Transcript: Ocugen Q2 2026 Earnings Conference Call

Ocugen (NASDAQ: OCGN ) held its second-quarter earnings conference call on Thursday. Below is the complete transcript from the call. APIs provide real-time access to earnings call transcripts and financial data. Visit to learn more.

View the webcast at Summary Ocugen Inc. 2 million a year earlier. 4 million as of June 30, 2026. Phase 3 trials for OCU410 and OCU400 are progressing, targeting significant unmet needs in ophthalmology; OCU410 received FDA clearance for its Phase 3 trial, and OCU400 is advancing with complete enrollment in its Phase 3 Limelight trial.

Strategic initiatives include a binding term sheet with Roots Pharmaceutical for OCU400 in the MENA region, and ongoing commercialization planning for multiple global markets. Management emphasized Ocugen's gene-agnostic platform as a differentiator in addressing complex retinal diseases and highlighted the potential for multiple upcoming BLA submissions by 2028. Full Transcript OPERATOR Good morning and welcome to Ocugen's second quarter 2026 financial results and business update. All participants are in listen-only mode.

Following the speakers' commentary, there will be a question-and-answer session. I will now turn the call over to Chris Clark, Ocugen's Head of Communications. You may begin. Chris Clark, Head of Communications 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 June 30, 2026. Avi Gupta, Executive Vice President of Commercial and Business Development, and Dr.

Mohamed Genead, who joined Ocugen as Chief Medical Officer in June, will be available to answer questions following the presentation. This morning we issued a press release covering our business and operational highlights for the second quarter of 2026. com. A replay of this call, along with the accompanying slide presentation, will be available on the Investors section of the Ocugen website.

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 timelines, 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 second quarter of 2026 will be filed today. I will now turn the call over to Dr. Musunuri. Shankar Musunuri, Chairman, CEO and Co-Founder Thank you, Chris, and good morning, everyone.

The second quarter was a defining one for Ocugen. The FDA cleared our Phase 3 trial for OCU410 to initiate dosing in geographic atrophy patients and granted RMAT designation for the program. We signed a binding term sheet with Roots Pharmaceutical to negotiate an exclusive license for OCU400 in retinitis pigmentosa across the Middle East and North Africa (MENA) region. And from the closing of $130 million convertible notes financing, we extended our cash runway into 2028, now able to support all three of our late-stage programs.

Before I walk through the quarter, I want to step back because Ocugen's potential is worth putting into context. For more than a decade, gene therapy in ophthalmology has been confined to a single gene, a single mutation and a 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 multiple gene networks.

The platform is gene-agnostic, inherently multifactorial, and designed to deliver durable benefit from a single, one-time subretinal injection. What this means in practice is that Ocugen is not building three separate drugs. We're advancing one platform across three late-stage programs, each targeting a major cause of blindness for which patients today have either no approved treatment whatsoever or therapies that demand chronic injections and carry meaningful safety burdens.

Retinitis pigmentosa (RP), Stargardt disease, and geographic atrophy together affect approximately 3 million people across the United States and Europe—a combined patient population and a commercial opportunity 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 325 patients, including EAP, through multiple doses and indications, and we have not observed a drug-related serious adverse event. We remain on track to file three BLAs by 2028.

This positions the first half of 2027 as a catalyst-rich window for Ocugen, with the top-line data for OCU400 and OCU410ST and our planned BLA submissions following over a short period. Let me walk you through how each program is advancing, then I will hand over the call to Rita for financials, starting with OCU410 for GA secondary to dry age-related macular degeneration (dry AMD). S. and in Europe combined.

There are currently no approved treatments for GA in Europe. S. target only one complement pathway and require frequent intravitreal injections, which has been associated with treatment discontinuation in clinical practice. GA is a multifactorial disease driven by four distinct pathways that contribute to the progressive degeneration of the macula: drusen, inflammation, oxidative stress, and complement activation.

S. address only one of these four pathways—the complement system—which is partly why they have been unable to demonstrate meaningful functional outcomes for patients. OCU410 operates differently by delivering RORα, 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 and has the potential to redefine the standard of care in this indication.

We recently received FDA clearance for the OCU410 Phase 3 registration trial for GA. The trial, ARMADA-3, is planned to be a global study of approximately 237 subjects using an adaptive design powered at 95% for the primary endpoint, with the BLA and Marketing Authorization Application filings targeted for 2028. We plan to initiate Phase 3 by September 2026. This design is anchored by positive 12-month data from our Phase 2 ARMADA trial at the optimal dose.

5 mm²—the criteria to be used in our Phase 3 pivotal trial—versus control, approximately twice the benefit of approved complement inhibitors and from a single injection. We also saw 27% preservation of the ellipsoid zone within the same patient population and no drug-related serious adverse events reported to date. Importantly, these Phase 2 data helped support the FDA's decision to grant RMAT designation for OCU410. Turning to OCU410ST for Stargardt disease.

S. and Europe and roughly 1 million people globally. There are no approved therapies available for these patients today. OCU410ST is designed to address over 1,200 pathogenic mutations in the ABCA4 gene with a single, one-time treatment.

On April 1st, we announced the completion of enrollment and dosing in our Phase 2/3 GARDian pivotal confirmatory trial, enrolling 63 participants. We expect the interim outcome decision for the first 50% of subjects at eight months in the third quarter of 2026, and top-line Phase 2/3 data in the second quarter of 2027, with our BLA submission following mid-2027. Moving to OCU400 for RP. The Phase 3 Limelight trial is the first and largest genetic medicine registration trial for broad RP, spanning more than 30 genetic mutations.

S. and Europe are living with RP, which is caused by mutations in more than 100 genes. The only approved gene therapy for RP today targets a single gene, RPE65, which accounts for less than 2% of all RP cases. OCU400 is designed to provide a therapeutic option for all RP patients, and that is a fundamentally different commercial opportunity.

Enrollment in Limelight is complete, with 140 patients randomized 2:1, treated versus control, across the RHO and gene-agnostic arms, spanning more than 30 genetic mutations associated with early- to late-stage RP, including pediatrics. The breadth of the population is intended to validate the gene-agnostic mechanism of action of our novel modified gene therapy platform. The primary endpoint is 12 months' change in visual function assessed by Luminance Dependent Navigation Assessment (LDNA). Subjects are followed for one year post-dosing for the primary endpoint analysis.

Top-line Phase 3 data is expected in the first quarter of 2027, advancing OCU400 to a potential approval in the fourth quarter of 2027. FDA feedback confirmed that the path to rolling BLA submission remains tied to top-line data expected in the first quarter of 2027. On the manufacturing side, our Process Performance Qualification (PPQ) batches are complete, supporting BLA and commercial launch supplies. Brand planning and marketing initiatives led by Avi Gupta, our EVP of Commercial and Business Development, continue to scale in preparation for launch.

We also advanced our global commercialization strategy for OCU400 during the quarter. In July, we signed a binding term sheet with Roots Pharmaceutical and its strategic partner Aldao International Holdings for exclusive rights to OCU400 in the Middle East and North Africa. We're active on the BD front to find other global partners for regional commercialization partnerships where RP is most prevalent. Here is a snapshot of the market opportunity across our three late-stage development programs.

While OCU410 for GA represents our largest commercial opportunity, we believe all three programs have the potential to generate significant revenue while addressing areas of substantial unmet medical need. As we continue advancing our pipeline, we're also building the foundational commercial capabilities to support future global access. Our efforts are focused on five key areas. First, we're in discussions with CMS and payers to establish early market access and reimbursement strategies.

Second, we continue to identify and evaluate specialized centers of excellence with expertise in subretinal surgical procedures that could support future treatment delivery. Third, we are mapping the patient journey from diagnosis through treatment and long-term follow-up with the goal of facilitating a seamless experience for patients, caregivers and healthcare providers. Fourth, we are assessing manufacturing, supply chain and distribution requirements to help ensure operational readiness. Finally, we are beginning to build out our commercial infrastructure, including our marketing and sales capabilities, as we ramp up for launch.

With that, I will turn the call over to Rita for the financial update. Rita. Rita Johnson-Greene, MBA — CFO Thank you, Shankar. Good morning everyone.

2 million. 8 million. 4 million. 2 million.

05 net loss per common share for the three months ended June 30, 2025. 4 million as of June 30, 2026, extending our cash runway into 2028. The company had 339 million shares of common stock outstanding as of June 30, 2026. That concludes my financial update.

Shankar, back to you. Shankar Musunuri, Chairman, CEO and Co-Founder Thank you, Rita. The second quarter was a quarter of execution. The remainder of 2026 is supposed to be impactful.

We expect the OCU410ST interim outcome decision in the third quarter and we expect to initiate the OCU410 Phase 3 trial in this quarter. Looking to 2027, we expect top-line data from both OCU400 and OCU410ST in the first half of the year followed by our planned BLA submissions. Each of these milestones brings us a step closer to delivering on our commitment to three BLAs by 2028, offering potentially life-altering improvement to patients coping with blindness-causing diseases. I want to thank our investigators and patients who have trusted us with their participation and our shareholders for their continued belief in our mission to advance cures for blindness.

We'll now open the call for questions. Operator. OPERATOR Thank you, ladies and gentlemen. We will now begin the question and answer session.

And at this time I would like to remind everyone, in order to ask a question, please press star followed by the number one on your telephone keypad. And if you would like to withdraw your question, simply press star one again. Again, if you would like to ask a question, press star one on your telephone keypad. Our first question comes from the line of Michael Okunwich with Maxim Group.

Please go ahead. Michael Okunwich, Analyst at Maxim Group Hey there. Thank you so much for taking my questions and congrats on all the great progress. Shankar Musunuri, Chairman, CEO and Co-Founder Thank you, Michael.

Michael Okunwich, Analyst at Maxim Group Sir, I wanted to ask, you now have a handful of international partnerships which makes OCU400 a truly international program at this point. S. jurisdictions, what's required there and how those timelines could vary versus your BLA path. Shankar Musunuri, Chairman, CEO and Co-Founder Michael, what we have with OCU400, we got alignment from EMA in addition to FDA with the same.

S. S. approval. S.

FDA approval in MENA and other regions. Michael Okunwich, Analyst at Maxim Group All right, thank you. And then I wanted to see also if you could just highlight some of the key differences in the trial design between Armada 3 and the Phase II Armada trial. Shankar Musunuri, Chairman, CEO and Co-Founder I'll let our CMO, Dr.

Gini, answer that. Mohamed Genead, MD, MSc. — Chief Medical Officer Thank you, Michael. Regarding Armada 3, which is our global Phase 3 trial for GA, which we just got the approval from FDA just recently to be initiated this quarter.

The Phase 3 trial design for Armada 3 will be one treatment arm with OCU410 versus a control, with 2-to-1 randomization allocation. And that data will follow each subject up to 12 months, and this is where we're going to be looking at the primary efficacy endpoint plus other key functional endpoints. Armada 1, the earlier Phase I/II GA trials, was similar on the efficacy. So we should expect similar outcome.

Here we're going to look—the numbers obviously are different. We're going to be enrolling in Armada 3 close to 237 subjects, 2-to-1 allocation. It's going to be global. , we're going to go to Europe and other territorial parts in the world.

But the primary endpoint will be very similar, so we should expect to see similar trend to what we saw from Armada 1, the Phase I/II GA trial. Michael Okunwich, Analyst at Maxim Group All right, thank you. And then just one last one for me before I hop back into the queue. So it looks like in Stargardt there is a chance that we'll have an approved therapy sometime around when you'll be completing your own BLA filing.

So it would be a chronic therapy versus a one-time. But I wanted to ask how important the pricing on other therapies, since we don't have any pricing comps, would be to inform your own pricing strategy and if there's any way that we can think about how to translate pricing between a chronic ongoing therapy and a one-time therapy.