On November 10, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical-stage company focused on developing new therapies in oncology and obesity, reported a corporate update and reported financial results for the 2026 third quarter ended September 30, 2026.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"During the third quarter, we achieved key milestones with both clinical programs: initiating dosing in our TEMPO-1 Phase 3 study of sutantatug envedotin in oropharyngeal cancer and announcing positive topline data from our CANYON-1 Phase 1b study of CRB-913 in obesity," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "The commencement of the TEMPO-1 trial marks our transition to late-stage clinical development, bringing us meaningfully closer to delivering sutantatug envedotin as a potentially novel, targeted therapeutic for those impacted by OPSCC who were previously treated with platinum-based and anti-PD1 therapy. Based on our Phase 1/2 data, we believe that sutantatug envedotin has the potential to address the critical unmet need of patients with this difficult-to-treat, primarily HPV-driven disease. For CRB-913, our topline CANYON-1 data demonstrated, for the first time, that a highly peripherally restricted CB1 inverse agonist can deliver a safe and tolerable therapeutic alternative with competitive weight loss to oral GLP-1s. We look forward to presenting additional data at ObesityWeek."
Key Corporate and Program Updates
Sutantatug envedotin (CRB-701) is a next-generation, highly stable Nectin-4-targeting antibody drug conjugate (ADC) being developed to treat oropharyngeal squamous cell carcinoma (OPSCC), a subtype of head and neck squamous cell carcinoma (HNSCC), as well as cervical cancer. The U.S. Food and Drug Administration (FDA) has granted Fast Track designations to sutantatug envedotin for the treatment of both cancer types. Sutantatug envedotin is licensed from CSPC Megalith Biopharmaceutical Co. Ltd (CSPC).
Received FDA clearance in July 2026 to proceed with the TEMPO-1 study, the first registrational trial launched that is specifically designed to evaluate a targeted treatment in patients with 2L+ OPSCC, and initiated dosing in September 2026.
TEMPO-1 is a randomized controlled study (n=250) comparing sutantatug envedotin with investigators’ choice of capecitabine, cetuximab or docetaxel in 2L+ OPSCC. The primary endpoint to support potential accelerated approval is objective response rate, while overall survival serves as the primary endpoint to support a potential conversion to full approval.
Anticipate reporting sutantatug envedotin plus Keytruda combination data in first-line (1L) OPSCC in Q1 2027 to support potential further registration-enabling trials in the 1L setting.
CRB-913 is a highly peripherally restricted oral CB1 inverse agonist for the treatment of obesity.
Reported topline data in the CANYON-1 Phase 1b trial, a 16-week, double-blind, placebo-controlled, dose-ranging study that enrolled 254 obese, non-diabetic adults at multiple U.S. sites. Participants received CRB-913 at 20 mg, 40 mg or 60 mg once daily, or placebo, for 12 weeks, followed by 4 weeks of safety follow-up.
The data demonstrated statistically significant and clinically meaningful weight loss at all three doses with the 60 mg dose achieving a mean weight loss of 5% at 12 weeks (<0.0001). No plateau was observed at any dose.
CRB-913 was associated with a favorable safety profile and notably fewer and milder gastrointestinal (GI) adverse events based on cross-trial comparison with published data of currently marketed oral GLP-1 drugs.
Taken together, these data support CRB-913’s potential to establish a new class of oral, non-incretin obesity medicines.
Topline data press release available here.
Data to be presented in a late-breaking poster at ObesityWeek 2026 on November 15, 2026.
The Company plans to engage with the FDA on the development plan and is also evaluating the potential to combine CRB-913 with GLP-1 therapy.
Chief Medical Officer Appointment
Announced appointment of Leonardo Viana Nicacio, M.D., as Chief Medical Officer, in August 2026. Dr. Nicacio has more than 20 years of pharmaceutical industry experience, with leadership roles in clinical development and global medical affairs at Protara Therapeutics, Stemline Therapeutics, Seagen (now part of Pfizer), AstraZeneca, Flatiron Health, Sanofi and YM Biosciences. His experience spans oncology drug development across multiple tumor types, including significant contributions to the development and approval of the ADCs PADCEV for urothelial carcinoma and TIVDAK for metastatic cervical cancer.
Financial Results for the Quarter Ended September 30, 2026
The Company reported a net loss of approximately $37.8 million, or a net loss per basic and diluted share of $1.81, for the three months ended September 30, 2026, compared to a net loss of approximately $23.3 million, or a net loss per basic and diluted share of $1.90, for the three months ended September 30, 2025.
Operating expenses increased by $14.4 million to approximately $38.8 million for the three months ended September 30, 2026, compared to approximately $24.4 million for the three months ended September 30, 2025. The increase was primarily attributable to a $15.0 million development milestone incurred in Q3 2026 pursuant to the CSPC licensing agreement for sutantatug envedotin.
The Company had $115.3 million of cash, cash equivalents, and investments on hand as of September 30, 2026, which is expected to fund operations into 2028 based on current operating plans and planned expenditures.
(Press release, Corbus Pharmaceuticals, NOV 10, 2026, View Source [SID1234674556])