Corvus Pharmaceuticals is actively advancing its clinical programs, with a focus on soquelitinib, a selective ITK inhibitor. The company provided a business update and reported financial results for the third quarter ended September 30, 2024, highlighting progress in clinical trials and financial stability.
Soquelitinib Clinical Trials
Soquelitinib is currently undergoing two clinical trials: a Phase 3 trial for Peripheral T Cell Lymphoma (PTCL) and a Phase 1 trial for atopic dermatitis. Interim data from the atopic dermatitis trial is anticipated in December 2024. Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus, noted the strong interest from clinicians and patients in both clinical programs.
The Phase 1 clinical trial for atopic dermatitis is a randomized, placebo-controlled study evaluating the safety and efficacy of soquelitinib in patients with moderate to severe atopic dermatitis. Enrollment in the first cohort (100 mg, twice per day) has been completed, with no safety signals observed. The second cohort (200 mg, once-daily) is now enrolling patients. The primary endpoints include safety and improvement in the Eczema Area and Severity Index (EASI).
The Phase 3 clinical trial for PTCL is a registrational trial evaluating soquelitinib versus physician's choice of either belinostat or pralatrexate in patients with relapsed PTCL. The primary endpoint of the trial is progression-free survival. 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.
Ciforadenant Collaboration
Corvus is collaborating with the Kidney Cancer Research Consortium 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). As of September 30, 2024, 46 patients were enrolled in the trial. The trial continues to meet the pre-specified statistical threshold for efficacy, defined as a 50% increase above the 32% deep response rate seen with previous ipilimumab/nivolumab combination trials in RCC. Data presentation is targeted for 2025.
Financial Update
As of September 30, 2024, Corvus had cash, cash equivalents, and marketable securities of $41.7 million, compared to $27.1 million as of December 31, 2023. In October 2024, the early exercise of common stock warrants resulted in cash proceeds of approximately $5.9 million. The company expects its cash to fund operations into 2026.
Research and development expenses for the three months ended September 30, 2024, totaled $5.2 million, compared to $4.0 million for the same period in 2023. The net loss for the three months ended September 30, 2024, was $40.2 million, compared to a net loss of $6.0 million for the same period in 2023. The increased net loss was primarily due to a $32.8 million non-cash loss related to an increase in the fair value of its warrant liability.
