Patients in 200 mg BID cohort had median progression free survival of 6.2 months and median overall survival of 28.1 months, comparing favorably to results with other therapies Data supports ongoing registration Phase 3 trial in r/r PTCL, Phase 1 trial in atopic dermatitis and potential expansion into other immune and inflammatory diseases Highlights ITK inhibition novel mechanism of action affecting T cell receptor signaling and T cell differentiation Presented in an oral session at the 67th American Soci ...

Summary of Corvus Pharmaceuticals FY Conference Call Company Overview - **Company**: Corvus Pharmaceuticals (NasdaqGM:CRVS) - **Focus**: Development of first-in-class immune modulators for cancer and immune diseases - **Lead Program**: Soquelitinib, an oral targeted therapy inhibiting ITK (interleukin-2-inducible T-cell kinase) [2][3] Key Points and Arguments Clinical Trials and Data - **Current Trials**: - Phase III trial for peripheral T-cell lymphoma (PTCL) - Phase IB trial and upcoming Phase II trial for moderate to severe atopic dermatitis (AD) [2] - **Phase I Data**: - 28-day data shows safety profile similar to placebo - Efficacy demonstrated with a statistical separation from placebo at p=0.036 [5] - Observed potential remissive effect with continued separation of treatment curves after stopping at 28 days [5][10] - **Cohort Four**: - Same dose as cohort three (200 mg b.i.d.) - Focus on 56 days of efficacy to assess incremental benefits [9][11] Biomarkers and Mechanism - **Mechanism**: - Targets TH2 and TH17 pathways, blocking cytokines like IL-4 and IL-17, which are relevant for AD [4] - **Biomarkers**: - Increased Tregs and decreased IL-5, IL-17, and IL-31 observed in clinical trials [7] - Plans for skin biopsies in Phase II trial to further assess biomarkers [7][32] Market Opportunity - **Atopic Dermatitis (AD)**: - High unmet need for safe and effective oral therapies - Each 1% market share in AD equates to $1 billion; significant opportunity with only 15% penetration of advanced therapies [26] - **Asthma Study**: - Planned study for asthma, another TH2-driven disease, targeting a market of 60 million patients [27][28] Competitive Landscape - **Differentiation**: - First-in-class selective ITK inhibitor with oral administration preferred by patients - Limited competition in the oral space, with most alternatives being injectables [34][35] - **Partnerships**: - Collaboration with Angelini Pharma for a Phase II AD trial in China [39] Financials - **Cash Position**: - As of September 30, the company has $65 million in cash, providing runway through Q4 2026 [41] Additional Considerations - **Future Trials**: - Phase II study design includes multiple arms and aims to stratify by prior systemic therapies [19][22] - **Data Reporting**: - Upcoming data expected in January, including efficacy and biomarker results [33] This summary encapsulates the critical insights from the conference call, highlighting Corvus Pharmaceuticals' strategic focus, clinical advancements, market potential, and financial health.

Core Insights - The article discusses Corvus Pharmaceuticals, Inc. (CRVS) and its stock performance, highlighting a significant rally that occurred nearly a year ago [1]. Group 1: Company Overview - Corvus Pharmaceuticals, Inc. is being revisited after a substantial period, indicating a renewed interest in the company's stock performance [1]. - The company is part of a broader discussion on biotech stocks, which are characterized by high volatility and potential for large returns [1]. Group 2: Analyst Background - Bret Jensen, a market analyst with over 13 years of experience, specializes in identifying high-potential biotech investments [1]. - Jensen leads The Biotech Forum, which offers a model portfolio of 12-20 biotech stocks with high upside potential, along with live discussions and weekly updates [1].

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]