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): May 18, 2015

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 7.01. Regulation FD Disclosure.

On May 18, 2015, Eleven Biotherapeutics, Inc. (the “Company”) issued a press release announcing the results from the Company’s first pivotal Phase 3 trial of its lead drug candidate, EBI-005, in moderate to severe dry eye disease. A copy of the press release is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.

On May 18, 2015, representatives of the Company will present by conference call and audio webcast information about the results of the Company’s Phase 3 trial of EBI-005 in moderate to severe dry eye disease described in the slides attached to this report as Exhibit 99.2 hereto, which are hereby incorporated by reference into this Item 7.01.

The information in this Item 7.01 (including Exhibits 99.1 and 99.2) is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item 7.01 will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 is not intended to, and does not, constitute a determination or admission by the Company that this information is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.

Item 8.01. Other Events.

On May 18, 2015, the Company announced top-line results from the Company’s first pivotal Phase 3 trial of EBI-005 in moderate to severe dry eye disease. This trial was a double masked, randomized, placebo controlled trial in 669 patients with moderate to severe dry eye disease. Patients were randomly assigned, or randomized, to receive topical administration in each eye three times per day for 12 weeks of EBI-005 at 5 mg/ml or vehicle control beginning at randomization. We refer to the time at which we randomized a patient as baseline. The patients underwent study evaluations at weeks one, three, six, nine and 12 following randomization. The last dose of EBI-005 or vehicle was completed 12 weeks after randomization. We required patients to attend a final visit three weeks after their week 12 visit.

One co-primary endpoint of this Phase 3 trial was mean change in the total corneal fluorescein staining, or CFS, score, a sign of dry eye disease, from baseline at week 12 with EBI-005 treatment compared to mean change from baseline at week 12 with vehicle control. The other co-primary endpoint in this Phase 3 trial was mean change in pain and discomfort as measured by the painful or sore eyes question on the ocular surface disease index, or OSDI, a symptom of dry eye disease, from baseline at week 12 with EBI-005 treatment compared to mean change from baseline at week 12 with vehicle control. EBI-005 did not meet either of these two co-primary endpoints.

There was no statistically significant difference between the EBI-005 treated group and the vehicle control group on the co-primary endpoints or any secondary endpoints. Patients with dry eye disease in both the EBI-005 and vehicle treatment groups showed statistically significant improvement from baseline on the co-primary endpoints. While the change from baseline on the co-primary endpoints was greater in the vehicle group than the EBI-005 group, the differences between the two groups were not statistically significant and we believe the differences were not clinically meaningful.

EBI-005 was generally well tolerated in the Phase 3 trial with fewer than 5% of patients reporting eye irritation and no treatment related serious adverse events. We did not observe any significant imbalances between the EBI-005 treatment group and the vehicle control group in the incidence of ocular adverse events or systemic adverse events. Approximately 13% of patients in the trial reported some use of artificial tears, with no difference in artificial tear use between the EBI-005 treated and vehicle control groups. Overall, 92% of patients completed the trial, with 33 patients having dropped out of the EBI-005 group and 20 patients having dropped out of the vehicle control group.

The graph below sets forth with respect to the EBI-005 treatment group and the vehicle control group the mean change in CFS scores from baseline at each evaluation visit following randomization during the trial period.

The graph below sets forth with respect to the EBI-005 treatment group and the vehicle control group the mean change in score on the OSDI question regarding painful or sore eyes from baseline at each evaluation visit following randomization during the trial period.

The table below sets forth for the EBI-005 treatment group and the vehicle control group the mean score at baseline and the mean change from baseline at week 12 on the following co-primary endpoints.

EBI-005-3		Baseline	Week 12
Total CFS	EBI-005	8.5 Points	-2.4 Points
	Vehicle	8.6 Points	-2.7 Points
OSDI Pain	EBI-005	1.2 Points	-.3 Points
	Vehicle	1.3 Points	-.5 Points

The table below sets forth for the EBI-005 treatment group and the vehicle control group the number and percentage of patients with one or more treatment emergent ocular adverse events and the number and percentage of patients with the most common ocular adverse events. All other ocular adverse events occurred in fewer than 2% of patients.

	Vehicle (N=334)			EBI-005 (N=335)
Subjects with at least one TEAE		58 (17.4	%)		68 (20.3	%)
Eye Irritation		15 (4.5	%)		15 (4.5	%)
Eye Pain		8 (2.4	%)		9 (2.7	%)
Conjunctival Hyperemia		5 (1.5	%)		9 (2.7	%)
Eyelid Itching		5 (1.5	%)		9 (2.7	%)

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

The following exhibits relating to Item 7.01 shall be deemed to be furnished, and not filed:

99.1	Press release issued by the Company on May 18, 2015
99.2	EBI-005 Phase 3 Dry Eye Disease Trial Data Review dated May 18, 2015

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: May 18, 2015	By:	/s/ Abbie C. Celniker
		Abbie C. Celniker, Ph.D. President & Chief Executive Officer

EX-99.1

Exhibit 99.1

Eleven Biotherapeutics Announces Top-Line Results from Pivotal Phase 3 Study of EBI-005 in Patients with Moderate to Severe Dry Eye Disease

– Study Did Not Achieve Primary Endpoints; No Statistical Difference between EBI-005 and Vehicle Control –

– EBI-005 Program to Focus on Allergic Conjunctivitis with Pivotal Phase 3 Study to Initiate in Second Half of 2015 –

– Conference Call Scheduled for 8:30 a.m. ET Today –

CAMBRIDGE, Mass. – May 18, 2015- 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 OASIS study, the company’s first pivotal Phase 3 study of its lead drug candidate, EBI-005, in moderate to severe dry eye disease. The co-primary endpoints of the Phase 3 study were the total corneal fluorescein staining score and the patient-reported measurement related to ocular pain and discomfort based on the ocular surface disease index (OSDI), comparing the mean change from baseline at week 12 for treatment with EBI-005 to treatment with vehicle control. In this study, EBI-005 did not meet either of these two co-primary endpoints.

There was no statistically significant difference between the EBI-005 treated group and the vehicle control group on the co-primary endpoints or any secondary endpoints. Patients with dry eye disease in both the EBI-005 and vehicle treatment groups showed statistically significant improvement from baseline on the co-primary endpoints. While the change from baseline on the co-primary endpoints was greater in the vehicle group than the EBI-005 group, the differences between the two groups were not statistically significant and the company believes the differences were not clinically meaningful. EBI-005 was generally well tolerated in the Phase 3 study with fewer than 5% of patients reporting eye irritation and no treatment related serious adverse events. Approximately 13% of patients in the study reported some use of artificial tears, with no difference in artificial tear use between the EBI-005 treated and vehicle control groups. Overall, 92% of patients completed the study, with 33 patients having dropped out of the EBI-005 group and 20 patients having dropped out of the vehicle control group.

“We are disappointed that our Phase 3 study in dry eye disease did not meet its primary efficacy endpoints, but we are encouraged that we continue to see a favorable tolerability profile for EBI-005. Our key focus will be on continuing to develop EBI-005 to meet unmet medical needs in allergic conjunctivitis, based on our previously-reported Phase 2 data and scientific rationale supporting EBI-005 as a treatment for allergic conjunctivitis,” said Abbie Celniker, PhD, President and Chief Executive Officer of Eleven Biotherapeutics. “Based on these top-line results, the company does not see an immediate

path forward for EBI-005 in dry eye disease, and we will not be initiating the second Phase 3 study of EBI-005 in dry eye disease that we had planned to start in the second half of this year. However we need to further assess the results from the OASIS study to fully inform our evaluation of future plans in dry eye disease, including the ongoing Phase 3 safety study.”

Dr. Celniker commented further, “We have sufficient capital to continue to invest in our promising pipeline and remain confident in the potential for our novel protein therapeutic drug candidates for ocular disease. Our team continues to be committed to moving forward with our upcoming plans including advancing EBI-005 into a pivotal study for allergic conjunctivitis and continuing to progress EBI-031 for diabetic macular edema.”

Eleven continues to prepare to advance EBI-005 into late-stage clinical development for allergic conjunctivitis, with plans to initiate a pivotal Phase 3 study in patients with moderate to severe allergic conjunctivitis in the second half of 2015. Allergic conjunctivitis is a mechanistically different ocular disease from dry eye disease. The ocular surface inflammation associated with allergic conjunctivitis is initiated by a single, central mechanism of allergen stimulation, while the underlying causes of ocular surface inflammation in dry eye disease are diverse. In October 2014, Eleven reported results from a Phase 2 study of EBI-005 in allergic conjunctivitis which demonstrated statistically significant improvements in ocular itching, tearing and nasal symptoms in the late phase allergy response in moderate to severe allergic conjunctivitis patients challenged with allergen, using the conjunctival allergen provocation model. The company also plans to continue to invest in its pipeline.

Financial Expectations

Eleven has approximately $59 million of cash and cash equivalents, which the company expects will finance its current plans into the second half of 2016. The company has approximately $15 million in debt.

About the Phase 3 OASIS Study of EBI-005 in Dry Eye Disease

The pivotal Phase 3 OASIS study (a Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Control In Subjects With Moderate to Severe Dry Eye Disease), was designed to evaluate the safety and efficacy of EBI-005. The study evaluated 669 patients with moderate to severe dry eye disease. The co-primary endpoints were evaluation of mean change from baseline at week 12 with EBI-005 treatment compared to vehicle control on the total corneal fluorescein staining score and on the patient-reported measurement related to ocular pain and discomfort based on the ocular surface disease index (OSDI), a questionnaire used to measure the symptoms of dry eye disease.

Conference Call Information

Eleven Biotherapeutics’ management team will host a conference call and audio webcast today, May 18, 2015 at 8:30 a.m. ET to discuss the top-line pivotal Phase 3 clinical study results of EBI-005 in dry eye disease. 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 50470033.

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.

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 filed with the Securities and Exchange Commission on April 30, 2015 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:

Eleven Biotherapeutics

Leah Monteiro, 617-714-0619

Leah.Monteiro@elevenbio.com

EX-99.2

EBI-005 Phase 3 Dry Eye

Disease Trial

May 18, 2015

Exhibit 99.2

•

Natural environmental study

•

Double masked, vehicle controlled

•

U.S. study, 669 subjects enrolled

•

Inclusion criteria

•

CFS: Screen moderate-to-severe

•

OSDI: Screen moderate-to-severe

•

<50 at randomization

•

Rescue tear use restricted

Objectives

•

•

•

5 to 7 Days

Prior to Day 1

Day 1

Week 3

Week 6

Week 9

Week 12

RUN IN

EVALUATION VISITS

FOLLOW UP

21 Days

Follow Up

Post Week 12

1

Week

Run In

3

Week

Follow

Up

Vehicle

Control

—

3

times

daily

(~325 Subjects)

EBI-005

5

mg/ml

—

3

times

daily

(~325 Subjects)

Screening

Randomization

Off Treatment

Week 1

CFS= Corneal Fluorescein Staining

OSDI= Ocular Surface Disease Index

2

Co-Primary: CFS; pain or soreness by OSDI

Secondary: e.g. Total OSDI; CFS regions

Safety, tolerability, and immunogenicity

EBI-005 Phase 3 Study in Dry Eye Disease

3

Vehicle

EBI-005

N

334

335

Age

59.75 (20-87)

59.65 (23-92)

Gender

82% F

83%F

Race

81% (White)

83% (White)

Drop Outs

20 (6%)

33 (10%)

AT use during study

43 (13%)

43 (13%)

Baseline Demographics

Differences between EBI-005 and vehicle were not statistically significant

-6

-5

-4

-3

-2

-1

0

0

1

3

6

9

12

15

Vehicle

EBI-005

Time (Weeks)

Change from Baseline for Total CFS at each Visit

(Standard Deviation)

Change from Baseline for OSDI Pain/Sore Eye at

each Visit (Standard Deviation)

Differences between EBI-005 and vehicle were not statistically significant

-1.6

-1.4

-1.2

-1

-0.8

-0.6

-0.4

-0.2

0

0

1

3

6

9

12

15

Vehicle

EBI-005

Time (Weeks)

Vehicle

(N=334)

EBI-005

(N=335)

Subjects with at least one TEAE

58 (17.4%)

68 (20.3%)

Eye Irritation

15 (4.5%)

15 (4.5%)

Eye Pain

8 (2.4%)

9 (2.7%)

Conjunctival Hyperemia

5 (1.5%)

9 (2.7%)

Eyelid Itching

5 (1.5%)

9 (2.7%)

All other ocular AE’s below 2%

Ocular Treatment Emergent Adverse Events

EBI-005-3

Baseline

Week 12

Total CFS

EBI-005

8.5

-2.4

Vehicle

8.6

-2.7

OSDI Pain

EBI-005

1.2

-.3

Vehicle

1.3

-.5

Phase 3 Study Baseline Values with Change

From Baseline (Week 12)