CRVS

Business Context and Reporting Period

Company: Corvus Pharmaceuticals, Inc. (CRVS)
Filing Type: Form 8-K (Current Report)
Date: January 13, 2025
Subject: Announcement of new interim data from a Phase 1 clinical trial evaluating soquelitinib for moderate to severe atopic dermatitis.

Key Financial Metrics

This filing is a current report regarding clinical trial progress and does not contain financial statements. The text does not provide values for revenue, profit, cash flow, margins, debt, or liquidity.

Material Changes and Clinical Results

The Company reported interim results from a randomized, double-blind, placebo-controlled Phase 1 trial involving 26 patients (19 soquelitinib, 7 placebo) who completed 28 days of treatment across two cohorts:

• Cohort 1: 12 patients received 100 mg soquelitinib twice daily; 4 received placebo.
• Cohort 2: 7 patients received 200 mg soquelitinib once daily; 3 received placebo.
• Efficacy (Soquelitinib Group): 26% achieved Investigator's Global Assessment (IGA) 0 or 1; 37% achieved Eczema Area and Severity Index (EASI) 75.
• Efficacy (Placebo Group): 0% achieved IGA 0 or 1 or EASI 75.
• Safety: No significant safety issues or clinically significant laboratory abnormalities were observed.

Outlook, Risks, and Management Commentary

Future Plans:

• Cohort 2 is fully enrolled (N=16).
• The trial is planned to enroll a total of 64 patients across four dosing cohorts.
• Full results from all four cohorts are expected to be reported in the second quarter of 2025.

Risks and Uncertainties:

• Interim data may not be predictive of future results.
• Risks include the ability to demonstrate sufficient efficacy and safety, patient enrollment challenges, and regulatory unpredictability.
• Costs of clinical trials may exceed expectations, and the Company may need to raise additional capital.

Context: The doses tested in Cohorts 1 and 2 are lower than the 200 mg twice-daily regimen being evaluated in the Company's ongoing Phase 3 registrational trial for peripheral T cell lymphoma.

Investor Verification Checklist

• Verify the full enrollment status and timeline for the remaining two dosing cohorts (200 mg twice daily and 400 mg once daily).
• Confirm the Company's cash runway and capital requirements given the ongoing Phase 3 trial in lymphoma and the expansion of the atopic dermatitis trial.
• Monitor the upcoming Q2 2025 data release for full cohort results and safety profile confirmation.
• Review the Company's most recent Form 10-Q (filed November 12, 2024) for detailed financial position and risk factors.