module will also be submitted this year. 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 date of 6 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, CMS. 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.
We want to really identify the centers for excellence where our gene therapy can be administered. That's what we're working on, that's the second step.
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 year before, later part of the year, getting into the early next year, that's when we'll start bulk of the commercial work.
Sounds great. Thank you again.
Operator
Your next questions comes from the line of Michael Okunewitch from Maxim Group. Please go ahead.
Michael Okunewitch
Hey there. Thank you for taking my questions today.
Good morning, everyone, and congrats on all the great progress you've been making.
Shankar Musunuri
Thank you.
Michael Okunewitch
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? 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 Musunuri
Now, good question. If everything goes according to the plan, they could be within 6 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 who are administering for RP.
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. When Stargardt is going to come later within 6 months, we should be in a great shape from commercial perspective and launch perspective.
Michael Okunewitch
All right. 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?
Shankar Musunuri
Go ahead, Huma.
Huma Qamar
Good morning. This is Huma Qamar.
I'm going to take this question. Good question.
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. The centers are almost the same, and also, as Shankar has mentioned, centers for excellence, there's an increased demand for, as we have now closed the enrollment for both the programs, to go as fast as we could per the protocols.
There will be some overlap, but there are quite a few more centers that we have identified as well.
Shankar Musunuri
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.
Michael Okunewitch
Yeah. Of course.
Thank you very much. I appreciate the additional clarity, and once again, congrats on all the progress.
Shankar Musunuri
Thank you.
Operator
Your next questions comes from the line of Robert LeBoyer from Noble Capital Markets. Please go ahead.
Robert LeBoyer
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. I was quite 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 Musunuri
Yeah. Good question.
Obviously this vitrectomy, it's not a big surgery. I think any of our 2,500 well-trained retinal surgeons in our country can do that.
However, it's a one-and-done treatment. It's a one-time administration for life.
We want to make sure whatever centers they're going to participate in the commercial, and they get trained on the same surgical manual we've been using in the clinical trials, which has been worked successfully. That's the goal.
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. As a company, we just want to make sure we train a group of people.
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 LeBoyer
Okay. Just my understanding was that anyone who's 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?
Huma Qamar
I can answer that, Robert. Good to hear from you.
Yes, it's a vitrectomy, which is pretty common, it's 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. When we are launching the centers of excellence, that would be the main centers that could further train down the next few centers down there.
The initial launch definitely we have all across, they're covering majority of the centers. 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 the initial ones that take the burden of first launch and then go towards the next. 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 Musunuri
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.
There is a 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. Just wanted to make it very clear in gene therapy space.
Robert LeBoyer
Yes. Okay.
That's a very good point. Okay.
Thank you.
Operator
Your next questions comes from the line of [Whitney Ijem?] from [Canaccord Genuity?]
. Please go ahead.
Whitney Ijem
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, what was assumed, and then what should we all be expecting to see in that readout? Then third part of this question is just what is the range of outcomes based on that data for the study moving forward?
Shankar Musunuri
Yeah. I think Whitney, this is outcome analysis.
It's not really giving any interim analysis like we expect, primary endpoint and secondary endpoint analysis. This is done under strict guidance of Data Monitoring Committee.
Why do you do adaptive design? To minimize any further risk to Phase 3 clinical trial.
In Phase 3 clinical trial, we have a true control arm, untreated arm, which will be compared with the treatment arm. The DMC looks at predictive analytics and see the study is designed for 12 months, and at 8 months, when 50% of the patients have completed, they're going to look at it, compared to control arm, are we going to meet the success?
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 few weeks after that, and then the clock starts for PDUFA date.
The outcome number two: we did recruit additional patients in the trial, obviously anticipating dropouts and all that, but if the analytics show you need to increase number by certain number, we have to again recruit. That means you have to monitor those patients for additional 1 year.
That has impact on the top-line results in the filing. During the 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 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 extended to 16 months.
Those are the two options we have. Obviously, the DMC, with a blinded staff at Ocugen, they're going to look at it carefully and present this option to agency and get the buy-in from FDA, which they've recommended these two options in the past.
Then, once the outcome is finalized with agency's concurrence, we're going to let the markets know. 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. There's a delay of 6 months.
Those are the outcomes we'll discuss with the market.
Whitney Ijem
Got it. Okay.
That's really helpful. Then going back to the just powering question, what have you disclosed the powering of the study on the primary endpoint?
Shankar Musunuri
Go ahead, Huma.
Huma Qamar
Yes. Basically, we have, for the Stargardt disease, 51 subjects: 34 treatment, 17 control, and adaptive design would be for 24 16 treatment, 8 control.
Yes, it's adequately powered, around 90% or more. 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. The interim outcome would be either sample size re-estimation or no.
Whitney Ijem
Got it. Okay.
That's helpful. 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 a best case, oh, we're going to end early or something like that, right?
Shankar Musunuri
Yeah. That's right.
I think, Whitney, if you look at many products which got approvals, some of them got approvals with 30 patients, right? With orphan diseases, obviously with, as Huma stated, at 50% reaching 8 months, 8 months, I think we have to be also practical.
If it's a 1 year, it's a different story. For gene therapies, for us, modified genes to start working, minimum you need 6 months to show something.
At 1-year time frame, you really reach the effect size and everything else. 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 at the interim, if you really hit it out of the park, agencies will consider that. 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. 1 year itself, if you look at all our clinical trials compared to other things going on the industry across all our three 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.
Whitney Ijem
Yeah. That makes perfect sense.
Okay. Then just moving on, a cash question.
What does the new guidance into 2028 assume in terms of GA Phase 3 spend?
Rita Johnson-Greene
Yeah. The GA Phase 3 spend is included in the new cash runway into Q1 or into 2028.
We do anticipate being able to cover the expenses for that trial.
Whitney Ijem
Okay. Got it.
I guess, 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, again, from a cash estimation perspective?
Shankar Musunuri
It's 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. It's 2-to-1 ratio: 200 in treatment and 100 in untreated control.
It's powered at over 95%
Whitney Ijem
on
Shankar Musunuri
the primary endpoint, and 90 92% for EZ, ellipsoid zone, secondary endpoint. It has an adaptive design when 150 patients reach 1 year, we can take a look.
Whitney Ijem
Got it. Okay.
Perfect. That's it for me.
Thanks so much.
Operator
Your next questions comes from the line of [Ramakanth Swayampakula?] from [H.C.
Wainwright?] .
Please go ahead.
Swayampakula Ramakanth
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 OCU400, where you're planning to start the rolling BLA in third quarter, can you confirm your PPQ runs would be completed in time, by end of second quarter or so, so that you can initiate your rolling BLA?
Shankar Musunuri
Yeah. Absolutely.
We're on target to complete them this quarter.
Swayampakula Ramakanth
Okay. Perfect.
Shankar Musunuri
That, yep, and support the rolling BLA submission.
Swayampakula Ramakanth
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? Relatedly, on the BD side of things, what progress has been made, especially for 400 and 410, in terms of ex-US licensing?
Rita Johnson-Greene
Yeah. Thank you for your questions.
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? If you're looking at OCU410ST and OCU410 GA, we accelerated those timelines, and so when you think about us completing our enrollment for OCU400 and OCU410ST, 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.
We feel really confidently about the anticipated spend that we have in 2026 going into 2027. We're averaging around $50 to $60 million per year from a spend perspective, which is why we believe that our cash runway is into 2028.
Then going to the business development, we are actively evaluating various BD deals for ex-US for both OCU400 and OCU410ST. We have term sheets that we're looking at.
There's a lot of work going on as Shankar said that Abby 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 OCU410 GA, 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.
Swayampakula Ramakanth
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, especially from recent conversations from your payers as you're getting closer to commercialization, especially with the price tag that you're thinking for some of your drugs?
Shankar Musunuri
Yeah. Obviously, there is a publication in Retina, that talks about potential pharmacoeconomic model justifying $1 to $2 million somewhere in the range price tag.
Also, there is a publication in 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. The publication clearly goes into pay-over-time and subscription models, which can help with the budgetary constraints we have, how can we work.
Everything is very creative, RK, as I mentioned before, from launch, treatment centers to how the CMMI is looking. I'm very pleased to say, obviously these are one-time treatments, right?
We need to think about some creative ways. How can we work with payers and make sure, especially if CMS, 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 they're going to get a bigger chunk of economy and budget from CMS.
We need to really think into all those options, how we can provide market access to more patients and who need them. That NEJM 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. Those are very good models coming out.
It's a very creative thinking, and we are aligned with that strategy.
Swayampakula Ramakanth
Perfect. Thank you.
Thanks for taking all my questions.
Operator
Your next questions comes from the line of Daniil Gataulin from Chardan. Please go ahead.
Daniil Gataulin
Yes. Hi.
Good morning, guys. Thank you for taking my question.
I have a more general question on EZ preservation. It appears to be emerging as an important endpoint.
Wanted to ask, in your conversations with the regulators, what would you say their most recent position is on the importance of EZ preservation? Two, are there any differences in how US and EU regulators are thinking about EZ preservation?
Thank you.
Shankar Musunuri
Daniil, a good question. We just submitted our meeting requests both FDA and EMA.
Obviously, I will let you know by early third quarter the input and alignment with them. Obviously you saw GA trial what we publicly stated, our primary endpoint is lesion, because that's an approved endpoint in two commercial products in US.
The secondary endpoint we're proposing is ellipsoid zone, because it correlates to visual function. We believe that should satisfy them, EU regulators.
Obviously, we're going to wait until we complete all the meetings, everything buttoned up and aligned, then we'll let the markets know.
Daniil Gataulin
Yeah. Thank you.
Operator
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.