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Belite Bio Presents Additional Analysis from Phase 2 Study of Tinlarebant in Stargardt Disease at the ARVO Annual Meeting
Newsfilter· 2024-05-06 12:00
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 ...
Belite Bio Announces Presentation at the Association for Research in Vision and Ophthalmology 2024 Annual Meeting
Newsfilter· 2024-05-01 20:15
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 ...
Belite Bio Announces $25 Million Registered Direct Offering
Newsfilter· 2024-04-25 23:15
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 ...
Does Belite Bio (BLTE) Have the Potential to Rally 41.14% as Wall Street Analysts Expect?
Zacks Investment Research· 2024-04-10 14:56
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 ...
Belite Bio Announces PMDA Submission of Tinlarebant for Stargardt Disease Clinical Trial in Japan
Newsfilter· 2024-03-22 12:00
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 ...
Belite Bio(BLTE) - 2023 Q4 - Earnings Call Transcript
2024-03-12 23:53
Belite Bio, Inc (NASDAQ:BLTE) Q4 2023 Results Conference Call March 12, 2024 4:30 PM ET Company Participants Tom Lin - Chiarman and Chief Executive Officer Nathan Mata - Chief Scientific Officer Hao-Yuan Chuang - Chief Financial Officer Conference Call Participants Jennifer Kim - Cantor Yi Chen - H.C. Wainwright Bruce Jackson - Benchmark Operator Hello, and thank you for joining us to discuss Belite Bio’s Fourth Quarter and Full-Year 2023 Financial Results. Joining the call are Dr. Tom Lin, Chairman and CEO ...
Belite Bio Announces Availability of Annual Report on Form 20-F Through Company Website
Newsfilter· 2024-03-12 02:28
SAN DIEGO, March 11, 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 its annual report on Form 20-F, containing audited consolidated financial statements for the year ended December 31, 2023, as filed with the Securities and Exchange Commission on March 11, 2024, is available through its website (ht ...
Belite Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
Newsfilter· 2024-03-12 01:27
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 ...
Belite Bio(BLTE) - 2023 Q4 - Annual Report
2024-03-11 16:00
Financial Position - As of December 31, 2023, the company had cash of approximately US$88.2 million, with no significant exposure to interest rate risk[1380]. - The company expects no significant credit risk associated with its cash, which is held by reputable financial institutions[1381]. - The company does not believe its cash has significant risk of default or illiquidity and will continue to monitor the creditworthiness of financial institutions[1380]. Financial Instruments and Risks - The company has not used any derivative financial instruments to manage interest rate risk exposure[1380]. - The company is exposed to foreign currency exchange rate fluctuations due to contracts with CROs and CMOs globally, although substantially all liabilities are denominated in U.S. dollars[1382]. - The company has incurred expenses for converting foreign currency into U.S. dollars, although specific amounts are not detailed[1370]. Shareholder Information - The company issued warrants to purchase 2,000,000 ordinary shares at an exercise price of US$18.00 per share, with 894,022 warrants remaining outstanding and exercisable as of the report date[1387]. - The Representative's Warrants issued during the IPO have an exercise price of US$7.50 per ADS and are exercisable until April 28, 2027[1383]. - The company has a service fee structure for ADS holders, including fees of up to US$0.05 per ADS for various services[1386]. Reimbursement and Payments - The company received after-tax reimbursement payments of US$66,366.49 in 2022 and US$28,442.79 in 2023 from the depositary related to the ADR program[1392].
Belite Bio(BLTE) - 2023 Q4 - Annual Report
2024-03-11 16:00
Exhibit 99.1 · Enrollment of a pivotal global Phase 3 trial of Tinlarebant in adolescent STGD1 subjects ("DRAGON") has been completed with 104 subjects across 11 countries SAN DIEGO, March 11, 2024 - 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 its audited financial results for full-year 2023 ...