Belite Bio (BLTE) Q3 2024 earnings summary

Executive summary

• Advanced Tinlarebant clinical programs for Stargardt disease (STGD1) and geographic atrophy (GA), with global phase III trials ongoing and DRAGON fully enrolled; PHOENIX has enrolled over 280 of ~430 planned subjects.

• Dosed first patient in Phase 2/3 DRAGON II trial in Japan and completed Phase 1b study.

• Tinlarebant has received Rare Pediatric Disease, Fast Track, Sakigake (Japan), and Orphan Drug designations in major markets.

• No FDA-approved treatments exist for STGD1 or orally administered treatments for GA, highlighting significant unmet market opportunities.

• Welcomed Dr. Hendrik Scholl as Chief Medical Officer, a leading expert in retinal diseases.

Financial highlights

• Q3 2024 R&D expenses were $6.8 million, down from $8.7 million in Q3 2023; nine-month R&D expenses rose to $22.7 million from $20.0 million year-over-year.

• Q3 2024 G&A expenses were $2.9 million, up from $2.2 million in Q3 2023; nine-month G&A expenses increased to $5.9 million from $4.7 million year-over-year.

• Net loss for Q3 2024 was $8.7 million, improved from $10.9 million in Q3 2023; nine-month net loss was $26.0 million, up from $24.6 million year-over-year.

• Cash, money market funds, time deposits, and U.S. Treasury bills totaled $109 million as of September 30, 2024.

• $28.75 million raised from warrant exercises to support general corporate purposes.

Outlook and guidance

• Interim analysis for the pivotal Phase 3 DRAGON trial expected by end of 2024 or early 2025, pending DSMB review.

• PHOENIX phase III trial for GA has enrolled over 280 of ~430 planned subjects, with ongoing recruitment and interim analysis planned at study midpoint.

• DRAGON II trial enrollment anticipated to complete by Q2 2025.

• Additional Phase 3 study in GA expected to be required prior to NDA filing.

• Company expects to pursue a broad label for Tinlarebant in GA, leveraging oral administration as a competitive advantage.