Financial Data and Key Metrics Changes - In Q3 2024, the company reported R&D expenses of $6.8 million, a decrease from $8.7 million in Q3 2023, primarily due to fewer CRO milestone payments related to the DRAGON trial, partially offset by increased expenses in the DRAGON 2 trial [26] - G&A expenses increased to $2.9 million in Q3 2024 from $2.2 million in the same period in 2023, mainly due to increased share-based compensation [26] - The net loss for Q3 2024 was $8.7 million, compared to $10.9 million for the same period in 2023 [26] - The company maintains a strong balance sheet with total cash of $109 million, providing an estimated four years of cash runway to execute key milestones [27] Business Line Data and Key Metrics Changes - The company is advancing its lead product, Tinlarebant, in clinical trials for Stargardt disease and geographic atrophy, with significant progress reported in both the DRAGON and PHOENIX trials [10][13] - The DRAGON 2 trial is fully enrolled with 104 patients, and the DRAGON trial is expected to enroll 60 subjects across the U.S., U.K., and Japan [11][12] Market Data and Key Metrics Changes - The company has received multiple designations for Tinlarebant, including Rare Pediatric Disease and Fast Track designations in the U.S., and orphan drug designations in the U.S., E.U., and Japan, highlighting the significant unmet need for treatments in these indications [9][10] Company Strategy and Development Direction - The company is focused on early intervention in retinal diseases, aiming to slow or stop the progression of Stargardt disease and geographic atrophy through Tinlarebant [8] - The management emphasizes the importance of their clinical programs and the potential of Tinlarebant to address significant unmet medical needs in ophthalmology [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical programs and the potential of Tinlarebant, particularly in light of the promising data from ongoing trials [6][10] - The company is optimistic about the future, with plans to continue advancing its clinical trials and addressing the needs of patients suffering from retinal diseases [28] Other Important Information - The company welcomed Dr. Hendrik Scholl as the new Chief Medical Officer, who brings extensive expertise in retinal diseases and will lead the clinical program [5][6] Q&A Session Summary Question: Market research on GA patients' tolerance to ocular AEs - Management expects a higher incidence of ocular AEs in GA patients due to more extensive disease involvement, but believes patients will tolerate these AEs well [29][30] Question: Discontinuation rates in the PHOENIX trial - The discontinuation rate is around 15%, which includes all reasons, not just ocular AEs [32] Question: Interim analysis for the DRAGON trial - The interim analysis will occur once all subjects complete their month 12 visit, with data cleaning and DSMB review expected around December or early January [33][34] Question: Enrollment status in DRAGON 2 - Enrollment is ongoing, with expectations to complete by Q2 next year [35] Question: Baseline characteristics of PHOENIX trial subjects - The subjects in the PHOENIX trial have similar baseline characteristics to those in approved GA therapies, with a focus on smaller lesion sizes [38][39] Question: Differences between Tinlarebant and other therapies - Tinlarebant reduces the accumulation of toxic retinal byproducts, while other therapies may increase vitamin A levels, leading to different mechanisms of action [49][50]

Company Overview - Belite Bio, Inc is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting 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) [3] Upcoming Events - The company will host a webcast on November 12, 2024, at 4:30 p.m. Eastern Time to discuss its financial results and provide a business update for the third quarter ended September 30, 2024 [1][2] Product Development - Belite's lead candidate, Tinlarebant, is an oral therapy aimed at reducing the accumulation of toxins in the eye and is currently being evaluated in multiple studies: a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) for adolescent STGD1 subjects, as well as a Phase 3 study (PHOENIX) for subjects with GA [3]

Core Viewpoint - Belite Bio, Inc has entered into a definitive agreement for the immediate exercise of outstanding warrants, which will generate approximately US$28.75 million in gross proceeds for the company [1][2]. Group 1: Financial Details - The company will exercise warrants to purchase up to 651,380 ordinary shares at an exercise price of US$44.14 per share [1]. - The new warrants will allow the purchase of the same number of ordinary shares at an exercise price of US$70.00 per share, potentially generating an additional US$45.6 million if fully exercised [3]. Group 2: Regulatory and Compliance - The ordinary shares from the warrant exercise are registered under an effective registration statement filed with the SEC [2]. - The new warrants are offered in a private placement and have not been registered under the Securities Act of 1933, meaning they cannot be sold in the U.S. without proper registration or exemption [4]. Group 3: Company Overview - Belite Bio is focused on developing novel therapeutics for degenerative retinal diseases, including atrophic age-related macular degeneration and Stargardt disease type 1 [6].

Scholl , Sept. 04, 2024 (GLOBE NEWSWIRE) -- Belite Bio, IncBLTE"Belite Bio""" Hendrik P. N. Scholl Scholl AMD Belite Bio Tinlarebant Belite BioTom Lin"Hendrik Scholl Belite BioScholl 2 3 Belite Bio Tinlarebant TinlarebantHendrik Scholl" " Belite Bio"Scholl "Belite Bio, " Scholl IOB EVICR.net Swiss Association for Research in Vision and Ophthalmology, ARVO-SWISS Scholl · Wilmer · Wilmer · Hendrik SchollProgStar StudyProgStar Study 365 10 280W. Richard GreenPaul HenkindAlfred-Vogt ARVOKupfer 25 Scholl Pro Re ...

Dr. Scholl is a globally recognized leader in the field of ophthalmology and the coordinating principal investigator of the largest ever natural history study of Stargardt disease SAN DIEGO, Sept. 01, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) ("Belite Bio" or the "Company"), 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 its board of direc ...

| --- | --- | --- | |-------|--------------------------------------------------------------------------------------|-----------------------------------------------| | | | | | | Q2 2024 Financial Results Conference Call August 12, 2024, 4:30 p.m. ET Nasdaq: BLTE | | | | | For more info please visit: www.belitebio.com | Forward-Looking Statements and Legal Disclaimer This presentation (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, r ...

Belite Bio, Inc (NASDAQ:BLTE) Q2 2024 Earnings Conference Call August 12, 2024 4:30 PM ET Company Participants Tom Lin - Chairman and Chief Executive Officer Nathan Mata - Chief Scientific Officer Hao-Yuan Chuang - Chief Financial Officer Conference Call Participants Basma Radwan - Leerink Partners Jennifer Kim - Cantor Yi Chen - H.C. Wainwright Bruce Jackson - Benchmark Operator Hello, and thank you for joining us to discuss Belite Bio's Second Quarter 2024 Financial Results. Joining the call today are Dr. ...

Tinlarebant, a novel oral therapy, is intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Phase 1b & 2/3 ("DRAGON II") trial of Tinlarebant in adolescent STGD1 patients has been initiated and have completed enrollment for Phase 1b with six subjects in Japan Tinlarebant granted Orphan Drug and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1 Pivotal global Phase 3 ...

SAN DIEGO, Aug. 08, 2024 (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 Dr. Nathan Mata, Chief Scientific Officer of Belite Bio, will present a corporate update at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference. A webcast of the presentation will be available on Thursday, August 15, 2 ...

Sakigake designation was established by MHLW to accelerate drug approval process in Japan for innovative drugs with prominent effectiveness targeting serious diseases, in order to make them available to patients in Japan ahead of the rest of the world, by providing (a) prioritized consultation, (b) pre-application consultation, (c) prioritized review, (d) assignment of a review partner, and (e) extension of re-examination period. Stargardt Disease (STGD1) SAN DIEGO, June 12, 2024 (GLOBE NEWSWIRE) -- Belite ...