Belite Bio, Inc

Ladies and gentlemen, thank you for joining us and welcome to the Be Light Bio third quarter 2025 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 star nine to raise your hand and star six to unmute. I will now hand the call over to Julie Fallon. Please go ahead.

Good afternoon, everyone. Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of Be Light Bio, Dr. Hendrik Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Wan Xiong, 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. And now I'll turn the call over to Dr. Lin. Dr. Lin?

Thank you for joining today's call to discuss our third quarter 2025 financial results. I'd like to start immediately by highlighting our recent progress. For GA, we completed the enrollment of the Phase 3 Phoenix trial with 530 subjects. For Stargus disease, we have completed the Phase 3 Dragon trial, and we now look forward to reporting the final top-line data by end of this month. The Dragon 2 trial have enrolled approximately 35 subjects of our targeted enrollment of approximately 60 subjects, including 10 Japanese subjects. The data from the Japanese subjects is intended to expedite a new drug application in Japan. We have been in close communications with Japan's PMDA and Sakigake designated concierge to ensure that our JNDA is submitted as one of the first countries for market authorization. We also recently received positive feedback from regulatory authorities. Specifically, China's NMPA agreed to accept NDA for priority review based on the interim analysis results from the Phase 3 Dragon trial. Additionally, the UK's MHRA agreed to accept conditional marketing authorization application also based on Dragon's interim analysis results. With the consistent feedback from major regulatory agencies across the world, We are encouraged that the Dragon trial provides a strong foundation for global submissions and potential approvals. Lastly, we have completed a $50 million registered direct offering and an upsized $125 million private placement with leading healthcare investors, with the potential for an additional $165 million upon full-on exercise. This investment puts us in a very good position to advance and prepare for 10-day advance commercialization. I'll now turn over the presentation to Haoyan. Haoyan?

Thank you, Tom. For Q3 2025, we had R&D expenses of 10.3 million compared to 6.8 million for the same period last year. The increase was mainly due to expenses related to the Dragon trial and the Phoenix trial, partially offsetting by the Australian R&D tax incentive program. It was also due to an increase in shared base compensation expenses. Regarding GNN expenses, we had GNN expenses of $12.7 million compared to $2.9 million for the same period last year. The increase was primarily driven by an increase in share-based compensation expenses from the new grant of equity incentive plan this year, which has become higher as our share price and exercise price increased. Overall, we had a net loss of $21.7 million compared to a net loss of $8.7 million for the same period last year. It is important to note that, as I said, the majority of our extensive increase came from the share-based compensation, which was about $12.9 million and was not cash-related. Our total operating cash outflow for the third quarter was approximately $9.3 million, similar to $8.6 million in the second quarter. Moving to the balance sheet, as Tom shared, we were pleased to complete a registered offering in a significant pipe with gross proceeds of a total of $140 million, with potential for up to additional $165 million upon full order exercise. With that, at the end of Q3, we had $275.6 million in cash, liquidity from town deposit and U.S. Treasury bills. We have made significant progress to our key milestone year today. We sincerely appreciate the continued trust and support from our shareholders. Our balance sheet remains strong and is expected to provide sufficient funding to support our clinical trials and preparation for commercializations. We are well positioned to achieve our future objective. With that, I'll 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 into today's call, please press star 9 to raise your hand and star 6 to unmute. Please stand by while we compile the Q&A roster. Your first question comes from the line of Yi Chen with H.C. Wainwright. Your line is open. Please go ahead.

Hello. Thank you for taking my questions. So can you tell us whether you have submitted the application to the regulatory agency in China and UK? And if not, when do you plan to do so?

Ohayi, no, we have not. We plan to submit our first half next year. As you can see, there's a couple of regulatory agencies that has given us the green light to submit, whether it be based on interim analysis or waiting for the final report for the Dragon Study to come out. We want to maintain the consistent data package across all regulatory agencies. And therefore, the timeline for that will be first half of 2026. All right.

And can you also provide us with the current amount of shares outstanding after the most recent?

How? This is probably a question for you.

Yeah, I think it's somewhere like the total outstanding shares. I think it's listed on the recent F3. I think it's somewhere like 35 million.

35 million. Okay, got it. Thank you.

Thanks. Thanks to you.

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

Hi, good afternoon, and thank you for taking my questions. Following up on the last question about the international submissions, when do you think you might be submitting the application in Japan?

Actually, we are still in discussion with Japan on how the application Basically, the different modules that we need to submit with Japan, we're still going through this with Japan. So the expected timeline will be first half. But given that we have several countries that we need to prioritize first, we still haven't had a we still we still need to wait until the data comes out and then prioritize which countries will be submitted first certainly japan is up there but having three four countries submitted at once we definitely wouldn't have the bandwidth to handle all those submissions and getting questions from regulatory agencies across several regions. So we still haven't had the list of where to prioritize first, but certainly FDA is one of the first authorities that we need to submit first. Okay. Yeah, so I don't know if that answers your question, but at this point, we got several that we had a green light to submit in Japan.

Okay. Then turning over to the PHOENIX trial, are you going to have an interim analysis that is structured in a way that was similar to the DRAGON trial? So we're going to be testing for either futility or for adequacy of the sample size?

Yes, we do. So at this point, we have an interim analysis plan for next year, probably around second half next year. But regarding how we're going to go about that, I probably will refer to Nathan. Do you have a better idea on the structure of the interim analysis?

Well, very likely it will be a sample size estimation as we did for dragon same sort of scenario where we set up a conditional window statistically referred to as a promising zone to look for efficacy trends within that window to determine whether or not we can supplement the sample size of additional subjects.

Okay, super. Then last question for me. The SG&A levels have been moving around a little bit with all the milestone payments. What should we be assuming as kind of like the baseline level for SG&A expenses going forward?

Well, Bruce, that's a good one. But it's also a little bit hard to estimate at this point in time. As you can see, we are starting to prepare for commercialization. So we're expanding the team now. So we don't have a clear... Also, many of that will involve some ESOP as well. And ESOP has become a big... a moving factor based on the share price on the actual expenses being recognized on the income statement. So we have a better understanding about the cash flow, but for the income statement itself, the GNA, it's a little bit hard to estimate a correct number given it was so much related to the valuation of the ESOP.

Okay, got it. Thank you. Thank you.

As a reminder, if you would like to ask a question, please raise your hand. The raise hand button can be found in the center of the toolbar at the bottom of your screen on Zoom desktop and on the left side of the toolbar on Zoom mobile. If you have dialed into the call, please press star nine to raise your hand and star six to unmute. Your next question comes from the line of Michael Okunowicz with Maxim. Your line is open. Please go ahead.

Hey guys, thank you so much for taking my questions today. I just wanted to ask a couple of questions on your commercial preparations. In particular, what steps are you taking right now to prepare for a potential approval and launch? And then how are you prioritizing different regions since the Dragon trial should serve for several different geographies?

Sure. How? You want to give more details on this?

Sure, sure. Well, apparently US is the focus, given the potential size. But we are, you know, applying for NDA in all the regions, probably US or, you know, some smaller single market. such as Japan, will be relatively easy for us to focus on. And, you know, we remain open to see cooperation and partnership with all the other regions. Yeah, but for now, I think, you know, we're targeting on those markets that we think will be easier to handle by ourselves.

And do you have a sense of how large of a sales force you would need for the U.S.? ?

Sure. We probably will start with 20 people and then maybe up to 40 people.

And then one last from me and I'll hop back into the queue. Just given that you have raised this additional 125 and you have a pretty strong cash position, are you anticipating that your current cash should be sufficient for the commercial preparation and launch of Tinlaraban?

Well, that's a good question. So, you know, we estimate it could be probably about 200 million to commercialize saga in the U.S. That's how we designed the recent hype transaction with additional cash coming from the Warren. So potentially, yeah, we think we should have enough. But, you know, of course, that is just estimation.

Thank you very much and congratulations on all the progress. Thank you. Thanks, Mike.

As a final reminder, 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. Your next question comes from the line of Mark Goodman with Leerink. Your line is open. Please go ahead.

Can you confirm that the UK, the Supreme asked for the same interim breakthrough destination? I mean, is all of this the same exact information or in China as well? Did they get anything different? Everybody got the same information?

Yes. So everyone will present the same information. I'll let Hendrik answer this question since he presented to them. Hendrik?

Yeah. Thank you, Tom. Yes, Mark. This was the same set of information. The type of presentation was different. It was an in-person presentation. presentation in Beijing to the NMPA, including a large panel of experts from China, while for the UK, as an example, this was an online meeting with the agency. But the data set that was the basis for the presentation and the discussion was exactly the same.

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