Financial Data and Key Metrics Changes - For Q3 2025, the company reported R&D expenses of $10.3 million, an increase from $6.8 million in the same period last year, primarily due to expenses related to the DRAGON and Phoenix trials [5] - G&A expenses rose to $12.7 million from $2.9 million year-over-year, driven by increased share-based compensation expenses [5] - The net loss for Q3 2025 was $21.7 million, compared to a net loss of $8.7 million for the same period last year [5] - Total operating cash outflow for Q3 was approximately $9.3 million, similar to $8.6 million in Q2 [6] - At the end of Q3, the company had $275.6 million in cash and liquidity from time deposits and US Treasury bills [6] Business Line Data and Key Metrics Changes - The company completed enrollment for the phase 3 Phoenix trial with 530 subjects and the phase 3 DRAGON trial, with approximately 35 subjects enrolled out of a targeted 60 [3][4] - Positive feedback was received from regulatory authorities, including China's NMPA and the U.K.'s MHRA, regarding the DRAGON trial [4] Market Data and Key Metrics Changes - The company is preparing for submissions in multiple regions, including the U.S., Japan, and the U.K., with a focus on maintaining a consistent data package across regulatory agencies [8][14] - The company plans to submit applications in the first half of 2026 for regulatory approval in China and the U.K. [8] Company Strategy and Development Direction - The company is focused on advancing clinical trials and preparing for commercialization, with a strong balance sheet to support these efforts [6] - The U.S. market is prioritized for commercialization, with plans to apply for NDA in all regions, while seeking partnerships for other markets [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong foundation provided by the DRAGON trial for global submissions and potential approvals [4] - The company estimates that approximately $200 million will be needed for the commercialization of Saga in the U.S. [25] Other Important Information - The company completed a $50 million registered direct offering and a $125 million private placement, with potential for an additional $165 million upon full bond exercise [4] - The increase in share-based compensation expenses was a significant factor in the overall expense increase [6] Q&A Session Summary Question: Has the application been submitted to regulatory agencies in China and the U.K.? - The company plans to submit applications in the first half of 2026 [8] Question: What is the current amount of shares outstanding? - The total outstanding shares are approximately 35 million [10] Question: When will the application be submitted in Japan? - The expected timeline for submission in Japan is also the first half of 2026 [14] Question: Will there be an interim analysis for the Phoenix trial similar to the DRAGON trial? - Yes, an interim analysis is planned for the second half of next year [16] Question: What should be assumed as the baseline level for SG&A expenses going forward? - It is difficult to estimate a clear baseline due to the variability related to share price and ESOP [18] Question: What steps are being taken to prepare for potential approval and launch? - The focus is on the U.S. market, with plans to start with a sales force of 20 to 40 people [23] Question: Is the current cash sufficient for commercial preparation and launch? - The company estimates that $200 million will be needed for commercialization, and believes current cash should be sufficient [25] Question: Did the U.K. request the same interim information as the U.S. FDA? - Yes, the same dataset was presented to both the U.K. and China [30]

Q3 2025 Financial Results Conference Call B E L I T E B I O / 2 November 10, 2025, 4:30 p.m. ET Nasdaq: BLTE Tom Lin, MMED, PhD, MBA (Chairman, CEO) For more info please visit: www.belitebio.com Experienced Leadership Team Belite Management Team Hao-Yuan Chuang, CFA, MBA, FRM (CFO) 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, represent or form part of any offer, i ...

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]

Early Intervention with an Oral Treatment for Macular Degeneration Mission for Vision Nasdaq: BLTE B E L I T E B I O / 1 Forward-Looking Statements and Legal Disclaimer Market data and industry information used throughout this presentation are based on the knowledge of the industry and the good faith estimates of Belite Bio's management. The Company also relied, to the extent available, upon management's review of independent industry surveys and publications and other publicly available information prepare ...

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] - The company will host a webcast on November 10, 2025, to discuss its financial results and provide a business update for Q3 2025 [1][2] Company Overview - Belite Bio targets degenerative retinal diseases such as Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD) [3] - The lead candidate, Tinlarebant, is an oral therapy aimed at reducing toxin accumulation in the eye, currently evaluated in multiple clinical studies [3]

Core Insights - Belite Bio, Inc. has received acceptance from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for a Conditional Marketing Authorization application for Tinlarebant, aimed at treating Stargardt disease based on interim analysis results from the Phase 3 DRAGON trial [1][3][8] 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 in advanced dry age-related macular degeneration [6] - The lead candidate, Tinlarebant, is an oral therapy designed to reduce the accumulation of vitamin A-based toxins in the eye, which are implicated in retinal diseases [5][6] 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 [4] - The primary efficacy endpoint of the trial is the growth rate of atrophic lesions, alongside safety and tolerability assessments [4] Regulatory Progress - The interim analysis results from the DRAGON trial met the criteria for the Conditional Marketing Authorization application, with final topline data expected to be reported in Q4 2025 [3][8] - The company is optimistic about the global submissions and potential approvals based on consistent feedback from major regulatory agencies [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 [1][3] - The company will present at the dbVIC - Deutsche Bank American Depositary Receipt Virtual Investor Conference on November 4th, 2025 [1][2] - Belite's lead candidate, Tinlarebant, is currently in multiple clinical trials targeting conditions such as STGD1 and GA [3] Company Overview - Belite Bio specializes in developing therapies for degenerative retinal diseases, including STGD1 and GA in advanced dry AMD, as well as specific metabolic diseases [3] - The lead candidate, Tinlarebant, is an oral therapy aimed at reducing bisretinoid toxin accumulation in the eye and is being evaluated in Phase 3 and Phase 2/3 studies [3] Event Details - The virtual conference will allow real-time interaction between investors and the company, with an archived webcast available for those unable to attend live [2] - Participation in the event is free of charge, and pre-registration is recommended for a smoother experience [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 [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]