Bayer and Kumquat join forces to advance groundbreaking KRAS G12D cancer therapy, targeting hard-to-treat tumors worldwide.

Berlin/San Diego: Bayer AG and Kumquat Biosciences Inc. have entered into an exclusive global license and collaboration agreement to develop and commercialize Kumquat’s investigational KRAS G12D inhibitor, a potential breakthrough therapy for hard-to-treat cancers such as pancreatic, colorectal, and lung cancer.

Under the deal, Kumquat will lead initiation and completion of a Phase Ia clinical trial, while Bayer will oversee subsequent development and commercialization activities worldwide. The agreement includes potential payments of up to $1.3 billion to Kumquat, comprising upfront fees, clinical and commercial milestone payments, and tiered royalties on global net sales. Kumquat also retains an exclusive option to negotiate a profit-and-loss sharing arrangement for the U.S. market.

Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division, stated: "We are constantly evaluating innovative approaches to improve outcomes for patients, focusing on areas of high unmet medical need. We look forward to collaborating with Kumquat, an accomplished team of experts with deep KRAS insights. Our intent is to explore the development of a potential new treatment option for patients, while further complementing Bayer’s robust early precision oncology pipeline."

The KRAS G12D inhibitor received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) in July 2025. KRAS mutations are implicated in nearly 25% of all human cancers, yet effective treatment options for the most prevalent KRAS variant, G12D, remain elusive. Notably, KRAS G12D mutations occur 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 cancers, has a five-year survival rate below 10% and limited treatment options beyond chemotherapy. Global incidence of pancreatic cancer is projected to rise by over 95% by 2050, potentially reaching nearly one million new cases annually.

Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division, commented: “KRAS mutations are crucial for cancer development and can be targeted with specific therapies in a more selective manner. KRAS mutations occur in nearly 25 percent of human cancers, yet the most prevalent and oncogenic KRAS (G12D) variant still lacks effective treatment options. We look forward to exploring the investigational KRAS G12D inhibitor, which targets a highly relevant signaling pathway that promotes tumor growth and survival.”

Yi Liu, Chief Executive Officer of Kumquat, said, “Since pioneering the direct targeting of KRAS G12C mutation over a decade ago, we have continued to discover innovative strategies to target other KRAS mutants, including KRAS G12D. Advancing our novel KRAS G12D asset into the clinic reflects our commitment to delivering durable therapies for KRAS patients suffering from deadly malignancies such as pancreatic, lung and colorectal cancers. This collaboration with Bayer validates the strength of our platform and the potential of our KRAS G12D candidate to address long-standing unmet needs in oncology. We are thrilled to collaborate with Bayer, who shares our vision and strategy for realizing the benefit of small molecule-based transformative treatments. While advancing optimally our KRAS G12D program through the clinic, this collaboration provides Kumquat the financial resources to accelerate its broader clinical pipeline for long-term value, and position Kumquat to deliver life-changing medicines and achieve sustained growth in the coming years.”