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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Upcoming AACR and EASL poster presentations support Nimbus’ novel, liver-directed approach to allosteric ACC inhibition across liver disease spectrum, including NASH and HCC

CAMBRIDGE, Mass. – April 21, 2015 – Nimbus Therapeutics announced today that it has initiated a Phase I clinical program for NDI-010976, an allosteric Acetyl CoA Carboxylase (ACC) inhibitor, for the treatment of non-alcoholic steatohepatitis (NASH) and related fatty liver disease-spectrum disorders. The single site, open-label Phase I study is being conducted in healthy human volunteers to assess the safety, pharmacokinetic (PK) behavior and maximum tolerated dose of NDI-010976. A subsequent Phase Ib study will enroll obese patients with metabolic syndrome in order to measure key pharmacodynamic (PD) markers that are relevant to the NASH patient population. Nimbus expects all Phase I studies will be completed this year and Phase II studies will begin early next year.

“We believe that ACC inhibition offers a potentially novel and important approach to the treatment of NASH and related disorders since it precisely targets a key enzyme which is required for the formation of lipids that accumulate in the liver during NASH that drive pathogenesis of the disease,” said Don Nicholson, Ph.D., Chief Executive Officer at Nimbus. “Furthermore, our preclinical data demonstrate that the effects of ACC inhibition extend to reducing inflammation and limiting fibrosis, which are hallmarks of NASH progression. We look forward to sharing these data with the scientific and medical community as we progress NDI-010976 through clinical development.”

NDI-010976 represents the first liver-targeted allosteric inhibitor of ACC intended for the treatment of NASH, an increasingly common, serious liver disease which is estimated to affect 16 million Americans.¹ NASH can lead to liver cirrhosis, often resulting in the need for a liver transplant, as well as other complications including hepatocellular carcinoma (HCC), a liver cancer with high mortality rates. Currently there are no therapies specifically approved to treat NASH, and limited options for patients with advanced HCC, and there are no other ACC inhibitors publicly disclosed to be in development for these diseases. In addition to NDI-010976, Nimbus is continuing to advance a pipeline of novel small molecules, including those for IRAK4, Tyk2, KRas and other medically important targets. 

¹Frontline Gastroenterol. 2014 Jul; 5(3): 211-218; Aliment Pharmacol Ther. 2011 Aug; 34(3): 274-85; World J Transplant. 2014 Jun 24; 4(2): 81-92; Hematology. 2014 Dec 29

Upcoming Poster Presentations

American Association of Cancer Research (AACR) Annual Meeting
April 18 – 22, 2015; Philadelphia, Penn.
Poster Title: Liver selective acetyl-CoA carboxylase inhibition by ND-654 improves survival in cirrhotic rats with hepatocellular carcinoma
Presentation Date and Time: Tuesday, April 21, 2015; 1:00 – 5:00 p.m. ET
Abstract #4452, Section 30, Poster Board #9

Nimbus, in collaboration with researchers from Massachusetts General Hospital, previously presented data (PDF File) demonstrating that daily oral administration of its ACC inhibitor ND-654 reduced tumor incidence by 55 percent in an animal model of cirrhosis and HCC. At today’s poster session, the researchers will present data showing that ND-654 significantly improved median survival time in this model, decreased tumor cell proliferation, induced tumor necrosis and decreased fibrosis. 

European Association for the Study of the Liver (EASL) 50th International Liver Congress 2015
April 22 – 26, 2015; Vienna, Austria
Poster Title: Liver-directed allosteric inhibitors of acetyl-CoA carboxylase favorably impact pathophysiology in the progression from NAFLD to NASH and Hepatocellular Carcinoma, including hepatic steatosis, inflammation, and fibrosis
Presentation Date and Time: Saturday, April 25, 2015; 3:30 – 4:00 p.m. CET
Poster Viewing: Saturday, April 25, 2015; 4:00 – 6:00 p.m. CET
Poster #LP-30

Note: The full abstract will be made available on the conference website at 7 a.m. CET on the day of the presentation.

About ACC and NASH

Acetyl CoA Carboxylase (ACC), a master regulator of fatty acid synthesis and oxidation, has been a sought-after, yet intractable target over the past two decades. Successful inhibition of ACC may enable new strategies to reduce lipids, inflammation, fibrosis, blood glucose, weight and cardiovascular risk. Nimbus is the first company to successfully design drug-quality allosteric inhibitors targeting ACC for the treatment of metabolic disease as well as cancer.

The company’s first indication for ACC-focused clinical development in metabolic disease is Non-alcoholic Steatohepatitis, or NASH, a serious condition that can lead to liver cirrhosis, often leading to transplant, and other complications including hepatocellular carcinoma (liver cancer). Currently there are no therapies specifically approved to treat NASH. Other possible metabolic disease indications for ACC inhibition include type 2 diabetes and hypertriglyceridemia.

About Nimbus

Nimbus Therapeutics harnesses the power 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 is driven by its selection of well validated targets that have proven intractable to the approaches taken by others in the pharmaceutical and biotechnology industry. Using its unique approach and technological capabilities, Nimbus is rapidly progressing highly selective and potent small molecules through discovery and development. The company’s advanced programs include ACC, IRAK4 and Tyk2. Nimbus is headquartered in Cambridge, Massachusetts (USA). To learn more, please visit www.nimbustx.com.

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Pfizer Venture Investments and Lightstone Ventures join existing investor syndicate; 
Company will enter clinical stage in 2015 with first ACC Inhibitor for NASH

CAMBRIDGE, Mass. – March 18, 2015 – Nimbus Therapeutics, a biotechnology company focused on designing highly selective and potent medicines to disrupt known drivers of serious diseases, today announced the successful completion of an oversubscribed $43 million Series B financing led by Pfizer Venture Investments and Lightstone Ventures. All of the company’s Series A investors, including Atlas Venture, SR One, Lilly Ventures and Bill Gates, also participated in the Series B round. Coinciding with this announcement, the company recently changed its name from “Nimbus Discovery” to “Nimbus Therapeutics,” to signal its transition to a clinical stage company.

“Our ability to attract such a high-caliber cadre of new and existing investors reinforces our belief in the boundless potential of our novel computational technology-driven approach to drug discovery and development,” said Donald “Don” Nicholson, Ph.D., chief executive officer at Nimbus. “This financing round sets the foundational stage for several key inflection points for Nimbus in 2015 and beyond. Progressing the first of our pipeline of small molecules into the clinic, we hope to make substantial strides this year toward realizing our mission to turn historically difficult targets into medicines that matter for patients.”

Nimbus plans to use the funds from the Series B round to advance its lead program, an Acetyl CoA Carboxylase (ACC) inhibitor, into clinical development, representing the first allosteric and liver-targeted inhibitor intended for the treatment of Non-alcoholic Steatohepatitis, or NASH, an increasingly common liver disease which is estimated to affect 16 million Americans.¹ Nimbus plans to report Phase 1 data from this program later this year. Additionally, the company will continue to advance its preclinical programs of novel small molecules including those for IRAK4, Tyk2, KRas and other medically-important targets.

“It’s clear that Nimbus not only is employing a breakthrough technological approach for drug discovery and development, but also has the scientific expertise and management acumen to translate the company’s vision into reality,” said Chris Christoffersen, Ph.D., General Partner, Lightstone Ventures. “We look forward to supporting Nimbus in the critical years ahead as it advances its promising therapeutics for people impacted by NASH and a broad spectrum of diseases with high unmet needs, and expands its potential reach and impact through new collaborations and partnerships.”

Nimbus’ programs address well-validated biological mechanisms implicated in areas of metabolic disease, cancer and immune-inflammatory disorders, which have proven intractable by traditional drug discovery methods. Employing a novel approach to research and development, Nimbus deeply integrates computer-driven drug design, chemistry and pharmacology, working in close coordination with its co-founding partner, Schrödinger, and a highly integrated network of partners and collaborators. The company has demonstrated the ability to accelerate discovery, design and optimization of drug candidates and rapidly move investigational medicines into the clinic. 

¹Frontline Gastroenterol. 2014 Jul; 5(3): 211-218; Aliment Pharmacol Ther. 2011 Aug; 34(3): 274-85; World J Transplant. 2014 Jun 24; 4(2): 81-92; Hematology. 2014 Dec 29

About ACC and NASH

Acetyl CoA Carboxylase (ACC), a master regulator of fatty acid synthesis and oxidation, has been a sought-after, yet intractable target over the past two decades. Successful inhibition of ACC may enable new strategies to reduce lipids, blood glucose, weight and cardiovascular risk. Nimbus is the first company to successfully design drug-quality allosteric inhibitors targeting ACC for the treatment of metabolic disease as well as cancer.

The company’s first indication for ACC-focused clinical development in metabolic disease is Non-alcoholic Steatohepatitis, or NASH, a serious condition that can lead to liver cirrhosis, often leading to transplant, and other complications including hepatocellular carcinoma, a liver cancer with high mortality rates. Currently there are no therapies specifically approved to treat NASH. Other possible metabolic disease indications for ACC inhibition include type 2 diabetes and hypertriglyceridemia.

About Nimbus

Nimbus Therapeutics harnesses the power 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 is driven by its selection of well validated targets that have proven intractable to the approaches taken by others in the pharmaceutical and biotechnology industry. Using its unique approach and technological capabilities, Nimbus is rapidly progressing highly selective and potent small molecules through discovery and development. The company’s advanced programs include ACC, IRAK4, and Tyk2. Nimbus is headquartered in Cambridge, Massachusetts (USA). To learn more, please visit www.nimbustx.com.

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