Eleven Biotherapeutics Reports Fourth Quarter and Full Year 2015 Financial Results and Provides Strategic Update
"We continue to seek to create value by advancing our internal development programs and remain on target to make our planned submission of an investigational new drug application for EBI-031 during the second quarter of 2016," said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics. "We are sufficiently funded to continue operational activities as we engage in a careful, ongoing review of external strategic alternatives designed to maximize shareholder value."
Strategic Update and Recent Business Highlights:
- We are in the process of reviewing a range of strategic alternatives with the goal of maximizing shareholder value and are actively working with an investment bank in this process. Potential strategic alternatives to be explored and evaluated during the review process may include the sale of the Company, a strategic partnership with one or more parties, or the licensing, sale or divestiture of some of the Company's proprietary technologies. Pending any decision to undertake any strategic alternative, we are continuing our development activities in accordance with our existing business strategy while managing our cash position.
- Albumedix acquired Eleven's proprietary Supermin® albumin variant assets in an effort to enhance the systemic product profile of drugs. Eleven retains the right to the license of the technology for internal research.
- Reported top-line results from the Phase 3 clinical trial of isunakinra (EBI-005) for the treatment of severe allergic conjunctivitis. Isunakinra showed no statistically significant difference between the isunakinra treated group and the vehicle control group on any endpoints. Eleven does not see an immediate path forward for isunakinra.
March 2016, we prepaid all outstanding amounts owed to Silicon Valley Bank under a loan and security agreement.
John J. McCabe, CPA from Senior Vice President of Finance to Chief Financial Officer.
Fourth Quarter and Year-End 2015 Financial Results:
- Revenue: Revenue was $0.6 million for the three months ended December 31, 2015, compared to $0.4 million for the same period in 2014. Revenue was $1.0 million for the twelve months ended December 31, 2015, compared to $2.2 million for the same period in 2014.
- R&D Expenses: Research and development expenses were $8.1 million for the three months ended December 31, 2015, compared to $5.3 million for the same period in 2014. This increase was primarily due to higher EBI-031 related development expenses partially offset by decreases in isunakinra related development expenses. Research and development expenses were $26.3 million for the twelve months ended December 31, 2015, compared to $26.7 million for the same period in 2014.
- G&A Expenses: General and administrative expenses were $2.3 million for the three months ended December 31, 2015, compared to $2.2 million for the same period in 2014. General and administrative expenses were $9.9 million for the twelve months ended December 31, 2015, compared to $8.5 million for the same period in 2014.
- Net Loss: Net loss applicable to common stockholders was $10.3 million, or $0.53 per share, for the three months ended December 31, 2015, compared to net loss applicable to common stockholders of $8.1 million, or $0.49 per share, for the same period in 2014. Net loss applicable to common stockholders was $33.5 million, or $1.76 per share, for the twelve months ended December 31, 2015, compared to net loss applicable to common stockholders of $34.7 million, or $2.37 per share, for the same period in 2014.
Cash and Cash Equivalents: Cash and cash equivalents were $36.1
million as of December 31, 2015. We believe that our current cash and
cash equivalents, after giving effect to the
$14.9 millionprepayment to Silicon Valley Bank, will be sufficient to fund our operating expenses into the fourth quarter of 2016.
Upcoming Events and Presentations:
Association for Research in Vision and Ophthalmology(ARVO) annual meeting, in Seattle, May 1-5, 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 quarterly report on Form 10-Q
for the quarter ended
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
Three Months Ended
Twelve Months Ended
|Research and development||8,084||5,258||26,336||26,703|
|General and administrative||2,319||2,212||9,850||8,471|
|Total operating expenses||10,403||7,470||36,186||35,174|
|Loss from operations||(9,838||)||(7,095||)||(35,196||)||(32,931||)|
|Other income (expense), net||(491||)||(1,044||)||1,744||(1,225||)|
|Cumulative preferred stock dividends||-||-||-||(519||)|
|Net loss applicable to common stockholders||$||(10,329||)||$||(8,139||)||$||(33,452||)||$||(34,675||)|
|Net loss per share applicable to common stockholders—basic and|
|Weighted-average number of common shares used in net loss per|
|share applicable to common stockholders—basic and diluted||19,547||16,692||18,993||14,644|
|ELEVEN BIOTHRAPEUTICS, INC.|
|CONDENSED BALANCE SHEETS|
|Cash and cash equivalents||$||36,079||$||54,059|
|Prepaid expenses and other current assets||232||342|
|Total current assets||36,311||54,401|
|Property and equipment, net||407||486|
|Liabilities and stockholders' equity|
|Notes payable, current portion||4,134||251|
|Total current liabilities||7,580||5,202|
|Notes payable, net of current portion||9,763||9,749|
|Additional paid-in capital||144,126||128,558|
|Total stockholders' equity||18,944||36,826|
|Total liabilities and stockholders' equity||$||36,825||$||55,000|
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