BLTE

Belite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate Update

Belite Bio Tinlarebant NDA Accepted; Priority Review with Feb 2027 PDUFA

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    <h3>Information</h3>
    <p>&lt;link type=&quot;text/css&quot; rel=&quot;stylesheet&quot; href=&quot;https://www.globenewswire.com/styles/gnw_nitf.css&quot;&gt;&lt;/li...</p>
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    <h3>AI Summary</h3>
    <p>Belite Bio reported that the FDA accepted tinlarebant’s NDA for Stargardt disease type 1 with Priority Review and a February 12, 2027 PDUFA date. Positive DRAGON II/ASRS data reinforce efficacy signals, while commercialization preparations advance. The company ended Q2 2026 with $279.9 million in cash and $500.1 million in Treasury investments, supporting regulatory and launch activities.</p>
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    <h3>Key Points</h3>
    <ul><li>FDA accepts NDA for tinlarebant in STGD1; Priority Review, PDUFA date Feb 12, 2027.</li><li>ASRS data show qAF divergence; tinlarebant-treated patients stable or down slightly.</li><li>DRAGON: 24-month Phase 3 in 104 STGD1 patients; PDUFA target date set.</li><li>Belite&#039;s cash runway and treasury holdings support NDA process and commercialization prep.</li></ul>
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    <h3>Companies Mentioned</h3>
    <ul><li><strong>Belite Bio, Inc. (BLTE)</strong>: Lead candidate tinlarebant; NDA submitted; prioritized regulatory review with near-term launch potential.</li><li><strong>ASRS (N/A)</strong>: Presented DRAGON trial secondary endpoints; strengthens clinical data narrative around tinlarebant.</li></ul>
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    <h3>Corporate Developments</h3>
    <p>Category aligns with Corporate Developments; regulatory milestones and clinical-program updates are driving factors for Belite Bio’s valuation and strategic trajectory.</p>
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  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>FDA NDA acceptance with Priority Review is a major near-term price driver.</li><li>PDUFA date targeted for Feb 12, 2027 could re-rate the stock on progress.</li><li>Positive qAF data at ASRS supports tinlarebant’s efficacy signal.</li><li>Strong cash position funds regulatory and go-to-market activities.</li></ul>
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  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>NDA accepted by FDA for tinlarebant in STGD1; Priority Review; PDUFA date Feb 12, 2027.</li><li>DRAGON trial: 24 months, 104 subjects, STGD1; randomized, double-masked, global study.</li><li>DRAGON II: Enrollment completed; 73 subjects (including 15 Japanese); aims for Japan NDA.</li><li>PHOENIX GA trial: 24 months, 530 subjects; interim analysis planned.</li><li>Cash and cash equivalents: $279.9 million as of 6/30/2026; investments: $500.1 million.</li></ul>
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  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>Bullish on BLTE over the next 6–12 months as NDA approval catalysts unfold and data milestones reinforce value.</p>
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  <h1>Belite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate Update</h1>

  <p>Belite Bio, Inc. (BLTE), a clinical-stage drug development company focused on advances in degenerative retinal diseases, today announced its unaudited financial results for the second quarter ended June 30, 2026, and provided a corporate update. The company highlighted key regulatory progress for tinlarebant in Stargardt disease type 1 (STGD1), including the U.S. FDA’s acceptance of its NDA with Priority Review and a PDUFA target action date of February 12, 2027. Belite Bio also disclosed additional positive secondary endpoint data from the Phase 3 DRAGON trial and announced an upcoming conference call and webcast on Thursday, August 13, 2026, at 4:30 p.m. ET.</p>

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    <h2>Key Regulatory Milestones and Clinical Data</h2>
    <p>The U.S. Food and Drug Administration (FDA) accepted Belite Bio's New Drug Application (NDA) with Priority Review for tinlarebant to treat Stargardt disease type 1 (STGD1). The Prescription Drug User Fee Act (PDUFA) target action date is February 12, 2027. This milestone underscores the potential for the first approved treatment for STGD1 if the review is successful.</p>
    <p>At the American Society of Retina Specialists (ASRS) Annual Meeting, Belite Bio presented additional positive secondary endpoint data from the Phase 3 DRAGON trial. The data focused on quantitative autofluorescence (qAF), a marker of toxic bisretinoid accumulation, showing a marked divergence between tinlarebant-treated and placebo-treated groups.</p>

    <ul>
      <li><em>DRAGON Trial: Completed, 24-month, 104 subjects, aged 12 to 20 years old, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent and adult STGD1 patients.</em></li>
      <li><em>The FDA had accepted the NDA submission and granted Priority Review, with an assigned PDUFA target action date of February 12, 2027.</em></li>
      <li><em>At month 25, qAF values in tinlarebant-treated subjects remained stable to slightly decreased from baseline (approximately 2%), whereas placebo-treated subjects showed an approximate 20% increase from baseline, further strengthening the clinical body of evidence showing the efficacy of tinlarebant in STGD1.</em></li>
    </ul>

    <p>DRAGON II combines a Phase 1b open-label pharmacokinetics/pharmacodynamics study in adolescent Japanese STGD1 patients with a Phase 2/3, 24-month, randomized (1:1, active: placebo), double-masked, placebo-controlled, multi-center trial in STGD1 patients aged 12 to 20 years old across Japan, the U.S., and the United Kingdom. The trial completed enrollment with 73 subjects, including 15 Japanese subjects for the Phase 2/3 portion. The trial design and inclusion of Japanese patients are intended to facilitate a potential future NDA in Japan. The primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed.</p>
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    <h2>Geographic Atrophy (GA) Program and Corporate Updates</h2>
    <p>PHOENIX, Belite Bio's GA program, is ongoing as a 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center pivotal Phase 3 trial in GA patients. Enrollment has been completed with 530 subjects. The primary efficacy endpoint is the growth rate of atrophic lesions, and safety and tolerability will also be assessed. The company expects to conduct an interim analysis.</p>

    <p>Corporate highlights include commercialization preparations for STGD1 and plans for a Commercial Day in September to provide an update on market strategy and readiness. These activities are part of Belite Bio's broader efforts to build out commercial and operational infrastructures in support of tinlarebant’s potential launch and long-term success.</p>
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    <h2>Second Quarter 2026 Financial Results</h2>
    <p>The following financial highlights reflect the unaudited results for the quarter ended June 30, 2026, and provide context for Belite Bio's liquidity and operating plan.</p>

    <ul>
      <li><strong>Cash and Cash Equivalents:</strong> As of June 30, 2026, the Company had <strong>$279.9 million</strong> in cash and cash equivalents, compared with <strong>$352.9 million</strong> on December 31, 2025.</li>
      <li><strong>Investments:</strong> As of June 30, 2026, the Company had <strong>$500.1 million</strong> in U.S. treasury bills and U.S. treasury notes, compared to <strong>$419.7 million</strong> as of December 31, 2025.</li>
      <li><strong>Research and Development (R&D) Expenses:</strong> For the three months ended June 30, 2026, R&amp;D expenses were <strong>$18.2 million</strong> compared to <strong>$11.0 million</strong> for the same period in 2025. The increase in R&amp;D expenses in the quarter was primarily attributable to a royalty payment for an additional milestone achieved under the license agreement.</li>
      <li>For the six months ended June 30, 2026, R&amp;D expenses were <strong>$33.9 million</strong> compared to <strong>$20.4 million</strong> for the same period in 2025. The increase in R&amp;D expenses year-to-date was primarily attributable to (i) a royalty payment for an additional milestone achieved under the license agreement, (ii) increases in active pharmaceutical ingredient ("API") and drug product ("DP") manufacturing expenses and (iii) increases in consultant fees.</li>
      <li>On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP R&amp;D expenses for the three months ended June 30, 2026, were <strong>$17.2 million</strong> compared to <strong>$8.6 million</strong> for the same period in 2025. For the six months ended June 30, 2026, non-GAAP R&amp;D expenses were <strong>$31.0 million</strong> compared to <strong>$16.0 million</strong> for the same period in 2025.</li>
      <li><strong>Selling, General, and Administrative (SG&amp;A) Expenses:</strong> For the three months ended June 30, 2026, SG&amp;A expenses were <strong>$16.7 million</strong> compared to <strong>$6.5 million</strong> for the same period in 2025. The increase in SG&amp;A expenses in the quarter was primarily attributable to increases in professional service fees, and wages and salaries resulting from our team expansion.</li>
      <li>For the six months ended June 30, 2026, SG&amp;A expenses were <strong>$33.7 million</strong> compared to <strong>$12.7 million</strong> for the same period in 2025. The increase in SG&amp;A expenses year-to-date was primarily attributable to increases in professional service fees, share-based compensation expenses, and wages and salaries resulting from our team expansion.</li>
      <li>On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP SG&amp;A expenses for the three months ended June 30, 2026, were <strong>$10.9 million</strong> compared to <strong>$1.3 million</strong> for the same period in 2025. For the six months ended June 30, 2026, non-GAAP SG&amp;A expenses were <strong>$16.6 million</strong> compared to <strong>$2.8 million</strong> for the same period in 2025.</li>
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  <section>
    <h2>Quote from Belite Bio Leadership</h2>
    <p>"We continue to make significant strides in advancing tinlarebant in Stargardt disease. The FDA's acceptance of our NDA is a pivotal milestone for Belite Bio and the STGD1 community, bringing us meaningfully closer to potentially delivering the first ever approved treatment for STGD1. We believe the Priority Review status reflects the strength of our data and recognizes the tremendous unmet need for people living with this debilitating retinal disease," said Dr. Tom Lin, Chairman and Chief Executive Officer of Belite Bio. "Simultaneously, our launch preparations are well underway, including continuing our team expansion and building out our commercial and operational infrastructures. We believe we will be well positioned for both a strong launch and long-term success."</p>
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  <section>
    <h2>Conference Call and Webcast</h2>
    <p>Belite Bio has scheduled a conference call and webcast for Thursday, August 13, 2026, at 4:30 p.m. ET to discuss these results and provide a corporate update.</p>
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  <section>
    <h2>About Belite Bio</h2>
    <p>Belite Bio, Inc (NASDAQ: <strong>BLTE</strong>) is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs.</p>
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</article>

Belite Bio reported that the FDA accepted tinlarebant’s NDA for Stargardt disease type 1 with Priority Review and a February 12, 2027 PDUFA date. Positive DRAGON II/ASRS data reinforce efficacy signals, while commercialization preparations advance. The company ended Q2 2026 with $279.9 million in cash and $500.1 million in Treasury investments, supporting regulatory and launch activities.

News insight

Belite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate Update

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Corporate Developments