Belite Bio (BLTE) Q2 2026 earnings call transcript

I will now hand the conference over to Julie Fallon. Please go ahead. Thank you for joining us on the call today or Dr. Tom Lin, Chairman and CEO of Belight Bios, Dr. Hendrick Scholl, Chief Medical Officer, Dr. Nathan Marra, Chief Scientific Officer, and Hao Young, 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-GAP financial measures, reconciliations to the most directly comparable GAP measures are provided in the press release we issued today.

And now I'll turn the call over to Dr. Lin. Dr. Lin.

Thank you, Julie. Good afternoon, everyone. Thank you for joining our second quarter twenty twenty six financial results and corporate update call. The first half of this year has been both exciting and deeply productive for Belight Bios. As we rapidly approach a potential regulatory approval of Teletra Band for Stagas Disease in the U. S. , we are very pleased to announce that the FDA has accepted our new drug application for Teletra Band with priority review and establishing a productive date of February 12, 2027. We believe this reflects the strength, consistency, and depth of clinical data generated across our development program. In parallel, with our pre-commercial preparations, we remain highly engaged with the medical and patient communities.

The enthusiasm we are seeing underscores the profound need for a new treatment paradigm in Stagas Disease. This quarter represented our Phase III drug and study results at four medical conferences across four countries, including the recent American Society of Right on Specialist, ASIS, annual meeting. At ASIS, we presented new secondary endpoint data demonstrating subject treated with Teletra Band showed a halt to slightly decrease QAF values, decreased by approximately two percent at month 25 compared to baseline. In contrast, subjects in the placebo group exhibited an approximately 20 percent increase in QAF values over the same period. Quantitated Autofarescence, or QAF, is a marker of toxic breast retinoid accumulation, a key driver of retinal degeneration in Stagas Disease.

The prevention or reduction of QAF strongly aligns with Teletra Band's mechanism of action, reinforcing its potential to halt or slow lesion growth. Looking ahead, we remain confident in our data, our science and the transformative potential of Teletra Band for patients living with Stagas Disease. We look forward to providing further updates as they become available. I'll now turn the presentation over to Howie and to discuss the financials. How?

Thank you, Tom. We have had a strong first half of the year and continue to execute well against our plan. Let me recap our financial statements. For the second quarter of 2026, our R&D expenses were 18.2 million compared to 11 million for the same period in 2025. The increase was primarily due to a royalty payment for additional milestone achieved under the license agreement. On a non-gapped basis, excluding share-based compensation expenses, R&D expenses for the second quarter were 17.2 million compared to 8.6 million in the second quarter of 2025.

As GNA expenses in Q2 was 16.7 million compared to 6.5 million for the same period in 2025. The increase was primarily due to increase in professional service fee, wages and salary resulting from our team expansions. On a non-gapped basis, SGN expenses for the second quarter were 10.9 million compared to 1.3 million in 2025 second quarter. The gap net loss in the second quarter was 28.4 million compared to 16.3 million in the same quarter in 2025. On a non-gapped basis, we report a net loss of 21.6 million for the second quarter, compared to 8.7 million in 2025, same quarter. We ended the quarter with 780 million in cash, cash equivalents and U. S. treasury bills. Overall, our balance sheet remained very strong, and we are extremely well funded into the future with a cash runway to commercialize scenario ban following a potential regulatory approval and to continue to advance our pipelines.

With that, I'll turn the call back to the operator for Q&A.

Thank you. Thanks. Good questions. For the Dragon 2, I think at this stage, it's still pretty much a Japan study for the PMDA. Right now, we don't think we don't believe that the Dragon 2 will contribute to the NDA process.

As for the pediatric study, we do have plans and I'll let Hendrik shed more light on the details of that study.

Yeah, happy to. Thank you, Tom. So to that, we are initiating a PIP study, a pediatric study in London, where we will investigate Tim Larabant in patients of the age 3 to 11. And this will be the basis to inform regulatory processes for patients that are younger than 12 years old. Thanks.

How do you want to take this given that they'd see your royalty payments?

Yeah. Well, the first one is related to the completion of the phase three study. And I think I can also take the third question. As we said on the press release, we do plan to host commercial day events, going to be virtual in September. And we'll disclose about the numbers that we have surveyed about the question you just asked. How much was the royalty payment?

No, we cannot disclose that Columbia has to keep that as a confidential. But it's related to the phase three completion.

And then just thoughts on European filing? Okay, so I can take that. So right now we are focused on the FDA with the producer date in February 12. So that's our top priority. We will be highly focused in the next six months on getting the drug approved. So the European filing will probably be sometime after the FDA approval. We want to align everything with the FDA approval and all that. And there will be a consistent message and communications with the regulatory authorities outside of the U. S. Given what we discuss with the FDA and the approval. And then there will be a strategy for ongoing regulatory filings.

There's a few questions there. So I'll answer the first one. And then I probably have to get you to repeat the last two, three two, three, privilege to to review it right now. The names of the CDMOs, but these are all big names in the field in the industry. So we have a XUS and then a U. S. based CDMO for that. So I hope that answers your question. What's the second and third question?

It was more about the FDA. And given the consolidated timeline for review, what is your thought about having an outcome? Has the agency talked about that? And realistically, when is the latest? They could tell you if they were going to give you an outcome. So right now, we don't believe there is an outcome being planned. But that doesn't mean that, you know, further down the line, the FDA would want to use an outcome. So nothing on that right now.

So I would say that once we have more updates further down the line, then we'll probably rebuild that update that by the more appropriate time. But at this stage, we just receive the acceptance. So we don't have any further details on that.

How you want to do expect that if we receive approval, we should get the priority review voucher, just because we do have the rare pediatric disease designation. We have not decided whether we're going to sell it or we're going to use it. So we will confirm that later. What we wanted to monitor the market and our pipeline, et cetera.

Sure, I can answer this question. But is another question regarding the cash runway?

I was just interested in the PDF voucher for our own modeling purposes, but how you want to answer it? Thank you.

All right, thanks. So the GA interim analysis falls during the busiest time with interacting with the FDA. So with the producer date in mid-February, I would expect the busiest time to be in December and January, 2027.

So with that time, our top priority is with the FDA approval. So I suspect that not with the interim analysis for the GA will probably sometime first call the next year, probably after February.

Is that correct? So right now, there's haven't been any discussion on the label yet. I believe there will become some time later in the process, in the review process. But at the stage, given the data and all that, we expect that we would be able to get the full label or the more broader label. I'll ask Hendrick who gives more expert advice on this.

Hendrick? Yeah, I'm happy to. And I think it's important to understand that lesion growth is not dramatically different across different age groups. That was shown in the Proxis study. We have essentially the same progression rate of patients any age underneath 18 and 18 to 50 and patients 50 plus, sure, the slightly larger, but still similar progression rate when we look at DDAF progression. Given that the underlying cause of the disease, namely, ABCF4 dysfunction is exactly the same. I would see no reason why the label would not include patients older than 20. But I think it's important that we do not really want to comment on potential label via the NDAF on the review.

Nathan, do you want to answer this question? I'm sorry, could you repeat the question?

Sorry, I'm making my audio. 4% of your patients have been compliant with the dosing regimen after 24 months.

Japan will concurrently happening at the same time. So, given the Sagi Gake designation, it will probably be around three months after FDA approval. They want to approve the drug in Japan. So, it's happening as we speak with the FDS submission, and the PMD submission is in parallel.