Financial Performance - Total operating expenses for Q3 2025 were $23018 thousand, compared to $9740 thousand in Q3 2024[16] - R&D expenses for Q3 2025 were $10307 thousand[16] - G&A expenses for Q3 2025 were $12711 thousand[16] - Net loss for Q3 2025 was $21690 thousand, compared to a net loss of $8679 thousand in Q3 2024[16] - The company's cash, liquidity fund, time deposits, and U S treasury bills totaled $2756 million[16] - Total operating cash outflow for the third quarter was approximately $93 million, compared to $86 million in the second quarter[16] Pipeline and Regulatory Updates - The company completed a $15 million registered direct offering and a $125 million private placement, with potential for an additional $165 million upon full warrant exercise[13] - The pivotal phase 3 DRAGON trial in Stargardt disease (STGD) has been completed, with topline data expected in Q4 2025[13] - China's NMPA has agreed to accept a New Drug Application with priority review for Tinlarebant for the treatment of Stargardt disease based on interim analysis results of the DRAGON trial[13] - The United Kingdom's MHRA has agreed to accept a Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results of the DRAGON trial[13]

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 - The Depositary Receipts Virtual Investor Conference ("dbVIC") was held on November 4th, 2025, and the presentations are now available for online viewing [1][2] - The company presentations will be accessible 24/7 for a duration of 90 days, allowing investors, advisors, and analysts to download materials [2] Company Presentations - The following companies presented at the conference: - HUTCHMED (China) Limited (AIM: HCM, NASDAQ: HCM, HKEX: 13) - First Pacific Company Ltd (HKEX: 142, OTC: FPAFY) - Viomi Technology Co., Ltd (NASDAQ: VIOT) - Epiroc AB (Nasdaq Stockholm: EPIA, OTC: EPOAY) - Yiren Digital Ltd. (NYSE: YRD) - Belite Bio, Inc (NASDAQ: BLTE) - Deutsche Lufthansa AG (FRA: LHA, OTCQX: DLAKY) - Lotus Technology Inc (NASDAQ: LOT) - 51Talk Online Education Group (NYSE American: COE) - Radiopharm Theranostics Ltd (Nasdaq: RADX; ASX: RAD) - Repsol S.A (BME: REP, OTCQX: REPYY) [3] About Virtual Investor Conferences - Virtual Investor Conferences (VIC) is recognized as the leading proprietary investor conference series, providing an interactive platform for publicly traded companies to present directly to investors [4] - VIC offers a real-time investor engagement solution, designed to enhance investor access and replicate the components of an on-site investor conference [5]

Core Points - Belite Bio is presenting at the Deutsche Bank Virtual Investor Conference, with their ADRs listed on NASDAQ under the symbol BLTE [1][2] - The presentation is expected to last around 30 minutes and will be recorded for later access on the Deutsche Bank website [1]

Summary of Belite Bio Conference Call Company Overview - **Company**: Belite Bio - **Ticker Symbol**: BLTE (NASDAQ) - **Focus**: Development of therapeutics for Stargardt disease and age-related macular degeneration (AMD) Key Points Industry and Market Opportunity - **Stargardt Disease**: Most common inherited retinal dystrophy, affecting approximately 1 in 8,800 people, with an estimated 53,000 cases in the US and a larger population in China [9][10] - **Geographic Atrophy (GA)**: Advanced form of dry AMD, with around 1 million patients in the US [11] - **Market Gap**: No FDA-approved treatments for Stargardt disease and no orally approved treatments for GA [7] Drug Development - **Drug Name**: Timlerapat (also referred to as teleribat) - **Mechanism**: Designed to reduce toxic byproducts of vitamin A implicated in disease progression by binding to retinal binding protein 4 [7][18] - **Phase 3 Trials**: - **Dragon Study**: Completed with 104 subjects aged 12-20, focusing on Stargardt disease; top-line data expected in 3-4 weeks [5][39] - **PHOENIX Study**: Ongoing phase 3 study for GA with 530 subjects enrolled [6][55] Clinical Data and Efficacy - **Phase 2 Study Results**: Showed a 50% reduction in lesion growth in treated subjects compared to natural history data [37][38] - **Interim Analysis of Dragon Study**: Indicated a statistically significant treatment effect, leading to breakthrough therapy designation from the FDA [43] - **Safety Profile**: Withdrawal rate less than 10%, with ocular adverse events at less than 4% [44] Drug Design and Advantages - **Advantages of Timlerapat**: - Purpose-built antagonist of retinal binding protein 4, with improved bioavailability and potency compared to previous drugs like phenretinide [31][30] - Designed to be taken without regard to food, addressing compliance issues seen in earlier studies [30] Adverse Events - **Common Adverse Events**: - Xanthopsia (color perception changes) and delayed dark adaptation, both mild and transient [46][48] - No significant systemic adverse events reported, except for mild acne in some subjects [50] Future Outlook - **Positive Expectations**: Success in the Dragon study is expected to predict similar outcomes in the Dragon 2 and PHOENIX trials, reducing risk for investors [55] Conclusion Belite Bio is advancing its drug timlerapat through critical phase 3 trials for Stargardt disease and geographic atrophy, addressing significant unmet medical needs in the ophthalmology space. The company has demonstrated promising clinical data and a favorable safety profile, positioning itself for potential regulatory approval and market entry.

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]