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.
The Belite Bio, Inc (NASDAQ: BLTE) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as a foreign private issuer, including Form 6‑K current reports and shelf registration materials. These documents show how Belite Bio communicates key developments around its clinical programs, financings, and regulatory interactions for its lead candidate, Tinlarebant.
Belite Bio uses Form 6‑K to furnish press releases on topics such as quarterly financial results and corporate updates, completion of enrollment in pivotal trials like the global Phase 3 PHOENIX study in geographic atrophy, and progress in the Phase 3 DRAGON program in Stargardt disease type 1 (STGD1). Other 6‑K filings describe securities purchase agreements for registered direct offerings and private placements, including details on American Depositary Shares, warrants, and registration rights agreements.
Through its filings, the company also references its shelf registration statement on Form F‑3, which supports offerings of American Depositary Shares used to fund clinical development, regulatory milestones, and commercialization preparation. While Belite Bio’s filings do not include U.S. domestic forms such as 10‑K or 10‑Q, they serve a similar role in updating investors on business progress, clinical trial status, and capital structure.
On Stock Titan, users can review Belite Bio’s SEC submissions in one place and use AI-powered summaries to interpret complex financing terms, understand the context of clinical and regulatory announcements, and see how new capital raises relate to ongoing trials in STGD1 and geographic atrophy. Filings related to equity offerings, warrants, and registration rights can help readers follow potential dilution, capital availability, and the company’s strategy for funding late-stage drug development.
BELITE BIO director John Michael Longo reported his initial beneficial ownership on a Form 3, showing two stock option awards over ordinary shares. One option allows him to buy 50,000 shares at $6.0000 per share, expiring on April 17, 2032, vesting monthly from April 28, 2022 over three years. A second option covers 60,000 shares at an exercise price of $58.8800, expiring on April 14, 2035, vesting in 36 equal monthly installments starting after April 15, 2025, subject to continued service.
BELITE BIO, INC director Lu Ita filed an initial Form 3 showing existing stock option holdings. The filing reports a stock option over 50,000 ordinary shares with a $14.45 exercise price, expiring on July 16, 2033. This option vests 22,500 shares on July 17, 2023, with the remaining 27,500 shares vesting in 22 equal monthly installments following June 28, 2023, subject to continued service.
The filing also reports a second stock option over 60,000 ordinary shares with a $58.88 exercise price, expiring on April 14, 2035. This option vests in 36 equal monthly installments for each full month of services completed following April 15, 2025, also subject to continued service. The document records holdings only and does not show any new purchases or sales.
Belite Bio director Gary Clark Biddle filed an initial ownership report showing stock option holdings in the company. He holds options covering 50,000 ordinary shares at an exercise price of $6.00 per share, expiring on April 17, 2032. This option vests over three years: 20,000 shares vest in 12 equal monthly installments after April 28, 2022, and the remaining 30,000 vest in 24 monthly installments after the first anniversary of that date, all subject to continued service. He also holds options over 60,000 ordinary shares at an exercise price of $58.88 per share, expiring on April 14, 2035, which vest in 36 equal monthly installments after April 15, 2025, subject to continued service. The filing lists these option positions and vesting terms rather than reporting any share purchases or sales.
Belite Bio, Inc. director and CEO Lin Yu-Hsin has reported initial equity holdings, including stock options and share positions. The filing lists multiple stock options over ordinary shares with exercise prices from $0.4386 to $158.3600, expiring between 2030 and 2036. Several options are already fully vested, while others vest monthly through August 2028 and in annual tranches on January 9, 2027, January 9, 2028, and January 9, 2029. Lin also holds American depositary shares and ordinary shares directly. This Form 3 records existing positions; it does not show new buying or selling activity.
Belite Bio director Chen Wan-Shan filed an initial ownership report showing direct holdings in the company. The filing lists 10,196 American depositary shares and 23,463 ordinary shares held directly. A footnote explains that each American depositary share represents one ordinary share of Belite Bio.
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.