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 orphan and other serious growing liver diseases with high unmet medical need.

Ocera’s lead drug prorgam is OCR-002, a novel and validated ammonia scavenger which rapidly removes ammonia from the blood. Elevated ammonia is believed to be one of the primary causes of hepatic encephalopathy (HE), a neurocognitive disorder associated with serious liver disease. An intravenously-administered form of OCR-002 was the subject of a recently completed Phase 2b trial, STOP-HE, in patients hospitalized with HE, and an oral form of the study drug is being evaluated in an ongoing Phase 2a trial in patients with cirrhosis. OCR-002 has received Orphan Drug designation and has been granted Fast Track status by the U.S. Food and Drug Administration. See OCR-002 for additional information.

Products to Treat Acute and Chronic Orphan and Other Serious Growing Liver Diseases

Ocera’s drug candidate OCR-002 (ornithine phenylacetate) is a validated 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 and as our President and Chief Executive Officer since the date of the merger with Tranzyme, Inc. in July 2013 (the “Merger”), as a member of the Board of Directors of Ocera Therapeutics, Inc. when it was a privately held Delaware corporation (“Private Ocera”) since January 2008 and as President and Chief Executive Officer of Private Ocera since June 2012. Prior to her employment by Private 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. She currently serves on the board of directors of Arca Biopharma, Inc. (NASDAQ:ABIO) and PRA Health Sciences (NASDAQ:PRAH). 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.

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. has served as the Chairman of Ocera’s Board of Directors since the closing of the Merger in July 2013. Dr. Weber was a co-founder of Private Ocera and served as Chief Executive Officer from February 2005 to August 2005, a member of its board of directors from its inception in December 2004 to July 2013, and as the chairman of Private Ocera’s board of directors from 2004 to July 2013. Dr. Weber is also a partner with Domain Associates, L.L.C., a private venture capital management firm focused on life sciences, a position he has held since 2001. Dr. Weber is chairman of the board of Tragara Pharmaceuticals, Inc. Dr. Weber is a member of the board of directors of Adynxx, Inc. and Alyrxx, Inc. During the last five years, Dr. Weber served on the board of Atara Biotherapeutics, Inc. (NASDAQ:ATRA), Orexigen Therapeutics, Inc. (NASDAQ:OREX), and Tobira Therapeutics, Inc. (NASDAQ:TBRA). Dr. Weber was chairman of Peninsula Pharmaceuticals, Inc., until the company was sold to Johnson & Johnson in 2005, chairman of Cerexa, Inc., until the company was sold to Forest Laboratories, Inc., in January 2007, chairman of NovaCardia, Inc., until the company was sold to Merck in September 2007, chairman of Calixa Therapeutics until the company was sold to Cubist Pharmaceuticals in December 2009 and a board member of Conforma Therapeutics Corporation and Cabrellis Pharmaceuticals Corporation until they were sold to Biogen-IDEC, Inc., and Pharmion Corporation, respectively. Dr. Weber also has over 20 years of drug discovery and development experience and has been a consultant to biotechnology and pharmaceutical companies. Until 1995, he was a tenured Professor of Pharmacology at the University of California, Irvine. Dr. Weber is the inventor or co-inventor of numerous patents and patent applications, and has published over 130 papers in scientific periodicals. Dr. Weber holds an undergraduate degree from Kolping Kolleg in Germany and an M.D. (Dr. med.) from the University of Ulm Medical School in 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 and as our President and Chief Executive Officer since the date of the merger with Tranzyme, Inc. in July 2013 (the “Merger”), as a member of the Board of Directors of Ocera Therapeutics, Inc. when it was a privately held Delaware corporation (“Private Ocera”) since January 2008 and as President and Chief Executive Officer of Private Ocera since June 2012. Prior to her employment by Private 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. She currently serves on the board of directors of Arca Biopharma, Inc. (NASDAQ:ABIO) and PRA Health Sciences (NASDAQ:PRAH). 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.

Willard Dere, M.D. has served on Ocera’s Board of Directors since October 2016. 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. Dr. Dere currently serves on the Board of Directors of Radius Health, Inc. (NASDAQ:RDUS) and BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) and serves on the Scientific Advisory Board of the California Institute of Regenerative Medicine. Previously, Dr. Dere served on the faculty at the University of Utah for four years and is a fellow in the American College of Physicians. Dr. Dere received his B.A. and M.D. from the University of California, Davis.

Steven P. James

Director

Steven P. James has served as Ocera’s Lead Independent Director since September 2014. Mr. James is interim Chief Executive Officer and serves on the board of PIONYR Immunotherapeutics, a biopharmaceutical company developing oncology drugs. 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, from December 2012 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., (“KAI”), which was acquired 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 also currently serves on the board of Cascadian Therapeutics (NASDAQ:CASC), formerly Oncothyreon Inc., and several private biotechnology companies and is a member of the board of trustees of Middlebridge School in Rhode Island.

Nina Kjellson

Director

Nina Kjellson has served on the Board of Directors of Ocera since the closing of the Merger in July 2013. Ms. Kjellson served as a member of the board of directors of Private Ocera from June 2011 to July 2013. Ms. Kjellson is a managing director at Canaan Partners, a venture capital firm, where she has been employed since September 2015. From June 2002 to August 2015, she served as a principal and General Partner at InterWest Partners, a venture capital firm. From June 2000 to June 2002, she served as an investment manager at Bay City Capital, a life sciences merchant bank, and from October 1999 to June 2000, as a research associate at Oracle Partners, a healthcare‑focused hedge fund. From August 1997 to September 1999, Ms. Kjellson conducted health policy and survey research with the Kaiser Family Foundation, a private foundation focusing on healthcare issues. She holds a B.A. in Human Biology from Stanford University. Ms. Kjellson has served as a member of the previously privately-held Eiger BioPharmaceuticals, Inc., now listed on the NASDAQ (NASDAQ:EIGR), a biopharmaceutical company focused on the development of novel products for the treatment of orphan diseases. Ms. Kjellson also served on the board of directors of Trius Therapeutics, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of antibiotics for serious infections formerly listed on the NASDAQ, from February 2007 until its acquisition by Cubist Pharmaceuticals, Inc. in September 2013.

Anne M. VanLent

Director

Anne M. VanLent has served on the Board of Directors of Ocera since the closing of the Merger in July 2013. Ms. VanLent served as a director of Tranzyme, Inc. from March 2011 to July 2013. Ms. VanLent is currently the President of AMV Advisors, a company which she founded in May 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. Ms. VanLent also currently serves as lead independent director of, chair of the audit committee of and a member of the nominating and corporate governance committee of Aviragen Therapeutics, Inc. (NASDAQ:AVIR), and as a director of, and chair of the audit committee of Advanced Genetic Technologies Corporation (NASDAQ:AGTC), and as a director of, and a member of the compliance committee and audit committees of Novelion Therapeutics, Inc. (NASDAQ:NVLN). Novelion was recently formed from the merger of QLT, Inc. (NASDAQ:QLTI) and Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR), where she served as a director, chair of the audit committee, and member of the compliance committee. Within the past five years, Ms. VanLent formerly served on the board of directors of Integra Life Sciences Holding Corporation (NASDAQ:IART) and Onconova Therapeutics, Inc. (NASDQA:ONTX). Ms. VanLent received a B.A. degree in Physics from Mount Holyoke College.

Dr. Wierenga has served on Ocera’s Board of Directors since December 2013. Dr. Wierenga has served on the Boards of Directors of eight biotech companies including Onyx Pharmaceuticals Inc., which was listed on the NASDAQ until its acquisition by Amgen Inc. in October 2013, and currently, serves on the boards of Cytokinetics, Incorporated (NASDAQ:CYTK), Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) and Apricus Biosciences, Inc. (NASDAQ:APRI). Dr. Wierenga has also 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. (“Santarus”) from June 2011 until January 2014. Prior to joining Santarus in June 2011, he was Executive Vice President of research and development at Ambit Biosciences, Inc., a biopharmaceutical company engaged in the discovery and development of small‑molecule kinase inhibitors, since January 2007. Dr. Wierenga served as Executive Vice President of research and development at Neurocrine Biosciences, Inc., a biopharmaceutical company developing therapeutics for neuropsychiatric, neuroinflammatory and neurodegenerative diseases, from 2003 to 2007. From 2000 to 2003, Dr. Wierenga was Chief Executive Officer of Syrrx, Inc. (“Syrrx”), a company focused on small‑molecule drug compounds. Prior to joining Syrrx, from 1990 to 2000, he was Senior Vice President of worldwide pharmaceutical sciences, technologies and development at Parke‑Davis, a division of Warner Lambert Co., a pharmaceutical company, acquired by Pfizer Inc. in 2000. Prior to Parke‑Davis, Dr. Wierenga worked at Upjohn Co., later Pharmacia & Upjohn, Inc., a pharmaceutical and biotechnology company, for 16 years in various positions, most recently as Executive Director of discovery research. Pfizer acquired Pharmacia & Upjohn, then named Pharmacia Corp., in 2002. Dr. Wierenga has led or participated in the research and development of more than 70 Investigational New Drugs, over 15 New Drug Applications and 16 marketed products, including Lipitor, Neurontin, Lyrica, and Uceris. Dr. Wierenga received a B.S. from Hope College and a Ph.D. in chemistry from Stanford University.