On November 12, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported financial results for the third quarter ended September 30, 2026 and recent business highlights.

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"This has been a defining year for Crescent. We advanced three programs into the clinic and established a leading position in developing next generation IO and ADC combinations which we believe have the potential to redefine cancer care. Together with our partner Kelun-Biotech, we have achieved a remarkable nine IND clearances, and anticipate that more than 2,000 patients will be dosed across our portfolio by mid-2027. We plan to aggressively pursue additional combination opportunities that can further our efforts to develop CR-001 as a best-in-class IO backbone therapy. Building on the pipeline progress we outlined last month, we are pleased to have now commenced patient dosing in the global APOLLO trial of CR-002, our PD-L1-targeted ADC," said Joshua Brumm, chief executive officer of Crescent. "The team’s strong execution has positioned us for several meaningful clinical data readouts in 2027, beginning in the first quarter with monotherapy results from our global ASCEND trial of CR-001, including first-line NSCLC patients, followed by initial standard of care chemotherapy combination data from multiple tumor types. We are poised for an exciting year ahead as we work to deliver the next wave of therapies for people living with cancer."

Recent Business Highlights & Anticipated Milestones

CR-001, PD-1 x VEGF Bispecific Antibody
Clinical Execution Progress in ASCEND, a Global Phase 1/2 Trial of CR-001
•In October 2026, Crescent announced completion of dose escalation in ASCEND, a global Phase 1/2 trial of CR-001, its investigational PD-1 x VEGF bispecific, with patients enrolled across several tumor types at clinical sites in the United States, Europe and South Korea.
•Crescent is on track to report initial monotherapy data from ASCEND in the first quarter of 2027, including:
◦Preliminary antitumor response as measured by overall response rate (ORR) from a first-line NSCLC cohort of up to 12 patients.

◦Safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naïve and previously treated patients across multiple solid tumor types.
•Patient dosing has commenced in ASCEND expansion cohorts which are evaluating CR-001 with various standard of care chemotherapy combinations across several solid tumor types in treatment-naive and previously treated patients, including first-line NSCLC, colorectal, biliary tract, gastric and endometrial cancers. Crescent is on track to report initial data from hundreds of patients in mid-2027 (Q2/Q3).
•Data from the expansion cohorts, along with monotherapy data from ASCEND, will inform future clinical development for CR-001. Pending results and further interactions with regulators, Crescent plans to initiate the first of multiple Phase 3 trials of CR-001 in early 2028.
•Trial in progress posters of the ASCEND study design were featured during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress held October 23-27, 2026 in Madrid, Spain and at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting held November 4-8, 2026 in Phoenix, Arizona.
Multiple Studies Evaluating CR-001 in Combination with Novel ADCs
•Under a collaboration agreement, Crescent granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., ("Kelun-Biotech") exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China. Both Kelun-Biotech and Crescent have rights to independently develop CR-001 in combinations, including with their respective antibody-drug conjugate (ADC) pipelines.
•Kelun-Biotech is conducting multiple Phase 2 trials in China evaluating CR-001 (SKB118) in combination with sacituzumab tirumotecan (sac-TMT), its TROP2-directed ADC. Initial data from a study in patients with locally advanced or metastatic NSCLC are expected in mid-2027 (Q2/Q3). Additional studies are underway in participants with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-squamous NSCLC who have failed EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy, as well as in patients with advanced solid tumors.
•A Phase 1/2 trial of CR-001(SKB118) in combination with CR-003 (also known as SKB105), an integrin-beta 6 (ITGB6)-directed ADC, is expected to commence in the first half of 2027.
CR-002, Topoisomerase Inhibitor ADC Targeting PD-L1
•Earlier this month, the first patient was dosed in the global Phase 1/2 APOLLO trial of CR-002, a topoisomerase inhibitor ADC targeting programmed cell death ligand 1 (PD-L1). APOLLO is designed to enroll patients in the United States, Europe and Asia Pacific with advanced solid tumors, including NSCLC, head and neck squamous cell carcinoma (HNSCC), and various gastrointestinal and gynecological tumors. The study’s dose escalation and tumor-specific backfill cohorts are expected to enroll approximately 200 participants with the opportunity for additional participants in expansion cohorts.
•Crescent anticipates reporting initial data from APOLLO in the second half of 2027, including safety, tolerability, pharmacokinetics and preliminary antitumor activity.
•Preclinical data for CR-002 will be featured in a poster presentation at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held November 18-20, 2026 in Barcelona, Spain.

CR-003, Topoisomerase Inhibitor ADC Targeting ITGB6

•Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105), an ITGB6-targeted ADC, in the United States, Europe and all markets outside of Greater China.

•A Phase 1/2 trial of CR-003 (SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. Crescent plans to leverage data generated in China to support the global clinical development of CR-003 (SKB105).

Third Quarter 2026 Financial Results

Cash position: Cash and cash equivalents were $289.4 million as of September 30, 2026 which includes the $133.4 million in net proceeds from the July 2026 public offering. Crescent expects that its existing cash and cash equivalents will fund operations into the second half of 2028.

Research and development (R&D) expenses: R&D expenses were $34.3 million and $20.3 million for the three months ended September 30, 2026 and 2025, respectively. R&D expenses increased to support the increased clinical development on the global Phase 1/2 ASCEND trial and the costs incurred in preparation for the initiation on the global Phase 1/2 APOLLO trial.

General and administrative (G&A) expenses: G&A expenses were $8.7 million and $5.5 million for the three months ended September 30, 2026 and 2025, respectively. The increase in G&A expenses was primarily driven by increased personnel costs, including increased share-based compensation and professional service costs in continued support of the Company’s pipeline.

Net loss: Net loss was $37.7 million and $24.6 million, or $0.90 and $1.27 per basic and diluted share, for the three months ended September 30, 2026 and 2025, respectively.

Shares outstanding: As of September 30, 2026, Crescent had approximately 44.1 million ordinary shares and ordinary share equivalents issued and outstanding, including ordinary shares underlying pre-funded warrants and non-voting convertible preferred stock.

(Press release, Crescent Biopharma, NOV 12, 2026, View Source [SID1234674669])