On March 25, 2025 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the fourth quarter and year ended December 31, 2024 (Press release, Corvus Pharmaceuticals, MAR 25, 2025, View Source [SID1234651402]).
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"We continue to advance our selective ITK inhibitor, soquelitinib, in a range of diseases," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Our Phase 1 clinical trial in atopic dermatitis is nearing completion of enrollment in the third cohort at a dose level that we anticipate may be optimum based on our experience in T cell lymphomas. The results from the first two cohorts demonstrated safety and activity compared to placebo utilizing the rigorous endpoint of EASI 75 and IGA 0 or 1. Our Phase 3 registration clinical trial in peripheral T cell lymphoma (PTCL) is enrolling at multiple sites and we have recently initiated a Phase 2 trial in autoimmune lymphoproliferative syndrome (ALPS), a rare life-threatening genetic disease with multiple autoimmune manifestations. Our clinical strategy is to demonstrate the value of soquelitinib’s novel mechanism of action in both cancers and immune diseases, across multiple disease indications. This includes our planned solid tumor clinical trial, which we now anticipate initiating in the third quarter 2025."
Business Update and Strategy
Soquelitinib (Corvus’ selective ITK inhibitor)
Soquelitinib for Immune Diseases
On January 13, 2025, Corvus reported interim results from the first two cohorts of its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis that demonstrated a favorable safety profile and efficacy profile. This includes significant responses in the soquelitinib treatment groups compared to placebo for clinically significant endpoints of IGA (Investigator Global Assessment) 0 or 1 and EASI (Eczema Area and Severity Index) 75. Specifically, the Company reported results from 16 patients in Cohort 1 (12 patients in the soquelitinib group receiving 100 mg orally twice per day vs. four receiving placebo) and 10 patients in Cohort 2 (seven patients in the soquelitinib group receiving 200 mg orally once per day vs. three receiving placebo) for which 28 days of treatment had been completed. For those 19 patients in the soquelitinib group, 26% achieved IGA 0 or 1 and 37% achieved EASI 75; and of the seven in the placebo group, none achieved IGA 0 or 1 or EASI 75. No significant safety issues were observed and no clinically significant laboratory abnormalities were seen.
Corvus is nearing completion of patient enrollment in the third cohort (200 mg orally twice per day) of the trial and plans to announce additional results from the study including data from Cohorts 1, 2 and 3 in May 2025.
The atopic dermatitis Phase 1 clinical trial is enrolling patients with moderate to severe atopic dermatitis that previously failed at least one prior topical or systemic therapy. Enrollment in the first two cohorts is complete, and the third cohort is near completion of enrollment. Each cohort covers a 28-day dosing regimen and includes 12 patients that receive soquelitinib and 4 patients that receive placebo, for a total of 16 patients in each cohort. Patients are followed for an additional 30 days after completing the 28-day course of therapy. The endpoints include safety and improvement in the Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA). Patients and physicians are blinded to the treatment assignment.
The Company also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation that is optimized for specific immunology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
In March, the Company initiated a Phase 2 clinical trial in patients with ALPS under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing. Two dosing cohorts will be studied. The patients will receive soquelitinib doses of 200 mg or 400 mg twice per day for a period of up to 360 days. The primary endpoint of the trial is efficacy determined by reductions in splenomegaly (enlarged spleen) and lymph node volumes as measured by computed tomography (CT). Improvements in cytopenias will be assessed by complete blood count (CBC). Cytopenias are caused by autoantibodies (antibodies that target the body’s own cells) that may lead to destruction of red blood cells, platelets and/or neutrophils leading to anemia, thrombocytopenia or neutropenia. Improvements in cytopenias can improve quality of life and overall health, and they also serve as a valuable biomarker associated with ALPS disease activity. Secondary endpoints include safety and tolerability.
Soquelitinib for T Cell Lymphoma
Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory peripheral T cell lymphoma after at least 2 lines of systemic therapy.
In March, additional data from the Phase 1/1b clinical trial of soquelitinib for patients with T cell lymphoma that continued to demonstrate strong indications of anti-tumor activity was presented at the 16th Annual T-Cell Lymphoma Forum.
Data supporting the potential of soquelitinib as a novel approach to modulate tumor immunity was published in npj Drug Discovery (part of the Nature portfolio of journals), an open access, international, peer-reviewed journal dedicated to publishing the highest quality research relevant to all aspects of drug design and discovery.
Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor)
Corvus is collaborating with the Kidney Cancer Research Consortium (KCRC) in a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The efficacy endpoint for the trial is deep response rate, defined as CR plus PRs of greater than 50% tumor volume reduction. The trial is now fully enrolled (n=60) and patients are being followed.
The Phase 1b/2 clinical trial in patients with metastatic RCC is supported by data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting highlighting the potential of ciforadenant to overcome immunotherapy resistance in metastatic castration resistant prostate cancer. The data was presented in an oral session and was selected as a top 100 abstract. This work was recently published in January in the journal Nature 637:1207, 2025.
Partner Led Program: Mupadolimab (anti-CD73)
Angel Pharmaceuticals, Corvus’ partner in China, continues to monitor patients in an expansion cohort of its Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC).
Financial Results
As of December 31, 2024, Corvus had cash, cash equivalents and marketable securities of $52.0 million as compared to $27.1 million as of December 31, 2023. During the year ended December 31, 2024, the Company completed a registered direct offering in which it sold shares of common stock, pre-funded warrants and common warrants, generating $30.3 million in net proceeds. During the quarter ended December 31, 2024, two holders of 5,311,198 common stock warrants early exercised all of their warrants in advance of the June 30, 2025 expiration date, resulting in cash proceeds to the Company of approximately $18.6 million. Based on its current plans, Corvus expects its cash to fund operations into the first quarter of 2026.
Research and development expenses for the three months and full year ended December 31, 2024 totaled $6.0 million and $19.4 million, respectively, compared to $4.0 million and $16.5 million for the same periods in 2023. For the full year 2024, the increase of approximately $2.9 million was primarily due to higher clinical trial costs associated with the development of soquelitinib.
The net loss for the three months ended December 31, 2024 was $12.1 million compared to a net loss of $6.7 million for the same period in 2023. Total stock compensation expense for the three months ended December 31, 2024 was $0.8 million compared to $0.6 million for the same period in 2023 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $2.2 million for the three months ended December 31, 2024 compared to a loss of $1.4 million for the same period in 2023. In addition, the Company recorded a non-cash loss of $2.3 million related to an increase in the fair value of its warrant liability during the three months ended December 31, 2024. The Company issued approximately 17.1 million common stock warrants in its May 2024 registered direct offering with an exercise price of $3.50 per common stock warrant. After the early exercise of 5,311,198 common warrants during the three months ended December 31, 2024, 11,778,238 common stock warrants remain outstanding. The common stock warrants expire on June 30, 2025.
Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, March 25, 2025, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2024 financial results. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.