Eleven Biotherapeutics Reports Third Quarter 2014 Financial Results
Management to host conference call today at
"We have made good progress advancing our lead product candidate,
EBI-005, since the second quarter of this year. We are encouraged by the
Phase 2 top-line safety and efficacy results for EBI-005 in patients
with moderate to severe allergic conjunctivitis, as we believe these
data further validate EBI-005 as a clinically active anti-inflammatory
ocular agent," said
Recent Business Highlights:
- Reported top-line results from our proof of concept Phase 2 clinical trial of EBI-005 in patients with moderate to severe allergic conjunctivitis where we compared two models of the disease. In a modified CAPT (conjunctival allergen provocation test) model, patients treated with EBI-005 showed statistically significant improvements in a number of clinically meaningful symptoms that were secondary and exploratory endpoints in this trial, including reduction of ocular itching, nasal symptoms and tearing. Importantly, EBI-005 was generally well-tolerated, with no treatment-related serious adverse events and no drug-specific antibodies detected. This Phase 2 study did not meet the primary endpoint of reduction in mean ocular itching in patients treated with EBI-005 compared to vehicle-control in a modified environmental exposure chamber model. These data will help us to determine our path forward with EBI-005 as a potential new treatment option for patients with moderate to severe allergic conjunctivitis.
- Completed patient enrollment in the OASIS study (A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Control in Subjects with Moderate to Severe Dry Eye Disease), our first pivotal Phase 3 clinical study for EBI-005 in patients with dry eye disease. Over half of the subjects have completed the study, and we expect to report top-line results in the second quarter of 2015.
- Granted a U.S. patent for EBI-005 which contains both composition-of-matter and methods of use claims, which expires in 2031.
Appointed industry veteran
Wendy L. Dixon, PhD, former Chief Marketing Officer and President of Global Marketing for Bristol Myers Squibb, to our Board of Directors.
Third Quarter 2014 Financial Results
Revenue: Revenue was
$0.5 millionfor the three months ended September 30, 2014, compared to $0.6 millionfor the same period in 2013.
R&D Expenses: Research and development expenses were
$8.9 millionfor the three months ended September 30, 2014compared to $3.4 millionfor the same period in 2013. This increase was primarily due to EBI-005 related development expenses.
G&A Expenses: General and administrative expenses were
$2.3 millionfor the three months ended September 30, 2014, compared to $0.8 millionfor the same period in 2013. This increase was primarily due to increased operating costs related to operating as a public company since February 2014and increased stock-based compensation expense.
Net Loss: Net loss applicable to common stockholders was
$10.7 million, or $0.66per share, for the three months ended September 30, 2014, compared to net loss applicable to common stockholders of $4.7 million, or $3.39per share, for the same period in 2013.
Cash and Cash Equivalents: Cash and cash equivalents were
$35.9 millionas of September 30, 2014. We believe that our cash and cash equivalents as of September 30, 2014will enable us to fund our operating expenses, debt service obligations and capital expenditure requirements into the first quarter of 2016.
Upcoming Events and Presentations:
Medical Contact Lens and Ocular Surface Association's 21st Annual
Scientific Meeting in
Londonon Friday, November 28, 2014
Oppenheimer 25th Annual Healthcare Conference in
New Yorkon December 11, 2014at 10:55 a.m. ET
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.
Eleven Biotherapeutics' most advanced product candidate is EBI-005, a novel, topically-administered interleukin-1 (IL-1) receptor blocker in development as a protein therapeutic for dry eye disease and allergic conjunctivitis. The EBI-005 program is based on the role that elevated levels of the inflammatory cytokine IL-1 play in the initiation and maintenance of the inflammation and pain associated with dry eye disease and the itching and other symptoms associated with allergic conjunctivitis. EBI-005 has been evaluated in a Phase 2 study in patients with moderate to severe allergic conjunctivitis and is currently being evaluated in a pivotal Phase 3 study in dry eye disease.
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, 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 filed with the Securities and Exchange Commission on August 13, 2014 and other reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
Three Months Ended
Nine Months Ended
|Research and development||8,872||3,376||21,445||10,576|
|General and administrative||2,269||786||6,259||2,606|
|Total operating expenses||11,141||4,162||27,704||13,182|
|Loss from operations||(10,602||)||(3,540||)||(25,836||)||(12,358||)|
|Other income (expense):|
|Other income, net||2||16||56||(96||)|
|Interest expense, net||(74||)||(289||)||(237||)||(505||)|
|Total other expense||(72||)||(273||)||(181||)||(601||)|
|Cumulative preferred stock dividends||-||(905||)||(519||)||(2,715||)|
|Net loss applicable to common stockholders||$||(10,674||)||$||(4,718||)||$||(26,536||)||$||(15,674||)|
|Net loss per share applicable to common stockholders—basic and|
|Weighted-average number of common shares used in net loss per|
|share applicable to common stockholders—basic and diluted||16,098||1,390||13,954||1,320|
|ELEVEN BIOTHRAPEUTICS, INC.|
|CONDENSED BALANCE SHEETS|
|Cash and cash equivalents||$||35,943||$||7,942|
|Prepaid expenses and other current assets||348||88|
|Total current assets||36,291||8,030|
|Property and equipment, net||585||759|
|Liabilities, convertible preferred stock, and stockholders' equity (deficit)|
|Notes payable, current portion||1,642||1,642|
|Deferred revenue, current portion||621||1,115|
|Total current liabilities||6,507||5,353|
|Deferred revenue, net of current portion||45||355|
|Restricted stock liability||6||10|
|Notes payable, net of current portion||1,645||2,876|
|Series A convertible preferred stock||-||45,035|
|Series B convertible preferred stock||-||11,643|
|Stockholders' equity (deficit):|
|Additional paid-in capital||112,373||3,260|
|Total stockholders' equity (deficit)||28,778||(54,332||)|
|Total liabilities, convertible preferred stock and stockholders' equity (deficit)||$||36,981||$||11,237|
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