Eleven Biotherapeutics - Ophthalmology Innovation Summit

Eleven Biotherapeutics
Abbie Celniker, CEO
4th Annual Ophthalmology
Innovation Summit @ ASCRS
Thursday, April 16, 2015
Proprietary and Confidential
1
Forward-Looking Statements
This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other
than statements of historical facts, contained in this presentation, including statements regarding our strategy, future
operations, clinical development of our protein therapies, future financial position, future revenues, projected costs,
prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions are intended to identify forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, although not all forward-looking statements contain these identifying words.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you
should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various important
factors, including: 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 on March 6, 2015 in the “Risk
Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange
Commission, and other reports on file with the Securities and Exchange Commission. The forward-looking statements
contained in this presentation reflect Eleven’s current views as of the date hereof with respect to future events, and Eleven
assumes no obligation to update any forward-looking statements except as required by applicable law. These forwardlooking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
2
Unmet Need Requires a Differentiated
Approach
Proteins designed specifically as ophthalmic therapies provide innovative
approaches for ocular conditions with significant unmet need
Eleven
Product
Candidates
Approved
Ophthalmic
Proteins
EBI-031*
Target: IL-6
Indication: DME
EBI-028
Target: IL-17
Indication: Uveitis
EBI-005
Target: IL-1 Receptor
Indications:
• DED
• Allergic
Conjunctivitis
Lucentis®,
Eylea™
Target: VEGF
Indications:
• Wet AMD
• CRVO
• DME
*Previously EBI-029
• Aging population and
co-morbidities driving
increased prevalence
of ocular diseases
• Historical therapies
were reformulations
of pharmaceuticals
originally developed
for non-ocular
diseases
• Inflammatory
cytokines and growth
factors (VEGF)
identified
as targets in many
ophthalmic diseases
3
Product Pipeline
DEVELOPMENT STAGE
PROGRAM
EBI-005
(Topical)
TARGET
INDICATION
OUR
COMMERCIA
L RIGHTS
Dry Eye
Disease
Worldwide
Allergic
Conjunctivitis
Worldwide
Worldwide
Worldwide
DISCOVER
Y
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
IL-1
Receptor
EBI-031
(intravitreal
injection)
IL-6
Diabetic
Macular
Edema
EBI-028
(intravitreal
injection)
IL-17
Uveitis
4
Significant need for new therapies in DED
Proprietary and Confidential
5
EBI-005: Topical IL-1 blockade is active in
DED – Phase 3 read out in 2Q15
• Protein eye drop for the
treatment of DED
• Phase 2 data used to design
pivotal program and identify
optimal patient population
~ Half the
number of
tear doses in
drug treated
group
• First P3 study read out in 2Q15
>30%
improvement
in Signs
>60%
improvement
in Symptoms
U.S. Allergic Conjunctivitis Market Segmentation
Provides Opportunity for EBI-005
The U.S. diagnosed population is estimated at ~11MM*
Mild
5.2 Million
Mild
Mostly Seasonal
Moderate
4.0 Million
Moderate
Seasonal & Perennial
Severe
1.8 Million
Severe,
Chronic, Seasonal,
Perennial, VKC & AKC
Histamine/Early Phase (Acute)
Inflammatory IL-1/Late Phase
* Based on Eleven primary market
research
7
EBI-005: Activity in allergic conjunctivitis
late phase response
IL-1 is a Key Mediator of the Late
Phase Allergic Response
Mean Change in Ocular Itching
Following Multiple Days of Allergen
EBI-005: Late phase response measured by
multiple endpoints at multiple time-points
• Response to drug with multiple
allergen challenges
• Statistically significant
separation from vehicle for
itching, tearing and nasal
symptoms
EBI-031: Anti-IL-6 in Diabetic Macular Edema
• Inflammation drives onset of
DME
• IL-6 is elevated in patients with
DME including those refractory
to anti-VEGF therapy
• IL-6 drives VEGF production
Extended intra-vitreal retention
Efficacy in CNV similar to standard of
care
Key Upcoming Milestones
Update on AC development plans
Early 2015
Topline Phase 3 dry eye disease results
Q2 15
Begin Phase 3 in allergic conjunctivitis
2H 15
Begin 2nd Phase 3 in dry eye disease
2H 15
File IND for EBI-031
End of 2015
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