Ocugen Q3 2026 Earnings Call Transcript

Ocugen (NASDAQ:OCGN) reported third-quarter financial results on Wednesday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Ocugen Inc reported significant progress in its late-stage gene therapy programs, with all three now in Phase 3 trials, targeting Geographic Atrophy, Retinitis Pigmentosa, and Stargardt disease.

Financially, the company ended the quarter with $84.6 million in cash and equivalents, expecting this to fund operations into 2028, covering two of the three late-stage programs through their anticipated BLA filings. The company reported a $0.01 net loss per share, an improvement from the $0.07 loss in the same period last year.

Strategic initiatives included a licensing deal for OCU400 in the Middle East and North Africa, and provisional approval in The Bahamas, opening pathways for international expansion and potential revenue generation.

Operational highlights include the completion of enrollment in the Phase 3 trial for OCU400, the first patient dosed in the OCU410 trial for GA, and continued progress in the OCU410ST trial for Stargardt disease.

Management emphasized confidence in their gene therapy platform’s ability to address multiple retinal diseases, with a focus on executing key milestones in 2027 and filing three BLAs by 2028.

Full Transcript

OPERATOR

Good morning and welcome to Ocugen’s third quarter 2026 financial results and business update. All participants are currently in listen-only mode. Following the speakers’ commentary, there will be a question-and-answer session. I will now turn the call over to Chris Clark, Ocugen’s VP of Communications. You may begin.

Chris Clark (Vice President of Communications)

Thank you, operator, and good morning, everyone. Joining me on today’s call and webcast is Dr. Shankar Musunuri, Ocugen’s Chairman, CEO and Co-Founder, who will provide a business update and an overview of our clinical and operational progress. Rita Johnson-Greene, our Chief Financial Officer, is also on the call to provide a financial update for the quarter ended September 30, 2026. Dr. Mohamed Genead, our Chief Medical Officer, Dr. Arun Upadhyay, our Chief Scientific Officer, and Avi Gupta, Executive Vice President of Commercial and Business Development, will be available to answer questions following the presentation.

This morning we issued a press release covering our business and operational highlights for the third 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 slide presentation will be available on the Investors section of the Ocugen website. Before we begin, please note that certain statements made during today’s discussion may be forward-looking in nature, including those related to our clinical development pipeline, regulatory timelines, commercialization strategy, international expansion 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 materially differ 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 third quarter of 2026 will be filed today. I will now turn the call over to Dr. Musunuri.

Shankar Musunuri (Chairman, CEO & Co-Founder)

Thank you, Chris, and good morning, everyone. The third quarter was a quarter of execution for Ocugen. We now have all three of our late-stage modifier gene therapy programs in phase three, we advanced our business development strategy, and we established a presence in Europe to support pre-commercial activities. With three phase three programs underway, we’re executing against a clear strategy to advance our pipeline and build our global presence through strategic partnerships to bring our therapies to patients around the world.

Our modifier gene therapy platform remains the foundation of everything we do. Rather than targeting a single mutation, it is designed to address the underlying biology of complex retinal disease by restoring balance across multiple gene networks. The platform is gene-agnostic, it is multifactorial, and it is designed to deliver durable benefit from a single one-time injection. That approach is what allows us to advance one platform across three major causes of blindness—Geographic Atrophy, Retinitis Pigmentosa, and Stargardt disease.

We remain on track to file three BLAs by 2028, and our next major milestone is clear: OCU400 is expected to be the first of our phase three programs to read out, with top-line data anticipated in the first quarter of 2027. Let me walk you through the progress made across each program this quarter. I will begin with OCU400 in RP, followed by OCU410ST in Stargardt disease and OCU410 in GA, before handing the call to Rita for the financial update. In OCU400 for RP, this was an especially productive quarter for the program with progress on clinical, regulatory, and commercial fronts. On the clinical side, we completed enrollment in our phase 3 LIMELIGHT trial with 140 patients. Top-line data from the trial are expected in the first quarter of 2027, followed by our planned BLA submission. Our process performance qualification batches are complete, which supports both our BLA and the commercial launch supply of OCU400.

On the commercial side, in October we completed an exclusive OCU400 license deal for the Middle East and North Africa with Routes Pharmaceutical, finalizing the binding term sheet we announced in July. Under the agreement, Ocugen is eligible for up to $4 million in combined upfront and potential initial development milestone payments, up to $255 million in potential sales milestones, and a 22% royalty on net sales, and we will manufacture commercial supply.

This is our second regional OCU400 license following our agreement with Guangdong Pharmaceutical in South Korea. On the regulatory and access side, OCU400 received provisional approval and priority designation in The Bahamas under its Longevity and Regenerative Therapies Act. We have executed an agreement with a local partner, the Global Alliance for Regenerative Medicine, to coordinate and manage patient care, and we are progressing site readiness in preparation for full LARTA approval. We are advancing toward potential patient enrollment as early as year end.

This pathway is a meaningful step toward expanding access for RP patients while potentially generating commercial revenues. Taken together, the access pathway from The Bahamas and the Routes license agreement reflect a deliberate strategy. We intend to bring OCU400 to patients in the United States and to extend its reach internationally through regional partnerships at commercial scale without requiring us to build our own infrastructure in every market.

As we build that international reach, we remain focused on the clinical development pathway that will underpin our efforts to bring OCU400 to patients in major markets. Our phase 1/2 experience also provides important context for the phase 3 LIMELIGHT study. In a post hoc analysis of seven phase 1/2 subjects meeting phase 3 eligibility criteria, five out of seven treated eyes, or 71.4%, are projected to meet the phase 3 responder threshold of at least a two-level improvement on the LDNA scale from baseline at week 52.

LDNA measures functional vision with a wider range and finer resolution than the mobility test used in phase 1/2. Our previously reported three-year follow-up adds a longer-term perspective: seven out of eight evaluable consented treated subjects, or 88%, showed improvement or preservation of LLVA compared with untreated eyes at year three, with no serious adverse events related to OCU400 reported through three years. Separately, our phase 3 power analysis shows that even at a hypothetical treatment responder rate of just 20% compared with 1% in untreated controls, the model estimates 93.2% power to detect a difference on the primary endpoint.

We believe these data support both the design of LIMELIGHT and the potential of OCU400, and we look forward to top-line results in the first quarter of 2027. Turning to OCU410ST for Stargardt disease, a pediatric-onset retinal disorder for which there are no approved therapies, we continue to advance our global phase 2/3 GUARDIAN trial per protocol, and we anticipate top-line data in the second quarter of 2027, with the BLA submission to follow. Finally, OCU410 for GA, an advanced form of dry age-related macular degeneration and our largest commercial opportunity. This quarter marked an important transition for the program into phase three. In September, we announced the first patient dosed in ARMADA-3, our global phase 3 clinical trial. We plan to complete trial enrollment next year with a target BLA filing in 2028. ARMADA-3 is a 237-subject study that randomizes patients 2 to 1 to a single subretinal injection of OCU410 or untreated control across the United States, Canada, and Europe.

The primary endpoint is GA lesion growth over 12 months. This is the first pivotal gene therapy trial in Geographic Atrophy. Today’s approved GA therapies target a single pathway and require ongoing intravitreal injections as often as monthly. OCU410 is designed to address multiple pathways underlying the disease with a single one-time treatment. We believe that combination of mechanism and durability gives OCU410 a clear competitive advantage. Here is a snapshot of the market opportunity across our three late-stage development programs, with OCU410 for GA representing our largest commercial opportunity. We believe all three programs have the potential to generate significant revenue while addressing areas of substantial unmet medical need. With that, I will turn the call over to Rita for the financial update. Rita.

Rita Johnson-Greene (Chief Financial Officer)

Thank you, Shankar. Good morning, everyone. Our cash, cash equivalents, restricted cash, and short-term investments totaled $84.6 million as of September 30, 2026. We expect this balance to support our cash runway into 2028, which funds two of our three late-stage programs through their anticipated BLA filings. We had 339.3 million shares of common stock outstanding as of September 30, 2026. Total operating expenses for the three months ended September 30, 2026 were $19.7 million and included research and development expenses of $12.5 million and general and administrative expenses of $7.2 million. This compared to total operating expenses for the three months ended September 30, 2025 of $19.4 million, which included research and development expenses of $11.1 million and general and administrative expenses of $8.2 million. Ocugen reported a $0.01 net loss per common share for the three months ended September 30, 2026 compared to a $0.07 net loss per common share for the three months ended September 30, 2025.

Total operating expenses for the nine months ended September 30, 2026 were $57.0 million and included research and development expenses of $34.4 million and general and administrative expenses of $22.6 million, compared to total operating expenses for the nine months ended September 30, 2025 of $50.5 million that included research and development expenses of $29.1 million and general and administrative expenses of $24.4 million. Ocugen reported a $0.14 net loss per common share for the nine months ended September 30, 2026 compared to a $0.17 net loss per common share for the nine months ended September 30, 2025.

That concludes my financial update. Shankar, back to you.

Shankar Musunuri (Chairman, CEO & Co-Founder)

Thank you, Rita. The progress we made this quarter reinforces our confidence in the path ahead. We moved OCU410 into phase three with the first patient dosed in ARMADA-3. We completed our regional licensing agreement for OCU400 in the Middle East and North Africa. We opened a pathway to treat RP patients in The Bahamas, and we established a European presence to support our development and commercialization in that region. Each of these moves supports the same objective, which is advancing three late-stage gene therapy programs toward approval and bringing them to patients around the world.

Looking ahead, our focus is firmly on execution. The most important near-term catalyst is top-line data from OCU400 in the first quarter of 2027, followed by our planned BLA submission. We then expect top-line from OCU410ST in the second quarter of 2027. We remain on track to deliver three BLAs over the next three years. I want to thank our employees, our investigators, and the patients who have placed their trust in us, as well as our shareholders for their continued support of our mission to advance cures for blindness. We will now open the call for questions. Operator.

OPERATOR

At this time I would like to remind everyone, in order to ask a question, press star then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Swayam Pakula Ramakant with H.C. Wainwright. Your line is open.

Raghuram Selvaraju (Analyst)

Thank you. This is RK from H.C. Wainwright. Good morning, Shankar, Rita, and the rest of the team. Just wanted to understand a little bit about the ST program—the Stargardt program. Shankar, you know in September you had the DMC recommendation come to you. When will the full cohort actually complete the follow-up period, the eight-month follow-up period? And beyond that, what sort of data do you need to make your next decision? And also I think you’re still planning to file in 2Q27, so what else needs to get resolved by then?

Shankar Musunuri (Chairman, CEO & Co-Founder)

Yeah, thank you. Okay. Good morning. Yeah, the protocol is targeted for a 12-month read in the second quarter. I’ll let our CMO, Dr. Ganit, answer the questions. Go ahead.

Mohamed A. Genead (Chief Medical Officer)

Thank you, Shankar. Good morning, RK. As we specified in the protocol, this interim analysis was prespecified in the original protocol we discussed with the agency, and it was a part of our adaptive design to look at any adjustment needed during the trial conduct. And the DMC was assembled, as you’re aware, and they recommended to continue the study without modification. So we—the company, all the team—are still blinded. We are continuing the study till month 12, and we’re looking forward to release the data by the second quarter next year in 2027.

As you are aware too, this interim analysis was done in a small cohort of patients in the study, at an early time point—month 8 versus month 12 at the primary. As you know, for Stargardt disease, it’s a slowly progressive retinal degenerative disease, so we wouldn’t expect to see too much at month 8 versus month 12. In addition, as you know, with gene therapy products the expression of the transgene from the product takes time. What we are trying to do here is look at the data at month 12 per the original design and the prespecified protocol.

Raghuram Selvaraju (Analyst)

Okay, thank you. So if I understand this right—I know I misspoke, I said second quarter ’27 filing—there is the readout in the second quarter, just as you said. So once you have all that data, do you anticipate meeting with the FDA before moving forward, or what other steps would you be taking once you get that 12‑month data point, just as you suggested?

Shankar Musunuri (Chairman, CEO & Co-Founder)

Yeah, great. Yeah, I think that’s the standard operating procedure, RK. When you get the top-line data, you need to discuss with the agency first. Then, if the data falls the way you anticipate following the protocol and SAP analysis—what we agreed with the FDA, obviously—then you move on to the next step, have a pre‑BLA meeting, and move on to filing the BLA.

Raghuram Selvaraju (Analyst)

Fantastic. Then regarding the LARDA approval in the Bahamas—first of all, I think it’s a good opportunity for you folks to get something commercial and also see how patients react or adopt in the real world, which is fantastic. So when you say by year‑end, by the end of this year, what would we see? Is it just going to be full approval and potentially somebody lining up to have their initial surgery, or you just will have the full approval and the hospital will be trying to get somebody in, get a surgery done in the new—in ’27, I mean?

Shankar Musunuri (Chairman, CEO & Co-Founder)

Yeah, so okay, I’ll let—you know, we have our commercial head here—

Ami Gupta (Head of Commercial)

Right. Marc, nice to hear from you. So the LARDA program in the Bahamas really represents something really innovative across our industry. And yes, in addition, right now we have a conditional provisional approval, but by the end of the year we can expect a full approval. We don’t necessarily share forecasts on patients, especially for EAP, but stay tuned and we will be sharing more catalysts on that specific program.

Raghuram Selvaraju (Analyst)

Perfect, thank you. Thanks for taking the questions. I’ll step back.

OPERATOR

Your next question comes from the line of Robert LeBoyer with Noble. Your line is open.

Robert LeBoyer (Analyst)

Good morning everyone, and congratulations on the progress during the quarter. My question only has to do with the 410 program, and good news that you initiated patient treatment during the quarter. My understanding is it’s a two‑to‑one randomization, but I don’t have anything about any kind of interim analysis. Is there anything planned like that?

Shankar Musunuri (Chairman, CEO & Co-Founder)

Yeah, Robert. This is a one‑year trial. That means after recruitment we’re going to monitor patients for one year, looking for primary and secondary analysis. And currently we’re not planning an interim.

Robert LeBoyer (Analyst)

Okay, are there any milestones for recruitment that you’re planning to announce, or is it just when you complete the full enrollment?

Shankar Musunuri (Chairman, CEO & Co-Founder)

Our goal is to complete enrollment in 2027, in line for BLA filing in 2028.

Robert LeBoyer (Analyst)

Okay, great. So everything’s on track. Sounds good. Okay, thank you very much.

Shankar Musunuri (Chairman, CEO & Co-Founder)

Thank you, Robert.

OPERATOR

Your next question comes from the line of Michael Okoniewicz with Maxim Group. Your line is open.

Michael Okoniewicz (Analyst)

Hi, thank you guys for taking my question. Congrats on all the progress this quarter.

Shankar Musunuri (Chairman, CEO & Co-Founder)

Thank you.

Michael Okoniewicz (Analyst)

I’d like to see if you could just talk a little bit more about the upcoming DMC review in Stargardt and provide some context on what the issues raised to the prior one—did this have anything to do with the magnitude of treatment effect over the time period? Was it fluctuation in functional measures over that period with a smaller population, or was it statistical noise at baseline that kind of led them to say, we want to see the full picture before making a decision?

Mohamed A. Genead (Chief Medical Officer)

Yeah, thank you for the question. So it’s all of the above, but let me give you more specifics. Let’s just go back to the disease progression because this is important to understand. Stargardt, as you know, is one of those slowly progressive retinal degenerative diseases, and it takes time to see any delta, and eight months was quite an early time point. This is number one. Number two, if you remember the interim analysis, we also looked at only a snapshot of certain patients—less than half of the patients in that trial—so the small N definitely influenced the outcome.

The other big piece was, in this analysis, the heterogeneity we saw at baseline. Remember, still less than half of the patients enrolled in the trial, and the baseline characteristics were heterogeneous. It was quite variable from small to large, so we cannot conclude—you cannot claim—anything as well. Lastly, and I want to reiterate this part, this was not an efficacy analysis; it was a part of the adaptive design to look at any need to do any adjustment on the trial design—increase duration or increase the number of patients.

And the DMC recommended to continue without any modification. For us as a company, we will continue to follow the patients per the existing protocol till month 12, and then we’ll look at the data on the full set of patients at month 12.

Michael Okoniewicz (Analyst)

And just how confident are you that the N equals 63 total size of the study is large enough to ameliorate any of those baseline differences?

Mohamed A. Genead (Chief Medical Officer)

Yeah, good point. Based on the prior data from the phase 1/2, we saw treatment effect in a small number of patients—an N of 9. We saw this 54% reduction, or slower lesion growth, in the treated eyes versus the untreated. Also, we saw functional benefit on the visual acuity. Back to your question about the N of 63: it will be the full set of patients. The study was powered, based on the early assumption, to show significance at month 12 with close to 90% power, and we should see a more homogeneous population—the baseline characteristics should be balanced between the control and treated.

That also will drive different value. In addition, we have a longer time point—month 12 versus month 8—and we saw the delta in our early study at month 12 versus month 8.

Michael Okoniewicz (Analyst)

All right, thank you. And then just one more before I hop back into the queue—I want to switch gears and talk a little bit about the Bahamas program. In particular, what the payment model looks like under LARDA and who is the target patient for that. Would that be patients that live locally in the Bahamas? Would it be people flying in for potential medical tourism to get early access to the treatment? Could you just provide a bit more color on what that looks like?

Shankar Musunuri (Chairman, CEO & Co-Founder)

Yeah, I’ll let Ami answer that. Go ahead.

Ami Gupta (Head of Commercial)

Yeah, so I think first on—the program is open globally, and yes, it’s looking at the Bahama population, but much more broadly. So it is truly a global program. Secondly, the way that the model works in terms of pricing is something that’s consistent with the way that the Bahama system is set up, and so it is a little bit more towards commercial than it is towards clinical. And that’s something specific that the Bahama regulatory body enables Ocugen to do.

Shankar Musunuri (Chairman, CEO & Co-Founder)

So, Michael, just to recap: anybody globally who is eligible can go get the treatment at this stage under this approval.

Michael Okoniewicz (Analyst)

All right. Would pricing match what you would be targeting for U.S. or international pricing, or is this more of an exploratory?

Ami Gupta (Head of Commercial)

Yeah, it would be—it would be matching U.S. price.

Michael Okoniewicz (Analyst)

Well, thank you very much. I appreciate the additional clarity.

Shankar Musunuri (Chairman, CEO & Co-Founder)

Thank you.

OPERATOR

Your next question comes from the line of Falimer Piros with Lucid Capital Markets. Your line is open.

Falimer Piros (Analyst)

Yes, good morning. Just one more follow-up on the Bahamas treatment availability. How would patients learn about that? Is there a payer in the Bahamas for them? What sort of marketing effort are you thinking of undertaking?

Ami Gupta (Head of Commercial)

Yes, as Ocugen, we don’t market EAPs, but we are working with a local vendor that’s responsible for all patient-related activities. And so they would be the one educating not only patients but KOLs, including the community, about this world’s first option for a global EAP.

Falimer Piros (Analyst)

Okay, and coming back to the interim analysis, was the DMC equipped with trying to model potential outcomes if they were to normalize the baseline characteristics to be even between the two arms?

Mohamed A. Genead (Chief Medical Officer)

So DMC, as you know, is an advisory body and also an independent, unblinded body assigned to the study. The DMC had a very clear per‑protocol assignment. They were looking at, as part of the adaptive design, three outcomes. Again, it’s not an efficacy outcome; it’s just part of the adaptive design for sample size recalculation or adjustment if needed. They had access to the unblinded data. They looked at all the efficacy, including the primary—the lesion size—and all the other functional, including also the genetic correlation.

So they were equipped to make a decision based on data. As we said before—and this is important again to reiterate—the sample size was small, early time point, and also we had some heterogeneity at the baseline characteristics in that interim analysis. The good news, also remember, they had the opportunity to do different outcomes. They continued the study without modification because they believe with the full set of patients at month 12 the heterogeneity and all this baseline heterogeneity will be normalized at month 12.

And this is what we also believe, based on our data and also patient selection in the trial.

Falimer Piros (Analyst)

And so you can confirm that since you have all the baseline characteristics of the patients that the full data set is going to be well balanced between the two treatment arms.

Mohamed A. Genead (Chief Medical Officer)

That’s correct.

Falimer Piros (Analyst)

Okay. Okay, thank you very much. That’s all what I had.

OPERATOR

Your next question comes from the line of Leland Gerfil with Oppenheimer and Company. Your line is open.

Mohamed A. Genead (Chief Medical Officer)

No, it’s a pleasure, and no. So the DMC is an independent body. They have access to the unblinded data; we don’t. The company—the study—is still blinded, and all the team running the study is still blinded. If you’re asking, will the DMC do another analysis at eight months with a full data set? No. We are continuing the study till month 12, and this is when we’re going to look at all the data from the trial as a company—by month 12. And this is part of the design of the study. This is a preexisting protocol. This is what we communicated to the agency, and we believe the reason why is because eight months is an early time point and we have a small number of patients.

So we want to see the full set of patients at month 12 per the existing protocol. Did I answer your question? Yeah. So the primary analysis for this study was based on the atrophic lesion size change over time till month 12, and the study was powered close to 90% to look at that delta—the delta you’re talking about, close to 25% delta. If you remember the Phase 1/2 data we shared earlier, or we discussed earlier, we showed close to 54% reduction in the lesion size. But this was an early study; it was also a small number of patients, and that was our benchmark.

But we went more conservative, and we talked about a 25% delta between the treated and the control eyes to show statistical significance. That’s on the lesion size growth. Also, we’re looking at other functional endpoints, including the BCVA and other functional endpoints in the study. And we saw earlier in our Phase 1/2 functional benefit as well from baseline to month 12, up to 6-letter gain in the treated eye versus contralateral untreated eye. So we believe, based on this earlier data, we should also see a similar trend on the structural and functional improvement in those subjects.

OPERATOR

Your next question comes from the line of Whitney Ajam with Canaccord Genuity. Your line is open.

Whitney Ajam (Analyst)

Hey guys, thanks for taking the question on OCU400 and the powering—thank you for walking through that. I guess, can you remind us from the Phase 1/2 experience, first of all, how were you defining responder in the Phase 1/2 as it relates to the mobility testing, and what are the differences between how you’re defining it there versus the Phase 3? And then remind us, what was the responder rate, particularly in the RHO population in Phase 1/2? And remind us what percent of the Phase 3 are RHO patients?

That’s part one. And then I have a follow-up. Sorry for so many questions.

Mohamed A. Genead (Chief Medical Officer)

Hi, Whitney, thank you for your question. You know, regarding the Phase 1/2—what we saw from the Phase 1/2 in the RP, the OCU400 program—this was n of 18 subjects. As you remember, we did some subgroup analysis. But what we saw based on the mobility test—and we used the same test Luxturna used for their approval, which is called the Multi-Luminance Mobility Test, MLMT—what we saw in that study in the treated eye that received OCU400, we saw 43% of the eyes improved 2 lux levels on the mobility test, which is the approval endpoint for RP, versus 0% of the control untreated eyes.

And then, when we projected this to our Phase 3 mobility test, which we call the LDNA—which is very similar to the MLMT, but it’s a broader range, 10 lux levels versus 6, but using the same methodology, the 2-lux-level improvement—our projection at that time went from 43% up to 71% improvement in the treated eye versus 0% in the control. So when we built our Phase 3 assumptions, Whitney, it was based on a very conservative analysis. We didn’t say we’re going to go with 71% improvement; we said the treated eye assumption was 50% improvement versus 10% control. And remember, in the Phase 1/2, the control was 0%. So if you went with the 50% treated versus the 10% control, the delta is 40%. That will give us 99% power in the study.

Okay. And if you look at this another way, right—if you look at the half full or half empty—right—even if the treated eye showed only 20% treatment effect, which is not our assumption, but if you went to 20% and the control behaved exactly the way it behaved in the Phase 1/2, which is close to 0%—give it 1%—we’re still hitting 93% power. So what we’re saying here, in a different way, is we have very high confidence with OCU400, especially as the study is well powered to show statistical significance at month 12 using the 2-lux-level improvement, the same one Luxturna used for their approval.

Did I answer your question?

Whitney Ajam (Analyst)

That’s really helpful. Yes, that’s really helpful. And then just on the RHO bit—am I remembering correctly that in the Phase 1/2 the responder rate in the RHO subgroup was higher? And either way, I guess, can you remind us what percent of patients in the pivotal are RHO patients?

Mohamed A. Genead (Chief Medical Officer)

Yeah. So for the pivotal trial, the Lyme Lite—just to remind, it’s 140 subjects enrolled, randomized 2 to 1. Ninety-two were treated and 48 were untreated, or the control arm. We have rhodopsin patients in the Phase 3 trials, but the majority will be non–rhodopsin—we call it gene-agnostic. But we have a very large number of patients in the Phase 3 trials who have rhodopsin mutation. And you’re correct, we saw a very positive trend in the rhodopsin subpopulation in the Phase 1/2.

So we are expecting to replicate, if not do better, in our Phase 3 trials.

Whitney Ajam (Analyst)

Got it. Excuse me. All right, that’s helpful. And then this last question is just on timing. I believe you announced completion of enrollment in the study in the beginning of March. Can you just help us understand how quickly after enrollment was that final patient treated, and how long you think it might take to kind of organize, clean up the database, etc., before you can lock it and announce top line?

Mohamed A. Genead (Chief Medical Officer)

I mean, as we stated before, Whitney, we’re ready to do all that. That’s why we’re doing a lot of work behind the scenes. As we announced before, by end of first quarter we’ll be able to announce that top line.

Whitney Ajam (Analyst)

Got it. Okay. Thanks for the question.

OPERATOR

Thank you. I will now turn the call back over to Shankar Musunuri for closing remarks.

Shankar Musunuri (Chairman, CEO & Co-Founder)

Thank you. Thank you for attending another good progressive earnings call today. Thanks to all our shareholders, patients, and all our employees for supporting Ocugen. Thank you.

OPERATOR

Ladies and gentlemen, that concludes today’s call. Thank you all for joining. You may now disconnect.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.