11/10/2025

speaker
Operator
Conference Operator

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.

speaker
Julie Fallon
Head of Investor Relations

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?

speaker
Dr. Tom Lin
Chairman and Chief Executive Officer

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?

Disclaimer

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Investor presentation