Developing Innovative Therapeutics for People with Orphan Liver Disease

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1 Developing Innovative Therapeutics for People with Orphan Liver Disease PIPELINE PROGRESS AND FIRST QUARTER 2015 EARNINGS UPDATE NASDAQ: OCRX

2 Forward-Looking Statements Certain statements in this presentation constitute forward-looking statements within the meaning of the Securities Act of 1933, as amended (the Securities Act ), and Securities Exchange Act of 1934, as amended ( Exchange Act ), including, without limitation, all statements related to the OCR-002 clinical development program, including patient enrollment estimates, expected timing for the receipt of clinical data, the potential success of OCR-002 in clinical trials, as well as cash projections, and we intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Securities Act and the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control, including those risks and uncertainties discussed under Risk Factors in our Annual Report on form 10-K for the year ended December 31, 2014, as well as other risks detailed in our subsequent filings with the SEC. All information in this presentation is as of the date of this presentation, and we undertake no duty to update this information unless required by law. 2

3 When the liver fails, the brain fails. Professor Rajiv Jalan; University College London Blood Stream Hepatic Encephalopathy: Neurocognitive Disorder in Serious Liver Disease Personality Changes Disorientation Impaired Motor Skills Stupor Coma Death Ammonia Gut Elevated ammonia levels drive HE 3

4 Liver Disease Causes Hepatic Encephalopathy (HE) Alcohol Use Hepatitis Drug Exposure Autoimmune Diseases NASH / Fatty Liver 1 Million Liver Cirrhosis Diabetes Obesity ~500K At Risk for HE 8 Million Chronic Liver Disease in U.S. ~120K Hospitalized Annually with Acute HE 4

5 The Demons of the Disease Progressive, episodic disorder with high mortality rate Majority of affected individuals eventually lose independence; significant impact on quality of life for patients and families Advanced HE marked by delirium, overactive reflexes and coma 1 Hospitalized patients can be very sick, stuporous, intubated and unable to eat 1 Current trends in the treatment of hepatic encephalopathy. Al Sibae MR, McGuire BM. Journal of Therapeutics and Clinical Risk Management 2009;5(3):

6 STOP-HE Phase 2b Ocera Study: OCR-002 IV for Acute HE Efficacy RANDOMIZED DOUBLE-BLIND TRIAL HOSPITALIZED CIRRHOTICS Key Inclusion West Haven* Score 2 Ammonia >ULN Key Exclusion Kidney failure/dialysis Life expectancy < 2 weeks OCR g** per 24 hours + Standard of Care Placebo + Standard of Care ~230 patients ~90 U.S. and Europe sites Per protocol interim analysis PRIMARY ENDPOINT: Time to meaningful clinical improvement in encephalopathy symptoms Powered 80% to detect the difference at study-end that was observed at the planned interim analysis SECONDARY ENDPOINTS: Time to complete resolution of HE symptoms, ammonia reduction, length of hospital stay *As scored by a modified version of the West Haven Scale **May be adjusted to 15 or 10g based on degree of liver impairment to achieve comparable exposure levels 6

7 Meaningful Clinical Improvement = Event As Scored by Modified Version of West Haven Scale Stage / Symptoms Meaningful Clinical Improvement Mild Moderate Severe Comatose Stuporous Difficult to Arouse Disoriented Asterixis Mild Confusion --- Hospitalization to 2 or lower 3 to 2 or lower 2 to 1 or lower 0 Normal 7

8 Illustration of Time to Event Analysis INITIAL ASSUMPTIONS: Sample Size: 200 patients; n=100 per arm OCR-002 response rate at day 5 = 65% PBO response rate at day 5 = 45% 20% difference in response rates leads to approximately 2.5 day (60 hr) Response Rate % treatment benefit 2.5 days Days Control Test Test Median Control Median New sample size of ~230 very similar to original assumptions 8

9 STOP-HE Phase 2b Ocera Study: Enrollment ~90 Sites in U.S., Europe, Russia and Israel >70 patients enrolled to date >40 patients enrolled in first 4 months of 2015 Expect to complete enrollment target of ~230 patients in H

10 Significant Opportunity for IV and Oral OCR-002 IV ORAL ~175K Annual Hospitalizations 1 Potentially Favorable Reimbursement Sole Standard of Care $ MM $ MM Continuity of Care Following Treatment with IV Can be Combined with Rifaximin Protocol in Most Institutions ~120K Patients Annually 1 ~$1.5B U.S. Opportunity 1 Company estimates based on 2012 data Source: HCUP Database, Medicare ICD-9 Codes, Internal Modeling 10

11 OCR-002: Continuity of Care for HE Patients OCR-002 CANDIDATES Indication Commercial Rights Value IV Treatment of Hospitalized HE All Unmet Medical Need Optimal Formulation for Acute Patient Population ORAL Maintenance of Chronic HE Remission All Continuity of Care post IV Non-Antibiotic, Complementary to Rifaximin Objectives Standard of Care Only Ammonia Scavenger for HE (Treatment & Prevention) 11

12 Current Treatment of HE: Need for New Therapy Lactulose Standard of care in acute and chronic HE Laxative, indirectly reduces ammonia by flushing gut Difficult administration and diarrhea Poor patient compliance Rifaximin Non-absorbed antibiotic approved for prevention of HE Limited evidence of efficacy in acute care of hospitalized cirrhotic patients with HE 1 Does not directly clear circulating ammonia 1 Rifaximin vs Conventional Oral Therapy for Hepatic Encephalopathy: a Meta-analysis Eltawil, et al. World J of Gastroenterology,

13 Financial Results Q Cash balance at March 31, $46.1 million Net cash utilization for 2015 expected to be $28-$32 million Existing cash resources fund operations to Q4-16 Q1-15 Net Loss - $6.7 million 13

14 Building a Liver Disease Medicines Company Differentiated Product Candidate: OCR-002 Therapeutics for Hepatic Encephalopathy (HE) IV and oral formulations Targeting $1.5B U.S. opportunity Strong patent coverage; worldwide rights retained Multiple Catalysts in 2015 STOP-HE Phase 2b positive interim analysis Confirmed ammonia lowering signal in upper GI-bleed IST Completion of Acute Liver Failure (ALF) IST OCR-002 Oral Phase 1 study initiation Strong Balance Sheet Funds to complete enrollment of STOP-HE and initiate Phase 1 oral program Rev

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