Carisma Therapeutics (CARM) 8-K Eleven Biotherapeutics Announces Top-Line Results from Pivotal Phase 3 Study of EBI-005 in Patients with Moderate to Severe Dry Eye Disease

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)