Belite Bio, Inc

Ladies and gentlemen, thank you for joining us and welcome to the Be Light Bio fourth quarter and fiscal year end 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 conference over to Sophie Hunt. Please go ahead.

Good afternoon, everyone. Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of BeLightBio, Dr. Hendrik Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Yuan Chung, BelieveBio's 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-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release issued earlier today. And now I'll turn the call over to Hao. Hao?

Thank you for joining today's call to discuss our fourth quarter and four-year 2025 financial results. 2025 was a year of significant progress for us as we achieved several key milestones. We look forward to a truly transformative year in 2026 as we position Teleriband to potentially become the first ever approved therapy for people living with Saga disease. a devastating eye disease that usually begins in childhood or young adulthood and leads to progressive vision loss and then legal blindness in almost all cases. Today, I'll provide a recap of our 2025 achievement, key milestone for 2026, and financial results. Starting with 2025 achievement, of course, the most significant achievement was the announcement of our top-line result for the Phase III Pivotal Dragon Trial in December. We're very excited to share that the trial met its primary efficacy endpoint, demonstrating statistically significant and clinically meaningful 36% reduction in the growth rate of ocular lesion measured by definitely decreased autofluorescence by fundus autofluorescence imaging compared with placebo. These results position us well for engagement with the regulatory authorities as we see a path to commercialization in Stalker disease. In the Dragon 2 study, we reached the target number of 60 subjects in January. As of February 27, we had enrolled 72 subjects. A subject who had passed the screening before the registration closed can still be admitted to the trial. We expect the final number of subjects enrolled to be between 72 and 75. We also completed enrollment in the Phase 3 Phoenix trial in GA with 130 subjects. Finally, we complete a $402 million public offering with over-allotment fully exercised by the underwriter in Q4. Importantly, the net proceeds from this, along with other raises completed in the year, has just done us extremely well to support commercialization preparation for starter VCs, development and expansion of pipelines, and general corporate purpose. Now, moving to 2026. As I said, this will be a transformative year for Be.Light. The top priority in our plan to end the submission to the FDA in the second quarter of 2026. And with our NDA submission planted, we have also kicked off our commercialization preparation work for StarverDZ. I'm pleased to share that we have hired all of the key leadership positions and are now in the process of building our organization in sales, market access, medical affairs, marketing, regulatory, and operations, etc. It's a busy but exciting time for us, and we look forward to sharing more as we progress with our launch preparation works. Last but not least, I'll now close with a financial recap. For the fourth quarter, R&D expenses were 14.6 million compared to 7.3 million in Q4 2024. The increase was primarily due to, first, expenses related to the Drought and Truth trial. Second, we received a lower Australian R&D tax incentive in Q4 2025, as such incentive was received in Q3 2025 versus last year it was received in Q4 2024. And third, API manufacturing expenses. On a non-GAAP basis, which is glue share-based compensation expenses, Part of the expenses for the fourth quarter was $12.2 million compared to $5.7 million for the same period in 2024. We believe this non-GAAP basis provides a better picture about operating expenses since our share-based compensation expenses is heavily driven by achieving development milestones and the volatility of our own stock price and the comparable company stock price using the valuation. SG&A expenses were $13.5 million compared to $4.2 million in Q4 2024. The increase was primarily due to an increase in share-based compensation expenses and professional service fee, as we achieved development milestones and started to prepare for commercialization and value. On a non-GAAP basis, SG&A expenses for the fourth quarter was $4.2 million compared to $1.5 million in Q4 2024. Overall, the fourth quarter, we report a net loss of 25.3 million compared to 10.1 million in Q4 2024. On a non-GAAP basis, we report a net loss of 13.6 million for the fourth quarter compared to 5.9 million for Q4 2024. For the full year, R&D expenses were $45.4 million compared to $29.9 million for the full year, 2024. The full year increase was primarily due to first, expenses related to Phoenix trial, second, share-based compensation expenses, and third, APA manufacturing expenses, partially offset by the royalty payment recognized in 2024. On a non-GAAP basis, excluding share-based compensation expenses, the R&D expenses for the full year was $36.2 million compared to $26.2 million for the same period in 2014. SG&A expenses were $38.9 million compared to $10.1 million in 2024. The increase was primarily due to increase in share-based compensation expenses and professional service fee. As we achieved the bottom milestone and started to prepare for filing and commercialization. On a non-GAAP basis, SG&A expenses for the full year were $9.1 million compared to $4.8 million in 2024. For the full year, we report a net loss of 77.6 million compared to a net loss of 36.1 million in 2024. On a non-GAAP basis, net loss was 38.7 million compared to a non-GAAP net loss of 27.2 million in 2024. Moving to the balance sheet, as I said, we had a successful year of fundraising through underwritten public offering, two registered direct offering, and a significant pie. We're very grateful to our shareholders for their strong support. As a result, we closed the year with $772.6 million in cash, cash equivalent US treasury bills and notes, as compared with $145.2 million at the end of 2024. Our balance sheet remains strong, and we are well-positioned to deliver our near and long-term objective, including the commercial launch for Starla DCs. With that, I'll turn the call back to the operator for Q&A.