Corvus Pharmaceuticals Conference Call Summary Company Overview - **Company**: Corvus Pharmaceuticals (NasdaqGM:CRVS) - **Date**: January 20, 2026 - **Key Executives Present**: Dr. Richard Miller (CEO), Leif Lea (CFO), Jeff Arcara (CBO), Dr. Ben Jones (SVP, Pharmaceutical Development), Dr. Suresh Mahabhashyam (VP, Clinical Development) [2][3] Core Industry and Product Focus - **Industry**: Pharmaceuticals, specifically focusing on immune diseases and atopic dermatitis - **Product**: Socalitinib, a first-in-class oral drug targeting interleukin-2 inducible T-cell kinase (ITK) [4][39] Key Findings and Data from Clinical Trials - **Phase I Clinical Trial Results**: - Socalitinib shows potential as a leading therapy for atopic dermatitis, achieving significant clinical results [5][6] - Efficacy metrics: - EASI 75: 75% of patients - EASI 90: 25% of patients - IGA 0/1: 33% of patients - Mean percent reduction in EASI score: 72% at eight weeks [6][24] - Responses are durable, with continued reduction in EASI scores post-treatment [6][21] - **Cohort 4 Specifics**: - 24 patients enrolled with a one-to-one randomization of active versus placebo - Treatment duration extended to eight weeks, confirming positive results from earlier cohorts [18][24] - EASI score reduction: 72% for Socalitinib vs. 40% for placebo, p-value of 0.035 [24][26] - **Prior Systemic Therapy**: - 35% of all patients had prior therapies, with 50% in cohort 4 - Socalitinib demonstrated efficacy in patients with prior systemic therapy, indicating no resistance [27][30] Mechanism of Action - Socalitinib selectively inhibits ITK, leading to a rebalancing of the immune system without causing immunosuppression [9][10] - Induction of T regulatory cells (Tregs) contributes to durable suppression of inflammation [21][30] Market Opportunity - Over 3 million patients with moderate to severe atopic dermatitis, with a significant unmet need for safe and effective oral therapies [15][38] - The market for atopic dermatitis is projected to grow to $170 billion by 2030, with oral agents expected to gain a larger share [38] Future Plans - Initiation of a phase 2 randomized placebo-controlled trial in atopic dermatitis, planned to enroll 200 patients [37][39] - Exploration of Socalitinib's efficacy in other immune diseases, including hidradenitis suppurativa and asthma [39] Safety Profile - No new safety signals observed in cohort 4; adverse events (AEs) were similar between active and placebo groups [31][55] - Historical data from lymphoma studies indicate a strong safety profile, with no patients discontinuing due to safety concerns [54][55] Conclusion - Socalitinib is positioned as a promising treatment for atopic dermatitis and potentially other immune diseases, with a strong clinical efficacy and safety profile [39][40]

Core Insights - Corvus Pharmaceuticals is advancing the development of its ITK inhibitor, soquelitinib, for treating atopic dermatitis and T cell lymphomas, with significant clinical trials underway [3][4][5] Clinical Development - Enrollment in the Phase 1 trial extension cohort 4 for soquelitinib in atopic dermatitis has been completed, involving 24 patients receiving a 200 mg BID dose over an 8-week treatment period, with data expected in January 2026 [7] - The Phase 2 trial for atopic dermatitis is set to begin in early Q1 2026, targeting approximately 200 patients who have not responded to prior therapies [7] - The Phase 3 registrational trial for soquelitinib in relapsed/refractory peripheral T cell lymphoma (PTCL) is currently enrolling patients across multiple sites, with the final Phase 1/1b results to be presented at the American Society of Hematology Annual Meeting [6][8] Financial Overview - As of September 30, 2025, Corvus reported cash, cash equivalents, and marketable securities totaling $65.7 million, an increase from $52.0 million at the end of 2024, with expectations to fund operations into Q4 2026 [9] - Research and development expenses for Q3 2025 were $8.5 million, up from $5.2 million in Q3 2024, primarily due to increased clinical trial and manufacturing costs [10] - The net loss for Q3 2025 was $10.2 million, a significant reduction from a net loss of $40.2 million in the same period of 2024, which included a non-cash loss related to warrant liability [11] Strategic Collaborations - Corvus is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) for a Phase 2 clinical trial of soquelitinib in Autoimmune Lymphoproliferative Syndrome (ALPS), aiming to enroll up to 30 patients [5] Product Information - Soquelitinib is an investigational oral small molecule designed to selectively inhibit ITK, which plays a crucial role in T cell immune function, potentially benefiting patients with various cancers and autoimmune diseases [14][18]

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]

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]

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 reported favorable safety and efficacy data for soquelitinib in atopic dermatitis, showing earlier and deeper responses in cohort 3 compared to cohorts 1 and 2 [1][6] - The company is advancing multiple clinical trials for soquelitinib, including a Phase 3 trial for peripheral T cell lymphoma (PTCL) and a Phase 2 trial for autoimmune lymphoproliferative syndrome (ALPS) [2][5] - Corvus raised approximately $31.3 million through the early exercise of common stock warrants by stockholders [1][10] Business Update and Strategy - Soquelitinib is positioned as a potential new treatment for atopic dermatitis and other immune diseases, with ongoing clinical trials and data expected in the fourth quarter [2][3] - The Phase 3 trial for PTCL is enrolling patients at multiple sites, aiming for a total of 150 participants [5][7] - The company is also developing next-generation ITK inhibitors for specific immunology indications [6] Financial Results - As of March 31, 2025, Corvus had cash, cash equivalents, and marketable securities totaling $44.2 million, down from $52.0 million at the end of 2024 [10][29] - Research and development expenses for Q1 2025 were $7.5 million, an increase from $4.1 million in Q1 2024, primarily due to higher clinical trial costs [11] - The net income for Q1 2025 was $15.2 million, including a gain of $25.1 million from changes in the fair value of the company's warrant liability [12][26]

Financial Data and Key Metrics Changes - Research and development (R&D) expenses in Q4 2024 were $5.2 million, up from $3.2 million in Q4 2023, primarily due to increased clinical trial expenses for socalitinib [6] - Full year R&D expenses for 2024 totaled $19.4 million, compared to $16.5 million in 2023, reflecting an increase of approximately $2.9 million [7] - The net loss for Q4 2024 was $12.1 million, compared to a net loss of $6.7 million in Q4 2023 [8] - Total stock compensation expense for Q4 2024 was $0.8 million, compared to $0.6 million in Q4 2023 [8] - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $52 million, up from $27.1 million at the end of 2023 [9] Business Line Data and Key Metrics Changes - Socalitinib showed a 39% objective response rate in the Phase 1 trial for relapsed T-cell lymphoma, with a 26% complete response rate, significantly higher than standard chemotherapies [12] - Interim data from the Phase 1 trial of socalitinib in moderate to severe atopic dermatitis indicated significant responses compared to placebo [13] Market Data and Key Metrics Changes - The company is enrolling a registrational Phase 3 trial of socalitinib in patients with relapsed peripheral T-cell lymphoma [12] - The Phase 1 trial for atopic dermatitis includes four cohorts, with a total of 16 subjects each, showing promising efficacy results [15][19] Company Strategy and Development Direction - The company aims to position socalitinib as a first-in-class oral therapy for immune diseases and cancer, leveraging its unique mechanism of action [11] - Plans include advancing multiple clinical trials for socalitinib, including a Phase 2 trial in solid tumors and a Phase 2 trial in atopic dermatitis [29][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of socalitinib, citing a strong body of evidence from clinical and preclinical research [11] - The company anticipates its cash runway will extend into the first quarter of 2026, allowing for the execution of key milestones [10][33] Other Important Information - The company is also advancing other clinical stage development programs, including adenosine A2A receptor antagonists for cancer treatment [30] - The ALPS trial is being conducted under a clinical research agreement with the NIH, targeting a rare autoimmune disease with a patient population of approximately 2,500 in the U.S. [68] Q&A Session Summary Question: Will the May update include full data on cohorts three and additional patients on cohort two? - Management confirmed that the May meeting will report full datasets on cohorts one, two, and three, including biomarker data [38] Question: What efficacy hurdles are being considered for the Phase 2a trial? - Management indicated satisfaction with the efficacy seen in cohorts one and two, noting a significant difference compared to placebo [41][44] Question: What are the plans for cohort four and the rationale for dosing? - Management stated that cohort four is planned at a 400 mg dose, pending review of cohort three data [50][52] Question: What is the addressable patient population for the ALPS indication? - Management noted approximately 2,500 patients in the U.S. with ALPS, emphasizing the potential for long-term treatment [68] Question: What subpopulations are being targeted in the upcoming Phase 2 for atopic dermatitis? - Management indicated that the focus will be on patients with moderate to severe atopic dermatitis who have failed prior treatments [76]