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]

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]

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)

EXHIBIT 99.1 Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2025 Financial Results Soquelitinib data from cohort 3 of atopic dermatitis Phase 1 clinical trial demonstrates earlier and deeper responses compared to cohorts 1-2 along with clinically meaningful reduction in itch as early as day 8 Enrollment ongoing in Phase 1 trial extension cohort 4 exploring the same cohort 3 dose (200 mg BID) for a longer 8-week treatment period; Phase 2 trial on track to initiate before end of ye ...

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]

Company to host conference call and webcast at 4:30 pm ET / 1:30 pm PT SOUTH SAN FRANCISCO, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc.(NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the company will host a conference call and webcast on August 7, 2025 at 4:30 pm ET (1:30 pm PT) to provide a business update and report second quarter 2025 financial results. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-3 ...

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]

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]

Core Viewpoint - Corvus Pharmaceuticals has announced the approval of an IND application for a Phase 1b/2 clinical trial of soquelitinib in China, targeting patients with moderate-to-severe atopic dermatitis, which is expected to begin patient enrollment in Q3 2025 [1][3]. Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing ITK inhibition as a new immunotherapy approach for various cancers and immune diseases [6][7]. - Angel Pharmaceuticals, co-founded by Corvus, is responsible for developing, manufacturing, and commercializing soquelitinib in greater China, with Corvus holding approximately 49.7% ownership [2][5]. Clinical Trial Details - The Phase 1b/2 trial will study a 12-week treatment period with a 400 mg once-daily dose of soquelitinib, building on previous clinical data [3][6]. - The trial will be randomized, double-blinded, and placebo-controlled, enrolling patients with moderate-to-severe atopic dermatitis [3][6]. - The Phase 1b trial will include two cohorts, each with 24 patients, testing different dosing regimens [6]. Market Context - Atopic dermatitis is a growing concern globally, with increasing use of biologics and systemic therapies, particularly in China [3].

Core Insights - Corvus Pharmaceuticals announced preclinical data on soquelitinib's potential to treat systemic sclerosis, to be presented at the EULAR 2025 Congress [1] - The presentation was selected as a top 10 abstract by the Emerging EULAR Network, indicating significant interest in the research [1] - The company is focusing on developing soquelitinib for various conditions, including peripheral T cell lymphoma and atopic dermatitis, while considering future trials for systemic sclerosis [2] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company specializing in ITK inhibition for cancer and immune diseases [3] - The lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK [3] - The company is also developing other clinical-stage candidates for various cancer indications [3]