管理層發言
Thank you for joining us for the Belite Bio Third Quarter 2025 Earnings Call. I will now turn the call over to Julie Fallon.
Good afternoon, everyone. Thank you for joining us. On the call today 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. 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 III PHOENIX trial with 530 subjects. For Stargardt’s disease, we have completed the Phase III DRAGON trial, and we now look forward to reporting the final top line data by the end of this month. The DRAGON II trial has enrolled approximately 35 subjects of our targeted enrollment of approximately 60 subjects, including 10 Japanese subjects. The data from 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 our NDA for priority review based on the interim analysis results from the Phase III DRAGON trial.
Additionally, the U.K.'s MHRA agreed to accept our 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 warrant exercise. This investment puts us in a very good position to advance and prepare for Tinlarebant's commercialization. I'll now turn over the presentation to Hao-Yuan. Hao-Yuan?
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 offset by the Australian R&D tax incentive program. It was also due to an increase in share-based compensation expenses. Regarding G&A expenses, we had G&A 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 the 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 expense 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 direct offering and a significant private placement with gross proceeds of a total of $140 million with the potential for up to an additional $165 million from our full warrant exercise. With that, at the end of Q3, we had $275.6 million in cash, liquidity from time deposits, and U.S. treasury bills. We have made significant progress toward our key milestones year-to-date. 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 commercialization. We are well positioned to achieve our future objectives. With that, I'll turn the call back to the operator for Q&A. Operator?
分析師問答
Your first question comes from Yi Chen with H.C. Wainwright.
So can you tell us whether you have submitted the application to the regulatory agency in China and U.K.? And if not, when do you plan to do so?
No, we have not. We plan to submit in the first half of next year. As you can see, there are a couple of regulatory agencies that have 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 a consistent data package across all regulatory agencies. Therefore, the timeline for that will be in the first half of 2026.
Got it. And can you also provide us with the current amount of shares outstanding after the most recent announcement?
Hao-Yuan, this is probably a question for you.
Yes, I think the total outstanding shares are listed on the recent S3. I think it's somewhere around $35 million.
Your next question comes from the line of Bruce Jackson with Benchmark.
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 to structure the different modules that we need to submit. We're still going through this with Japan. So the expected timeline will be in the first half. However, given that we have several countries that we need to prioritize, we still haven't had a finalized list of priorities. Certainly, Japan is a top priority. But with multiple countries needing submission at once, we wouldn't have the bandwidth to handle all submissions and respond to questions from regulatory agencies across several regions. So we still haven't finalized the submission order, but certainly, the FDA is among the first authorities that we need to submit to. So yes, I hope that answers your question.
Yes. Okay. Then turning over to the PHOENIX trial. Are you planning to have an interim analysis structured in a way similar to the DRAGON trial? Will it be testing for either futility or for adequacy of the sample size?
Yes, we do. So at this point, we have an interim analysis planned for next year, probably around the second half of the year. Regarding the structure of the interim analysis, I would refer you to Nathan. Do you have a better idea on the structure of the interim analysis?
Very likely, it will involve sample size re-estimation as we did for DRAGON. It will be a similar setup with a conditional window specifically 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 with 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 a baseline level for SG&A expenses going forward?
Hao?
Well, Bruce, that's a good question, but it's also a bit hard to estimate at this point in time. As you can see, we are starting to prepare for commercialization. So we're expanding our team now. We don’t have a clear number yet, and much of this will involve some ESOP as well. ESOP has also become a big moving factor based on the share price and how actual expenses are recognized on the income statement. So we have a better understanding of the cash flow, but for the income statement itself, estimating a correct number for G&A is a bit challenging given its correlation to the valuation of the ESOP.
Your next question comes from the line of Michael Okunewitch with Maxim.
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 how are you prioritizing different regions since the DRAGON trial should serve several different geographies?
Sure. Hao, do you want to give more details on this?
Sure, sure. Well, obviously the U.S. is the focus given its potential size, but we are applying for NDA in all regions. The U.S. or some smaller markets such as Japan will be relatively easier for us to handle. We remain open to seeking cooperation and partnerships for all other regions. However, for now, we're targeting those markets that we think we can manage more easily on our own.
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 expand to up to 40 people.
And then one last for me, and I'll hop back into the queue. Just given that you have raised this additional $125 million 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 Tinlarebant?
Well, that's a good question. We estimate it could be approximately $200 million to commercialize Stargardt in the U.S. That's how we designed the recent transaction with additional cash coming from the warrant. So potentially, yes, we think we should have enough. But of course, that is just an estimation.
Your next question comes from the line of Marc Goodman with Leerink.
Yes. Can you confirm the U.K. basically asked for the same interim information that you sent to the U.S. FDA that got you the breakthrough designation? I mean, is all of this the same exact information and in China as well – did they get anything different? Did everybody get the same information?
Yes. So everyone will present the same information. I’ll let Hendrik answer those questions since he presented to them. Hendrik?
Yes, thank you, Tom. Yes, Marc, this was the same set of information. The type of presentation was different. There was an in-person presentation in Beijing to the NMPA, including a large panel of experts from China. While for the U.K., as an example, this was an online meeting with the agency. But the data set that was the basis for the presentation and 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.