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): August 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 2.01 Completion of Acquisition or Disposition of Assets

As previously reported in a Current Report on Form 8-K filed on August 15, 2016, at a special meeting of stockholders, Eleven Biotherapeutics, Inc. (the “Company”) obtained stockholder approval authorizing the transactions contemplated by the License Agreement, dated as of June 10, 2016 (the “License Agreement”), by and between the Company, F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. relating to EBI-031 and all other IL-6 antagonist antibody technology owned by the Company, including the grant of the exclusive licenses thereunder.

As a result, the license under the License Agreement became effective in accordance with the terms of the License Agreement on August 16, 2016, the business day following the date the license under the License Agreement was approved by the stockholders of the Company.

Under the License Agreement, the Company agreed to grant Roche an exclusive, worldwide license, including the right to sublicense, to its patent rights and know-how related to the Company’s monoclonal antibody EBI-031 or any other IL-6 antagonist anti-IL-6 monoclonal antibody, to make, have made, use, have used, register, have registered, sell, have sold, offer for sale, import and export any product containing such an antibody or any companion diagnostic used to predict or monitor response to treatment with such a product.

Pursuant to the terms of the License Agreement, Roche agreed to pay an up-front license fee of $7.5 million within 30 days after the effective date of the license under the License Agreement and receipt of an invoice from the Company, and up to an additional $262.5 million upon the achievement of specified regulatory, development and commercial milestones, including a $22.5 million payment upon the effectiveness of the Investigational New Drug Application for EBI-031 (the “IND Application”). On July 7, 2016, the Company announced that the IND Application had become effective. On August 16, 2016, the Company delivered invoices to Roche in respect of the up-front license fee and the milestone in respect of the effectiveness of the IND Application, and expects to receive a payment of approximately $30 million on or about September 15, 2016.

The Company will also be entitled to receive royalty payments in accordance with a tiered royalty rate scale, with rates ranging from 7.5% to 15% for net sales of potential future products containing EBI-031 and 50% of these rates for net sales of potential future products containing other IL-6 compounds, with each of the royalties subject to reduction under certain circumstances and to the buy-out options of Roche.

In addition, the License Agreement provides for two “option periods” during which Roche may elect to make a one-time payment to the Company and, in turn, terminate its remaining diligence, milestone and royalty payment obligations under the License Agreement. Specifically, (i) Roche may exercise a buy-out option following the first dosing (“Initiation”) in the first Phase II study for a Licensed Product until the day before Initiation of the first Phase III study for a Licensed Product, in which case Roche is required to pay the Company $135 million within 30 days after Roche’s exercise of such buy-out option and receipt of an invoice from the Company, or (ii) Roche may exercise a buy-out option following the day after Initiation of the first Phase III study for a Licensed Product until the day before the acceptance for review by the FDA or other regulatory authority of a biologics license application (“BLA”) or similar application for marketing approval for a Licensed Product in either the United States or in the European Union, in which case Roche is required to pay the Company, within 30 days after Roche’s exercise of such buy-out option and receipt of an invoice from the Company, $265 million (which amount would be reduced to $220

million if none of the Company’s patent rights containing a composition of matter claim covering any compound or Licensed Product has issued in the European Union).

The foregoingdescriptionof the License Agreement and the transactions contemplated thereby does not purport to be complete and is qualified in its entirety by reference to the License Agreement, a copy of which was filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2016, and is incorporated herein by reference.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

(b) On August 15, 2016, David A. Berry, M.D., Ph.D. notified the Company of his resignation as a member of the board of directors of the Company and the compensation committee thereof, effective immediately. Dr. Berry’s decision to resign did not result from any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.

Item 5.07 Submission of Matters to a Vote of Security Holders

The Company held a special meeting of stockholders on August 15, 2016. The final voting results for the matters submitted to a vote of the stockholders at the special meeting, which are described in detail in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on July 14, 2016, are as follows:

a) The stockholders of the Company approved the proposal to authorize the transactions contemplated by the License Agreement, dated as of June 10, 2016, by and between the Company and F. Hoffmann-La Roche Ltd and Hoffmann-La Roche, Inc., including the grant of the exclusive licenses thereunder. The results of the stockholders’ vote with respect to this proposal were as follows:

For	Against	Abstain	Broker Non-Votes
10,559,553	36,820	25,000	0

Item 8.01 Other Events

On August 16, 2016, the Company issued a press release with respect to the effectiveness of the License Agreement. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01		Financial Statements and Exhibits
(b)	Pro Forma Financial Information.

Attached as Exhibit 99.2 hereto and incorporated by reference are unaudited pro forma condensed consolidated financial statements as of and for the six months ended June 30, 2016 and for the year ended December 31, 2015, in each case giving pro forma effect to the License Agreement.

(d)    Exhibits

10.1 License Agreement, dated as of June 10, 2016, by and among Eleven Biotherapeutics, Inc., F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q filed with the SEC on August 12, 2016)

99.1 Press Release, dated August 16, 2016, announcing the effectiveness of the license under the License Agreement

99.2 Unauditedpro formacondensed consolidated statements of operations for the six months ended June 30, 2016 and the year ended December 31, 2015 and unauditedpro forma condensed balance sheet as of June 30, 2016

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	ELEVEN BIOTHERAPEUTICS, INC.
Date: August 19, 2016	By:	/s/ Abbie C. Celniker
		Abbie C. Celniker, Ph.D. President & Chief Executive Officer

EXHIBIT INDEX

Exhibit No.	Description
10.1†	License Agreement, dated as of June 10, 2016, by and among Eleven Biotherapeutics, Inc., F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q filed with the SEC on August 12, 2016)
99.1*	Press Release, dated August 16, 2016, announcing effectiveness of the license under the License Agreement
99.2*	Unaudited pro forma condensed consolidated statements of operations for the six months ended June 30, 2016 and the year ended December 31, 2015 and unaudited pro forma condensed balance sheet as of June 30, 2016

* Filed herewith.

† Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.

EX-99.1

Eleven Biotherapeutics Completes Exclusive Licensing Deal for IL-6 Antagonist Antibody Technology, Including EBI-031

Eleven entitled to $30 million payment

Cambridge, MA – August 16, 2016 – Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced the effectiveness of the exclusive licensing deal with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche). Eleven has granted Roche an exclusive, worldwide license to develop and commercialize EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven. EBI-031 is a humanized monoclonal antibody that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6 cytokine signaling. EBI-031 is currently in development for the treatment of ocular diseases. Eleven is entitled to receive $30 million in payments from Roche, including a $7.5 million upfront payment in connection with the effectiveness of the license agreement, and a $22.5 million milestone payment based on the Investigational New Drug application (IND) for EBI-031 becoming effective.

Under the terms of the agreement, Eleven could receive up to an additional $240 million upon the achievement of certain future regulatory, development and commercialization milestones. In addition, Eleven could be entitled to receive royalties for net sales of potential future products containing EBI-031 or any other potential future products containing other Eleven IL-6 compounds.

“With the completion of this licensing deal and the IND being effective, we look forward to the future clinical advancement of EBI-031 by Roche as they explore its potential use for ocular diseases, including diabetic macular edema,” said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics.

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 Eleven’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). Eleven filed an IND with the FDA in June 2016 and received clearance in July 2016 for the purpose of conducting clinical trials of EBI-031 in DME and uveitis.

About Eleven Biotherapeutics

Eleven Biotherapeutics, Inc. is a preclinical-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 potential effectiveness of the license agreement or receipt of payments thereunder, the future rights and obligations of the parties under the license agreement, the Company's strategy, future operations, advancement or maturation of its product candidates and product pipeline, clinical development of the Company's product candidates, including expectations regarding timing of regulatory submissions and initiation of clinical trials, regulatory requirements for initiation of clinical trials and registration of product candidates, the review of its strategic alternatives and the outcome of such review, the results of strategic transactions, 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 occurrence of any event, change or other circumstances that could give rise to the termination of the license agreement, the outcome of any legal proceedings that could be instituted against the Company or its directors related to the license agreement, the inability to consummate the transactions contemplated by the license agreement due to the failure to obtain the requisite approval of the Company’s stockholders, 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 June 30, 2016 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:

John McCabe

617-858-0907

EX-99.2

Unaudited pro forma consolidated financial information

On August 15, 2016 at a special meeting of stockholders, Eleven Biotherapeutics, Inc. (the “Company”) obtained stockholder approval authorizing the transactions contemplated by the License Agreement, dated as of June 10, 2016 (the “License Agreement”), by and between the Company, F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively, "Roche") relating to EBI-031 and all other IL-6 antagonist antibody technology owned by the Company, including the grant of the exclusive licenses thereunder. As a result of obtaining such stockholder approval, the License Agreement became effective on August 16, 2016.

The following supplemental pro forma information is presented for informational purposes only, to provide an understanding of the Company’s historical financial results as adjusted for the License Agreement. These pro forma condensed financial statements should not be considered a substitute for the actual historical financial information prepared in accordance with generally accepted accounting principles, as presented in the Company’s filings on Form 10-Q and 10-K. The unaudited pro forma condensed financial information disclosed in this report is for illustrative purposes only and is not necessarily indicative of results of operations that would have been achieved had the pro forma events taken place on the dates indicated, or our future results of operations.

The License Agreement represents a substantial outlicense of most rights and obligations concerning EBI-031 and all other IL-6 antagonist antibody technology, such that the Company would not expect to have any further direct involvement in its ongoing development and commercialization of the technology that is subject to the License Agreement. Among other customary closing conditions, Roche negotiated the License Agreement to be contingent upon obtaining shareholder approval of the arrangement, which occurred on August 15, 2016.

The unaudited pro forma condensed statements of operations for the six months ended June 30, 2016 and for the year ended December 31, 2015 present our condensed results of operations giving pro forma effect to the License Agreement as if it had occurred on January 1, 2015. The unaudited condensed pro forma balance sheet as of June 30, 2016 presents the financial position giving effect to the License Agreement as if it had occurred on June 30, 2016. These pro forma condensed financial statements should be read in connection with the Company’s historical condensed financial statements for the period ended June 30, 2016 which were included in the Form 10-Q filed on August 12, 2016 and the Company’s historical financial statements for the year ended December 31, 2015, which were included in the Form 10-K filed on March 25, 2016.

The pro forma adjustments are based on currently available information, estimates and assumptions that the Company believes are reasonable in order to reflect, on a pro forma basis, the impact of this License Agreement on its historical financial information.

ELEVEN BIOTHERAPEUTICS, INC.
UNAUDITED CONDENSED PRO FORMA STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
FOR THE SIX MONTHS ENDED JUNE 30, 2016
($, in thousands, except per share amounts)
						Pro Forma
			Historical			Adjustments			Notes	Pro Forma
Revenue			$	506						$	506
Operating expenses:
	Research and development		7,930			(2,752		)	(a)	5,178
	General and administrative		5,618							5,618
		Total operating expenses	13,548			(2,752		)		10,796
Loss from operations			(13,042		)	2,752				(10,290		)
Other income (expense):
	Other income, net		139							139
	Loss on extinguishment of debt		(915		)					(915		)
	Interest expense, net		(247		)					(247		)
		Total other expense	(1,023		)	—				(1,023		)
Net loss and comprehensive loss			$	(14,065	)	$	2,752			$	(11,313	)
Net loss per share applicable to common stockholders—basic and diluted			$	(0.71	)					$	(0.57	)
Weighted-average number of common shares used in net loss per share applicable to common stockholders—basic and diluted			19,756							19,756

ELEVEN BIOTHERAPEUTICS, INC.
UNAUDITED CONDENSED PRO FORMA STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
FOR THE YEAR ENDED DECEMBER 31, 2015
($, in thousands, except per share amounts)
						Pro Forma
			Historical			Adjustments			Notes	Pro Forma
Collaboration revenue			$	490						$	490
Other revenue			500							500
		Total revenue	990			—				990
Operating expenses:
	Research and development		26,336			(5,384		)	(a)	20,952
	General and administrative		9,850							9,850
		Total operating expenses	36,186			(5,384		)		30,802
Loss from operations			(35,196		)	5,384				(29,812		)
Other income (expense):
	Other income, net		3,139							3,139
	Interest expense, net		(1,395		)					(1,395		)
		Total other expense	1,744			—				1,744
Net loss and comprehensive loss			$	(33,452	)	$	5,384			$	(28,068	)
Net loss per share applicable to common stockholders—basic and diluted			$	(1.76	)					$	(1.48	)
Weighted-average number of common shares used in net loss per share applicable to common stockholders—basic and diluted			18,993							18,993

ELEVEN BIOTHERAPEUTICS, INC.
UNAUDITED CONDENSED PRO FORMA BALANCE SHEET
AS OF JUNE 30, 2016
($, in thousands, except share and per share data)
						Pro Forma
			Historical			Adjustments			Notes	Pro Forma
Assets
Current assets:
	Cash and cash equivalents		$	8,484		$	29,900		(b)	$	38,384
	Prepaid expenses and other current assets		350			(38		)	(a)	312
		Total current assets	8,834			29,862				38,696
Property and equipment, net			314							314
Restricted cash			119							119
Other assets			—							—
Total assets			$	9,267		$	29,862			$	39,129
Liabilities and stockholders' equity
Current liabilities
	Accounts payable		$	1,855		(232		)	(a)	$	1,623
	Accrued expenses		1,153			(114		)	(a)	1,039
	Notes payable, current portion		—							—
	Deferred revenue, current portion		—							—
		Total current liabilities	3,008			(346		)		2,662
Other Liabilities			73							73
Accrued interest			—							—
Notes payable, net of current portion			—							—
Warrant liability			13							13
Commitments and contingencies
Stockholders' equity
	Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2016 and December 31, 2015, respectively, and 20,005,771 and 19,619,124 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively		20							20
	Additional paid-in capital		145,420							145,420
	Accumulated deficit		(139,267		)	30,208				(109,059		)
Total stockholders' equity			6,173			30,208				36,381
Total liabilities and stockholders' equity			$	9,267		$	29,862			$	39,129

(a) To eliminate the direct research and development expenses, prepaid expenses, accounts payable and accrued expenses associated with EBI-031. We have not reflected employee and contractor-related costs, costs associated with our platform and facility expenses, including depreciation or other indirect costs, as a pro forma adjustment as these costs are deployed across multiple product programs under research and development and are not directly related to EBI-031.

(b) To record the up-front license fee of $7.5 million and the first development milestone payment of $22.5 million (minus the exclusivity fee of $0.1 million) as a non-recurring one-time payment under the License Agreement, and presented as an opening balance sheet pro forma adjustment of $29.9 million, that was receivable at the time the License Agreement became effective. The License Agreement includes payments of an upfront license fee of $7.5 million payable within 30 days after achievement of specified regulatory, development and commercial milestones with respect to up to two unrelated indications. Specifically, an aggregate amount of up to $197.5 million is payable to the Company for the achievement of specified milestones with respect to the first indication: $72.5 million in development milestones, $50.0 million in regulatory milestones and $75.0 million with respect to the first indication: $72.5 million in development milestones, $50.0 million in regulatory milestones and $75.0 million in commercialization milestones. The first development milestone in the amount of $22.5 million is payable as a result of the IND application for EBI-031 which became effective July 7, 2016. Additional amounts of up to $65.0 million are payable upon the achievement of specified development and regulatory milestones in a second indication.