November 01, 2016

Nimbus Therapeutics announces $200 million milestone payment from Gilead Sciences for Allosteric ACC Inhibitor program in Non-alcoholic steatohepatitis (NASH)

CAMBRIDGE, Mass. – Nov. 1, 2016 – Nimbus Therapeutics, a biotech that integrates computational chemistry and other advanced technologies to design breakthrough medicines and transform drug development, today announced that it has received a $200 million milestone payment from Gilead Sciences, Inc., related to Gilead’s allosteric Acetyl-CoA Carboxylase (ACC) inhibitor program with NDI-010976 (now GS-0976) previously acquired from Nimbus.

In April of this year, the companies announced an upfront payment from Gilead of $400 million for the acquisition of Nimbus Apollo, Inc., and another potential $800 million in development-related payments; the milestone announced today represents the first of those additional payments. Nimbus has now received half of the total potential deal value within six months of the acquisition being completed.

“We are thrilled at the rapid progress that Gilead has made in developing the ACC program, which is currently in Phase 2 clinical trials for NASH,” said Don Nicholson, Ph.D., Chief Executive Officer of Nimbus. “As the first prospectively in silico-designed molecule to reach human clinical testing, NDI-010976 is an important validation of our unique computational chemistry approach. We are applying this model to design medicines that have a meaningful impact on the mechanistically interrelated areas of metabolic disease, oncology and immunology.”

Nimbus’ investors and employees have reinvested a significant portion of the proceeds from both the upfront and the first milestone back into Nimbus to further expand its core capabilities and advance a diverse, preclinical pipeline focused on an unrivaled set of promising targets, including Tyk2 allosteric inhibitors; STING (STimulator of INterferon Genes) non-nucleotide agonists for immuno-oncology and antagonists for autoimmune disease; and other currently undisclosed programs.

About NASH

Non-alcoholic steatohepatitis (NASH) is a serious chronic liver disease caused by excessive fat accumulation in the liver. It affects between five and 10 percent of the adult population in the United States and represents a growing and underserved medical need. A substantial fraction of those affected by NASH will progress to advanced fibrosis (liver scarring) and cirrhosis (over a million Americans), which frequently leads to liver failure and death. End-stage liver disease secondary to NASH is predicted to become the leading cause of liver transplants within the next decade, surpassing chronic hepatitis C and alcoholic liver disease. Currently, there are no approved therapeutics for the treatment of NASH or related fatty-liver diseases, underscoring the need for effective treatments.

About ACC and NDI-010976

Acetyl-CoA carboxylase (ACC) is an enzyme with two isoforms (ACC1 and ACC2) that is involved in de novo lipogenesis (the synthesis of endogenous fatty acids) and the regulation of beta-oxidation (the process by which fatty acids are broken down at a cellular level). Inhibitors of ACC, therefore, have the potential to prevent production of new lipids within the liver and stimulate their breakdown. In animal models of fatty liver, ACC inhibition reduces hepatic fat content, inflammation and fibrosis (scarring), all of which are important hallmarks of NASH progression. NDI-010976 is a potent, liver-targeted, allosteric inhibitor of both ACC isoforms. NDI-010976 (now GS-0976) is an investigational therapy and has not been proven safe or efficacious.

About Nimbus Therapeutics

Nimbus Therapeutics is a biotechnology company headquartered in Cambridge, Massachusetts (USA). With its breakthrough computational chemistry platform, enabled through its privileged partnership with co-founder, Schrödinger, Inc., Nimbus is pioneering the application of computational chemistry to design treatments for substantial and underserved human diseases. The company’s focus on metabolic diseases, cancer and immune-inflammatory disorders reflects the mechanistic relationship between these disorders, and Nimbus’ ability to rapidly tackle well validated targets as well as those that have proven intractable to the approaches taken by others in the pharmaceutical and biotechnology industry, resulting in medicines with high potency, selectivity and other desirable drug-like properties. To learn more, please visit www.nimbustx.com.

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