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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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Targeting fat to treat cancer – Salk Institute researchers and collaborators develop novel cancer treatment that halts fat synthesis in cells, stunting tumors

LA JOLLA – Sept. 19, 2016 – Fat isn’t just something we eat: it may also lie at the heart of a new approach to treating cancer. Cells create their own fat molecules to build their plasma membranes and other critical structures. Now, researchers at the Salk Institute, along with academic and industry collaborators, have found a way to obstruct this instrumental process to stifle cancer’s growth, detailed September 19, 2016 in Nature Medicine. Like halting the delivery of supplies to a construction site, the approach stalls the molecular building blocks cancer needs to grow.

“Cancer cells rewire their metabolism to support their rapid division,” says Salk Professor Reuben Shaw, whose lab has made significant progress in establishing the ties between cancer and metabolic processes. “Because cancer cells are more reliant on lipid synthesis activity than normal cells, we thought there might be subsets of cancers sensitive to a drug that could interrupt this vital metabolic process.”

Researchers had previously hypothesized that interrupting cells’ lipid assembly line could disable cancer, but it was only recently that they were able to disrupt the process and test this theory. Shaw’s team partnered with a Boston-based biotech, Nimbus Therapeutics, which discovers and develops small molecules in the hopes of treating a variety of diseases, who were developing a molecule to shut off a critical player in lipid synthesis, an enzyme called Acetyl-CoA Carboxylase, or ACC.

“This confirms that shutting down endogenous lipid synthesis could be beneficial in some cancers and that inhibitors of the ACC enzyme represent a feasible way to do it,” said Rosana Kapeller, Chief Scientific Officer at Nimbus Therapeutics and a co-author of the paper. “We’ve taken a novel computational chemistry approach to designing high-potency allosteric inhibitors of this difficult enzyme, and we are very encouraged by the results.”

In multiple and extensive large-scale tests in both animal models of cancer and in transplanted human lung cancer cells, the results of the novel ACC inhibitor, dubbed ND-646, were far more promising than expected: tumor mass shrank by roughly two-thirds compared to untreated animals. And when the researchers paired ND-646 with one of the common treatments for non-small lung cancer called carboplatin, the anti-tumor response was even greater: a dramatic 87 percent of tumors were suppressed, compared to 50 percent with the standard treatment of carboplatin alone.

This combination of carboplatin (which damages DNA, a problem for rapidly dividing cells) and ND-646 (knocking out ACC and halting lipid synthesis) didn’t seem to impair normal cells even as it dramatically slowed cancer growth.

“We found surprisingly well-tolerated dosing with some of these novel ACC inhibitors that have broad bioavailability and should not be far away from what would be needed to initiate clinical trials,” says first author Robert Svensson, a Salk research associate.

“This is the first time anyone has shown that this enzyme, ACC, is required for the growth of tumors and this represents compelling data validating the concept of being able to target fat synthesis as a novel anticancer approach,” adds Shaw, who is the holder of the William R. Brody Chair. “The implications are that we have a very promising drug for clinical trials for subtypes of lung cancer as well as liver and other types of cancer. This represents a new weapon in the arsenal to fight cancer.”

Other authors on the work include: Lillian J. Eichner, Matthew J. Kolar, Sonja N. Brun, Portia S. Lombardo, Jeanine L. Van Nostrand, Amanda Hutchins, Lilliana Vera, Laurie Gerken, and Alan Saghatelian of the Salk Institute; Jeremy Greenwood and Sathesh Bhat of Schrödinger; Geraldine Harriman, William F. Westlin and H. James Harwood Jr., of Nimbus Therapeutics; and Seth J. Parker, Martina Wallace, and Christian M. Metallo of the University of California, San Diego.

The work was funded by: National Institutes of Health (R01CA172229, P01CA120964), the Samuel Waxman Cancer Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust and the Department of Defense.

About ND-646

Gilead Sciences, Inc. acquired Nimbus’ ACC inhibitor program in May 2016, including ND-646 and other ACC inhibitors for the treatment of non-alcoholic steatohepatitis (NASH) and for the potential treatment of hepatocellular carcinoma (HCC) and other diseases. For more information, please visit www.NimbusTx.com.

About the Salk Institute for Biological Studies

Every cure has a starting point. The Salk Institute embodies Jonas Salk’s mission to dare to make dreams into reality. Its internationally renowned and award-winning scientists explore the very foundations of life, seeking new understandings in neuroscience, genetics, immunology and more. The Institute is an independent nonprofit organization and architectural landmark: small by choice, intimate by nature and fearless in the face of any challenge. Be it cancer or Alzheimer’s, aging or diabetes, Salk is where cures begin. Learn more at: salk.edu.

For more information

Journal title: Nature Medicine

Paper title: Inhibition of acetyl-CoA carboxylase suppresses fatty acid synthesis and tumor growth of non-small cell lung cancer in preclinical models

Authors: Robert U. Svensson, Seth J. Parker, Lillian J. Eichner, Matthew J. Kolar, Martina Wallace, Sonja N. Brun, Portia S. Lombardo, Jeanine L. Van Nostrand, Amanda Hutchins, Lilliana Vera, Laurie Gerken, Jeremy Greenwood, Sathesh Bhat, Geraldine Harriman, William F. Westlin, H. James Harwood Jr., Alan Saghatelian, Rosana Kapeller, Christian M. Metallo and Reuben J. Shaw

Advancing pipeline of therapeutic candidates focused on key interrelated targets in oncology, immunology and metabolic diseases

CAMBRIDGE, Mass. – May 17, 2016 – Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthrough drugs for serious, underserved human diseases, today announced the recent closing of Gilead Sciences, Inc.’s acquisition of Nimbus Apollo, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its Acetyl-CoA Carboxylase (ACC) inhibitor program. The acquisition’s completion triggered a $400 million upfront payment to Nimbus from Gilead. Per the agreement between the two companies, Nimbus has the potential to receive an additional $800 million in development-related milestones from Gilead over time.

The Nimbus Apollo program includes the lead candidate NDI-010976, a hepatotropic allosteric ACC inhibitor, and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis (NASH), and for the potential treatment of hepatocellular carcinoma (HCC) and other diseases. With the completion of the acquisition, Nimbus Apollo is now a wholly-owned subsidiary of Gilead, and Gilead has assumed sole responsibility for future development and commercialization of NDI-010976 and other ACC inhibitors.

Nimbus continues to progress a diverse pipeline of therapeutic candidates focused on serious unmet needs in oncology, immunology and metabolic diseases. Placing a particular emphasis on the mechanistic relationship between and among these primary therapeutic focus areas, Nimbus is leveraging its unique computational chemistry approach to advance novel molecules in cancer metabolism, immuno-oncology and immuno-metabolism. The company’s pipeline addresses key biological targets including Tyk2, KRas, and the recently unveiled addition of non-nucleotide agonist and antagonist programs for STING (STimulator of INterferon Genes) as well as other undisclosed targets.

“We’re pleased to announce the completion of Gilead’s acquisition of Nimbus Apollo, and we look forward to following the clinical progress of NDI-010976,” said Don Nicholson, Ph.D., Chief Executive Officer at Nimbus. “Our long-term vision at Nimbus is to build a robust biotechnology company that is supportive of our mission to turn difficult targets into medicines that matter. With our breakthrough science, unmatched team and novel corporate structure, we are confident that we can make significant contributions to human health.”

Nimbus is structured as a series of independent C corporations, each of which houses distinct research and development programs focused on a highly desirable, yet previously intractable disease target. This model enables Nimbus to make investment and partnership decisions on an asset versus pipeline basis, ensuring the full value of each program is realized. It also affords Nimbus broad flexibility when determining optimal clinical development plans, with the opportunity to advance programs internally or consider a variety of partnering and collaboration scenarios.

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. Nimbus’ approach results in therapeutic candidates with high potency, selectivity and other desirable drug-like properties. To learn more, please visit www.nimbustx.com.

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FOSTER CITY, Calif. & CAMBRIDGE, Mass. – April 4, 2016 – Gilead Sciences, Inc. (NASDAQ: GILD) and Nimbus Therapeutics, LLC today announced that the companies have signed a definitive agreement under which Gilead will acquire Nimbus Apollo, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its Acetyl-CoA Carboxylase (ACC) inhibitor program. Nimbus Therapeutics will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time.

The Nimbus Apollo program includes the lead candidate NDI-010976, an ACC inhibitor, and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis (NASH), and for the potential treatment of hepatocellular carcinoma (HCC) and other diseases. NDI-010976 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in February 2016 and Phase 1 data for the compound will be presented next month during an oral session at The International Liver Congress 2016, the annual meeting of the European Association for the Study of the Liver (EASL).

NASH is a serious liver disease resulting from metabolic dysfunction associated with steatosis (fat within the liver) that can lead to inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. Affecting up to 15 million people in the United States, NASH is expected to become the leading indication for liver transplantation by 2020. ACC inhibitors target a central cause of the disease – reducing aberrant lipid-derived signaling that can result in steatosis, inflammation and fibrosis.

“The acquisition of Nimbus’ ACC-inhibitor program represents a timely and important opportunity to accelerate Gilead’s ongoing efforts to address unmet needs in NASH,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “These molecules will complement and further strengthen Gilead’s pipeline and capabilities to advance a broad clinical program in NASH that includes compounds targeting multiple key pathways involved in the pathogenesis of the disease.”

“Given the company’s long-standing commitment to and expertise in liver disease, we are confident that Gilead is the ideal partner to accelerate and maximize the potential of the ACC inhibitor program,” said Don Nicholson, PhD, Chief Executive Officer of Nimbus Therapeutics. “This agreement underscores Nimbus’ ability to rapidly discover, design and optimize promising therapeutics in areas of unmet need, an approach we will continue to apply against other medically important targets.”

Upon completion of the acquisition, Nimbus Apollo will become a wholly-owned subsidiary of Gilead. Nimbus Therapeutics will retain ownership of its other research and development subsidiaries. Gilead will be solely responsible for future development and commercialization of NDI-010976 and other ACC inhibitors.

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 break down. 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.

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.

Nimbus is structured as a series of independent C corporations, each of which houses distinct research and development programs focused on a highly desirable, yet previously intractable disease target. This model enables Nimbus to make investment and partnership decisions on an asset versus pipeline basis, ensuring the full value of each program is realized. To learn more, please visit www.nimbustx.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Gilead Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including risks that Gilead may be unable to develop NDI-010976 and any other compounds acquired from Nimbus. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

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CAMBRIDGE, Mass. – February 2, 2016 – Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthrough drugs for serious, underserved human diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for NDI-010976, Nimbus’ liver-targeted allosteric inhibitor of acetyl-CoA carboxylase (ACC), for the treatment of NASH (non-alcoholic steatohepatitis).

In addition, the company announced that it is on track to start Phase II clinical testing in the first half of this year, and that the results of the Phase I program to support entry into Phase II will be presented at the upcoming European Association for the Study of Liver Diseases (EASL) meeting in April.

“Inhibitors of ACC have the potential to become important therapeutics in the treatment of NASH, as well as other important diseases.” said Don Nicholson, Ph.D., Chief Executive Officer (CEO) at Nimbus. “We are very pleased that the FDA provided us the opportunity to engage them more directly to help expedite our clinical development program so that we can bring NDI-010976 to patients sooner.”

The FDA’s Fast Track program is designed to facilitate and expedite development and review of new drugs to treat serious or life-threatening conditions and address unmet medical needs. Companies receiving Fast Track designation benefit from more frequent meetings and communications with the FDA regarding development plans to support product registration. In addition, companies with Fast Track designation may be eligible for rolling review, such that sections of a New Drug Application (NDA) are reviewed once available and prior to submission of the complete application. Fast Track development programs may also be eligible for priority review, which carries an abbreviated review timeline of six months.

About NASH

Non-alcoholic steatohepatitis (NASH) is a serious chronic liver disease caused by excessive fat accumulation in the liver. It affects between 5-10% 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 a pair of enzymes that catalyze a very early biochemical step in the synthesis of endogenous fatty acids (de novo lipogenesis). In addition, the product of the ACC reaction regulates the ability of cellular mitochondria to ‘burn’ pre-existing fat through beta-oxidation. Inhibitors of ACC therefore prevent both new fat synthesis and stimulate mitochondrial beta-oxidation in certain tissues. In animal models of fatty liver diseases like NASH, the effects of ACC inhibition extend to reducing liver inflammation and limiting fibrosis (scarring), which are important hallmarks of NASH progression. NDI-010976 is a high-potency allosteric inhibitor of both ACC enzymes. By design, it is hepatotropic (liver ‘homing’), which directs it to the target organ for NASH and related diseases that Nimbus is pursuing. Nimbus is also developing allosteric ACC inhibitors with broad distribution in the body to treat immune- inflammatory disorders and cancer.

About Nimbus

Nimbus Therapeutics is a biotechnology company headquartered in Cambridge, Massachusetts (USA). It is pioneering the application of computational chemistry to design breakthroughs for the treatment of 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. To learn more, please visit www.nimbustx.com.

Media Contact

Liz Melone
Feinstein Kean Healthcare (617) 761-6727

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Novel, broad-spectrum fungicides are progressed to follow-on crop field trials

CAMBRIDGE, Mass. and ST. LOUIS, Mo. – December 22, 2015 – Nimbus Therapeutics, LLC, a biotechnology company discovering novel approaches for previously inaccessible disease targets, and Monsanto Company, today announced the achievement of the second milestone in their research collaboration. The research collaboration, which was announced in 2013, focuses on the development of new discoveries to help farmers control diseases and promote overall plant health.

Under the collaboration, Nimbus and Monsanto are co-developing agricultural fungicides using Nimbus’ innovative research tools and Monsanto’s agricultural testing capabilities. The breakthrough science collaboration pairs computational technology and robust experimental screens in a rapid cycle discovery process. This process allows the companies to identify and optimize agrochemicals that can help farmers mitigate challenges on-farm and deliver better harvests.

The Nimbus-Monsanto collaboration is already highlighting early season seed treatment benefits in row crops as well as strong foliar disease control in vegetable trials. With today’s announcement, Monsanto will make an undisclosed payment to Nimbus based on the further progression of novel broad-spectrum fungicides in crop field trials.

Growers around the world are continuously searching for new tools to help them control fungal infestations which impact their harvest on farms. Today, it is estimated that fungal infestations reduce global yields 13 percent on average despite the use of resistant crop varieties and the approximately $14 billion that is spent annually on fungicide treatments.

Fungal infections appear as rusts, leaf spots, mildews and blights on a range of important crops. Novel fungicides would provide growers with additional tools to prevent yield loss, as well as combat emerging resistance to existing fungicide treatments or applications.

Under the terms of the agreement, a jointly-owned entity has been created that has access to Nimbus’ validated computational and molecular-evolution platform. Monsanto has rights to applications within agriculture, and Nimbus will retain rights for all other applications.

About Nimbus

Nimbus Therapeutics is a biotechnology company headquartered in Cambridge, Mass., that is pioneering a new computational technology-driven paradigm to rapidly advance a diverse pipeline of novel small molecule product candidates into clinical development.

We are designing highly selective and potent medicines to disrupt known drivers of serious diseases, including metabolic disease, cancer and immune-inflammatory disorders.

Nimbus’ development programs target well-characterized biological mechanisms which have proven unreachable by traditional drug development methods. Our lead targets – ACC, IRAK4, Tyk2, and KRas – were each discovered more than a decade ago, but have proven elusive to drug intervention due to limitations of potency, selectivity and pharmacokinetics in first-generation molecules.

We overcome these challenges through a deep integration of multiple disciplines, including computer-aided drug design, chemistry and pharmacology, working in close coordination with a focused network of close partners and collaborators. For more information please visit www.nimbustx.com.

About Monsanto Company

Monsanto Company is a leading global provider of technology-based solutions and agricultural products that improve farm productivity and food quality. Monsanto remains focused on enabling both small-holder and large-scale farmers to produce more from their land while conserving more of our world’s natural resources such as water and energy. To learn more about our business and our commitments, please

visit: www.monsanto.com. Follow our business on Twitter® at www.twitter.com/MonsantoCo, on the company blog, Beyond the Rows® at www.monsantoblog.com, or subscribe to our News Release RSS Feed.

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Monsanto Cautionary Statements Regarding Forward-Looking Information:

Certain statements contained in this release are “forward-looking statements,” such as statements concerning the company’s anticipated financial results, current and future product performance, regulatory approvals, business and financial plans and other non- historical facts. These statements are based on current expectations and currently available information. However, since these statements are based on factors that involve risks and uncertainties, the company’s actual performance and results may differ materially from those described or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, among others: continued

competition in seeds, traits and agricultural chemicals; the company’s exposure to various contingencies, including those related to intellectual property protection, regulatory compliance and the speed with which approvals are received, and public acceptance of biotechnology products; the success of the company’s research and development activities; the outcomes of major lawsuits and the previously-announced SEC investigation; developments related to foreign currencies and economies; successful operation of recent acquisitions; fluctuations in commodity prices; compliance with regulations affecting our manufacturing; the accuracy of the company’s estimates related to distribution inventory levels; the company’s ability to fund its short- term financing needs and to obtain payment for the products that it sells; the effect of weather conditions, natural disasters and accidents on the agriculture business or the company’s facilities; and other risks and factors detailed in the company’s most recent Form 10-K Report to the SEC. Undue reliance should not be placed on these forward- looking statements, which are current only as of the date of this release. The company disclaims any current intention or obligation to update any forward-looking statements or any of the factors that may affect actual results.

Contact:

Nimbus Therapeutics, LLC Liz Melone

Feinstein Kean Healthcare Phone:
+1 (617) 761-6727

Monsanto Company

Sara Miller
Monsanto Public Affairs Phone:
+ 1 (314) 694-5824

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Cambridge, Mass. – November 10, 2015 – Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthroughs for serious, underserved human diseases, today announced further scientific progress on its core programs that are being presented at two key scientific meetings.

“Following our recent announcement that we have partnered our IRAK4 program with Genentech, we are pleased to report exciting progress on our Tyk2 and ACC programs that we are presenting at meetings of the ACR (American College of Rheumatology) and AASLD (American Association for the Study of Liver Diseases) this week in San Francisco,” said Donald Nicholson, Ph.D., Chief Executive Officer of Nimbus Therapeutics. “In addition, our ongoing Phase 1b studies with NDI-010976, an allosteric ACC inhibitor for the treatment of NASH (non-alcoholic steatohepatitis), are looking very promising, and we anticipate sharing that data with the scientific and medical community as we embark on Phase 2 next year,” Dr. Nicholson said.

At the ACR meeting, Nimbus shared data on its highly selective Tyk2 inhibitors (abstract #1943; presented Nov. 9). Compelling human genomic evidence suggests that Tyk2 inhibitors should be of value for the treatment of inflammatory and auto-immune disorders, such as rheumatoid arthritis, lupus and others. At the AASLD meeting, Nimbus will present two posters that are collaborations with scientists from the Massachusetts General Hospital; one demonstrating the efficacy of liver-targeted allosteric inhibitors of ACC (acetyl-CoA carboxylase) in animal models of metabolic disorders including NASH (abstract #957; presenting Nov. 15), and another that demonstrates the efficacy of these ACC inhibitors in animal models of liver cancer (HCC, hepatocellular carcinoma) including benefits when combined with sorafenib, the current clinical standard of care for treating HCC (abstract #1938; presenting Nov. 17).

Poster Presentations

American College of Rheumatology (ACR) Annual Meeting

Nov. 6-11, 2015; San Francisco, Calif.

Poster Title: Potent and Selective Tyk2 Inhibitors Block Th1- and Th17- Mediated Immune Responses and Reduce Disease Progression in Rodent Models of Delayed-Type Hypersensitivity and Psoriasis
Presentation Date and Time: Monday, Nov. 9, 2015; 9 a.m. – 11 a.m.
Abstract #1943, Poster Session I

American Association for the Study of Liver Diseases (AASLD) Liver Meeting

Nov. 13-17, 2015; San Francisco, Calif.

Poster Title: Liver-Directed Allosteric Inhibitors of Acetyl-CoA Carboxylase Reduce Hepatic Steatosis and Improve Dyslipidemia in Diet-Induced Obese Rat Models and Reduce Inflammation and Fibrosis in a Cirrhotic Rat Model
Presentation Date and Time: Sunday, Nov. 15, 2015; 8 a.m. – 5 p.m.
Abstract #957, Poster Session II

Poster Title: Liver Selective Acetyl-CoA Carboxylase Inhibitor ND-654 Improves Sorafenib Efficacy in the Treatment of Hepatocellular Carcinoma in Cirrhotic Rats
Presentation Date and Time: Tuesday, Nov. 17, 2015; 8 a.m. – Noon
Abstract #1938, Poster Session IV

About Nimbus

Nimbus Therapeutics is a biotechnology company headquartered in Cambridge, Massachusetts (U.S.). It is pioneering the application of computational chemistry to design breakthroughs for the treatment of substantial and underserved human diseases. The Company works on difficult and valuable targets across the three closely related fields of immunology, metabolism, and oncology. Nimbus’ unique approach and technological prowess fuel the Company’s ability to rapidly tackle targets that have proven intractable to the approaches taken by others in the pharmaceutical and biotechnology industry. Nimbus’ most advanced program, an allosteric inhibitor of acetyl-CoA carboxylase (ACC) for the treatment of non-alcoholic steatohepatitis (NASH), is currently in Phase 1 clinical testing. To learn more, please visit www.nimbustx.com.

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Cambridge, Mass. – October 20, 2015 – Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthroughs for serious, underserved diseases, today announced an exclusive worldwide license agreement with Genentech, a member of the Roche Group, to discover and develop small molecule inhibitors of interleukin-1 receptor-associated kinase 4 (IRAK4).

Under the terms of the agreement, Nimbus will receive an undisclosed upfront payment and is eligible to receive milestone payments based on achievement of certain predetermined milestones. In addition, Nimbus is eligible to receive royalties on sales of certain products resulting from the license agreement. Genentech will be responsible for all preclinical and clinical development, manufacturing and commercialization. Financial terms have not been disclosed.

“With its expertise, capabilities and global reach, Genentech is the best partner to rapidly advance these promising candidates to the clinic and, ultimately, bring new treatments to patients,” said Don Nicholson, Chief Executive Officer of Nimbus.

“Genentech is dedicated to bringing forth treatments for patients with serious and life-threatening diseases,” said James Sabry, Senior Vice President and Global Head of Genentech Partnering. “Nimbus’ unique approach to drug discovery will enhance our research and development programs for immunological disorders.”

About Nimbus

Nimbus Therapeutics is a biotechnology company headquartered in Cambridge, Massachusetts (U.S.). It is pioneering the application of computational chemistry to design breakthroughs for the treatment of substantial and underserved human diseases. The Company works on difficult and valuable targets across the three closely related fields of immunology, metabolism, and oncology. Nimbus’ unique approach and technological prowess fuel the Company’s ability to rapidly tackle targets that have proven intractable to the approaches taken by others in the pharmaceutical and biotechnology industry. Nimbus’ most advanced program, an allosteric inhibitor of acetyl-CoA carboxylase (ACC) for the treatment of non-alcoholic steatohepatitis (NASH), is currently in Phase I clinical testing. To learn more, please visit www.nimbustx.com.

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CAMBRIDGE, Mass. – September 9, 2015 – Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthroughs for serious, underserved diseases, today announced the appointment of Annie C. Chen, M.D., M.P.H., as Chief Medical Officer. Dr. Chen brings more than a decade of industry experience and joins Nimbus from Merck & Co., where she most recently served as Executive Director of Clinical Research, Section Head of Vaccines.

“We are thrilled to welcome Annie to our team. As CMO, she will play a critical role in helping advance Nimbus’ mission to deliver medicines that truly matter and bring a meaningful difference to patients,” said Don Nicholson, Ph.D., Chief Executive Officer at Nimbus. “I am extremely proud of the top industry talent we continue to attract and the world-class leadership team we are building at Nimbus. We look forward to leveraging Annie’s deep experience as we continue to evolve as a clinical-stage company and progress our broad pipeline in metabolic disease, cancer and immune-inflammatory disorders.”

Over the course of her career, Dr. Chen has been responsible for overseeing the global clinical development and regulatory filings of key therapeutics spanning small molecule, protein therapeutics and vaccines. At Merck, Dr. Chen oversaw clinical research activities for a broad portfolio of vaccines, from discovery through Phase III, and marketed products. She served as alternating chair of Merck’s vaccines therapeutic area development review committee, and previously as a clinical reviewer for the document review committee covering all therapeutic areas, including oncology, infectious diseases, respiratory and immunology, metabolic disorders and vaccines. At Merck, Dr. Chen also previously held the position of Executive Director Clinical Research, Section Head Immunology. Prior to Merck, Dr. Chen held several roles at Genentech, including Senior Medical Director, where she facilitated approvals and expanded indications for the company’s blockbuster biologic treatments, including

Rituxan® and ACTEMRA®. Dr. Chen previously served as Medical Director of Celera Genomics, where she designed, implemented and monitored crucial phase 1 clinical trials in oncology and autoimmune diseases.

Dr. Chen was formerly an Assistant Clinical Professor of Medicine at the University of California and has published a number of influential scientific papers throughout her career. A qualified adult rheumatologist, Dr. Chen is a member of the American College of Rheumatology. She received her M.P.H. in Epidemiology from the University of California Berkley, her M.D. from Cornell University and her B.A. in Biological Sciences from Harvard University.

“I am very excited to begin working with Don and the entire Nimbus team, particularly at this moment in time when we’re experiencing such explosive, unprecedented advancement,” said Dr. Chen. “Industry wide we’re seeing remarkable progress advancing new approaches to address long-held, significant unmet needs. Nimbus’ computational chemistry approach and the company’s ability to design highly specific therapies to interrupt critical, yet until now undruggable targets is quite thrilling, and I believe places the company at the forefront of this revolution in medicine.”

About Nimbus

Nimbus Therapeutics is a biotechnology company headquartered in Cambridge, Massachusetts (U.S.). It is pioneering the application of computational chemistry to design breakthroughs for the treatment of 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. Nimbus’ most advanced program, an allosteric inhibitor of acetyl-CoA carboxylase (ACC) for the treatment of non-alcoholic steatohepatitis (NASH) is currently in Phase I clinical testing. To learn more, please visit www.nimbustx.com.

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Cambridge, Mass. – July 7, 2015 – Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthroughs for serious, underserved diseases, today announced the appointment of industry leaders Mark Iwicki and George P. Vlasuk, Ph.D., as independent members of its Board of Directors.

“We are thrilled to have Mark and George share their expertise and leadership skills as Nimbus Therapeutics takes on the challenges and opportunities of its next critical phase of growth,” said Don Nicholson, Ph.D., Chief Executive Officer (CEO) at Nimbus. 

Mr. Iwicki and Dr. Vlasuk join Elaine Jones, Ph.D., Executive Director of Pfizer Venture Investments, and Chris Christoffersen, Ph.D., General Partner with Lightstone Ventures, who also joined Nimbus’ Board as part of Nimbus’ recent $43 million Series B financing round.

“Along with our existing Board members from the Series A investment, the contributions of our new Board members will be instrumental as we continue to advance the Phase I clinical program for our ACC inhibitor for the treatment of NASH and related disorders, progress our pipeline, and pursue our mission of turning difficult targets into medicines that matter,” added Dr. Nicholson.

“Nimbus’ unique computational technology-driven model for drug discovery and development has yielded a pipeline of novel small molecule compounds with truly exciting, breakthrough approaches to some of the most sought-after yet elusive targets in oncology, metabolism and inflammation,” said Mr. Iwicki. “I look forward to working with the leadership team and fellow Board members as Nimbus continues to make significant strides as a clinical-stage company committed to improving patients’ lives.” 

Mark Iwicki has 25 years of experience as a pharmaceutical industry leader managing all stages of drug development and commercialization in multiple therapeutic areas for several high-performance companies. Most recently, Mr. Iwicki served as CEO of Civitas Therapeutics, which was sold to Acorda Therapeutics in 2014. Prior to joining Civitas, he was President and CEO of Blend Therapeutics, a nanotechnology oncology biotech company. He also served as President and CEO of Sunovion Pharmaceuticals, where he provided leadership for the successful launch of that company, which was created following the acquisition of Sepracor by Dainippon Sumitomo Pharmaceuticals. Mr. Iwicki also previously held key senior leadership roles with Sepracor and Novartis Pharmaceuticals. He currently also sits on the Board of Directors for Kala Pharmaceuticals, Allergen Research Corporation and Taris Biomedical.

George P. Vlasuk, Ph.D., is a scientifically-trained executive with nearly 30 years of leadership experience in drug discovery and development at small and large biotechnology and pharmaceutical companies. Dr. Vlasuk currently is President and CEO at Navitor Pharmaceuticals. Before joining Navitor, he served as CEO of Sirtris, a GlaxoSmithKline Company. Prior to Sirtris, Dr. Vlasuk was Vice President, Metabolic Disease and Hemophilia Research, at Wyeth Pharmaceuticals. Dr. Vlasuk also previously served as Chief Scientific Officer and Executive Vice President of Research and Development at Corvas International, prior to the merger of Corvas and Dendreon Corporation. Earlier in his career, Dr. Vlasuk led a research team at Merck and Co., and was responsible for multiple discovery programs in the field of cardiovascular medicine. Dr. Vlasuk is the author of more than 100 peer-reviewed scientific publications, book chapters and reviews, and 38 issued U.S. and foreign patents.

About Nimbus

Nimbus Therapeutics is a biotechnology company headquartered in Cambridge, Massachusetts (U.S.). It is pioneering the application of computational chemistry to design breakthroughs for the treatment of 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. Nimbus’ most advanced program, an allosteric inhibitor of acetyl-CoA carboxylase (ACC) for the treatment of non-alcoholic steatohepatitis (NASH) is currently in Phase I clinical testing. To learn more, please visit www.nimbustx.com.

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