FOR RETINAL DISEASES
May 2021
NASDAQ: ISEE
FORWARD-LOOKING STATEMENTS
Any statements in this presentation about the Company's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company's strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "seek," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.
In this presentation, the Company's forward looking statements include statements about its expectations regarding patient enrollment and retention in its second Phase 3 trial (GATHER2) of Zimura in geographic atrophy secondary to AMD and use of its completed clinical trial of Zimura for the treatment of geographic atrophy secondary to AMD (GATHER1) as a Phase 3 trial, its development and regulatory strategy for Zimura and its other product candidates, including additional indications that the Company may pursue for the development of Zimura and IC-500, the Company's hypotheses regarding complement inhibition and HtrA1 inhibition as potential mechanisms of action for the treatment of retinal diseases, the implementation of its business and hiring plan, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities, including regulatory submissions, the clinical meaningfulness of clinical trial results, the potential utility of its product candidates, estimates regarding the number of patients affected by the diseases and indications the Company's product candidates are intended to treat and statements regarding the potential for the Company's business development strategy.
Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's research and development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the progression and duration of the COVID-19 pandemic and responsive measures thereto and related effects on the Company's research and development programs, operations and financial position, the initiation and the progress of research and development programs and clinical trials, including enrollment and retention in clinical trials, availability of data from these programs, reliance on contract development and manufacturing organizations, university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, developments from the Company's competitors and the marketplace for the Company's products, need for additional financing and other factors discussed in the "Risk Factors" section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission.
Any forward-looking statements represent the Company's views only as of the date of this presentation. The Company anticipates that subsequent events and developments will cause its views to change. 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 except as required by law.
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A DIVERSIFIED PORTFOLIO FOCUSED ON RETINAL DISEASES
Therapeutics for Age-Related Retinal Diseases (Large Market)
- Zimura (C5 inhibitor):
- Positive data for the first of two Phase 3 trials (GATHER1)
- Statistically significant 27% reduction in GA growth over 12 months (primary endpoint achieved)
- Targeting completion of patient enrollment for second Phase 3 trial (GATHER2) 3Q 2021
- Potential expansion into intermediate AMD, wet AMD and lifecycle initiatives
- IC-500(HtrA1 Inhibitor): Complementary MOA adding to development stage AMD franchise
Gene Therapy for Inherited Retinal Diseases (Orphan)
- Broad and diversified pipeline
- Novel and cutting edge AAV gene therapy options
- Five programs in orphan inherited retinal diseases w/ no currently approved therapies
Experienced Team with Extensive Drug Development Expertise in Retina
Strong Cash Position and Well-Capitalized
• ~$180 million in cash and marketable securities as of 3/31/21
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STRONG SENIOR TEAM WITH SIGNIFICANT OPHTHALMOLOGY EXPERIENCE
GLENN SBLENDORIO
Chief Executive Officer
PRAVIN DUGEL, MD
President
DAVID CARROLL
Chief Financial Officer
KEITH WESTBY
Chief Operating Officer
ABRAHAM SCARIA, PHD
Chief Scientific Officer
EVELYN HARRISON
Chief Clinical Operations Officer
DHAVAL DESAI, PHARMD
Chief Development Officer
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IVERIC BIO PIPELINE
Indication | Res Pre-clin P1 | P2 | P3 | Status / Milestones | ||||
• | GATHER1 (1st Phase 3): Positive 12 & 18- | |||||||
Therapeutics | Zimura: | month data reported | ||||||
GA secondary to AMD | • | GATHER2 (2nd Phase 3): Target completion | ||||||
of enrollment 3Q 2021 | ||||||||
Zimura: | • | Expanded enrollment (up to ~25 additional | ||||||
Stargardt Disease | patients) ongoing | |||||||
IC-500(anti-HtrA1): | • | Plan to file IND in 2H 2022 | ||||||
GA secondary to AMD | ||||||||
Therapies | IC-200: | • | Plan to initiate Phase 1/2 in 2H 2021 | |||||
BEST1-related IRDs | ||||||||
miniCEP290: | • | Lead construct identified; planning | ||||||
IC-100: | • | Evaluating pre-clinical data; regulatory | ||||||
RHO-adRP | interaction planned | |||||||
Gene | LCA10 | development | ||||||
miniABCA4: | • | Additional results expected in 2Q 2021 | ||||||
Stargardt Disease* | ||||||||
AAV | ||||||||
miniUSH2A: | • | Preliminary results expected in 2H 2021 | ||||||
USH2A-related IRDs* | ||||||||
5 *We have an option to exclusively in-license intellectual property resulting from ongoing sponsored research.
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Iveric Bio Inc. published this content on 05 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 May 2021 14:21:04 UTC.