Investor Presentation
July 2024
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
Legal Disclaimers
Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limited to statements about the sufficiency of our existing cash resources through topline data for Phase 3 clinical trials for DURAVYU in wet AMD; our expectations regarding the timing and clinical development of our product candidates, including DURAVYU and EYP-2301; the potential for DURAVYU as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration, non-proliferative diabetic retinopathy and diabetic macular edema; and our longer term financial and business goals and expectations, are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward- looking statements are risks and uncertainties inherent in our business including, without limitation: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; our ability to access needed capital; termination or breach of current and future license agreements; our dependence on contract research organizations and other outside vendors and service providers; effects of guidelines, recommendations and studies; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of our stock price; possible dilution; absence of dividends; the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
2 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
Phase 3 Clinical Stage Company Pursuing Multi-Billion Dollar Markets
Phase 3
Asset
Compelling
Pipeline
Proven
Technology
Strong
Balance
Sheet
3 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
DURAVYU (vorolanib intravitreal insert)
Multi-billion-dollar market opportunities
Proprietary Durasert E drug delivery technology
~$280M of cash and investments1
No debt
1-Unaudited estimate for June 30, 2024
DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.
Potential Multi Billion-Dollar Product Opportunities Leveraging Innovative Drug Delivery Technology, Bioerodible Durasert E
Durasert E Programs | Indication | Discovery | Pre-Clin | Phase 1 | Phase 2 | Phase 3 | Next Milestone |
Wet AMD | STATISTICALLY NON-INFERIOR TO SOC | First Phase 3 Trial | |||||
patient randomized | |||||||
2H 2024 | |||||||
DURAVYU (EYP-1901) - | BIOLOGIC EFFECT WITH | ||||||
vorolanib in Durasert E | NPDR | 12-month data Q3 | |||||
(tyrosine kinase inhibitor) | CONTINUED FAVORABLE SAFETY | 2024 | |||||
DME | FULLY ENROLLED | Topline data in | |||||
Q1 2025 | |||||||
EYP-2301 - razuprotafib in | serious retinal | Pre-clin tox and PK | |||||
Durasert E | |||||||
diseases | data | ||||||
(TIE-2 agonist) | |||||||
Complement inhibition | GA | Potential product | |||||
candidate in 2024 | |||||||
non-clinical | trial underway | ||
4 | ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. | wet AMD, wet age-related macular degeneration; EOP2, End of Phase 2; FPI, first patient in; NPDR, | |
non-proliferative diabetic retinopathy; DME, diabetic macular edema; GA, geographic atrophy | |||
TECHNOLOGY
BIOERODIBLE DURASERT E
Safe, Sustained-Release IVT Drug Delivery
- Delivered via a standard in-office IVT injection
- Continuous, daily therapeutic dose
- Zero-orderkinetics drug release
Durasert E : bioerodible
- Drug embedded within a bioerodible matrix as a solid insert
-
Designed to deplete drug load before matrix fully erodes
‣ DURAVYU
5 | ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. | IVT, intravitreal |
5 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
Vorolanib is a Potent and Highly Selective Pan-VEGF Receptor Inhibitor
- Best-in-classTKI
- Composition of matter patent into 2037
- Demonstrated neuroprotection
- Potential antifibrotic
- Does not inhibit TIE-21
6 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
ANG2 | VEGFB | VEGFA | VEGFC | |
PLGF | ||||
ANG1 | VEGFD | PDGF | ||
TIE2 | VEGFR1 | VEGFR2 | VEGFR3 | PDGFR | |||||
VOROL ANIB | |||||||||
Blood vessel | Angiogenesis, | Proliferation, | |||||||
permeability, leakage, growth, | |||||||||
stability | migration, and proliferation | motility | |||||||
Endothelial cell | Pericyte |
1. Sophie Bakri, M.D., et al. PLOS ONE,https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0304782, 2024.
VEGF(R), vascular endothelial growth factor (receptor); TKI, tyrosine kinase inhibitor;
PDGF(R), platelet-derived growth factor (receptor); TIE-2,tyrosine-protein kinase receptor
DURAVYU: Vorolanib in Bioerodible Durasert E
Insert is ~1/5000 of vitreous
volume and >90% drug
- Immediately bioavailable
- Controlled release for at least six months enables redosing regimen
- No free-floating drug - fully eluted prior to bioerosion of matrix
- Routine, in-office intravitreal injection
- Shipped and stored at ambient temperature
7 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
DURAVYU Demonstrated Clinically Meaningful Safety and Efficacy Outcomes Across Multiple Indications
DURAVYU HAS BEEN EVALUATED IN 191 PATIENTS TO DATE ACROSS DIFFERENT INDICATIONS
Trial Indication
DAVIO | wet AMD | |
DAVIO 2 | wet AMD |
PAVIANPDR
VERONA1DME
Safety
Favorable
safety profile
No DURAVYU
related ocular or systemic SAEs
Key Efficacy Outcomes
- Stable BCVA and OCT
- 74% reduction in treatment burden
- Statistically non-inferior BCVA
- >80% reduction in treatment burden
- Stable OCT
- Stable to improved disease severity up to 9- months; trial continuing 12 months
- Trial underway
1. Interim, masked safety as of June 2024
8 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.Wet AMD, wet age-related macular degeneration; NPDR, non-proliferative diabetic retinopathy; DME, diabetic macular edema
Phase 2 DAVIO 2 Clinical Trial 6-Month Topline Results in wet
AMD
A NON-INFERIORITY TRIAL VERSUS AN AFLIBERCEPT CONTROL
©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved.
DAVIO 2 Clinical Trial is Randomized, Double-Masked, Aflibercept Controlled* with a Single DURAVYU Treatment at Two Doses
-D14 to -D7 | D1 | W4 | W8 | W12 | W16 | W20 | W24 | W28 | W32 W36 to W56 |
DURAVYU 2mg low dose n=53
DURAVYU 3mg high dose n=54
Aflibercept 2mg q8W n=54
R A N D O MI Z A T I O N | AFLIBERCEPT q8W | ||||
DURAVYU/AFLIBERCEPT | 1⁰ ENDPOINT BLEND W 28 | ||||
AND W 32; UNMASK W 32 | |||||
SUPPLEMENTAL ANTI - VEGF INJECTION | |||||
BASED ON PRE - SPECIFIED CRITERIA | |||||
REQUIRED AFLIBERCEPT | VISIT | DURAVYU DOSE | SHAM INJECTION FOR MASKING | ||
INJECTION VISIT | SCHEDULED | ||||
10 ©2024 EyePoint Pharmaceuticals, Inc. All Rights Reserved. | *Aflibercept on-label control required by FDA |
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EyePoint Pharmaceuticals Inc. published this content on 09 July 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 July 2024 21:50:02 UTC.