Eleven Biotherapeutics
August 13, 2015
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Eleven Biotherapeutics Reports Second 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 second quarter ended June 30, 2015, and recent business highlights.

"We are continuing to focus on advancing our ocular therapeutics pipeline. We recently initiated a pivotal Phase 3 study of EBI-005 in moderate to severe allergic conjunctivitis patients suffering from the late-phase inflammatory response and are now planning to advance development of EBI-031 for the treatment of diabetic macular edema and uveitis with an IND filing expected in the first half of 2016. Our development plans are supported by data presented recently on both EBI-005 and EBI-031 at the ARVO 2015 Annual Meeting," said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics. "We are excited about the potential of our novel protein therapeutic drug candidates for the treatment of ocular disease and have sufficient financial resources to continue to invest in this promising pipeline."

Second Quarter and Recent Business Highlights:

Second 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 second 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 98342235.

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 inflammatory diseases at the surface of the eye. 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, pain, redness, itching and other symptoms associated with ocular surface diseases. EBI-005 is currently in Phase 3 clinical development for the treatment of moderate to severe allergic conjunctivitis. In a completed Phase 2 clinical trial, EBI-005 exhibited biological activity in improving the symptoms of late-phase allergic responses in patients with moderate to severe allergic conjunctivitis in a CAPT model.

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 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 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 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. The Company'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 quarterly report on Form 10-Q most recently 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 BIOTHERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
 
              Three Months Ended June 30,     Six Months Ended June 30,

2015

   

2014

2015

   

2014

 
Collaboration revenue $ 114   $ 761   $ 358   $ 1,329  
Operating expenses:
Research and development 6,269 6,754 11,507 12,573
General and administrative   2,247     2,052     4,850     3,990  
Total operating expenses   8,516     8,806     16,357     16,563  
Loss from operations   (8,402 )   (8,045 )   (15,999 )   (15,234 )
Other income (expense), net   1,496     (76 )   2,569     (109 )
Net loss $ (6,906 ) $ (8,121 ) $ (13,430 ) $ (15,343 )
Cumulative preferred stock dividends   -     -     -     (519 )
Net loss applicable to common stockholders $ (6,906 ) $ (8,121 ) $ (13,430 ) $ (15,862 )
Net loss per share applicable to common stockholders—basic and
diluted $ (0.36 ) $ (0.51 ) $ (0.72 ) $ (1.23 )
Weighted-average number of common shares used in net loss per
share applicable to common stockholders—basic and diluted   19,087     16,055     18,532     12,863  
 
 
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands)
 
                June 30,     December 31,
  2015     2014  
 
Assets
Current assets:
Cash and cash equivalents $ 53,494 $ 54,059
Prepaid expenses and other current assets   938     342  
Total current assets 54,432 54,401
Property and equipment, net 580 486
Restricted cash 94 94
Other assets   16     19  
 
Total assets $ 55,122   $ 55,000  
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 1,880 $ 2,458
Accrued expenses 618 1,987
Notes payable, current portion 2,523 251
Deferred revenue   451     506  
Total current liabilities 5,472 5,202
Other liabilities 164 4
Notes payable, net of current portion 12,171 9,749
Warrant liability 96 3,219
 
Stockholders' equity:
Common stock 19 18
Additional paid-in capital 142,380 128,558
Accumulated deficit   (105,180 )   (91,750 )
Total stockholders' equity   37,219     36,826  
 
Total liabilities and stockholders' equity $ 55,122   $ 55,000  
 

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

Source: Eleven Biotherapeutics, Inc.

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