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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
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]
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
[Introduction & Corporate Update](index=1&type=section&id=Introduction%20%26%20Corporate%20Update) The CEO highlighted 2023 milestones, including Phase 3 trial initiations and positive Phase 2 data, with further updates planned for 2024 [CEO's Statement & 2023 Highlights](index=1&type=section&id=CEO%27s%20Statement%20%26%202023%20Highlights) The CEO highlighted 2023 as a productive year, marked by the initiation of the Phase 3 GA trial, completion of enrollment for the Phase 3 Stargardt disease trial, and positive 24-month data from the Phase 2 Stargardt trial - The CEO emphasized key 2023 milestones: initiating the Phase 3 GA trial, completing enrollment for the Phase 3 Stargardt disease trial, and obtaining positive 24-month data from the Phase 2 Stargardt trial[26](index=26&type=chunk) - The company plans to share additional analysis from its Phase 2 Stargardt trial at the ARVO annual meeting in May and expects one-year interim data from the Phase 3 DRAGON trial later in 2024[26](index=26&type=chunk) [Clinical Development Update](index=1&type=section&id=Clinical%20Development%20Update) Updates on Tinlarebant's clinical progress include ongoing Phase 3 trials for Stargardt Disease and Geographic Atrophy, building on positive Phase 2 data [Tinlarebant (LBS-008) Overview](index=1&type=section&id=Tinlarebant%20%28LBS-008%29%20Overview) Tinlarebant is an oral, once-daily RBP4 antagonist designed to slow disease progression in Stargardt Disease (STGD1) and Geographic Atrophy (GA) - Tinlarebant is an orally administered tablet intended to slow disease progression in patients with Stargardt Disease (STGD1) and Geographic Atrophy (GA)[11](index=11&type=chunk) - Its mechanism involves acting as a retinol binding protein 4 (RBP4) antagonist to decrease the delivery of vitamin A (retinol) to the eye, reducing the accumulation of toxic byproducts[35](index=35&type=chunk) - Tinlarebant has received Fast Track, Rare Pediatric Disease (RPD), and Orphan Drug Designations (ODD) from the FDA for STGD1[3](index=3&type=chunk) [Stargardt Disease (STGD1) Program](index=1&type=section&id=Stargardt%20Disease%20%28STGD1%29%20Program) The pivotal global Phase 3 "DRAGON" trial has completed enrollment with 104 adolescent subjects, with interim data expected in Q4 2024 - The pivotal global Phase 3 "DRAGON" trial has completed enrollment with **104 subjects** across **11 countries**, with interim data expected in **Q4 2024**[2](index=2&type=chunk)[25](index=25&type=chunk)[27](index=27&type=chunk) - Data from a 24-month Phase 2 trial showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to a similar control group (**p<0.001**)[25](index=25&type=chunk)[20](index=20&type=chunk) - In the Phase 2 trial, **42%** of Tinlarebant-treated subjects (**5 out of 12**) did not develop atrophic retinal lesions during the 24-month treatment period[34](index=34&type=chunk)[36](index=36&type=chunk) [Geographic Atrophy (GA) Program](index=1&type=section&id=Geographic%20Atrophy%20%28GA%29%20Program) The company has initiated the pivotal global Phase 3 "PHOENIX" trial for Tinlarebant in GA subjects - The pivotal global Phase 3 "PHOENIX" trial in GA subjects has been initiated, with the first patient dosed in **Q3 2023**[11](index=11&type=chunk)[4](index=4&type=chunk) - The trial is a 24-month, randomized (**2:1 active:placebo**), double-masked, placebo-controlled study targeting approximately **430 subjects**[13](index=13&type=chunk) - As of the report date, the PHOENIX trial has enrolled **56 subjects** and received approval to initiate in **eight countries**[28](index=28&type=chunk)[11](index=11&type=chunk) [Financial Results](index=4&type=section&id=Audited%20Full%20Year%202023%20and%20Unaudited%20and%20Unreviewed%20Fourth%20Quarter%202023%20Financial%20Results) The company reported a strong cash position at year-end 2023, despite an increased net loss driven by higher R&D expenses for clinical trials [Financial Highlights](index=4&type=section&id=Financial%20Highlights) Belite Bio ended 2023 with a strong cash position of **$88.2 million**, more than double the **$42.1 million** at year-end 2022, bolstered by financing activities - Cash position increased to **$88.2 million** as of December 31, 2023, compared to **$42.1 million** on December 31, 2022[37](index=37&type=chunk)[22](index=22&type=chunk) - The company raised **$22 million** from the exercise of warrants and **$29 million** from its ATM Offering as of December 31, 2023[29](index=29&type=chunk)[5](index=5&type=chunk) Net Loss Summary | Period | Net Loss | Net Loss per Share | | :--- | :--- | :--- | | **Full Year 2023** | $31.6 million | ($1.19) | | **Full Year 2022** | $12.6 million | ($0.63) | | **Q4 2023** | $7.0 million | ($0.25) | | **Q4 2022** | $6.8 million | ($0.27) | [Expense Analysis](index=4&type=section&id=Expense%20Analysis) For the full year 2023, R&D expenses surged to **$24.8 million** from **$8.9 million** in 2022, primarily due to costs associated with the DRAGON and PHOENIX Phase 3 trials - Full-year 2023 R&D expenses were **$24.8 million**, a significant increase from **$8.9 million** in 2022, primarily due to expenses for the DRAGON and PHOENIX trials[29](index=29&type=chunk) - Full-year 2023 G&A expenses were **$6.8 million**, up from **$4.0 million** in 2022, mainly due to increased share-based compensation and professional service fees[21](index=21&type=chunk) - For Q4 2023, R&D expenses were **$4.9 million** (vs. **$5.2 million** in Q4 2022), and G&A expenses were **$2.1 million** (vs. **$1.5 million** in Q4 2022)[29](index=29&type=chunk)[21](index=21&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show a significant increase in total assets and shareholders' equity, alongside higher operating expenses and net loss for 2023 [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=BELITE%20BIO%2C%20INC%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) The company's total operating expenses for FY 2023 were **$31.67 million**, a sharp increase from **$12.82 million** in FY 2022, leading to a net loss of **$31.63 million** Full Year Operations (Audited, in thousands of USD) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | 24,844 | 8,869 | | General and administrative | 6,824 | 3,952 | | **Total operating expenses** | **31,668** | **12,821** | | **Loss from operations** | **(31,668)** | **(12,821)** | | **Net loss** | **(31,632)** | **(12,648)** | Fourth Quarter Operations (Unaudited, in thousands of USD) | | Three Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | 4,862 | 5,226 | | General and administrative | 2,093 | 1,495 | | **Total operating expenses** | **6,955** | **6,721** | | **Net loss** | **(6,991)** | **(6,783)** | [Consolidated Balance Sheets](index=7&type=section&id=BELITE%20BIO%2C%20INC%20CONSOLIDATED%20BALANCE%20SHEETS) As of December 31, 2023, Belite Bio's total assets grew to **$94.6 million** from **$44.3 million** in the prior year, driven by a significant increase in cash to **$88.2 million** Assets (in thousands of USD) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash | 88,157 | 42,089 | | Total current assets | 89,940 | 42,807 | | **TOTAL ASSETS** | **94,642** | **44,273** | Liabilities and Shareholders' Equity (in thousands of USD) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Total current liabilities | 3,633 | 2,104 | | **TOTAL LIABILITIES** | **4,211** | **2,772** | | **Total shareholders' equity** | **90,431** | **41,501** | | **TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY** | **94,642** | **44,273** | [Other Information](index=4&type=section&id=Other%20Information) The company announced a webcast to discuss results and provided important cautions regarding forward-looking statements and associated risks [Webcast and Contact Information](index=7&type=section&id=Webcast%20and%20Contact%20Information) The company announced it would host a webcast on March 12, 2024, to discuss financial results and provide a business update - A webcast was scheduled for **March 12, 2024**, at **4:30 p.m. Eastern Time** to discuss financial results and provide a business update[16](index=16&type=chunk)[30](index=30&type=chunk) - Contact information for Media and Investor Relations is provided in the report[24](index=24&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Important%20Cautions%20Regarding%20Forward%20Looking%20Statements) This press release includes forward-looking statements concerning clinical data, development timelines, regulatory milestones, and the potential efficacy of Tinlarebant - The report contains forward-looking statements regarding the company's expectations for clinical development, regulatory milestones, and commercialization of its product candidates[17](index=17&type=chunk) - Key risks that could cause actual results to differ include the ability to demonstrate safety and efficacy, clinical results not supporting further development, and the timing of regulatory decisions[17](index=17&type=chunk)
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].