Focused on rare diseases and their ripple effects.

Overview

Ocera Therapeutics (NASDAQ:OCRX) is a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for patients with serious diseases in areas of high unmet medical need.

Ocera’s lead drug candidate OCR-002 is a novel ammonia scavenger which rapidly removes ammonia from the blood. Elevated ammonia is believed to be one of the primary causes of hepatic encephalopathy (HE). OCR-002 is the subject of STOP-HE, a Company-sponsored Phase 2b trial, a Company-sponsored Phase 1 trial, and two externally-sponsored Phase 2a trials. OCR-002 has received Orphan Drug designation in both the U.S. and Europe and has been granted Fast Track status by the U.S. Food and Drug Administration.

Products to Treat Acute and Chronic Orphan Liver Diseases

Ocera’s drug candidate OCR-002 (ornithine phenylacetate) is an ammonia scavenger, designed to treat hyperammonemia (elevated ammonia in the blood) and associated hepatic encephalopathy, a complication of patients with liver cirrhosis or acute liver failure. When the liver is no longer able to remove toxic substances from the blood, there is an accumulation of such toxins, particularly ammonia. Ammonia accumulation in the blood impairs brain cell function, and can lead to a neuropsychiatric condition called hepatic encephalopathy, or HE.

Management Team

Linda S. Grais, M.D.

President and Chief Executive Officer

Dr. Grais has served as a member of the Board of Directors of Ocera Therapeutics, Inc. since January 2008 and as President and Chief Executive Officer of Ocera Therapeutics, Inc. since June 2012. Prior to her employment by Ocera, Dr. Grais served as a Managing Member at InterWest Partners, a venture capital firm from May 2005 until February 2011. From July 1998 to July 2003, Dr. Grais was a founder and executive vice president of SGX Pharmaceuticals Inc., a drug discovery company focusing on new treatments for cancer. Prior to that, she was a corporate attorney at Wilson Sonsini Goodrich & Rosati, where she practiced in such areas as venture financings, public offerings and strategic partnerships. Before practicing law, Dr. Grais worked as an assistant clinical professor of Internal Medicine and Critical Care at the University of California, San Francisco. Dr. Grais received a B.A. from Yale University, magna cum laude, and Phi Beta Kappa, an M.D. from Yale Medical School and a J.D. from Stanford Law School. She currently serves on the Board of Directors of Arca Biopharma, Inc. and PRA Health Sciences, Inc.

Stan Bukofzer, M.D.

Chief Medical Officer

Dr. Bukofzer joined Ocera Therapeutics, Inc. in January 2016. Prior to his employment with Ocera, he served as Chief Medical Officer of Hospira, Inc., where he was responsible for providing strategic and operational direction for clinical development, pharmacovigilance and safety and medical affairs across Hospira’s three business units. Prior to joining Hospira, Dr. Bukofzer was Vice President of Astellas Scientific and Medical Affairs, where he had responsibility for seven therapeutic areas including oncology, immunology, hematology, anti-infectives, dermatology, cardiovascular and transplant. Dr. Bukofzer began his pharmaceutical career at Abbott Laboratories where he held a variety of positions with increasing responsibility, including Global Venture Head for Abbott’s anti-infective development programs. He last served as Divisional Vice President and Head of Global Medical Affairs where he was responsible for Abbott’s global health economics and outcomes research, European clinical operations, and oversight for global medical and scientific functions. Dr. Bukofzer received his medical degrees from the University of Witwatersrand in South Africa and was accredited in internal medicine, as well as gastroenterology and hepatology. His research focus was in hepatitis B mutant virus genome expression. Following the completion of his studies, Dr. Bukofzer served in the military and practiced in both academia and private practice. He previously sat on the executive committee of the South Africa Gastroenterology Association, and is a founding member of Children’s Liver Disease Foundation in South Africa.

Michael Byrnes, M.B.A.

Chief Financial Officer

Mr. Byrnes has served as Chief Financial Officer of Ocera Therapeutics, Inc. since December 2014. He joined Ocera in June 2014 as Vice President, Finance. Prior to joining Ocera, Mr. Byrnes served as Corporate Controller of Maxygen, Inc., MAXY since March 2010. From June 2007 to March 2010, Mr. Byrnes worked for NeurogesX, Inc., NGSX, in financial roles of increasing responsibility, most recently as Director of Finance. From December 2002 to June 2007, Mr. Byrnes served as Finance and Accounting Manager for Lipid Sciences Inc., LIPD. Mr. Byrnes’ experience also includes a variety of finance and accounting roles from 1996 to 2002 at ADAC Labs (a Philips Medical Systems company) and Bay View Capital Corporation. Mr. Byrnes received a B.S.C. in Finance from Santa Clara University and an M.B.A. from California State University, Hayward.

Mark D. Coffin, Ph.D.

Vice President, Pharmaceutical Development and Manufacturing

Dr. Coffin joined Ocera Therapeutics, Inc. in July 2015. Prior to his employment with Ocera, he worked at GlaxoSmithKline (GSK) in Pharmaceutical Development from October 1990 to July 2015. While at GSK, Dr. Coffin acquired extensive experience in all phases of drug development, including the support of drug discovery in candidate selection, development of formulations for use in Phase 1, 2, and 3 clinical trials, filing of new drug marketing applications, and technical support of post-approval changes for marketed products. In his last role at GSK, he served as the Director of Process Robustness and Second Generation Drug Product Development, US. Dr. Coffin received his Ph.D. from the College of Pharmacy at the University of Texas at Austin, and his B.S. in Pharmacy from Purdue University.

Amy Potthoff

Vice President, Clinical Operations

Ms. Potthoff joined Ocera Therapeutics, Inc. in March 2016. Prior to her employment with Ocera, she served as Vice President of Medical Operations at Hospira, Inc., where she was responsible for delivering clinical programs globally and led Clinical Program Management, Medical Writing, Document Management, Quality and Compliance and CMO Operations. Prior to Hospira, Amy began her pharmaceutical career at Abbott Laboratories where she acquired extensive experience in all phases of drug development and held a variety of positions with increasing responsibility, lastly as Division Vice President of Development Operations. In this role she led multiple functions located around the world including Clinical Program Management, Clinical Field Operations, Document Management, Medical Writing, Medical Publishing, Safety Management, Clinical Compliance, Clinical Services and Clinical Planning and Resource Management with a mission of delivering clinical programs globally.  While at Abbott, Amy was also led the clinical operation aspects for the successful Phase 3 program, submission and approval of Abbott Laboratories HIV protease inhibitor Norvir®, and the successful development program, submission and approval of HIV protease inhibitor Kaletra®.  Amy holds a bachelor’s degree in Microbiology from the University of Illinois.

Board of Directors

Eckard Weber, M.D.

Chairman of the Board

Eckard Weber, M.D. is a co-founder of Ocera and serves as the chairman of our board of directors. Eckard is a partner with Domain Associates, LLC, a private venture capital management firm focused on life sciences. He specializes in creating companies around promising new pharmaceutical products and has led Domain’s initiatives in Japanese in-licensing.

Eckard also currently serves as chairman of the board at Tragara Pharmaceuticals. Eckard is a board member of Adynxx, Atara Biotherapeutics, and Tobira Therapeutics and a board observer of Syndax Pharmaceuticals.

He has been founding CEO of multiple biopharmaceutical companies in the Domain portfolio including Acea Pharmaceuticals, Ascenta Therapeutics, Calixa Therapeutics, Cytovia, Domain Anti Bacterial Acquisition Corporation, NovaCardia, Novacea, Novalar Pharmaceuticals, Ocera Therapeutics, Orexigen Therapeutics, Sonexa Therapeutics, Syndax Pharmaceuticals, Tobira Therapeutics.

Eckard was chairman of a number of companies until their successful exit including Peninsula Pharmaceuticals (sold to Johnson & Johnson, 2005), Cerexa (sold to Forest Laboratories, 2007), NovaCardia (sold to Merck, 2007), Calixa (sold to Cubist Pharmaceuticals, 2009). He was also a board member of Conforma Therapeutics (sold to Biogen-IDEC, 2006) and Cabrellis Pharmaceuticals (sold to Pharmion, 2006).

Previously, Eckard was a tenured professor of pharmacology at the University of California at Irvine. He has more than 20 years of drug discovery and development experience and has been a consultant to biotechnology and pharmaceutical companies. He is the inventor or co-inventor of numerous patents and patent applications, and he has published more than 130 papers in scientific periodicals.

Eckard completed his Abitur from Kolping Kollege, Friedrichshafen, Germany and his M.D. from the University of Ulm Medical School, Germany. He received his postdoctoral training in neuroscience at Stanford University Medical School.

Linda S. Grais, M.D.

President and Chief Executive Officer

Dr. Grais has served as a member of the Board of Directors of Ocera Therapeutics, Inc. since January 2008 and as President and Chief Executive Officer of Ocera Therapeutics, Inc. since June 2012. Prior to her employment by Ocera, Dr. Grais served as a Managing Member at InterWest Partners, a venture capital firm from May 2005 until February 2011. From July 1998 to July 2003, Dr. Grais was a founder and executive vice president of SGX Pharmaceuticals Inc., a drug discovery company focusing on new treatments for cancer. Prior to that, she was a corporate attorney at Wilson Sonsini Goodrich & Rosati, where she practiced in such areas as venture financings, public offerings and strategic partnerships. Before practicing law, Dr. Grais worked as an assistant clinical professor of Internal Medicine and Critical Care at the University of California, San Francisco. Dr. Grais received a B.A. from Yale University, magna cum laude, and Phi Beta Kappa, an M.D. from Yale Medical School and a J.D. from Stanford Law School. She currently serves on the Board of Directors of Arca Biopharma, Inc. and PRA Health Sciences, Inc.

Dr. Dere serves as the Professor of Internal Medicine; B. Lue and Hope S. Bettilyon Presidential Endowed Chair in Internal Medicine for Diabetes Research, Executive Director of Personalized Health, and Co-Principal Investigator of the Center for Clinical and Translational Science at the University of Utah Health Sciences Center. Prior to re-joining academia in November 2014, Dr. Dere was in the biopharmaceutical industry for 25 years. He joined Amgen in 2003 where he held multiple roles including head of global development, international research and development, and both corporate and international chief medical officer. He led the development program for Prolia and several other programs, and retired from Amgen in October 2014. He began his career at Eli Lilly in 1989, and held a number of different global roles in clinical pharmacology, regulatory affairs, and both early-stage translational, and late-stage clinical research. While at Eli Lilly, he led the development of Evista and Forteo. Since 2014, he has been a member of the Board of Directors of Radius Health and serves on the scientific advisory board of the California Institute of Regenerative Medicine. In addition, he joined the Board of Directors of BioMarin in July 2016.

Dr. Dere attended undergraduate and medical school at the University of California, Davis. He trained in internal medicine at the University of Utah and endocrinology/ metabolism at the University of California at San Francisco, and was on the Internal Medicine faculty at the University of Utah for 4 years during which time he was recognized annually with teaching awards. He has published numerous articles; wrote and co-edited a primary care textbook; was awarded the 2008 transformational leadership award from his alma mater; and is a fellow in the American College of Physicians.

Steven P. James

Director

Steven P. James has served on Ocera’s board of directors since September 2014. Prior to joining the Board, Mr. James served as the President and Founding Chief Executive Officer of Labrys Biologics, Inc., a private venture-backed start-up developing a monoclonal antibody for the prevention of chronic migraine, until the company was acquired by Teva Pharmaceuticals in July 2014. From October 2004 to December 2012, Mr. James served as President and Chief Executive Officer of KAI Pharmaceuticals, Inc., until its acquisition by Amgen in 2012. Prior to joining KAI, he held leadership positions at Exelixis, Inc., Sunesis Pharmaceuticals, Inc., and Isis Pharmaceuticals. Mr. James previously held business development, marketing and general management positions with Landec Corporation, California Biotechnology and Eli Lilly & Company. Mr. James holds a B.A. in Biology from Brown University and a Masters in Management from the Kellogg Graduate School of Management at Northwestern University. Mr. James is currently a director of Cascadian Therapeutics, Antiva Biosciences, Allakos Inc, Precision Immune Inc., Chrono Therapeutics and is a trustee of Middlebridge School in Rhode Island.

Nina Kjellson

Director

Nina Kjellson joined Canaan’s healthcare team from InterWest Partners where she has been investing in healthcare start-ups since 2002. She focuses primarily on investments in biopharmaceuticals and digital health. Nina is co-founder and co-chair of ConsumerMed.org<http://consumermed.org>, a forum to address the convergence of health care and consumer innovation and serves as a mentor to Blueprint Health, a digital health incubator and Springboard Life Sciences, an accelerator for healthcare companies driven by women entrepreneurs. Investment themes include innovative therapeutics for serious and underserved conditions, IT-enabled transformation of healthcare delivery and patient/consumer engagement. Current investments include Cidara (CDTX), Eiger Biopharmaceuticals, Lycera, Ocera (OCRX), Paratek (PRTK), and WellTok. Previous investments include Labrys Biologics (acquired by Teva), Alt12 (acquired by Honest Company), Trius Therapeutics (TSRX; acquired by Cubist), CNS Therapeutics (acquired by Covidien), NovaCardia (acquired by Merck), and Aspreva (ASPV; acquired by Galenica). Prior to InterWest, Nina was an investment manager at Bay City Capital, a life sciences merchant bank, and a research associate at Oracle Partners, a health care-focused hedge fund. Nina began her career conducting health policy and survey research with the Kaiser Family Foundation. Nina received a B.A. in human biology from Stanford University (1997). She serves on the California Leadership Council for the Nature Conservancy and has been nominated to join the board of the California Family Health Council.

Dr. Michael Powell, Ph.D., has served on Ocera’s Board of Directors since June 2006. Dr. Powell has been a General Partner of Sofinnova Ventures, a venture capital firm, since 1997. Previously, Dr. Powell has held positions at Genentech, a biotechnology company, Cytel, a research and development company, and Syntex Research, a pharmaceutical company. Dr. Powell was an early investor and board member of Actelion (ATLN), Intermune (ITMN), Orexigen (OREX), Seattle Genetics (SGEN), Threshold (THLD), Trius (TSRX), and other public and private companies such as Intellikine (sold to Millenium-Takeda), Mirna, and Labrys Biologics (acquired by Teva Pharmaceutical). Dr. Powell is an Adjunct Professor at the University of Kansas in the Department of Pharmaceutical Chemistry, and on the Board of Trustees of Washington University in St Louis.  Dr. Powell received a Ph.D. in physical chemistry from the University of Toronto, and completed his postdoctoral work in bioorganic chemistry at the University of California.

Anne M. VanLent

Director

Anne M. VanLent has served as a director of Ocera (formerly Tranzyme) since March 2011. Ms. VanLent is currently the President of AMV Advisors, an advisory firm which she founded in 2008 to provide corporate strategy and financial consulting services to emerging growth life sciences companies. From May 2002 through April 2008, Ms. VanLent was the Executive Vice President and Chief Financial Officer of Barrier Therapeutics, Inc., a company that developed and marketed prescription dermatology products that was publicly-traded before being acquired by Stiefel Laboratories in August 2008. From July 1997 to October 2001, she was the Executive Vice President – Portfolio Management for Sarnoff Corporation, a multidisciplinary research and development firm. From 1985 to 1993, she served as the Senior Vice President and Chief Financial Officer of The Liposome Company, Inc., a publicly-traded biopharmaceutical company. In April and May 2013, respectively, Ms. VanLent was appointed to serve as a director of and chair of the audit committee of Aegerion Pharmaceuticals, Inc. and Aviragen Pharmaceuticals, Inc. (formerly Biota), both NASDAQ listed companies. She served as a director of Integra Life Sciences Holding Corporation (NasdaqGS: IART) from 1997 to May 2013 and chaired its audit committee from 2006 until 2012. She also served as a director and chair of the audit committee of Penwest Pharmaceuticals, a NASDAQ-listed company from 1998 through its sale to Endo Pharmaceuticals, Inc. in the fall of 2010. She later served as a director, chair of the audit committee and member of the compensation committee of Onconova Therapeutics from July 2013 to May 2016. Ms. VanLent received a B.A. degree in Physics from Mount Holyoke College.

Dr. Wierenga has served on the boards of directors of five biotech companies including Onyx Pharmaceuticals, and currently, Cytokinetics, XenoPort, Apricus Biosciences, Concert Pharmaceuticals, and Anacor Pharmaceuticals, and has been a member of the scientific advisory board of seven biotech and pharmaceutical companies. Most recently, Dr. Wierenga was executive vice president, research and development at Santarus, Inc. Previously Dr. Wierenga held leadership positions at Ambit Biosciences Corporation, Neurocrine Biosciences, Inc., and Syrrx, Inc. as well as with Parke-Davis/Warner-Lambert (now Pfizer) where he held positions including senior vice president, worldwide pharmaceutical sciences, technologies and development. Dr. Wierenga has led or participated in the research and development of more than 70 INDs, over 15 NDAs and 16 marketed products, including Lipitor, Neurontin, Lyrica, and Uceris. Dr. Wierenga earned his Ph.D. in chemistry from Stanford University.