Press Release<< Back
Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Third Quarter 2015 Financial Results
"Our team remains focused and eager to advance the ETC-1002 development program into Phase 3 before year-end with the launch of our long-term safety study," said
Development Program and Company Highlights
July 28, 2015: Announced positive top-line results from the Phase 2 ETC-1002-014 clinical study in patients with both hypercholesterolemia and hypertension. July 30, 2015: Hosted Second Annual Investor Day in New York City.
- Early August: Held End-of-Phase 2 meeting with the
- Late September: Announced updates from the final End-of-Phase 2 meeting minutes.
November 9, 2015: Two oral presentations at the American Heart Association(AHA) Scientific Sessions in Orlando FL:
- "Identification of a Tissue Specific Very Long Chain Acyl-CoA Synthetase Involved in the Inhibition of ATP-Citrate Lyase (ACL) by ETC-1002: A Novel Mechanism for Cholesterol Biosynthesis Inhibition in the Liver," presented by
Stephen Pinkosky, Sr.Scientist, Head of Translational Research, Esperion Therapeutics, at 11:45amin Room W303;
- "ETC-1002 Incrementally Lowers Low Density Lipoprotein Cholesterol in Patients with Hypercholesterolemia Receiving Stable Statin Therapy," presented by
Christie BallantyneMD, Baylor College of Medicine, at 6:30pmin Room W205. November 10, 2015: Presentation and webcast of full results of the Phase 2b ETC-1002-009 clinical study and new data on ATP Citrate Lyase inhibition, the mechanism of action of LDL-C lowering for ETC-1002. December 2015:
- Initiation of the Phase 2 ETC-1002-035 clinical study evaluating ETC-1002 in combination with high-dose statins (HDS);
- Initiation of the Phase 3 ETC-1002-040 long-term safety study evaluating ETC-1002 compared to placebo in patients on background statin therapy.
- 1H 2016:
- File Investigational New Drug Application (IND) for the fixed dose combination of ETC-1002 and ezetimibe;
- Announce Phase 3 worldwide development plans for ETC-1002.
- Announce top-line results from the Phase 2 ETC-1002-035 clinical study evaluating ETC-1002 in combination with high-dose statins (HDS);
- Initiation of the Phase 3 efficacy study of ETC-1002 in patients with statin intolerance.
- 2H 2016:
- Initiation of the Phase 3 cardiovascular outcomes study for ETC-1002.
2015 Third Quarter Financial Results
Research and development expenses were
General and administrative expenses were
Esperion had a net loss of
Esperion had approximately 22.5 million shares of common stock outstanding, with an additional 2.9 million shares issuable upon exercise of stock options and warrants and vesting of restricted stock, and
2015 Financial Outlook
Esperion expects that the net cash used to fund operating activities in 2015 will be approximately
Conference Call and Webcast Information
Esperion's management team will not host a conference call to review financial results from the third quarter ended
Esperion's Commitment to Cardiometabolic Disease
Esperion is committed to improving the lives of patients with hypercholesterolemia by developing therapies to lower LDL-C. Esperion scientists discovered ETC-1002 and the LDL-C lowering therapy is in late stage development. Esperion plans to develop both ETC-1002 and a fixed dose combination of ETC-1002 and ezetimibe with a particular focus on patients with hypercholesterolemia who are considered intolerant of statin therapy. It is estimated that approximately 10% of patients who are prescribed statins, 3.5 million patients in the U.S., are considered statin intolerant.
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential of, and clinical development plan for, ETC-1002 and the fixed-dose combination of ETC-1002 and ezetimibe. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, the risk that
|Balance Sheet Data|
|Cash and cash equivalents||$||80,824||$||85,038|
|Total long-term debt||3,084||4,231|
|Total stockholders' equity||296,482||133,554|
|Statement of Operations|
|(In thousands, except share and per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||7,247||$||7,174||$||21,846||$||19,102|
|General and administrative||5,672||2,526||14,960||7,742|
|Total operating expenses||12,919||9,700||36,806||26,844|
|Loss from operations||(12,919||)||(9,700||)||(36,806||)||(26,844||)|
|Other income, net||248||29||543||62|
|Net loss per common share (basic and diluted)||$||(0.57||)||$||(0.64||)||$||(1.68||)||$||(1.75||)|
|Weighted average shares outstanding (basic and diluted)||22,494,075||15,432,641||21,854,685||15,397,745|
News Provided by Acquire Media