Corvus Pharmaceuticals(CRVS) - 2025 Q2 - Quarterly Results

Executive Summary and Recent Developments Corvus reported positive Phase 1 soquelitinib data for atopic dermatitis, ongoing Phase 3 PTCL enrollment, and $35.7 million from warrant exercises Q2 2025 Highlights Corvus Pharmaceuticals reported positive data from the Phase 1 clinical trial of soquelitinib for atopic dermatitis, showing earlier and deeper responses, with ongoing enrollment for the Phase 1 extension cohort and the Phase 3 trial for PTCL, and secured $35.7 million in cash proceeds from warrant exercises - Soquelitinib data from cohort 3 of the atopic dermatitis Phase 1 clinical trial demonstrated earlier and deeper responses compared to cohorts 1-2, with clinically meaningful reduction in itch as early as day 8[1] - Enrollment is ongoing in Phase 1 trial extension cohort 4 for atopic dermatitis, exploring the same cohort 3 dose (200 mg BID) for a longer 8-week treatment period, with a Phase 2 trial on track to initiate before year-end[1][3] - The Phase 3 registrational clinical trial of soquelitinib in relapsed/refractory peripheral T cell lymphoma (PTCL) is enrolling with multiple clinical sites open[1] Cash proceeds from common stock warrant exercises | Metric | Amount | | :----- | :----- | | Cash proceeds from common stock warrant exercises | $35.7 million | Business Update and Strategy Corvus provided updates on soquelitinib's clinical development for immune diseases and T cell lymphoma, along with progress on other pipeline candidates and partner-led programs Soquelitinib (Corvus' selective ITK inhibitor) for Immune Diseases Corvus provided updates on the clinical development of soquelitinib for immune diseases, highlighting positive Phase 1 results in atopic dermatitis, ongoing enrollment in an extension cohort, and continued patient enrollment in the ALPS Phase 2 clinical trial Atopic Dermatitis Clinical Trial Update - Interim results from the Phase 1 clinical trial of soquelitinib in moderate to severe atopic dermatitis continued to demonstrate a favorable safety and efficacy profile[4] Phase 1 Atopic Dermatitis Trial Efficacy (Day 28) | Cohort | Mean Reduction in EASI (%) | | :----- | :--------------------- | | Cohort 3 (n=12) | 64.8% | | Cohorts 1 and 2 combined (n=24) | 54.6% | | Placebo (n=12) | 34.4% | - Cohort 3 patients experienced earlier responses and deeper separation from placebo starting by day 8, with EASI scores continuing to improve out to day 58[4] - In cohort 3, 50% (4 of 8 evaluable patients) had a ≥4 point reduction in PP-NRS score from baseline at day 28, with itch reduction seen as early as day 8[4] - Soquelitinib was well tolerated in the Phase 1 trial with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities[4] - Enrollment initiated in extension cohort 4 of the Phase 1 trial, studying 24 patients randomized 1:1 (soquelitinib 200 mg BID vs. placebo) for an 8-week treatment period[4] Collaboration with National Institute of Allergy and Infectious Diseases (NIAID) - Patient enrollment continues in the ALPS Phase 2 clinical trial, conducted under a clinical research and development agreement with NIAID[5] - The Phase 2 trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS[5] Soquelitinib for T Cell Lymphoma Corvus is actively enrolling patients in a registrational Phase 3 clinical trial of soquelitinib for relapsed/refractory PTCL, a disease with no fully approved FDA agents, and soquelitinib has received Orphan Drug and Fast Track designations for this indication - Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites[6] - The randomized controlled trial is anticipated to enroll 150 patients, evaluating soquelitinib versus physicians' choice of belinostat or pralatrexate, with progression-free survival as the primary endpoint[6] - Soquelitinib has been granted Orphan Drug Designation for T cell lymphoma and Fast Track designation for adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy[6] Other Pipeline Programs Corvus provided updates on its other clinical-stage candidates, ciforadenant and mupadolimab, which are being developed through collaborations and partner-led programs Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor) - The Phase 1b/2 clinical trial evaluating ciforadenant as a potential first-line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab and nivolumab is fully enrolled, and patients are being followed[7] Partner Led Program: Mupadolimab (anti-CD73) - Angel Pharmaceuticals continues to evaluate data from its Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC)[8] Partner-Led Programs & Preclinical Development Corvus's partner, Angel Pharmaceuticals, received approval to initiate a Phase 1b/2 clinical trial of soquelitinib for atopic dermatitis in China, with preclinical data for soquelitinib in systemic sclerosis presented, and Corvus continues to advance its next-generation ITK inhibitor candidates - Angel Pharmaceuticals, Corvus' partner in China, has been approved to initiate a Phase 1b/2 clinical trial of soquelitinib for moderate-to-severe atopic dermatitis in China, planned to enroll 48 patients and study four doses and placebo over a 12-week treatment period[12] - Preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis was presented at the EULAR 2025 Congress and selected as a top 10 abstract[12] - Corvus continues to advance its next-generation ITK inhibitor preclinical product candidates, designed for precise T-cell modulation optimized for specific immunology indications[12] Financial Results Corvus reported increased cash from warrant exercises, higher R&D expenses, and a net loss for Q2 2025, with detailed financial statements provided Q2 2025 Financial Highlights Corvus Pharmaceuticals reported an increase in cash, cash equivalents, and marketable securities to $74.4 million as of June 30, 2025, largely due to $35.7 million in proceeds from warrant exercises, with research and development expenses increasing significantly, leading to a higher net loss for the quarter compared to the prior year Cash, Cash Equivalents and Marketable Securities (in thousands) | Date | Amount | | :--- | :----- | | June 30, 2025 | $74,407 | | December 31, 2024 | $51,964 | - During Q2 2025, all remaining outstanding common stock warrants were exercised, generating $35.7 million in proceeds, including $2.0 million from warrants exercised by Corvus' CEO[9] Research and Development Expenses (in millions) | Period | 2025 | 2024 | Change | | :----- | :--- | :--- | :----- | | Three months ended June 30 | $7.9 | $4.1 | +$3.8 (92.7%) | - The increase in R&D expenses was primarily due to higher clinical trial and manufacturing costs associated with soquelitinib development, as well as increased personnel-related costs[10] Net Loss (in millions) | Period | 2025 | 2024 | Change | | :----- | :--- | :--- | :----- | | Three months ended June 30 | $(8.0) | $(4.3) | $(3.7) (86.0%) | - Corvus expects its current cash to fund operations into the fourth quarter of 2026[9] Condensed Consolidated Statements of Operations The condensed consolidated statements of operations show a significant increase in operating expenses, particularly R&D, leading to a higher net loss for the three months ended June 30, 2025, compared to the same period in **202