Core Points - Belite Bio, Inc. has received Breakthrough Therapy Designation from the FDA for Tinlarebant, aimed at treating Stargardt disease (STGD1), which currently has no approved therapies [1][2] - The designation is based on interim data from the Phase 3 DRAGON trial, indicating substantial improvement over existing therapies and a favorable safety profile [2][6] - The DRAGON trial is a global study involving 104 subjects across 11 jurisdictions, designed to evaluate the safety and efficacy of Tinlarebant [5][6] Company Overview - Belite Bio is focused on developing novel therapeutics for degenerative retinal diseases, including STGD1 and Geographic Atrophy (GA) [8] - Tinlarebant is an orally administered tablet intended for early intervention in maintaining retinal health, with no current FDA-approved treatments for STGD1 or GA [7][8] - The company is also conducting a Phase 2/3 study (DRAGON II) and a Phase 3 study (PHOENIX) for other related conditions [8] Clinical Trial Insights - The Phase 3 DRAGON trial is randomized, double-masked, and placebo-controlled, with a primary efficacy endpoint focused on the growth rate of atrophic lesions [5] - The trial's completion is expected by Q4 2025, including a three-month follow-up period [6] - Tinlarebant has previously received multiple designations, including Fast Track and Rare Pediatric Disease Designations in the U.S. [6]

Core Viewpoint - Belite Bio, Inc is advancing its clinical development of Tinlarebant, targeting degenerative retinal diseases, with positive interim results from the Phase 3 DRAGON trial and plans for trial completion by the end of 2025 [2][4]. Clinical Highlights - Tinlarebant is an oral, once-daily RBP4 antagonist that reduces RBP4 levels in the blood, decreasing vitamin A delivery to the eye, which is crucial for normal vision but can lead to toxicity in certain retinal diseases [3]. - The independent Data Safety Monitoring Board (DSMB) recommended the continuation of the DRAGON trial without modifications, with completion expected in Q4 2025 [4]. - The ongoing Phase 3 trial (PHOENIX) for Tinlarebant in geographic atrophy (GA) patients has enrolled 464 out of the targeted 500 subjects [4][14]. Financial Highlights - As of March 31, 2025, the company reported current assets of $157.4 million, including cash and liquidity funds [7]. - Research and development expenses for Q1 2025 were $9.4 million, up from $6.8 million in Q1 2024, primarily due to increased share-based compensation and clinical trial expenses [8]. - General and administrative expenses rose to $6.1 million in Q1 2025 from $1.6 million in Q1 2024, attributed to share-based compensation [9]. - The company reported a net loss of $14.3 million for Q1 2025, compared to a net loss of $7.9 million in the same period of 2024 [11][17]. Corporate Highlights - In February 2025, Belite Bio raised $15 million in gross proceeds through a registered direct offering, with potential additional proceeds from warrant exercises [6]. - The company is focused on maintaining strong execution across its late-stage clinical programs to deliver new treatment options for degenerative retinal diseases [2]. Upcoming Milestones - A conference call and webcast is scheduled for May 14, 2025, to discuss financial results and provide a business update [12]. - The primary efficacy endpoint for the DRAGON trial is the growth rate of atrophic lesions, with safety and tolerability also being assessed [5][14].

SAN DIEGO, May 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that CSO, Dr. Nathan L. Mata will present at the dbVIC - Deutsche Bank American Depositary Receipt (ADR) Virtual Investor Conference on May 15, 2025. This virtual investor conference is aimed exclusively at introducing global companies wi ...

SAN DIEGO, May 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the executive management team will participate in four upcoming investor conferences. Details of the presentations are as follows: Deutsche Bank Depositary Receipts Virtual Investor Conference (Virtual) May 15, 2025, at 12:30 pm ET, ...

Date: Wednesday, May 14, 2025 Time: 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) Webcast Link: https://events.q4inc.com/attendee/137642555 Media and Investor Relations Contact: Jennifer Wu ir@belitebio.com Webcast Link Instructions You can join the live webcast by visiting the link above or the "Presentations & Events" section of the Company's Investor Relations website at https://investors.belitebio.com/presentations-events/events. A replay will be available for approximately 90 days after the event. Ab ...

SAN DIEGO, April 29, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Company will give two poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held May 4–8, 2025, in Salt Lake City, Utah. The presentations will highlight baseline patient ...

Belite Bio, Inc. (NASDAQ:BLTE) Q4 2024 Results Conference Call March 17, 2025 4:30 PM ET Company Participants Julie Fallon - Investor Relations Tom Lin - Chairman and Chief Executive Officer Nathan Mata - Chief Scientific Officer Hendrik Scholl - Chief Medical Officer Hao-Yuan Chuang - Chief Financial Officer Conference Call Participants Jennifer Kim - Cantor Basma Radwan - Leerink Partners Yi Chen - H.C. Wainwright Bruce Jackson - Benchmark Michael Okunewitch - Maxim Group Operator Ladies and gentlemen, th ...