Gilead and insitro Announce Strategic Collaboration to Discover and Develop Novel Therapies for NASH

Gilead Sciences Inc. and insitro announced today that the companies have entered into a strategic collaboration to discover and develop therapies for patients with nonalcoholic steatohepatitis (NASH).

Under the terms of the three-year collaboration, insitro’s proprietary platform will be utilized to create disease models for NASH and discover targets that have an influence on clinical progression and regression of the disease. The insitro Human (ISH) platform applies machine learning, human genetics and functional genomics to generate and optimize unique in vitro models and drive therapeutic discovery and development. The ISH platform will provide insights into disease progression, suggest candidate targets, and predict patient responses to potential therapeutic interventions. Gilead can advance up to five targets identified through this collaboration and will be responsible for chemistry and development against these targets.

“Gilead is committed to researching and developing treatments for patients living with NASH, particularly those with advanced fibrosis who have the greatest unmet need,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “We are excited about the opportunity to partner with insitro to tackle the scientific challenges associated with this complex disease. Through this collaboration we will utilize deep learning to explore the scientific underpinnings of the biology and clinical spectrum of NASH, with the goal of accelerating the development of highly effective treatment options for patients with this disease.”

“NASH is a progressive liver disease that can lead to fibrosis, cirrhosis, and liver cancer and will soon be the predominant cause of liver transplantation in the U.S.,” said Daphne Koller, Ph.D., CEO and founder of insitro. “We are excited to work with Gilead, a leader in liver disease, in bringing to bear novel tools toward identifying new therapeutics for NASH and helping the many patients in need around the world.”

Under the terms of the agreement, insitro will receive an upfront payment of $15 million, with additional near-term payments up to $35 million based on operational milestones. insitro will be eligible to receive up to $200 million for the achievement of preclinical, development, regulatory and commercial milestones for each of the five Gilead targets; and up to low double-digit tiered royalties on net sales. For programs where insitro opts in, it will have the right to co-develop and co-detail in the U.S., receive a profit share in China and receive milestone payments and royalties on other ex-U.S. sales.

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