Core Insights - Belite Bio, Inc. reported significant progress in its clinical trials for Tinlarebant, aimed at treating Stargardt disease, with positive responses from regulatory bodies in China and the UK [2][4] - The company completed a $15 million registered direct offering and a $125 million private placement, enhancing its financial position to support ongoing clinical developments [2][7] Clinical Highlights - Tinlarebant is an oral RBP4 antagonist designed to reduce toxic vitamin A accumulation in the eye, which is critical for patients with Stargardt disease and geographic atrophy [3][5] - The pivotal Phase 3 DRAGON trial for Stargardt disease has completed enrollment with 530 subjects, and final topline data is expected in Q4 2025 [4][13] - The Phase 3 PHOENIX trial for geographic atrophy has also completed enrollment, with a focus on the growth rate of atrophic lesions as the primary efficacy endpoint [13] Financial Overview - As of September 30, 2025, the company reported current assets of $275.6 million, indicating a strong liquidity position [8][20] - Research and development expenses for Q3 2025 were $10.3 million, up from $6.8 million in Q3 2024, primarily due to costs associated with ongoing clinical trials [9] - General and administrative expenses rose significantly to $12.7 million in Q3 2025 from $2.9 million in Q3 2024, largely due to increased share-based compensation [10] - The net loss for Q3 2025 was $21.7 million, compared to a net loss of $8.7 million in Q3 2024, reflecting increased operational costs [14][18]

Core Insights - Belite Bio Inc is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical needs [3] Group 1: Company Overview - Belite Bio is advancing therapeutics targeting conditions such as STGD1 and GA in advanced dry AMD, as well as specific metabolic diseases [3] - The company's lead candidate, Tinlarebant, is an oral therapy aimed at reducing bisretinoid toxin accumulation in the eye [3] - Tinlarebant is currently being evaluated in multiple studies: a Phase 3 study (DRAGON), a Phase 2/3 study (DRAGON II) for adolescent STGD1 subjects, and a Phase 3 study (PHOENIX) for subjects with GA [3] Group 2: Upcoming Events - The executive management team will present at the Deutsche Bank ADR Virtual Investor Conference on November 4, 2025, at 10:30 am ET [1] - A webcast of the presentation will be available on the conference website, with a replay accessible for 90 days post-presentation [2]

Core Insights - Belite Bio Inc is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical needs [2] Group 1: Company Overview - Belite Bio is targeting diseases such as STGD1 and GA in advanced dry AMD, as well as specific metabolic diseases [2] - The lead candidate, Tinlarebant, is an oral therapy aimed at reducing bisretinoid toxin accumulation in the eye [2] - Tinlarebant is currently undergoing multiple clinical trials, including a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) for adolescent STGD1 subjects, and a Phase 3 study (PHOENIX) for subjects with GA [2] Group 2: Upcoming Events - The executive management team will participate in the Maxim Growth Summit on October 22, 2025 [1] - Interested parties can schedule one-on-one meetings with management through their Maxim representative [1]

Core Insights - Belite Bio, Inc. has received acceptance from China's NMPA for a priority review of the New Drug Application (NDA) for Tinlarebant, aimed at treating Stargardt disease, based on interim analysis results from the Phase 3 DRAGON trial [1][2] Company Overview - Belite Bio is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including Stargardt disease and geographic atrophy [5] - The lead candidate, Tinlarebant, is an oral therapy designed to reduce the accumulation of vitamin A-based toxins in the eye, which are linked to retinal diseases [4][5] Clinical Trial Details - The Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled study evaluating the safety and efficacy of Tinlarebant in 104 adolescent patients with Stargardt disease across 11 jurisdictions [3] - The primary efficacy endpoint of the trial is the growth rate of atrophic lesions, with safety and tolerability also being assessed [3] Regulatory Milestones - The NMPA's acceptance of the NDA is a significant milestone for Belite Bio and the Stargardt community, highlighting the urgent need for effective therapies in this area [2] - Final topline data from the Phase 3 DRAGON trial is expected to be reported in Q4 2025, which will be submitted to the NMPA as part of the NDA [2][7]

Core Insights - Belite Bio Inc has completed the last subject visit in the Phase 3 DRAGON clinical trial for Tinlarebant, aimed at treating Stargardt disease type 1 (STGD1) [1][2] - The DRAGON trial involved 104 adolescent subjects across 11 jurisdictions, with a 2:1 randomization of Tinlarebant to placebo, and 94 subjects completed the study [2] - Top-line results from the DRAGON trial are expected to be reported in Q4 2025, with plans to file New Drug Applications in the first half of 2026 [3] Company Overview - Belite Bio is focused on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including STGD1 and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD) [5] - The lead candidate, Tinlarebant, is an oral therapy designed to reduce the accumulation of vitamin A-based toxins (bisretinoids) that contribute to retinal disease [4][5] - Tinlarebant has received multiple designations, including Fast Track and Rare Pediatric Disease in the U.S., and Orphan Drug Designation in the U.S., Europe, and Japan [4][7]

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]