Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for Stargardt diseaseLast subject visit completed in the pivotal Phase 3 DRAGON trial of Tinlarebant in Stargardt diseaseTopline data expected in Q4 2025 SAN DIEGO, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical-stage drug development company f ...

Company Overview - Belite Bio, Inc is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including Stargardt disease type 1 and Geographic Atrophy in advanced dry age-related macular degeneration [2] - The lead candidate, Tinlarebant, is an oral therapy aimed at reducing toxin accumulation in the eye, currently undergoing Phase 3 and Phase 2/3 studies [2] Upcoming Events - The executive management team will participate in three investor conferences: - Cantor Global Healthcare Conference on September 5, 2025, at 8:00 am ET - Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, at 5:35 pm ET - H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 8:00 am ET [3] - Webcasts of the presentations will be available on the investor relations section of the Belite Bio website, with replays archived for 90 days [1]

Group 1 - Belite Bio, Inc is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical needs [2] - The company is participating in the BTIG Virtual Biotechnology Conference on July 29-30, 2025, allowing for one-on-one meetings with management [1] - Belite's lead candidate, Tinlarebant, is an oral therapy aimed at reducing toxin accumulation in the eye, currently evaluated in multiple clinical studies [2] Group 2 - The specific diseases targeted by Belite include Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD) [2] - Tinlarebant is being assessed in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) for STGD1, as well as a Phase 3 study (PHOENIX) for GA [2]

Company Overview - Belite Bio, Inc is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD) [4] - The lead candidate, Tinlarebant, is an oral therapy aimed at reducing toxin accumulation in the eye and is currently undergoing multiple clinical trials, including a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) for STGD1, as well as a Phase 3 study (PHOENIX) for GA [4][7] Recent Developments - Dr. Nathan L. Mata, the Chief Scientific Officer, will present at the dbVIC - Deutsche Bank American Depositary Receipt (ADR) Virtual Investor Conference on May 15, 2025, providing an opportunity for investors to engage with the company [1] - The DRAGON trial, a pivotal global Phase 3 trial for Tinlarebant in adolescent STGD1 subjects, is expected to be completed by Q4 2025, with an independent DSMB recommending submission of interim analysis data for regulatory review [7] - The ongoing PHOENIX trial for Tinlarebant in GA subjects has enrolled over 460 participants [7] Event Details - The virtual investor conference will take place on May 15, 2025, at 12:30 pm ET, allowing real-time interaction between investors and the company [2] - Participation in the conference is free of charge, and an archived webcast will be available for those unable to attend live [3][2]