0001485003-16-000035.txt : 20160115 0001485003-16-000035.hdr.sgml : 20160115 20160115163012 ACCESSION NUMBER: 0001485003-16-000035 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160115 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160115 DATE AS OF CHANGE: 20160115 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Eleven Biotherapeutics, Inc. CENTRAL INDEX KEY: 0001485003 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 252025616 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36296 FILM NUMBER: 161345790 BUSINESS ADDRESS: STREET 1: 215 FIRST STREET STREET 2: SUITE 400 CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 617-871-9911 MAIL ADDRESS: STREET 1: 215 FIRST STREET STREET 2: SUITE 400 CITY: CAMBRIDGE STATE: MA ZIP: 02142 8-K 1 form8-kxacphase3data.htm 8-K 8-K


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
                                                    
FORM 8-K
 
                                                     
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 15, 2016
 
                                                    
ELEVEN BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
 
                                                     
 
 
 
 
 
 
Delaware
 
001-36296
 
26-2025616
(State or Other Jurisdiction
of Incorporation
 
(Commission File Number)
 
(IRS Employer
Identification No.)
 
 
 
 
215 First Street, Suite 400
Cambridge, MA
 
02142
(Address of Principal Executive Offices)
 
(Zip Code)
Registrant’s telephone number, including area code: (617) 871-9911
None
(Former Name or Former Address, if Changed Since Last Report)
 
                                                    
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
¬
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
¬
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
¬
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 




¬
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

Item 2.02. Results of Operations and Financial Condition.
The information required by this Item 2.02 relating to the public announcement by Eleven Biotherapeutics, Inc. (the “Company”) of certain financial results and its financial condition is contained in Item 8.01 below and is incorporated herein by reference. A copy of the press release with respect to this public announcement is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 2.02.

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
The information required by this Item 2.03 is contained in Item 8.01 below and is incorporated herein by reference.

Item 7.01. Regulation FD Disclosure.

On January 15, 2016, the Company issued a press release announcing the results from the Company’s Phase 3 clinical trial of its lead drug candidate, isunakinra (EBI-005), for the treatment of severe allergic conjunctivitis. A copy of the press release is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.

The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.
On January 15, 2016, the Company announced top-line results from the Company’s Phase 3 clinical trial of isunakinra for the treatment of severe allergic conjunctivitis. The multi-center, double-masked, randomized, vehicle controlled Phase 3 clinical trial was designed to evaluate the safety and efficacy of isunakinra for up to four weeks in patients with moderate to severe allergic conjunctivitis in an environmental setting. A total of 258 patients were randomized 1:1 to receive treatment with isunakinra or with vehicle control. In this trial, there were no statistically significant differences between the isunakinra treated group and the vehicle control group on the primary endpoint of ocular itching or on any secondary endpoints. Isunakinra was generally well tolerated, with 94% of the patients completing the trial and there were no serious adverse events reported.

As of December 31, 2015, the Company had approximately $36.1 million of cash and cash equivalents. As a result of the outcome of this trial, which constituted a “Study Discontinuation Event” pursuant to the terms of the Loan and Security Agreement, dated as of May 27, 2010, as amended on September 4, 2012, November 25, 2014 and December 4, 2015, (the “Loan Agreement”), by and between the Company and the Silicon Valley Bank (the “Lender”), the Company is required to fund a cash collateral account with the Lender in an amount equal to approximately $15.1 million, representing the outstanding obligations under the Loan Agreement. As of December 31, 2015, the outstanding principal balance under the Loan Agreement was $14.1 million. The Loan Agreement provides for an interest rate of 3.75% above the prime lending rate. In addition, the Company is required to make a final payment to Silicon Valley Bank upon maturity in an amount equal to $900,000. The Company currently expects its unrestricted cash and cash equivalents will enable the Company to fund its operating plans into the fourth quarter of 2016.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

The following exhibit shall be deemed to be furnished, and not filed:

99.1        Press release issued by the Company on January 15, 2016





Cautionary Note on Forward-Looking Statements

Any statements in this Form 8-K 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 clinical trials or regulatory submissions, regulatory requirements for initiation of clinical trials and registration of product candidates, 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 quarterly report on Form 10-Q for the quarter ended September 30, 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 Form 8-K 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.




SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 
 
 
 
 
ELEVEN BIOTHERAPEUTICS, INC.
 
 
 
Date: June 15, 2016
 
By:
 
/s/ Abbie C. Celniker
 
 
 
 
Abbie C. Celniker, Ph.D.
President & Chief Executive Officer





EXHIBIT INDEX


Exhibit Number        Description of Exhibit

99.1            Press release issued by the Company on January 15, 2016



 EX-99.1 2 a005acph3prfinal.htm EXHIBIT 99.1 Exhibit


Eleven Biotherapeutics Reports Phase 3 Data on Isunakinra (EBI-005) in Allergic Conjunctivitis
-Isunakinra Misses Primary Endpoint of Ocular Itching-
-Company Plans to Advance Development of EBI-031 for Diabetic Macular Edema and Uveitis with an IND Submission Planned for the First Half of 2016-

Cambridge, MA – January 15, 2016 –Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced top-line results from the Phase 3 clinical trial of its lead drug candidate, isunakinra (EBI-005), for the treatment of severe allergic conjunctivitis. In this trial, there were no statistically significant differences between the isunakinra treated group and the vehicle control group on the primary endpoint of ocular itching or on any secondary endpoints. Isunakinra was generally well tolerated, with 94% of the patients completing the trial and there were no serious adverse events reported.
The multi-center, double-masked, randomized, vehicle controlled Phase 3 clinical trial was designed to evaluate the safety and efficacy of isunakinra for up to four weeks in patients with moderate to severe allergic conjunctivitis in an environmental setting. A total of 258 patients were randomized 1:1 to receive treatment with isunakinra or with vehicle control.
“We are disappointed that isunakinra failed to meet its primary endpoint, and based on these overall results we see no immediate path forward in allergic conjunctivitis,” said Abbie Celniker, PhD, President and CEO of Eleven Biotherapeutics. “Our efforts will be focused on submitting an investigational new drug application (IND) for EBI-031 in diabetic macular edema in the first half of 2016. In addition, we plan to provide an update on our corporate strategy later this quarter during our 2015 year-end financial results conference call.”
Michael Goldstein, MD, Chief Medical Officer of Eleven Biotherapeutics commented, “Despite this outcome, we plan to continue to assess interleukin-1 (IL-1) genotyping in ocular surface diseases by evaluating data from patient subsets in this clinical trial identified to be high producers of IL-1.”
Cash Position
As of December 31, 2015, Eleven had approximately $36.1 million of cash and cash equivalents. As a result of the outcome of this trial, Eleven is required to fund a cash collateral account with Silicon Valley Bank in an amount equal to approximately $15.1 million, representing the outstanding amounts under its loan agreement with Silicon Valley Bank. Eleven Biotherapeutics currently expects its unrestricted cash and cash equivalents will enable the Company to fund its operating plans into the fourth quarter of 2016.



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 the Company’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. The Company is undertaking 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. 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 clinical trials or regulatory submissions, regulatory requirements for initiation of clinical trials and registration of product candidates, 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 quarterly report on Form 10-Q for the quarter ended September 30, 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.



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


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