On August 7, 2025 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the second quarter ended June 30, 2025 (Press release, Corvus Pharmaceuticals, AUG 7, 2025, View Source [SID1234654969]).

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"We are excited by the data reported from our Phase 1 trial of soquelitinib for atopic dermatitis and are advancing its development for this indication on multiple fronts," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "This includes patient enrollment in the extension cohort 4 of the Phase 1 trial, which is exploring an 8-week treatment period and is on track to report data in the fourth quarter 2025, along with near-final plans for a Phase 2 trial that we expect to initiate before year-end. In China, our partner Angel Pharmaceuticals plans to initiate a separate Phase 1b/2 trial, which will further expand the clinical experience with soquelitinib, including a 12-week treatment period and a 400 mg once-daily dose. In addition, enrollment continues in our Phase 3 registration clinical trial in PTCL and the Phase 2 trial in autoimmune lymphoproliferative syndrome (ALPS), reflecting the broader opportunity for ITK inhibition across a range of immune diseases."

Business Update and Strategy

Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases

On June 4, 2025, Corvus reported interim results (data cutoff date of May 28, 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. Patients in cohort 3 had more advanced disease with a higher mean baseline EASI (Eczema Area and Severity Index) score compared to patients in cohorts 1 and 2. At 28 days, the mean reduction in EASI for cohort 3 (n=12) was 64.8%, compared to 54.6% for cohort 1 and 2 combined (n=24) and 34.4% for placebo (n=12). Cohort 3 patients experienced earlier responses and deeper separation from placebo compared to cohorts 1 and 2 starting by day 8. EASI scores continue to improve further in treated patients from all cohorts out to day 58.
In cohort 3, of the patients for whom adequate PP-NRS (Peak Pruritus Numerical Rating Scale) data was available, 4 of 8 (50%) had a ≥4 point reduction in PP-NRS score from baseline at day 28, with a reduction in itch seen as early as day 8. Of the remaining patients, two had baseline PP-NRS of less than 4 and two had incomplete PP-NRS data. One of 10 evaluable placebo patients (10%) experienced a ≥4 point reduction in PP-NRS score at Day 28.
As of the data cutoff, soquelitinib was well tolerated in the Phase 1 clinical trial, with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts.
Corvus initiated enrollment in extension cohort 4 of the Phase 1 clinical trial, which is planned to study 24 patients randomized 1:1 between active (soquelitinib 200 mg twice per day, the same dose as cohort 3) and placebo. The treatment period for this group is 8 weeks, compared to 4 weeks in cohorts 1-3, with the same additional 30-day follow-up period with no treatment.
Angel Pharmaceuticals, Corvus’ partner in China, has been approved by the Center for Drug Evaluation of the China National Medical Products Administration to initiate a Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China. The trial, which is planned to enroll 48 patients and will study four soquelitinib doses and placebo, will further expand the clinical experience with soquelitinib in atopic dermatitis, including a 12-week treatment period and a 400 mg once-daily dose.
Preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis was presented in a poster session at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, where it was selected as a top 10 abstract by the Emerging EULAR Network (EMEUNET), a network of young rheumatologists and researchers in the field of rheumatology in Europe and beyond.
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)

Patient enrollment continues in the 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/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory 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/refractory 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 PTCL after at least 2 lines of systemic therapy.
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 trial is fully enrolled and patients are being followed.
Partner Led Program: Mupadolimab (anti-CD73)

Angel Pharmaceuticals 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 June 30, 2025, Corvus had cash, cash equivalents and marketable securities of $74.4 million as compared to $52.0 million as of December 31, 2024. During the three months ended June 30, 2025, all of the remaining outstanding common stock warrants were exercised, resulting in proceeds of $35.7 million which included $2.0 million from warrants exercised by Corvus’ CEO, Dr. Miller. 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 June 30, 2025 totaled $7.9 million compared to $4.1 million for the same period in 2024. The increase of approximately $3.8 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 loss for the three months ended June 30, 2025 was $8.0 million compared to a net loss of $4.3 million for the same period in 2024. Included in net loss for the three months ended June 30, 2024 and 2025 was a gain of $2.0 million and $1.8 million, respectively, associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended June 30, 2025 was $1.3 million compared to $0.8 million for the same period in 2024, and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.4 million for the three months ended June 30, 2025 compared to non-cash income of $0.6 million for the same period in 2024.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, August 7, 2025, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second 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.