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Belite Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
BLTEBelite Bio(BLTE) Newsfilter·2025-03-17 10:00

Core Insights - Belite Bio, Inc is advancing its clinical development of Tinlarebant, a novel therapeutic for degenerative retinal diseases, with significant progress in the Phase 3 DRAGON trial for Stargardt disease type 1 (STGD1) [2][3][4] Financial Results - As of December 31, 2024, the company reported cash of 31.7million,adecreasefrom31.7 million, a decrease from 88.2 million on December 31, 2023 [8][20] - The company had 113.5millionininvestmentsasofDecember31,2024,comparedtononeonDecember31,2023[8][20]−FortheyearendedDecember31,2024,researchanddevelopmentexpenseswere113.5 million in investments as of December 31, 2024, compared to none on December 31, 2023 [8][20] - For the year ended December 31, 2024, research and development expenses were 29.9 million, up from 24.8millionin2023[10][18]−GeneralandadministrativeexpensesfortheyearendedDecember31,2024,were24.8 million in 2023 [10][18] - General and administrative expenses for the year ended December 31, 2024, were 10.1 million, compared to 6.8millionin2023[11][18]−ThenetlossfortheyearendedDecember31,2024,was6.8 million in 2023 [11][18] - The net loss for the year ended December 31, 2024, was 36.1 million, or (1.18)pershare,comparedtoanetlossof1.18) per share, compared to a net loss of 31.6 million, or (1.19)persharein2023[13][18]ClinicalDevelopmentHighlights−TheDRAGONtrialforSTGD1subjectsisongoing,withcompletionexpectedinQ42025,followingapositiveinterimanalysisbytheDataSafetyMonitoringBoard(DSMB)[4][5]−ThePHOENIXtrialforgeographicatrophy(GA)subjectsisalsoongoing,with406subjectsenrolledandanincreasedsamplesizetargetof500[14]−Tinlarebanthasreceivedmultipledesignations,includingFastTrackandOrphanDrugDesignationintheU.S.forSTGD1[5][16]CorporateActions−Thecompanyraised1.19) per share in 2023 [13][18] Clinical Development Highlights - The DRAGON trial for STGD1 subjects is ongoing, with completion expected in Q4 2025, following a positive interim analysis by the Data Safety Monitoring Board (DSMB) [4][5] - The PHOENIX trial for geographic atrophy (GA) subjects is also ongoing, with 406 subjects enrolled and an increased sample size target of 500 [14] - Tinlarebant has received multiple designations, including Fast Track and Orphan Drug Designation in the U.S. for STGD1 [5][16] Corporate Actions - The company raised 15 million in gross proceeds through a registered direct offering on February 5, 2025, with potential additional proceeds from warrant exercises [4][7] - A conference call and webcast were scheduled for March 17, 2025, to discuss financial results and business updates [15]