Conatus Pharmaceuticals Reports 2018 Financial Results and Program Updates
The company is conducting three double-blind, placebo-controlled Phase 2b clinical trials in collaboration with
- The ENCORE-NF (for NASH Fibrosis) clinical trial, initiated in the first quarter of 2016, has enrolled approximately 330 patients with baseline NASH Clinical Research Network (CRN) fibrosis scores of F1 (up to 20% of enrolled patients), F2, and F3. The primary endpoint is a biopsy-based one point or greater improvement in NASH CRN fibrosis score compared with placebo at week 72, with no worsening of steatohepatitis. The primary endpoint will be evaluated and can be achieved in either of two prospectively defined patient populations – the F1/F2/F3 population or the F2/F3 population. Either of these populations may be used in a future Phase 3 trial. The company believes that the ENCORE-NF analysis plan has the potential to facilitate discussions with regulatory authorities regarding its use as a study to support regulatory approval. Top-line results from ENCORE-NF are expected in the first half of 2019.
- 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. Post hoc analyses showed clinically meaningful treatment effects for emricasan compared with placebo and a trend toward clinical benefit in the prespecified subpopulation of compensated patients, with the greatest improvement in compensated patients with baseline HVPG ≥16 mmHg. Patients had the option to continue on their assigned doses of treatment or placebo in a double-blind 24-week extension period to evaluate longer term safety, liver function and clinical outcomes. Results following the extension period are expected in mid-2019.
In its internal development program, the company has assembled a proprietary portfolio of orally active molecules that inhibit the NLRP3 inflammasome pathway and the activation of the potent inflammatory cytokine IL-1b. Inhibition of IL-1b is a clinically validated approach to treating inflammatory diseases, with several injectable biologic products using that mechanism of action already on the market. The NLRP3 inflammasome pathway is dependent upon caspase 1, which activates IL-1b. Caspase 1 occupies a uniquely central position in the inflammasome pathway, and the company has leveraged its scientific expertise in caspase research and development to design potent, selective and orally bioavailable inhibitors of caspase 1. Excess IL-1b has been linked to a variety of diseases including rare genetic inflammatory diseases, cancer, liver and other gastrointestinal diseases, and cardiovascular diseases.
The company is announcing today the selection of its first internally developed product candidate, CTS-2090, based on its preclinical profile, including high selectivity for caspase 1, and drug-like properties. CTS-2090 is currently in preclinical development and IND-enabling studies, with an initial clinical trial expected to begin by the first half of 2020. Additional details will be discussed in the conference call and webcast scheduled for
The net loss for the fourth quarter of 2018 was
Total revenues were
Research and development expenses were
General and administrative expenses were
Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at
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 expectation and timeline to begin an initial clinical trial of CTS-2090; the projected year-end cash balance; emricasan’s potential as a treatment for NASH-driven chronic liver diseases; and CTS-2090’s potential as a treatment for chronic diseases involving inflammasome pathways. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” 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||Twelve Months Ended|
|Statements of Operations||December 31,||December 31,|
|Research and development||8,886||10,911||41,368||43,220|
|General and administrative||2,528||2,301||10,495||9,707|
|Total operating expenses||11,414||13,212||51,863||52,927|
|Loss from operations||(4,005||)||(4,407||)||(18,277||)||(17,550||)|
|Net loss per share, basic and diluted||$||(0.13||)||$||(0.15||)||$||(0.59||)||$||(0.61||)|
|Weighted average shares outstanding used in computing|
|net loss per share, basic and diluted||31,118||30,018||30,370||28,587|
|Cash, cash equivalents and marketable securities||$||40,692||$||74,853|
|Prepaid and other current assets||3,057||1,004|
|Total current assets||47,426||79,224|
|Property and equipment, net||154||179|
|Liabilities and stockholders' equity|
|Accounts payable and other accrued expenses||$||8,446||$||13,970|
|Current portion of deferred revenue||10,075||14,172|
|Total current liabilities||18,521||28,142|
|Deferred revenue, less current portion||2,815||12,519|
|Convertible note payable||-||13,158|
|Total liabilities and stockholders' equity||$||48,803||$||81,941|
Source: Conatus Pharmaceuticals Inc.