On November 4, 2025 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the third quarter ended September 30, 2025.

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"We are advancing the development of our ITK inhibitor, soquelitinib, in both atopic dermatitis and T cell lymphomas. We believe soquelitinib has the potential to be ideally positioned as a well-tolerated treatment for a range of immune diseases and cancers that works through a novel mechanism of action," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We look forward to reporting results from extension cohort 4 of the soquelitinib Phase 1 trial in atopic dermatitis in the coming months, which will provide additional information on the 200 mg twice daily dose and a longer 8-week treatment period. In addition, we remain on track to initiate an atopic dermatitis Phase 2 trial with soquelitinib in early Q1 2026. In oncology, our Phase 3 registration clinical trial in PTCL continues to enroll and we are pleased that the final results from the related Phase 1/1b trial will be presented in an oral session at ASH (Free ASH Whitepaper). These data add to the growing clinical evidence supporting soquelitinib as a safe and active agent with potential in a range of diseases."

Business Update and Strategy

Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases

Completed enrollment in extension cohort 4 of the soquelitinib atopic dermatitis Phase 1 clinical trial, which includes 24 patients randomized 1:1 between active (soquelitinib 200 mg twice per day) and placebo. The treatment period for this group is 8 weeks with a 30-day follow-up period with no treatment. The extension cohort 4 is studying the same dose as cohort 3 of the Phase 1 trial, but for a longer treatment period (cohort 3 was 4 weeks). Cohort 3 patients experienced earlier responses and deeper separation from placebo compared to cohorts 1 and 2, which studied a lower dose of 100 mg twice per day or 200 mg once per day. Cohort 3 patients also had a clinically meaningful reduction in itch as early as day 8. Announcement of data from extension cohort 4 is anticipated in January 2026.
On track to initiate atopic dermatitis Phase 2 clinical trial in early Q1 2026. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. The trial is anticipated to enroll four cohorts of 50 patients each, with soquelitinib doses of: 200 mg once per day; 200 mg twice per day; and 400 mg once per day; along with a placebo group. The treatment period is anticipated to be 12 weeks with a 30-day follow-up period with no treatment.
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 and oncology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

Patient enrollment continues in the Autoimmune Lymphoproliferative Syndrome (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.
The final data from the Company’s Phase 1/1b clinical trial evaluating soquelitinib in patients with T cell lymphoma will be reported in an oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2025. Previously reported interim data from this trial supported the initiation of the ongoing registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL.
Financial Results
As of September 30, 2025, Corvus had cash, cash equivalents and marketable securities of $65.7 million as compared to $52.0 million as of December 31, 2024. Consistent with last quarter, Corvus expects its cash to fund operations into the fourth quarter of 2026.

Research and development expenses for the three months ended September 30, 2025 totaled $8.5 million compared to $5.2 million for the same period in 2024. The increase of approximately $3.3 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 September 30, 2025 was $10.2 million compared to a net loss of $40.2 million for the same period in 2024. Included in net loss for the three months ended September 30, 2024 was a non-cash loss of $32.8 million associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended September 30, 2025 was $1.2 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 $0.3 million for the three months ended September 30, 2025 compared to a non-cash loss of $0.7 million for the same period in 2024.

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

(Press release, Corvus Pharmaceuticals, NOV 4, 2025, View Source [SID1234659349])