Crescent Biopharma (CBIO) Stifel 2026 Healthcare Conference 2026 summary

Strategic positioning

• Strategy centers on CR-001 as a next-generation PD-1/VEGF immuno-oncology backbone; management cited post-ASCO HARMONi-6 results as validation of bispecifics.

• More than 2,000 patients across the portfolio are targeted by mid-2027; initial phase III starts are planned for early 2028.

• Management estimates $2B-$10B in revenue potential from the initial phase III studies, before additional ADC combination opportunities.

ASCEND monotherapy data

• Global phase I/II ASCEND began dosing in February 2026; more than 125 patients have received monotherapy CR-001, dose escalation is complete, and tumor-specific backfill continues.

• Q1 2027 data are expected to include safety and tolerability across tumor types and dose levels, plus PK and PD-1 receptor occupancy and VEGF neutralization data.

• Efficacy disclosure will focus on up to 12 frontline NSCLC patients with TPS ≥1%; ORR will be compared with a 50% HARMONi-2 benchmark, while DOR follow-up is still short.

• Enrolled tumor types include NSCLC; colorectal, gastric, HCC and biliary cancers; and endometrial, cervical and ovarian cancers.

Combination development and trial plans

• The strategy is to build monotherapy, chemotherapy-combination and ADC-combination safety and efficacy evidence, aiming to position CR-001 as a backbone therapy by mid-2027.

• Chemotherapy cohorts are expected to include 20-40 patients each; planned disclosures may include ORR, safety, tolerability and PK, with selected cohorts potentially prioritized for phase III.

• Three Kelun-sponsored phase II studies of sac-TMT plus CR-001 are underway in China across NSCLC and other advanced solid tumors; initial lung data are expected May 27, with more than 850 patients across the studies.

• Phase III choices will weigh internal and competitor data, market opportunity and ROI; management cited potential to pursue both chemotherapy and ADC combinations in indications such as lung cancer.

• ASCEND is intended to generate data before registration-enabling studies, avoiding a dose-escalation component in phase III; management plans to enter FDA discussions with comprehensive data.