Ladies and gentlemen, thank you for joining us, and welcome to the Belite Bio Third Quarter 2026 Earnings Call. After today's prepared remarks, we will host a question-and-answer session. If you would like to ask a question, please raise your hand. If you have dialed in to today's call, please press star nine to raise your hand and star six to unmute. I will now hand the conference over to Julie Fallon. Please go ahead.
Good afternoon. Thank you for joining us today. On the call are Dr. Tom Lin, Chairman and CEO of Belite Bio, Dr. Hendrik Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Yuan Chuang, Chief Financial Officer. Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Additionally, today we will be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today. Now I'll turn the call over to Dr. Lin. Dr. Lin?
Thank you, Julie. Good afternoon, everyone. Thank you for joining our third quarter 2026 financial results and corporate update call. This has been a transformative year for Belite Bio, and we are rapidly progressing on the regulatory front as we work to bring tinlarebant to patients. We were very excited to report in August that the FDA accepted our NDA for tinlarebant with priority review and a PDUFA date of February 12, 2027. The FDA has also informed us that it will not convene an advisory committee meeting to discuss the NDA for tinlarebant in Stargardt disease. Since our U.S. NDA submission, we have also submitted a JNDA in Japan under Sakigake designation for accelerated review. If approved, this will be the first Sakigake pharmaceutical product for ophthalmology disease in Japan.
We have also submitted a marketing authorization application to the regulatory authorities in the U.K., Switzerland, and Singapore via the Access Consortium framework. While we will be thoughtful and measured in our international rollout strategy, these regulatory submissions are an important step toward a goal of making tinlarebant available to Stargardt patients worldwide. On another note, we have recently announced that our stock has been uplisted from the Nasdaq Capital Market to the Nasdaq Global Select Market. This is the highest of the three Nasdaq market tiers. The uplisting reflects the company's compliance with the Nasdaq Global Select Market's more stringent financial and liquidity standards, as well as our continued progress in strengthening our financial profile and capital market presence. We are very proud of this achievement as we look to continually drive value for shareholders.
As we make progress on the regulatory front, we are also continuing to build on our commercial plans and working to ensure optimal patient access to tinlarebant by engaging early with payers and pharmacy benefit managers. We have already begun forging these important relationships to help us support broad coverage following potential approval. We look forward to providing further updates as we come down to our PDUFA date, and I am confident in our ability to execute a quick launch and to rapidly begin bringing this medicine to patients. I will now turn the presentation over to Hao-Yuan to discuss the financials. Hao?
Thank you, Tom. We have had a strong year so far and have executed well financially as we prepare for our first potential product launch. Let me recap our financial statements. For the third quarter of 2026, our R&D expenses were $15.5 million compared to $10.3 million in 2025. The increase in R&D expenses in the quarter was primarily attributable to the increase in API manufacturing and DP manufacturing expenses, consulting fees, and sponsorship fundings. On a non-GAAP basis, excluding share-based compensation expenses, R&D expenses in the third quarter was $14.7 million compared to $8 million in 2025. SG&A expenses in Q3 were $21.4 million compared to $12.7 million in 2025. The increase in SG&A expenses in the quarter was primarily attributable to an increase in professional service fee. On a non-GAAP basis, SG&A expenses for the third quarter was $16.3 million compared to $2.1 million in 2025.
GAAP net loss in the third quarter was $30.3 million compared to $21.7 million in 2025. On a non-GAAP basis, excluding share-based compensation, we reported a non-GAAP net loss of $24.3 million for the third quarter compared to $8.8 million in 2025. We ended the quarter with $774 million in cash equivalents, and U.S. Treasury bills, compared to $780 million in Q2 2026. Overall, our balance sheet remains strong, and we are extremely well-funded. Looking ahead, we believe our current cash runway is sufficient to support the potential commercialization of tinlarebant, subject to regulatory approval, and to continue advancing our pipelines. With that, I will now turn the call back to the operator for Q&A. Operator?
Thank you. 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 into today's call, please press star nine to raise your hand and star six to unmute. Please stand by as we compile the Q&A roster. Your first question comes from the line of Maxwell Skor with Morgan Stanley. Your line is open. Please go ahead.
Great. Thank you very much for taking my question. Since PHOENIX enrolled patients with smaller lesions, how do you think about earlier intervention as a way to stand out in the GA market? Thanks.
Thank you. Thanks, Maxwell. Hendrik, I think you are the best person to answer this.
Yeah, I'm happy to take that question. The inclusion criteria of our PHOENIX trial include a range of lesion sizes that would also cover smaller lesions. If we find specifically positive effect on smaller lesions, that would become obvious when the trial results are available. It is correct that targeting bisretinoid accumulation in the RPE could indeed be something that preserves RPE and photoreceptors early on, and could indeed have a very positive treatment effect in earlier disease stages, while geographic atrophy is already a late disease stage of AMD.
Great. Thank you.
Your next question comes from Tazeen Ahmad with Bank of America. Your line is open. Please go ahead.
Can you hear me now?
Yeah. I can hear you.
Hello? Okay, great. Sorry, I'm traveling, and I can't see the screen. Thanks for the update about the AdCom. Making the assumption that it's more likely that the product does get approved on time, looking at a February PDUFA, can you talk to us about what your plans are for submission for ex-U.S. geographies and possible timelines for the first approval in your first country there? For GA, have you had any discussions with FDA on what exactly they would want to see on an interim analysis? Thank you.
First, on the GA, we haven't had much communication with the FDA regarding the GA study. So far, we want to keep the FDA focused on our Stargardt NDA submission. I think that's the most important thing for us right now. In terms of submissions for regulatory authorities worldwide, right now, it's the FDA and then the Japan PMDA, and of course, the U.K., Switzerland, and Singapore consortium. That's the current submission so far. We're planning for others to roll out, but we can only take on so many regulatory reviews. It's a lot of work, and we don't want to take on too much work, as we are still focused on the U.S. FDA, and it's the most important approval.
Yeah, but we definitely recognize there's an urgent need for therapies for Stargardt disease, so we're doing everything we can to try to bring the treatment to the patient worldwide as soon as we can.
If I may add to the interim analysis, at this time, we plan to conduct an interim analysis, but we have not confirmed the design, as we have been focusing on the Stargardt commercial preparedness. We will share more information once we confirm.
Thank you. Your next question comes from the line of Steve Seedhouse with Cantor. Your line is open. Please go ahead.
Great. Thank you. I just wanted to confirm first, because it's a question we get a lot and keep getting. Have you had your mid-cycle review meeting with the FDA, and generally, how do you feel the dialogue with FDA has been going with respect to the tinlarebant review?
Yes. The answer is yes, we had our mid-cycle review already. It has been incredibly smooth so far, but we don't want to over-speculate, and we remain neutral for now.
Okay, great. Thanks. Wanted to ask about Japan. What steps have you taken as a company to prepare for commercialization in Japan, I guess, which could be possible next year? Maybe you could talk a little bit about the Stargardt market in Japan by comparison to the U.S.
Hao, you want to answer this question?
Sure. Yes. We do know that there's about 10,000 Stargardt disease patients by the prevalence rate in Japan. We have built a Japan team that is ready to launch in Japan. There are disease website also launched in Japanese, in Japan. There's some of the disease education activity, pre-approval kind of compliant, that we're working on right now. So yeah, the team is doing the same as what the U.S. team is doing to get the commercialization ready.
On the regulatory part, I think the PMDA, the pace of PMDA is incredibly fast. It has been very smooth so far, but again, we want to remain neutral and don't want to over-speculate.
Very good. Thanks. Then just lastly, I was hoping you could provide an update on if there are plans still this year to start the study in younger children. I think that was intended to start in the U.K. initially, and just wanted to get an update on that study in children under 12.
Yes, of course. Hendrik, you want to give an update?
Yeah, happy to take the question. We needed one extra IRB review that came back positive, I believe four or three weeks ago. So we will definitely start this PIP study, this pediatric study at Moorfields Eye Hospital in this quarter, so before the end of the year.
Great. Thank you so much.
Your next question comes from the line of Marc Goodman with Leerink. Your line is open. Please go ahead. A reminder to unmute yourself locally.
Is that good? So, based on your FDA interactions, what are you expecting the label to look like? Second question is, what do you think right now consensus is for pricing, and how do you think about that? Then third, did I hear you correctly? Japan, the plan is to go it alone in Japan and build an infrastructure there and sell it yourself. Thank you.
Yes. The question regarding Japan, yes, we already built a team. It's a fully functional team in Japan, and we expect to market the drug in Japan ourselves. What's the second question? Sorry.
FDA interactions, what you expect the label to look like.
So far, we haven't had a discussion on the label yet. I think right now, given the questions that were asked from the FDA, everything is still remain on the path that we expect. Again, I can't reveal too much at this moment, but we want to stay neutral. Of course, if there's more information that we could reveal, then we'll do this when we have a better Once the information becomes more clear, then we can discuss this openly.
Right. Just to be clear, your expectation and hope was always that you'd get a broad label from the beginning, right?
At this moment, yes, that is what our expectation is. We do not want to, again, over-speculate too much at this moment.
Yeah. That is fair. Then just-
Maybe, Marc, if I can add here. I mean, this was discussed before, and there is a clear understanding at the FDA that this is a genetically caused disease due to dysfunction of ABCA4 , and that is true for all patients regardless of disease onset or age. It is also true, and this was shown in the ProgStar study, that lesion growth profiles are not dramatically different between adolescent and adult patients. There is also no evidence to suggest that there would be a difference between the two patient populations in treatment response. That is a scientific response, but I think it is important to understand there that disease progression and growth profiles are quite homogeneous across all ages.
Then the other question was just, what is the consensus view right now on pricing out there?
Well, Marc, I cannot say we did a consensus out there for everyone. But we have disclosed that we have done several payers survey, and the payers all seems to be very supportive and recognize the strong unmet need of Stargardt disease . Everybody recognize Stargardt disease is a rare, progressive, vision-threatening disease with no treatment. So, we believe that being a potential first-in-class treatment, we expect the pricing to reflect the rare disease profile, clinical benefit, and the unmet need, and benchmarking with other rare ophthalmology and pediatric orphan therapies. Yeah, we still think that the rare disease pricing is still the guidance that we can provide.
Excellent.
Thank you.
Your next question comes from Whitney Ijem with Canaccord. Your line is open. Please go ahead.
Hey, guys. Thanks for taking the questions. Excuse me. Just first, wanted to go back to some of the patient characterization you did in the U.S. I think you talked about 20,000 patients diagnosed and 50% genetically tested. Of the genetically tested folks, just curious, what percent of those are kind of like actively under the care of an IRD specialist or a retina specialist? I know there had also been some discussion about as patients get more comfortable with their disease, they kind of come in less frequently. So just curious how many are kind of actively in the system. And is there any information you're willing to give at this point about how concentrated they are versus more dispersed, just relative to your kind of initial target docs or centers?
Hendrik, you want to answer this question?
Yeah, happy to take the question. It is complex. To the first question, patients that have been genetically confirmed belong to the subgroup of all patients out there. The U.S. numbers would be roughly 10,000 compared to total population of 53,000, and this represents a more engaged patient population, which was the reason in the beginning why they would undergo genetic confirmation. I think this is important. Out of the 53,000 patients out there, this subgroup would be more readily available because they would typically be under regular care. The second question, how concentrated are these patients? It is still an IRD, an Inherited Retinal Disease. It is still monogenic. It comes through genetic testing. These patients are typically being seen by IRD specialists, but also retinal specialists, not so much by general ophthalmologists, but they would be referred from general ophthalmologists to retinal specialists and/or IRD specialists.
There is a concentration of patients in larger centers, large private practices, and academic centers. Given that the disease is not so rare, there are also other patients out there that would need to be diagnosed and then treated by retinal specialists that are not necessarily in large practices and academic centers. Our market research shows that we can find these patients, and we can provide information to those general ophthalmologists and retinal specialists that do not necessarily work in large centers.
Got it. Excuse me. Very helpful. Do you have similar numbers in terms of Japan, in terms of the diagnosed patients and then percent genetically tested? Thanks.
Yeah.
So, we know-
Yeah, but maybe what we can say about Japan is we have a heavily engaged IRD specialist community. It is a real pleasure to work with those academic centers in Japan. In Japan, the concentration that we just discussed is more significant than in the U.S. Those patients are almost exclusively seen in larger academic centers. And Japanese physicians are very much willing and happy to perform genetic testing on their patients.
Yeah. Japan will be fairly quickly, we believe, to catch up on those testing because they work as a national healthcare system. Once a testing is approved and reimbursed by the government, Japan is relatively concentrated on major hospitals for these kind of testing. And I think currently they have 12, and they are adding that additionally. So, we think that testing rate will easily be covered once the reimbursement by the government is announced, which we know is on the way.
Great. Thank you.
Your next question comes from the line of Graig Suvannavejh with Mizuho. Your line is open. Please go ahead. A reminder to unmute locally.
Hi. Can you hear me okay?
Yeah.
Yeah.
Thank you so much. Thanks for taking my question, and congrats on the progress. I know you had commented on the mid-cycle review. Can you comment maybe on your, if a late-cycle review meeting has happened, and maybe in connection or related to that, can you comment on pre-approval inspection timelines, labeling discussion timelines? Just trying to figure out what is left from your perspective that still needs to be checked in terms of boxes. Thanks.
Yeah. We already have a date for schedule for late-cycle review, but I think that is as much as we can say for now.
Okay, great. Thank you very much. Maybe then just a follow-up on the GA opportunity, which I don't think a lot of investors have given you much credit for just yet. Can you just remind us on the communication strategy around that data readout and timing?
Yes. Right now, all our team that is involved in the NDA submission process, the scientific team, the same scientific team will be the team that is going to coordinate and organize that GA interim analysis. We do not want to take away the bandwidth. We remain that Stargardt study is still the most important, that the Stargardt approval is still the most important milestone for this company. We were only going to get on the GA interim analysis once we have the February PDUFA date completed, and then we can move on to the GA analysis.
Okay. Thank you very much.
Yeah.
We have a follow-up question from Tazeen Ahmad with Bank of America. Your line is open. Please go ahead. Oh, please go ahead. Your line is open, Tazeen. Please go ahead. Your line is open, Tazeen. Can you hear us? All right. This concludes today's call. Thank you for attending. You may now disconnect.