NASDAQ: KOD KODIAK.COM
THE OPHTHALMOLOGY MEDICINES COMPANY
January 2022
S P E C I A L N O T E R E G A R D I N G
FOR WARD-LOOKING ST ATEMENTS
These slides contain forward-looking statements and information. The use of words such as "may," "might," "will," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding: our ability to submit a BLA for KSI-301 in wet AMD, DME and RVO and a supplemental BLA in diabetic retinopathy; our platform technology and potential therapies; development plans; clinical and regulatory objectives and the expected timing thereof; expectations regarding the potential efficacy, labeling and commercial prospects of our product candidates; the anticipated timing of presentation of additional data; the results of our research and development efforts; planned manufacturing activities and expected manufacturing capacity; expectations regarding available capital resources; and our ability to advance our product candidates into later stages of development and potential commercialization. All forward-looking statements are based on management's current expectations, and future events are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the safety, efficacy and durability data for our KSI-301 product candidate may not continue or persist; cessation or delay of any of the ongoing clinical studies and/or our development of KSI-301 may occur, including as a result of the ongoing COVID-19 pandemic; future potential regulatory milestones of KSI-301, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; anticipated presentation of data at upcoming conferences may not occur when expected, or at all; our research and development efforts and our ability to advance our product candidates into later stages of development may fail; any one or more of our product candidates may not be successfully developed, approved or commercialized; adverse conditions in the general domestic and global economic markets, including the ongoing COVID-19 pandemic, which may significantly impact our business and operations, including out of our headquarters in the San Francisco Bay Area and our clinical trial sites, as well as the business or operations of our manufacturers, contract research organizations or other third parties with whom we conduct business; as well as the other risks identified in our filings with the Securities and Exchange Commission. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
2
T H E O P H T H A L M O L O G Y M E D I C I N E S C O M P A N Y
FOCUSED ON DEVELOPING ABC MEDICINES
FOR HIGH PREVALENCE RETINAL DISEASES
K S I - 3 0 1 A N D K S I - 5 0 1 F O R R E T I N A L V A S C U L A R D I S E A S E S
A G R O W I N G $ 1 2 . 5 B + M A R K E T W I T H C L E A R U N M E T N E E D S
- Wet age-related macular degeneration (wet AMD) remains a leading cause of vision loss in the elderly
- Diabetes is the leading cause of vision loss in working-age adults
- Novel agents such as KSI-301 are needed to provide long treatment-free durability and/or improve response to therapy
- KSI-501targets both VEGF & Interleukin-6; supplemental targeting of retinal microvascular inflammation through Interleukin-6 may be of additional clinical benefit
K S I - 6 0 1 T R I P L E T S F O R D R Y A M D
D R Y A M D I S 1 0 T I M E S M O R E P R E V A L E N T T H A N W E T A M D A N D H A S N O A V A I L A B L E T H E R A P I E S
- Dry AMD also frequently leads to irreversible vision loss, substantial functional vision limitations and loss of independence
- There are no available therapies for dry AMD; drugs targeting single pathways have repeatedly yielded no / limited efficacy
- Targeting multiple biological pathways - both intracellular and extracellular - as enabled by our triplet inhibitor technology may be required to achieve meaningful treatment for complex multifactorial diseases such as dry AMD
- Durability of a potential treatment will be key due both to chronic nature of the disease and size of the patient population and will be enabled by ABC Platform based triplets
T R I P L E T S F O R T H E N E U R O D E G E N E R A T I V E A S P E C T S O F G L A U C O M A
G L A U C O M A I S A L E A D I N G C A U S E O F I R R E V E R S I B L E B L I N D N E S S W O R L D W I D E
- Many patients experience progression of glaucoma and lose vision over time despite maximum medical therapy
- Available therapies today treat intraocular pressure, not the fundamental biology of retinal neural cell loss which is multifactorial in nature
- Our triplets technology is designed to target multiple intra- and extracellular pathways implicated in the neurobiology of glaucoma
- Durability of potential treatment will be key and will be enabled by ABC Platform based triplets
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KSI-301 clinical development: Where we are today
~2500 patients dosed, 6 pivotal studies, all 4 major anti-VEGF indications - wAMD, DME, RVO, NPDR
Initial BLA | 2019 | 2020 | 2021 | 2022 | 2023 | |||||
DAZZLE | 550 Patients; | Year 1 Primary Endpoint | Year 2 | |||||||
wAMD Phase 2b / 3 | ||||||||||
Q12-20WKSI-301 vs Q8W Eylea | ||||||||||
Enrollment Completed | ||||||||||
DAYLIGHT | ||||||||||
wAMD Phase 3 | 500 Patients | 10-month Primary | ||||||||
Enrolling | Q4W KSI-301 vs Q8W Eylea | Endpoint | ||||||||
(55% Complete) | ||||||||||
GLEAM | ||||||||||
DME Phase 3 | 450 Patients | Year 1 Primary Endpoint | Year 2 | |||||||
Enrolling | Q8-24WKSI-301 vs Q8W Eylea | |||||||||
(90% Complete) | ||||||||||
GLIMMER | ||||||||||
DME Phase 3 | 450 Patients | Year 1 Primary Endpoint | Year 2 | |||||||
Enrolling | Q8-24WKSI-301 vs Q8W Eylea | |||||||||
(95% Complete) | ||||||||||
BEACON | 550 Patients | 6-month | 6-month | 6-month | ||||||
RVO Phase 3 | Primary | open label | ||||||||
Q8W KSI-301 vs Q4W Eylea | H2H "PRN" | |||||||||
Enrollment Completed | Endpoint | extension | ||||||||
Supplemental BLA | ||||||||||
GLOW | ||||||||||
NPDR Phase 3 | 240 Patients | Year 1 | ||||||||
Enrolling | Q24W KSI-301 | vs Sham | ||||||||
(20% Complete) | ||||||||||
Primary Endpoint
Readout
1Q 2022
1Q 2023
1Q 2023
1Q 2023
3Q 2022
wAMD: wet age-related macular degeneration; DME: diabetic macular edema; RVO: retinal vein occlusion; NPDR: non-proliferative diabetic retinopathy; | 4 |
BLA, biologics license application; sBLA, supplemental BLA; H2H, head to head; PRN, pro re nata | |
Broadest label KSI-301 program: includes a wide range of dosing intervals to maximize flexibility and reimbursement confidence for physicians and patients
Wet AMD
C o m p ar a t or
Aflibercept
once every 2 months
after 3 monthly loading doses
DAZZLE Study1
KSI-301
once every 3, 4 or 5 months after 3 monthly loading doses
5 | 2 |
Minimum | Minimum |
doses in | doses in |
Year 1a | Year 2a |
Wet AMD
Comparator
Aflibercept
once every 2 months
after 3 monthly loading doses
DAYLIGHT Study2
KSI-301
once every month
Monthly Dosinga
Diabetic
Macular Edema
Comparator
Aflibercept
once every 2 months after 5 monthly doses
GLEAM and
GLIMMER Studies3
KSI-301
once every 2 to 6 months
after 3 monthly loading doses
4 | 2 |
Minimum | Minimum |
doses in | doses in |
Year 1a | Year 2a |
Retinal Vein Occlusion
Comparator
Aflibercept
once every month
BEACON Study4
KSI-301
once every 2 months or longer after 2 monthly loading doses
4
Minimum doses
in Year 1a
Non-Proliferative
Diabetic Retinopathy
Comparator
Sham
GLOW Study5
KSI-301
once every 6 months after 3 initiating doses
4 | 2 |
Doses in | Doses in |
Year 1a | Year 2a |
Once every 4-20 weeks | Once every 4-24 weeks |
Targeted label at launch
Once every 4-8 weeks
Once every 24 weeks
Targeted label with sBLA
1. NCT04049266. 2. NCT04964089. 3. NCT04611152 and NCT04603937. 4. NCT04592419. 5. NCT05066230 a. Based on study design; sBLA: supplemental BLA 5
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Kodiak Sciences Inc. published this content on 10 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2022 16:47:11 UTC.