Belite Bio (BLTE) Q4 2025 Earnings Call Transcript

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Date

Monday, March 2, 2026 at 4:30 p.m. ET

Call participants

• Chief Executive Officer — Hao-Yuan Chuang
• Chief Financial Officer — Tom Lin
• Chief Scientific Officer — Nathan Mata
• Chief Medical Officer — Hendrik Scholl

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Takeaways

• Phase III DRAGON trial outcome -- Top-line results announced in December showed Tadaraben reduced the growth rate of atrophy in Stargardt disease by 36% versus placebo, meeting the study's primary efficacy endpoint.
• DRAGON-2 enrollment -- DRAGON-2 study reached 72 enrolled subjects as of February 27, with final enrollment expected between 72 and 75.
• PHOENIX trial completion -- Phase III PHOENIX trial for geographic atrophy completed enrollment with under 30 subjects.
• Public offering proceeds -- Completed a $402 million public offering with over-allotment exercised in the fourth quarter, contributing to year-end liquidity.
• Cash and equivalents -- Ended the year with $772.6 million in cash, cash equivalents, U.S. Treasury bills, and notes, up from $145.2 million at prior year end.
• Quarterly R&D expenses -- Research and development expenses totaled $14.6 million, compared to $7.3 million in the fiscal fourth quarter of 2024 (period ended Dec. 31, 2024); on a non-GAAP basis, $12.2 million versus $5.7 million, mainly due to DRAGON-2 trial, timing of Australian R&D tax incentive, and API manufacturing costs.
• Quarterly SG&A expenses -- Selling, general, and administrative expenses were $13.5 million, up from $4.2 million year over year; on a non-GAAP basis, $4.2 million, up from $1.5 million, primarily driven by share-based compensation and professional service fees related to milestones and commercialization preparation.
• Quarterly net loss -- Reported net loss of $25.3 million, up from $10.1 million, and a non-GAAP net loss of $13.6 million versus $5.9 million for fiscal 2024.
• Full-year R&D spend -- Full-year research and development expenses were $145.4 million, compared to $29.9 million, with a non-GAAP figure of $36.2 million versus $26.2 million, reflecting PHOENIX trial costs, share-based compensation, and API manufacturing, partially offset by prior year's royalty payment.
• Full-year SG&A spend -- Annual SG&A expenses reached $38.9 million, compared to $10.1 million, with non-GAAP SG&A at $9.1 million, up from $4.8 million.
• Annual net loss -- Reported a net loss of $77.6 million for the year, compared to $36.1 million, and a non-GAAP net loss of $38.7 million versus $27.2 million.
• Commercialization budget -- Projected commercialization costs over the next three years are estimated between $100 million and $250 million.
• Pipeline development budget -- Anticipated pipeline and R&D-related activities are projected to require approximately $150 million over the next three years.
• NDA submission -- The NDA submission to the FDA is planned as a rolling submission, targeting Q2, pending finalization of the clinical study report.
• Label expansion strategy -- The company is actively pursuing a broad label for Tadaraben to include all Stargardt disease patients aged 12 and older based on regulator feedback and clinical similarity across age groups.
• Pediatric program initiation -- A two-year pediatric investigational plan with EMA, studying children aged three to eleven, is scheduled to initiate in April.
• Launch timing expectation -- Anticipates U.S. commercial launch of Tadaraben by first quarter 2027, with an initial team of 25 to 30 representatives focused on genetic testing and brand awareness.
• Pricing reference point -- Management noted U.S. rare disease drug pricing averages near $350,000, with the statement that "we ourselves can be doing better than that," while reiterating that it is too early to set a price.
• Ex-U.S. filing prioritization -- Management is prioritizing FDA submission ahead of ex-U.S. filings, with subsequent focus on EMA and Japan, then China and others.
• DRAGON-2's regulatory purpose -- DRAGON-2 trial is intended solely for Japanese regulatory submission, per requirements for local patient data.
• PHOENIX trial interim update -- Interim look for the PHOENIX trial in geographic atrophy is expected in the second half of the year.
• LBS-009 pipeline status -- No additional plans for LBS-009 progression at this time, as all resources are being directed to Tadaraben.

Summary

Belite Bio (NASDAQ:BLTE) reported that the pivotal Phase III DRAGON trial for Tadaraben met its primary efficacy endpoint, reducing the rate of atrophy growth in Stargardt disease patients by 36% compared to placebo. Management confirmed robust cash reserves of $772.6 million, strengthened by a $402 million public offering, positioning the company to fund planned NDA submission, commercialization preparation, and pediatric expansion. The company expects to submit an NDA to the FDA in the second quarter, targeting a U.S. commercial launch by early 2027 and seeking a broad indication for patients aged 12 and older. Key operational focus remains on successful regulatory milestones in the United States, with ex-U.S. submissions to follow.

• Management stated, "we have hired all of the key leadership positions" and are actively building teams across sales, market access, medical affairs, marketing, regulatory, and operations.
• According to the company, large patient databases with genotyped individuals are available at academic centers, facilitating rapid patient identification post-approval.
• The planned pediatric expansion involves a two-year EMA-agreed study in children aged three to eleven, launching in the second quarter.
• Management noted the reliance on definitely decreased autofluorescence as the primary efficacy endpoint, citing its correlation with visual acuity loss in Stargardt disease.

Industry glossary

• Stargardt disease: A rare genetic eye disorder causing progressive vision loss and legal blindness, typically starting in childhood or young adulthood.
• Geographic atrophy (GA): An advanced form of age-related macular degeneration characterized by the degeneration of retinal cells, leading to vision impairment.
• DDAF (definitely decreased autofluorescence): Imaging endpoint measuring areas of retinal atrophy in clinical trials of retinal diseases.
• NDA (new drug application): Regulatory submission seeking U.S. FDA approval to market a new pharmaceutical product.
• API (active pharmaceutical ingredient): The biologically active component of a pharmaceutical drug.

Full Conference Call Transcript

Hao-Yuan Chuang: Thank you for joining today's call to discuss our fourth quarter and full year 2025 financial results. 2025 was a year of significant progress for us as we achieved several key milestones. We look forward to a truly transformative year in 2026, as we position Tadaraben to potentially become the first ever approved therapy for people living with Stargardt disease, a devastating eye disease that usually begins in childhood or young adulthood and leads to progressive vision loss and then legal blindness in almost all cases. Today, I will provide a recap of our 2025 achievements, key milestones for 2026, and financial results.

Starting with 2025 achievements, of course, the most significant achievement was the announcement of our top-line results of the Phase III pivotal DRAGON trial in December. We are very excited to share that the trial met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful 36% reduction in the growth rate of atrophy, measured by definitely decreased autofluorescence by fundus autofluorescence imaging, compared with placebo. These results position us well for engagement with the regulatory authorities as we see a path to commercialization in Stargardt disease. In our DRAGON-2 study, we reached the target number of 60 subjects in January. As of February 27, we have enrolled 72 subjects.

Subjects who had passed screening before the registration closed will still be admitted to the trial. We expect the final number of subjects enrolled to be between 72 and 75. We also completed enrollment in the Phase III PHOENIX trial in GA with under 30 subjects. Finally, we completed a $402 million public offering. Over-allotment was exercised by the underwriter in Q4. Importantly, the net proceeds from this, along with other raises completed in the year, position us extremely well to support commercialization preparation for Stargardt disease, development and expansion of pipelines, and general corporate purposes. Now moving to 2026, as I said, this will be a transformative year for Belite Bio, Inc.

The top priority is our NDA submission to the FDA in 2026. With our NDA submission planned, we have also kicked off our commercialization preparation work for Stargardt disease. I am pleased to share that we have hired all of the key leadership positions. We are now in the process of building our organization in sales, market access, medical affairs, marketing, regulatory, and operations, etc. It is a busy but exciting time for us. We look forward to sharing more as we progress with our launch preparation work. Last but not least, I will now close with a financial recap. For the fourth quarter, R&D expenses were $14.6 million compared to $7.3 million in Q4 2024.

The increase was primarily due to, first, expenses related to the DRAGON-2 trial; second, we received a lower Australian R&D tax incentive in Q4 2025, as such incentive was received in Q3 2025, versus last year, it was received in Q4 2024; and third, API manufacturing expenses. On a non-GAAP basis, which excludes share-based compensation expenses, R&D expenses for the fourth quarter were $12.2 million compared to $5.7 million for the same period in 2024. We believe this non-GAAP basis provides a better picture of operating expenses since our share-based compensation expense is heavily driven by achieving the development milestone, the volatility of our own stock price, and the comparable company stock price used in valuation.

SG&A expenses were $13.5 million compared to $4.2 million in 2024. The increase was primarily due to an increase in share-based compensation expenses and professional service fees, as we achieved development milestones and started to prepare for commercialization and filing. On a non-GAAP basis, SG&A expenses for the fourth quarter were $4.2 million compared to $1.5 million in Q4 2024. Overall, for the fourth quarter, we reported a net loss of $25.3 million compared to $10.1 million in Q4 2024. On a non-GAAP basis, we reported a net loss of $13.6 million for the fourth quarter compared to $5.9 million for Q4 2024.

For the full year, R&D expenses were $145.4 million compared to $29.9 million for the full year 2024. The full-year increase was primarily due to, first, expenses related to the PHOENIX trial; second, share-based compensation expenses; and third, API manufacturing expenses, partially offset by the royalty payment recognized in 2024. On a non-GAAP basis, excluding share-based compensation expenses, R&D expenses for the full year were $36.2 million compared to $26.2 million for the same period in 2024. SG&A expenses were $38.9 million compared to $10.1 million in 2024. The increase was primarily due to an increase in share-based compensation expenses and professional service fees, as we achieved development milestones and started to prepare for filing and commercialization.

On a non-GAAP basis, SG&A expenses for the full year were $9.1 million compared to $4.8 million in 2024. For the full year, we reported a net loss of $77.6 million compared to a net loss of $36.1 million in 2024. On a non-GAAP basis, net loss was $38.7 million compared to a non-GAAP net loss of $27.2 million in 2024. Moving to the balance sheet, as I said, we had a successful year of fundraising through an underwritten offering, two registered direct offerings, and a significant PIPE. We are very grateful to our shareholders for their strong support. As a result, we closed the year with $772.6 million in cash, cash equivalents, U.S.

Treasury bills and notes, as compared with $145.2 million at year-end 2024. Our balance sheet remains strong. We are well positioned to deliver our near- and long-term objectives, including the commercial launch for Stargardt disease. With that, I will turn the call back to the operator for Q&A.

Operator: We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. If you have dialed in to today's call, please press 9 to raise your hand and 6 to unmute. Your first question comes from the line of Judah Frommer with Morgan Stanley. Your line is open. Please go ahead.

Judah Frommer: Hi, guys. Thanks for the update. Just a couple questions for us. I guess on the NDA submission, are you still thinking about that being a rolling submission? And what role would DRAGON-2 play within that submission process? I would maybe in the U.S., and other geographies as well. And then I guess just given the cash balance that you have amassed here, can you help us with the uses of cash between getting through the remaining Stargardt trials, getting through GA, commercialization, and anything else we should be thinking about. Thank you.

Tom Lin: Okay. I will answer the first question regarding the NDA. So it will be a rolling submission. We are on track. We are expecting the CSR to finalize this month for the NDA submission in Q2. And once that is finalized, we are ready to submit pretty soon. What is the next question? The DRAGON-2. Yes. So the DRAGON-2 will be for Japan only because the Japanese authorities would like to see the data on Japanese patients. So that is strictly for Japan only. And the commercialization and the budget, I think it was the other question. I will refer that to Hao. Hao? Yep.

Hao-Yuan Chuang: So for the next three years, we expect the existing pipeline, including the NDA submission and those, what we call R&D-related activities, will cost us about $150 million. And for the commercialization itself for the next three years, it is probably somewhere between $100 million to $250 million.

Judah Frommer: Great. Thank you.

Operator: Your next question comes from the line of Tazeen Ahmad with Bank of America. Your line is open. Please go ahead.

Tazeen Ahmad: Okay, great. Good afternoon. Thanks for taking my questions. Can you just give us a little bit of guidance on how we should be thinking about pricing? Given the profile of the drug and given the unmet need, we would be curious to maybe get a sense of a range of what would be appropriate to be considering here. And then can you just remind us what are the key gating items left before you submit the NDA in the second quarter? Thank you.

Tom Lin: Hao, you want to take this one as well?

Hao-Yuan Chuang: Sure. Well, for the pricing, apparently, it is still early for us to set a price. But I think we have been seeing that the average rare disease drug pricing in the U.S. being somewhere about $350,000. And we do think it is fair to say that we ourselves can be doing better than that. But it is still early to really set a price.

Tazeen Ahmad: So what was the other question? Yeah. What are the gating factors left before you submit for approval in February?

Tom Lin: I guess we have everything ready. So we are just waiting for the clinical study report. So as we speak, we are on track.

Tazeen Ahmad: Okay. Great. Thank you.

Operator: Your next question comes from the line of Marc Goodman with Leerink. Your line is open. Please go ahead. Marc, as a reminder, kindly unmute yourself by pressing star 6.

Operator: Moving on.

Operator: Your next question comes from the line of Timur Ivanikov with Cantor. Your line is open. Please go ahead.

Timur Ivanikov: Yes. Thank you. This is Timur Ivanikov on for Steve Seedhouse. So our question is about the timing of your potential launch. So assuming you have an NDA filing in the second quarter, do you have initial expectations on the launch timing? And then I think you were talking about maybe 25 field reps. But how quickly after the approval do you think you can launch, and how do you assess the difficulty of this launch maybe to other rare diseases or other retinal diseases? Thank you.

Tom Lin: Hao, you want to take this one as well?

Hao-Yuan Chuang: Sure. Sure. Well, we expect we probably will launch by Q1 2027. The sales team, as you said, we expect that we have probably a team more focused on genetic testing, which will be one of the key factors to get the patient confirmed. The second team will be more about the drug, about the brand. So total somewhere like 25 to 30, we think it is a fair assumption at launch. Potentially, after two years of launch, you may expand that team further as you want to get to every corner in the U.S. So I think being able to launch by Q1 2027 is our goal.

And to your question about the challenges, we think compared with other diseases, given there is no treatment for Stargardt disease, this should be a fairly straightforward drug. The difficulty will really be in getting patients, getting the physicians to be aware that this treatment is available, and then shorten the time it takes for people to get the genetic testing done and get their insurance coverage. I think these will be the few execution tasks that we will be focused on, but I would not see those as challenges for us.

Tom Lin: So, Hao, maybe we could get Hendrik to also add more color to this question given that he is a prescriber himself. He looks after these Stargardt patients and he knows the whole clinical landscape very well. So, Hendrik, do you want to add anything, any details?

Hendrik Scholl: Yeah. Thank you, Tom, but I would like to confirm what Hao just pointed out. There is—it is a fact that many patients are lined up in large databases. Many suspected patients, it includes genetic testing to make the diagnosis, are being seen in large centers, including large academic centers, and such centers typically have databases of patients where they also include the genotype of these patients. So these patients, therefore, are immediately available because they are known to the centers, and patients can be contacted by treating physicians if the patient him or herself would not seek clinical care immediately.

So I believe, because this is a monogenic disease, there is an extra opportunity to get to patients very quickly.

Timur Ivanikov: Okay. Thank you very much.

Operator: Your next question comes from the line of Marc Goodman with Leerink. Your line is open. Please go ahead.

Marc Goodman: Yes. Sorry about the confusion, guys. Can you talk about your filing plans OUS? And then secondly, what are your latest thoughts on the timing of an interim look for the GA work you are doing? Thanks.

Tom Lin: Thanks, Marc. So you are saying the timing of ex-U.S. and the submissions or the U.S. alone?

Marc Goodman: Yes. OUS. Exactly. Ex-U.S.

Tom Lin: Oh, ex-U.S. Right. Okay. So we want to set the priority over the FDA or U.S. We want to pool resources to make sure that we are successful with the NDA in the U.S. So everything outside of the U.S. will build onto that. And this requires discussions with the regulatory authorities in different regions to see what type of timing they are expecting. So this will be an update as to which regions we will prioritize after the U.S. We are in constant communications with the EMA, the PMDA, and other authorities as well. So we want to keep all the bandwidth on the U.S. FDA, given that we expect there will be a lot of questions.

So we do not want to dilute our resources at this point by spreading it out and then submitting in too many regions.

Tom Lin: What was the other one?

Marc Goodman: The interim look for the geographic atrophy. Just curious what your latest thoughts are.

Tom Lin: Yeah. So, right now, we are probably expecting that would be somewhere in the second half of the year. We have not actually looked at it yet because we are prioritizing everything on launching Tadaraben for Stargardt. So we will have a further update for that probably next quarter.

Marc Goodman: Thanks.

Operator: Your next question comes from the line of Yi Chen with H.C. Wainwright.

Eduardo: Hi. This is Eduardo on for Yi. Just following up on the geographic atrophy trial, do you have any idea of what level of lesion growth inhibition you are targeting to consider that trial a success in that broad population? And then also if you had any comments on capital allocation for the LBS-009 and how you prioritize that and when you expect to maybe move into a phase 1 study and if you have any details on specific liver indication as a primary lead.

Tom Lin: So I will get Hendrik to answer on the GA one. I will start with the 009. Right now, there are no plans for 009 yet. So, again, we are prioritizing everything on Tadaraben and being a successful launch in the U.S. first. All the others will follow and will be prioritized after that.

Hendrik Scholl: And I am—and I am happy—Thank you, Tom. I am very happy to take the question on what is the threshold that would make the treatment of GA a success with our oral compound. When you think about OAKS, DERBY, and GATHER2, the injectables—so, avacincaptad pegol—they found efficacy signals of 13%, 21%, and 14% in their registration trials. Given that these are injectables that need to be injected essentially monthly for the rest of the life of patients affected by GA, we feel that if we reach that threshold, then it is already a success. Having said that, we are more ambitious.

Given what we found in Stargardt disease—36%—we feel that reaching 13%, 21%, 14%—so roughly something between 15% and 20%—should absolutely be possible, and we would like to go beyond that. But, again, since our compound is an oral compound, if we reach the same threshold, we will be the standard of care because it will be a very hard sell for patients to tell them to come in for injections every month if there is an oral treatment.

Eduardo: Got it. Thanks so much for taking the questions.

Operator: Your next question comes from the line of Boris Peaker with Titan. Your line is open. Please go ahead.

Boris Peaker: Great. Thank you very much for taking my question and congrats on the progress. I guess maybe we will start with Stargardt. Do you anticipate the label to become a broad Stargardt label for all patients? Or would it, you think, potentially be restricted to patients ages 12 to 20, similar to the pivotal study?

Tom Lin: I will refer this to Nathan and, of course, Hendrik to add more details as well. Nathan? Yeah.

Nathan Mata: Here, the CSO. So we have had that discussion with FDA and we have made the argument that basically it is the same disease, whether it is affecting children or adults. And they concurred. There is no evidence to suggest that these patient populations would be any different. Of course, Hendrik notes from the ProgStar data that the lesion growth profiles are not dramatically different between children and adults. So yes, we will be pressing for the full label for subjects 12 and older because, again, it is the same disease, same genetic sort of dysfunction that leads to the dysfunction of the same protein. So, again, spectrum of the same disease across different populations.

Hendrik Scholl: No. I just wanted to add that it is all about the generalizability of the data. Right? And there has rarely been such an easy case to convince the regulator this is the same disease. And we included adult subjects, 18 to 20 years, but we also included adolescents, as you know. Right? But if there is a patient affected at age 22, 28, 32, with biallelic mutations in ABCA4, why would that be considered a different disease? Why would somebody believe there would be no efficacy if you treat later? Because, and Nathan pointed it out, the ProgStar study has shown that progression rates amongst different age groups—12 to 18, 18 to 50, and beyond 50—were essentially similar.

Boris Peaker: Got it. And just another follow-up on Stargardt. Now I understand your initial emphasis is obviously going to be on the U.S. market. But I am just curious, for the ex-U.S. opportunity, how important is visual acuity, I guess, for approval and potentially for just reimbursement and justifying pricing?

Tom Lin: Hendrik, you want to take this as well?

Hendrik Scholl: Certainly. I mean, to be clear, visual acuity is important for every regulator. Right? It is just how realistic is it that any given trial in Stargardt disease would find a visual acuity efficacy signal. Right? When you look at the ProgStar data, an average visual acuity loss of 0.55 letters per year, but life expectancy of 60 to 80 years after the first diagnosis, that means that it is simply impossible, even if you have a treatment that arrests the progression, to find an efficacy signal when visual acuity is the primary outcome measure.

If you arrest progression and the progression is 1.1 letters in two years, that would be the difference that you would target, but everybody knows that there is a 15-letter threshold set by the FDA to be clinically meaningful. And the intersession variability of visual acuity measurements in a population of macular degeneration patients, such as Stargardt, is eight letters. So meaning that visual acuity as outcome measure is an unrealistic target. But DDAF, which is our primary endpoint, has been shown in cross-sectional correlations in the ProgStar study to be highly significantly correlated with visual acuity loss. It just means that you have to treat for a while until eventually you will see a visual acuity benefit.

Boris Peaker: Got it. Thank you very much for taking my questions.

Operator: As a reminder, if you would like to ask a question, please raise your hand now. If you have dialed into today's call, please press 9 to raise your hand and star 6 to unmute. Your next question comes from the line of Bruce Jackson with Benchmark. Your line is open. Please go ahead.

Bruce Jackson: Hi. Good afternoon. So in terms of the commercialization strategy in the United States, you have chosen to go direct. Have you given any thought to what your international commercialization strategy might look like?

Tom Lin: Yeah. Of course. So right now, we are open—we are pretty flexible—that we do have multinational pharmaceutical companies wanting to partner or license. Right now, that is still open, but we believe right now our regulatory submission pathway is pretty straightforward for all regulatory authorities. So we believe we can add more value at least starting from the FDA. Once we get the approval, we will see how it goes in other regions. But we believe that we have a very straightforward approval path for all other regions as well. So it depends on what kind of reasonable deals or deals that we think would be a good partnership after the FDA. After we get an FDA approval.

Bruce Jackson: Okay. Great. And then if I could just get a follow-up on the ex-U.S. regulatory strategy. You have got quite a bit going on this year. Do you intend to seek further approvals in Europe, and when might those get submitted? And that is a—

Tom Lin: Yes. Of course. So the FDA being top of our priority, and then second, I would say the EMA. And probably next to it would be Japan as well, and then followed by China and all other regions.

Bruce Jackson: Got it. Thank you.

Operator: Your final question will be from the line of Michael Okunewitch with Maxim. Your line is open. Please go ahead.

Michael Okunewitch: Hey there. Thanks for taking my questions today and congrats on all the great progress. I guess I would like to see if you could help me understand just how well understood the true prevalence of Stargardt disease is, given there have been no approved therapies. Do you expect that having something available could help build awareness and uncover additional undiagnosed patients?

Tom Lin: Hendrik, can we field this question to you?

Hendrik Scholl: Yeah. I am happy to answer the question. So the answer is absolutely. Absolutely. If there is a treatment—and we have seen that about a decade ago for patients affected by biallelic mutations in RPE65 to be treated with LUX-2, another first gene therapy for that condition—absolutely led to a whole wave of patients that had been undiagnosed before to be diagnosed. And that includes a proper diagnosis clinically and genetic testing. In Stargardt disease, the symptoms are more straightforward than in RPE65. It is a much more diffuse disease affecting night vision in the periphery. In Stargardt disease, central vision is affected. Patients seek clinical care, but we will need a genetic diagnosis in order to treat patients.

What is the true prevalence of Stargardt disease? In the past, for rare diseases, it was very difficult to find out what the actual prevalence is. It is only known in the Blue Mountain Eye Study and Rotterdam Eye Study what the prevalent eye diseases are, but there is a new opportunity since about a decade or so to study genetic databases, knowing about the mutations in the target gene and the penetrance rate, and this allows us to estimate—taking into account the race mix in the United States—that we need to consider about 53,000 patients being affected by ABCA4-mutated retinal disease, including Stargardt disease.

So I think that it is a realistic number now, which is firmly based on genetic databases that are available for populations of European descent, East Asian descent, and African descent.

Tom Lin: Nathan, I believe you have published on this a few times. Anything you want to add?

Nathan Mata: No. No. I think Hendrik covered it very nicely. Yes. We did publish a review article recently, capping the prevalence of Stargardt disease, looking at it geographically across the world. And you can really look for that paper. It is published under my name and Hendrik’s name, just recently. But, yeah, so 53,000 in the United States and ex-U.S., of course, more than that globally. So, again, the genetics really tell us what the prevalences are, and that is what the data are based upon in terms of the publication that we recently submitted that recently got accepted. Thank you.

Michael Okunewitch: Thank you. And then just one more as a follow-up, if you do not mind. I wanted to see—do you expect that there would be any value in looking into patients younger than 12 years old? And are there any plans for this expansion?

Nathan Mata: So definitely. Yeah. Let me just take that real quick. So we do have an approved pediatric investigational plan with EMA, which we plan to initiate in April of this year. So that is coming up very soon. That is a two-year study, looking at safety and efficacy in children three to eleven years of age. We will have to wait to see what the safety and efficacy data look like at the end of the two-year study. But, certainly, we do have plans to establish safety and efficacy in patients younger than 12.

Tom Lin: And, Hendrik, I believe that you answered the same question as well at one of the medical conferences just a month ago.

Hendrik Scholl: Indeed. And we feel that although in DRAGON patients already had significantly lost vision on average, we feel that patients before losing significant vision will strongly benefit from Tadaraben treatment, and that would typically be relatively young patients. So we feel that we absolutely must expand into the pediatric population. And as Nathan pointed out, it will be based on our findings in our pediatric study that we will start in the second quarter of this year.

Michael Okunewitch: Thank you very much.

Operator: There are no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.

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