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 ...

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 ...

[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)

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, Inc. (NASDAQ:BLTE) Q3 2023 Earnings Conference Call November 14, 2023 4:30 PM ET Â Company Participants Tom Lin - Chairman and Chief Executive Officer Basma Radwan - Leerink Partners Yi Chen - HC Wainwright Hello and thank you for joining us to discuss BeliteÂ's Third Quarter 2023 Financial Results. Joining the call is Dr. Tom Lin, Chairman and CEO, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Wan Zhang, Chief Financial Officer of BeLite Bio. Before we begin, let me point out that we will ...

| --- | --- | --- | |-------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------| | | | | | | | | | | Early Intervention with | | | | Mission for Vision Nasdaq: BLTE Media and Investor Relations Contact: Jennifer Wu / ir@belitebio.com an Oral Treatment for Macular Degeneration | | Any statements in this presentation about Belite Bio's future expectations, plans and prospects constitute forward-looking state ...

Conference Call Participants Basma Radwan - Leerink Partners Operator Good morning, and welcome to the Belite Bio Q2 2023 Financial Results Conference Call. At this time, all attendees are in a listen-only mode. A question-and-answer session will follow the formal presentations. [Operator Instructions] As a reminder, this call is being recorded and a replay will be made available on the Belite Bio website following the conclusion of the event. With that, IÂ'd like to turn the call over to your host Tom Lin, ...

Clinical Trial & Results (STGD1) - Belite Bio's Tinlarebant (LBS-008) is in Phase 3 clinical trials for Stargardt Disease (STGD1)[6, 21] - Phase 2 interim data showed a 60% reduction in mean DAF lesion growth rate compared to a prospective cohort study[48] - In the Phase 2 study, 58.3% of subjects showed no development of DDAF at the 18-month timepoint[27] - In the Phase 2 study, plasma RBP4 levels were reduced by approximately 80% relative to baseline during daily dosing at 5 mg over 18 months[46] - In the Phase 2 study, the mean change in BCVA (ETDRS letters lost) within the study cohort over 18 months of treatment was -3 ± 1 letters in the Study eye and -2 ± 2 letters in the Fellow eye[31] Clinical Trial & Results (GA) - Belite Bio's Tinlarebant is in Phase 3 clinical trials for Geographic Atrophy (GA)[7, 21] - Phase 2 interim data continues to show slowing of lesion growth; 24-month data expected in Q4 2023[7] - Belite Bio believes that early intervention directed at emerging retinal pathology, which is not mediated by inflammation, would be the best approach to potentially slow disease progression in STGD1 & GA[7] Financial Status - Belite Bio's cash position is $57.4 million[65] - Total operating expenses for the three months ended June 30, 2023 were $6.871 million, including $5.516 million in R&D expenses and $1.355 million in G&A expenses[70] - Net loss for the three months ended June 30, 2023 was $(6.811) million[70]

Belite Bio, Inc (NASDAQ:BLTE) Q1 2023 Earnings Conference Call May 11, 2023 8:00 AM ET Operator Thank you, Tara. Thank you, everyone, for joining our financial results for first quarter 2023. Joining me today is our CSO, Nathan Mata, who will be updating our recent clinical trial progress; and our CFO, Hao-Yuan, who will be updating our Q1 financial results. And now I would like to pass it on to our CSO to give an update on our clinical trials. Nathan? In fact, we've had interim analyses that's periodically ...

Belite Bio, Inc (NASDAQ:BLTE) Q4 2022 Earnings Conference Call April 3, 2023 4:30 PM ET Company Participants Tom Lin - Chief Executive Officer Nathan Mata - Chief Scientific Officer Hao-Yuan Chuang - Chief Financial Officer Conference Call Participants Jennifer Kim - Cantor Fitzgerald Lachlan Hanbury-Brown - William Blair Yi Chen - H.C. Wainwright Bruce Jackson - The Benchmark Company Yuan Zhi - B. Riley Securities Operator Good afternoon and welcome to the Belite Bio 2022 Full Year Financial Results Confer ...