Conatus Pharmaceuticals Reports First Quarter 2019 Financial Results and Program Updates
The company is currently conducting two double-blind, placebo-controlled Phase 2b clinical trials in collaboration with
- The ENCORE-LF (for Liver Function) clinical trial, initiated in the second quarter of 2017, has enrolled approximately 210 patients with stable decompensated NASH cirrhosis. The primary endpoint is event-free survival, which is a composite of all-cause mortality, new decompensation events, or ≥4 points progression in Model for End-stage Liver Disease (MELD) score. Enrollment was completed in the first quarter of 2019. Top-line results triggered by reaching a prespecified number of events are expected in mid-2019.
- The ENCORE-PH (for Portal Hypertension) clinical trial, initiated in the fourth quarter of 2016, enrolled 263 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension. The trial’s primary endpoint was change in mean hepatic venous pressure gradient (HVPG) from baseline to Week 24 in any of three emricasan dosing groups compared with placebo. Top-line results were reported in
December 2018showing HVPG trends consistently favoring emricasan compared with placebo in the overall population but not meeting the primary endpoint. The greatest improvement was observed in patients with a baseline HVPG of 16 mmHg or higher.
Week 24 results from the ENCORE-PH clinical trial were detailed in a late-breaker oral presentation at The International Liver Congress™ 2019, the Annual Meeting of the
European Association for the Study of the Liver(EASL) in Vienna, Austria, on April 13, 2019. The associated abstract was also selected by EASL for inclusion in the “Best of ILC” summary slide deck highlighting the most noteworthy contributions to the scientific program at this year’s meeting. A copy of the presentation is available in the Investors section of the Conatus website at www.conatuspharma.com.
Patients had the option to continue on their assigned doses of treatment or placebo in a double-blind 24-week extension period. Results following the extension period are expected in mid-2019 and will include longer term safety, liver function and clinical outcomes, but there will be no additional HVPG measurements.
During the first quarter of 2019, the company announced top-line results from a third double-blind, placebo-controlled Phase 2b clinical trial, the ENCORE-NF (for NASH Fibrosis) clinical trial in patients with biopsy-confirmed NASH and liver fibrosis. The trial’s primary endpoint was a ≥1 CRN fibrosis stage improvement with no worsening of steatohepatitis compared with placebo at week 72. The trial did not meet the primary endpoint.
The company announced in
The net loss was
Total revenues were
Research and development expenses were
General and administrative expenses were
Cash, cash equivalents and marketable securities were
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat chronic diseases with significant unmet need. In collaboration with
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward looking statements, including statements regarding: the timelines to announce results from the ENCORE clinical trials; the plan and timeline to begin an initial clinical trial of CTS-2090; the initial clinical targets for CTS-2090; and the projected year-end cash balance. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continues” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including: Conatus’ ability to successfully complete its ongoing and planned clinical trials;
|Conatus Pharmaceuticals Inc.|
|Selected Condensed Financial Information|
|(In thousands, except per share data)|
|Three Months Ended|
|Statements of Operations||March 31,|
|Research and development||9,383||12,081|
|General and administrative||2,591||2,713|
|Total operating expenses||11,974||14,794|
|Loss from operations||(4,950||)||(5,057||)|
|Net loss per share, basic and diluted||$||(0.14||)||$||(0.17||)|
|Weighted average shares outstanding used in computing|
|net loss per share, basic and diluted||33,165||30,048|
|March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||33,833||$||40,692|
|Prepaid and other current assets||2,633||3,057|
|Total current assets||40,326||47,426|
|Property and equipment, net||145||154|
|Liabilities and stockholders' equity|
|Accounts payable and other current liabilities||$||8,625||$||8,446|
|Current portion of deferred revenue||8,150||10,075|
|Total current liabilities||16,775||18,521|
|Deferred revenue, less current portion||1,576||2,815|
|Other long-term liabilities||229||68|
|Total liabilities and stockholders' equity||$||42,178||$||48,803|
Source: Conatus Pharmaceuticals Inc.