Corvus Pharmaceuticals(CRVS)
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Corvus Pharmaceuticals Announces Presentation of Interim Data from the Phase 1b/2 Clinical Trial of Ciforadenant for Patients with Metastatic Renal Cell Cancer at the European Society for Medical Oncology (ESMO) Congress 2025
Globenewswire· 2025-10-17 14:00
Core Insights - The interim data from the Phase 1b/2 clinical trial of ciforadenant in combination with ipilimumab and nivolumab shows feasibility and tolerability as a potential first-line therapy for metastatic renal cell cancer (RCC) [1][4][5] Group 1: Trial Overview - The trial enrolled 50 patients with newly diagnosed or recurrent stage IV clear cell RCC, with 8 in Phase 1b and 42 in Phase 2 [2][3] - Patients received ciforadenant 100 mg orally twice daily, ipilimumab 1 mg/kg every three weeks for twelve weeks, and nivolumab 3 mg/kg every three weeks [2] Group 2: Key Findings - The deep response rate was 34%, which is an improvement compared to historical data for the combination of ipilimumab and nivolumab alone [4] - The overall response rate (ORR) was 46%, including two complete responses and 21 partial responses [4] - The median progression-free survival (PFS) was reported at 11.04 months [4] Group 3: Patient Characteristics - The median age of patients in the trial was 61.5 years, with only 54% having undergone prior nephrectomy, indicating more unfavorable disease characteristics [4] - 82% of patients had a poor or intermediate prognosis according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria [4] Group 4: Future Directions - The company plans to continue following the 19 patients who remain on therapy to better understand the potential benefits of this treatment approach [2][5]
Corvus Pharmaceuticals Appoints David Moore to Board of Directors
Globenewswire· 2025-10-02 20:01
Core Insights - Corvus Pharmaceuticals has appointed David Moore to its Board of Directors, bringing extensive experience from his 27-year career in the pharmaceutical and biotech industries [1][2] - Mr. Moore's background includes leadership roles at Novo Nordisk, where he oversaw successful GLP-1 franchises, which is expected to be a strategic asset for Corvus as it develops its ITK inhibitor platform [2] - Corvus is focused on developing ITK inhibition as a novel immunotherapy approach for cancer and immune diseases, with its lead candidate being soquelitinib [3] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company specializing in ITK inhibition for treating various cancer and immune diseases [3] - The company's lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK [3] Leadership Experience - David Moore has held significant positions at Novo Nordisk, including Executive Vice President of US Operations and President of Novo Nordisk Inc., contributing to corporate strategy and business development [2] - His previous roles also include being an investment partner at Gurnet Point Capital and CEO of Lysovant Sciences, showcasing a diverse background in both operational and investment capacities [2]
Corvus Pharmaceuticals: Positive Phase 1 Soquelitiinb Trial Data Brings 2025 Catalysts
Seeking Alpha· 2025-08-13 03:31
Group 1 - Corvus Pharmaceuticals (NASDAQ: CRVS) is evaluating its interleukin-2-inducible T cell kinase (ITK) inhibitor for treating various lymphoma types, solid tumors, and autoimmune disorders [2] Group 2 - The Biotech Analysis Central service offers a comprehensive analysis of pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2]
Corvus Pharmaceuticals(CRVS) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Financial Data and Key Metrics Changes - Research and development expenses for Q2 2025 totaled $7.9 million, up from $4.1 million in Q2 2024, primarily due to higher clinical trial and manufacturing costs related to selcolitinib [4] - The net loss for Q2 2025 was $8 million, compared to a net loss of $4.3 million in Q2 2024, which included a non-cash gain of $1.8 million related to warrant liability [5] - As of June 30, 2025, cash, cash equivalents, and marketable securities amounted to $74.4 million, an increase from $52 million at the end of 2024 [5] Business Line Data and Key Metrics Changes - The focus remains on the development of socolitinib for atopic dermatitis, with encouraging data from the Phase one trial showing a mean percent reduction of EASI score of 64.8% in cohort three compared to 54.6% in combined cohorts one and two [8][9] - In cohort three, 50% of patients achieved EZ75, 8% achieved EZ90, and 25% achieved IGA 0 or 1, indicating a favorable response compared to earlier cohorts [9] Market Data and Key Metrics Changes - The company is advancing clinical development in multiple areas, including atopic dermatitis and T cell lymphoma, with ongoing trials and expected data releases in late 2025 and 2026 [18] Company Strategy and Development Direction - The company aims to maintain a presence in dermatology while exploring new indications such as hidradenitis suppurativa and asthma, leveraging existing data and mechanisms of action [22][24] - The strategy includes the development of next-generation ITK inhibitors to target various diseases involving inflammation and cancer [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of socolitinib, highlighting its favorable safety and efficacy profile [7] - The company anticipates that current cash reserves will fund operations into 2026, indicating a stable financial outlook [6] Other Important Information - The company plans to initiate a Phase 2 clinical trial for socolitinib in atopic dermatitis, enrolling approximately 200 patients with a focus on various dosing regimens [13][14] - A Phase 1b/2 trial of socolitinib for atopic dermatitis is set to begin in China, further expanding the drug's development [16] Q&A Session Summary Question: Thoughts on next indications for socolitinib in autoimmune disease - Management is considering hidradenitis suppurativa and asthma as potential follow-up indications due to unmet needs and existing data [22][24] Question: Update on ciforadenant in renal cell cancer - Management is awaiting data from the ESMO presentation and will decide next steps based on the results [26][28] Question: Enrollment status for PTCL trial - Enrollment is proceeding as planned with approximately 20 centers open, and guidance for data release remains intact [32][33] Question: Phase 2 trial design for atopic dermatitis - The trial will include four cohorts with different dosing regimens, and the design is standard for such studies [39][43] Question: Timeline for results from the Phase 2 trial - Enrollment is expected to take 12 to 15 months, with results anticipated in about 18 months [48] Question: Next-generation ITK inhibitors - Details on differences from socolitinib are limited due to intellectual property reasons, but the company believes they may target various mechanisms effectively [54]
Corvus Pharmaceuticals(CRVS) - 2025 Q2 - Quarterly Report
2025-08-07 20:02
PART I — FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The unaudited condensed consolidated financial statements for the quarter and six months ended June 30, 2025, are presented, highlighting key financial positions and performance [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to $89.5 million, liabilities decreased to $9.2 million, and stockholders' equity grew to $80.2 million, primarily due to warrant exercises Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $14,691 | $8,740 | | Marketable securities | $59,716 | $43,224 | | Total current assets | $75,780 | $54,407 | | Total assets | $89,461 | $68,907 | | **Liabilities & Stockholders' Equity** | | | | Warrant liability | $0 | $28,910 | | Total liabilities | $9,233 | $36,339 | | Total stockholders' equity | $80,228 | $32,568 | | Total liabilities and stockholders' equity | $89,461 | $68,907 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2025, a net loss of $8.0 million was reported, while the six months ended June 30, 2025, saw a net income of $7.2 million, driven by a non-cash gain from warrant liability revaluation Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,873 | $4,114 | $15,326 | $8,189 | | General and administrative | $2,387 | $1,821 | $4,856 | $3,999 | | Loss from operations | $(10,260) | $(5,935) | $(20,182) | $(12,188) | | Change in fair value of warrant liability | $2,012 | $1,816 | $27,141 | $1,816 | | **Net income (loss)** | **$(7,998)** | **$(4,262)** | **$7,195** | **$(9,963)** | | Net income (loss) per share, basic | $(0.10) | $(0.07) | $0.10 | $(0.18) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity significantly increased to $80.2 million by June 30, 2025, primarily due to proceeds from common stock and pre-funded warrant exercises - The exercise of common stock warrants during the first half of 2025 was a major driver of the increase in stockholders' equity, adding **$23.1 million** from common stock issuance and **$14.5 million** from pre-funded warrant issuance to additional paid-in capital[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $14.0 million, offset by $36.0 million from financing activities, primarily warrant exercises, leading to a $6.0 million net increase in cash for the six months ended June 30, 2025 Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,040) | $(10,638) | | Net cash used in investing activities | $(16,058) | $(17,511) | | Net cash provided by financing activities | $36,049 | $30,370 | | **Net increase in cash and cash equivalents** | **$5,951** | **$2,221** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail accounting policies, liquidity, the impact of warrant exercises, and the company's equity method investment in Angel Pharmaceuticals - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of **$74.4 million**, which management believes is sufficient to fund planned operations for at least 12 months[31](index=31&type=chunk) - All common warrants were exercised as of June 30, 2025, resulting in total proceeds of **$54.3 million** and eliminating the warrant liability. This led to a recognized gain of **$27.1 million** from the change in fair value for the six months ended June 30, 2025[29](index=29&type=chunk)[81](index=81&type=chunk) - The company holds an approximate **49.7%** ownership interest in Angel Pharmaceuticals and recognized its share of loss from this equity method investment, amounting to **$0.9 million** for the six months ended June 30, 2025[65](index=65&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses the company's clinical pipeline, financial performance, including increased R&D expenses and a net income driven by warrant revaluation, and its liquidity position [Overview and Pipeline Development](index=31&type=section&id=Overview%20and%20Pipeline%20Development) This section provides an overview of Corvus's clinical-stage pipeline, highlighting the lead candidate soquelitinib in Phase 3 for T cell lymphomas and Phase 1 for atopic dermatitis - Soquelitinib is in a registrational Phase 3 trial for relapsed/refractory peripheral T cell lymphoma (PTCL) after receiving FDA Fast Track designation[108](index=108&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) - In the Phase 1 trial for atopic dermatitis, soquelitinib showed a mean EASI score reduction of **64.8%** in the highest dose cohort (**200 mg BID**) at 28 days, compared to **34.4%** for placebo. The trial protocol was amended to add an expansion cohort at this dose for an 8-week treatment period[128](index=128&type=chunk)[137](index=137&type=chunk) - The company plans to initiate a Phase 2 clinical trial for soquelitinib in atopic dermatitis by the end of 2025, expecting to enroll approximately **200 patients**[140](index=140&type=chunk) [Results of Operations](index=46&type=section&id=Results%20of%20Operations) Operating expenses, particularly R&D, increased significantly, but a $27.1 million non-cash gain from warrant liability revaluation resulted in a net income for the first half of 2025 Research and Development Expenses by Program (in thousands) | Program | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Soquelitinib | $8,842 | $2,841 | $6,001 | | Ciforadenant | $95 | $408 | $(313) | | Mupadolimab | $48 | $(55) | $103 | | Unallocated employee and overhead costs | $6,341 | $4,995 | $1,346 | | **Total R&D Expenses** | **$15,326** | **$8,189** | **$7,137** | - The increase in soquelitinib costs for H1 2025 was primarily due to a **$3.3 million** increase in drug manufacturing and a **$2.6 million** increase in clinical trial expenses[168](index=168&type=chunk) - The change in fair value of warrant liability resulted in a non-operating income of **$27.1 million** for the six months ended June 30, 2025, as all common warrants were exercised during the period[177](index=177&type=chunk) [Liquidity and Capital Resources](index=50&type=section&id=Liquidity%20and%20Capital%20Resources) The company held $74.4 million in cash and marketable securities as of June 30, 2025, deemed sufficient for 12 months, bolstered by warrant exercise proceeds and an available ATM program - The company's cash, cash equivalents, and marketable securities totaled **$74.4 million** as of June 30, 2025[180](index=180&type=chunk) - Management believes existing cash is sufficient to fund planned operations for at least **12 months** from the date of the financial statement issuance[152](index=152&type=chunk) - During H1 2025, financing activities provided **$36.0 million** in cash, primarily from **$35.7 million** in proceeds from the exercise of common warrants[192](index=192&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=54&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate changes on its $74.4 million cash and marketable securities portfolio, which is managed through low-risk, short-term investments - The company's main market risk is interest rate changes affecting its **$74.4 million** in cash and marketable securities[196](index=196&type=chunk) - Due to the short-term and low-risk nature of its investments, the company does not expect a **10%** change in interest rates to have a material effect on its portfolio's fair value[196](index=196&type=chunk) [Item 4. Controls and Procedures](index=54&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[198](index=198&type=chunk) - There were no material changes to the company's internal control over financial reporting during the second quarter of 2025[199](index=199&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=55&type=section&id=Item%201.%20Legal%20Proceedings) The company states that it is not currently involved in any material legal proceedings - As of the report date, Corvus Pharmaceuticals is not a party to any material litigation or legal proceedings[201](index=201&type=chunk) [Item 1A. Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks, including historical losses, the need for future financing, uncertainties in clinical development, reliance on third parties, and intellectual property challenges - The company has a history of significant operating losses (**$389.8 million** accumulated deficit as of June 30, 2025) and will require substantial additional financing to achieve its goals[204](index=204&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk) - Clinical drug development is lengthy, expensive, and uncertain. Product candidates may fail in later-stage trials despite promising early results, and any delays could increase costs and harm commercial prospects[218](index=218&type=chunk)[223](index=223&type=chunk) - The company relies heavily on third parties, such as contract research organizations (CROs) and contract manufacturers, to conduct clinical trials and produce drug supplies. Poor performance by these third parties could delay or jeopardize development programs[248](index=248&type=chunk)[253](index=253&type=chunk) - The business faces intense competition from larger, better-funded pharmaceutical companies, and its success depends on its ability to protect its intellectual property through patents and trade secrets, which may be challenged or circumvented[308](index=308&type=chunk)[340](index=340&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=133&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities during the reporting period - The company made no sales of unregistered securities during the quarter[415](index=415&type=chunk) [Item 5. Other Information](index=135&type=section&id=Item%205.%20Other%20Information) The company reports that none of its directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - During the quarter ended June 30, 2025, no directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan[416](index=416&type=chunk) [Item 6. Exhibits](index=135&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate documents, CEO/CFO certifications, and financial data in Inline XBRL format - The report includes required certifications from the CEO and CFO (Exhibits **31.1**, **31.2**, **32.1**) and financial data in Inline XBRL format (Exhibit **101** series)[419](index=419&type=chunk)
Corvus Pharmaceuticals(CRVS) - 2025 Q2 - Quarterly Results
2025-08-07 20:01
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](index=1&type=section&id=Q2%202025%20Highlights) 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](index=1&type=chunk) - 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](index=1&type=chunk)[3](index=3&type=chunk) - The **Phase 3** registrational clinical trial of soquelitinib in relapsed/refractory peripheral T cell lymphoma (PTCL) is enrolling with multiple clinical sites open[1](index=1&type=chunk) 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](index=1&type=section&id=Soquelitinib%20%28Corvus%27%20selective%20ITK%20inhibitor%29%20for%20Immune%20Diseases) 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](index=1&type=section&id=Atopic%20Dermatitis%20Clinical%20Trial%20Update) - 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](index=4&type=chunk) 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](index=4&type=chunk) - 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](index=4&type=chunk) - Soquelitinib was well tolerated in the **Phase 1** trial with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities[4](index=4&type=chunk) - 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](index=4&type=chunk) [Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)](index=2&type=section&id=Collaboration%20with%20National%20Institute%20of%20Allergy%20and%20Infectious%20Diseases%20%28NIAID%29) - Patient enrollment continues in the ALPS **Phase 2** clinical trial, conducted under a clinical research and development agreement with NIAID[5](index=5&type=chunk) - The **Phase 2** trial (NCT06730126) is anticipated to enroll up to **30** patients aged **16** or older with confirmed ALPS[5](index=5&type=chunk) [Soquelitinib for T Cell Lymphoma](index=2&type=section&id=Soquelitinib%20for%20T%20Cell%20Lymphoma) 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](index=6&type=chunk) - 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](index=6&type=chunk) - 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](index=6&type=chunk) [Other Pipeline Programs](index=2&type=section&id=Other%20Pipeline%20Programs) 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)](index=2&type=section&id=Collaboration%20with%20Kidney%20Cancer%20Research%20Consortium%3A%20Ciforadenant%20%28adenosine%20A2a%20receptor%20inhibitor%29) - 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](index=7&type=chunk) [Partner Led Program: Mupadolimab (anti-CD73)](index=2&type=section&id=Partner%20Led%20Program%3A%20Mupadolimab%20%28anti-CD73%29) - 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](index=8&type=chunk) [Partner-Led Programs & Preclinical Development](index=2&type=section&id=Partner-Led%20Programs%20%26%20Preclinical%20Development) 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](index=12&type=chunk) - 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](index=12&type=chunk) - Corvus continues to advance its next-generation ITK inhibitor preclinical product candidates, designed for precise T-cell modulation optimized for specific immunology indications[12](index=12&type=chunk) 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](index=2&type=section&id=Q2%202025%20Financial%20Highlights) 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](index=9&type=chunk) 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](index=10&type=chunk) 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](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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
Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-07 20:01
Core Insights - Corvus Pharmaceuticals reported positive interim results from the Phase 1 clinical trial of soquelitinib for atopic dermatitis, showing earlier and deeper responses compared to earlier cohorts, with a significant reduction in itch as early as day 8 [1][4][3] - The company is advancing its clinical trials, with ongoing enrollment in Phase 1 trial extension cohort 4 and plans to initiate a Phase 2 trial before the end of the year [1][3] - Corvus is also enrolling patients in a Phase 3 registrational clinical trial of soquelitinib for relapsed/refractory peripheral T cell lymphoma (PTCL) [1][6] Clinical Development - Soquelitinib demonstrated a mean reduction in Eczema Area and Severity Index (EASI) score of 64.8% in cohort 3 at 28 days, compared to 54.6% for cohorts 1 and 2 combined [4] - The Phase 1 trial showed a favorable safety profile, with no dose-limiting toxicities reported [4] - A separate Phase 1b/2 trial in China is planned to further explore soquelitinib's efficacy in atopic dermatitis with a 12-week treatment period [3][4] Financial Performance - As of June 30, 2025, Corvus had cash, cash equivalents, and marketable securities totaling $74.4 million, an increase from $52.0 million at the end of 2024 [9] - The company reported a net loss of $8.0 million for the second quarter of 2025, compared to a net loss of $4.3 million for the same period in 2024 [11] - Research and development expenses for the second quarter of 2025 were $7.9 million, up from $4.1 million in the same period in 2024, primarily due to increased clinical trial costs [10] Strategic Collaborations - Corvus is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) for a Phase 2 clinical trial in autoimmune lymphoproliferative syndrome (ALPS) [5] - The company has partnered with Angel Pharmaceuticals to develop and commercialize its clinical-stage candidates in China [23] Upcoming Events - A conference call and webcast is scheduled for August 7, 2025, to discuss the business update and second-quarter financial results [12][13]
Corvus Pharmaceuticals to Provide Business Update and Second Quarter 2025 Financial Results on August 7, 2025
Globenewswire· 2025-07-31 20:01
Core Viewpoint - Corvus Pharmaceuticals will host a conference call and webcast on August 7, 2025, to provide a business update and report its second quarter 2025 financial results [1]. Group 1: Conference Call Details - The conference call is scheduled for 4:30 pm ET (1:30 pm PT) [1]. - Access to the conference call can be made via a toll-free domestic number (1-800-717-1738) or an international number (1-646-307-1865) [2]. - A live webcast will be available on the investor relations section of the Corvus website, with a replay accessible for 90 days [2]. Group 2: Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [3]. - The lead product candidate is soquelitinib, an investigational oral small molecule drug that selectively inhibits ITK [3]. - The company is developing other clinical-stage candidates targeting a variety of cancer indications [3].
Corvus Pharmaceuticals(CRVS) - 2025 Q1 - Earnings Call Presentation
2025-07-04 07:38
Soquelitinib Atopic Dermatitis Phase 1 Data - A Phase 1 clinical trial of Soquelitinib in Atopic Dermatitis (AD) demonstrated activity through a novel mechanism of action[7] - The study included 64 participants with moderate to severe AD, randomized into different Soquelitinib dosage cohorts (100 mg BID, 200 mg QD, 200 mg BID, 400 mg QD) and placebo groups[9] - In Cohorts 1 and 2, the Soquelitinib group (N=24) showed a 54.6% mean reduction in EASI score at 4 weeks, compared to a 30.6% reduction in the placebo group (N=8)[15] - In Cohort 3, the Soquelitinib group (N=8) achieved a 71.1% mean reduction in EASI score at 4 weeks, while the placebo group (N=4) had a 42.1% reduction[15] - At day 28, 63% of patients in Soquelitinib Cohort 3 achieved EASI 75, and 25% achieved IGA 0 or 1, compared to 0% in the placebo group[21] - Across Cohorts 1, 2, and 3, 33.3% of Soquelitinib-treated subjects (N=36) experienced Adverse Events (AEs), compared to 25% in the placebo group (N=12)[22] Business Update and Protocol Amendment - A protocol amendment replaces Cohort 4 with an extension cohort to optimize Phase 2 plans, increasing the treatment duration to 8 weeks for 24 patients randomized 1:1 to Soquelitinib 200 mg BID or placebo[24, 25, 26] - The extension cohort will evaluate a longer 56-day treatment duration[27]
Corvus Pharmaceuticals (CRVS) Earnings Call Presentation
2025-07-04 07:37
Soquelitinib作用机制和潜力 - Soquelitinib 是一种 First-in-Class 的免疫调节剂,在癌症和免疫疾病领域具有广泛的机会[4] - Soquelitinib 通过阻断 ITK 信号通路,能够调节 Th1/Th2/Th17 细胞的平衡,从而影响多种炎症细胞因子的产生[11, 29] - ITK 抑制剂具有广阔的治疗潜力,包括肿瘤免疫治疗、免疫疾病、肺部炎症、胃肠道疾病、纤维化疾病和皮肤病等[7] - Corvus 团队的领导成员曾参与 rituximab 和 ibrutinib 的开发[5] Soquelitinib 在 Atopic Dermatitis (AD) 临床试验中的结果 - 在 AD 的 Phase 1 临床试验中,Soquelitinib 在 Cohorts 1 和 2 中显示出 54.6% 的 EASI 平均降低[42] - Cohort 3 的 EASI 平均降低为 64.8%[42] - Cohort 3 中,50% 的患者在第 28 天实现了 PP-NRS 评分至少降低 4 分,表明瘙痒症状得到显著改善[53] - 在接受 Soquelitinib 治疗的患者中,75% 在 EASI 50 中有所改善,83% 在 EASI 50 中有所改善[42] - 29% 的患者在 EASI 75 中有所改善,50% 的患者在 EASI 75 中有所改善[42] - 4% 的患者在 EASI 90 中有所改善,8% 的患者在 EASI 90 中有所改善[42] - 21% 的患者 IGA 0 或 1 中有所改善,25% 的患者 IGA 0 或 1 中有所改善[42] Soquelitinib 的安全性 - 在 Cohorts 1、2 和 3 中,Soquelitinib 表现出良好的安全性和耐受性,未发生严重不良事件[49] - 38.9% 的 Soquelitinib 治疗患者出现不良反应,而安慰剂组为 25%[49] AD 市场机会 - G7 国家有大约 30 million 的 AD 患者,其中约 3 million 为中重度患者,但只有 10% 接受了先进疗法治疗[34] - AD 市场预计到 2030 年将达到 280 亿美元[34]