ANN ARBOR — Esperion Therapeutics Inc. (Nasdaq: ESPR), the Ann Arbor pharmaceutical startup working on a new class of cholesterol-cutting drugs, said it lost $17.4 million or 77 cents a share in the third quarter ended Sept. 30, vs. a loss of $12.8 million or 57 cents a share in the year-earlier period.
The company does not yet have revenue.
For the nine months, the loss was $46 million or $2.04 a share, compared to $36.7 million or $1.68 a share in the first nine months of 2015.
Last month, the company reported positive results in its Phase 1 and Phase 2 clinical studies of its lead drug candidate, bempedoic acid (ETC-1002), in combination iwth high-dose statins. It also amended and expanded a Phase 3 study to include 1,950 patients.
“With the delivery of positive top-line results from the clinical studies of bempedoic acid in combination with high-dose statins, we will enroll patients with hypercholesterolemia on maximally tolerated lipid-modifying therapy, including patients on any statin at any dose, into our global pivotal Phase 3 program,” said Tim Mayleben, president and CEO, in a statement. “While we continue to rapidly enroll patients into the global long-term safety study, we look forward to initiating the global pivotal Phase 3 LDL-C lowering efficacy studies and cardiovascular outcomes trial for bempedoic acid before year-end. With our available cash resources, we remain focused on delivering top-line results from our Phase 3 efficacy and long-term safety studies by mid-2018.”
The company said its Phase 3 studies are expected to support global regulatory submissions for the drug, with a special focus on those for whom statin drugs have bad side effects. Bempedoic acid reduces cholesterol biosynthesis and lowers elevated levels of LDL-C, but with reduced potential for muscle-related side effects.
In Phase 1 trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase 2 trials, the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. And in Phase 3, the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
As of Sept. 30, the company had $259.7 million in cash and securities available for sale on hand, down from $292.6 million as of Dec. 31, 2015. Research and development expenses were $13.5 million for the third quarter and $33 million for the nine months ended Sept. 30, compared to $7.2 million and $21.8 million for the same periods in 2015. General and administrative expenses were $4.2 million for the third quarter and $13.9 million for the nine months ended Sept. 30, down from $5.7 million and $15 million for the comparable periods in 2015. The decrease in general and administrative expenses was primarily related to a reduction in pre-commercialization activities, partially offset by increases in costs to support public company operations, increases in the company’s headcount, and other costs to support Esperion’s growth.
Esperion expects full-year net cash used in operating activities in 2016 of $65 million and that its cash and cash equivalents and investment securities to be approximately $225 million at Dec. 31. The company said current cash resources are sufficient to fund operations into early 2019.
More at www.esperion.com.