Ocugen Q2 2025 Earnings Report

Ocugen EPS Results

• Actual EPS: -$0.05
• Consensus EPS: -$0.06
• Beat/Miss: Beat by +$0.01
• One Year Ago EPS: N/A

Ocugen Revenue Results

• Actual Revenue: $1.37 million
• Expected Revenue: $0.35 million
• Beat/Miss: Beat by +$1.02 million
• YoY Revenue Growth: N/A

Ocugen Announcement Details

• Quarter: Q2 2025
• Date: 8/1/2025
• Time: Before Market Opens
• Conference Call Date: Friday, August 1, 2025
• Conference Call Time: 8:30AM ET

Ocugen (NASDAQ:OCGN), a clinical-stage biopharmaceutical company, focuses on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve patients' health. The company's pipeline product includes OCU400, a novel gene therapy product candidate restoring retinal integrity and function across a range of genetically diverse inherited retinal diseases, currently under Phase 3 trials for the treatment of retinitis pigmentosa and Phase 1/2 trials for the treatment of leber congenital amaurosis; OCU410, a gene therapy under phase 1/2 for the treatment of dry age-related macular degeneration (AMD); and OCU410ST, a gene therapy under phase 1/2 for the treatment of Stargardt disease. It is also involved in the development of OCU200, a novel fusion protein that is in preclinical development stage for the treatment of diabetic macular edema, diabetic retinopathy, and wet age-related macular degeneration; and NeoCart, an autologous chondrocyte-derived neocartilage, currently under Phase 3 studies indicated for the repair of knee cartilage injuries in adult. In addition, the company is developing OCU500, a COVID-19 vaccine; OCU510, a seasonal quadrivalent flu vaccine; and OCU520, a combination quadrivalent seasonal flu and COVID-19 vaccine. It has collaboration agreements with National Institute of Allergy and Infectious Diseases for early clinical studies for the OCU500 program; and a strategic partnership with CanSino Biologics Inc. for manufacturing its modifier gene therapy pipeline product candidates. The company was founded in 2013 and is headquartered in Malvern, Pennsylvania.

Ocugen Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Ocugen’s three modified gene therapy candidates are advancing in clinical trials, with two in late-stage development and a goal to file three BLAs/MAAs within the next three years.
• Positive Sentiment: The Phase 3 Limelight trial for OCU400 in retinitis pigmentosa is enrolling on track with no serious AEs and Ocugen remains on schedule for BLA/MAA submissions in 2026, offering a gene-agnostic therapy addressing over 100 RP mutations.
• Positive Sentiment: Ocugen initiated the Phase 2/3 Guardian3 trial for OCU410 ST after receiving FDA rare pediatric disease designation, dosing the first patient this quarter and potentially accelerating development by 2–3 years.
• Positive Sentiment: Interim Phase 2 data for OCU410 in geographic atrophy shows a 27% reduction in lesion growth at six months—outperforming current intravitreal therapies—with full 12-month results expected in 2026.
• Negative Sentiment: Cash and equivalents dropped to $27.3 million at quarter-end from $58.8 million at year-end, underscoring the need for further financing or partnerships to sustain operations.

Presentation

[Operator]

Good morning, and welcome to Ocugen's second quarter twenty twenty five financial results and business update. Please note that this call is being recorded at this time. All participants' lines are in listen only mode. Following the speakers' commentary, there will be a question and answer session. I'll now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications. You may begin.

[Tiffany Hamilton, AVP & Head - Corporate Communications at Ocugen]

Thank you, operator, and good morning, everyone. Joining me on today's call and webcast is Doctor. Shankar Mussanuri, Ocugen's Chairman, CEO and Co Founder, who will provide a business update and an overview of our clinical and operational progress. Ramesh Ramachandran, our Chief Accounting Officer, is also on the call to provide a financial update for the quarter ended 06/30/2025. Doctor.

[Tiffany Hamilton, AVP & Head - Corporate Communications at Ocugen]

Huma Kumar, Chief Medical Officer and Doctor. Arun Upade, Chief Scientific Officer, will be available to answer questions following the presentation. This morning, we issued a press release detailing associated business and operational highlights for the 2025. We encourage listeners to review the press release, which is available on our website at occugen.com. This call is being recorded and a replay with the accompanying slide presentation will be available on the Investors section of the Ocugen website for approximately forty five days.

[Tiffany Hamilton, AVP & Head - Corporate Communications at Ocugen]

This presentation 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 include, but are not limited to, statements regarding our clinical development activities or related anticipated time lines. Such statements are subject to numerous important risk 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, the SEC, including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC.

[Tiffany Hamilton, AVP & Head - Corporate Communications at Ocugen]

Any forward looking statements that we make in this presentation speak only as of the date of this presentation. Except as required by law, we assume no obligation to update forward looking statements contained in this presentation, whether as a result of new information, future events or otherwise after the date of this presentation. I will now turn the call over to Doctor. Musanuri.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Thank you, Tiffany, and thank you all for joining us today. We're very enthusiastic about the progress of our novel modified gene therapy platform. All three candidates are advancing through the clinic, two in late stage. And we are on track to meet our goal of three biological licensing applications and market authorization application filings in the next three years. We remain steadfast in our mission to provide a one time therapy for life to address considerable unmet medical needs that exist for millions of patients facing the terrifying prospect of losing their vision.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Patients are actually being recruited in The United States and Canada for the novel modifier gene therapy OCU400 Phase three Limelight clinical trial for retinitis pigmentosa. And we are on target for BLA and MAA filings in 2026. You may have seen our recent social media collaboration with Molly Burke, an outspoken RP patient, and an advocate to raise awareness for the Limelight clinical trial. It's gratifying to see the increased visibility for the work we are doing, and the response has been very positive. Notable accomplishments this quarter included the FDA's agreement to proceed with the Phase twothree Guardian three pivotal confirmatory trial for OCU410 ST for Stargardt disease following rare pediatric disease designation, RPDD, and dosing of first patient earlier this month.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Additionally, phase one twelve month preliminary data for OCU410 ST and OCU410 is positive, demonstrating favorable safety and efficacy with improved structural and functional outcomes. The OCU400 phase three limelight clinical trial is the only global broad RP gene agnostic trial to address multiple genetic mutations with a single therapeutic approach. OCU400 has obtained multiple designations to assist with regulatory review, including Regenerative Medicine Advanced Therapy designation, and Orphan Drug Designation from the US Food and Drug Administration, as well as Orphan Medicinal Product Designation, OMPD, and Advanced Therapy Medicinal Product, ATMP classification from the European Medicines Agency, EMA. In the second quarter, the EMA granted eligibility to submit the OCU400 market authorization application, MAA, through the centralized procedure based on the current study design and statistical analysis plan. Due to its novel gene agnostic mechanism for action, OCU400 has potential to address more than 100 different mutations associated with RP.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

In contrast, a traditional gene therapy approach would require development of over 100 products to treat each individual mutation, which is commercially not feasible. Currently, the only approved gene therapy for RP targets a single gene, RPE65, which accounts for one to two percent of RP patient population. As a result, approximately two hundred and ninety eight thousand people in The US and Europe with other forms of RP remain without any approved treatment options. In anticipation of the planned BLA filing in 2026, we're actively ramping up preparation for commercialization. Process validation and manufacturing activities remain on track for completion this year.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

The Data and Safety Monitoring Board recently convened and reported no serious adverse events related to OCU400 and recommended continuing the study dosing as planned. Stargardt disease is an inherited retinal disorder primarily caused by mutations in the ABCA4 gene, with over twelve hundred different mutations in this gene identified to date. It typically presents in childhood or adolescence, and affects approximately one hundred thousand individuals in The United States and Europe combined, and an estimated one million people globally. Despite its prevalence, there is currently no FDA approved treatment available for Stargardt disease. The OCU410 ST clinical trial is progressing well, having achieved key milestones.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Receipt of rare pediatric disease designation in May, IND amendment clearance in June, and first patient dosing in July in registration trial. There is a clear sense of urgency from the agency to bring treatment options to patients who currently have no approved therapies. As we initiate the phase twothree registration trial, we're potentially accelerating clinical development of OCU-four ten SD by two to three years, potentially delivering an innovative gene therapy to patients in critical need even sooner than originally anticipated. The Guardian three clinical trial builds upon encouraging results and positive data from the phase one Guardian trial, which included a dose range and dose escalation study to evaluate the safety and preliminary efficacy of OCU410. In the phase one trial, evaluable treated eyes demonstrated a 48% slower lesion growth at twelve month follow-up compared to untreated eyes.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Additionally, treated eyes showed statistically significant with a p value of 0.031 and clinically meaningful improvement of nearly two line or nine letter gain in best corrected visual acuity, BCVA, at twelve month follow-up when compared to untreated eyes. Our third novel modified gene therapy candidate, OCU410, is specifically designed to treat geographic atrophy secondary to dry agilator macular degeneration, TAMD, a leading cause of irreversible vision loss in the elderly. Unlike current treatment options, though the target only one pathway, the complement system required frequent intravitreal injections, typically six to 12 per year, with associated safety concerns. Example, approximately twelve percent of patients develop wet AMD. Ocuforten offers a more comprehensive and one time therapeutic approach.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Ocuforten has the potential to regulate all four pathways related to disease progression, lipid metabolism, inflammation, oxidative stress, and the complement system, thereby addressing the underlying causes of disease with a single subretinal injection. The phase one data at twelve months demonstrated twenty three percent slower lesion growth in the treated eye when compared to the untreated fellow eye after a single subretinal injection. In addition to the structural improvement, treated eyes also demonstrated a stabilization or gain in visual function, low light, low luminescence visual equity with a two line octane lateral gain when compared to untreated fellow eyes. Preliminary results from six month interim analysis in 31 subjects demonstrated a twenty seven percent lesion growth and the preservation of retinal tissue in the treated eyes when compared to untreated control eyes. The 27% reduction in lesion growth at six months is more pronounced compared to currently approved intravitreal therapies.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Monthly and every other month, PEG, Cetacocline injections with demonstrated reductions of thirteen percent and twelve percent respectively. In addition to improved lesion reduction, a single subretinal injection of OCU410 demonstrates greater efficacy in preserving retinal tissue surrounding GI lesions compared to monthly and every other month packed cervical planned treatments. We plan to provide full twelve month data from the phase two study in the 2026 and initiate phase three in 2026. During the second quarter, we signed a binding term sheet for our first regional partnership for OCU400, announced the spin off of Neocart into OrthoCelix, two significant strategic events that we expect will make a considerable impact on Ocugen's financial position. Aligned with Ocugen's business development strategy for OCU400, the company signed a term sheet to negotiate and enter into a licensing agreement with a well established leader in the pharmaceutical and healthcare sector in Korea for exclusive Korean rights to OCU400.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

We are expecting to close the definitive agreement by September. This regional partnership approach will allow Ocugen to retain rights in larger geographies, maximizing global patient reach while generating value for shareholders. We are actively engaged in discussions to explore a range of strategic partnership opportunities for OCU400 and all of our gene therapy candidates. The proposed reverse merger with OrthoCelix, a wholly owned subsidiary, and Charisma Therapeutics will create a NASDAQ listed late clinical stage regenerative cell therapy company with a first in class technology platform focused on orthopedic diseases. The combined company will focus on the development of OrthoCelix's NeoCart technology for the treatment of knee particular cartilage defects.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

This strategic move is intended to create value for Ocugen stockholders without dilution of Ocugen stock, As Orthoselex is planned to be funded with $25,000,000 in private financing under the exchange ratio formula in the merger agreement, Orthoselex's value is estimated at 135,000,000 We believe there's a significant valuation increase opportunity for OrthoCelix upon initiation of phase three NeoCart clinical trial, given the more than $2,000,000,000 market cap of the only other autologous cartilage implant on the market today. Ocugen and industry experts believe this market is significantly under penetrated, and NeoCart could represent a true step forward in innovation for ACI. With our business rapidly evolving, it was imperative to make new appointments to our Board of Directors to round out the skill set needed at this pivotal time. During the annual meeting in June, we announced appointments of Blaise Coleman and Doctor. Satish Chandra.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Blaise, a pharmaceutical executive, brings deep financial expertise and a proven track record of leading successful transformations, most notably at Endo. Blaise also held senior financial roles at AstraZeneca, including CFO of The US diabetes business. Satish brings more than thirty years of leadership experience across academic research, early and mid stage biotechs, and large pharmaceutical companies, including Wyeth and Pfizer. Satish has his name on countless patents, and in recent years considers himself as a serial entrepreneur, leading biotech companies focused on developing products across a variety of therapeutic indications. We also made updates to the Retina Scientific Advisory Board to reflect the absolute best guidance in this space as we move closer to commercialization.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Three renowned retinal surgeons who are at the forefront of research and cutting edge advancements for retinal disease, doctors Jeff Hyer, Peter Kaiser, and Arshat Khanani have joined the SAB to help us bring meaningful innovative therapeutic options for patients living with serious retinal diseases. Finally, to optimize Ocugen's R and D and clinical efforts, and build upon positive momentum pursuing strategic partnerships and developing commercial strategy, we strengthen the company's internal expertise and critical functions. Vijay Kumar joined Ocugen in the newly created position of chief development officer and brings over thirty two years of global regulatory leadership with deep expertise in biotechnology, biosimilars, and complex regulatory submissions. Abhi Gupta has been named Executive Vice President and Commercial and Business Development following the retirement of Mike Shine. Abby has more than twenty years of experience across commercial strategy, gene therapy, and corporate development in the biopharmaceutical industry.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

And Michael Blackton is our new VP of Manufacturing and Supply, bringing over thirty years of experience in quality, operations, and manufacturing across the biotechnology and pharmaceutical industries. I'm delighted with these leadership changes and confident that we have the best people at the helm to take Ocugen to the next level of our success. With that, now I will turn the call over to Chief Accounting Officer, Ramesh Ramachandran, to provide an update on our financial results for the second quarter ended 06/30/2025. Ramesh?

[Ramesh Ramachandran, Chief Accounting Officer at Ocugen]

Thank you, Shankar. The company's cash, cash equivalents and restricted cash totaled $27,300,000 as of 06/30/2025, compared to $58,800,000 as of 12/31/2024. The company had $292,200,000.0 shares of common stock outstanding as of 06/30/2025. Total operating expenses for the three months ended 06/30/2025 were 15,200,000, including 8,400,000.0 in research and development expenses and $6,800,000 in general and administrative expenses. This compares to total operating expenses for the three months ended 06/30/2024 of $16,600,000 that included research and development expenses of $8,900,000 and general and administrative expenses of $7,700,000.

[Ramesh Ramachandran, Chief Accounting Officer at Ocugen]

As always, we are constantly exploring strategic and shareholder friendly opportunities to increase our working capital and continue to pursue strategic partnerships that will drive long term strategy. That concludes my update for the quarter. Tiffany, back to you.

[Tiffany Hamilton, AVP & Head - Corporate Communications at Ocugen]

Thank you, Ramesh. We will now open the call for questions. Operator?

[Operator]

Your first question comes from the line of Michael Okunwitch from Maxim Group. Your line is live.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

All right. Thank you, everyone. Thanks for taking my questions today, and congrats on all the progress you've made.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

You.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

So I guess to start out here, you've been quite busy. You did the ortho celic spin out. You did the Korea license agreement on the past couple of months. So are there any other deals that you might be looking to execute, whether these be regional license agreements, asset sales or spin outs? Is there anything that's kind of you've been working on in the pipeline or you've identified as a goal?

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Michael, yes. As we stated, we are continuously looking for potential partnership opportunities, including regional partnerships for all our gene therapy programs. Go ahead, Mike.

[Operator]

One moment. He just dropped the line. I'll put him back in now.

[Tiffany Hamilton, AVP & Head - Corporate Communications at Ocugen]

Okay.

[Operator]

Your line is live again, Michael. My apologies.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

No worries. Thank you. Yes, I just wanted to follow-up on the STARRUT Phase twothree now that that's started to enroll. Could you remind us how many sites you're including? And then do you anticipate that the rare nature of the disease may make it more challenging to enroll versus something like RP or GA?

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

I will let Huma answer the question. Thank

[Huma Qamar, Chief Medical Officer at Ocugen]

you for the question. Stargard Phase twothree pivotal confirmatory trial has already started dosing. And we have, not only dosed one, but quite a few patients have enrolled altogether, in the month of July. We do not anticipate any challenges in enrolling Stargardt patients because the stats in United States is forty four thousand approximately patients for Stargardt and there is no approved product. Our inclusion exclusion criteria is, very amenable and palatable to the population in terms of the BCVA.

[Huma Qamar, Chief Medical Officer at Ocugen]

And also this particular OQ410 for all ABCA4 related, retinopathies as well, covering all, the mutations that fall under Stargardt. We have 15 centers activated, and we are going to activate, a couple of centers to make 15 centers according to the protocol, and we are on track for the enrollment, and the BLA in 2027.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Thank you very much for the additional color. And then one last one for me, and I'll hop back into the queue. I'd like to see if you could just help us contextualize what a twenty seven percent lesion growth in GA might look like in terms of, from a patient perspective, in terms of delaying loss of vision and preservation of function.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Arun, you want to take that?

[Arun Upadhyay, Chief Scientific Officer & Head - Research & Development at Ocugen]

Sure. Thanks, Ankur. And thanks for asking this question. So, as you know, photoreceptors are critical, to maintain the vision in these patients.

[Arun Upadhyay, Chief Scientific Officer & Head - Research & Development at Ocugen]

So, if if you look at translational perspective, like how this twenty seven percent in six month will translate in long term, The way we look at like, you know, other product even even after a year or two year, you see very limited like, you know, reduction in lesion growth. So from that perspective, when when I look at twenty seven percent reduction in lesion growth, we see that it will it will help these patients, know, basically prevent them losing their their visual function, okay, significantly. And and as you know, this is a modified gene therapy approach. So not only it is going to preserve the photoreceptors, but also it is going to enhance the function of the photoreceptors, which eventually we believe that, will lead to the to the gain in the functional vision in these patients. Okay?

[Arun Upadhyay, Chief Scientific Officer & Head - Research & Development at Ocugen]

What what we have noticed in the phase one patient like, you know, in terms of low luminescence visual acuity. So, in summary I would say we would we would see the better impact on these patients as the modifier gene therapy product, you know, start making changes in the receptor function in these patients over time.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

All right. Thank you. I appreciate it. And once again, congrats on all the progress you've made.

[Arun Upadhyay, Chief Scientific Officer & Head - Research & Development at Ocugen]

Thank you.

[Operator]

Your next question comes from the line of Boris Peaker from Titan Partners. Your line is now live.

[Boris Peaker, Managing Director at Titan Partners]

Great. Thanks for taking my questions. Maybe I'll start with 400 in RP. Just when the DSMB convened to look at the interim data, was there a futility analysis, or was this just purely safety analysis to continue moving forward?

[Huma Qamar, Chief Medical Officer at Ocugen]

So I'll take that question. There is no futility analysis. This was just purely safety. Data and Safety Monitoring Board convened, and there were no serious adverse events or any adverse events of special interest related to the investigational product reported.

[Boris Peaker, Managing Director at Titan Partners]

Great. And maybe then we'll move on to four ten. Can you talk about the potential interim update, maybe confirm the kind of estimated timing for that update as well as what will be analyzed during that update?

[Huma Qamar, Chief Medical Officer at Ocugen]

Yes. So in terms of Q4, geographic atrophy, ARMOR trial, secondary to trial, age related macular degeneration, we are going to update, the interim analysis, data in the fourth quarter. We will be providing structural and functional outcomes, for that analysis.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

And Borey, just to clarify, we just gave some data at six months. And where total subjects including untreated control group is thirty one patients. That's twenty one percent reduction in lesion growth. That's structural. The data looks promising.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

And compared to currently upward market products, which are much lower, compared, in the lesion growth. The second thing, obviously as Arun stated before, from the structural changes to functional change such as an LLVA, a visual equity, it takes a little longer. And so by the time in the fourth quarter, we'll have some data from the later time points like nine months, maybe in some patients twelve. That should really enlighten any changes in the functional benefit to the patients.

[Boris Peaker, Managing Director at Titan Partners]

Gotcha. And maybe my last question is on the EMA or the European regulatory front, when will we get some feedback to kind of get a sense of if the pivotal study is sufficient to get approval there or not?

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Actually, on RT, we already have it. On Stargardt, we should be able to get it, by fourth quarter this year.

[Boris Peaker, Managing Director at Titan Partners]

Okay. Alright. Great. Actually, maybe lastly, just an accounting question. For this Korean partnership, when will we see that 11,000,000 recognized on the, income statement?

[Ramesh Ramachandran, Chief Accounting Officer at Ocugen]

That's over the period, certain period of time, which will extend up to into '27. So it's it's, in different phases, so it's not at one point of time.

[Boris Peaker, Managing Director at Titan Partners]

Okay. Got it. Thanks for clarifying. Well, you very much for taking my questions.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

You're welcome.

[Operator]

Your next question comes from the line of Swayampakula Ramakanth from H. C. Wainwright. Your line is live.

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

Thank you. Good morning, Shankar. A couple of quick questions from me. Regarding the Limelight trial, can you give us what the current enrollment percentage is? And also, when should we be expecting top line data from this study?

[Huma Qamar, Chief Medical Officer at Ocugen]

So, Arjun, I'll take the question. So we are on track for the enrollment and on track for our BLA in 2026. As, this is a blinded study, we will be releasing, just the periodic safety updates, but, the other data would be available after, the last patient, last visit is done.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

In '26.

[Huma Qamar, Chief Medical Officer at Ocugen]

In 2026. Or yeah.

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

Okay. Thank you for that, Huma. Is there any additional, DSMB looks into this study or the next, you know, major data update is is when you release that efficacy top line, in the in in early twenty I mean, in 2026?

[Huma Qamar, Chief Medical Officer at Ocugen]

Yes. So we will have another, safety, update in the fourth quarter.

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

Okay. Thanks for that. And then, Shankar, on the ortho, Alex, I'm just trying to understand, you know, would you get any non diluting funding from from this spin off? And and also on the on the financial side of things, you know, with your current funding, how do you plan to to bring in additional funds so that you can get all these three programs to the to the completion?

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Yeah, good question, RK. Just as, any growing biotech, the programs are moving well. I mean, obviously we're working hard on potential business development opportunities, partnership, and, that has tremendous potential to bring in non dilutive funding. In addition to that, as the market opens up, and we will be opportunistic, you know, as needed, we can also look into some equity. And so those are the things we always want to balance.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

You know, the shareholder dilution, we take that pretty seriously. So if there are ways we can, you know, minimize that with strategic partnerships, non dilutive funding, we'll try to maximize that. As far as Arthoselect is concerned, once the company is formed, after that, the company can independently seek any potential government grants, because there may be a need in that area, so they're open to all that.

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

Thank you. Thanks for taking my questions.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Thank you.

[Operator]

Your final question comes from the line of Daniel Yatlin from Poseidon. Your line is live.

[Daniil Gataulin, Senior Research Analyst at Chardan Capital Markets]

Yeah. Hey. Good morning, guys. Thanks for taking the question, and congrats on all the progress. Just a couple for me.

[Daniil Gataulin, Senior Research Analyst at Chardan Capital Markets]

First, on OCU200, in your press release, you mentioned that you intend to complete the Phase I trial in, the second half. How would you describe, patients' and physicians' interest in this program, given, a fairly large number of effective and approved options for these patients? And when are the expectors for the initial data from the program?

[Huma Qamar, Chief Medical Officer at Ocugen]

Yes. So, hey, Daniel. This is Sima. I, so in terms of OQ200, just the progress, we are, successfully dosing in Cohort three, right now, and the data is expected towards later this year, which would be, the safety and efficacy report on OCU200, a novel biologic, tomb statin transferrin recombinant infusion protein. In terms of the interest from the investigators, actually it is good because, not only from the safety perspective but also the dual nature of tomostat and transferrin novel recombinant fusion protein and also how the responders and rescue therapies are there.

[Huma Qamar, Chief Medical Officer at Ocugen]

So this seems like a potential, not only safe product in terms of intravenous administration, but also, to prevent the choroidal neovascularization and also, to look at the responders and, you know, non responders treatment, in further trial. And also currently, the rescue treatment that are being given, with patients of macular edema who have got the approved therapies.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

So I think, RK, just to clarify further, that currently there's a significant portion of the population for non responders to current treatments. That's where RK200 comes in. We think potentially this can treat both non responders and responders.

[Daniil Gataulin, Senior Research Analyst at Chardan Capital Markets]

Got it. Got it. Thank you. Another question on, OCU400, with respect to that licensing agreement in Korea. Can can you tell us what the regulatory path or approval path would look like for OCU 400 in Korea and potentially in other Asian markets?

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Yeah. Just as, EMA didn't require, I mean, waived a clinical trial, they're willing to take U. S. Data, The U. S.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Clinical trial, to give approval. Similarly, there are many markets. If you get, FDA or EMA approval, since it's an orphan drug, many countries we can use our US FDA approval to get approvals in other countries. So Korea is the same path. They potentially don't need any further clinical trials.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

And, they can use our US FDA approval to get approval to launch the product in Korea. Similarly, we're looking at our markets that don't have answer set, including Japan. We're still working with the PMDA. And, when we get a definitive response from them, we'll update the markets.

[Daniil Gataulin, Senior Research Analyst at Chardan Capital Markets]

Okay. Got it. Makes sense. And one last question. In terms of your interactions, with the FDA, how would you describe, you know, the the conversations in in the past few months?

[Daniil Gataulin, Senior Research Analyst at Chardan Capital Markets]

And, what changes, if any, do you expect with the recent departure of Doctor. Prasad from CBER?

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Good question. The FDA already have, put somebody in place of the super office, in charge with all the changes, And we're still getting pretty good response. Number one, the Stargardt disease, all the decisions they made working with us, approving, our IND amendment in record time, and getting the design, everything lined up in the last three months. And they're very supportive. In addition, any questions we have, any of our programs, from RP to Stargardt, they're reacting very promptly.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

So from our perspective, we're not seeing any impact on our programs.

[Daniil Gataulin, Senior Research Analyst at Chardan Capital Markets]

Got it. Okay. All right. Thank you very much for taking my questions.

[Operator]

You're welcome. This concludes the Q and A portion. I will now turn the call back over to Chairman, CEO, and Co Founder, Doctor. Shankar Moussinuri.

[Shankar Musunuri, CEO, Co-founder & Chairman of the Board at Ocugen]

Thank you everyone again. Thank you, operator. Thank you everyone for joining today. The meaningful progress Ocugen is making across its novel modifier gene therapy platform, along with notable leadership changes and significant external alliances, are evidence of a strong first half twenty twenty five. And we look forward to providing critical program updates and data in the coming months. Have a great day.

[Operator]

This concludes the meeting. You may now disconnect.

Participants

Executives

• Tiffany Hamilton, AVP & Head - Corporate Communications
• Shankar Musunuri, CEO, Co-founder & Chairman of the Board
• Ramesh Ramachandran, Chief Accounting Officer
• Huma Qamar, Chief Medical Officer
• Arun Upadhyay, Chief Scientific Officer & Head - Research & Development

Analysts

• Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group
• Boris Peaker, Managing Director at Titan Partners
• Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC
• Daniil Gataulin, Senior Research Analyst at Chardan Capital Markets