PLYMOUTH (WWJ) — Esperion Therapeutics Inc., (Nasdaq: ESPR), the pharmaceutical company developing promising new cholesterol therapies, reported a big loss for 2013 — but continued promising clincal trial results.
The company said it initiated its first Phase 2b clinical study of its lead product candidate, called ETC-1002, in patients with high cholesterol levels and an intolerance to today’s statin drugs for reducing cholesterol.
The study is evaluating parallel doses of ETC-1002 in 322 patients for 12 weeks as monotherapy, or in combination with ezetimibe. The goals of this study are to compare the LDL-cholesterol lowering efficacy of ETC-1002 with ezetimibe and to demonstrate comparable tolerability to ezetimibe. Top-line results are expected in the fourth quarter of 2014.
The company is also expecting to start another study this month of ETC-1002 in addition to statin therapy, and expects results before June 30 of long-term chronic toxicity studies.
The company reported cash available of $77.6 million as of Dec. 31, up from $6.5 million a year earlier. Research and development expense was $7.3 million for the fourth quarter of 2013 and $16 million for the year ended Dec. 31, compared to $1.7 million and $8 million for the comparable periods in 2012. The increase in research and development expenses was largely driven by the advancement of the ETC-1002 program through Phase 2 development.
General and administrative expense was $2.4 million for the fourth quarter of 2013 and $6.7 million for the year ending Dec. 31, compared to $500,000 and $2.2 million for the comparable periods in 2012. The increase in general and administrative expenses was largely driven by incremental expenses to support public company operations, changes in headcount, which includes increased stock-based compensation expense, and other costs to support Esperion’s growth.
Net loss was $9.7 million for the fourth quarter of 2013 and $26.1 million for the year ended Dec. 31, compared to a net loss of $2.8 million for the fourth quarter of 2012 and $11.7 million for the year ended Dec. 31, 2012.
Esperion said it expects full-year 2014 net cash used in operating activities to be $35 million to $40 million and its cash and cash equivalents and investment securities to be approximately $40 to 45 million at Dec. 31, 2014. The Company believes that existing cash resources will fund the Company through at least the end of 2015.
To listen to a conference call discussing these results, visit http://investor.esperion.com/events.