newsfilter
← Latest News
GlobeNewswire·

Belite Bio Reports Unaudited Third Quarter 2026 Financial Results and Provides a Corporate Update

BLTE
  • FDA granted Priority Review for the tinlarebant NDA in Stargardt disease type 1 (STGD1) in August 2026 with a PDUFA target action date of February 12, 2027.
  • The FDA will not convene an advisory committee meeting to discuss the tinlarebant NDA for STGD1.
  • The company submitted a Japanese NDA (J-NDA) for tinlarebant under Sakigake designation in September 2026.
  • Marketing Authorization Applications for tinlarebant were filed in Singapore, the United Kingdom, Switzerland via the Access Consortium in October 2026.
  • The DRAGON Phase 3 trial for STGD1 met its primary efficacy endpoint with a 35.7% reduction in retinal lesion growth and showed stable to slightly decreased quantitative autofluorescence values in treated subjects compared to a 20% increase in placebo subjects.
  • The DRAGON II trial, a combination of Phase 1b Phase 2/3 studies in adolescent STGD1 patients across Japan, the U.S., the U.K., has completed enrollment with 73 subjects.
  • The ongoing PHOENIX Phase 3 trial for Geographic Atrophy (GA) has completed enrollment with 530 subjects with an interim analysis expected.
  • Belite Bio uplisted its securities from the Nasdaq Capital Market to the Nasdaq Global Select Market on October 19, 2026.
  • Cash cash equivalents totaled $271.3 million as of September 30, 2026, down from $352.9 million on December 31, 2025.
  • Investments in U.S. treasury bills notes totaled $502.7 million as of September 30, 2026, compared to $419.7 million on December 31, 2025.
  • R&D expenses were $15.5 million for the three months ended September 30, 2026, $49.4 million for the nine months ended September 30, 2026.
  • SG&A expenses were $21.4 million for the three months ended September 30, 2026, $55.1 million for the nine months ended September 30, 2026.
  • The company reported a net loss of $30.3 million for the three months ended September 30, 2026, $85.6 million for the nine months ended September 30, 2026.
  • Other income was $6.7 million for the three months ended September 30, 2026, $18.9 million for the nine months ended September 30, 2026.
  • A conference call webcast to discuss financial results was scheduled for Thursday, November 12, 2026, at 4:30 p.m. ET.
Company
Belite Bio, Inc
Keywords
Nasdaq:BLTE, Belite Bio, Inc