OCGN

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:30 a.m. ET Chairman, Chief Executive Officer, and Co-Founder - Shankar Musunuri Chief Financial Officer - Rita Johnson-Greene Executive Vice President of Commercial and Business Development - Abhi Gupta Chief Medical Officer - Mohamed Genead Head of Communications - Chris Clark Need a quote from a Motley Fool analyst? Email [email protected] Operator: Good morning, and welcome to Ocugen's Second Quarter 2026 Financial Results and Business Update. [Operator Instructions] I will now turn the call over to Chris Clark, Ocugen's Head of Communications. You may begin. Chris Clark: 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; Abhi 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. We encourage listeners to review the press release, which is available on our website at ocugen.com. A replay of this call, along with the accompanying slide presentation, will be available on the Investors section of the Ocugen website. 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 time lines, 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: 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 3 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 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 multiple gene networks. The platform is gene-agnostic, inherently multifactorial, and designed to deliver a durable benefit from a single, one-time subretinal injection. What this means in practice is that Ocugen is not building 3 separate drugs. We're 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. 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 the commercial opportunity far larger than anything currently served by approved gene therapies in ophthalmology. Across our pipeline, spanning Phase I through Phase III, 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 3 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, a secondary to dry age-related macular degeneration or dry AMD. GA represents our largest commercial opportunity with approximately 2 million to 3 million patients in the U.S. and Europe combined. There are currently no approved treatments for GA in Europe. Current approved therapies in the U.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 4 distinct pathways that contribute to the progressive degeneration of the macula, drusen, inflammation, oxidative stress and complement RORA activation. The currently approved therapies in the U.S. 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. 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 4 disease pathways simultaneously with a single subretinal injection, has the potential to redefine the standard of care in this indication. We recently received FDA clearance for OCU410 Phase III registrational trial for GA. The trial, ArMaDa3, 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 III by September 2026. This design is anchored by positive 12-month data from our Phase II ArMaDa trial. At the optimal dose, OCU410 delivered a statistically significant 31% reduction in GA lesion growth within the patient population of lesion size 2.5 millimeter square and 17.5 millimeter square. The criteria to be used in our Phase III pivotal trials versus control, approximately twice the benefit of approved complement inhibitors and from a single injection. We also saw a 27% preservation of the ellipsoid zone within the same patient population and no drug-related serious adverse events reported to date. Importantly, these Phase II data help support the FDA's decision to grant RMAT designation for OCU410. Turning to OCU410ST for Stargardt disease. Stargardt is a pediatric onset retinal disorder affecting approximately 100,000 patients in the U.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 1, we announced the completion of enrollment and dosing in our Phase II/III GARDian3 pivotal confirmatory trial, enrolling 63 participants. We expect the interim outcome decision for the first 50% of subjects at 8 months in the third quarter of 2026 and top line Phase II/III data in the second quarter of 2027 with our BLA submission to follow mid-2027. Moving to OCU400 for RP. The Phase III liMeliGhT trial is the first and largest genetic medicine registration trial for broad RP, spanning more than 30 genetic mutations. Approximately 300,000 people in the U.S. and Europe are living with RP, which is caused by mutations in more than 100 genes. The only approved gene therapy for RP today targets a single gene, 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 the 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 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. Subjects are followed for 1 year post-dosing for the primary endpoint analysis. Top line Phase III 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 Abhi 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, Al-Dhow International Holding, for exclusive rights to OCU400 in the Middle East and North Africa. We are 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 all 3 late-stage development programs. While OCU410 for GA represents our largest commercial opportunity, we believe all 3 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 5 key areas. First, we're in discussions with CMS and peers 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'll turn the call over to Rita for the financial update. Rita? Rita Johnson-Greene: Thank you, Shankar. Good morning, everyone. Total operating expenses for the 3 months ended June 30, 2026, were $17.9 million, and included research and development expenses of $10.7 million, and general and administrative expenses of $7.2 million. This compares to total operating expenses for the 3 months ended June 30, 2025, of $15.2 million, which included research and development expenses of $8.4 million and general and administrative expenses of $6.8 million. Total operating expenses for the 6 months ended June 30, 2026, were $37.3 million and included research and development expenses of $21.9 million, and general and administrative expenses of $15.4 million. This compares to the total operating expenses for the 6 months ended June 30, 2025, of $31.2 million, which included research and development expenses of $17.9 million, and general and administrative expenses of $13.2 million. Ocugen reported a $0.07 net loss per common share for the 3 months ended June 30, 2026, compared to a $0.05 net loss per common share for the 3 months ended June 30, 2025. On our capital position, following the closing of the $130 million convertible notes financing, the company's cash, cash equivalents, and restricted cash totaled $100.4 million as of June 30, 2026, extending our cash runway into 2028. The company has 339 million shares of common stock outstanding as of June 30, 2026. That concludes my financial update. Shankar, back to you. Shankar Musunuri: Thank you, Rita. The second quarter was a quarter of execution. The remainder of 2026 is poised to be impactful. We expect the OCU410ST interim outcome decision in the third quarter, and we expect to initiate the OCU410 Phase III 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 3 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: [Operator Instructions] Our first question comes from the line of Michael Okunewitch with Maxim Group. Michael Okunewitch: Congrats on all the great progress. So, I wanted to ask, you now have a handful of international partnerships, which makes OCU400 a truly international program at this point. So I just wanted to see if you could share the regulatory plans in particular for ex-U.S. jurisdictions, what's required there, and how those time lines could vary versus your BLA path? Shankar Musunuri: Michael, what we have with OCU400, we got alignment from EMA in addition to FDA with the same -- the single trial we're doing in the U.S. is good for approvals. And across the globe for orphan gene therapies, typically they get approval based on U.S. approval. So everything will be linked to our U.S. FDA approval in MENA and other regions. Michael Okunewitch: All right. And then I wanted to see also if you could just highlight some of the key differences in the trial design between ArMaDa3 and the Phase II ArMaDa trial? Shankar Musunuri: I will let our CMO, Dr. Genead, answer that. Mohamed Genead: Thank you, Michael. Regarding ArMaDa3, which is our global Phase III trial for GA, which we just got the approval from FDA, just recently to be initiated this quarter. The Phase III trial designed for ArMaDa3 will be one treatment arm with OCU410 versus a control will be 2:1 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 endpoint. The ArMaDa1, 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 is different. We're going to be enrolling in ArMaDa3 close to 237 subjects in 2:1 allocation. It's going to be global. We're going to go ex-U.S. 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 what we saw from ArMaDa1, the Phase I/IIa GA trial. Michael Okunewitch: All right. And then just one last one from 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 will 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? Shankar Musunuri: Yes. Good question, Michael. I think the way you look at it is our treatments are one-and-done treatments potentially. So that will have a different pricing structure than ongoing chronic therapies. Number two, everything will be dictated by data. And if you have a safe one-time treatment, I think our gene therapies, once again, we're still collecting data, as you can see in some of the patients in RP, and as they approach like second year, third year, they're improving further. So the current therapies, if the oral therapy comes to the market, what patients -- providers are going to look for is that a therapy just reducing the degeneration of the disease or in some patients, is it stalling it, is it has potential to reverse it in some patients. At least, with our modified gene therapy in some of the patients we're seeing all those trends. So that could be a big differentiating factor. And also as you know, Stargardt impacts a lot of pediatric patients. And the current clinical trial they're conducting focuses on 12 plus. And our clinical trial focuses on 3 plus. So there are a lot of differentiators. So whenever we come for pricing, because of the differentiated disruptive technology platform we have, and obviously everybody will focus on safety, efficacy, and one-and-done treatment, there'll be more compliant for anyone. So I think all those factors will be rolled in. So I don't think we'll be truly comparing any pricing what the -- other chronic therapies are doing. If you have a me-too products, the answer is yes. But if you have truly a definitively disruptive technology, which is completely different, it'll come -- we can price it on its own merits. Operator: Our next question comes from the line of Whitney Ijem with Canaccord Genuity. Whitney Ijem: My congrats on all the progress as well. Just to keep going on the Stargardt discussion, Shankar, since you mentioned it, can you talk about a little bit more, I guess, around the TPP here and the potential to show kind of reversal of disease and improvement in visual acuity. Is that something that is reasonable to expect given the duration of follow-up in the ongoing Phase II/III study? And I guess if so, is there anything that was done in terms of entry criteria to maybe enrich for that outcome as far as patient baseline characteristics? Shankar Musunuri: I will ask Dr. Genead to talk about -- a little bit about baseline characteristics, then I'll answer the other question. Mohamed Genead: Thank you, Shankar. Whitney, yes, happy to answer. So our population was definitely broader than other competitors. Just to highlight, first, we included patients from early to late-stage Stargardt disease. That's number one. And as Shankar just mentioned, too, we included subjects are younger than, young adults. We included, subject, 3-plus years of age. So that's a very broad population. As you know, for Stargardt, the earlier the better, especially if it's a progressive retina generation disease. The lesion size, we also included in our trial, the Phase II/III GARDian trial, was more broader than what we saw with others. And our lesion size will include smaller lesion, also larger lesion. So we have a broad spectrum, and that's also going to be aligned with our early, late-stage strategy for the disease. We already included some of the subjects in our Phase II/III trials. So we will be excited to see the data. In addition to the gene mutation, specifically, we include all the variants and all the other specific mutations included in the ABCA4-related retinopathy. So it includes Stargardt and others as well. So this is also on the disease indication. It's overall. Based on your point about the functional, I think this is going to be a critical. So we saw from our Phase I data that we just published at the Eye Nature early in the year, we saw a very clear structure -- slowing in the structure progression in those patients. And also we saw functional benefit in those patients. And as you remember, as you know, in Stargardt disease, the first target is to hold that progression, to stop losing more retinal structure and function, which we achieved in our prior trial. The second goal, which will be the upside here and the ultimate goal to reverse that tide, try to improve on the disease outcome. And we saw that in our Phase I/II. We saw some of the patients did improve in visual function. The gain was 6 letters close to 1 line between the treated versus the untreated eyes. So we felt also very excited about the functional gain in the patient population. So that's kind of where we think the big differentiation, the broader application of our molecule. Shankar Musunuri: Whitney, just to clarify, the primary endpoint, because it's a 1-year trial, it's not a 2-year trial, it's still a lesion. Then there are secondary visual function we'll be monitoring. In addition to that, at the time of filing, we continue to monitor our early-stage Phase I patients, and so we'll have long-term data in those patients still. Whitney Ijem: Got it. Really helpful. And then just last question, and maybe Rita, this one is for you. Just -- can you help us understand how you're thinking about cash given the exciting progress with the GA study and the ability to start that study in September. I think you said, if there is a need to kind of pull levers to extend the cash runway further, how should we think about maybe the startup of GA versus commercial prep for RP or Stargardt, and just kind of how you guys are thinking about those different levers if needed? Rita Johnson-Greene: Yes. Thank you, Whitney. So, first of all, I mean, our primary goal is to make sure that we are minimizing shareholder dilution, but evaluating our opportunities in order to raise capital, just as you said, in order to bring these novel products to patients. So, just first of all, we have cash runway into 2028. And so I just want to remind everyone of that, which gives us the confidence to execute our clinical state -- our late-stage products that we have, and then progress to BLA submission for both OCU410 and OCU410ST in 2027, with the potential to commercialize OCU400 by the end of the year in 2027. We do have some additional levers that we can pull. One, we have the PRV for OCU410ST given the RPD designation that we have. And so, of course, we have the ability to sell that for somewhere between $100 to $200, even prior to approval. And that's something that we are evaluating. We also have various business development deals that we are looking at from a globalization perspective. We're looking at ex-U.S. for both OCU400, OCU410ST, and even GA, right, just depending upon what that term sheet looks like. So always looking for potential deals that we can make in order to again, just minimize that dilution. We also have the Janus Henderson warrants, right? There's another 10 million warrants at $1.50 strike price, which could bring in another $15 million, and those warrants expire in August of 2027. And then, of course, we anticipate a special meeting in September of this year in order to increase authorized shares, which will give us the ability to raise additional equity if we decide to do so. So again, just looking at both non-dilutive as well as dilutive options in order to make sure that we are able to bring these amazing and novel products to patients as well as looking at maximizing shareholder value. Operator: Our next question comes from the line of Charles Wallace with H.C. Wainwright. Charles Wallace: This is Charles from H.C. Wainwright, on for RK. Maybe a question on ArMaDa3 design. So it seems like based on the prior -- based on the prior earnings call, the study has been a little bit resized. I think previously you said it would be about 300 patients and now it's 237 patients. So I was just curious if this was something the FDA specifically asked for or if this was something you proposed? And then also if the assumptions change based on effect size, variability, dropout, or the narrower lesion size compared to the Phase II? Shankar Musunuri: Yes, Dr. Genead? Mohamed Genead: Thank you, Charles. Yes, we had a discussion with the agency, the FDA. So all this being aligned and discussed with the FDA. But to answer your question specifically, it was based on the sample size estimation and also the power calculation we did. So the estimate you're citing, the 300, was based on estimate. But when we saw the effect site based on our ArMaDa1, the Phase I/II trial, as we discussed today, we saw the 31% reduction in the median dose, the optimal dose, which is the one we are taking forward. When we did our calculation based on that, we saw the 237 total population to be enrolled will give us 95% power in our pivotal trial. All these pieces have been discussed with the agency. Obviously, it's based on the rate of change, the slope analysis for the primary efficacy. So, the effect size based on what we saw from earlier trial was very positive and was strong enough that we end up with 237. 2:1 randomization, as we mentioned earlier, 158 in the treatment arm and 79 in the control arm. So all this has been discussed and aligned, and as we announced today, we got the clearance from the FDA to initiate our Phase III trial in the next few weeks. Charles Wallace: Very helpful. And then I guess for -- on the rolling submission. So I think originally the guidance was to submit in the third quarter. And now I believe it's the first quarter after the liMeliGhT data. And, I think -- I guess my question is, what kind of changed between submitting the non-clinical module earlier compared to after the top line data of the liMeLight? Shankar Musunuri: Charles, I think from our perspective, we're ready. I mean, I think we are doing very well with our PPQs as we've mentioned. There are a lot of gene therapy companies stuck with CMC. We're ahead of the game. We used to commercial scale lots in our Phase III. We completed our PPQs on time. We got non-clinical and PPQ are done, so we have CMC non-clinical ready to go. I mean, obviously, this is where we have to work with agency when they're comfortable. And that's the time line they gave us, and we're going to be fine with that. The reason is, I just want to clarify, it's good to have rolling submission that gives a head start for agency, okay? It's for their own benefit. And if they want to wait until next year, I mean, we are ready to file it as soon as the top line comes for the pre-BLA meeting. We may still give them a head start of maybe a month or 2 months before we drop the clinical section. So however, I just want to clarify, until the final BLA is completed with the clinical section, the PDUFA date, the accelerated clock of 6 months doesn't start. I just want to clarify that. So once again, this is a collaboration between the sponsor and the agency. In this case, of course, we respect their decision, whatever they are, because they have a lot of programs and a lot of workload, whatever the reasons are, we are fine with it. I think we're ready from our perspective, and we will work with them closely in collaborative way. And whenever we have a top line, we'll be ready to file it. Charles Wallace: Great, very helpful. Shankar Musunuri: So it doesn't change any -- yes, filing clock, as we mentioned before, second quarter, complete the BLA filing, anticipated approval in fourth quarter, 6 months accelerated clock. Operator: [Operator Instructions] Our next question comes from the line of Robert LeBoyer with NOBLE Capital Markets. Robert LeBoyer: Congratulations on the progress. Just to follow up on that last question, my understanding was that the BLA submission will be completed in early 2027 when the clinical module is filed, that's when you get the PDUFA date and the approval launches based on that. But you also have rolling submission and have the option of filing the CMC and the other non-clinical modules before that. Is that still your plan? Shankar Musunuri: Yes, Robert, absolutely. Because based on agency's suggestion and recommendation, as soon as the top line comes out, we'll have a pre-BLA meeting. Right after that, we can file the 2 modules, non-clinical and CMC modules. So that will still give them a head start. And as soon as the clinical module is done when you file it, the PDUFA date starts. So that's basically our plan is to file that in second quarter, so 6 months' clock should be fourth quarter, approval clock. Operator: And at this time, we have no further questions. I would like to turn the call back over to the Ocugen team for closing remarks. Shankar Musunuri: Thank you all for attending today's webcast. Really appreciate all our investors, shareholders, patients, providers. Thank you. Operator: This concludes today's conference call. You may now disconnect. Have a good day. Before you buy stock in Ocugen, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Ocugen wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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Interested in Ocugen, Inc.? Here are five stocks we like better. Ocugen received FDA clearance and RMAT designation for OCU410 in geographic atrophy, with its 237-patient global Phase III trial expected to begin by September 2026. The company is targeting regulatory filings in 2028 after earlier data showed a 31% reduction in lesion growth at the selected dose. Ocugen completed enrollment in pivotal trials for OCU410ST in Stargardt disease and OCU400 in retinitis pigmentosa. Top-line data are expected in the second quarter of 2027 for OCU410ST and the first quarter of 2027 for OCU400, with potential approvals beginning in late 2027. Second-quarter operating expenses rose to $17.9 million, while a $130 million convertible-notes financing left Ocugen with $100.4 million in cash and extended its runway into 2028. The company is also pursuing regional licensing deals and other potential funding sources. Ocugen (NASDAQ:OCGN) said its second quarter marked progress across its late-stage ophthalmology pipeline, including FDA clearance to begin a Phase III study of OCU410 in geographic atrophy and an RMAT designation for the program. Chairman, Chief Executive Officer and Co-Founder Shankar Musunuri said the company’s modified gene therapy platform is designed to address complex retinal diseases by modulating nuclear hormone receptors that regulate multiple gene networks, rather than targeting individual mutations. The company is advancing the platform in retinitis pigmentosa, Stargardt disease and geographic atrophy. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Musunuri said the three diseases represent a combined patient population of about 3 million people across the U.S. and Europe. Across its pipeline, including expanded-access-program patients, Ocugen has treated more than 325 patients across multiple doses and indications without observing a drug-related serious adverse event, he said. The company said it remains on track to file three biologics license applications, or BLAs, by 2028. Ocugen expects top-line data for OCU400 and OCU410ST during the first half of 2027. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Ocugen received FDA clearance to initiate its ArMaDa-3 Phase III registrational trial of OCU410 for geographic atrophy secondary to dry age-related macular degeneration. The company plans to begin the global trial by September 2026. The study is expected to enroll about 237 participants and use a 2:1 randomization between the OCU410 treatment arm and control arm. Chief Medical Officer Mohammed Genead said participants will be followed for 12 months, with the study evaluating a primary efficacy endpoint as well as key functional endpoints. → Ulta's Growth Is Real, But So Are the Risks Genead said the sample size and 95% statistical power were based on results from the prior ArMaDa-1 Phase I/II trial and were discussed with the FDA. The prior trial showed a statistically significant 31% reduction in geographic atrophy lesion growth at the selected dose among patients with lesion sizes between 2.5 and 17.5 square millimeters, according to Musunuri. The company also reported 27% preservation of the ellipsoid zone in that population. Ocugen is targeting BLA and market authorization application filings for OCU410 in 2028. Musunuri said the company views geographic atrophy as its largest commercial opportunity, estimating a U.S. and European patient population of roughly 2 million to 3 million people. For OCU410ST in Stargardt disease, Ocugen completed enrollment and dosing in the Phase II/III GUARDIAN3 pivotal confirmatory trial, which enrolled 63 participants. The company expects an interim outcome decision involving the first half of enrolled subjects during the third quarter of 2026 and top-line data in the second quarter of 2027. A BLA submission is planned for mid-2027. Genead said the GUARDIAN3 study includes patients age 3 and older, a broad range of disease stages and lesion sizes, and variants associated with ABCA4-related retinopathy. The primary endpoint is lesion-based because the trial has a one-year duration, Musunuri said, while visual-function measures are being monitored as secondary endpoints. In discussing earlier data, Genead said the company observed slowing of structural progression and functional benefits in its Phase I study. He said some patients demonstrated improvement in visual function, including a six-letter gain, or nearly one line, between treated and untreated eyes. Meanwhile, enrollment has been completed in the Phase III liMeliGhT trial of OCU400 for retinitis pigmentosa. The trial enrolled 140 patients randomized 2:1 between treatment and control across RHO and gene-agnostic arms, encompassing more than 30 genetic mutations and patients from pediatric through later-stage disease populations. Top-line data from liMeliGhT are expected in the first quarter of 2027. Ocugen said it could potentially receive approval for OCU400 in the fourth quarter of 2027, contingent on the expected regulatory process. The primary endpoint in the trial is a 12-month change in visual function measured through luminance dependent navigation assessment. Musunuri said process performance qualification batches have been completed to support the BLA and commercial supply. In July, Ocugen signed a binding term sheet with Roots Pharmaceutical and strategic partner Al-Dhow International Holding to negotiate an exclusive license for OCU400 in retinitis pigmentosa across the Middle East and North Africa. Musunuri said the company has alignment from both the FDA and European Medicines Agency that the U.S. OCU400 trial could support approvals. He added that regulatory pathways in MENA and other regions are expected to be linked to U.S. FDA approval. Ocugen said it is also pursuing other regional commercialization partnerships. Its commercial preparations include discussions with CMS and payers, identifying specialized treatment centers capable of subretinal procedures, assessing manufacturing and distribution needs, and building marketing and sales capabilities. Chief Financial Officer Rita Johnson-Greene reported total operating expenses of $17.9 million in the second quarter, compared with $15.2 million in the prior-year quarter. Research and development expense rose to $10.7 million from $8.4 million, while general and administrative expense increased to $7.2 million from $6.8 million. For the first six months of 2026, operating expenses totaled $37.3 million, compared with $31.2 million a year earlier. Ocugen reported a net loss of $0.07 per common share for the second quarter, compared with a loss of $0.05 per share in the year-earlier period. Following a $130 million convertible notes financing, Ocugen had $100.4 million in cash equivalents and restricted cash as of June 30. Johnson-Greene said the financing extended the company’s cash runway into 2028 and supports execution of its late-stage clinical programs. She also cited potential additional funding sources, including a priority review voucher tied to OCU410ST’s rare pediatric disease designation, potential regional business-development agreements, Janus Henderson warrants that could provide $15 million if exercised, and potential equity financing. Ocugen expects to hold a special meeting in September to seek an increase in authorized shares. Ocugen Inc is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing gene therapies to treat rare inherited retinal diseases, as well as vaccines designed to address unmet needs in infectious diseases. Headquartered in Malvern, Pennsylvania, the company applies its proprietary gene therapy platform to create novel treatments aimed at preserving and restoring vision, while leveraging strategic partnerships to broaden its vaccine pipeline. In its gene therapy portfolio, Ocugen is advancing multiple programs targeting retinal disorders. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Ocugen Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Ocugen OCGN reported a second-quarter 2026 loss of 7 cents per share, which was wider than the Zacks Consensus Estimate as well as the year-ago loss of 5 cents. Higher research and development spending weighed on results. Revenues rose 8.4% year over year to $1.5 million and slightly beat the Zacks Consensus Estimate of $1.4 million. The company’s top line currently comprises only collaboration revenues. Total operating expenses increased 18.2% year over year to $17.9 million. Research and development expenses rose 27.2% to $10.7 million, while general and administrative expenses increased 7.0% to $7.2 million. Cash, cash equivalents and restricted cash totaled $100.4 million as of June 30, 2026, up from $32.2 million as of March 31. The increase followed the closing of $130.0 million of 6.75% convertible senior notes due 2034, which generated about $112.5 million in net proceeds. Ocugen used about $32.7 million of those proceeds to fully retire its Avenue Capital loan and eliminate 12.25% interest-rate debt. Management expects the financing to extend the cash runway into 2028, supporting the company’s late-stage clinical programs and planned regulatory submissions. Ocugen’s shares declined 3% on Wednesday after the results were announced. Year to date, shares of OCGN have declined 8.2% compared with the industry’s 3.5% decline. Image Source: Zacks Investment Research Ocugen is advancing its ophthalmology gene therapy pipeline, targeting three biologics license application (BLA) submissions by 2028. The first half of 2027 is expected to be catalyst-rich, with late-stage top-line data anticipated for OCU400 and OCU410ST. Enrollment has been completed in a phase III liMeliGhT study on lead modifier gene therapy candidate, OCU400, to treat Retinitis pigmentosa, or RP, a rare genetic disorder that can lead to vision loss and blindness. Top-line data from the phase III study is expected in the first quarter of 2027. Management said the FDA feedback keeps the rolling BLA pathway tied to the top-line data, with completion of the filing targeted for the second quarter of 2027 and potential approval in the fourth quarter as a treatment option for early- to late-stage RP. OCU410ST is being developed as a one-time gene therapy for the treatment of Stargardt disease, a rare inherited retinal disorder. In April 2026, the company completed enrollment and dosing in the phase II/III GARDian3 pivotal confirmatory study on OCU410ST for Stargardt disease. Management expects an interim outcome decision for the first 50% of subjects at eight months in the third quarter of 2026. Top-line data are anticipated in the second quarter of 2027, with a BLA submission planned for mid-2027. The FDA cleared the phase III ArMaDa3 registrational study of Ocugen’s another important candidate, OCU410, for geographic atrophy, an advanced stage of dry age-related macular degeneration. Ocugen plans to initiate the global phase III study by September. The program is supported by positive 12-month phase II data showing a statistically significant 31% reduction in geographic atrophy lesion growth at the optimal dose in the target lesion-size population. BLA and Marketing Authorization Application filings are targeted for 2028. Ocugen currently carries a Zacks Rank #3 (Hold). Ocugen, Inc. price-consensus-chart | Ocugen, Inc. Quote Some better-ranked stocks in the biotech sector are Repligen RGEN, Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 2.7% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.33. Over the same period, EPS estimates for 2027 have surged from $3.64 to $3.92. HRMY shares are up 3.6% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters, while beating in just one, with the average negative surprise being 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ocugen, Inc. (OCGN) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Ocugen Inc (NASDAQ:OCGN) received FDA clearance to initiate its Phase 3 registrational trial for OCU410 in geographic atrophy (GA) and was granted Regenerative Medicine Advanced Therapy (RMAT) designation for the program. The company's cash runway has been extended into 2028 following the closing of a $130 million convertible notes financing, providing support for all three late-stage programs. Phase 2 data for OCU410 in GA demonstrated a statistically significant 31% reduction in GA lesion growth at the optimal dose, approximately twice the benefit of approved complement inhibitors, with a single injection. Enrollment in the Phase 3 limelight trial for OCU400 in retinitis pigmentosa (RP) is complete with 140 patients, spanning more than 30 genetic mutations, validating the gene-agnostic platform. Ocugen Inc (NASDAQ:OCGN) has treated more than 325 patients across its pipeline without observing a drug-related serious adverse event, and remains on track to file three BLAs by 2028. The company signed a binding term sheet with Roots Pharmaceutical for exclusive rights to OCU400 in the Middle East and North Africa (MENA) region, advancing its global commercialization strategy. Ocugen Inc (NASDAQ:OCGN) reported a net loss of $0.07 per share for the second quarter of 2026, which is wider than the $0.05 loss per share reported in the same period of 2025. Total operating expenses increased to $17.9 million for the second quarter of 2026, up from $15.2 million in the prior year period, reflecting higher R&D and G&A costs. The company's cash position of $100.4 million as of June 30, 2026, is relatively low given the need to fund three late-stage programs, potentially requiring additional capital raises. The BLA submission for OCU400 has been pushed to the first quarter of 2027, tied to topline data, which is later than the previously guided third quarter of 2026 for rolling submission. Ocugen Inc (NASDAQ:OCGN) plans to hold a special meeting in September 2026 to increase authorized shares, which could lead to shareholder dilution if additional equity is raised. The Phase 3 Armada 3 trial for GA was resized down to 237 subjects from an earlier estimate of 300, which may raise questions about the robustness of the trial design despite the 95% power calculation. Warning! GuruFocus has detected 4 Warning Signs with OCGN. Is OCGN fairly valued? Test your thesis with our free DCF calculator. Q: Can you share the regulatory plans for OCU400 in ex-U.S. jurisdictions and how those timelines could vary versus the BLA path? A: Dr. Shankar Musunuri (Chairman, CEO, and Co-founder): We have alignment from the EMA in addition to the FDA, with the same single trial we're doing in the U.S. being sufficient for approvals. Across the globe, for orphan gene therapies, approvals are typically based on U.S. approval, so everything will be linked to our U.S. FDA approval in MENA and other regions. Q: Can you highlight the key differences in trial design between the Armada 3 phase 3 trial and the phase 2 Armada trial for OCU410 in geographic atrophy (GA)? A: Dr. Mohammad Jane (Chief Medical Officer): Armada 3 is a global safety trial for GA with a 2:1 randomization (one treatment arm with OCU410 versus control), following subjects for up to 12 months to assess the primary efficacy endpoint plus other key functional endpoints. The Armada 1 phase 1/2 trial was similar on efficacy, so we expect similar outcomes. We will enroll close to 237 subjects globally, including ex-U.S. and Europe, but the primary endpoint will be very similar to what we saw in Armada 1. Q: How important will the pricing of other chronic therapies (e.g., potential oral therapies for Stargardt) be in informing your own pricing strategy, and how should we think about translating pricing between a chronic therapy and a one-time therapy? A: Dr. Shankar Musunuri (Chairman, CEO, and Co-founder): Our treatments are one-and-done, so they will have a different pricing structure than ongoing chronic therapies. Everything will be dictated by data. If you have a safe one-time treatment, and we are seeing patients improve further in their 2nd and 3rd years, that is a big differentiator. Current therapies may only reduce degeneration, while our modified gene therapy has the potential to stall or even reverse it in some patients. Additionally, Stargardt impacts many pediatric patients; our trial focuses on patients 3 and older, while others focus on 12 and older. Because we have a differentiated, disruptive technology platform, we won't be truly comparing or pricing against chronic therapieswe can price it on its own merits. Q: Can you talk more about the target product profile (TPP) for OCU410 in Stargardt and the potential to show reversal of disease and improvement in visual acuity? Is that reasonable given the follow-up duration, and were entry criteria enriched for that outcome? A: Dr. Mohammad Jane (Chief Medical Officer): Our population was broader than competitorswe included patients from early to late-stage Stargardt disease, including subjects as young as 3 years old. We also included a broad spectrum of lesion sizes (smaller and larger). In our phase 1 data published in Nature earlier this year, we saw clear slowing of structural progression and functional benefit. The first goal is to halt progression, which we achieved. The upside is the potential to reverse the disease and improve outcomes; in our phase 1/2 trial, some patients improved by 6 letters (close to one line) in visual function between treated versus untreated eyes. The primary endpoint for the phase 2/3 trial is still lesion size at 1 year, with visual function as a secondary endpoint, and we will continue to monitor long-term data from early-stage patients. Q: How are you thinking about cash given the exciting progress with the GA study and the ability to start it in September? If needed, how should we think about pulling levers to extend cash runway, such as the startup of GA versus commercial prep for RP or Stargardt? A: Rita Johnson Green (Chief Financial Officer): Our primary goal is to minimize shareholder dilution while evaluating opportunities to raise capital. We have cash runway into 2028, which gives us confidence to execute our late-stage programs and progress to BLA submissions for both OCU410 and OCU410ST in 2027, with potential commercialization of OCU400 by the end of 2027. Additional levers include selling the Priority Review Voucher (PRV) for OCU410ST (valued between $100-$200 million, even prior to approval), various business development deals for ex-U.S. rights across all programs, and the Janus Henderson warrants (10 million warrants at $1.50 strike price, expiring August 2027, which could bring in another $15 million). We also anticipate a special meeting in September to increase authorized shares, giving us the ability to raise additional equity if we decide to do so. Q: The Armada 3 study was previously expected to be about 300 patients, but now it's 237. Was this a change the FDA specifically asked for, or was it proposed by you? Did assumptions change based on effect size, variability, or dropout? A: Dr. Mohammad Jane (Chief Medical Officer): All of this was discussed and aligned with the FDA. The sample size estimation and power calculation were based on the effect size we saw in the Armada 1 phase 1/2 triala 31% reduction in GA lesion growth at the optimal dose. Based on that, we calculated that 237 total patients would give us 95% power for the primary endpoint (slope analysis of the rate of change). The effect size was strong enough to support a 2:1 randomization (158 in the treatment arm and 79 in the control arm). We received FDA clearance to initiate the phase 3 trial in the next few weeks. Q: Regarding the rolling BLA submission for OCU400, the original guidance was to submit in the third quarter, but now it's the first quarter after the limelight data. What changed between submitting the non-clinical module earlier versus after the topline data? A: Dr. Shankar Musunuri (Chairman, CEO, and Co-founder): We are ahead of the game on CMCwe completed our PPQs on time and have non-clinical and CMC modules ready to go. The timeline is based on working with the agency and respecting their workload. Rolling submission gives the agency a head start, but the PDUFA date (6-month accelerated clock) doesn't start until the final BLA is completed with the clinical section. As soon as topline data comes out, we'll have a pre-BLA meeting and can file the non-clinical and CMC modules, giving them a head start of a month or two before we drop the clinical section. We plan to complete the BLA filing in the second quarter, with anticipated approval in the fourth For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Conference Call and Webcast Today at 8:30 a.m. ET Received U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (AMD); on track to initiate Phase 3 this quarter Granted Regenerative Medicine Advanced Therapy (RMAT) designation by FDA for OCU410, enabling eligibility for priority review and accelerated approval Signed a binding term sheet with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, to negotiate an exclusive license for OCU400 in retinitis pigmentosa (RP) across the Middle East and North Africa (MENA) region Successfully completed OCU400 Process Performance Qualification (PPQ) batches, supporting Biologics License Application (BLA) and commercial launch supplies Closed $130.0 million convertible senior notes financing, extending cash runway into 2028 Remain on track to announce top-line results for two late-stage clinical programs, OCU400 for RP and OCU410ST for Stargardt disease in 1Q 2027 and 2Q 2027, respectively Strengthened leadership team with the appointments of Mohamed Genead, M.D., M.Sc., as Chief Medical Officer and Chris Clark as Head of Corporate Communications MALVERN, Pa., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported second quarter 2026 financial results along with a general business update. “The second quarter of 2026 marked a pivotal inflection point for Ocugen. We closed $130 million convertible senior notes financing, extending our cash runway into 2028, and signed a binding term sheet for exclusive license of OCU400 in retinitis pigmentosa across the Middle East and North Africa region,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “Ocugen is a leading gene therapy company, focused on vision loss diseases with significant unmet medical needs, with multiple catalysts through 2028 across three distinct retinal disease indications. As we advance toward key data milestones in the first half of 2027, we remain focused on creating long-term value for our patients and shareholders.” Unlike traditional gene therapies that correct a single mutation, Ocugen's modifier gene therapy platform targets master regulatory genes that control multiple gene networks of biological pathways, supporting a gene-agnostic approach applicable across a broad range of genetic mutations, as well as diseases with complex pathways such as dry AMD. This allows the Company to address large, underserved patient populations rather than narrow single-gene subsets. This platform underpins each of Ocugen's three late-stage programs, which advanced meaningfully during the quarter. Clinical Program Updates OCU410 (GA) Received FDA clearance for the Phase 3 registrational trial (ArMaDa3) for GA secondary to dry age-related macular degeneration, anchored by positive 12-month Phase 2 ArMaDa data (statistically significant 31% reduction in GA lesion growth versus control [patient population: lesion size ≥2.5 mm2 and ≤17.5 mm2], p<0.05, at the optimal dose planned for Phase 3) Planned combined global Phase 3 trial of approximately 237 subjects powered at 95% for primary end point on track to initiate this quarter, with BLA and MAA filings targeted for 2028 Granted Regenerative Medicine Advanced Therapy RMAT designation by FDA, enabling eligibility for priority review and accelerated approval GA affects approximately 2 to 3 million people in the U.S. and Europe OCU410ST (Stargardt disease) Completed enrollment and dosing of 63 subjects ahead of schedule, in less than nine months, in the pivotal Phase 2/3 GARDian3 trial evaluating OCU410ST in patients with all mutations of Stargardt disease Topline results anticipated in the second quarter of 2027, with a BLA submission to follow mid-2027 Holds Orphan Drug and Rare Pediatric Disease Designations from the FDA and Orphan Medicinal Product Designation and Advanced Therapy Medicinal Product classification from the EMA Stargardt disease affects approximately 100,000 patients across the U.S. and Europe, with no approved therapies globally OCU400 (RP) Completed enrollment in liMeliGhT (N=140), the first and largest genetic medicine registrational trial for broad RP patients, spanning more than 30 genetic mutations FDA feedback confirmed that the path to rolling BLA submission remains tied to topline data expected in the first quarter of 2027, and the company is advancing preparation accordingly, including successfully completing Process Performance Qualification (PPQ) batches Approximately 300,000 people in the U.S. and Europe are living with RP Corporate Updates Closed the offering of $130.0 million aggregate principal amount of 6.75% Convertible Senior Notes due 2034, including the full exercise of the $15.0 million over-allotment option, for net proceeds of approximately $112.5 million Signed a binding term sheet with Roots Pharmaceutical to negotiate an exclusive OCU400 license in the MENA region, with up to $255 million in sales milestones and a 22% royalty on net sales, as well as moderate upfront payment to Ocugen Ocugen appointed two new members to its leadership team Second Quarter 2026 Financial Results The Company’s cash, cash equivalents, and restricted cash totaled $100.4 million as of June 30, 2026, compared to $32.2 million as of March 31, 2026. The Company had 339.0 million shares of common stock outstanding as of June 30, 2026. Total operating expenses for the three months ended June 30, 2026, were $17.9 million and included research and development expenses of $10.7 million and general and administrative expenses of $7.2 million, compared to total operating expenses for the three months ended June 30, 2025, of $15.2 million that included research and development expenses of $8.4 million and general and administrative expenses of $6.8 million. Ocugen reported a $0.07 net loss per common share for the three months ended June 30, 2026, compared to a $0.05 net loss per common share for the three months ended June 30, 2025. Conference Call and Webcast DetailsOcugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks. Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks. Attendees are invited to participate on the call using the following details: Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callersConference ID: 2222566Webcast: Available on the events section of the Ocugen investor site A replay of the call and archived webcast will be available on the Ocugen investor site. About Ocugen, Inc.Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness diseases. The Company’s breakthrough modifier gene therapy platform has the potential to address significant unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on LinkedIn and X. Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, including the timing of enrollment and data readouts, the ability to initiate new clinical programs, Ocugen’s financial condition and expected cash runway into 2028, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, statements regarding potential market size and commercial possibilities of Ocugen’s product candidates, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing may not be predictive of the results or success of later clinical trials; and that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release. Contacts: Investors:Candice Masseastr [email protected] Media:Chris [email protected] (Tables to follow)

Illumina (ILMN) came out with quarterly earnings of $1.31 per share, beating the Zacks Consensus Estimate of $1.23 per share. This compares to earnings of $1.19 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +6.50%. A quarter ago, it was expected that this genetic testing tools company would post earnings of $1.05 per share when it actually produced earnings of $1.15, delivering a surprise of +9.52%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Illumina, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $1.16 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.36%. This compares to year-ago revenues of $1.06 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Illumina shares have added about 48.5% since the beginning of the year versus the S&P 500's gain of 6.9%. While Illumina has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Illumina was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.35 on $1.13 billion in revenues for the coming quarter and $5.22 on $4.56 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Ocugen (OCGN), has yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This biotech knee implant developer is expected to post quarterly loss of $0.05 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Ocugen's revenues are expected to be $1.4 million, up 2.2% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Illumina, Inc. (ILMN) : Free Stock Analysis Report Ocugen, Inc. (OCGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

MALVERN, Pa., July 28, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2026 financial results and provide a business update at 8:30 a.m. ET on Thursday, August 6, 2026. Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details: Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callersConference ID: 2222566Webcast: Available on the events section of the Ocugen investor site A replay of the call and archived webcast will be available on the Ocugen investor site. About Ocugen, Inc.Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness. The Company’s breakthrough modifier gene therapy platform has the potential to address significant unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on LinkedIn and X. Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release. Contact:Investors:Candice Masseastr partners [email protected] Media: Chris Clark [email protected]

A month has gone by since the last earnings report for Ocugen (OCGN). Shares have lost about 10.7% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Ocugen due for a breakout? Well, first let's take a quick look at its latest earnings report in order to get a better handle on the recent catalysts for Ocugen, Inc. before we dive into how investors and analysts have reacted as of late. Ocugen incurred a loss of 6 cents per share in the first quarter of 2026, wider than the Zacks Consensus Estimate as well as the year-ago loss of 5 cents. Ocugen’s total revenues rose 3.5% year over year to $1.5 million in the first quarter, beating the Zacks Consensus Estimate of $1 million. The company’s top line currently comprises only collaboration revenues Ocugen’s operating expenses increased during the quarter as the company accelerated clinical development and commercial preparation activities. Research and development expenses were $11.3 million, up 18.1% from the year-ago quarter’s level. General and administrative expenses totaled $8.1 million, up 25.8% year over year. The company raised $37.5 million in gross proceeds during the first quarter of 2026, including $15 million from investors exercising their warrants. As a result, its cash, cash equivalents, and restricted cash increased to $32.2 million as of March 31, 2026, up from $18.9 million at the end of 2025. Following the $115 million offering of convertible senior notes, the company expects to have approximately $112.1 million in cash, cash equivalents, and restricted cash when the transaction closes, which includes the Avenue debt payoff. Since the earnings release, investors have witnessed a upward trend in fresh estimates. The consensus estimate has shifted 6.25% due to these changes. At this time, Ocugen has a subpar Growth Score of D, a score with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a score of F on the value side, putting it in the fifth quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Ocugen has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Ocugen is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Axsome Therapeutics (AXSM), a stock from the same industry, has gained 4.9%. The company reported its results for the quarter ended March 2026 more than a month ago. Axsome reported revenues of $191.2 million in the last reported quarter, representing a year-over-year change of +57.4%. EPS of -$1.26 for the same period compares with -$0.80 a year ago. Axsome is expected to post a loss of $0.83 per share for the current quarter, representing a year-over-year change of +9.8%. Over the last 30 days, the Zacks Consensus Estimate has changed -15.5%. Axsome has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ocugen, Inc. (OCGN) : Free Stock Analysis Report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Ocugen announced a $115 million offering of convertible senior notes expected to close May 7, 2026, which the company says will leave it with about $112.1 million in cash equivalents at closing (or ~$127.1 million if remaining warrants are exercised) and extend its cash runway into 2028. The Phase III OCU400 (liMeliGhT) trial is fully enrolled (140 patients) with PPQ batches on track in Q2 2026, a rolling BLA planned to start in Q3 2026, top-line data expected in Q1 2027, and potential FDA approval targeted for Q4 2027. Other pipeline moves: dosing is complete in the Phase II/III OCU410ST (GARDian3) trial with an interim outcome analysis due in Q3 2026 and a planned BLA by mid‑2027, while OCU410 (GA) showed positive Phase II results (31% reduction in lesion growth) and is planning a >95%‑powered Phase III with potential BLA by 2028. Interested in Ocugen, Inc.? Here are five stocks we like better. Ocugen (NASDAQ:OCGN) used its first-quarter 2026 earnings call to highlight progress across its retinal gene therapy pipeline and to outline a strengthened balance sheet following a newly announced financing. Chairman, CEO, and Co-founder Dr. Shankar Musunuri opened the call by discussing the company’s $115 million offering of convertible senior notes announced the prior day. Musunuri said Ocugen expects to have $112.1 million of cash equivalents and restricted cash at closing, which includes the payoff of Avenue debt. He added that the company plans to use remaining net proceeds for general corporate purposes and expects the transaction to extend cash runway into 2028. → Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook The offering is expected to close May 7, 2026, subject to customary conditions, and includes an option to retire the debt with a cash payment, Musunuri said. He also noted that if remaining Jones Henderson warrants are exercised, Ocugen would receive an additional $15 million in gross proceeds, increasing expected cash equivalents and restricted cash to $127.1 million. Musunuri positioned Ocugen’s ophthalmology programs as built on a “modified gene therapy platform” designed to be “gene-agnostic” by modulating “master regulators, nuclear hormone receptors that govern entire gene networks.” He said the company is advancing the platform across three late-stage programs—retinitis pigmentosa (RP), Stargardt disease, and geographic atrophy (GA)—which he said together affect approximately three million people across the U.S. and Europe. → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches Across the company’s development work, Musunuri said Ocugen has treated more than 250 patients across multiple doses and indications and has not observed a drug-related serious adverse event. He reiterated Ocugen’s goal to file three BLAs by 2028, with the first—OCU400 for RP—planned to begin rolling submission in the third quarter of 2026. Musunuri said the Phase III liMeliGhT trial for OCU400 is fully enrolled, with 140 patients randomized 2:1 across the RHO and gene-agnostic arms, covering over 25 genetic mutations associated with RP, including pediatric patients. The primary endpoint is 12-month change in visual function assessed by luminance dependent navigation assessment (LDNA). → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Ocugen expects to initiate a rolling BLA submission in Q3 2026 and complete the full submission by Q2 2027, Musunuri said. He added that Phase III top-line data is expected in Q1 2027, and Ocugen is targeting a potential FDA approval in Q4 2027. On manufacturing, Musunuri said process performance qualification (PPQ) batches are on track for completion in Q2 2026. In the Q&A, he told H.C. Wainwright’s Ramakanth Swayampakula the company is “on target” to complete PPQ runs in time to support the rolling BLA submission. Musunuri also reviewed Phase I/II durability data, stating that three-year results support sustained improvement in visual function compared with untreated eyes, with clinically meaningful mean changes in low-luminance visual acuity (LLVA) at years one, two, and three. He said that at the three-year time point, 88% of treated evaluable subjects showed improvement or preservation in visual function relative to untreated eyes, and that no serious adverse events were reported as treatment-related. In response to an Oppenheimer question on rolling submissions, Musunuri said Ocugen plans to start with the non-clinical module, followed by the CMC/manufacturing module (including PPQ lots). He said the final clinical module would be submitted next year after top-line results are available, which would start a six-month PDUFA clock. Musunuri said Ocugen completed enrollment and dosing in the Phase II/III GARDian3 pivotal confirmatory trial for OCU410ST, enrolling 63 participants in less than nine months, ahead of its original timeline. The company expects an interim outcome analysis in Q3 2026, with Phase II/III data expected in Q2 2027 and a planned BLA submission by mid-2027. He said OCU410ST has shown a favorable safety and tolerability profile with no product-related serious adverse events reported to date. Chief Medical Officer Dr. Huma Qamar said the Stargardt study includes 51 subjects in the core design (34 treatment, 17 control), with an adaptive design component described as 24 subjects (16 treatment, eight control). Qamar said the trial is “adequately powered around 90% or more,” and that the interim outcome would evaluate whether sample size re-estimation is needed. Musunuri emphasized the Q3 review is not a typical interim efficacy readout. He described it as an adaptive-design “outcome analysis” overseen by the data monitoring committee that could result in no changes, or in adjustments such as recruiting additional patients and/or adding a longer time point (for example, extending from 12 months to 16 months) depending on predictive analytics and discussions with the FDA. On potential launch timing, Musunuri told Maxim Group’s Michael Okunewitch that, if development proceeds as planned, RP and Stargardt approvals could be within six months of each other. He added that commercialization could benefit from overlap, since the company expects to use many of the same centers of excellence and surgeons for subretinal administration across programs. Musunuri said Ocugen’s Phase II ArMaDa trial in GA produced positive 12-month top-line results. The study enrolled 51 patients randomized 1:1:1 to medium dose, high dose, or no treatment. Musunuri said the medium dose was optimal and showed a 31% reduction in lesion growth versus control at 12 months (P < 0.05). He also said 55% of treated subjects showed a 30% or greater reduction in lesion size relative to control, and that the company observed a 27% slower rate of ellipsoid zone (EZ) loss. Ocugen is now working on an optimized Phase III design, including a targeted lesion size window and an adaptive design “powered at greater than 95%,” Musunuri said. He added the company expects to meet with the FDA and EMA and reach agreement on Phase III design by Q3 2026, with potential BLA filing by 2028. In the Q&A, Musunuri provided additional Phase III design assumptions discussed for planning purposes: a 300-patient global trial across the U.S., EU, and Canada, randomized 2:1 (200 treated, 100 untreated control). He said the primary endpoint would be lesion size and the secondary endpoint would be EZ, noting power of “92% for EZ” as a secondary endpoint and that an adaptive look could occur when 150 patients reach one year. Asked by Chardan’s Daniil Gataulin about regulators’ views on EZ preservation, Musunuri said the company had submitted meeting requests to both the FDA and EMA and would provide updates after those meetings. He reiterated that lesion growth is planned as the primary endpoint because it is used in approved U.S. products, while Ocugen is proposing EZ as a secondary endpoint because it correlates with visual function. Chief Financial Officer Rita Johnson-Greene reported total operating expenses of $19.4 million for the quarter ended March 31, 2026, including $11.3 million in R&D and $8.1 million in G&A. That compared with total operating expenses of $16.0 million in the first quarter of 2025, including $9.5 million in R&D and $6.5 million in G&A. Ocugen posted a $0.06 net loss per common share for the quarter, compared with a $0.05 net loss per common share in the prior-year quarter, Johnson-Greene said. Cash equivalents and restricted cash were $32.2 million as of March 31, 2026, compared with $18.9 million as of March 31, 2025. Johnson-Greene said the company received $37.5 million in gross proceeds in the first quarter of 2026, inclusive of $15 million from exercised warrants. She also reported 338.3 million shares of common stock outstanding as of March 31, 2026. Looking ahead, Johnson-Greene told analysts the company expects to average roughly $50 million to $60 million per year in spending, and said the cash runway outlook into 2028 includes anticipated costs for the planned GA Phase III trial. On commercialization planning for OCU400, Musunuri said Ocugen is working on pricing with CMS, standardizing the surgical procedure used in trials, and identifying centers of excellence for administration. He said the company expects to ramp more of the commercial build-out later in the year and into early next year. In response to questions about centers of excellence, Musunuri said the vitrectomy procedure is not “complex” and that any of the roughly 2,400 trained retinal surgeons in the U.S. could perform it, but the company wants to ensure consistency and patient safety by training initial centers on the same surgical manual used in trials. Qamar added that no special training is required beyond standard-of-care practice, but that product-specific guidelines would apply and initial centers could help train additional sites after launch. Johnson-Greene also said Ocugen is “actively evaluating” potential ex-U.S. business development deals for OCU400 and OCU410ST and is reviewing term sheets. For OCU410 in GA, she said the company is still looking to commercialize with a partner. On payer dynamics, Musunuri referenced publications discussing pharmacoeconomic models and said CMS and CMMI are evaluating approaches such as subscription models and “pay over time” structures for high-priced, one-time gene therapies, which he said could help address budget constraints while expanding patient access. Ocugen Inc is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing gene therapies to treat rare inherited retinal diseases, as well as vaccines designed to address unmet needs in infectious diseases. Headquartered in Malvern, Pennsylvania, the company applies its proprietary gene therapy platform to create novel treatments aimed at preserving and restoring vision, while leveraging strategic partnerships to broaden its vaccine pipeline. In its gene therapy portfolio, Ocugen is advancing multiple programs targeting retinal disorders. The article "Ocugen Q1 Earnings Call Highlights" was originally published by MarketBeat.