On November 5, 2026 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, 2026.
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"We continue to drive the science and advance the breadth of potential clinical indications for ITK inhibition with soquelitinib," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Our Phase 3 PTCL and Phase 2 atopic dermatitis clinical trials are on track and there has been strong interest in our new hidradenitis suppurativa trial. We also are making good progress towards initiating a unique asthma trial that will include both T2 and non-T2 patients by Q1 2027. We believe soquelitinib has the potential to be effective in both types of asthma patients based on its mechanism of action affecting Th2, Th17 and T regulatory cells, which we will be closely analyzing in our hidradenitis suppurativa trial. Taken altogether, we are positioned for a series of potentially significant data milestones across our soquelitinib development pipeline in 2027."
Business Update and Strategy
Soquelitinib for Immune Diseases
Corvus is enrolling patients in the SIERRA1 Phase 2 randomized, blinded, placebo-controlled atopic dermatitis clinical trial. 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. This includes 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 12 weeks with a 90-day follow-up period with no treatment. The primary endpoint of the trial is the percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12 compared to placebo.
Angel Pharmaceuticals (Angel Pharma), Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitinib doses of 100 mg twice per day, 200 mg once per day, 200 mg twice per day and 400 mg once per day. The patient eligibility and endpoints are similar to those used previously by Corvus. Depending on the results from the Phase 1b portion of the study, an additional 60-90 patients will be enrolled in the Phase 2 portion of the study. The trial is open at several leading dermatology centers in China who have been involved in global registration trials. The study is conducted in close collaboration with Corvus. Angel Pharma completed enrollment in cohort 1 (n=24, 100 mg twice per day, 200 mg once per day and placebo) of the Phase 1b portion of the trial and results from this cohort are anticipated in March 2027. The baseline characteristics of the 24 patients enrolled in cohort 1 are similar to the baseline characteristics of the 72 patients in Corvus’ Phase 1 atopic dermatitis clinical trial, including the subset of eight Asian patients in the Corvus trial. This includes similar mean age, baseline EASI, baseline Investigator’s Global Assessment (IGA) and use of prior systemic therapies.
Corvus is enrolling patients in a Phase 1b clinical trial evaluating soquelitinib in patients with hidradenitis suppurativa (HS). The trial is designed to enroll up to 25 patients with moderate to severe HS. All patients will receive a soquelitinib dose of 200 mg twice per day for 12 weeks, followed by a 90-day follow-up period with no treatment. The primary endpoint of the trial is safety and tolerability. The key efficacy endpoint is the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50/75 at week 12, and the trial will also evaluate skin and blood biomarkers. Initial data from the trial is anticipated in the 1H 2027.
Corvus plans to initiate a Phase 2 trial evaluating soquelitinib in patients with asthma, by Q1 2027. Angel Pharma anticipates that it will initiate a Phase 2 trial of soquelitinib in patients with asthma in Q2 2027.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation for specific immunology and oncology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
The Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial continues to advance. This trial is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.
Initial data from the ALPS Phase 2 trial was published in November 2026 in an abstract and will be presented in greater detail in a poster presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in December 2026. Three patients have been treated in the trial, each completing 360 days of treatment at the 200 mg twice per day dose. The data is consistent with the safety profile observed in Corvus’ T cell lymphoma and atopic dermatitis trials and all three patients had a positive response to soquelitinib therapy. Key highlights include:
The treatment was well tolerated, with no grade 3 or 4 adverse events and no interruptions in therapy.
All three patients were able to discontinue background medications including steroids and reported improvement in ALPS related systemic symptoms.
The investigational new drug (IND) application for soquelitinib treatment of ALPS patients is planned to be transferred to Corvus. The Company plans to meet with the U.S. Food and Drug Administration (FDA) to expand the number of treatment centers and to reduce the age eligibility to include pediatric patients.
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 chemotherapies. 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 two lines of systemic therapy.
New biopsy analysis from patients with mycosis fungoides treated in the Company’s Phase 1/1b T cell lymphoma trial support soquelitinib’s mechanism of action, showing an inhibition of cancerous Th2 cells and a skewing to Th1 cells. The analysis was conducted by a team from Memorial Sloan Kettering Cancer Center and will be available online in the 2026 abstract supplement for the ASH (Free ASH Whitepaper) Annual Meeting.
Final data from the Phase 1/1b trial of soquelitinib in patients with T cell lymphoma were published in Blood, the peer-reviewed journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The publication discusses results demonstrating soquelitinib’s anti-tumor activity based on tumor intrinsic and tumor extrinsic effects on microenvironment which we believe supports the Company’s ongoing and planned soquelitinib clinical trials and highlights the ITK inhibition novel mechanism of action.
Financial Results
As of September 30, 2026, Corvus had cash, cash equivalents and marketable securities of $202.9 million compared to $56.8 million as of December 31, 2025. Cash, cash equivalents and marketable securities as of September 30, 2026 included approximately $189.4 million in net proceeds received in a financing completed on January 23, 2026. Based on its current plans, Corvus expects its cash, cash equivalents and marketable securities to fund operations into the second quarter of 2028.
Research and development expenses for the three months ended September 30, 2026 totaled $17.8 million compared to $8.5 million for the same period in 2025. The increase in research and development expenses of $9.3 million was primarily due to higher clinical trial 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, 2026 was $20.3 million compared to $10.2 million for the same period in 2025. Included in net loss for the three months ended September 30, 2026 and 2025 were non-cash losses of $0.9 million and $0.3 million, respectively, from Corvus’ investment in Angel Pharma. Total stock compensation expense for the three months ended September 30, 2026 was $2.8 million compared to $1.2 million for the same period in 2025.
(Press release, Corvus Pharmaceuticals, NOV 5, 2026, View Source [SID1234674303])