Eleven Biotherapeutics
May 5, 2016
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Eleven Biotherapeutics Reports First Quarter 2016 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today reported financial results for the first quarter ended March 31, 2016 and provided a review of recent business highlights.

"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:

First Quarter 2016 Financial Results:

About EBI-031

Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was designed and engineered for intravitreal delivery using Eleven's AMP-Rx platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R) and has demonstrated a longer vitreal retention time in preclinical models than antibodies and antibody like molecules approved for intravitreal injection. Eleven is undertaking the necessary manufacturing development work and nonclinical safety studies to support the submission of an investigational new drug application, or IND, to the FDA in the first half of 2016 for the purpose of conducting clinical trials of EBI-031 in DME and uveitis.

About Eleven Biotherapeutics

Eleven Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. Eleven's therapeutic approach is based on the role of cytokines in diseases of the eye, the Company's understanding of the structural biology of cytokines and the Company's ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects. For more information please refer to the Company's website www.elevenbio.com.

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 December 31, 2015 as filed with the Securities and Exchange Commission 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.

 
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands)
       
March 31,
2016
December 31,
2015
 
Assets
Current assets:
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
Restricted cash 174 94
Other assets   -     13  
 
Total assets $ 14,333   $ 36,825  
 
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 1,588 $ 1,246
Accrued expenses 491 1,794
Notes payable, current portion - 4,134
Deferred revenue   203     406  
Total current liabilities 2,282 7,580
Other liabilities 81 423
Notes payable, net of current portion - 9,763
Warrant liability - 115
 
Stockholders' equity:
Common stock 20 20
Additional paid-in capital 144,726 144,126
Accumulated deficit   (132,776 )   (125,202 )
Total stockholders' equity   11,970     18,944  
 
Total liabilities and stockholders' equity $ 14,333   $ 36,825  
 
 
ELEVEN BIOTHERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
       
 
Three Months Ended March 31,

2016

2015

 

Total revenue $ 229 $ 244
Operating expenses:
Research and development 4,632 5,238
General and administrative   2,147     2,603  

Total operating expenses

  6,779     7,841  
Loss from operations (6,550 ) (7,597 )
Other (expense) income, net   (1,024 )   1,073  
Net loss $ (7,574 ) $ (6,524 )

Net loss per share applicable to common stockholders—basic and diluted

$ (0.39 ) $ (0.36 )

Weighted-average number of common shares used in net loss per share
applicable to common stockholders—basic and diluted

19,639 17,971
 

Eleven Biotherapeutics
Leah Monteiro, 617-714-0619
Leah.Monteiro@elevenbio.com

Source: Eleven Biotherapeutics, Inc.

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