BELITE BIO, INC Q3 FY2024 earnings call

• Introduced Dr. Hendrik Scholl as new Chief Medical Officer, a world expert in Stargardt disease and age-related macular degeneration.
• Progress in Tinlarebant trials: DRAGON 2 trial fully enrolled with 104 patients, first patient dosed in Phase 2-3 portion, Phase 1B study in Japanese subjects completed; DRAGON trial expected to enroll 60 subjects in U.S., U.K., Japan. PHOENIX trial for GA expected to enroll 429 subjects, already enrolled over 280.
• Phase 2 study data: Tinlarebant slowed lesion growth in Stargardt disease, stabilized visual acuity loss, and was safe and well tolerated with adverse events like delayed dark adaptation and xanthopsia being common but transient.
• Clinical trial designs for DRAGON and DRAGON 2 studies, similarities and differences in subject number, geography, and randomization; PHOENIX trial design similar to Stargardt trials with focus on atrophic lesion growth as endpoint.
• R&D and G&A expense details and cash position with ~4 years cash runway.

In Q3 2024, R&D expenses were $6.8 million compared to $8.7 million in Q3 2023, mainly due to fewer CRO milestone payments related to the DRAGON trial offset by increase in DRAGON 2 trial expenses. G&A expenses were $2.9 million in Q3 2024 vs $2.2 million in Q3 2023, primarily due to increase in share-based compensation. Net loss was $8.7 million in Q3 2024 vs $10.9 million in Q3 2023. Cash totaled $109 million in money market fund, time deposit, and U.S. Treasury bills, with an expected ~4 years cash runway to execute key milestones. Revenue contribution details not applicable as it's a biotech focused on clinical trials.

• Hao-Yuan Chuang stated that with the funds raised year-to-date and recent warrant exercise, there is an expected ~4 years cash runway to execute all key milestones.

Forward-looking statements are subject to certain risks and uncertainties, with actual results possibly differing materially from current expectations. Specific risks related to trial outcomes, regulatory approvals, and market acceptance of the therapy were not explicitly detailed but implied by forward-looking nature of remarks.

Q: Basma Radwan asked about tolerance of GA patients to ocular AEs and impact on uptake.

A: Nathan Mata responded that GA patients might have higher incidence and severity of ocular AEs due to more macular involvement, but majority of patients tolerate them well.

Q: Jennifer Kim inquired about discontinuation rates in PHOENIX trial, interim analysis for DRAGON, and enrollment in DRAGON 2.

A: Nathan Mata said discontinuation rate in PHOENIX was around 15%; interim analysis for DRAGON expected around December/early January after data cleaning and DSMB review; Hao-Yuan Chuang mentioned DRAGON 2 enrollment ongoing with expectation of full enrollment by Q2 next year.

Q: Yi Chen asked about baseline characteristics of PHOENIX trial subjects vs approved GA therapy.

A: Hendrik Scholl and Nathan Mata explained differences in lesion size and inflammation; PHOENIX trial subjects have smaller lesions with less inflammation compared to those in approved GA therapy studies.

Q: Michael Okunewitch asked about DRAGON 2's role in FDA filing, segmented strategy for GA, and comparison to Alkeus.

A: Tom Lin and Nathan Mata responded that DRAGON 2 could serve as a second study if needed; Tinlarebant has a broader label potential; key difference in MOA with Alkeus where Tinlarebant reduces all transretinal accumulation vs synthetic vitamins increasing it, leading to better expected effect.