Eleven Biotherapeutics Reports Second Quarter 2014 Financial Results
Management to host conference call today at
"We made significant progress advancing our clinical pipeline of novel
therapeutics for ocular disease this quarter, including EBI-005, our
lead product candidate in development as one of the first topically
administered proteins for the treatment of inflammatory ocular surface
disease," said
Pipeline Highlights:
- Remain on track to report top-line data for our proof of concept Phase 2 clinical trial of EBI-005 in allergic conjunctivitis in the fourth quarter of 2014.
- On track to report top-line Phase 3 clinical data for EBI-005 in dry eye disease in early 2015.
- Continue to make progress advancing development of EBI-029 for back of the eye disease, including diabetic macular edema.
Second Quarter 2014 Financial Results
-
Revenues: Revenues were
$0.8 million for the three months endedJune 30, 2014 , compared to$0.2 million for the same period in 2013. This increase was primarily due to revenue recognized from the ThromboGenics collaboration which began inMay 2013 . -
R&D Expenses: Research and development expenses were
$6.8 million for the three months endedJune 30, 2014 compared to$2.7 million for the same period in 2013. This increase was primarily due to EBI-005 related development expenses. -
G&A Expenses: General and administrative expenses were
$2.1 million for the three months endedJune 30, 2014 , compared to$0.9 million for the same period in 2013. This increase was primarily due to increased operating costs related to operating as a public company sinceFebruary 2013 and increased stock-based compensation expense. -
Operating Loss: Net loss applicable to common stockholders was
$8.1 million , or$0.51 per share, for the three months endedJune 30, 2014 , compared to net loss applicable to common stockholders of$4.6 million , or$3.44 per share, for the same period in 2013. -
Cash and Cash Equivalents: Cash and cash equivalents were
$45.0 million as ofJune 30, 2014 . We believe that our cash and cash equivalents as ofJune 30, 2014 will enable us to fund our operating expenses, debt service obligations and capital expenditure requirements into the first quarter of 2016.
Upcoming Events and Presentations:
-
Citi 9th Annual
Biotech Conference inBoston onThursday, September 4, 2014
Conference Call Information:
Eleven Biotherapeutics' management team will host a conference call and
audio webcast today at
An audio webcast of the call will also be available on the Investors & Media section of the Company's website www.elevenbio.com. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.
About EBI-005
Eleven Biotherapeutics' most advanced product candidate is EBI-005,
which was designed, engineered and generated using the Company's AMP-Rx
platform and is being developed as a topical treatment for dry eye
disease and allergic conjunctivitis. In 2013,
About
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
therapeutic candidates, including expectations regarding timing of
initiation of clinical trials, patient enrollment and availability of
results, regulatory requirements for initiation of clinical trials and
registration of product candidates, sufficiency of 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 ongoing clinical
trials, whether results of early clinical trials will be indicative of
the results of future trials, 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 filed with the
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CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||||||||||||||||||||||||
(unaudited) | |||||||||||||||||||||||||||||||||||||
(in thousands, except per share data) | |||||||||||||||||||||||||||||||||||||
(in thousands, except per share data) |
Three Months Ended |
Six Months Ended |
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2014 |
2013 |
2014 |
2013 |
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Collaboration revenue | $ | 761 | $ | 202 | $ | 1,329 | $ | 202 | |||||||||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||||||||||||
Research and development | 6,754 | 2,704 | 12,573 | 7,200 | |||||||||||||||||||||||||||||||||
General and administrative | 2,052 | 881 | 3,990 | 1,820 | |||||||||||||||||||||||||||||||||
Total operating expenses | 8,806 | 3,585 | 16,563 | 9,020 | |||||||||||||||||||||||||||||||||
Loss from operations | (8,045 | ) | (3,383 | ) | (15,234 | ) | (8,818 | ) | |||||||||||||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||||||||||||||||
Other income, net | 3 | (114 | ) | 54 | (112 | ) | |||||||||||||||||||||||||||||||
Interest expense, net | (79 | ) | (137 | ) | (163 | ) | (216 | ) | |||||||||||||||||||||||||||||
Total other expense | (76 | ) | (251 | ) | (109 | ) | (328 | ) | |||||||||||||||||||||||||||||
Net loss and comprehensive loss | $ | (8,121 | ) | $ | (3,634 | ) | $ | (15,343 | ) | $ | (9,146 | ) | |||||||||||||||||||||||||
Cumulative preferred stock dividends | - | (917 | ) | (519 | ) | (1,810 | ) | ||||||||||||||||||||||||||||||
Net loss applicable to common stockholders | $ | (8,121 | ) | $ | (4,551 | ) | $ | (15,862 | ) | $ | (10,956 | ) | |||||||||||||||||||||||||
Net loss per share applicable to common stockholders—basic and | |||||||||||||||||||||||||||||||||||||
diluted | $ | (0.51 | ) | $ | (3.44 | ) | $ | (1.23 | ) | $ | (8.53 | ) | |||||||||||||||||||||||||
Weighted-average number of common shares used in net loss per | |||||||||||||||||||||||||||||||||||||
share applicable to common stockholders—basic and diluted | 16,055 | 1,322 | 12,863 | 1,285 | |||||||||||||||||||||||||||||||||
ELEVEN BIOTHRAPEUTICS, INC. | ||||||||||||||||||||||||
CONDENSED BALANCE SHEETS | ||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||||
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2014 | 2013 | |||||||||||||||||||||||
Assets | ||||||||||||||||||||||||
Current assets: | ||||||||||||||||||||||||
Cash and cash equivalents | $ | 45,031 | $ | 7,942 | ||||||||||||||||||||
Prepaid expenses and other current assets | 1,002 | 88 | ||||||||||||||||||||||
Total current assets | 46,033 | 8,030 | ||||||||||||||||||||||
Property and equipment, net | 682 | 759 | ||||||||||||||||||||||
Restricted cash | 94 | 94 | ||||||||||||||||||||||
Other assets | 15 | 2,354 | ||||||||||||||||||||||
Total assets | $ | 46,824 | $ | 11,237 | ||||||||||||||||||||
Liabilities, convertible preferred stock, and stockholders' equity (deficit) | ||||||||||||||||||||||||
Current liabilities: | ||||||||||||||||||||||||
Accounts payable | $ | 2,602 | $ | 1,746 | ||||||||||||||||||||
Accrued expenses | 1,140 | 850 | ||||||||||||||||||||||
Notes payable, current portion | 1,642 | 1,642 | ||||||||||||||||||||||
Deferred revenue, current portion | 643 | 1,115 | ||||||||||||||||||||||
Total current liabilities | 6,027 | 5,353 | ||||||||||||||||||||||
Deferred revenue, net of current portion | 112 | 355 | ||||||||||||||||||||||
Restricted stock liability | 7 | 10 | ||||||||||||||||||||||
Notes payable, net of current portion | 2,055 | 2,876 | ||||||||||||||||||||||
Warrant liability | - | 297 | ||||||||||||||||||||||
Series A convertible preferred stock | - | 45,035 | ||||||||||||||||||||||
Series B convertible preferred stock | - | 11,643 | ||||||||||||||||||||||
Stockholders' equity (deficit): | ||||||||||||||||||||||||
Preferred stock | - | - | ||||||||||||||||||||||
Common stock | 16 | 2 | ||||||||||||||||||||||
Additional paid-in capital | 111,544 | 3,260 | ||||||||||||||||||||||
Accumulated deficit | (72,937 | ) | (57,594 | ) | ||||||||||||||||||||
Total stockholders' equity (deficit) | 38,623 | (54,332 | ) | |||||||||||||||||||||
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 46,824 | $ | 11,237 | ||||||||||||||||||||
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