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 (BLTE) Q4 2024 Earnings Call March 17, 2025 10:58 PM ET Company Participants Julie Fallon - Managing DirectorYu-Hsin Lin - Chairman of the Board of Directors & CEONathan L. Mata - Chief Scientific OfficerHendrik Scholl - CMOHao-Yuan Chuang - CFO & DirectorJennifer Kim - Equity Research DirectorBasma Radwan - Equity Research AssociateYi Chen - Managing Director, Equity Research Conference Call Participants Bruce Jackson - Senior AnalystMichael Okunewitch - Senior Biotechnology Analyst Operator Lad ...

Exhibit 99.1 · Following a pre-specified interim analysis, the Data Safety Monitoring Board (DSMB) recommended the DRAGON trial, a pivotal Phase 3 trial in adolescent Stargardt 1 (STGD1) subjects, proceed without any modification; trial completion expected Q4 2025 (including a three-month follow-up period) · Pivotal global Phase 3 PHOENIX trial of Tinlarebant in geographic atrophy (GA) subjects is ongoing with 406 subjects enrolled · Raised $15 million in gross proceeds in a registered direct of ering on Fe ...

Product Development and Regulatory Approval - The company is highly dependent on the success of its lead product candidate, Tinlarebant, which is currently in clinical trials for the treatment of autosomal recessive Stargardt disease (STGD1) [28]. - The company currently has no products approved for commercial sale and may never be able to develop marketable products, making investment riskier compared to companies with multiple late-stage product candidates [28]. - Significant delays in obtaining regulatory approvals for Tinlarebant could adversely affect the company's business and financial condition [42]. - The success of Tinlarebant will depend on successful completion of ongoing clinical trials and timely receipt of marketing approvals from regulatory authorities [30]. - The company faces risks related to the regulatory approval processes, which are time-consuming and may evolve over time [25]. - The regulatory approval process for the company's product candidates is expensive and may take many years, with potential delays due to additional required clinical trials [72]. - The company has never obtained marketing approval for any product candidate, and regulatory authorities may require additional trials or studies before reconsidering applications [73]. - The company may need to conduct additional clinical trials if initial results are not positive, which could delay regulatory approval and commercialization prospects [58]. - The inability to obtain marketing approvals could prevent the commercialization of product candidates, significantly harming the business [74]. - Regulatory authorities may impose additional restrictions or require recalls if product candidates are found to be less effective or cause undesirable side effects post-approval [75]. - The company may face challenges in obtaining regulatory approvals from authorities such as the FDA, TGA, NMPA, EMA, and PMDA, which can be time-consuming and uncertain [121]. - Regulatory approval processes may require additional preclinical or clinical data, potentially delaying commercialization plans [124]. - Ongoing regulatory obligations post-approval may lead to significant additional expenses and potential penalties for non-compliance [138]. Financial Performance and Funding - The company has incurred significant net operating losses of approximately US$12.6 million, US$31.6 million, and US$36.1 million for the years ended December 31, 2022, 2023, and 2024, respectively, with an accumulated deficit of approximately US$107.6 million as of December 31, 2024 [115]. - The company expects to continue incurring substantial expenses related to ongoing clinical trials and research and development efforts, which will require additional funding [107]. - The net cash used in operating activities was approximately US$11.5 million, US$29.8 million, and US$29.2 million for the years ended December 31, 2022, 2023, and 2024, respectively [106]. - The company has no products approved for commercial sale and has not generated any revenue from product sales, indicating a high level of uncertainty regarding future profitability [112]. - The company anticipates that its expenses will increase significantly as it seeks regulatory approvals and commercializes its product candidates [116]. - The company has recorded net cash outflow from operating activities since its inception, indicating a need for additional financing to fund operations [105]. - The company may seek additional funding through equity offerings, debt financings, collaborations, and licensing arrangements, which could dilute existing shareholders' ownership [119]. Clinical Trials and Patient Enrollment - The timely completion of clinical trials is contingent on the ability to enroll a sufficient number of patients, which may be affected by various factors [48]. - Clinical trials may face competition for patient enrollment, which could limit the number and types of patients available for the company's trials [53]. - The company may incur additional costs or experience delays if clinical trials do not demonstrate safety and efficacy to the satisfaction of regulatory authorities [54]. - Manufacturing issues, including supply quality and compliance with good manufacturing practices, could significantly impact the company's clinical trials and product availability [71]. Intellectual Property and Competition - The company holds a portfolio of 23 issued U.S. patents and 9 pending U.S. patent applications, along with 23 issued foreign patents and 44 pending foreign patent applications, providing protection in multiple regions [151]. - The patent position of the company is uncertain, and challenges to patent validity could limit competitive advantages [152]. - The company may face increased competition if a competitor's drug is approved earlier for the same condition, potentially impacting market share despite orphan drug exclusivity [134]. - Competition in the biopharmaceutical industry is intense, with competitors potentially achieving regulatory approval and market penetration faster [82]. - The company may face claims regarding the wrongful use of trade secrets from former employers of its employees, which could lead to litigation and loss of intellectual property rights [185]. - There is a risk of costly litigation if third parties claim that the company's products infringe on their intellectual property rights [193]. Operational Risks and Management - The company must maintain an effective system of internal controls to accurately report its results and prevent fraud, as failure to do so could adversely affect investor confidence [25]. - The adequacy of the company's internal control over financial reporting is crucial for maintaining investor confidence and preventing material misstatements [205]. - The company may experience difficulties in managing growth as it plans to significantly increase the number of employees and consultants [216]. - The company is exposed to risks of misconduct by employees and contractors, which could harm its reputation and financial standing [215]. - The company may not be able to effectively manage outsourced activities, potentially leading to delays in regulatory approvals [217]. Market and Commercialization Challenges - Market acceptance of product candidates is crucial for commercial success, and failure to achieve this could result in insufficient revenue generation [79]. - Reimbursement for approved product candidates may be limited or unavailable, impacting the ability to commercialize successfully [89]. - The potential market opportunity for the company's product candidates may be limited, depending on regulatory approvals and market acceptance [98]. - Legislative changes, such as the ACA, may impose additional costs and requirements on the company, affecting marketing approvals and pricing strategies [146]. Risks Related to Manufacturing and Supply Chain - The company relies entirely on third-party contractors for cGMP manufacturing capabilities, which poses risks of delays in clinical supply and commercialization if issues arise [70]. - The company relies on third parties for conducting clinical trials and manufacturing, and any failure in these relationships could harm its business [25]. - The company maintains liability insurance for clinical trials, but coverage may be insufficient for product liability claims [219].

Core Insights - Belite Bio, Inc is advancing its clinical development of Tinlarebant, a novel therapeutic for degenerative retinal diseases, with significant progress in the Phase 3 DRAGON trial for Stargardt disease type 1 (STGD1) [2][3][4] Financial Results - As of December 31, 2024, the company reported cash of $31.7 million, a decrease from $88.2 million on December 31, 2023 [8][20] - The company had $113.5 million in investments as of December 31, 2024, compared to none on December 31, 2023 [8][20] - For the year ended December 31, 2024, research and development expenses were $29.9 million, up from $24.8 million in 2023 [10][18] - General and administrative expenses for the year ended December 31, 2024, were $10.1 million, compared to $6.8 million in 2023 [11][18] - The net loss for the year ended December 31, 2024, was $36.1 million, or ($1.18) per share, compared to a net loss of $31.6 million, or ($1.19) per share in 2023 [13][18] Clinical Development Highlights - The DRAGON trial for STGD1 subjects is ongoing, with completion expected in Q4 2025, following a positive interim analysis by the Data Safety Monitoring Board (DSMB) [4][5] - The PHOENIX trial for geographic atrophy (GA) subjects is also ongoing, with 406 subjects enrolled and an increased sample size target of 500 [14] - Tinlarebant has received multiple designations, including Fast Track and Orphan Drug Designation in the U.S. for STGD1 [5][16] Corporate Actions - The company raised $15 million in gross proceeds through a registered direct offering on February 5, 2025, with potential additional proceeds from warrant exercises [4][7] - A conference call and webcast were scheduled for March 17, 2025, to discuss financial results and business updates [15]

Group 1 - Belite Bio, Inc is a clinical-stage biopharmaceutical company focused on developing therapies for degenerative retinal diseases and specific metabolic diseases [2] - The company has filed its annual report on Form 20-F for the year ended December 31, 2024, with the Securities and Exchange Commission [1] - Belite's lead candidate, Tinlarebant, is currently undergoing multiple clinical trials, including a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) for Stargardt disease type 1, as well as a Phase 3 study (PHOENIX) for Geographic Atrophy [2] Group 2 - The annual report is available on the company's website, and shareholders can request a hard copy free of charge [1] - Belite Bio targets significant unmet medical needs in retinal diseases, such as Stargardt disease type 1 and Geographic Atrophy in advanced dry age-related macular degeneration [2]