Core Viewpoint - Belite Bio, Inc has announced a public offering of 2,272,727 American Depositary Shares (ADSs) at a price of $154.00 per ADS, aiming to raise approximately $350 million for commercialization and pipeline development [1][2]. Group 1: Offering Details - The public offering consists of 2,272,727 ADSs priced at $154.00 each, with an additional option for underwriters to purchase up to 340,909 more ADSs [1]. - The expected gross proceeds from the offering are approximately $350 million before deducting underwriting discounts and commissions [1]. - The closing of the offering is anticipated to occur around December 3, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated for commercialization preparation, including building an in-house commercialization team and establishing sales networks [2]. - Funds will also be used for the development and expansion of the company's drug pipeline [2]. - Additional proceeds will support working capital and other general corporate purposes [2]. Group 3: Company Overview - Belite Bio is focused on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs, such as Stargardt disease type 1 and geographic atrophy in advanced dry age-related macular degeneration [6]. - The company's lead candidate, Tinlarebant, is an oral therapy aimed at reducing bisretinoid toxins in the eye and has completed a Phase 3 trial in adolescent STGD1 subjects [6].

Core Viewpoint - Belite Bio is experiencing positive market sentiment due to the successful results of its experimental drug for a rare genetic eye disease, leading to a new price target set by H.C. Wainwright, indicating potential growth in the company's market performance [1][2][5] Company Performance - Belite Bio's stock is currently priced at $147.01, reflecting a 6.96% increase following the positive trial results [3][5] - The stock has shown significant volatility, with a trading range between $130.06 and $159.71, and a yearly high of $154.99 and a low of $49 [3] - The company's market capitalization is approximately $5.13 billion, indicating a substantial presence in the biopharmaceutical industry [4] Market Sentiment - H.C. Wainwright has set a new price target of $185 for Belite Bio, representing a 20.4% potential upside from its current trading price [1][5] - The positive trial results and the new price target have likely driven active investor interest, as evidenced by a trading volume of 651,051 shares [4]

Core Viewpoint - Belite Bio is nearing the commercialization of its leading drug candidate, tinlarebant, following positive results from a phase 3 trial, which significantly boosted its stock price by 12% [1][2]. Group 1: Drug Candidate and Trial Results - Tinlarebant met its primary endpoint in a phase 3 trial aimed at treating adolescents with Stargardt disease, a condition that can lead to loss of central vision [2][4]. - The drug demonstrated a nearly 36% reduction in lesion growth compared to a placebo, indicating its efficacy in slowing the progression of the disease [3]. - Minimal change in visual acuity was recorded after 24 months, further supporting the drug's potential [3]. Group 2: Company Statements and Future Plans - CEO Tom Lin highlighted that tinlarebant is the first oral treatment to show a clinically meaningful outcome in retinal degenerative disease [4]. - Belite Bio plans to submit New Drug Applications for tinlarebant in the first half of next year, indicating a proactive approach towards regulatory approval [4]. Group 3: Market Reaction and Financial Data - Following the announcement, Belite Bio's stock price rose to $16.58, reflecting a market capitalization of $5 billion [5]. - The stock's trading range for the day was between $130.06 and $154.99, with a 52-week range of $49.00 to $154.99 [6].

Core Viewpoint - Belite Bio Inc. has received a stock upgrade to "Buy" with a price target increase, driven by positive trial results for its drug Tinlarebant targeting a rare eye disease [1][5]. Group 1: Stock Performance - H.C. Wainwright upgraded Belite Bio's stock from a price target of $98 to $185, reflecting strong market sentiment [1][5]. - Following the successful trial results, the stock price rose to approximately $153.59, marking an increase of about 11.75% or $16.15 [4]. - The stock has fluctuated between $130.06 and $154.99, with the latter being its highest price in the past year [4]. - Belite Bio's market capitalization is approximately $5.36 billion, with a trading volume of 596,581 shares, indicating strong investor interest [4]. Group 2: Clinical Trial Results - The Phase 3 DRAGON trial for Tinlarebant demonstrated a 36% reduction in lesion growth compared to placebo, marking a significant milestone for treating Stargardt disease type 1 (STGD1) [2][5]. - The trial enrolled 104 patients and is noted as the first successful pivotal trial for STGD1, a rare eye disease causing progressive vision loss [2]. Group 3: Future Plans - Belite Bio plans to file a New Drug Application (NDA) with the FDA in the first half of 2026, which is a crucial step towards commercialization [3][5]. - Tinlarebant works by lowering serum retinol binding protein 4 (RBP4) levels, thereby reducing harmful bisretinoids in the eye, offering hope for over 50,000 STGD1 patients in the U.S. [3].

SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it has commenced an underwritten public offering of American Depositary Shares (“ADSs”), each representing one of its ordinary shares. All of the securities in the offering are to be sold by Belite Bio. In addition, B ...

PresentationLadies and gentlemen, thank you for joining us, and welcome to Belite Bio's Phase III DRAGON Topline Results Conference Call. [Operator Instructions] I will now hand the conference over to Nathan Mata. Please go ahead.Nathan L. MataChief Scientific Officer Welcome, everyone, to the webcast presentation of topline data from our 2-year Phase III trial of Tinlarebant in Stargardt disease. This pivotal trial is known as the DRAGON study and is the largest interventional trial ever conducted in adole ...

Core Insights - Belite Bio Inc. announced successful topline results from the Phase 3 DRAGON trial of Tinlarebant for treating Stargardt disease type 1 (STGD1), marking a significant milestone in the development of therapies for this condition [1] Group 1: Trial Results - The Phase 3 DRAGON trial enrolled 104 patients and demonstrated a statistically significant reduction in lesion growth rate of 35.7% compared to placebo (p-value of 0.0033) [3] - A treatment effect was also observed in the fellow eye, with a 33.6% reduction in lesion growth (p = 0.041) [3] - Tinlarebant slowed decreased autofluorescence (DAF) lesion growth by 33.7% in the study eye (p = 0.027) and 32.7% in the fellow eye (p = 0.017) [4] Group 2: Mechanism of Action - Tinlarebant reduces the accumulation of vitamin A-based toxins (bisretinoids) by modulating retinol transport to the eye, specifically by reducing serum retinol binding protein 4 (RBP4) levels [2] - The 5 mg daily dose achieved an approximate 80% reduction in RBP4 levels relative to baseline, with levels returning to 84% of baseline at the end of the study [4] Group 3: Safety and Future Plans - The safety profile of Tinlarebant was consistent with previous reports, with only four treatment-related discontinuations noted [6] - The company plans to engage regulatory authorities and submit New Drug Applications for Tinlarebant in the first half of 2026 [6] Group 4: Market Reaction - Following the announcement, Belite Bio Inc.'s stock rose by 11.3%, reaching $153.05 during premarket trading [6]

Summary of Belite Bio's Phase Three DRAGON Study Conference Call Company and Industry - **Company**: Belite Bio - **Industry**: Biotechnology, specifically focusing on treatments for retinal diseases, particularly Stargardt disease Core Points and Arguments 1. **Study Overview**: The DRAGON Study is a phase three trial evaluating Tinlarebant for treating Stargardt disease, the largest interventional trial conducted in adolescent patients with this condition [2][4][6] 2. **Significant Results**: Tinlarebant demonstrated a statistically significant and clinically meaningful reduction in the annualized rate of lesion growth in Stargardt disease, achieving a treatment effect size of 36% compared to placebo [17][24] 3. **Mechanism of Action**: Tinlarebant is an orally administered small molecule that targets retinal binding protein 4 (RBP4) to reduce vitamin A delivery to the eye, thereby slowing disease progression [5][24] 4. **Patient Impact**: The slowing of lesion growth is expected to lead to a longer preservation of vision, allowing patients to maintain daily activities longer [26][32] 5. **Safety Profile**: The treatment maintained an excellent safety and tolerability profile over the two-year study period, with no serious treatment-related adverse events reported [22][23][33] 6. **Regulatory Pathway**: Belite Bio plans to submit the full data package to regulatory agencies, with confidence that the DDAF (definitely decreased autofluorescence) endpoint will be accepted for approval [41][48] Additional Important Content 1. **Epidemiology**: Stargardt disease affects approximately 53,000 people in the U.S. and over 100,000 in Europe and China, making it one of the most prevalent inherited retinal diseases [8][57] 2. **Visual Acuity Findings**: Best-corrected visual acuity did not show significant changes over the study duration, which aligns with the natural history of Stargardt disease [20][21] 3. **Fellow Eye Data**: Statistically significant treatment effects were also observed in the fellow eye, providing strong confirmatory evidence for the treatment's efficacy [18][52] 4. **Market Potential**: The estimated patient population for Stargardt disease is around 50,000 in the U.S., with expectations of increased diagnosis rates following the introduction of a treatment [56][57] 5. **Future Directions**: The company aims to transform the management of Stargardt disease by shifting focus to earlier diagnosis and treatment, potentially before significant vision loss occurs [35][36] This summary encapsulates the key findings and implications from the conference call regarding Belite Bio's Tinlarebant and its potential impact on the treatment of Stargardt disease.

Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in a global Phase 3 trial for Stargardt disease, achieving a statistically significant p-value of 0.0033Tinlarebant met the primary efficacy endpoint, demonstrating clinical benefit by significantly reducing the lesion growth rate by 36% compared to placebo, as measured by retinal imagingTinlarebant was well tolerated throughout the trial Stargardt disease impacts more than 50,000 patients in the U.S. Belite Bio plans to file an ...

Financial Data and Key Metrics Changes - For Q3 2025, the company reported R&D expenses of $10.3 million, an increase from $6.8 million in the same period last year, primarily due to expenses related to the DRAGON and Phoenix trials [5] - G&A expenses rose to $12.7 million from $2.9 million year-over-year, driven by increased share-based compensation expenses [5] - The net loss for Q3 2025 was $21.7 million, compared to a net loss of $8.7 million for the same period last year [5] - Total operating cash outflow for Q3 was approximately $9.3 million, similar to $8.6 million in Q2 [6] - At the end of Q3, the company had $275.6 million in cash and liquidity from time deposits and US Treasury bills [6] Business Line Data and Key Metrics Changes - The company completed enrollment for the phase 3 Phoenix trial with 530 subjects and the phase 3 DRAGON trial, with approximately 35 subjects enrolled out of a targeted 60 [3][4] - Positive feedback was received from regulatory authorities, including China's NMPA and the U.K.'s MHRA, regarding the DRAGON trial [4] Market Data and Key Metrics Changes - The company is preparing for submissions in multiple regions, including the U.S., Japan, and the U.K., with a focus on maintaining a consistent data package across regulatory agencies [8][14] - The company plans to submit applications in the first half of 2026 for regulatory approval in China and the U.K. [8] Company Strategy and Development Direction - The company is focused on advancing clinical trials and preparing for commercialization, with a strong balance sheet to support these efforts [6] - The U.S. market is prioritized for commercialization, with plans to apply for NDA in all regions, while seeking partnerships for other markets [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong foundation provided by the DRAGON trial for global submissions and potential approvals [4] - The company estimates that approximately $200 million will be needed for the commercialization of Saga in the U.S. [25] Other Important Information - The company completed a $50 million registered direct offering and a $125 million private placement, with potential for an additional $165 million upon full bond exercise [4] - The increase in share-based compensation expenses was a significant factor in the overall expense increase [6] Q&A Session Summary Question: Has the application been submitted to regulatory agencies in China and the U.K.? - The company plans to submit applications in the first half of 2026 [8] Question: What is the current amount of shares outstanding? - The total outstanding shares are approximately 35 million [10] Question: When will the application be submitted in Japan? - The expected timeline for submission in Japan is also the first half of 2026 [14] Question: Will there be an interim analysis for the Phoenix trial similar to the DRAGON trial? - Yes, an interim analysis is planned for the second half of next year [16] Question: What should be assumed as the baseline level for SG&A expenses going forward? - It is difficult to estimate a clear baseline due to the variability related to share price and ESOP [18] Question: What steps are being taken to prepare for potential approval and launch? - The focus is on the U.S. market, with plans to start with a sales force of 20 to 40 people [23] Question: Is the current cash sufficient for commercial preparation and launch? - The company estimates that $200 million will be needed for commercialization, and believes current cash should be sufficient [25] Question: Did the U.K. request the same interim information as the U.S. FDA? - Yes, the same dataset was presented to both the U.K. and China [30]