Eleven Biotherapeutics
November 14, 2016
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Eleven Biotherapeutics Reports Third Quarter 2016 Financial Results

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

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeting Protein Therapeutics (TPTs) platform, today reported financial results for the third quarter ended September 30, 2016, and recent business highlights.

"This is an exciting period for Eleven. We completed the Roche licensing deal, including $30 million in upfront and milestone payments received to date. We also completed the acquisition of Viventia Bio Inc. which allowed us to become a late-stage oncology company. Perhaps most excitingly, we are making significant progress in moving forward what we believe could be therapeutics that materially improve patients' lives. We anticipate complete enrollment in the first half of next year for our Phase 3 clinical trial of Vicinium™ as a potential treatment for high-grade non-muscle invasive bladder cancer, and expect topline data in the first half of 2018," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "We also plan to initiate our Phase 2 trial in late-stage squamous cell carcinoma of the head and neck with Proxinium in combination with a checkpoint inhibitor in the first half of 2017. Also in 2017, we plan on submitting an IND with the FDA for our lead product in our systemic pipeline based on our proprietary payload deBouganin. With the combined expertise of Eleven and the Viventia team, I am very excited about the opportunities we have ahead."

Third Quarter and Recent Business Highlights:

Third Quarter 2016 Financial Results:

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 third quarter 2016 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 14447038.

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 Eleven Biotherapeutics

Eleven Biotherapeutics, Inc. is a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based upon the Company's targeted protein therapeutics (TPTs) platform. The Company's TPTs incorporate a tumor-targeting antibody fragment and a protein cytotoxic payload into a single protein molecule in order to achieve focused tumor cell killing. The TPTs fusion protein construction provides enhanced linker stability and an efficient and cost effective manufacturing process. The Company believes its TPT approach offers significant advantages in treating cancer over existing antibody drug conjugate technologies. The Company believes its TPTs provide effective tumor targeting with broader cancer cell-killing properties than are achievable with small molecule payloads that require tumor cell proliferation and face multi-drug resistance mechanisms. Additionally, the Company believes that its TPT's cancer cell-killing properties promote an anti-tumor immune response that will potentially combine well with immune oncology drugs such as checkpoint inhibitors. For more information please refer to the Company's website at www.elevenbio.com.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, 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 occurrence of any event change or other circumstances that could give rise to the termination of the License Agreement, the uncertainties inherent in receiving future payments pursuant to the License Agreement, the uncertainties inherent in the initiation and conduct of clinical trials, our ability to successfully develop our product candidates and complete our planned clinical programs, our ability to obtain marketing approvals for our product candidates, expectations regarding our ongoing clinical trials, availability and timing of data from clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical studies will be indicative of the results of future studies, the adequacy of any clinical models, expectations regarding regulatory approvals, our ability to obtain, maintain and protect our intellectual property for our technology and products, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the financial performance of the Company, other matters that could affect the availability or commercial potential of the Company's product candidates and other factors discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, the "Risk Factors of Viventia's Business" filed as Exhibit 99.2 to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on September 21, 2016 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 CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
           
Three Months Ended September 30,     Nine Months Ended September 30,

2016

2015

2016

2015

 
Total revenue $ 28,650 $ 67

$

29,156

$ 425
Operating expenses:
Research and development 2,754 6,745 10,684 18,252
General and administrative   6,366     2,681         11,984     7,531  
Total operating expenses   9,120     9,426         22,668     25,783  
Income (loss) from operations 19,530 (9,359 ) 6,488 (25,358 )
Other income (expense), net   (43 )   (334 )       (1,066 )   2,235  
Net income (loss) $ 19,487   $ (9,693 )     $ 5,422   $ (23,123 )
Net income (loss) per share —basic $ 0.95   $ (0.50 )     $ 0.27   $ (1.23 )
Weighted-average number of common shares used in net income
(loss) per share —basic   20,495     19,345         20,004     18,806  
Net income (loss) per share —diluted $ 0.91   $ (0.50 )     $ 0.26   $ (1.23 )
Weighted-average number of common shares used in net income
(loss) per share —diluted   21,423     19,345         20,796     18,806  
 
       

ELEVEN BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands)
       
September 30, December 31,
  2016     2015  
 
Assets
Current assets:
Cash and cash equivalents $ 30,716 $ 36,079
Restricted cash 94 -
Prepaid expenses and other current assets 952 232
Due from related party   50     -  
Total current assets 31,812 36,311
Property and equipment, net 894 407
Restricted cash 10 94
Intangible assets 36,200
Goodwill 10,312
Other assets   350     13  
 
Total assets $ 79,578   $ 36,825  
 
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 1,761 $ 1,246
Accrued expenses 2,492 1,794
Deferred revenue 1,250 406
Due to related party 697 -
Other current liabilities 65 -
Notes payable, current portion   -     4,134  
Total current liabilities 6,265 7,580
Other liabilities - 423
Notes payable, net of current portion - 9,763
Due to related party 117
Warrant liability 77 115
Deferred tax liability 9,774 -
Contingent consideration 21,900 -
 
Stockholders' equity:
Common stock 24 20
Additional paid-in capital 161,201 144,126
Accumulated deficit   (119,780 )   (125,202 )
Total stockholders' equity   41,445     18,944  
 
Total liabilities and stockholders' equity $ 79,578   $ 36,825  
 

Eleven Biotherapeutics
Leah Monteiro, 617-444-8556
Leah.monteiro@elevenbio.com

Source: Eleven Biotherapeutics, Inc.

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