Eleven Biotherapeutics
March 4, 2015
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Eleven Biotherapeutics Reports Fourth Quarter and Year-End 2014 Financial Results


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

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Eleven Biotherapeutics (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today reported financial results for the fourth quarter and full year ended December 31, 2014.

"We made significant progress advancing our pipeline of novel protein therapeutics for eye disease including our lead product candidate, EBI-005, which is in late-stage clinical development for dry eye disease and allergic conjunctivitis," said Abbie Celniker, Ph.D., President and Chief Executive Officer. "We completed patient enrollment in our pivotal Phase 3 clinical study for EBI-005 in patients with moderate to severe dry eye disease and expect to report top-line results from that study in the second quarter of 2015. One of the requirements for regulatory approval and an important milestone for the pivotal clinical program was the initiation of a twelve-month safety study with EBI-005 in dry eye disease. We also reported encouraging Phase 2 top-line safety and efficacy results for EBI-005 in patients with moderate to severe allergic conjunctivitis, further validating EBI-005 as a clinically active anti-inflammatory ocular agent. In addition to the progress made with EBI-005 we are also pleased with the progress that we have made with our second product candidate in development for diabetic macular edema with a planned IND filing by the end of 2015."

Fourth Quarter and Recent Business Highlights:

Fourth Quarter and Year-End 2014 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. EST to discuss the fourth quarter and year-end 2014 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 87544666.

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. We designed and engineered EBI-031 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 a longer vitreal retention time than antibodies and antibody like molecules approved for intravitreal injection. We are undertaking the necessary CMC 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.

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.

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 November 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.

(in thousands, except per share data)
                  Three Months Ended December 31,     Twelve Months Ended December 31,








Collaboration revenue     $ 375     $ 510       $ 2,243     $ 1,334  
Operating expenses:                    
  Research and development       5,258       3,212         26,703       13,788  
  General and administrative       2,212       1,418         8,471       4,024  
            Total operating expenses       7,470       4,630         35,174       17,812  
Loss from operations       (7,095 )     (4,120 )       (32,931 )     (16,478 )
Other income (expense):                    
  Other expense, net       (905 )     (51 )       (849 )     (147 )
  Interest expense, net       (139 )     (895 )       (376 )     (1,400 )
            Total other expense       (1,044 )     (946 )       (1,225 )     (1,547 )
Net loss           $ (8,139 )   $ (5,066 )     $ (34,156 )   $ (18,025 )
Cumulative preferred stock dividends       -       (1,142 )       (519 )     (3,857 )
Net loss applicable to common stockholders     $ (8,139 )   $ (6,208 )     $ (34,675 )   $ (21,882 )
Net loss per share applicable to common stockholders—basic and                    
  diluted       $ (0.49 )   $ (4.29 )     $ (2.37 )   $ (16.18 )
Weighted-average number of common shares used in net loss per                    
  share applicable to common stockholders—basic and diluted       16,692       1,447         14,644       1,352  
(in thousands)
                  December 31,




Current assets:          
  Cash and cash equivalents     $ 54,059     $ 7,942  
  Prepaid expenses and other current assets       342       88  
          Total current assets       54,401       8,030  
Property and equipment, net       486       759  
Restricted cash       94       94  
Other assets       19       2,354  
Total assets     $ 55,000     $ 11,237  
Liabilities, convertible preferred stock, and stockholders' equity (deficit)          
Current liabilities:          
  Accounts payable     $ 2,458     $ 1,746  
  Accrued expenses       1,987       850  
  Notes payable, current portion       251       1,642  
  Deferred revenue, current portion       506       1,115  
          Total current liabilities       5,202       5,353  
Deferred revenue, net of current portion       -       355  
Restricted stock liability       4       10  
Notes payable, net of current portion       9,749       2,876  
Warrant liability       3,219       297  
Series A convertible preferred stock       -       45,035  
Series B convertible preferred stock       -       11,643  
Stockholders' equity (deficit):          
  Preferred stock       -       -  
  Common stock       18       2  
  Additional paid-in capital       128,558       3,260  
  Accumulated deficit       (91,750 )     (57,594 )
Total stockholders' equity (deficit)       36,826       (54,332 )
Total liabilities, convertible preferred stock and stockholders' equity (deficit)     $ 55,000     $ 11,237  


Eleven Biotherapeutics
Leah Monteiro, 617-714-0619

Source: Eleven Biotherapeutics



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