Bayer and Kumquat Biosciences agree on global collaboration

Under the terms of the agreement, Kumquat will be responsible for initiating and completing the Phase Ia trial, while Bayer will be responsible for the remaining development and commercialization activities.

Kumquat received approval from the US Food and Drug Administration (FDA) in July 2025 for an Investigational New Drug (IND) application for its KRAS-G12D inhibitor. Under the terms of the agreement, Kumquat may receive payments of up to $1.3 billion, including upfront payments, clinical and commercial milestone payments and additional tiered, ongoing payments on net sales. Kumquat retains an exclusive option to negotiate a profit and loss sharing arrangement in the US.

“We are constantly evaluating innovative approaches to improve outcomes for patients, focusing on areas of high unmet medical need,” said Juergen Eckhardt, Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. “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.”

Oncogenic driver mutations, such as KRAS mutations, are changes in the DNA of genes that promote the development and growth of tumors. These mutations are often identified as important targets for cancer treatment, which in turn enables the development of targeted drugs. KRAS-G12D mutations are most commonly diagnosed in 37% of pancreatic ductal adenocarcinomas (PDAC), 13% of colorectal cancers and 4% of non-small cell lung cancers.2 PDAC is the most common type of pancreatic cancer (85% of cases) and remains one of the most difficult tumors to treat. There are few treatment options for patients other than chemotherapy, and the five-year survival rate is less than 10%.3 Pancreatic cancer is the sixth leading cause of cancer-related deaths worldwide.4 The incidence continues to rise annually, with projections suggesting a 95.4% increase in new cases by 2050. This would correspond to a potential total of 998,663 new cases worldwide.4

“KRAS mutations are crucial for cancer development and can be targeted with specific therapies in a more selective manner,” said Dominik Ruettinger, Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division. “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.”

“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,” said Yi Liu, Chief Executive Officer of Kumquat. 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.”