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The call presented multiple strong positives: robust early efficacy signals (notably cohort 4 AD results), durable responses without rebound, a clean safety profile across >150 patients, supportive biomarker data, favorable PTCL survival metrics versus historical controls, clear plans to expand into multiple indications, and a substantial $189M financing that increases pro forma cash to ~$246M providing runway into Q2 2028. Offsetting factors include materially higher R&D spending, continued quarterly net losses, reliance on small early cohorts pending larger confirmatory trials, timeline uncertainty for registrational data (primary Phase II AD mid-2027; PTCL full readout late 2027), and execution/regulatory risks inherent to multiple concurrent development programs. Overall, the positives (clinical signal, durability, safety, biomarker rationale, and strengthened balance sheet) outweigh the near-term financial and execution challenges, but success depends on upcoming larger trials and interim readouts.
On the call management provided detailed financial and clinical guidance with numerous metrics: Q4 R&D expense was $9.9M (FY2025 $33.7M vs $19.4M in FY2024), Q4 net loss $12.3M (including a $0.7M non‑cash equity invest. loss), total stock‑comp $1.6M for the quarter, and year‑end cash, cash equivalents and marketable securities of $56.8M (vs $52.0M a year earlier); the company closed an upsized public offering that generated $189M net proceeds (also described as a ~$200M financing), bringing pro‑forma cash to ~$246M and extending the cash runway into Q2 2028. Clinical metrics and program timelines: soquelitinib cohort 4 showed mean EASI reduction 72% vs 40% placebo (p=0.035), 9/12 (75%) achieved EASI‑75 (+1 at EASI‑74), 25% EASI‑90, 33% IGA 0/1, 11/12 EASI‑50, with placebo EASI‑75 ~20% (or 17% adjusted) and two placebo patients needing rescue; in patients with prior systemic therapy, 0/7 placebo vs 3/5 (60%) active hit EASI‑75. Development plans and readouts: a randomized Phase II AD trial (200 patients; 4 cohorts of 50; doses 200 mg QD, 200 mg BID, 400 mg QD and placebo; 12‑week treatment + 90‑day follow‑up; primary endpoint median % EASI reduction) was initiated with data expected mid‑2027; Angel’s China Phase Ib/II (48 pts initial; 100 mg BID, 200 mg QD, 200 mg BID, 400 mg QD; potential +60–90 pts) should report initial data late this year; PTCL Phase III enrollment continues with an interim analysis later this year (Phase I 200 mg BID showed median PFS 6.2 months and median OS 28 months vs historical chemo PFS <3.5 months and OS <1 year); planned Phase II HS (~60 pts; 200 mg BID, 400 mg QD, placebo; 12 weeks; HiSCR50/75 endpoints) and an asthma study (~150 pts for 3 months) targeted later in 2026, and biomarker/durability signals (Treg increase, ↓IL‑4/IL‑5/IL‑17, small ↓TARC, maintained responses out to ~90–118 days post‑treatment) underpin expansion plans.
Cohort 4 (n=12) showed a mean percent reduction in EASI of 72% versus 40% for placebo (p=0.035). 75% (9/12) achieved EASI-75 (one additional patient EASI‑74), 25% achieved EASI-90, 33% achieved IGA 0/1, and 92% (11/12) achieved EASI-50. Placebo EASI-75 was ~20% (17% if adjusted for missed visit patients).
Responses were maintained out to 90 days post-treatment (observed in cohorts 3 and 4) with over 90% of patients not relapsing in the follow-up period, suggesting durable remission and a potential for intermittent dosing strategies.
No new safety signals in cohort 4 or across the Phase I program: no hepatic abnormalities, similar minor infection rates versus placebo, and no evidence of EBV reactivation in >150 patients representing >14,000 patient-days of exposure, including long-term treatment (>2 years in some patients).
Biomarkers show decreases in IL-4, IL-5 and IL-17, a small reduction in TARC, reduced Th2 cells and an increase in regulatory T cells (Tregs), supporting ITK inhibition-mediated immune rebalancing and providing translational rationale for multiple inflammatory indications.
Initiated a randomized Phase II atopic dermatitis trial (200 patients, 4 arms; doses: 200 mg QD, 200 mg BID, 400 mg QD, placebo; 12-week treatment + 90-day follow-up) with data anticipated mid-2027; ongoing Phase III PTCL enrollment with an interim analysis later this year; planned Phase II trials for hidradenitis suppurativa (~60 patients) and asthma (~150 patients) later this year; Angel Pharmaceuticals conducting a blinded Phase Ib/II AD trial in China with initial cohort results expected late this year.
Phase I/Ib PTCL results (200 mg BID cohort) showed median progression-free survival (PFS) of 6.2 months and median overall survival (OS) of 28 months, comparing favorably to historical chemotherapy PFS <3.5 months and median OS <12 months.
Closed an upsized underwritten public offering in January that generated net proceeds of $189 million; cash, cash equivalents and marketable securities were $56.8 million at Dec 31, 2025 (vs $52.0M at Dec 31, 2024, ≈+9.2%), and pro forma cash including the financing was ~ $246 million, extending the cash runway into Q2 2028 and beyond key planned data readouts.
Good afternoon, everyone, and thank you for standing by, and welcome to the Corvus Pharmaceuticals Fourth Quarter and Full Year 2025 Business Update and Financial Results Conference Call. [Operator Instructions] It is now my pleasure to turn the call over to Mr. Zack Kubow from Real Chemistry. Please go ahead, sir.
Thank you, operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals Fourth Quarter and Full Year 2025 Business Update and Financial Results Conference Call. On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer; Leiv Lea, Chief Financial Officer; Jeff Arcara, Chief Business Officer; and Ben Jones, Senior Vice President of Regulatory and Pharmaceutical Sciences. The executive team will open the call with some prepared remarks followed by a question-and-answer period. I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements. Forward-looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by those statements, including the risks and uncertainties described in Corvus' annual report on Form 10-K for the year ended December 31, 2025, and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. With that, I'd like to turn the call over to Leiv.
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