Eleven Biotherapeutics Reports First Quarter 2016 Financial Results
"We remain on target to make our planned submission of an investigational new drug application for EBI-031 for the treatment of diabetic macular edema this quarter," said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics. "In addition, we were pleased to have several opportunities to showcase our data at this week's ARVO Annual Meeting. We also continue to evaluate strategic alternatives, as previously communicated, with a goal to maximize shareholder value."
Recent Business Highlights:
Presenting one oral presentation on EBI-031 today and three posters on
isunakinra at the
Association for Research in Vision and Ophthalmology(ARVO) 2016 Annual Meeting taking place May 1 to 5, 2016in Seattle.
- The EBI-031 presentation will discuss the findings from a non-human primate study, including intravitreal half-life of 5 days, systemic half-life of 0.85 days, immune response, in vitro potency, and the appropriate species to use in IND-enabling, non-human primate toxicology studies.
Isunakinra posters showed results in an environmental study in
patients with moderate to severe allergic conjunctivitis as well
as efficacy and safety data from a study with patients with
moderate to severe dry eye disease. Top-line results from these
two Phase 3 clinical trials had been previously reported in
January 2016and May 2015, respectively. A post-hoc analysis identified a subset of subjects known to be high interleukin-1 (IL-1) producers identified by genotyping that showed an increased response to treatment with isunakinra compared with vehicle in both allergic conjunctivitis and dry eye disease. Interleukin-1 is a cytokine known to play a central role in the regulation of immune and inflammatory responses. As previously reported, Eleven does not plan to pursue further development of isunakinra.
First Quarter 2016 Financial Results:
- Revenue: Revenue was $0.2 million for the three months ended March 31, 2016, compared to $0.2 million for the same period in 2015.
- R&D Expenses: Research and development expenses were $4.6 million for the three months ended March 31, 2016, compared to $5.2 million for the same period in 2015. This decrease was primarily due to lower isunakinra related development expenses partially offset by higher EBI-031 related development expenses.
- G&A Expenses: General and administrative expenses were $2.1 million for the three months ended March 31, 2016, compared to $2.6 million for the same period in 2015.
Net Loss: Net loss applicable to common stockholders was $7.6
million, or $0.39 per share, for the three months ended March 31,
2016, compared to net loss applicable to common stockholders of $6.5
million, or $0.36 per share, for the same period in 2015. Net loss
applicable to common stockholders for the three months ended
March 31, 2016includes $0.9 millionassociated with the extinguishment of debt.
Cash and Cash Equivalents: Cash and cash equivalents were $13.4
million as of March 31, 2016. On
March 1, 2016, we prepaid all outstanding amounts owed to Silicon Valley Bank with existing cash on hand and terminated our loan agreement. We believe that our current cash and cash equivalents will be sufficient to fund our operating expenses into the fourth quarter of 2016.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the Company's
strategy, future operations, advancement or maturation of its product
candidates and product pipeline, clinical development of the Company's
product candidates, including expectations regarding timing of
regulatory submissions and initiation of clinical trials, regulatory
requirements for initiation of clinical trials and registration of
product candidates, the review of its strategic alternatives and the
outcome of such review, the sufficiency of its cash resources and other
statements containing the words "anticipate," "believe," "estimate,"
"expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and similar
expressions, constitute forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
uncertainties inherent in the initiation and conduct of clinical trials,
availability and timing of data from clinical trials, whether results of
early clinical trials or preclinical studies will be indicative of the
results of future trials, the adequacy of any clinical models,
uncertainties associated with regulatory review of clinical trials and
applications for marketing approvals and other factors discussed in the
"Risk Factors" section of the Company's annual report on Form 10-K for
the year ended
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED BALANCE SHEETS
|Cash and cash equivalents||$||13,419||$||36,079|
|Prepaid expenses and other current assets||387||232|
|Total current assets||13,806||36,311|
|Property and equipment, net||353||407|
|Liabilities and stockholders' equity|
|Notes payable, current portion||-||4,134|
|Total current liabilities||2,282||7,580|
|Notes payable, net of current portion||-||9,763|
|Additional paid-in capital||144,726||144,126|
|Total stockholders' equity||11,970||18,944|
|Total liabilities and stockholders' equity||$||14,333||$||36,825|
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months Ended
|Research and development||4,632||5,238|
|General and administrative||2,147||2,603|
Total operating expenses
|Loss from operations||(6,550||)||(7,597||)|
|Other (expense) income, net||(1,024||)||1,073|
Net loss per share applicable to common stockholders—basic and diluted
Weighted-average number of common shares used in net loss per share
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