Eleven Biotherapeutics
April 30, 2015
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Eleven Biotherapeutics Reports First Quarter 2015 Financial Results

Management to host conference call today at 8:30 a.m. ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today reported financial results for the first quarter ended March 31, 2015, and recent business highlights.

"Recently, we've presented and published a comprehensive body of clinical data related to Eleven's ocular therapeutics pipeline in peer-reviewed journals and at ocular disease meetings," said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics. "These data further define the patient population and proposed Phase 3 trial design for EBI-005 in the treatment of allergic conjunctivitis and describe how data from the completed phase 1b/2a study of EBI-005 in patients with dry eye disease influenced the design of the pivotal Phase 3 study. We remain on-track with our pivotal Phase 3 clinical study of EBI-005 in dry eye disease. Patient enrollment in this study completed in the fourth quarter of 2014 and communication of top line data is expected this quarter sometime after ARVO 2015."

First Quarter and Recent Business Highlights:

First Quarter 2015 Financial Results

Upcoming Events and Presentations:

Conference Call Information:

Eleven Biotherapeutics' management team will host a conference call and audio webcast today at 8:30 a.m. ET to discuss the first quarter 2015 results and provide a corporate update. To access the conference call, please dial 844-831-3025 (domestic) or 315-625-6887 (international) at least five minutes prior to the start time and refer to conference ID 14070086.

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, 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.

About EBI-031

Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME. EBI-031 has been designed and engineered for intravitreal delivery using our 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. We are 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 by the end of 2015 for the purpose of conducting clinical trials of EBI-031 in DME.

About Eleven Biotherapeutics

Eleven Biotherapeutics, Inc. is a clinical-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 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 annual report on Form 10-K filed with the Securities and Exchange Commission on March 6, 2015 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 BIOTHERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
 
 
Three Months Ended March 31,
2015 2014
 
Collaboration revenue $ 244   $ 568  
Operating expenses:
Research and development 5,238 5,819
General and administrative   2,603     1,938  

Total operating expenses

  7,841     7,757  
Loss from operations (7,597 ) (7,189 )
Other income (expense), net   1,073     (33 )
Net loss $ (6,524 ) $ (7,222 )
Cumulative preferred stock dividends   -     (519 )
Net loss applicable to common stockholders $ (6,524 ) $ (7,741 )

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

$ (0.36 ) $ (0.80 )

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

  17,971     9,635  
 
 
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands)
     
March 31,
2015
December 31,
2014
 
Assets
Current assets:
Cash and cash equivalents $ 45,549 $ 54,059
Prepaid expenses and other current assets 495 342
Restricted cash   94     -  
Total current assets 46,138 54,401
Property and equipment, net 422 486
Restricted cash - 94
Other assets   18     19  
 
Total assets $ 46,578   $ 55,000  
Liabilities and stockholders' equity (deficit)
Current liabilities:
Accounts payable $ 2,043 $ 2,458
Accrued expenses 1,327 1,987
Notes payable, current portion 1,010 251
Deferred revenue   262     506  
Total current liabilities 4,642 5,202
Other liabilities 65 4
Notes payable, net of current portion 8,990 9,749
Warrant liability 1,915 3,219
 
Stockholders' equity:
Common stock 18 18
Additional paid-in capital 129,222 128,558
Accumulated deficit   (98,274 )   (91,750 )
Total stockholders' equity   30,966     36,826  
 
Total liabilities and stockholders' equity $ 46,578   $ 55,000  
 

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

Source: Eleven Biotherapeutics, Inc.

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