Belite Bio, Inc (BLTE) Earnings Call Transcript & Summary

We appreciate everyone being with us; participating in today's call are Belite Bio's Chairman and Chief Executive Officer, Dr. Tom Lin; our Chief Medical Officer, Dr. Hendrik Scholl; Dr. Nathan L. Mata, who serves as Chief Scientific Officer; and Chief Financial Officer Hao-Yuan Chuang. Prior to getting started, please note that forward looking statements will be made, which rest on what we currently expect and believe. Such statements carry certain risks and uncertainties, and outcomes could actually turn out materially different. We suggest you review the risk factors described in our SEC filings for more information. In addition, certain non GAAP financial measures will be covered on this call. You can find reconciliations to the most directly comparable GAAP measures in the press release issued today. I'll now hand the call over to Dr. Lin. Dr. Lin?

Thanks, Julie. Hello, everyone, and good afternoon. We appreciate you being on this call covering our financial results for the second quarter of 26 along with a corporate update. For Belite Bio, the opening half of this year has been equally thrilling and extremely productive. We're moving quickly toward what could be a regulatory green light for tinlarebant in the US for Stargardt disease. It's our great pleasure to share that the FDA has accepted our new drug application for tinlarebant under priority review. A PDUFA date of 02/12/2027 has been set. In our view, this speaks to how strong, consistent, and deep the clinical data is that we've produced throughout our development program. While we continue our precommercial work, we're also staying very involved with the medical community and patients. The excitement we're encountering highlights just how great the need is for a fresh treatment paradigm in Stargardt disease. During this quarter, we shared the results of our Phase 3 Dragon study at 4 medical conferences in 4 countries. That includes the latest American Society of Retinal Specialists, ASRS, annual. At ASRS, we shared new secondary endpoint data showing subjects who received tinlarebant experienced a halt to QAF values that had declined slightly, dropping by roughly 2%. This was at month 25 against baseline. By comparison, subjects given placebo showed roughly a 20% rise in QAF values across that same span. Quantitative autofluorescence, or QAF, serves as a marker for toxic bisretinoid accumulation. It's a major force behind retinal degeneration in Stargardt disease. Preventing or lowering QAF lines up closely with how tinlarebant works. That strengthens the case for its ability to stop or slow lesion growth. Going forward, we have confidence in our data. Our science, and what tinlarebant could transform for patients dealing with Stargardt's disease; we're eager to give more updates whenever they're ready. I'll hand the presentation now to Hao-Yuan for the financial discussion. Hao-Yuan?

Thank you, Tom. It's been a solid opening six months, and we're still carrying out our strategy effectively. Now let me walk through the numbers; during Q2 of 26, our research and development costs came to $18.2 million, versus $11 million across the equivalent stretch of 2025. That rise largely reflected a royalty payment tied to a further milestone reached through the license agreement. On a non GAAP basis, once share based compensation expenses are excluded, R and D expense for Q2 totaled $17.2 million, against $8.6 million in the second quarter 25. SG&A costs during Q2 reached $16.7 million, versus $6.5 million across the matching period in 2025. That growth mostly came from higher professional service fee wages, plus salary, driven by our team expansions. Measured on a non GAAP basis, SG&A expense during the second quarter came in at $10.9 million, against $1.3 million in 25 second quarter. Our GAAP net loss during the second quarter was $28.4 million, versus $16.3 million in that same quarter; in 2025. On a non GAAP basis, we posted a net loss of $21.6 million during the second quarter, versus $8.7 million in 2025 same quarter. We closed out the quarter holding $780 million in cash, cash equivalents and U. S. Treasury bills. All told, our balance sheet stayed very strong; and we are extremely well funded into the future, with a cash runway to commercialize tinlarebant following a potential regulatory approval and to keep advancing our pipelines. With that, I'll hand the call back to the operator for Q&A. Operator?

Yeah. Hello, everyone. Nice work on the advancement, and I appreciate you fielding our questions. We have a couple. Now that the NDA has been accepted, I suppose, how do you view the part Dragon 2 might play for the US filing or, and or, the regulatory pathway? Is there any extra FDA dialogue that could clarify what that trial might potentially be used for in the US? And then, what's the current thinking about moving to younger ages, into peds, for tinlarebant? Are there trial plans to extend the label under 12 years old soon? Thank you.

Thanks. Good questions. Regarding Dragon 2, I think at this point, it remains largely a Japan study for the PMDA. At present, we don't think, we don't believe that, you know, Dragon 2 will add to the NDA process. On the pediatric study, we do have plans, and I'll let Hendrik provide more detail on that study.

Absolutely. Thanks for asking, Tom. So yes, we're kicking off a PIP study — that's a pediatric trial based in London — where tinlarebant is going to be examined in patients between the ages of 3 and 11. That will serve as the foundation for informing regulatory pathways for patients below 12 years of age. Appreciate it.

Okay, hello. Would you be able to share the size of that royalty payment — the one-time item sitting inside R&D? Then for my second question, please walk us through your thinking regarding the European filing. And third, has any claims database analysis been carried out to determine, precisely, how many patients in the United States actually appear, you know, within the claims database. Thank you.

Hao-Yuan, since it involves zero royalty payments, would you like to handle this?

Yeah. So the first one has to do with wrapping up that Phase 3 trial; and I believe I can handle the third question as well. As we mentioned in the press release, we intend to hold a commercial day event. It'll be virtual. In September, and we'd share the figures we have, you know, from the survey regarding what you just asked.

What was the amount paid in royalties?

No, that's not something we can share. Columbia has requested that we treat it as confidential. But yes, it does tie back to the completion of phase 3. Okay.

And what about the filing in Europe — any thoughts there?

Alright, that one's mine to answer. At this moment, our attention is on the FDA, with a PDUFA date of February 12. That's the number one item for us. Over the next 6 months, we will likely be putting a great deal of focus on securing approval for the drug. As a result, the European filing will most likely happen at some point following the FDA's approval. Our aim is to have everything lined up with the FDA — the approval and all of that — and there will be a consistent message, along with communications, toward the regulatory authorities beyond the US. That comes out of what we talked about with the FDA and the approval. After that, we'll have our plan for regulatory filings that continue. Thanks.

A couple of things from me. On the manufacturing side, have you said yet where the manufacturing site is located, and has that facility been through an FDA inspection lately, or will that end up being one of the requirements for approval? Then second, I'd like to hear your current thinking on whether an AdCom might happen, given the combined amount of time the FDA would need for its review. Realistically, when is the latest you figure you'd be informed if the agency chose to convene 1? Thanks.

That's several questions in there. Let me take the first 1, and then I'll need you to go over the last 2 or 3 questions again. On that first 1, we do have a CDMO located in the US. All of these — we aren't free to disclose the CDMO names at this point, but every one of them is a major name in this field, in the industry. So for that we have an ex-US CDMO plus a CDMO based in the US. I hope that addresses what you asked. What were the second and third questions?

The focus was really on the FDA side of things. With the review clock now consolidated, how are you thinking about the possibility of an AdCom? Has there been any discussion with the agency on that front? And practically speaking, how late could they inform you that an AdCom was going to happen?

At this moment, our understanding is that no AdCom is in the works, though that doesn't rule out the FDA deciding to convene one at some later point; so as of now, there's nothing to report on that. I'd say that when additional developments come through down the road, we'll likely share them and provide an update at a point when it's more suitable. But as things stand, we've only just gotten the acceptance, so we don't have anything more to share on that. Okay. Thanks.