On May 8, 2025 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and provided financial results for the first quarter ended March 31, 2025 (Press release, Corvus Pharmaceuticals, MAY 8, 2025, View Source [SID1234652739]).

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"The new soquelitinib data being presented at the Society for Investigative Dermatology annual meeting supports its potential to be a meaningful new treatment for atopic dermatitis, along with the broader opportunity for ITK inhibition to provide a new mechanism of action to treat a range of immune diseases," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Looking forward, we remain on track with our key potential value-driving initiatives for soquelitinib in atopic dermatitis, including data from our new extension cohort in the fourth quarter and initiating a Phase 2 clinical trial before year-end. We also remain excited about our other soquelitinib clinical programs – patient enrollment in the Phase 3 registration clinical trial in peripheral T cell lymphoma (PTCL) and the Phase 2 trial in autoimmune lymphoproliferative syndrome (ALPS) is ongoing, and we plan to initiate a solid tumor clinical trial later in 2025."

Business Update and Strategy

Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases

On May 8, 2025, Corvus reported interim results (data as of May 6, 2025) from the first three cohorts of its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis that continued to demonstrate a favorable safety profile and efficacy profile. This includes earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 mg) compared to cohorts 1 and 2 (100 mg twice per day and 200 mg once per day, total daily dose 200 mg). Overall, all three cohorts showed significant responses in the soquelitinib treatment groups compared to placebo for clinically significant endpoints of EASI (Eczema Area and Severity Index) 75 and IGA (Investigator Global Assessment) 0 or 1. Soquelitinib was well tolerated, with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts.
Corvus amended the clinical trial protocol to replace cohort 4 (400 mg once per day) with 24 patients randomized 1:1 between active and placebo. Treatment for this group will be extended to 8 weeks with additional 30 day follow-up with no treatment. The dose level for this group is planned to be the same as cohort 3 – 200 mg orally twice per day.
Corvus 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 April, the first patient was enrolled in the recently initiated ALPS Phase 2 clinical trial, which is being conducted 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.
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.
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 complete response (CR) plus partial responses (PRs) of greater than 50% tumor volume reduction. The trial is fully enrolled and patients are being followed.
Partner Led Program: Mupadolimab (anti-CD73)

Angel Pharmaceuticals, Corvus’ partner in China, continues to evaluate data from its Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC).
Financial Results
As of March 31, 2025, Corvus had cash, cash equivalents and marketable securities of $44.2 million as compared to $52.0 million as of December 31, 2024. In May 2025, holders of 8,945,175 common stock warrants to purchase 8,945,175 shares of common stock, exercised all of their warrants at $3.50 per share in advance of the June 30, 2025 expiration date which resulted in cash proceeds to Corvus of approximately $31.3 million. Included in the 8,945,175 shares were 559,073 shares purchased for $1,956,756 by Richard Miller, Corvus’ CEO, related to his early exercise of common stock warrants. Based on its current plans, Corvus expects its cash to fund operations into the fourth quarter of 2026.

Research and development expenses for the three months ended March 31, 2025 totaled $7.5 million compared to $4.1 million for the same period in 2024. The increase of approximately $3.4 million was primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net income for the three months ended March 31, 2025 was $15.2 million, which included a gain of $25.1 million associated with the change in fair value of the Company’s warrant liability. Net loss for the same period in 2024 was $5.7 million. Total stock compensation expense for the three months ended March 31, 2025 was $1.3 million compared to $0.7 million for the same period in 2024 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.5 million for the three months ended March 31, 2025 compared to non-cash income of $0.2 million for the same period in 2024.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, May 8, 2025, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the first quarter 2025 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.