Welcome to our dedicated page for Belite Bio SEC filings (Ticker: BLTE), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Belite Bio, Inc. filings document foreign-issuer disclosures for a clinical-stage biopharmaceutical company developing tinlarebant for degenerative retinal diseases. Form 6-K reports furnish press releases on clinical-trial progress, FDA-related regulatory updates, financial results, annual-report availability, material agreements, shareholder matters, and capital-structure activity involving American Depositary Shares.
The company's Form 20-F reporting framework covers audited consolidated financial statements and public-company disclosure for BLTE as a foreign private issuer. Its filing record centers on STGD1, geographic atrophy in advanced dry AMD, tinlarebant development, financing activity, governance matters, and the incorporation of furnished reports into effective Securities Act registration statements.
Belite Bio reported preliminary, unaudited fourth quarter and full-year 2025 results alongside a corporate update. The year was highlighted by positive topline data from the pivotal Phase 3 DRAGON trial of tinlarebant in Stargardt disease and completion of a $402 million public offering, strengthening the balance sheet.
As of December 31, 2025, cash and cash equivalents were $352.9 million and investments in U.S. treasuries were $419.7 million. Full-year 2025 GAAP research and development expenses were $45.4 million and selling, general and administrative expenses were $38.8 million, driving a GAAP net loss of $77.6 million, or $2.31 per share. On a non-GAAP basis, excluding share-based compensation, full-year net loss was $38.7 million. Management plans to submit an NDA for tinlarebant to the FDA in the second quarter of 2026.
Belite Bio reported preliminary, unaudited fourth quarter and full-year 2025 results alongside a corporate update. The year was highlighted by positive topline data from the pivotal Phase 3 DRAGON trial of tinlarebant in Stargardt disease and completion of a $402 million public offering, strengthening the balance sheet.
As of December 31, 2025, cash and cash equivalents were $352.9 million and investments in U.S. treasuries were $419.7 million. Full-year 2025 GAAP research and development expenses were $45.4 million and selling, general and administrative expenses were $38.8 million, driving a GAAP net loss of $77.6 million, or $2.31 per share. On a non-GAAP basis, excluding share-based compensation, full-year net loss was $38.7 million. Management plans to submit an NDA for tinlarebant to the FDA in the second quarter of 2026.
Belite Bio, Inc. received an amended Schedule 13G showing that Darwin Global Management, its Chief Investment Officer Dr. Abhishek Trehan, and Darwin Global Master Fund report beneficial ownership of 3,027,704 Ordinary Shares, or 8.1% of the company. This percentage is based on 37,514,630 Ordinary Shares reported as outstanding in a company prospectus filed on December 2, 2025. Within this total, Darwin Global Master Fund directly holds 2,928,575 Ordinary Shares, or 7.8% of the class. The reporting group certifies that the shares were not acquired and are not held for the purpose of changing or influencing control of Belite Bio.
Belite Bio reported that it has completed enrollment of 60 adolescent patients, including 15 in Japan, in its global Phase 2/3 DRAGON II clinical trial of oral drug candidate tinlarebant for Stargardt disease type 1 (STGD1). DRAGON II is a 24‑month, randomized, double‑masked, placebo‑controlled study in patients aged 12 to 20 across Japan, the United States, and the United Kingdom, with participants assigned 1:1 to tinlarebant or placebo to assess efficacy, safety, and tolerability.
The company says it remains on track to submit a New Drug Application (NDA) to the U.S. FDA for tinlarebant in the first half of 2026. Tinlarebant aims to reduce vitamin A‑based toxins in the retina by lowering serum retinol binding protein 4, and has received multiple expedited and orphan designations in the U.S., Europe, and Japan for STGD1. Belite Bio notes it has already completed a separate Phase 3 DRAGON trial in adolescent STGD1 and is also running a Phase 3 PHOENIX trial in geographic atrophy.
Belite Bio, Inc furnished a Form 6-K to provide investors with a press release titled “Belite Bio Reports Third Quarter 2025 Financial Results and Provides a Corporate Update.” The press release is attached as Exhibit 99.1 and incorporated by reference, meaning its contents are formally included in Belite Bio’s effective Securities Act registration statements from the filing date unless later superseded.
Belite Bio, Inc. (BLTE) Form 144 shows an insider sale notice for 96,950 American Depositary Shares (ADS), each representing one ordinary share, scheduled approximately for 09/18/2025 through J.P. Morgan Securities LLC. The filing reports an aggregate market value of $7,077,350 based on the shares to be sold, against 32,833,402 shares outstanding. The ADS were acquired on 12/31/2021 via an employee stock option exercise and were paid for in cash. The filer, identified as Yu‑Hsin Lin (c/o Belite Bio), previously sold small blocks of ADS on 08/07/2025 (269 ADS, $19,906) and 08/12/2025 (700 ADS, $51,856).
The filer attests they are not aware of any undisclosed material adverse information and the notice includes the usual certification language required by Rule 144.
Belite Bio, Inc. (BLTE) Form 144 shows an insider sale notice for 96,950 American Depositary Shares (ADS), each representing one ordinary share, scheduled approximately for 09/18/2025 through J.P. Morgan Securities LLC. The filing reports an aggregate market value of $7,077,350 based on the shares to be sold, against 32,833,402 shares outstanding. The ADS were acquired on 12/31/2021 via an employee stock option exercise and were paid for in cash. The filer, identified as Yu‑Hsin Lin (c/o Belite Bio), previously sold small blocks of ADS on 08/07/2025 (269 ADS, $19,906) and 08/12/2025 (700 ADS, $51,856).
The filer attests they are not aware of any undisclosed material adverse information and the notice includes the usual certification language required by Rule 144.
Belite Bio, Inc. entered into securities purchase agreements for a private investment in public equity (PIPE), selling 1,953,124 ordinary shares and issuing Warrants to purchase 1,953,124 ordinary shares. The securities are priced at $64.00 per ordinary share with an accompanying Warrant, and each Warrant is immediately exercisable at an exercise price of $76.80 per share for two years.
The PIPE is expected to generate gross proceeds of approximately $125 million before fees, with potential additional proceeds of about $150 million if all Warrants are exercised. Closing is expected on or about September 9, 2025, subject to customary conditions. Belite Bio also granted investors registration rights, committing to file a resale registration statement with the SEC within 45 days after closing and to use reasonable best efforts to have it declared effective within specified timeframes.
Form 144 filing for Belite Bio, Inc. (BLTE) reports a proposed sale of 30,000 American Depositary Shares (each representing one ordinary share) through J.P. Morgan Securities LLC on NASDAQ with an aggregate market value of $1,902,600 and an approximate sale date of 08/21/2025. The filer acquired the 30,000 ADS on 03/07/2025 by exercising stock options and paid cash on that date. The filer states there were no securities sold in the past three months attributable to the same person, and the notice includes the standard Rule 144 representation about lack of undisclosed material information.
Belite Bio, Inc. filed a Form 6-K to furnish a press release dated August 11, 2025, in which the company reported its second quarter 2025 financial results and provided a corporate update. The press release is attached as Exhibit 99.1 and is incorporated by reference.
The 6-K also states that this report is deemed incorporated by reference into all of Belite Bio’s effective registration statements under the Securities Act of 1933 from the filing date, unless later superseded. The filing is signed by Chief Executive Officer and Chairman Yu-Hsin Lin.
Belite Bio (Nasdaq: BLTE) filed a 424B5 to raise capital via a direct, best-efforts placement of 230,770 ADSs (1 ADS = 1 ordinary share) at $65.00 each, bundled one-for-one with five-year warrants exercisable at the same price. Gross proceeds total $15.0 million; the placement-agent fee is 6.5% ($0.975 m), leaving $14.0 m before other expenses. Proceeds are earmarked for working capital and general corporate purposes.
Post-offering share count rises to 32.83 m (33.06 m fully diluted). Warrants are immediately exercisable, unlisted, and capped at 9.99% beneficial ownership. Company lock-ups: 30 days (issuer) and 60 days (insiders & ≥5% holder). Closing is expected on 8 Aug 2025; Titan Partners Group acts as exclusive placement agent.
Risks disclosed include continued cash burn, reliance on lead drug Tinlarebant, potential PRC regulatory exposure despite limited China operations, likely PFIC status, dilution (immediate book-value drop of $59.75/ADS) and controlled-company governance exemptions. Last BLTE close (6 Aug 2025) was $67.99, implying a modest 4.4% discount. No change to Nasdaq listing of ADSs; warrants will not be listed.