New Risk • Aug 12
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$87m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$87m free cash flow). Shareholders have been substantially diluted in the past year (58% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$160m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Announcement • Jul 28
Corbus Pharmaceuticals Announces FDA Clearance to Initiate Tempo-1 Registrational Study of CRB-701 in Patients with 2L Oropharyngeal Cancer Corbus Pharmaceuticals Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the start of the Company’s registrational study (“TEMPO-1”) of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC). TEMPO-1 is a randomized controlled study (n=250) designed to evaluate the efficacy and safety of CRB-701 compared with investigator’s choice of capecitabine, cetuximab or docetaxel. The study's primary endpoint is objective response rate (ORR), which is intended to support a potential accelerated approval; overall survival (OS) is intended to support potential conversion to full approval. The incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection. Each year approximately 14,000 OPSCC patients are estimated to be eligible for 2L treatment and approximately 7,000 patients are estimated to succumb to the disease in the United States alone. The FDA's decision to allow the registrational study to proceed was supported by results from Corbus' ongoing Phase 1/2 clinical study of CRB-701, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. In an analysis of patients with 2L+ OPSCC treated at the 3.6 mg/kg dose, CRB-701 achieved a confirmed ORR of 42.9%, with a median duration of response (DoR) of 6.3 months and a median progression-free survival (PFS) of 5.6 months (ongoing). CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using monomethyl auristatin E (MMAE) as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and highly expressed in other tumor types such as cervical and head and neck squamous cell carcinoma (HNSCC). The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. Announcement • Jul 06
Corbus Pharmaceuticals Holdings, Inc. Announces Appointment of Leonardo Viana Nicacio as Chief Medical Officer Corbus Pharmaceuticals Holdings, Inc. announced the appointment of Leonardo Viana Nicacio, M.D., as Chief Medical Officer. Dr. Nicacio’s career spans over 20 years in the pharmaceutical industry. Prior to joining Corbus, he was the Chief Medical Officer at Protara Therapeutics, a clinical-stage company developing therapies for the treatment of cancer and rare diseases. Prior to Protara, Dr. Nicacio served as Senior Vice President, Head of Clinical Development and Global Medical Affairs at Stemline Therapeutics, a subsidiary of the Menarini Group, where he was responsible for establishing and executing global strategies for solid tumor development. From 2017 to 2023, he held roles of increasing responsibility at Seagen (acquired by Pfizer in December 2023), most recently as Vice President of Clinical Development, overseeing programs across a range of cancers, including bladder, breast, gynecologic, lung, colorectal, and head and neck cancers, and most notably worked on a therapeutic for metastatic cervical cancer, TIVDAK®. Earlier in his career, Dr. Nicacio served as Senior Global Medical Lead in Global Medical Affairs at AstraZeneca, where he played an integral role in clinical, regulatory, and launch preparation activities leading up to the approval of durvalumab in bladder cancer. He also held leadership roles at Flatiron Health, where he was instrumental in building the first health technology platform focused on organizing real-world oncology data. Additionally, Dr. Nicacio held positions at Sanofi and YM Biosciences. Dr. Nicacio holds a Medical Degree from Faculdade de Ciências Médicas de Minas Gerais in Brazil and completed a molecular biology fellowship at the New York Blood Center. He is board-certified in internal medicine and medical oncology and has published extensively in top medical journals. Dr. Nicacio is an active member of the American Society of Clinical Oncology and the European Society of Medical Oncology. 
