Bayer and Kumquat Biosciences Inc., a clinical-stage biotech founded by pioneers in KRAS pathway research, have entered into an exclusive global licensing and collaboration agreement to develop and commercialize Kumquat’s KRAS G12D inhibitor.
Under the agreement, Kumquat will initiate and complete the Phase Ia clinical trial, after which Bayer will lead further development and commercialization. Kumquat received U.S. FDA clearance for its investigational new drug (IND) application for the KRAS G12D inhibitor in July 2025.
The deal grants Kumquat up to $1.3 billion in upfront, clinical, and commercial milestone payments, plus tiered royalties on net sales. Kumquat also retains an option to negotiate U.S. profit–loss sharing.
KRAS mutations are a major driver of cancer development and growth. The KRAS G12D variant is found in 37% of pancreatic ductal adenocarcinoma (PDAC) cases, 13% of colorectal cancers, and 4% of non-small cell lung cancers. PDAC, which accounts for 85% of pancreatic cancer cases, is among the most challenging cancers to treat, with a five-year survival rate below 10%. Pancreatic cancer is the sixth leading cause of cancer-related deaths worldwide, and its incidence is projected to rise by 95.4% by 2050, reaching nearly one million new cases annually.
Bayer’s leadership highlighted the high unmet need and the potential of KRAS G12D-targeted therapy to complement its early precision oncology pipeline. Kumquat emphasized that the collaboration will accelerate clinical development and expand its broader pipeline, aiming to deliver life-changing treatments for pancreatic, lung, and colorectal cancers.