Belite Bio (BLTE) Q2 2024 earnings summary

Executive summary

• Advanced Tinlarebant clinical programs for Stargardt Disease (STGD1) and Geographic Atrophy (GA), achieving key milestones such as full Phase 1b enrollment in Japan and progress in global Phase 3 trials, with regulatory designations granted in the US, Europe, and Japan.

• Received Sakigake (Pioneer Drug) designation in Japan, the first for an ophthalmic drug, and Orphan Drug status in multiple regions, highlighting significant unmet need.

• Raised $25 million in April 2024 via a registered direct offering, strengthening the balance sheet for ongoing R&D and clinical activities.

Financial highlights

• R&D expenses were $9.1 million in Q2 2024, up from $5.5 million in Q2 2023, mainly due to milestone payments and share-based compensation.

• G&A expenses remained stable at $1.4 million year-over-year.

• Net loss was $9.5 million in Q2 2024, compared to $6.8 million in Q2 2023.

• Cash, time deposits, and US treasury bills totaled $112.3 million as of June 30, 2024.

• Other income rose to $1.0 million in Q2 2024 from $0.1 million in Q2 2023, driven by interest from deposits and treasury bills.

Outlook and guidance

• Interim analysis for the pivotal Phase 3 DRAGON trial in adolescent STGD1 expected in Q4 2024 or early 2025.

• PHOENIX Phase 3 trial in GA is ongoing, targeting ~430 subjects globally, with interim analysis planned at the trial's midpoint.

• R&D expenses projected at $30–$35 million for 2024 and $35–$40 million for 2025, reflecting ongoing trial activity.