Strong Varseta-M Clinical Activity
Phase I updated efficacy in late-line metastatic colorectal cancer: confirmed overall response rate (ORR) between 20% and 32% and median progression-free survival (PFS) of approximately 7 months — materially higher than current therapies which show single-digit ORRs and only a few months of PFS.
Completed Dose Optimization Enrollment; Path to Registrational Study
Dose optimization cohorts now fully enrolled with 40 patients at 8.6 and 10 mg/kg, taking total Phase I enrollment to 113 patients. Company on track to prioritize one dose and advance into a registrational (pivotal) late-line CRC study targeted for the first half of 2027.
Safety Management Progress for Varseta-M
Updated adverse event management strategies (upfront loperamide and budesonide) showed preliminary improvement: initial look from the first 20 optimization patients reported Grade 3 diarrhea at ~10%. Company target is to manage Grade 3 diarrhea into a 10%–20% range.
Combination and Expansion Strategy to Enable Earlier Lines
Initiated Varseta-M + bevacizumab combination (q2w and q4w schedules) with initial data expected by H1 2027; plan to start a Phase I/II chemotherapy (triplet including bevacizumab) combination study in H2 2026; Phase I expansion cohorts in additional EpCAM-expressing indications planned in H2 2026 to support pan-tumor strategy.
Progress on CX-801 (Masked IFN-α2b)
CX-801 advanced to the fourth dose level in monotherapy (exceeding approved clinical dose of unmasked interferon alpha-2b) and has been well tolerated to date. Combination dose escalation with KEYTRUDA is enrolling (third dose level). Initial clinical data expected by year-end.
Strengthened Balance Sheet and Runway
Closed financing in March and ended Q1 2026 with $346.7 million in cash, cash equivalents and investments versus $137.1 million at 12/31/2025 — a cash increase of ~152.9% — with projected runway to at least the second half of 2028, enabling planned advancement of Varseta-M into a registrational study.
Focused Capital Allocation and Execution Plan
Company communicated disciplined capital allocation with near- to medium-term prioritization of Varseta-M programs (monotherapy registrational path, bev and chemo combinations, and non-CRC expansions) and expectations to deliver multiple clinical readouts through 2026–2027.
Planned Data and Regulatory Timeline
Company expects an overall Phase I data update including safety and efficacy from the monotherapy dose optimization in the second half of 2026, and multiple FDA interactions in 2026 to inform dose selection and registrational study design.