Q1 2026 Ocugen Inc Earnings Call

May 5, 2026

Operator 1: Ladies and gentlemen, this is the operator. Today's conference is scheduled to begin momentarily. Thank you for your patience.

Shankar Musunuri: Good morning. Welcome to Ocugen Q1 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, Ocugen Head of Corporate Communications.

Operator: Good morning. Welcome to Ocugen Q1 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, Ocugen Head of Corporate Communications.

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: 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-Green, our Chief Financial Officer, is also on the call to provide a financial update for the quarter ended 31 March 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 Q1 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.

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 31 March 2026. Dr. Huma Qamar, Chief Medical Officer, will be available to answer questions following the presentation.

Thank you, operator, and good morning, everyone joining me on today's call in webcast, is Dr. Chancre museri occupants, chairman CEO. And co-founder who will provide a business update and an overview of our clinical and operational progress.

Tiffany Hamilton: This morning, we issued a press release covering our business and operational highlights for Q1 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.

Rita Johnson green. Our Chief Financial Officer is also on the call to provide a financial update for the quarter. Ended March 31st 2026 Dr. Houma Kamar. 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 oyun.com.

Tiffany Hamilton: 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 Q1 2026 will be filed today. I will now turn the call over to Dr. Musunuri.

A replay of this call along with the accompanying. 5 presentation will be available on the investor section of the Octagon website. Before we begin, please note, that certain statements made during today's discussion, may be forwarded looking in nature, including those related to our clinical development pipeline regulatory pipelines, commercialization strategy, and financial information, and our anticipated cash Runway.

Tiffany Hamilton: 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 Q1 2026 will be filed today. I will now turn the call over to Dr. Musunuri.

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 more comprehensive understanding of these potential risks.

Finally, Ogden's quarterly report on Form 10-Q covering the first quarter of 2026 will be filed today.

Shankar Musunuri: Thank you, Tiffany, and good morning, everyone. Before I walk through the quarter, I want to discuss the $115 million offering of convertible senior notes that we announced yesterday. With the recent offering, the company is expected to have cash 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 7 May 2026, subject to customary closing conditions, and includes an option to retire the debt with a cash payment. If the remaining Jones Henderson warrants are exercised, the company will receive an additional $15 million in gross proceeds, increasing expected cash equivalent and restricted cash to $127.1 million.

I will now turn the call over to Dr. Mouser

Thank you, Tiffany. 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.

Shankar Musunuri: The offering is expected to close on 7 May 2026, subject to customary closing conditions, and includes an option to retire the debt with a cash payment. If the remaining Jones Henderson warrants are exercised, the company will receive an additional $15 million in gross proceeds, increasing expected cash equivalent and restricted cash to $127.1 million. Now, I would like to step back because Ocugen's potential is worth putting into context.

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 even your debt payoff. The company will use the remaining net proceeds for a 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 the cash payment. If the remaining Janice Anderson 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

Shankar Musunuri: Now, I would like to step back because Ocugen'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 modified gene therapy platform takes a fundamentally different approach. Rather than targeting individual mutations, it is designed to address the root cause of complex retinal diseases by modulating master regulators, nuclear hormone receptors that govern 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.

Hours.

Shankar Musunuri: 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 modified gene therapy platform takes a fundamentally different approach. Rather than targeting individual mutations, it is designed to address the root cause of complex retinal diseases by modulating master regulators, nuclear hormone receptors that govern entire gene networks.

Now, I'd like to step back because oxygens potential is worth putting into context for more than a decade, gene therapy and Opthalmology has been confined to a single Gene, a single mutation, and a single small patient population.

Shankar Musunuri: 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.

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, where modulating Master Regulators, nuclear hormone receptors that go on entire Gene networks. The platform is Gene agnostic.

Inherently multifactorial and designed to deliver durable benefit from a single 1-time subretinal injection.

Shankar Musunuri: 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 at one-time injection.

What this means in practice is that oxygen is not building 3 separate drugs, where advancing 1 platform across 3 late stage programs. Each targeting a major cause of blindness for which patients today have either no approved treatment whatsoever or therapies that demand, chronic injections and carry meaningful safety burdens.

Shankar Musunuri: 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 at one-time injection. We remain on track to file 3 BLAs over next 3 years by 2028. First of those, OCU400 for RP, will begin rolling submission in Q3 of this year.

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 for larger than anything currently served by approved Gene therapies and Opthalmology.

Across our pipeline spanning fish. 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, AQ 410, demonstrated approximately twice.

The treatment benefit or currently approved Therapies in GA delivered at 1 time injection.

Shankar Musunuri: We remain on track to file 3 BLAs over next 3 years by 2028. First of those, OCU400 for RP, will begin rolling submission in Q3 of this year. This positions H1 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 2 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.

We remain on track to file three BLAs over the next three years, by 2028.

Shankar Musunuri: This positions H1 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 2 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.

And first of those occup 400 for RP, will begin rolling submission in the third quarter of this year.

For oxygen with phase 3, Topline data for oq 400 Topline Phase 23 data for acq, 410 St. And ba submissions, all expected to converge over a short period. In the first months of 2026, we completed enrollment in 2 of our late stage programs delivered positive Phase 2, Topline data in the third and our diligently working toward initiating. Our first pla submission later this year.

Let me walk you through how each program is advancing.

Shankar Musunuri: 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.

Shankar Musunuri: 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.

Starting with oq 400 for RP, the phase 3, Limelight clinical trial is the only broad Gene, agnostic, artery 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 or P 65 which accounts for just 1 to 2% of all RP cases.

Okay, 400 is designed to provide a therapeutic option for the remaining 98 to 99% of RP patients, and that is a fundamentally different commercial opportunity.

Shankar Musunuri: 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 Q3 2026 and complete BLA submission by Q2 2027. Phase 3 top-line data is expected in Q1 2027, with a potential FDA approval targeted for Q4 2027. On the manufacturing side, process performance qualifications, PPQ batches completion is on track for Q2 2026. Brand planning and marketing initiatives led by Abhi Gupta, our EVP of Commercial and Business Development, continue to scale in preparation for launch.

Shankar Musunuri: 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 Q3 2026 and complete BLA submission by Q2 2027. Phase 3 top-line data is expected in Q1 2027, with a potential FDA approval targeted for Q4 2027. On the manufacturing side, process performance qualifications, PPQ batches completion is on track for Q2 2026.

Enrollment in Limelight is now complete with 140, patients randomized 2:1 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, assessed by luminance dependent navigation, assessment, or ldma.

We plan to initiate the rolling BLS submission for OQ 400 in the third quarter of 2026 and complete BLA submission by the second quarter of 2027.

Phase 3 topline data is expected in the first quarter of 2027, with potential FDA approval targeted for the fourth quarter of 2027.

Shankar Musunuri: Brand planning and marketing initiatives led by Abhi Gupta, our EVP of Commercial and Business Development, continue to scale in preparation for launch. OCU400 continues to demonstrate encouraging long-term durability with the 3-year data supporting sustained improvement in visual function compared with untreated eyes.

On the manufacturing site, process performance, qualifications PPQ. Batches completion is on track for the second quarter of 2026 and brand planning and marketing initiatives. Led by ADI Gupta, our EVP of commercial and business development continued to scale and preparation for launch.

Shankar Musunuri: 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 the clinically meaningful mean changes in LLVA observed at years 1, 2, and 3 in both the multiple mutation and rho subgroups. Importantly, these results suggest the benefit is not limited to a single genetic subtype, reinforcing the program's gene agnostic mechanism of action. From a safety perspective, OCU400 continues to show a favorable profile with no serious adverse events reported as being related to treatment. At the 3-year time point, 88% of treated evaluable subjects demonstrated either improvement or preservation in visual function relative to untreated eyes, highlighting both the durability and consistency of the response.

Shankar Musunuri: 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 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.

AQ 400 continues to demonstrate encouraging long-term durability with the 3-year data supporting sustained Improvement in visual function, compared with untreated eyes in the face. You want to study the treatment effect was maintained or time across a valuable subjects with the clinically meaningful mean. Changes in llba. Absorbed it years, 1, 2 and 3 in both, the M 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, faction,

Shankar Musunuri: At the 3-year time point, 88% of treated evaluable subjects demonstrated either improvement or preservation in visual function relative to untreated eyes, highlighting both the durability and consistency of the response. Taken together, these data support the potential for OCU400 to deliver sustained clinical benefit over time in retinitis pigmentosa while maintaining a strong safety profile. Turning to OCU410ST for Stargardt disease.

From a safety perspective, okay, 400 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 valuable subjects, demonstrated either Improvement or preservation in visual function, relative to untreated eyes, highlighting both durability.

Shankar Musunuri: 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 1 April, 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.

And consistency of the response taken together. These data support the potential for ocy, 400 to deliver sustained clinical benefit over time in written night's Pigmentosa while maintaining a strong safety profile.

Shankar Musunuri: 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 1 April, 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.

Turning to ocu for Tennessee 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 okq 14st is designed to address or 12200 pathogenic mutations in the abca4 gene with a single 1-time treatment.

Shankar Musunuri: 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 Q3 2026, with the top-line Phase 2/3 data expected in Q2 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.

On April 1st, we announced the completion of enrollment inducing in our Phase 23, Guardian 3 total confirmatory trial, enrolling 63, participants in less than 9 months. Well, Errol the originally planned timeline.

Shankar Musunuri: The interim analysis is planned for Q3 2026, with the top-line Phase 2/3 data expected in Q2 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%.

That pace reflects what the depth of unmet need in stargard disease and the exceptional engagement of our investigators and patient community.

The interim analysis is planned.

Thank you for tuning in. Stay continues to demonstrate a favorable safety and tolerability profile. With no product related. Serious Adverse Events reported to date.

Turning now to ocu 410 for GA.

Shankar Musunuri: 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%.

Late stage dry age related macular degeneration.

Shankar Musunuri: 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.

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 that therapy is required. 612 intra betrayal injections per year, indefinitely carry meaningful, safety risks, including conversion to, with AMD and roughly 12% of treated patients and face. Real world, Dropout rates of nearly 40%

GA is a multi-factorial disease driven by 4 distinct Pathways that contribute to the progressive degeneration of the macula lipid deposits, Drew in, chronic information, oxidative stress and complement activation.

The currently approved Therapies in the US address only 1 of these 4 Pathways the complement system which is partly why they have been unable to demonstrate meaningful functional outcomes for patients.

Shankar Musunuri: 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.

A key for an operates differently by delivering Aurora, a nuclear hormone receptor that acts as a master regulator of retinol homeostasis.

Acupuncture is designed to address All 4 disease, Pathways simultaneously with a single subretinal injection has a potential to redefine the standard of care in this indication.

Shankar Musunuri: The study enrolled 51 patients aged 50 years and older with the GA lesions in the foveal or non-foveal region, randomized one to one to one to receive a single subretinal administration of OCU410 at the medium dose, high dose, or no treatment in the control group. The optimal dose, which is the medium dose, demonstrated a 31% reduction in lesion growth relative to control at 12 months, with a P value of less than 0.05. To put this in context, currently approved intravitreal therapies have shown approximately 15% reduction at 12 months for avacincaptad pegol and 22% reduction at 24 months for pegcetacoplan. OCU410 administered as a single one-time injection has shown the potential for an approximately 2-fold treatment benefit relative to approved therapies that require continuous chronic dosing regimens.

In March, we reported positive Topline, 12 month data from All Phase 2 or model clinical trial.

The study enrolled 51 patients, aged 50 years.

And older with the ga lesions and the phobia are non-fed 1 to 1 to 1 to receive a single subretinal administration of ocu for 10 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.

Shankar Musunuri: 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 2-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.

With the P value of less than 0.05.

To put this in context, currently approved intravitreal therapies are shown approximately 15% reduction at 12 months.

For advanced.

Ago and 22% reduction at 24 months for PEX set-acl plan. Oq 410 administered as a single 1-time injection.

Shankar Musunuri: 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, 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 Q3 2026, with potential BLA filing by 2028.

As shown the potential for an approximately 2 4 treatment benefit relative to approved therapies that require continuous, chronic dosing regimens.

Shankar Musunuri: 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, 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%.

Across the treated population 55% of treated subjects, demonstrated a 30% or greater reduction in lesion size related to control. We also observed, a 27% slower rate of ellipsoid Zone loss, which is structural biomarker that correlates with the preservation of photo receptor, integrity and visual function.

On safety occup for 10 continues to demonstrate a safe and tolerable profile with no serious Adverse Events. No Adverse Events of special interest related to occup for 10 reported today.

Shankar Musunuri: We are now on track to meet with FDA and EMA to align on the Phase 3 study design and reach regulatory agreement by Q3 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 I clinical trial enrollment in Q1 2026.

We are now incorporating these results into an optimized phase 3. Trial design, including a targeted GL, lesion, size window, and an Adaptive design powered at greater than 95%.

Shankar Musunuri: 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 I clinical trial enrollment in Q1 2026. No serious adverse events or adverse events related to OCU200 have been reported to date. On OCU500, our first-in-class inhaled mucosal COVID-19 vaccine candidate designed to be administered via inhalation and intranasal delivery, NIAID intends to initiate the OCU500 phase I clinical trial in Q2 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.

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 AIP, 410 has the potential to eliminate the chronic treatment burden and patient fatigue associated with current therapies, and to offer a lasting solution for the 2 to 3 million patients in the US and Europe living with GA.

Shankar Musunuri: No serious adverse events or adverse events related to OCU200 have been reported to date. On OCU500, our first-in-class inhaled mucosal COVID-19 vaccine candidate designed to be administered via inhalation and intranasal delivery, NIAID intends to initiate the OCU500 phase I clinical trial in Q2 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.

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 are Adverse Events related to okay, 200 have been reported today

On occupy, 500, our first and last inhale, mucosal coid, 19, vaccine candidate designed to be administered. Via inhalation, and initial delivery knee Aid, intends to initiate the ocu, 400 Phase 1, clinical trial in the second quarter of 2026.

Shankar Musunuri: 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 Q3 of 2026 and top-line results anticipated in the Q2 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.

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.

Shankar Musunuri: 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 31 March 2026. Rita?

In 2026 with phase 3, Topline data expected in 2027, and the potential for bla and launched thereafter for oq, for Dynasty and stargardt disease. We have completed dosing ahead of schedule in our pivotal Phase 23. Guardian 3 trial with intro analysis, expected in the third quarter of 2026 and Topline results anticipated in the second quarter of 2027 followed by a planned bla submission.

Shankar Musunuri: I'll now turn the call over to Rita to provide an update on our financial results for the quarter ended 31 March 2026. Rita?

Rita Johnson-Green: Thank you, Shankar. Good morning, everyone. Total operating expenses for the 3 months ended 31 March 2026 were $19.4 million and included research and development expenses of $11.3 million and general and administrative expenses of $8.1 million, compared to total operating expenses for the 3 months ended 31 March 2025 of $16 million that included research and development expenses of $9.5 million and general and administrative expenses of $6.5 million. Ocugen reported a $0.06 net loss per common share for the 3 months ended 31 March 2026, compared to a $0.05 net loss per common share for the 3 months ended 31 March 2025.

Rita Johnson-Greene: Thank you, Shankar. Good morning, everyone. Total operating expenses for the 3 months ended 31 March 2026 were $19.4 million and included research and development expenses of $11.3 million and general and administrative expenses of $8.1 million, compared to total operating expenses for the 3 months ended 31 March 2025 of $16 million that included research and development expenses of $9.5 million and general and administrative expenses of $6.5 million.

For ocu, 410. In Geographic atrophy, we continue to advance toward phase, 3 development following encouraging, Phase 2 Data. But 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. And now turn the call over to Rita to provide an update on our financial results for the quarter end date, March 31st, 2026 Rita

Thank you, Shankar. Good morning, everyone.

Total operating expenses for the 3 months, ended, March 31st, 2026 or 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 this 3 months ended, March 31st 2025 of 16 million.

Rita Johnson-Greene: Ocugen reported a $0.06 net loss per common share for the 3 months ended 31 March 2026, compared to a $0.05 net loss per common share for the 3 months ended 31 March 2025. The company's cash equivalents, and restricted cash totaled $32.2 million as of 31 March 2026, compared to $18.9 million as of 31 March 2025. The company received $37.5 million in gross proceeds, inclusive of $15 million due to exercised warrants in Q1 2026.

That included research and development expenses of $9.5 million, and general and administrative expenses of $6.5 million.

Rita Johnson-Green: The company's cash equivalents, and restricted cash totaled $32.2 million as of 31 March 2026, compared to $18.9 million as of 31 March 2025. The company received $37.5 million in gross proceeds, inclusive of $15 million due to exercised warrants in Q1 2026. With the recent offering, the company is expected to have 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 31 March 2026. That concludes my financial update. Shankar, back to you.

oxygen reported a 6 Cent net loss per common share for the 3 months ended March 31st, 2026 compared to a 5 Cent, net loss per common share for the 3 months ended March, 31st 2025

Rita Johnson-Greene: With the recent offering, the company is expected to have 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 31 March 2026. That concludes my financial update. Shankar, back to you.

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 dollars 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 and expects to extend cash Runway into 2028.

Shankar Musunuri: Thank you, Rita. The Q1 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 Q3, regulatory alignment with FDA and EMA on the OCU410 phase 3 design in Q3, and the initiation of our first BLA submission for OCU400 also in Q3. Each of these milestones bring us a step closer to delivering on our commitment of 3 BLAs by 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. Thank you Rita the first quarter of 2026 was a quarter defined by execution we delivered positive. 12 months, Phase 2 data for AIP for 10 and ga

Completed enrollment and dosing in the guardian 3 trial. Well ahead of schedule and continued advancing. Okay, 400 towards its rolling bla submission. Later this year.

Shankar Musunuri: We expect interim outcome analysis from GARDian3 in Q3, regulatory alignment with FDA and EMA on the OCU410 phase 3 design in Q3, and the initiation of our first BLA submission for OCU400 also in Q3. Each of these milestones bring us a step closer to delivering on our commitment of 3 BLAs by 2028. I want to thank our employees, investigators, and patients who have trusted us with their participation, and our shareholders for continued belief in our mission to advance cures for blindness. We'll now open the call for questions. Operator?

Shankar Musunuri: 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?

Looking ahead. The remainder of 2026 is poised to be consequential with multiple meaningful infection points. We expect interim outcome analysis, from Guardian 3 in the third quarter regulatory alignment, the FDA and EMA on the ocu, 410 phase 3, design, and 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 3, Bloss 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 2: 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.

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.

At this time, I would like to remind everyone that in order to ask a question, please press star then the number 1 on your telephone keypad.

We will pause for just a moment to comply the to compile the Q&A roster.

Your first questions comes from the line of lelander shell.

From open hype open himer, please go ahead.

[Analyst] (Oppenheimer): Hey, Ocugen team. This is Jason on for Leland. It seems like it's gearing up to be an exciting year for OCU400 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? How else are you thinking about the pre-commercialization activities going into 2027 launch? Thank you.

About the pre-commercial commercialization activities going into 2027 launch.

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 a PDUFA date of 6 months clock, expected to get the approval in the Q4 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 with 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 patient.

Thank you.

Yeah. Yep.

So the rolling submission, um, as we stated, um, will start with non-clinical Section module. And uh, also, we're completing, uh, our PPQ Lots from CMC manufacturing perspective. That module will also be submitted this year and next year, as soon as the Topline results come in, within weeks after that,

The final clinical module will be submitted, and that will trigger a P24 data six-month clock.

Expected to get the approval in the fourth quarter and launch.

Shankar Musunuri: As we mentioned before, we're working on one thing on the pricing with 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 patient. We want to really identify the centers for excellence where our gene therapy can be administered. That's what we're working on as the second step. The third step is, of course, getting up for sales and marketing and really commercial plans.

From commercial perspective, uh, there are multiple things we are doing as we mentioned before. Um, we're working on 1 thing on the pricing, the government CMS and second step is of course as a company

Shankar Musunuri: We want to really identify the centers for excellence where our gene therapy can be administered. That's what we're working on as the second step. The third step is, of course, getting up for sales and marketing and really commercial plans. I think we're working on the strategy. 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.

Shankar Musunuri: I think we're working on the strategy. 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.

We have established very standard way of treating these patients with our, uh, surgery procedure, which we use in clinical trials, uh, 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 with the second step. And the third step is, of course, getting up for sales and marketing and really commercial clients that you are working on a strategy and a 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.

[Analyst] (Oppenheimer): Sounds great. Thank you again.

Sounds great. Thank you again.

Shankar Musunuri: Thank you.

Operator 2: Your next questions comes from the line of Michael Okunewitch from Maxim Group. Please go ahead.

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.

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? Are there any additional commercial considerations you're evaluating with the possibility that you will be kind of ramping both of these launches contemporaneously?

Thank you.

Um, I guess just to to start off, I'd like to see given how quickly the star guard program has been moving

Um, 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?

Shankar Musunuri: No, good question. I mean, 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 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'll always help with Stargardt disease. When Stargardt, you know, is going to come later within 6 months, we should be in a great shape, from commercial perspective and launch perspective.

No, good question. I mean if everything goes according to the plan, they could be within 6 months of each other.

Shankar Musunuri: When Stargardt, you know, is going to come later within 6 months, we should be in a great shape, from commercial perspective and launch perspective.

Um, obviously, um, from launch, your commercial perspective. Again, we're targeting the same centers for excellence, for Ginter P 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 its Target disease.

So, when Tsar Guard, um, you know, is going to come later within six months, we should be in great shape.

Um, from, um, a commercial perspective and launch perspective.

Michael Okunewitch: All right. How much overlap is there between the.

Michael Okunewitch: All right. How much overlap is there between the. The liMeliGhT and the GARDian3 studies, are they largely at the same centers, or if you take them combined, do they reach a broader swath of the overall market?

Whitney Ijem: The liMeliGhT and the GARDian3 studies, are they largely at the same centers, or if you take them combined, do they reach a broader swath of the overall market?

All right. And then, um, how much overlap is there between the, uh

The Limelight and the guardian studies are, are they largely at the same centers or 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. 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 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 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. You know, there will be some overlap, but there are quite a few more centers that we have identified as well.

Huma Qamar: 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. You know, 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.

Go ahead, good morning. Uh, this is Uma, gamar. I'm going to take this question. Uh, good question. So both represent inherited retinal diseases. Of course, recognized as Pigmentosa. Um, you know, we have almost the same centers. Uh, there is a single subretinal injection. Um, there is an overlap. Uh, however, there is no approved product, uh, for Star guard and, uh, we do have a huge unmet medical need in terms of RP, as well. So, the centers, uh, are almost the same and also as chancre has mentioned centers for excellence, there is an increase demand, um, for, as we have now closed the enrollment, uh, for both the programs to go as fast as we could per the protocols. And, um, you know, there will be some overlap but there are, uh, quite a few more centers that we have identified as well.

Michael Okunewitch: Yep. Of course. Thank you very much. I appreciate the additional clarity. Once again, congrats on all the progress.

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

Shankar Musunuri: Thank you.

Yeah, of course, thank you very much. I appreciate the additional Clarity. And once again, congrats on all the progress.

Thank you.

Operator 2: Your next questions comes from the line of Robert LeBoyer from Noble Capital Markets. Please go ahead.

Operator: Your next questions comes from the line of Robert LeBoyer from Noble Capital Markets. Please go ahead.

Your next question comes from the line of Robert Leo 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 wondering about the centers of excellence and how you're gonna launch the product, if it's going to be a broad launch or focused on specific areas or treatment centers in the marketplace?

Of sex centers for excellence. My understanding was that the product is something that can be administered by any opthalmologist and anyone who, who treats patients,

Robert LeBoyer: I was wondering about the centers of excellence and how you're gonna launch the product, if it's going to be a broad launch or focused on specific areas or treatment centers in the marketplace?

And is very easy to fit into the current practice. Uh, so 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 or treatment centers in the marketplace?

Shankar Musunuri: Yeah. I mean, good question. I mean, obviously, this vitrectomy, it's not a big surgery. I think any of our 2,400 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. 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. That's the goal. I mean, once again, I just want to clarify, this is not a, you know, complex surgery, and any of those surgeons, the 2,400 smart retinal surgeons can do this. As a company, we just want to make sure we train a group of people.

Shankar Musunuri: I mean, once again, I just want to clarify, this is not a, you know, complex surgery, and any of those surgeons, the 2,400 smart retinal surgeons can do this. 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.

Shankar Musunuri: 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.

Yeah, I mean a good question. I mean obviously this petami it's not a um a big surgery. I think any of our 2500 trained well trained retinal surgeons in our country can do that. However um, you know, it's a 1 and done treatment. It's a 1 time Administration for life. So we want to make sure uh whatever Center, they're going to participate in the commercial and 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 um, you know, complex surgery and any of those surgeons, the 2500 smart returns can do this. But as a company, we just want to make sure we trained. Um, a 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 and patient safety.

Robert LeBoyer: Okay. You know, just my understanding was that anyone who's a retinal surgeon can administer OCU400 without any special training. Is that correct? You know, just what is the difference between the clinical trial and actual practice?

Okay. And, you know, just my understanding was that

Anyone who's a retina surgeon can administer.

ocu 400 without any special training is that

Is that correct? Or, you know, 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, like 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. 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, I can answer that, Robert. Good to hear from you. So, um,

Huma Qamar: This is not a new treatment, new procedure, or single subretinal injection that we are giving. 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. Yes, you do not need any special training. This is pretty much standard of care. We have retro retinal surgeons that are pretty good in doing this. The only difference is this. There is, of course, with any product, you come up with the guidelines, and that's what they have to do.

Huma Qamar: Yes, you do not need any special training. This is pretty much standard of care. We have retro retinal surgeons that are pretty good in doing this. The only difference is this. There is, of course, with any product, you come up with the guidelines, and that's what they have to do.

Yes, it's a it's a retreat to me, 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 chancre is mentioning. Here, is actually every product has its specifications. So when we are launching the centers of accidents, that would be the main centers that could further train down the next few centers, like, um, 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, um, or sub 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, you know, further first launch and then go towards the next. So, uh, yes, you do not need any special training. This is pretty much standard of care. And, um, we

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. I just wanted to make it very clear in gene therapy space.

Have Victor retinal surgeons that are pretty good and and and 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 and Robert I think this is the first time. Remember we're not talking about going after 500 patients. A thousand patients. We're going to go after hundreds of thousands of patients with our Therapies.

So so there is a whole pair system and how you direct the patients. It's it's a new paradigm. Oxygen has to establish. It's nothing like anybody has done before. I just wanted to make it very clear in gene therapy space.

Robert LeBoyer: Yes, okay. That's a very good point. Okay, thank you.

Yes. Okay. That's that's a very good point. Okay. Thank you.

Operator 2: Your next questions comes from the line of Whitney Ijem from Canaccord Genuity. Please go ahead.

Operator: Your next questions comes from the line of Whitney Ijem from Canaccord Genuity. Please go ahead.

Your next question comes from the line of Whitney EJ from kind of core 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 Q3, can you remind us, first of all, the powering of that study? Like, what was assumed? What should we all be expecting to see in that readout? Sorry, third part of this question is just what is the range of outcomes based on that data for the study moving forward?

Hey guys, congrats on all the progress this quarter. Um

Shankar Musunuri: Yeah. I think, Whitney. This is outcome analysis. It's not really giving any interim analysis like we expect in our 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 that study is designed for 12 months. 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 1. No changes.

First question, I guess headed into the interim, uh, for the Stark art study in the third quarter. Can you remind us? First of all, the powering of that study, uh, like what was assumed. Um, and then what will, what should we all be expecting to see in in that readout. Uh, and then sorry. Third part of this question is just, what is the range of outcomes based on that data? Uh, for the, for the study of moving forward,

Yeah, I think, uh, um, um, Whitney.

so, the

Shankar Musunuri: 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 1. No changes. Top-line results come out in Q2 of next year. BLA will be filed few weeks after that. The clock starts for PDUFA date. The outcome number 2, I mean, we did recruit additional patients in the trial.

It's designed for 12 months, and at 8 months, 50% of the patients have completed. They're going to look at it.

Shankar Musunuri: Top-line results come out in Q2 of next year. BLA will be filed few weeks after that. The clock starts for PDUFA date. The outcome number 2, I mean, we did recruit additional patients in the trial. I mean, obviously anticipation of dropouts and all that. If the analytics show you need to increase number by a certain number, we have to again recruit. I mean, You know, that means you have to monitor those patients for additional 1 year. That has impact on the top-line results in the filing. During that timeframe, we're also, based on the discussions we had in the agency in the past, we have 2 options. Either you increase the size, and we can also look into adding an additional time point.

Shankar Musunuri: I mean, obviously anticipation of dropouts and all that. If the analytics show you need to increase number by a certain number, we have to again recruit. I mean, You know, that means you have to monitor those patients for additional 1 year. That has impact on the top-line results in the filing. During that timeframe, we're also, based on the discussions we had in the agency in the past, we have 2 options. Either you increase the size, and we can also look into adding an additional time point.

Shankar Musunuri: 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. Those are the 2 options we have. Obviously, the DMC with the 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 have recommended these 2 options in the past. Once the outcome is finalized by, with agency's concurrence, we're going to let the markets know. Just to sum it up, 1 of the outcomes is there's no change. We're on track. Everything is looking good. Another outcome is there is some delay, but the delay also minimizes any risk to the clinical trial we're adjusting.

Uh compared to control arm. Are we going to uh meet the success and and if there is nothing to be changed, you continue. That's outcome number 1. No changes Topline results come out. And second quarter of next year, ba will be fine a few weeks after that. And then the clock starts for 2 for date. The the outcome number 2. I mean we did recruit additional um 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 1 year. So that has impact on the Topline results in the filing. And the, and during that time frame, we're also based on the discussions, we had in the agency in the past. So we have 2 options, either, you increase the size and uh, we can also look into adding an additional time point from 12 months, you also can

At 16 months time point. You can also look into Predictive Analytics and see if you're going to meet the criteria of making a success if you extend it to 16 months. So those are the 2 options. We have obviously, um, the DMC with the blinded staff at oxygen. They're going to look at it carefully and present these options to agency and get the Buy in from FDA which they

Shankar Musunuri: Just to sum it up, 1 of the outcomes is there's no change. We're on track. Everything is looking good. Another outcome is there is some delay, but the delay also minimizes any risk to the clinical trial we're adjusting. There's a delay of, you know, 6 months. Those are the outcomes we'll discuss with the market.

Recommended these 2 options in the past. And then once the outcome is finalized by with the agency's concurrence, we're going to let the markets know. So just to

Sum it up.

1 of the outcomes is. There's no change. We're on track. Everything is looking good.

Shankar Musunuri: There's a delay of, you know, 6 months. Those are the outcomes we'll discuss with the market.

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, 6 months. Um, so those are the outcomes, we'll discuss with the market.

Whitney Ijem: Got it. Okay, that's really helpful. Can, 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.

The study, uh, on the primary endpoint.

Huma Qamar: Yes. Yes. Basically, we have for the Stargardt disease, 51 subjects, 34 treatment, 17 control. Adaptive design would be for a 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, you know, 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, like a best case, Oh, we're gonna end early, or something like that, right?

Go ahead. Yes, yes. So, basically, uh, we have, um, for the stronger disease 51 subjects, 34 treatment, 17 control and the Adaptive design would be for a 2416, uh, treatment 8 control. And, uh, yes. It's adequately, uh, powered, uh, around 90% or more and, uh, we are going to look at, um, the powering once again, uh, once the Adaptive, uh, you know, analysis interim outcome is going to be there. Um, however we are sufficiently powered uh, keeping in mind the prevalence as well as the no approved product right now in market. So, the income outcome would be either sample size re-estimation or no.

Got it. Okay, the helpful and then um just to double check in terms of the range of outcomes. There's no um I guess upside scenario, right? Just to make sure I'm 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 Musunuri: Yeah, that's right.

Whitney Ijem: Okay.

Shankar Musunuri: 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? With orphan diseases, I mean, obviously, with the, as Huma stated, it's 50% reaching 8 months. 8 months, I think we have to be also be practical. I mean, if it's a 1 year, it's a different story. For gene therapies, for us, modified genes to start working, you know, minimum you need, like, 6 months to show something. At 1 year timeframe, 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.

Shankar Musunuri: At 1 year timeframe, 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 the sometimes in 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.

Shankar Musunuri: If there's a significant unmet medical need, even the sometimes in 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, you know, other things going on in the industry across all our 3 programs, we are doing 1-year trials compared to anybody out there. Most of the people do 2-year trials because we're able to show effect size, treatment effect, and benefit in 1 year.

Shankar Musunuri: 1 year itself, if you look at all our clinical trials compared to, you know, other things going on in the industry across all our 3 programs, we are doing 1-year trials compared to anybody out there. Most of the people do 2-year trials because we're able to show effect size, treatment effect, and benefit in 1 year.

Yeah, that's right. Yeah, I think I mean unless unless yeah, I mean, um, with me 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 human stated it's 50% reaching 8 Months, 8 months, I think we have to be also be practical. Um, I mean, if it's a 1 year, it's a different story but gene therapy is for, for us modified is to start working, you know, minimum you need like 6 months to show something and at 1 year time frame, you really uh, Reach the, the effect size and everything else. So obviously, um, again the data will tell and we'll wait for our friend diseases. You're right. If there's a significant unmet medical need, even the sometimes, the interim, if you really hit it out of the park agencies will consider that. But I also want to be practical about it. I think 8 months is for adjustment um but typically it's good to look at it 1 year 1 year itself. If you look at all our clinical trials compared to

To, you know, other things going on the industry across all our 3 programs. We are doing 1 year trials. Compared to anybody out there. Most of the people do 2 year trials, because we're able to show FX size

Whitney Ijem: Yep. That makes perfect sense. Okay. Just moving on, a cash question. What does the new guidance into 2028 assume in terms of GA Phase 3 spend?

Treatment effect and benefit in 1 year.

Whitney Ijem: Yep. That makes perfect sense. Okay. Just moving on, a cash question. What does the new guidance into 2028 assume in terms of GA Phase 3 spend?

Mhm.

Yeah, that makes perfect sense. Okay. Uh and then just moving on a cache question. Um what does the the new guidance uh into 2028 assume in terms of GA based 3 steps?

Rita Johnson-Green: Yeah. It's included within the GA. The GA Phase 3 spend is included in the new cash runway into Q1 or into 2028. Yeah, we do anticipate being able to cover the expenses for that trial.

Rita Johnson-Greene: Yeah. It's included within the GA. The GA Phase 3 spend is included in the new cash runway into Q1 or into 2028. Yeah, we do anticipate being able to cover the expenses for that trial.

Whitney Ijem: Okay. Got it. 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?

Cash Runway into q1 of or into into 2028. Um, so yeah, we we do anticipate being able to cover um the expenses for that trial,

Shankar Musunuri: It's a 300 patients global trial in US, EU, and Canada together.

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

Whitney Ijem: Got it.

Shankar Musunuri: 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%.

It's it's a 300 patients, Global trial in USU and Canada together.

Shankar Musunuri: 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%.

and uh and most of the patients are majority will be in us because we have the existing centers

And, and so it's a 2-to-1 ratio—200 in treatment and 100 in untreated control.

Whitney Ijem: Yeah.

Whitney Ijem: for the primary endpoint.

Shankar Musunuri: for the primary endpoint.

It's powered at over 95%.

Whitney Ijem: Got it.

Whitney Ijem: 92% for easy ellipsoid zone secondary endpoint. It has adaptive design. At 150 patients reach 1 year, we can take a look.

Shankar Musunuri: 92% for easy ellipsoid zone secondary endpoint. It has adaptive design. At 150 patients reach 1 year, we can take a look.

On the premium point and and 90 92% for Easy Storage Zone. Secondary at the point,

And it has adaptive design at 150 patients, reach 1 year. We can take a look

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

Got it. Okay. Perfect, that's it for me. Thanks so much.

Operator 2: Your next questions comes from the line of Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.

Operator: Your next questions comes from the line of Swayampakula Ramakanth 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, you know, where you're planning to start the rolling BLA in Q3, can you confirm your PPQ runs would be completed, you know, in time, like, by end of Q2 or so that you can initiate your rolling BLA?

Your next question comes from the line of ram accounts. Why I'm pacula from HC rain right. Please go ahead.

Thank you. This is okay from HC V, right? Um, good morning, Sean Courant. Team. A lot of my questions have been answered, but I have couple of them. Um, on the oq 400, you know where you're planning for a to start the rolling bla in third quarter. Um,

Shankar Musunuri: Yeah, absolutely. We're on target to complete them this quarter.

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

Swayampakula Ramakanth: Okay. Perfect.

Yeah, absolutely. We're on target to complete them this quarter.

Shankar Musunuri: 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. 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 OCU400 and OCU410 in terms of ex-US licensing?

Okay, perfect. And then, yep, and support the rolling data submission.

Okay, great. Um,

It.

in terms of, um, expenses, you know, um,

we we have seen GNA and and R&D expenses grow up, uh this quarter, which is understandable, but how should we think about this going forward, especially into 2027, um, as you're preparing, you know, for for commercialization

and uh, relatively, um,

you know, on on the BD side of things, um,

What what what progress has been made.

Um, especially for 4410 um in terms of xus Licensing,

Rita Johnson-Green: Yeah. Thank you for your questions. 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? If you're looking at, you know, OCU410ST and OCU410, we accelerated those timelines. When you think about, you know, 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.

Rita Johnson-Greene: Yeah. Thank you for your questions. 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? If you're looking at, you know, OCU410ST and OCU410, we accelerated those timelines.

Rita Johnson-Greene: When you think about, you know, 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, you know, the anticipated spend that we have in 2026 going into 2027. 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.

Rita Johnson-Green: We feel really confidently about, you know, the anticipated spend that we have in 2026 going into 2027. 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. Then going to the business development, we are, you know, actively evaluating various BD deals for ex-US for both OCU400 and OCU410ST.

Rita Johnson-Greene: Then going to the business development, we are, you know, actively evaluating various BD deals for ex-US for both OCU400 and OCU410ST. 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 Abhi 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 Ocugen and for our shareholders.

Yeah, thank you for your questions. So first of all, just to kind of address the, um, you know, the the spend that you're seeing. Um, you have to consider part of it is, is due to timing. Uh, and then also related to, you know, using some of our programmatic Milestones, right? So, if you're looking at, you know, ocu, 410 St, and ocu, 410 G, we accelerated those timelines. Uh, and so, when you think about, you know, using complete completing our enrollment for ocu 400 and ocu for 10 St. Um, 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, of the year. So we feel really confidently about, you know, the the, the uh, anticipated spend that we have in 2026 going into um, going into 2027 and so we're you know averaging around 50 to 60 million dollars per year from us then perspective which is why we believe that our cash Runway is into 2028.

Rita Johnson-Green: 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 Abhi 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 Ocugen and for our shareholders. Lastly, from a commercialization perspective for OCU410 GA, 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.

Rita Johnson-Greene: Lastly, from a commercialization perspective for OCU410 GA, 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.

Um, and then going to the business development. Uh, we are, you know, actively evaluating, um, various BD deals for exas for both ocu, 400 and ocu for, um, ocu for 10 St. You know, we have, um, term sheets that we're looking at. So, you know, there's a lot of work going on. Uh, just the Shankar said that Obi is doing who leads our business development team, uh, to ensure that you know, we are evaluating those Alternatives and then making the best decision for Oyen and for our shareholders.

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, 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?

And then lastly, from a commercialization perspective for ocu for 10 G, we are still uh, looking to commercialize that with a partner. Um, although you know, as we talked about the spend associated with the clinical trials, we, uh, you know, we have that incorporated into our Runway,

Price tag that uh, you are thinking for some of your drugs.

Shankar Musunuri: Yeah. I mean, obviously, there is a publication in Retina, I mean, that talks about potential pharmacoeconomic model, justifying $1 to 2 million, somewhere in the range price tag. There is a publication from New England Journal of Medicine, 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. The publication clearly goes into payer 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, you know, I mean, treatment centers to, and 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.

Yeah, I mean obviously um um we there is a publication in retina. I mean the talks about um,

Shankar Musunuri: How can we work? Everything is very creative, RK, as I mentioned before, from launch, you know, I mean, treatment centers to, and 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, the government is spending a lot of money for orphan diseases or diseases like GA, which will help. Most of the patients are above 60, and they're going to get a bigger chunk of economy and budget from CMS.

Shankar Musunuri: 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 help. 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. Then, that NEJM article coming out of CMS is a good one. 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.

Um, potential harmful economic model. Uh, justifying 1 to 2 million somewhere in the range price tag. And also there is a publication from New England Journal of Medicine. And uh, this is again, uh, we're happy to State, uh, 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 your 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 to uh, and how the cmmi is looking. I'm very pleased to say it's obviously, these are 1-time treatments, right? So, we need to think about some creative ways. How can we work with payers, um, and make sure, especially if CMS. The government is spending a lot of money for Orphan diseases or diseases, like GA, which will um,

Shankar Musunuri: We need to really think into all those options, how we can provide market access to more patients and who need them. Then, that NEJM article coming out of CMS is a good one. 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. I mean, it's a very creative thinking, and we are aligned with that strategy.

Have most of the patients are about 60 and they're going to get a bigger chunk of economy and, and the budget from CMS. So we need to really think into all those options, how? Um, we can provide Market access to more patients and who need them and then uh, are there. So that that energy and article coming out of CMS is a good 1 and it goes.

Shankar Musunuri: I mean, it's a very creative thinking, and we are aligned with that strategy.

Swayampakula Ramakanth: Perfect. Thank you. Thanks for taking all my questions.

Listen to, okay? If the price tag is fine, you pay your time because if you say your therapy is 1 time, treatment for life, you stand by it. And so those are very good models coming out. I mean it's it's a very creative thinking and we are aligned with that strategy.

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

Operator 2: Your next questions comes from the line of Daniil Gataulin from Chardan. Please go ahead.

Operator: Your next questions comes from the line of Daniil Gataulin from Chardan. Please go ahead.

Your next question comes from. The comes from the line of denial from charging. Please go ahead.

Daniil Gataulin: Yes. Hi, good morning, guys. Thank you for taking my question. I have a more general question on ellipsoid zone 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 ellipsoid zone preservation? 2, are there any differences in how US and EU regulators are thinking about ellipsoid zone preservation? Thank you.

Shankar Musunuri: Daniel, good question. We just submitted our meeting request to both FDA and EMA. Obviously, I will let you know by early Q3, 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 in two commercial products in US. The secondary endpoint is we are 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.

Yes. Hi good morning guys. Uh thank you for taking my question. Um I have a more more general question on easy preservation. Um, it appears to be an emerging as an important endpoint. Um, so wanted to ask in your conversations with The Regulators, uh what would you say their most recent position is on the importance of easy preservation and uh 2 are there any differences in how you ask an EU Regulators are thinking about easy preservation, thank you.

Any good question. We just submitted um our meeting request, both FDA and Emma. Obviously, I will let you know, uh my early third quarter, the input and alignment with them. I mean obviously you saw G at trial but we publicly stated our primary end. Point is Legion because that's an approved end point in 2 products in us and the secondary end point is we're proposing is ellipsoid Zone because it correlates to visual function. We believe that should

Shankar Musunuri: Obviously, we're going to wait until we complete all the meetings, everything buttoned up and aligned, then we'll let the markets know.

Would satisfy them uh you regulators. And uh obviously we're going to wait until we complete. All the meetings.

Everything buttoned up and aligned then we'll let the markets now.

Daniil Gataulin: Got it. Thank you.

Got it. Thank you.

Operator 2: 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.

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.

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