Core Insights - Corvus Pharmaceuticals announced new interim data from a Phase 1 clinical trial of soquelitinib for moderate to severe atopic dermatitis, which will be presented at the Society for Investigative Dermatology 2025 Annual Meeting [1][2] - The company will discuss this data during its first quarter 2025 business update conference call scheduled for May 8, 2025 [1][3] Presentation Details - The presentation titled "Selective Soquelitinib, a selective ITK inhibitor demonstrates activity in atopic dermatitis phase 1 clinical trial by a novel mechanism of action" will be delivered by Dr. Albert S. Chiou [2] - The poster presentation is set for May 8, 2025, from 4:30 – 6:00 pm PT, while the oral presentation will occur on May 10, 2025, from 9:50 – 10:00 am PT [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 [4] - The lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK, with other candidates in development for different cancer indications [4]

Core Insights - Corvus Pharmaceuticals has appointed Richard van den Broek to its board of directors, bringing over 30 years of experience in the life sciences industry [1][2] - The company is focused on advancing ITK inhibition as a novel approach to immunotherapy for various cancers and immune diseases [3] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company developing ITK inhibition, with its lead product candidate being soquelitinib, an investigational oral small molecule drug [3] - The company is also working on other clinical-stage candidates targeting a range of cancer indications [3] Leadership Experience - Richard van den Broek has a strong background in biotechnology, having previously served on the board of Pharmacyclics, where he contributed to the development of the first BTK inhibitor for lymphomas and immune diseases [2] - He is currently the managing partner at HSMR Advisors and has held directorships at Pulse Biosciences and Cogstate [2]

Group 1 - Corvus Pharmaceuticals is a biopharmaceutical company focused on developing treatments for autoimmune conditions and cancer [1] - The leading candidate of the company is Soquelitinib, an ITK inhibitor that possesses anti-inflammatory and anti-tumor properties [1]

Core Insights - Corvus Pharmaceuticals (NASDAQ: CRVS) has been actively releasing new data and updates over the past nine months, indicating ongoing progress in its business and clinical endeavors [1] Company Updates - The company has continued to develop and present fresh rounds of clinical data, which may impact its market position and investor interest [1] Investment Perspective - The article reflects a positive sentiment towards Corvus Pharmaceuticals, suggesting potential for capital appreciation and growth in the pharmaceutical sector [1]

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 due to higher clinical trial costs [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 a 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 patients in a registrational Phase 3 trial of socalitinib for relapsed peripheral T-cell lymphoma, with a median progression-free survival of 6.2 months reported [24] - The ALPS trial will enroll up to 30 patients with autoimmune lymphoproliferative syndrome, a genetic disease affecting approximately 2,500 patients in the U.S. [68] Company Strategy and Development Direction - The company aims to position socalitinib as a first-in-class oral therapy for various immune diseases and cancers, leveraging its unique mechanism of action [11] - Plans include advancing multiple clinical trials, including a Phase 2 trial for solid tumors and a Phase 2 trial for 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 cash runway into Q1 2026, allowing for the execution of key milestones [10][33] Other Important Information - The company is also advancing second and third-generation ITK selective inhibitors and has a Phase 1b/2 trial for ciforadenant in metastatic renal cell cancer [30][31] Q&A Session Summary Question: Updates on atopic dermatitis data - Management plans to report full data on cohorts one, two, and three at the Society of Investigative Dermatology meeting in May [38] Question: Efficacy hurdles for Phase 2a - Management is pleased with the efficacy seen in cohorts one and two, noting a significant difference compared to placebo [41][42] Question: Plans for cohort four - The plan for cohort four is to evaluate a 400 mg dose, pending analysis of cohort three data [50][52] Question: Biomarker insights for atopic dermatitis - Management indicated ongoing studies are confirming previous biomarker findings, with promising early results [57] Question: Addressable patient population for ALPS - Approximately 2,500 patients in the U.S. are affected by ALPS, with no specific subset identified as more amenable to treatment [68] Question: Prioritization of opportunities for socalitinib - The strategy is to pursue approvals in both oncology and immunology, recognizing the unique challenges of each field [81] Question: Specific indications for solid tumor study - Initial focus will be on renal and lung cancers, with plans to evaluate different doses based on pharmacodynamic markers [91][92]

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]

Clinical Trials and Efficacy - Soquelitinib is currently in a registrational Phase 3 clinical trial for relapsed peripheral T cell lymphoma (PTCL) with a total enrollment target of 150 patients[32]. - Interim data from the Phase 1/1b clinical trial showed an objective response rate (ORR) of 39% in evaluable patients receiving 200 mg twice daily, including 26% complete responses (CRs)[31]. - The optimal dose of soquelitinib was determined to be 200 mg twice daily based on anti-tumor efficacy and pharmacodynamic studies[28]. - A Phase 1 clinical trial for soquelitinib in moderate to severe atopic dermatitis is planned to enroll 64 patients, with primary endpoints including safety and efficacy measured by Eczema Area and Severity Index (EASI) scores[38]. - In the Phase 1 clinical trial for atopic dermatitis, 26% of patients in the soquelitinib group achieved Investigator Global Assessment (IGA) 0 or 1, compared to none in the placebo group[39]. - Soquelitinib has shown potential to inhibit the production of inflammatory cytokines involved in diseases such as atopic dermatitis, asthma, and psoriasis[24]. - The company plans to conduct a Phase 1b/2 clinical trial of soquelitinib in solid tumors in patients with renal cell cancer who have failed checkpoint inhibitor therapy[34]. - Preclinical data suggest that soquelitinib enhances anti-tumor immunity by modulating T cell differentiation and reducing T cell exhaustion[33]. - Soquelitinib has been shown to provide statistically significant inhibition of tumor growth in various cancer models, including T cell lymphoma and colon cancer[35]. - Soquelitinib is currently in Phase 3 trials for relapsed and refractory PTCL and Phase 1 for atopic dermatitis, with over 100 patients treated to date[49]. - Ciforadenant is being evaluated in a Phase 1b/2 clinical trial for metastatic RCC, with a target enrollment of up to 60 patients and an interim efficacy threshold of a 50% increase over a 32% deep response rate[44]. - Mupadolimab is designed to enhance immune responses by activating B cells, with plans for a Phase 2 randomized clinical trial pending[45]. Regulatory Designations and Approvals - The FDA granted Fast Track designation to soquelitinib for the treatment of adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy[37]. - The FDA aims to complete a standard review of an NDA for a new molecular entity or an original BLA within ten months after the filing date, or within six months for priority review applications[86]. - Orphan Drug Designation is granted for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S., providing seven years of exclusivity upon first approval for the designated condition[90][91]. - Fast Track designation expedites the review process for drugs intended to treat serious conditions, allowing for rolling submissions of NDA sections[94]. - Breakthrough Therapy designation provides more intensive FDA interaction and guidance, aimed at expediting development for products showing substantial improvement over existing therapies[95]. - Priority review applications are expected to be reviewed within six months, compared to ten months for standard reviews, if they demonstrate significant improvements in safety or effectiveness[96]. - Accelerated approval may be granted based on surrogate endpoints that predict clinical benefit, with the requirement for confirmatory trials post-approval[97]. - The FDA may withdraw approval if compliance with regulatory standards is not maintained after market entry[99]. - Pediatric exclusivity can extend existing exclusivity periods by six months if clinical trials in children are conducted in response to FDA requests[103]. Financial and Operational Overview - The company incurred a net loss of $62.3 million, $27.0 million, and $41.3 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $397.0 million as of December 31, 2024[161]. - Cash, cash equivalents, and marketable securities were $52.0 million at December 31, 2024, which is insufficient to fund operations for at least 12 months beyond the filing of the Annual Report[162]. - The company has never generated revenue from product sales and is focused on developing lead product candidates soquelitinib, ciforadenant, and mupadolimab[161]. - The company expects to continue incurring significant losses as it seeks regulatory approval and prepares for commercialization of its product candidates[161]. - The company formed Angel Pharmaceuticals to develop and commercialize its product candidates in Greater China, which may affect its ability to retain rights and revenue streams[165]. - The company is classified as a "smaller reporting company" and benefits from scaled disclosures as long as its market value remains below $250 million or annual revenue is below $100 million[158]. - The company faces significant risks related to its limited operating history and the need for additional capital to support its research and development programs[161]. - The company has no products on the market, and its ability to achieve profitability depends on obtaining regulatory approvals for its product candidates[168]. - The company may need to seek additional funds through public or private equity, debt financings, or strategic collaborations, which could dilute stockholder equity[165]. Intellectual Property and Licensing - The company holds exclusive worldwide rights for all indications of its ITK inhibitors, except for greater China, and has issued patents covering their composition and uses[43]. - The patent portfolio includes 14 licensed U.S. issued patents and 13 owned U.S. issued patents, with expiration dates for various patents expected between 2036 and 2045[54][57]. - The company made a one-time cash payment of $1.0 million to Vernalis upon entering into the licensing agreement[61]. - The aggregate potential milestone payments to Vernalis are approximately $220 million for all indications as of December 31, 2024[61]. - The tiered royalty rates for products containing ciforadenant range from mid-single digits to low-double digits on a country-by-country net sales basis[62]. - The company made a one-time cash payment of $275,000 to Monash University and is obligated to pay an annual license maintenance fee of $25,000 until a development milestone is met[68]. - The aggregate potential milestone payments to Monash are $45.1 million as of December 31, 2024[68]. - The company is required to pay tiered royalties on net sales of licensed products at a rate ranging in the low-single digits[68]. - The company has the right to terminate the agreement with Vernalis at its convenience with 90 days written notice[63]. - The license agreement with Scripps includes a minimum annual fee of $25,000 and potential milestone payments of $2.6 million[65]. - The agreement with Monash is terminable at will by the company upon providing 30 days written notice[69]. Regulatory Compliance and Challenges - The company is subject to inspections by the FDA for compliance with cGMP and other U.S. regulatory requirements[152]. - Significant uncertainty exists regarding the coverage and reimbursement status of pharmaceutical products, which can affect sales and financial condition[139]. - Third-party payors may limit coverage to specific products, impacting physician utilization and sales[140]. - The Affordable Care Act increased minimum Medicaid rebates and introduced new methodologies for calculating rebates[144]. - The Inflation Reduction Act requires manufacturers to engage in price negotiations with Medicare starting in 2026[146]. - The company may be subject to significant civil and criminal penalties for non-compliance with data privacy and security laws[150]. - Future healthcare reforms may limit reimbursement amounts, affecting demand for the company's products[149]. - Regulatory compliance is costly and time-consuming, with the potential for unanticipated delays in obtaining necessary approvals[190]. - The approval process varies by country, and safety concerns can lead to increased scrutiny and delays in regulatory approvals[191]. - Changes in regulatory requirements may necessitate amendments to clinical trial protocols, impacting costs and timelines[184]. - The company may face challenges in demonstrating the safety and efficacy of product candidates to regulatory authorities, which could hinder approval[192]. Manufacturing and Supply Chain - The company relies on third-party manufacturers for the production of its product candidates, allowing it to focus on drug development without owning manufacturing facilities[46]. - The company does not have the infrastructure to manufacture clinical drug supplies and relies on contract manufacturers, which may face regulatory challenges[210]. - The company may face significant disruptions in commercial supply if there are interruptions from approved manufacturers, potentially leading to costly delays in clinical and commercial timelines[214]. - Manufacturing scale-up challenges could delay or prevent the development and commercialization of product candidates, impacting the company's business adversely[215]. - Supply chain complexities are expected to increase as the company expands clinical trial enrollments for multiple product candidates, which could disrupt product supply[216]. - The reliance on third-party manufacturers increases the risk of trade secret exposure, which could impair the company's competitive position[217]. Clinical Development Risks - The company acknowledges that the clinical development process is lengthy and expensive, with uncertain outcomes for its product candidates[174]. - Clinical testing is expensive and can take many years, with inherent uncertainties leading to potential failures at any stage of the clinical trial process[175]. - The collaboration with Angel Pharmaceuticals involves them managing clinical development and commercialization in greater China, with all related expenses covered by Angel[176]. - The FDA and other regulatory authorities may impose delays or denials of approval for product candidates, impacting the commercialization timeline[191]. - Delays in clinical trials can significantly increase costs and hinder the ability to generate revenue from product candidates[185]. - Interim data from clinical trials may change as more patient data becomes available, which could impact business prospects[186]. - The occurrence of serious complications or side effects during clinical trials could lead to the discontinuation of development programs and refusal of regulatory approvals[197]. - Regulatory authorities may withdraw approvals or require additional warnings if undesirable side effects are identified post-approval, impacting market acceptance[200]. - Compliance with Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP) regulations is essential for the approval of product candidates[206]. - Subject enrollment is critical for clinical trials, and difficulties in recruiting eligible subjects could lead to significant delays or abandonment of trials[194].

Financial Performance - The net loss for Q4 2024 was $12.1 million, compared to a net loss of $6.7 million for the same period in 2023[13]. - Corvus Pharmaceuticals reported a net loss of $12.1 million for Q4 2024, compared to a net loss of $6.7 million in Q4 2023, reflecting an increase of 81.5% year-over-year[28]. - Total operating expenses for the year ended December 31, 2024, were $27.5 million, up from $23.4 million in 2023, representing a 17.9% increase[27]. - The net loss per share for the year ended December 31, 2024, was $1.02, compared to $0.56 in 2023, reflecting a significant increase in losses per share[28]. - The company reported a change in fair value of warrant liability amounting to a loss of $33.4 million for the year ended December 31, 2024[28]. Cash and Funding - Corvus Pharmaceuticals reported cash, cash equivalents, and marketable securities of $52.0 million as of December 31, 2024, up from $27.1 million as of December 31, 2023[10]. - Cash, cash equivalents, and marketable securities increased to $52.0 million as of December 31, 2024, from $27.1 million in 2023, showing a growth of 91.7%[30]. - The company completed a registered direct offering generating $30.3 million in net proceeds during 2024[11]. - Corvus expects its cash to fund operations into the first quarter of 2026 based on current plans[11]. - The company anticipates funding operations into the first quarter of 2026, with ongoing clinical trials and product development milestones[25]. Research and Development - Research and development expenses for the full year 2024 totaled $19.4 million, an increase from $16.5 million in 2023, primarily due to higher clinical trial costs associated with soquelitinib[12]. - Research and development expenses for Q4 2024 were $6.0 million, compared to $4.0 million in Q4 2023, indicating a 49.3% increase[27]. - In the Phase 1 clinical trial for atopic dermatitis, 26% of patients in the soquelitinib group achieved IGA 0 or 1, and 37% achieved EASI 75, compared to none in the placebo group[4]. - The Phase 3 clinical trial for soquelitinib in relapsed peripheral T cell lymphoma (PTCL) is enrolling a total of 150 patients, with the primary endpoint being progression-free survival[10]. - Corvus initiated a Phase 2 clinical trial for autoimmune lymphoproliferative syndrome (ALPS) with an anticipated enrollment of up to 30 patients, focusing on efficacy determined by reductions in splenomegaly and lymph node volumes[6]. - The Phase 1b/2 clinical trial for ciforadenant in metastatic renal cell cancer is fully enrolled with 60 patients, evaluating deep response rate as the efficacy endpoint[10]. - Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial for advanced head and neck cancers and NSCLC patients[23]. - Corvus plans to announce additional results from the atopic dermatitis trial, including data from all cohorts, in May 2025[4]. Corporate Governance - The company has a 49.7% equity stake in Angel Pharmaceuticals, which is developing three clinical-stage candidates in Greater China[24]. - Corvus Pharmaceuticals has designated three individuals on Angel Pharmaceuticals' five-person Board of Directors, indicating strong governance collaboration[24].

Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Data From Cohorts 1-3 anticipated to be Presented in May Initial Results From First Two Cohorts Supports Safety and Efficacy with Oral Agent and Novel Mechanism of Action Registration Phase 3 Clinical Trial of Soquelitinib in Peripheral T Cell Lymphoma (PTCL) Enrolling with Multiple Clinical Sites Open Conference call today at 4:30 p.m. ET / 1:30 p.m. PT SOUTH SAN FRANCISCO, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus ...

Core Insights - Corvus Pharmaceuticals announced additional data from its Phase 1/1b clinical trial of soquelitinib for T cell lymphoma, showcasing strong anti-tumor activity and encouraging results compared to standard treatments [1][2] 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 [10] - The lead product candidate is soquelitinib, an investigational oral small molecule drug that selectively inhibits ITK [10] Clinical Trial Data - The Phase 1/1b trial enrolled 25 patients, with 23 evaluable patients showing a 39% objective response rate, including a 26% complete response rate [4][6] - The median duration of response was 17.2 months, with a median progression-free survival (PFS) of 6.2 months and an 18-month PFS rate of 30%, significantly better than the <20% rate for standard treatments [6] - Soquelitinib was well-tolerated, with no new safety signals or dose reductions reported [6] Future Trials - A registrational Phase 3 trial is underway for soquelitinib in patients with relapsed Peripheral T cell lymphoma (PTCL), aiming to enroll 150 patients [4] - The trial will compare soquelitinib against physician's choice of either belinostat or pralatrexate, with the primary endpoint being PFS [4] Mechanism of Action - Soquelitinib is designed to selectively inhibit ITK, which plays a crucial role in T cell immune function, potentially enhancing anti-tumor immunity by reducing T cell exhaustion [9] - The drug has shown the ability to shift T cell differentiation towards Th1 helper cells, which are essential for tumor immunity [9] Industry Context - Peripheral T cell lymphoma (PTCL) accounts for about 10% of non-Hodgkin's lymphomas in Western populations, with a high relapse rate and poor outcomes for patients [7] - There are currently no FDA-approved treatments for relapsed PTCL based on randomized trials, highlighting a significant unmet medical need [4][7]