CELC

Celcuity Inc. Reports Release of First Quarter 2026 Financial Results and Provides Corporate Update

Celcuity Reports Strong Progress in Gedatolisib Trials Ahead of FDA Review

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    <h3>Information</h3>
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    <h3>AI Summary</h3>
    <p>Celcuity Inc. reported significant progress in the gedatolisib clinical trials, particularly the VIKTORIA-1 study, which showed improved progression-free survival. With plans for a supplemental New Drug Application in Q3 2026, potential FDA approval appears promising, which could drive performance and investor interest in CELC.</p>
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  <section data-block="ai-summary-bullets">
    <h3>Key Points</h3>
    <ul><li>CELC&#039;s gedatolisib shows significant improvement in progression-free survival in trials.</li><li>Phase 3 VIKTORIA-1 results bolster gedatolisib&#039;s potential for FDA approval by Q3 2026.</li><li>VIKTORIA-2 trial expanded for endocrine-sensitive female patients with advanced breast cancer.</li><li>New subcutaneous formulation of gedatolisib under development; first patent filed.</li><li>Q1 2026 net loss increased to $52.8 million, impacting stock performance.</li></ul>
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  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Alpelisib (ALP)</strong>: Competitor drug that gedatolisib is compared against; performance impacts market perception.</li></ul>
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  <section data-block="category">
    <h3>Corporate Developments</h3>
    <p>This information falls under &#039;Corporate Developments&#039; as it highlights crucial clinical accomplishments and financial updates affecting Celcuity&#039;s future and stock valuation.</p>
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  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>FDA approval of gedatolisib could significantly boost revenue forecasts.</li><li>Presentation of trial results at ASCO may impact investor sentiment positively.</li><li>Launch of subcutaneous formulation could expand market opportunities and patient access.</li></ul>
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  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>Q1 2026 net loss was $52.8 million, $0.97 per share.</li><li>Gedatolisib demonstrated significant progression-free survival improvement in trials.</li><li>FDA PDUFA goal date for gedatolisib&#039;s NDA is July 17, 2026.</li><li>Gedatolisib Phase 3 trials involve over 1,000 patients across two studies.</li></ul>
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  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>CELC is poised for growth as gedatolisib approaches potential FDA approval in 2026.</p>
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<article>
    <h2>Celcuity Inc. (NASDAQ: CELC) Reports First Quarter 2026 Financial Results and Corporate Developments</h2>
    <p>MINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/quote/CELC">CELC</a>), a clinical-stage biotechnology company specializing in targeted therapies for various solid tumors, has released its financial results for the first quarter ended March 31, 2026, alongside recent business updates.</p>

    <h3>Key Highlights from Celcuity's Recent Trials</h3>
    <ul>
        <li><em>Phase 3 VIKTORIA-1 Trial:</em> Achieved its primary endpoint, showing a significant improvement in progression-free survival (PFS) for the PIK3CA mutant cohort. Detailed data will be presented at the upcoming 2026 ASCO Annual Meeting.</li>
        <li><em>Phase 3 VIKTORIA-2 Trial:</em> Expanded to include a second study to evaluate gedatolisib as a first-line treatment in patients with endocrine-sensitive HR+/HER2- advanced breast cancer.</li>
        <li>Development of a subcutaneous formulation for gedatolisib is in progress, with a patent application recently submitted to the U.S. Patent and Trademark Office.</li>
        <li>Management will hold a webcast and conference call today at 4:30 p.m. EDT.</li>
    </ul>

    <h3>CEO Insights on Future Prospects</h3>
    <p>Brian Sullivan, CEO and co-founder of Celcuity, stated, “With positive results in both cohorts of the pivotal VIKTORIA-1 study, we believe gedatolisib regimens could redefine the standard of care for many patients with HR+/HER2- advanced breast cancer. We aim to launch gedatolisib commercially, anticipating FDA approval in Q3 2026.”</p>
    <p>He further highlighted, “The encouraging results from our Phase 3 trial, alongside Phase 1b trial results in treatment-naive late-stage patients, support our initiative to explore gedatolisib combinations as a first-line therapy, potentially broadening accessibility for nearly all patients regardless of their endocrine sensitivity.”</p>

    <h3>First Quarter 2026 Business Developments</h3>
    <ul>
        <li>Positive topline results reported from the VIKTORIA-1 trial involving gedatolisib combined with fulvestrant, indicating a statistically significant improvement in PFS.</li>
        <li>Celcuity plans to submit these findings to the FDA in Q3 as a supplemental New Drug Application (sNDA).</li>
        <li>The VIKTORIA-2 trial is now split into two independent studies targeting different patient populations with HR+/HER2- advanced breast cancer.</li>
        <li>Approximately 60,000 adults are diagnosed each year in the United States with this particular breast cancer subtype.</li>
        <li>In January 2026, the FDA acknowledged the New Drug Application for gedatolisib in HR+/HER2- PIK3CA wild-type breast cancer, granting it Priority Review.</li>
    </ul>

    <h3>Financial Overview for Q1 2026</h3>
    <p>Net loss for the first quarter of 2026 totaled <strong>$52.8 million</strong>, or <strong>$0.97 per share</strong>, compared to a net loss of $37.0 million, or $0.86 per share, for the same period in 2025. The non-GAAP adjusted net loss was $46.8 million, or $0.86 per share, versus a loss of $34.7 million, or $0.81 per share, in Q1 2025.</p>

    <h3>Overall Operating Expenses</h3>
    <p>Celcuity's total operating expenses reached <strong>$50.5 million</strong> in Q1 2026, compared to <strong>$36.1 million</strong> in Q1 2025. Research and development (R&D) expenses were <strong>$33.1 million</strong>, reflecting an increase primarily due to higher employee-related and consulting costs.</p>

    <h3>Conclusion</h3>
    <p>Celcuity Inc. (NASDAQ: CELC) continues to progress toward key clinical milestones with gedatolisib while facing rising operational costs. As the company anticipates regulatory approvals and prepares for potential market entry, it remains focused on developing targeted therapies that could significantly impact patient care in breast cancer treatment.</p>
</article>

Celcuity Inc. reported significant progress in the gedatolisib clinical trials, particularly the VIKTORIA-1 study, which showed improved progression-free survival. With plans for a supplemental New Drug Application in Q3 2026, potential FDA approval appears promising, which could drive performance and investor interest in CELC.

Celcuity Inc. Reports Release of First Quarter 2026 Financial Results and Provides Corporate Update

AI Summary

Sentiment Rationale

Trading Thesis

Market-Moving

Key Facts

Companies Mentioned

Corporate Developments

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