Financial Data and Key Metrics Changes - Research and development expenses for Q3 2025 totaled $8.5 million, an increase from $5.2 million in Q3 2024, primarily due to higher clinical trial and manufacturing costs for soquelitinib and increased personnel-related costs [4] - The net loss for Q3 2025 was $10.2 million, significantly improved from a net loss of $40.2 million in Q3 2024, which included a $32.8 million non-cash loss related to warrant liability [4] - Cash, cash equivalents, and marketable securities as of September 30, 2025, were $65.7 million, up from $52 million at December 31, 2024, with expectations to fund operations into Q4 2026 [5] Business Line Data and Key Metrics Changes - The primary focus remains on the development of soquelitinib for atopic dermatitis and T-cell lymphomas, with several important milestones upcoming [6] - Enrollment in the extension cohort 4 of the phase I trial has been completed, with results expected in January [11] - The phase II atopic dermatitis trial is on track to initiate in early Q1 2026, involving approximately 200 patients who have failed prior therapies [12] Market Data and Key Metrics Changes - There is increasing interest in drugs with novel mechanisms to address atopic dermatitis and other inflammatory diseases, positioning soquelitinib favorably in the market [6] - The company is exploring potential next opportunities for its platform, indicating a broad market potential beyond current indications [7] Company Strategy and Development Direction - The company aims to establish selective blockade of ITK as a new therapeutic approach to autoimmune inflammatory diseases, leveraging the data from ongoing trials [16] - Plans to expand into other immune-related diseases, including asthma and hidradenitis suppurativa, are in consideration, with multiple trials intended to be run simultaneously [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of soquelitinib in atopic dermatitis and other immune diseases, citing encouraging clinical evidence [16] - The upcoming ASH presentation is expected to provide further insights into the efficacy of soquelitinib in T-cell lymphoma, which may also support its use in other immune diseases [14][20] Other Important Information - The company appointed David Moore to its board of directors, enhancing its strategic resources [15] - The final results from the phase 1b clinical trial of soquelitinib for T-cell lymphomas will be presented at the American Society of Hematology meeting in December [14] Q&A Session Summary Question: Can you provide context on the ASH abstract and the data to be presented? - Management highlighted impressive overall survival data and emphasized the drug's novel mechanism of action, which shows significant activity in T-cell lymphomas [18][19] Question: What are the expectations for the upcoming atopic dermatitis readout? - Management aims to confirm previous results in a larger patient cohort and assess whether extended treatment duration improves efficacy [21][23] Question: What are the plans for advancing soquelitinib in other indications? - The company is making plans to move into other immune-related diseases, with asthma and dermatologic conditions being key targets [24][32] Question: Will there be a post hoc analysis for Dupixent and JAK-exposed patients? - Management confirmed that post hoc analysis will be conducted to evaluate the drug's efficacy in these populations [36] Question: What is the timeline for the phase II trial and potential launch? - The phase II trial is expected to have a futility interim analysis at the end of 2026, with full data anticipated by the end of 2027 [34] Question: Are there plans for partnerships or licensing deals for soquelitinib? - The company is open to evaluating partnership opportunities while pushing forward with its cancer and immunology programs [41]

Clinical Trials and Efficacy - Soquelitinib has shown an objective response rate (ORR) of 33.3% in a Phase 1/1b clinical trial for relapsed/refractory T cell lymphomas, with 3 complete responses (CRs) and 4 partial responses (PRs) observed[122]. - As of July 16, 2024, the median progression-free survival (PFS) for evaluable patients at the 200 mg BID dose was 6.2 months, with 39% of patients achieving objective responses[123]. - The optimal dose of soquelitinib was determined to be 200 mg taken twice daily, based on anti-tumor efficacy and pharmacodynamic studies[121]. - The FDA has granted Fast Track designation and Orphan Drug Designation to soquelitinib for the treatment of adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL)[128]. - A registrational Phase 3 clinical trial for soquelitinib in relapsed/refractory PTCL is set to enroll 150 patients, with the primary endpoint being progression-free survival[127]. - In a Phase 1 clinical trial for atopic dermatitis, cohort 3 patients showed a mean reduction in Eczema Area and Severity Index (EASI) score of 64.8% after 28 days of treatment[136]. - The median duration of response for patients with objective response in the T cell lymphoma trial was reported as 17.2 months[131]. - Soquelitinib selectively inhibits ITK function, leading to Th1 skewing and production of cytokines important for tumor rejection[132]. - The Phase 1/1b trial for T cell lymphomas included patients from the United States, Australia, China, and South Korea, with no dose-limiting toxicities observed[121]. - Preclinical data suggest that ITK inhibition with soquelitinib enhances anti-tumor immunity and may be beneficial for treating solid tumors in future clinical trials[130]. Financial Performance and Projections - The net loss for the three months ended September 30, 2025, was $10.2 million, and for the nine months ended September 30, 2025, it was $3.0 million, including $27.1 million in non-operating income from the change in fair value of warrant liability[152]. - As of September 30, 2025, the accumulated deficit was $400.0 million, and the company expects losses to increase as it continues the development of its product candidates[152]. - The company had capital resources of approximately $65.7 million as of September 30, 2025, and anticipates needing additional funding by the fourth quarter of 2026[157]. - The company has not generated any revenue from product sales to date and does not expect to until regulatory approval is obtained[162]. - The company has raised a total of $70.6 million from its IPO in March 2016 and additional funds through follow-on offerings, with $100.0 million remaining for sale under the 2024 Sales Agreement[153][155]. - The company expects to continue incurring net operating losses for at least the next several years as it advances its product candidates through clinical development[187]. - The company anticipates that its existing cash resources will only be sufficient to fund operations into the fourth quarter of 2026, raising substantial doubt about its ability to continue as a going concern for at least the next 12 months[189]. Research and Development Expenses - The Phase 1 clinical trial for soquelitinib in atopic dermatitis is expected to lead to a Phase 2 clinical trial, anticipated to enroll approximately 200 patients[145][147]. - The company plans to increase research and development expenses substantially as it continues the development of its product candidates[163]. - For the three months ended September 30, 2025, total operating expenses increased by $3.3 million to $10.6 million compared to the same period in 2024, with research and development expenses rising by $3.2 million to $8.5 million[169]. - Research and development expenses for the nine months ended September 30, 2025, increased by $10.4 million to $23.8 million compared to the same period in 2024, driven mainly by costs associated with the drug Soquelitinib[169][171]. - General and administrative expenses for the nine months ended September 30, 2025, increased by $0.9 million to $7.0 million compared to the same period in 2024, primarily due to increased personnel costs[176]. Cash Flow and Financing Activities - Cash used in operating activities during the nine months ended September 30, 2025, was $23.6 million, primarily due to a net loss of $3.0 million adjusted by non-cash transactions totaling $23.5 million[192]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $65.7 million, with an accumulated deficit of $400.0 million[183]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $36.4 million, primarily from proceeds of $35.7 million from the exercise of common warrants[196]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $30.4 million, consisting of net proceeds of $16.4 million from common stock issuance and $5.0 million from pre-funded warrants[199]. - Cash used in operating activities for the nine months ended September 30, 2024, was $17.0 million, primarily due to a net loss of $50.2 million adjusted by net non-cash transactions of $33.4 million[193]. - Net cash flows used in investing activities for the nine months ended September 30, 2024, was $21.4 million, mainly from purchases of marketable securities totaling $49.8 million, partially offset by maturities of $28.4 million[195]. Changes in Financial Position - The change in fair value of warrant liabilities for the nine months ended September 30, 2025, was a decrease of $27.1 million, reflecting the fair value adjustment of common warrants[180]. - The company experienced an increase of $31.0 million in the fair value of warrant liability during the nine months ended September 30, 2024[193]. - The company reported a net loss of $50.2 million for the nine months ended September 30, 2024[193]. - The company incurred $2.2 million in stock compensation expense during the nine months ended September 30, 2024[193]. - The company had no material changes to its contractual obligations during the nine months ended September 30, 2025[200]. - There were no changes to critical accounting estimates during the nine months ended September 30, 2025[201].

Financial Performance - As of September 30, 2025, Corvus had cash, cash equivalents, and marketable securities of $65.7 million, up from $52.0 million as of December 31, 2024, indicating a 26.5% increase[9] - The net loss for Q3 2025 was $10.2 million, significantly reduced from a net loss of $40.2 million in Q3 2024, which included a non-cash loss of $32.8 million[11] - For the three months ended September 30, 2025, total operating expenses increased to $10,572,000, up from $7,255,000 in the same period of 2024, representing a 46.5% increase[25] - The net loss for the three months ended September 30, 2025, was $10,157,000, a decrease from a net loss of $40,217,000 in the same period of 2024[25] - The net loss per share, basic, for the three months ended September 30, 2025, was $0.12, compared to $0.60 in 2024[25] - Stockholders' equity rose to $71,768,000 as of September 30, 2025, compared to $32,568,000 as of December 31, 2024[28] - Interest income and other expense, net, for the three months ended September 30, 2025, was $738,000, up from $566,000 in 2024[25] - The investment in Angel Pharmaceuticals was valued at $11,530,000 as of September 30, 2025, down from $12,540,000 as of December 31, 2024[28] Research and Development - Research and development expenses for Q3 2025 totaled $8.5 million, compared to $5.2 million for the same period in 2024, reflecting an increase of approximately 63.5%[10] - Research and development expenses for the three months ended September 30, 2025, were $8,454,000, compared to $5,222,000 in 2024, reflecting a 62.5% increase[25] - Corvus completed enrollment in extension cohort 4 of the soquelitinib atopic dermatitis Phase 1 trial with 24 patients, and data announcement is anticipated in January 2026[6] - The Phase 2 clinical trial for atopic dermatitis is set to enroll approximately 200 patients in early Q1 2026, with a treatment period of 12 weeks[6] - The registrational Phase 3 clinical trial of soquelitinib in relapsed/refractory peripheral T cell lymphoma (PTCL) is ongoing, with an expected enrollment of 150 patients[15] - The final results from the Phase 1/1b trial of soquelitinib in T cell lymphoma will be presented at the American Society of Hematology Annual Meeting in December 2025[15] - Corvus continues collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) for the Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial[5] Cash Flow and Funding - Corvus anticipates its cash will fund operations into the fourth quarter of 2026[9] - Total assets as of September 30, 2025, were $80,474,000, an increase from $68,907,000 as of December 31, 2024[28] - Cash, cash equivalents, and marketable securities increased to $65,689,000 as of September 30, 2025, up from $51,964,000 as of December 31, 2024[28] Operational Loss - The company reported a loss from operations of $10,572,000 for the three months ended September 30, 2025, compared to a loss of $7,255,000 in the same period of 2024[25]

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]

Soquelitinib Overview - Soquelitinib is a first-in-class immune modulator with broad potential in cancer and immune diseases, targeting ITK [4, 5] - It has a novel mechanism of action with opportunities in oncology and immune diseases [5] - The drug has demonstrated a convenient oral dosing and attractive safety/tolerability profile in over 100 patients [5] - Corvus has strong IP protection with issued composition patents extending to November 2037 [5] Clinical Trials and Data - A randomized Phase 3 trial in PTCL is enrolling, with the potential for the first fully FDA-approved drug for PTCL [23, 24] - Phase 1 study in atopic dermatitis (AD) showed a significant reduction in EASI score at 28 days of treatment [68] - In the AD study, the 200 mg BID dose showed earlier and deeper responses, along with greater reductions in itch [68] - In AD Cohorts 1 and 2 (N=24), the mean EASI change was a 54.6% reduction, while in Cohort 3 (N=12), it was a 64.8% reduction, compared to a 34.4% reduction in the combined placebo group (N=12) [42] - In AD Cohort 3, 50% of patients with baseline PP-NRS ≥4 experienced a ≥ 4-point decrease in PP-NRS at Day 28 [53] Market and Future Development - The atopic dermatitis (AD) market is projected to reach $28 billion by 2030 [34] - Angel Pharma initiated a Phase 1b/2 trial in China for atopic dermatitis in Q4 2025 [59, 62] - Corvus anticipates data from the atopic dermatitis Phase 1 extension cohort 4 in January 2026 and plans to initiate a Phase 2 trial in early Q1 2026 [58, 69]

Core Insights - Corvus Pharmaceuticals is set to present final data from its Phase 1/1b trial of soquelitinib for T cell lymphoma at the 67th ASH Annual Meeting in December 2025 [1] - Soquelitinib is a selective interleukin-2-inducible T cell kinase (ITK) inhibitor, currently in a Phase 3 clinical trial for relapsed/refractory T cell lymphoma and a Phase 1 trial for atopic dermatitis [2] Group 1 - The oral presentation will take place on December 8, 2025, from 10:30 AM to 12:00 PM, with the specific presentation scheduled for 11:15 AM to 11:30 AM [1] - The publication number for the presentation is 778, focusing on the final results of the Phase 1 trial with soquelitinib [1] Group 2 - Corvus Pharmaceuticals is pioneering ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [2] - The company’s lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK [2]

Core Insights - Corvus Pharmaceuticals, Inc. will engage with investors through one-on-one meetings and a fireside chat at the Guggenheim 2 Annual Healthcare Innovation Conference in Boston, MA on November 10, 2025 at 8:30 am ET [1] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [3] - The company's lead product candidate is soquelitinib, an investigational oral small molecule drug that selectively inhibits ITK [3] - Corvus has additional clinical-stage candidates targeting a range of cancer indications [3] Event Details - A live webcast of the fireside chat will be available, along with access for 90 days post-event, through the investor relations section of the Corvus website [2]

Core Points - Corvus Pharmaceuticals, Inc. will host a conference call and webcast on November 4, 2025, at 4:30 pm ET to provide a business update and report third quarter 2025 financial results [1] - The conference call can be accessed via a toll-free number or through a link for instant access, with a replay available for 90 days on the company's website [2] - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition for immunotherapy targeting various cancers and immune diseases, with its lead product candidate being soquelitinib [3]

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]

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]