| --- | --- | --- | |-------|-----------------------------------------------------------------------------------|-----------------------------------------------| | | | | | | Q1 2024 Financial Results Conference Call May 14, 2024, 4:30 p.m. ET Nasdaq: BLTE | | | | | For more info please visit: www.belitebio.com | 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, invitation or soli ...

Hao-Yuan Chuang On G&A expenses in Q1 2024, G&A expenses was $1.6 million compared to $1.2 million in Q1 2023. The increase was primarily due to increasing share-based compensation granted in the third quarter of 2023. In addition, we raised additional $25 million from our registered rent offering in April. We expect cash runway beyond 2026. Thank you. Back to you, Tom. Thanks, Hao. I would like to conclude with the key milestones to expect for this year. We are still making good progress in the Phase 3 in ...

SAN DIEGO, May 13, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite" 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 its financial results for the first quarter ended March 31, 2024 and provided a general business update. "It has been a strong start to 2024 with the initiation of the DRAGON II trial and the recent closing of ...

Webinar, moderated by Cantor Fitzgerald, will be held on Monday, May 13, 2024, at 2:00 p.m. ET Discussion will feature Dr. Michel Michaelides, leading expert in the field of inherited eye disease in adults and children SAN DIEGO, May 06, 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 the executive ...

Additional analysis of visual acuity loss, genotypic profiles, and retinal imaging data from a 24-month Phase 2 trial of Tinlarebant in adolescent Stargardt disease patients provides further support for the potential of Tinlarebant to slow and potentially halt lesion growthIn 5 of 12 subjects (42%) with known pathogenic ABCA4 mutations, no incident atrophic (DDAF) lesions were formed during the 24-month treatment period and no change in QDAF was observedA novel lesion size quantification method that can bet ...

Tinlarebant is Belite Bio's orally administered tablet 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)Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar baseline characteristics (aged ≤18 years) (p<0.001)In the Phase 2 trial, 42% of Tinla ...

SAN DIEGO, April 25, 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 it has entered into a securities purchase agreement with an institutional investor, for the purchase and sale of up to an aggregate of 651,380 American Depositary Shares of the Company ("ADSs"), each ...

Shares of Belite Bio, Inc. Sponsored ADR (BLTE) have gained 2.5% over the past four weeks to close the last trading session at $40.03, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $56.50 indicates a potential upside of 41.1%.The average comprises four short-term price targets ranging from a low of $50 to a high of $60, with a standard deviation of $4.51. While the lowest esti ...

Tinlarebant is Belite Bio's orally administered tablet 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)Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar baseline characteristics (aged ≤18 years) (p<0.001)In the Phase 2 trial, 42% of Tinla ...

Financial Data and Key Metrics Changes - In 2023, the company reported R&D expenses of $24.8 million, a significant increase from $8.9 million in 2022, primarily due to expenses related to the DRAGON and PHOENIX trials [8] - The net loss for 2023 was $31.6 million, compared to $12.8 million in 2022 [9] - Cash reserves increased to $88.2 million by the end of 2023, up from $42.1 million at the end of 2022, attributed to a $52 million raise from offerings and an additional $29 million from an ATM offering [9] Business Line Data and Key Metrics Changes - The company is currently in global Phase 3 trials for Stargardt disease and Geographic Atrophy (GA), with no approved treatments available for these conditions [3][18] - The Phase 3 study for Stargardt disease is fully enrolled, with interim results expected by the end of 2024 or early 2025 [18] Market Data and Key Metrics Changes - The company has received fast track designation, rare pediatric disease designation, and orphan drug designation in the U.S., EU, and Japan for its treatment [3] - The Phase 3 trial designs for Stargardt disease and GA are similar, with the same drug, dose, and endpoints [22] Company Strategy and Development Direction - The company aims to address early intervention in retinol pathology to slow disease progression in Stargardt disease and GA [17] - The strategy includes presenting findings from the Phase 2 results at major conferences and expecting interim data for Phase 3 trials later this year or early next year [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in 2023 and the potential for future advancements [11] - The company is focused on ramping up enrollment in the PHOENIX trial and expects to have sufficient cash runway to support operations through the end of 2026 [59] Other Important Information - The company has developed a new imaging algorithm that improves the detection of atrophic lesions, which may enhance treatment outcomes [61] - The mechanism of action for the drug Tinlarebant targets the underlying pathology of Stargardt disease, potentially allowing for broader patient eligibility upon approval [64] Q&A Session Summary Question: Is there a delay in the trial timeline? - The trial is fully enrolled, and interim data is expected in Q4 or early Q1 next year, depending on data cleaning and DSMB review [26][27] Question: What are the scenarios for the interim readout? - The DSMB will assess whether to continue the study as is, increase the sample size, or halt the study based on the treatment effect observed [28][31] Question: What are the thoughts on cash runway and enrollment in PHOENIX? - The company has sufficient cash to complete the DRAGON study and expects to ramp up enrollment in PHOENIX, aiming for completion by the end of 2024 [59][66] Question: How does the new imaging algorithm impact patient eligibility? - The new algorithm allows for better identification of atrophic lesions, which is crucial for validating treatment effects in clinical trials [61][63] Question: What is the expected completion timeline for the PHOENIX trial? - The goal is to complete enrollment for 129 subjects by the end of 2024, with a buffer extending into Q1 of 2025 [66]