| Basic Facts for Quarter Ending September 30, 2018 (In thousands, except share and market cap data) | ||||
| Q3-2018 | Q2-2018 | Q1-2018 | Q3-2017 | |
| Collaboration Revenue | $7,666 | $8,744 | $9,737 | $9,566 |
| R&D Expense | 9,664 | 10,737 | 12,081 | 11,165 |
| SG&A Expenses | 2,660 | 2,713 | 2,713 | 2,449 |
| Total Operating Expenses | 12,324 | 13,331 | 14,794 | 13,615 |
| (Loss) from Operations | (4,658) | (4,557) | (5,057) | (4,049) |
| Net Loss | (4,589) | (4,497) | (5,018) | (4,000) |
| Comprehensive (loss) | (4,560) | (4,426) | (5,053) | (4,000) |
| Basic & diluted (loss) per share | (0.15) | (0.15) | (0.17) | (0.13) |
| Avg. Shares Outstanding | 30,190 | 30,114 | 30,048 | 20,004 |
| Recent Price (per share) | $ 4.28 (11/1/18) | $ 4.04 (8/1/18) | $ 3.59 (5/4/18) | $ 4.51 (11/1/17) |
| Market Capitalization | 129M | 121M | 108M | 135M |
| Cash & Equivalents | 13,308 | 11,369 | 16,615 | 14,360 |
| Marketable Securities | 36,312 | 46,079 | 50,136 | 70,823 |
| Conatus Pharmaceuticals - Clinical Milestones | |
| ENCORE Trials – The ENCORE program supports the design of the Phase III program. Each Phase IIb trial explores a different indication. Robust results, however, may support an FDA or EMA filing. The first results arrive in the first half of 2018. | |
| ENCORE-PH – Portal Hypertension – Patients with severe portal hypertension (SPH) that were cleared of Hepatitis C (HCV-SVR) and have NASH cirrhosis. The primary endpoint is a reduction of HVPG(Hepatic Venous Pressure Gradient) after 6 months of treatment, which may later serve as a valid surrogate.Includes a 6-month continuation phase to monitor continuing liver decompensation. | |
| 240 NASH Cirrhotic, HCV-SVR, SPH Pts 5mg, 25mg, or 50mg 2x/day, 24 Wks Top-line Results | Q4-2018 |
| ENCORE-PH Extension 24-Wks Treatment Extension | Mid-2019 |
| ENCORE-NF – NASH Fibrosis - NASH patients with fibrosis, but not cirrhosis, are measured according to the NASH CRN Histological Scoring System. The primary endpoint involves a biopsy-based change in the fibrosis score after 72 weeks of treatment. Based on previous studies in HCV patients, Conatus management expects the 5 mg dose to be as effective as higher doses in fibrosis patients. The 50-mg dose is being positioned for patients with cirrhosis and the 5-mg dose for patients with fibrosis. | |
| 330 Nash Fibrotic Pts - 5mg or 50mg 2x/day, 72 Wks Top-line Results | 1H-2019 |
| ENCORE-LF – Liver Function – NASH Cirrhosis + Clinically Significant Portal Hypertension (CSPH) – Pts have compensated cirrhosis and portal hypertension, and will examine the long-term impact of treatment. The ongoing liver cirrhosis trial results will inform the design decisions (e.g. sample size). The endpoints include: MELDor CPTto measure mortality risk in patients with liver disease; biomarkers (e.g. bilirubin, albumin). Event-free survival serves as the primary endpoint. Analysis is conducted after a pre-specified number of events occur. These events include: all-cause mortality, new decompensation events, or a progression of ≥4 points in the MELD score | |
| 210 NASH Cirrhotic Pts w/ Portal Hypertension 5mg or 25mg 2x/day, 48+ Wks Top-line Results | Q3-2019 |
| Post-treatment Follow-up – Observational study for patients from POLT-HCV-SVR, ENCORE-NF, ENCORE-PH, and ENCORE-LF. Patients treated with placebo and emricasan will be followed to estimate the event rate for liver cancer, and to confirm safety. | |
| Final Results – About 800 patients will be enrolled. | 2021* |
| HCV Fibrosis Recurrence Post-Transplant (POLT-HCV-SVR) These patients have fibrosis in their transplanted liver after being cleared of a hepatitis C viral infection. A diverse range of patient severity with Ishak Fibrosis Scores ranging from F2 (early stage fibrosis) to F6 (cirrhosis). The primary endpoint is the change in the Ishak Fibrosis Score. Conatus received an orphan designation from the FDA. | |
| Phase IIb Efficacy (60 Pts) – 25mg 2x/day, 24 months Detailed Results | AASLD Nov. 9-13, 2018 |
| IDN-7314 – Like emricasan, this is also a pan-caspase inhibitor. As a liver treatment, it falls within the current Conatus-Novartis agreement. | |
| Primary Sclerosing Cholangitis(PSC) – The company recently received orphan designation from the EMA(European Union) and the FDA (United States). | |
| Preclinical Animal Models | Ongoing |
