Belite Bio Q2 2025 Earnings Report

Belite Bio EPS Results

• Actual EPS: -$0.50
• Consensus EPS: -$0.47
• Beat/Miss: Missed by -$0.03
• One Year Ago EPS: -$0.31

Belite Bio Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Belite Bio Announcement Details

• Quarter: Q2 2025
• Date: 8/11/2025
• Time: After Market Closes
• Conference Call Date: Monday, August 11, 2025
• Conference Call Time: 4:30PM ET

Belite Bio (NASDAQ:BLTE), Inc, a clinical stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics targeting retinal degenerative eye diseases with unmet medical needs in the United States. The company's lead product candidate is LBS-008 (Tinlarebant), an orally administered once-a-day tablet for maintaining the health and integrity of retinal tissues in autosomal recessive Stargardt disease and geographic atrophy patients. It is also developing LBS-009, an anti-retinol binding protein 4 oral therapy that is in the preclinical development phase targeting liver disease, including non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, and type 2 diabetes. Belite Bio, Inc was founded in 2016 and is based in San Diego, California. Belite Bio, Inc is a subsidiary of Lin Bioscience International Ltd.

Belite Bio Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Tenereband’s Phase 3 Dragon trial interim analysis was completed without changes and remains on track for Q4 2025 completion, with the FDA granting breakthrough therapy designation.
• Neutral Sentiment: The Phase 3 Dragon 2 trial has enrolled 17 of the planned 60 subjects, including ~10 in Japan, to support a future Japanese NDA under its pioneer designation.
• Positive Sentiment: Global enrollment for the geographic atrophy Phase 3 study is now complete at 529 subjects, moving the program closer to key data milestones.
• Positive Sentiment: The company raised $15 million in a registered direct offering and holds $149.2 million in cash and equivalents, providing four years of cash runway to fund all three Phase 3 trials.
• Negative Sentiment: Q2 net loss widened to $16.3 million from $9.5 million year-over-year, driven by higher R&D and G&A expenses—largely non-cash share-based compensation—resulting in an $8.6 million operating cash outflow.

Presentation

[Operator]

Ladies and gentlemen, thank you for joining us and welcome to the BELIET Bio Second Quarter twenty twenty five 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 into today's call, please press 9 to raise your hand and 6 to unmute. I will now hand the call over to Sophie Hunt. Please go ahead.

[Sophie Hunt, Investor Relations at Belite Bio]

Good afternoon, everyone. Thank you for joining us. On the call today are Doctor. Tom Lin, Chairman and CEO of Bileep Bio Doctor. Nathan Mata, Chief Scientific Officer Doctor.

[Sophie Hunt, Investor Relations at Belite Bio]

Hendrik Scholl, Chief Medical Officer and Hao Yun 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. Now I'll turn the call over to Doctor. Lin.

[Tom Lin, Chairman & CEO at Belite Bio]

Thank you for joining today's call to discuss our second quarter twenty twenty five financial results. We have made excellent progress in the quarter towards advancing teneraband in patients living with Stargardt's disease and geographic atrophy. For those who are new to our story, teneraband is a first in class oral therapy intended to reduce the accumulation of toxic vitamin A byproducts, which is implicated in the progression of retinal lesions in patients with Stagler's disease and geographic atrophy. We believe this approach will be effective in slowing or halting lesion growth, which would ultimately preserve vision. To give you some perspective on the importance of this potential therapy, teneriban has been granted breakthrough therapy, rare pediatric disease, and fast track designations in The US and pioneer designation in Japan.

[Tom Lin, Chairman & CEO at Belite Bio]

It has also been granted orphan drug designation in The US, Europe, and Japan. We believe this speaks to the significant unmet need for both indications as currently there is no approved treatment for Stallard's disease and no approved oral treatment for geographic atrophy. As importantly, we are uniquely positioned to address these unmet needs as we are already in global phase three trials for both indications. So with that, let me provide a high level overview of the recent progress we have made. We have two studies underway with Tenereband in patients living with Stargardt's disease.

[Tom Lin, Chairman & CEO at Belite Bio]

These are the phase three Dragon trial and the phase twothree Dragon two trial. As part of the phase three Dragon trial, we were pleased to announce earlier in the year that the Data Safety Monitoring Board had completed its interim analysis and recommended that the trial proceed without a sample size increase or modifications. They also recommended that we submit the data for further regulatory review for drug approval. As a result, the FDA granted Tenarisvan breakthrough therapy designation, and we remain on track to complete the study in Q4 this year. The Dragon two trial also continues to be on track.

[Tom Lin, Chairman & CEO at Belite Bio]

We have enrolled 17 of our targeted enrollment of approximately 60 subjects, including about 10 Japanese subjects. The data from the Japanese subjects is intended to expedite a new drug application in Japan where we have already been granted a pioneer drug designation. In geographic atrophy, I'm pleased to share that we recently completed enrollment of our global phase three study with five twenty nine subjects enrolled. We recently also raised $15,000,000 in gross proceeds in a registered direct offering on August 8. To summarize, we made excellent progress against our key milestones in the first half of the year.

[Tom Lin, Chairman & CEO at Belite Bio]

We are looking to carry this momentum into the second half of the year. Our balance sheet is also strong with four years of cash runway. We remain well positioned to advance Teneriban as potentially the first oral treatment for people living with degenerative retinal disease. I'll now turn over the presentation to Hou Yan. Hou Yan?

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Thank you, Tom. For q two twenty twenty five, we had r and d expenses of 11,000,000 compared to 9,100,000.0 for the same period last year. The increase was mainly due to higher pass through expenses related to the PHOENIX trial and manufacturing expenses, which was partially offset by lower Gradon trial expenses and development milestone payment for the completion of the Phase two trial in 2024. Also, it's due to an increase in share based compensation expenses. Regarding G and A expenses, we had G and A expenses of $6,500,000 compared to $1,400,000 for the same period last year.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

The increase was mainly due to an increase in share based compensation expenses. Overall, we had a net loss of 16,300,000.0 compared to a net loss of 9,500,000.0 for the same period last year. One thing to note is that as the majority of the increase of the expenses came from the share based compensation, which was about 7,600,000.0 and was not cash related. The operating cash outflow was only about 8,600,000.0. As end of Q2, we had $149,200,000 in cash, liquidity fund, time deposit and U.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

S. Treasury bill. We also raised $15,000,000 in gross proceeds in the Regis Direct offering on August 8. We still expect four years of cash runway without considering the commercialization costs and expect to be able to complete all three Phase three trials with our current cash. Thank you. Back to you, operator.

[Operator]

Thank you. We will now begin the question and answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please raise your hand now. Your first question comes from the line of Boris Peaker with Titan Partners. Please go ahead.

[Boris Peaker, Managing Director at Titan Partners]

Can you guys hear me? Just want to confirm the line is live.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Yes. We can

[Boris Peaker, Managing Director at Titan Partners]

hear you. Congratulations on the progress. I guess, my first question is is what is the status of the FDA discussion regarding the interim data that you, from the Dragon trial? Just trying to get a sense if that could potentially be a a trigger for filing VLA. And if it's not, NDA in this case.

[Boris Peaker, Managing Director at Titan Partners]

Sorry. And if it's not, you know, what data would you think you'd need to actually get from Dragon two study? You know, one year follow-up, two year follow ups, how long prior to an NDA filing?

[Tom Lin, Chairman & CEO at Belite Bio]

Thank you. So I I can take this one. So, we've met with the so we filed filed, the breakthrough, based on the IA data. We've met with the f FDA. And, so given the IA criteria was met with all subjects achieved twelve months on study, majorities of subjects have already reached fifteen months.

[Tom Lin, Chairman & CEO at Belite Bio]

So, I mean, we could try for accelerated approval, but that will still require a confirmatory follow-up study. So the FDA recommended that we complete the twenty four month study, which we're about to complete coming up in, September, September, October. And so we will submit that final data, and there will possibly be a single study approval based on the robust statistical significance.

[Boris Peaker, Managing Director at Titan Partners]

Gotcha. So just to confirm, so there could be a possibility just filing on Dragon one and using that as braces and then Dragon two. And when would you actually know that if Dragon one in of itself is sufficient for approval?

[Tom Lin, Chairman & CEO at Belite Bio]

So so, I think based on the FDA's recommendation, that the p value would be robust enough, and we believe that we're on track to meet the criteria.

[Boris Peaker, Managing Director at Titan Partners]

Gotcha. Okay. Appreciate that. Maybe if I could squeeze in just one question on GA.

[Tom Lin, Chairman & CEO at Belite Bio]

Sure. Sure.

[Boris Peaker, Managing Director at Titan Partners]

Now that the PHOENIX trial has completed enrollment, can you discuss if there's gonna be an interim analysis, let's say, you know, a year from now or so or, you know, any other timing around the data readouts?

[Tom Lin, Chairman & CEO at Belite Bio]

Yeah. Sure. So, there will be a IA for, GA. I I think, based on the overall regulatory strategy right now, I don't think I have a time line with me, but it will be some it will be somewhere between, halfway, during the the similar similar to to the to the Stargardt. I just don't have the details, but it will be halfway mark.

[Boris Peaker, Managing Director at Titan Partners]

Gotcha. Well, I appreciate you taking my questions, and, congrats on progress again.

[Tom Lin, Chairman & CEO at Belite Bio]

Thank you so much.

[Operator]

Your next question comes from the line of Bruce Jackson with Benchmark. Please go ahead.

[Bruce Jackson, Equity Research Analyst at The Benchmark Company LLC]

Hi. Thank you for taking my questions. Can you hear me okay?

[Tom Lin, Chairman & CEO at Belite Bio]

Yeah.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Yep.

[Bruce Jackson, Equity Research Analyst at The Benchmark Company LLC]

Okay. Super. So you got the breakthrough therapy designation. And have you discussed with the FDA yet if there's a route to accelerated approval?

[Tom Lin, Chairman & CEO at Belite Bio]

Oh, yeah. Yes. So there there was a route for, accelerated approval, but the FDA, they recommended since that we are we have majority of the patients completing the fifteen months of, time point already, so it will be long to reach the twenty four months. And then, given that the XERO approval will still require a second study, they recommended for a single study I mean, they recommended for a path, single study path, with robust statistical significance.

[Bruce Jackson, Equity Research Analyst at The Benchmark Company LLC]

Okay. And then, my second question is about educating the medical community about about your drugs. So are there any upcoming presentations or data readouts that we can look to near term, not just the completion or the follow-up analysis of the study, anything in on an interim basis?

[Tom Lin, Chairman & CEO at Belite Bio]

Well, I guess that our time line is very tight, that we are expecting. So we we ran the time line with the FDA, and they acknowledge that we'll be submitting around our first quarter first half, sorry, first half of next year. And they want us to be, to remain confidential on revealing any efficacy data. So we were planning on, presenting the eye data at AAO, which is roughly around late October. But given that, we'll be submitting very soon after that, so the FDA would prefer that we stay, confidential on on the data.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Okay. Bruce, I think I can add that. So, once we have the final twenty four month data, we will announce that. But, so you you you wouldn't need wait until the submission to to see the data. But before that, we will not reveal interim data.

[Bruce Jackson, Equity Research Analyst at The Benchmark Company LLC]

Okay. That's it for me. Thank you.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Thank you.

[Operator]

Your next question comes from Jennifer Kim with Cantor. Please go ahead.

[Jennifer Kim, Equity Research Director, BioPharma & Biotech at Cantor Fitzgerald]

Hi, thanks for taking my questions. Can you hear me?

[Tom Lin, Chairman & CEO at Belite Bio]

Yes.

[Jennifer Kim, Equity Research Director, BioPharma & Biotech at Cantor Fitzgerald]

All right, maybe two. To start with Dragon, can you remind us what the exact timing of data will be after the trial finishes in the fourth quarter? And then how and what data will be communicated and what you're hoping to show in terms of efficacy to support filing? Maybe we can start there.

[Tom Lin, Chairman & CEO at Belite Bio]

Nathan, probably best that you have answered this question.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Yeah. I mean, as you know, we're looking at the change of atrophic lesion growth. Right? So lesion growth rate over time, in all in all subjects and all available time points. So we're looking for statistical significance between placebo and and and, treatment in terms of changing the the trajectory of lesion growth. So that's what we expect to show the agency is a statistically significant difference in lesion growth rates, and that is what you need for approval.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

It's the same endpoint that was used in geographic atrophy, to get the two intravitreal drugs approved. So it's basically the same metric.

[Jennifer Kim, Equity Research Director, BioPharma & Biotech at Cantor Fitzgerald]

And then my second, my second question is just for Pfenex. What is the latest dropout rate you've seen to date? Is this still in the twenty percent range? And what can we expect in terms of the depth of data in an interim analysis?

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Well, we're still within our expected range. The the depth of the the interim, we have not finalized the interim design yet, so we'll announce that once we know.

[Jennifer Kim, Equity Research Director, BioPharma & Biotech at Cantor Fitzgerald]

Alright. Thank you.

[Operator]

Your next question comes from the line of Yu Chen with H. C. Wainwright. Please go ahead.

[Yi Chen, MD - Equity Research at H.C. Wainwright & Co., LLC]

Thank you for taking my questions. So for the DRAGON-two trial, what is the current estimate timeline for reaching the target enrollment of 60 patients? Is the current enrollment speed meeting your expectation?

[Tom Lin, Chairman & CEO at Belite Bio]

Yeah. I I can take that question. So, we initially launched Dragon one oh, sorry, Dragon two in Japan, and now we are in process of expanding to in into additional countries, which we expect will accelerate enrollment. We strategically timed the Dragon two not to compete with Dragon one so that we can speed up the completion of Dragon one. And, of course, in the case, if the DSMB recommends further sample size addition, then, that would then slow down, the completion of Dragon one.

[Tom Lin, Chairman & CEO at Belite Bio]

But since that the DSMB that, recommended that we we wouldn't need to add any sample size, so we're kind of speeding up Dragon two. So we kind of purposely staggered, Dragon two to not compete with Dragon one. So, even though it's slower than what we expected, but, that is because of, that Dragon two would compete with Dragon one. So I think we are still on, on time. I think the, expectation of, completing the enrollment probably will take, I would say

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

End of this year.

[Tom Lin, Chairman & CEO at Belite Bio]

Yeah. End of this year. Yeah.

[Yi Chen, MD - Equity Research at H.C. Wainwright & Co., LLC]

Understood. Thank you. And I noticed that your operating expenses continue to rise in the second quarter. Can you talk about the primary drivers for operating expenses and whether the, you know, these kind of level of expensing is sustainable as you approach key clinical milestones later this year?

[Tom Lin, Chairman & CEO at Belite Bio]

Yeah. Sure. Well, first

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

of all, you know, the operating expenses does include majority of the expenses come from the the ship based compensation. So those are not cash related. And is it a little bit hard to really have a have a so called precise forecast about that because they are purely based on evaluation of, you know, the options and the probability of reaching those milestone. Many of our, you know, ESOP is gonna be related for development milestone. So, you know, purely based on the probability.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

So instead of time, you only get those vested as as long as after we reach those milestone. So if you if you remove those, then, the the cash outflow is actually pretty close to the q one twenty twenty five. This year and next year, we do expect to have higher, you know, cash burn given that we do expect to reach several milestone on both through the oh, not both of those. Two all three phase three studies. So this year, next year, we probably expect to have, you know, cash out for around 40 to 45,000,000, for two years, this and next year.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

And then you will dial down a lot starting from, three years from now. So that's why we still expect, four years of cash runway.

[Yi Chen, MD - Equity Research at H.C. Wainwright & Co., LLC]

Got it. Thank you.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Thank you.

[Operator]

A reminder that if you would like to ask a question, please raise your hand now. Your next question comes from the line of Michael Okunowicz with Maxim Group.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Congrats on all the great progress.

[Tom Lin, Chairman & CEO at Belite Bio]

Thank you.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

So I just wanted to follow-up a little bit on the single pivotal design, in particular if, under the current FDA, because there have been a lot of changes over the past several months, if you received any communication, from the current admin that confirms that single pivotal for full approval, perhaps around when you got breakthrough designation.

[Tom Lin, Chairman & CEO at Belite Bio]

I think we have so we met with the FDA after submitting the eye data, which we call breakthrough status. I think the path forward is very clear for us and very straightforward, for a single study. If we met the statistical significance, robust statistical significance that's that is p of less than point o one, then we have a single study, approval path.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Alright. Thank you. And then, just a follow-up. Do do you have a sense of what sort of scale of a commercial force you would need to actually bring this to market just given that you do have four years of runway, and it seems like you're pretty well positioned to reach approval here?

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Well, the current, cash burn that that we forecast for four years cap, runway has not include, the full, skill set of the commercialization cost, which, you know, we are in progress preparing that. So we will build the budget once we confirm.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

All right. Thank you very much for taking my questions. And once again, congrats on all the great progress.

[Tom Lin, Chairman & CEO at Belite Bio]

Thank you very much.

[Operator]

Your next question comes from the line of Mark Goodman with Leerink Partners. Please go ahead.

[Marc Goodman, Senior MD - Neuroscience at Leerink Partners]

Hi. Can you hear me there?

[Tom Lin, Chairman & CEO at Belite Bio]

Yes.

[Hao-Yuan Chuang, CFO & Director at Belite Bio]

Yes.

[Marc Goodman, Senior MD - Neuroscience at Leerink Partners]

Hey, guys. So I guess what I want to know is we get the data released in this press release that you were talking about late this year, early next year. We get good news. How soon after will we be able to file? What are the gating issues between that press release and the filing?

[Marc Goodman, Senior MD - Neuroscience at Leerink Partners]

Specifically, talk about CMC as well as long term safety data.

[Tom Lin, Chairman & CEO at Belite Bio]

So, I I can answer this question. So the first one, long term safety safety data, I think we will need, a data safety data of 300. I believe we've, acquired it. So, So, Hendrik, can you help me help me out on the GA study? We will have enough safety subjects. Right?

[Hendrik Scholl, Chief Medical Officer at Belite Bio]

Exactly, Tom. Right? So the requirement is that we would have 300 subjects that would be twelve months on the drug. And including our our PHOENIX trial, we easily will have that by the first quarter of next year.

[Tom Lin, Chairman & CEO at Belite Bio]

Mhmm. Sorry, Mark. What was your other question?

[Marc Goodman, Senior MD - Neuroscience at Leerink Partners]

So, basically, you could use the safety from both studies, you're saying, to include into that. That's why you're there. And the other one is the CMC.

[Tom Lin, Chairman & CEO at Belite Bio]

Oh, so we have ongoing discussion with the CMC with, the FDA. So, so far, we're on track. And so so it will probably be another discussion with the FDA, before we submit.

[Marc Goodman, Senior MD - Neuroscience at Leerink Partners]

Mhmm. But just remind us where are we on that and just just, you know, where's the whole

[Tom Lin, Chairman & CEO at Belite Bio]

process? On the registration batch that's required for, NDA.

[Marc Goodman, Senior MD - Neuroscience at Leerink Partners]

Right. Okay. Thank you.

[Tom Lin, Chairman & CEO at Belite Bio]

Thanks, Mark.

[Operator]

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

Participants

Executives

• Sophie Hunt, Investor Relations
• Tom Lin, Chairman & CEO
• Hao-Yuan Chuang, CFO & Director
• Hendrik Scholl, Chief Medical Officer

Analysts

• Boris Peaker, Managing Director at Titan Partners
• Bruce Jackson, Equity Research Analyst at The Benchmark Company LLC
• Jennifer Kim, Equity Research Director, BioPharma & Biotech at Cantor Fitzgerald
• Yi Chen, MD - Equity Research at H.C. Wainwright & Co., LLC
• Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group
• Marc Goodman, Senior MD - Neuroscience at Leerink Partners