KODIAK SCIENCES INC. SPECIAL NOTE REGARDING
FORWARD-LOOKING STATEMENTS
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 2022 Vision; our ability to submit a BLA for KSI-301 in wet AMD, DME, RVO and potentially diabetic retinopathy in 2022; the potential licensure of KSI-301 in the U.S. and EU in 2023; our platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof; the anticipated design of our clinical trials and regulatory submissions; expectations regarding the potential efficacy and commercial prospects of our product candidates; the anticipated presentation of additional data; the results of our research and development efforts; 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; 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.
KSI-301 CLINICAL EXPERIENCE
Clinical data from ~2,000 injections in ~500 patients representing ~350 patient-years of exposure in representative populations in wAMD, DME and RVO
▪ Safety: Tracking with current standard of care (Lucentis, Eylea)
▪ Efficacy: Vision & retinal anatomy improvements in line with current anti-VEGF agents
▪ Durability: 2 in every 3 patients going 6-months or longer between doses in wet AMD, DME and RVO
OPTIMIZED PIVOTAL STUDY PROGRAM
Objective to show disruptive durability with same safety and efficacy as Eylea
DAZZLE wet AMD study enrollment complete; BEACON RVO study and GLEAM & GLIMMER DME now enrolling - Data from all studies expected in 2022
Pivotal studies designed from phase 1b data with high dose (5.0 mg), high statistical power, tighter criteria for disease activity assessments, tighter dosing interval ranging, maintaining similar (80%+) U.S. treatment naïve population
OPERATING WITH CONVICTION
On track for a single BLA filing in the key indications of wAMD, DME, RVO treatment and with NPDR indication in a supplemental
Manufacturing investments aligned to clinical opportunity with commercial supply goal of 2.5M+ Prefilled Syringes in Year 1 of launch
Developing bispecific and triplet ABC Medicines for multi-mechanism diseases, including dry AMD and glaucoma
POISED COMMERCIAL OPPORTUNITY
Competitive landscape is clearing with competing molecules/technologies demonstrating poor risk-benefit profiles
We believe KSI-301 may be able to capture market share from standard of care agents, futurebiosimilars, and competing late-stage molecules in development
THE OPHTHALMOLOGY MEDICINES COMPANY
OUR MISSION
1
TRAILBLAZING | 2 GENERATION 2.0 | 3 SINGULAR FOCUS IN |
SCIENCE | MEDICINES | OPHTHALMOLOGY |
Our creative and | Our challenge to the | Our 24 / 7 / 365 |
thoughtful foundation | status quo |
A PIPELINE OF ABC S FOR RETINA
Kodiak's deepening pipeline of mono-, bi-specific and triplet inhibitors that merge biologics with small molecules to address major causes of vision loss beyond retinal vascular disease
MONOSPECIFIC
1 Molecule, 1 Target
Antibody conjugated to phosphorylcholine biopolymer
KSI-301 inhibits VEGF-
In Phase 3 clinical development
BISPECIFIC
1 Molecule, 2 Targets
Bispecific antibody conjugated to phosphorylcholine biopolymer
TRIPLET
1 Molecule, 3 Targets
KSI-501 inhibits VEGF and IL-6 for retinal diseases with inflammatory component - IND planned 2021
Bispecific antibody conjugated to phosphorylcholine biopolymer embedded with 100's of copies of small-molecule drug
KSI-601 for high-prevalence multifactorial diseases, such as dry AMD - IND planned 2022
THE OPHTHALMOLOGY MEDICINES COMPANY
FOCUSED ON DEVELOPING ABC MEDICINES FOR HIGH PREVALENCE RETINAL DISEASES
KSI-301 AND KSI-501 FOR RETINAL VASCULAR DISEASES
A GROWING $11B MARKET WITH CLEAR UNMET NEEDS
▪ Wet age-related macular degeneration (wet AMD) remains a leading cause of blindness in the elderly
▪ Diabetes is the leading cause of blindness 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-501 targets both VEGF & Interleukin-6; supplemental targeting of retinal microvascular inflammation through Interleukin-6 may be of additional clinical benefit
KSI-601 TRIPLETS FOR DRY AMD
DRY AMD IS 10 TIMES MORE PREVALENT THAN WET AMD AND HAS NO AVAILABLE THERAPIES
▪ Dry AMD frequently leads to irreversible vision loss and substantial functional vision limitations
▪ 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
TRIPLETS FOR THE NEURODEGENERATIVE ASPECTS OF GLAUCOMA
GLAUCOMA IS A LEADING CAUSE OF IRREVERSIBLE BLINDNESS WORLDWIDE
▪ 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
Recommended dosing in first year:
IN THEORY
Ranibizumab
Aflibercept
12
monthly
8
bi-monthly after 3 monthly loading doses
Intravitreal anti-VEGF agents improve & maintain vision when dosed per label…
PHASE III STUDY OF MONTHLY ANTI-VEGF 1
MARINA1
MEAN CHANGE IN
BCVA MeanChangeinVA
MONTH
1. Rosenfeld PJ et al; MARINA Study Group. N Engl J Med. 2006;355:1419-14313.
IN PRACTICE
…yet in the real word, visual gains are minimal and not maintained.
Patients cannot be treated frequently enough and are over-extended between doses in the real world.
Without continuous high-intensity treatment, vision loss can begin after only 3 months of anti-VEGF therapy.
This pattern is seen globally and with all current medicines.
MEANCHANGEINVA
10
EUROPE 1
(N = 2,227 patients)
BYCOUNTRY
5
No. of injections in 2 years
9.0 UK
8.7 NETHERLANDS
0
-5
5.6 GERMANY
6.3 FRANCE
DAYS
5.2
ITALY
4 years
2 years
1 Year
6
12
18
24
30
36
MONTHS
42
48
1. The AURA Study, adapted from Holz FG et al. Br J Ophthalmol 2015; 99 (2): 220-226.
3 years
2. Adapted from SIERRA-AMD, Khanani A, et al. Ophthal. Retina 2020 Feb; 4(2):122-123. EMR= Electronic Medical Records
WHY?
Bimonthly anti-VEGF therapy results in disease activity between doses due to insufficient durability.
Current, Generation 1.0 agents do not provide disease control for long enough between doses.
Undertreatment leads to disease progression and permanent retinal damage.
AFLIBERCEPT VIEW STUDIES 1
1. Heier JS. Ophthalmology. 2012 Dec;119(12):2537-48.
WHAT PROFILE MAY BE REQUIRED TO MEANINGFULLY CHANGE THE CURRENT PARADIGM?
Profile
Maintenance Phase
Durability
Loading Phase
Efficacy Profile
Safety Profile
wAMD: >50% reach Q20W
DME: >50% reach Q20W
5 to 6 months predominant
RVO: Non-inferior with Q8W
≤ 3 loading doses
NPDR: Compelling efficacy at 2x / year wAMD: >50% reach Q16W or better
DME: >50% reach Q16W or better
4 to 5 months predominant
RVO: Non-inferior with Q8W
NPDR: Compelling efficacy at 3x / year
≤ 3 loading doses
wAMD, DME, and RVO: Non-inferior to comparatorNPDR: 2 step change and / or lower event rate
wAMD, DME, and RVO: Non- inferior to comparatorNPDR: 2 step change and / or lower event rate
Safety profile is in line with aflibercept and ranibizumab
Safety profile is in line with aflibercept and ranibizumabwAMD: 33% Q8W, 33% Q12W, 33% Q16W
DME: >50% better than Q12W
3 to 4 months predominant
RVO: Non-inferior with Q8W
NPDR: Compelling efficacy at 4x / year
≥ 3 loading doses
wAMD, DME, and RVO: Non-inferior to comparatorNPDR: 2 step improvementSafety profile may be worse than aflibercept and ranibizumab
DISRUPTIVE DURABILITY WITH AN INTRAVITREAL BIOLOGIC:
2/3 OF PATIENTS ON A ≥6-MONTH TREATMENT-FREE INTERVAL AT YEAR 1 IN WET AMD, DME AND RVO
Interval at Year 1
Wet AMD N = 50 | DME RVO N = 32 N = 32 |
1 month
2 months
3 months
4 months
5 months
2% 14% 6% 4% 8%
3% 3%
3% 9%
9% 13%
6% 6%
9% 3%
≥6 months
66%
69%
66%
Mean # Injections during Year 1
5.0 (3 loading + 2.0 individualized) | 4.0 4.7 (3 loading + 1.0 individualized) (3 loading + 1.7 individualized) |
Safety and efficacy data in line with today's first-line medicines
Phase 1b interim data. 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52.
YEAR 1 DATA: EFFICACY ALIGNED WITH TODAY'S MEDICINES WITH MEANINGFULLY FEWER INJECTIONS
Year 1 Doses
Visual Acuity
Retinal Anatomy (OCT CST)
Mean △ From Baseline at Year 1
Mean BCVA | Mean △ From | Mean OCT |
at Year 1 | Baseline at Year 1 | CST at Year 1 |
69.7 | -105 | 345 |
73.9 | -136 | 317 |
+22.2 | 76.6 | 318 |
ETDRS Letters |
Microns
Interim data; 2.5 & 5 mg doses pooled. Observed data, includes only patients that received all (3) loading doses and reached Week 12 or later. Individualized doses reflect the number of injections received per patient between Week 12 and 48 inclusive. OCT CST site reported and includes the PED height for wet AMD. CST= central subfield thickness.
FOCUS ON KSI-301
YEAR 1 DATA: VISION IMPROVEMENTS SEEN IN ANTI-VEGF STUDIES ARE DEPENDENT ON BASELINE VISION
WET AMD ~YEAR 1 BCVA
BCVA(Letters)
80
60
70
50
65
75
55
Aflib 2 mg
KSI-301 2.5/5mgFari 6 mg
DME YEAR 1 BCVA
BCVA(Letters)
80
60
70
50
65
75
55
Ranib 0.3 mg
Aflib 2 mgFari 6 mgBrolu 6 mgAflib 2q8
Brolu 3 mgBrolu 6 mgAflib 2q8
Aflib 2q8
Aflib 0.5q4
Aflib 2q4
Ranib 0.5q4
Aflib 2q4
Aflib 0.5q4
Aflib 2q8
Ranib 0.5q4
KSI-301 2.5/5mgFari PTIFari 6q8
Aflib 2q8
Fari PTIFari 6q8
Aflib 2q8
Aflib 2q4
Aflib 2q8
Aflib 2q4
Aflib 2q8
Ranib 0.3 mgRanib 0.5 mgRanib 0.5 mg
Study designs, including inclusion / exclusion criteria, dosing regimens, cohort designs, comparator and other criteria may differ significantly among studies, BCVA = best-corrected visual acuity, Fari = faricimab, Brolu = Brolucizumab, Aflib = aflibercept, Ranib = ranibizumab 52 week data for KSI-301; primary endpoint data for all other studies, typically ~48-52 weeks except for faricimab wAMD which was 36-40-44 weeks
SAME WHERE IT MATTERS
o Clinically proven targets
o Antibody-based biologic
o Intravitreal: 25M+ injections annually
o Optically clear, no residues
o Fast and potent clinical responses
DIFFERENT WHERE IT COUNTS
o Designed-in ocular durability
o Designed-in rapid systemic clearance
o Improved bioavailability
o Improved biocompatibility
o Improved stability
GENERATION 2.0 ANTI-VEGF
KSI-301: AN ANTI-VEGF ABC
KSI-301's high molecular weight & formulation strength can provide an important dosing advantage
Drug: | RANIBIZUMAB (Lucentis) | AFLIBERCEPT (Eylea) | BEVACIZUMAB (Avastin) |
Molecule type | Antibody fragment | Recombinant fusion protein | Antibody |
Molecular structure | |||
Molecular weight | 48 kDa | 115 kDa | 149 kDa |
Clinical dose | 0.3-0.5 mg | 2 mg | 1.25 mg |
Equivalent molar dose | 0.5 | 1 | 0.9 |
Equivalent ocular PK | 0.7 | 1 | 1 |
Equivalent ocular concentration at 3 months | 0.001 | 1 | NA1 |
Equivalent values are showed as fold changes relative to aflibercept. kDa= kilodalton 1. Lower affinity of bevacizumab precludes a useful comparison
KSI-301 ANTIBODY BIOPOLYMER CONJUGATE
"MORE THAN THE SUM OF ITS PARTS"
Artistic representation Electron microscopeof KSI-301
image of KSI-301
Class-leading Intraocular
Deeper Inhibitory
Fast Systemic
Half-life1
Excellent Retinal Bioavailability2
Potency3
Clearance4
1. Data from rabbit model. Ranibizumab data: Gaudreault et al (2007) IOVS 46(2) 726 Gaudreault et al (2007) Retina 27(9) 1260 Bakri et al (2007) Ophthalmol 114(12) 2179 || Aflibercept data: EVER Congress Portoroz Slovenia (2008) Struble (Covance) Koehler-Stec (Regeneron). Aflibercept data adjusted arithmetically to reflect 2,000µg dose administered (based on rabbit in vivo dosing of 500 µg) || KSI-301 data on file, adjusted arithmetically to reflect 5,000 µg dose administered (based on rabbit in vivo dosing of 725 µg). Error bars reflects standard error of the mean
2. Covance rabbit ADME (absorption, distribution, metabolism, elimination) model: Aflibercept data (2008): EVER Congress Portoroz Slovenia Struble (Covance), Koehler-Stec (Regeneron). KSI-301 data (2017): Covance study, data on file. Error bars reflects standard error of the mean
3. KSI-301 data: data on file; Bevacizumab data: Yeung et al 2010 Cancer Research.
4. KSI-301 data: Non-human primate toxicology study, data on file; Bevacizumab data: Yeung et al 2010 Cancer Research.
OUR GOAL WITH KSI-301
Develop KSI-301 as a meaningfully differentiated first-line treatment in each retinal vascular disease
Patient & Patient's Family
Retina Specialist & Care TeamRetina Practice OwnerPayor
Better meet the individual needs of key stakeholders globally
Health System
We are developing KSI-301 to be first line in the 4 major retinal vascular diseases
Target enrollment exceeded
Recruitment closed
Wet AMDNow Recruiting
First patients randomized in GLEAM / GLIMMER and BEACON
Diabetic Macular Edema
Retinal Vein OcclusionEnrollment Start 1H 2021
Planned
Non-Proliferative Diabetic Retinopathy
KSI-301 pivotal studies enroll treatment-naïve patients and incorporate key learnings from our
Phase 1b study, supporting a high level of confidence in our KSI-301 development program
KSI-301 COMMERCIAL MANUFACTURING
BUILDING CAPACITY TO SUPPLY RAPID MARKET UPTAKE
Expected Year 1 manufacturing capacity to supply 2.5M+ doses with the ability to flex up to 15M+ doses
Integrated global pharmaceutical supply chain
Purpose-built Lonza IBEX Dedicate bioconjugation facility to support commercial launch
Case study on market adoption
Can Eylea market share growth educate KSI-301 adoption?
Worldwide anti-VEGF revenue
Billions of USD
8
6
4
2
0
2010
2011
2012
2013
2014
Kodiak aims to submit a single BLA for KSI-301 in wet AMD, DME and RVO in calendar year 2022
Company financial disclosures and product labeling
EYLEA Approval Date
U.S: wAMDU.S: CRVO EU: wAMDEU: CRVOU.S.: BRVO US & EU: DME
OUR 2022 VISION
3 BLA (wAMD, DME and RVO) 3
Indications submitted in
Clinical molecules
1 IND per year beginning 2021
MILESTONES AND KSI-301 DEVELOPMENT ACCELERATION
2019
KSI-301
✓
Safety, efficacy, durability proof-of-concept established
✓ Initiation of DAZZLE wAMD pivotal study
✓ FDA EOP2 meeting
✓ $225MM royalty financing
✓ $317MM equity financing
2020
KSI-301
✓ Additional readouts of Phase 1b data
✓ Maturation of data support pivotal clinical studies
✓ Manufacturing framework to supply millions of doses in first year of launch
✓ Initiate two DME Phase 3 trials (GLEAM & GLIMMER)
✓ Initiate RVO Phase 3 trial (BEACON)
✓ Complete enrollment in wAMD (DAZZLE)
✓ $645MM equity financing
2021
KSI-301
✓ Presentation of one-year
Phase 1b results in wet AMD, DME and RVO
• Initiate NPDR Phase 3 trial (GLOW)
• Complete enrollment in DME (GLEAM & GLIMMER) and RVO (BEACON) studies
• DAZZLE wet AMD last patient last visit for primary endpointKSI-501 (bispecific ABC)
• Submit IND
2022
KSI-301
• DAZZLE wAMD pivotal study top-line readout
• RVO pivotal study (BEACON) top-line readout
• DME pivotal studies (GLEAM & GLIMMER) top- line readouts
• Submit BLA for wAMD, DME and RVO
KSI-501
• Phase 1/2 data in inflammatory retinal diseases
KSI-601 (triplet ABC) for dry AMD
• Submit IND
2023
KSI-301
• Potential regulatory approval for wAMD, DME and RVO in US and EU
• Potential commercial launch for wAMD, DME, RVO in US
• DR pivotal study (GLOW) readout
• Submit sBLA for DR pivotal study (GLOW)
KSI-501
• Additional readouts of Phase 1/2 data
KSI-601
• Initiate Phase 1/2 study
AchievedPotential Milestones 2021 - 23
KSI-301 Accelerated Development Strategy
4 Pivotal Studies to support BLA with All 3 Major Anti-VEGF Indications Run Concurrently
2019 | 2020 | 2021 | 2022 | 2023 |
Phase 1b Ongoing | 121 treatment-naïve wAMD, DM Safety, efficacy, durability - 18 m | , RVO patients onths follow-up | U.S. commercial launch A | |
DAZZLE Pivotal wAMD Target Enrollment Exceeded | ~550 Q12W | treatment naïve patients -Q20W KSI-301 vs Q8W Eylea | 12-month endpoint | |
GLEAM DME Phase 3 Recruiting | ~450 trea Q8W-Q24 vs Q8W E | tment naïve pts. W KSI-301 ylea 12-m | nth endpoint Single BL | |
GLIMMER DME Phase 3 Recruiting | ~450 trea Q8W-Q24 vs Q8W E | tment naïve pts. W KSI-301 ylea 12-mo | 2022 nth endpoint | |
BEACON RVO Phase 3 Recruiting | ~550 trea or CRVO Q8W KSI | tment naïve BRVO patients 301 vs Q4W Eylea 6-mo endp | nth oint | |
GLOW DR without DME Phase 3 In Planning | ~240 patients Q24W KSI-301 after 3 i injections vs Sham | itiation 12-month | ndpoint sBLA 2023 |
BLA: biologics license application; RVO: retinal vein occlusion; BRVO: branch RVO; CRVO: central RVO; wAMD: wet age-related macular degeneration; DME: diabetic macular edema; DR: diabetic retinopathy
KSI-301
Clinical Data
130 patients dosed in Phase 1a/1b Program 168+ patient years of clinical experience
wAMD (n=51)
DME (n=35)
Randomized 1:3
KSI-301 2.5 mg (50 mL)
KSI-301 5 mg (100 mL)
Loading Phase | Durability Assessment Phase | Extension Study |
Weeks
0 | 4 | 8 | 12 to 72 (months 3 to 18) | 76 to 148 (months 19 to 36) |
Monthly monitoring with protocol guided retreatment | Monthly monitoring with protocol guided retreatment |
wAMD = wet age-related macular degeneration; DME = diabetic macular edema; RVO = retinal vein occlusion; Clinicaltrials.gov ID: NCT03790852
Fixed Treatment
KSI-301 Phase 1b Retreatment Criteria
▪ wAMD
- Increase in CST ≥75 µm with a decrease in BCVA of ≥ 5 letters compared to Week 12, OR
- Decrease in BCVA of > 5 letters compared to Day 1, due to worsening wAMD activity, OR
- Decrease in BCVA of ≥ 10 letters compared to the best prior BCVA, due to worsening wAMD activity, OR
- 6 months have elapsed since the last retreatment
▪ DME and RVO
- Increase in CST ≥75 µm with a decrease in BCVA of ≥ 5 letters compared to Week 12 or the prior visit, OR - Decrease in BCVA of ≥ 10 letters compared to the best prior BCVA, due to worsening DME/RVO disease activity
For all subjects, investigators can retreat at their discretion if significant disease activity is present that does not meet the above criteria
wAMD = wet age-related macular degeneration; DME = diabetic macular edema; RVO = retinal vein occlusion; CST = central subfield retinal thickness; BCVA = best corrected visual acuity. Clinicaltrials.gov ID: NCT03790852
Variable | wAMD Cohort (n=51) | DME Cohort (n=35) | RVO Cohort (n=35) |
Age, mean (SD), years | 77.9 (10.5) | 59.7 (11.7) | 63.6 (12.6) |
Gender, n (%), female | 32 (62.7) | 14 (40.0) | 13 (37.1) |
Race, n (%), White | 48 (94.1) | 28 (80.0) | 31 (88.6) |
BCVA, mean (SD), ETDRS letters | 63.3 (13.3) | 66.8 (10.2) | 54.9 (15.4) |
Snellen equivalent | ⁓20/50 | ⁓20/50 | 20/80 |
Snellen 20/40 or better, n (%) | 20 (39.2) | 16 (45.7) | 6 (17.1) |
OCT CST, mean (SD), microns | 450 (182) | 453 (110) | 675 (237) |
Includes all patients randomized. SD= standard deviation; BCVA= best corrected visual acuity; OCT= optical coherence tomography; CST= central subfield thickness
KSI-301 Phase 1b
wAMD Year 1 Data
BCVA ETDRSletters
52
0
4
8
12
16
20
500
24 Weeks 28
32
36
40
44
48
OCT CST microns
300
-105 |
N=50
3.0 | 2.0 |
Loading doses
Individualized doses
Interim data; 2.5 & 5 mg doses pooled. Observed data, includes only patients that received all (3) loading doses and reached Week 12 or later. Error bars represent standard error of the mean. Individualized doses reflect the number of injections received per patient between Week 12 and 48 inclusive. OCT CST site reported and includes the PED height. CST= central subfield thickness.
BCVA ETDRSletters
0
4
8
12
16
20
24
28
32
36
40
44
48
52
Interim data; 2.5 & 5 mg doses pooled. Observed data, include only patients that received all (3) loading doses and reached Week 12 or later. Error bars represent standard error of the mean. OCT CST site reported and includes the PED height for the overall wAMD cohort. High PED defined as >500 microns of CST in the presence of a PED; CST= central subfield thickness.
OCT CST microns
n= 50 Overall n= 45 Without high PEDs
100
Percentageofpatients (%)
80
54% of patients required only1 retreatment
60
54.0
40
20
0
1
2
3
Number of individualized doses in Year 1
Interim data; 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and received a dose before Week 52. Individualized doses reflect the number of injections received per patient between Week 12 and 48 inclusive. N=50
4
5
6+
100
Percentageofpatients (%)
80
66% of patients were on a 6-month treatment-free interval at Year 1
60
66.0
40
20
14.0
2.0
0
1 month
2 months
6.0
3 months
4.0
4 months
Treatment interval at Year 1
8.0
5 months
6 months
Interim data. 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Treatment interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52. N=50
Loading | Year 1 | Year 2 |
Overall Time on Study (weeks)
0
8
16
24
32
40
48
56
64
72
80
88
96
104
KSI-301 3
2.5 mg (n=12)
KSI-301 5 mg (n=38)
Total
(n=50)
11
1
5
7
9
11
1
3
5
7
9
13
15
17
19
21
23
25
27
29
31
33
35
37
≤2-month interval3-month interval
4-month interval5-month interval
Capped retreatment at 6 monthsCurrent follow-up (<6 months)Discontinuation
Interim data. Includes only randomized patients that reached the first retreatment opportunity (Week 12 visit). Each bar represents an individual patient. *Treatment intervals include only patients that received all (3) loading doses and received a dose before Week 52. Interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52. Interim data as of 29 Jan 2021
Interval at Year 1* | n=50 |
1 month | 2% |
2 months | 14% |
3 months or longer | 84% |
4 months or longer | 78% |
5 months or longer | 74% |
6 months | 66% |
80% have achieved a 6-month treatment-free interval at least once during follow-up
(Pre-Treatment)
Day 1
From Phase 1b Study
OCT Images
4 total injections in Year 1
Week 12 +8 letters
Week 32 +12 letters
Treatment Given
Week 56 +11 letters
3 Loading doses
Day 1
Week 4
Week 8
1 month after 3 loading doses
6 months after 3 loading doses
6 months after the last retreatment
Benchmarking in treatment-naïve wAMD: KSI-301 Phase 1b
"Generation 2.0" durability compared to Eylea long-interval RCT and Faricimab TENAYA/LUCERNE
75
ProportionofPatients OnEachTreatmentInterval(%)
Eylea RIVAL StudyKSI-301 Phase 1b Study (Year 1)Faricimab TENAYA / LUCERNE 60
45
30
15
0
4
6
8
10
12
16
20
24
Treatment Interval (Weeks)
1. Gillies MC, et al. Effect of Ranibizumab and Aflibercept on Best-Corrected Visual Acuity in Treat-and-Extend for Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2019;137(4):372-379. doi:10.1001/jamaophthalmol.2018.6776
2. Angiogenesis 2021 Presentation: Faricimab Phase 3 Topline Results in Exudative AMD - Jeffrey S. Heier, MD
3. For KSI-301: Treatment intervals include only patients that received all (3) loading doses and received a dose before Week 52. Interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available)
or the last interval before Week 52.
KSI-301 Phase 2b/3 wAMD DAZZLE Study
Dosing with KSI-301 as infrequently as every 20 weeks*
Wet AMD - Phase 1b
80% have achieved a 6-month treatment-free interval at leastonce during follow-up
Interval at Year 1 | Percentage (n=50) |
1 month | 2% |
2 months | 14% |
3 months or longer | 84% |
4 months or longer | 78% |
5 months or longer | 74% |
6 months | 66% |
DAZZLE pivotal study evaluates individualized
dosing of every 12, 16 or 20 weeks
KSI-301 injectionKSI-301 individualized treatment/Sham
Aflibercept injectionDisease Activity AssessmentSham injection
*After the loading phase. Clinicaltrials.gov ID NCT04049266, currently in late stages of recruitment
Interim data. Includes only randomized patients that reached the first retreatment opportunity (Week 12 visit).Treatment intervals include only patients that received all (3) loading doses and received a dose before Week 52. Interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52.
How do DAZZLE Study Disease Activity Assessment Criteria Compare to Phase 1b?
Parameters | Phase 1b Study1 | DAZZLE study2 | Change |
Visual and anatomical | Increase in CST ≥75 µm with a decrease in BCVA of ≥ 5 letters compared to Week 12, OR | Increase in CST ≥50 µm with a decrease in BCVA of ≥ 5 letters compared to Week 12, OR | Tighter CST control (25 microns) |
Visual only | Decrease in BCVA of ≥ 10 letters compared to the best prior BCVA, due to worsening wAMD activity, OR | Decrease in BCVA of ≥ 10 letters compared to the best prior BCVA, due to worsening wAMD activity, OR | No change |
Decrease in BCVA of > 5 letters compared to Day 1, due to worsening wAMD activity | N/A | Eliminated to reduce subjectivity and unnecessary retreatments | |
Anatomical only | N/A | Increase of ≥ 75 microns compared to Week 12, OR | Added two anatomical-only criteria |
N/A | New Macular Hemorrhage |
wAMD = wet age-related macular degeneration; CST = central subfield retinal thickness; BCVA = best corrected visual acuity.
1 Clinicaltrials.gov ID: NCT03790852
2 Clinicaltrials.gov ID NCT04049266
DAZZLE protocol optimization
▪ Building from the exploratory Phase 1b, DAZZLE maintains consistency of key features while further optimizing protocol design
1. Similar patient population - treatment naïve wAMD (~80% from USA)
2. Tighter dosing interval ranging - from Q4W-Q24W to Q12W-Q20W
3. Tighter disease control - tighter disease activity assessments to determine patients' dosing intervals
4. Decreased subjectivity - no physician discretion treatment (IRT driven)
5. High statistical power for non-inferiority (>90%)
6. High dose (5.0 mg) selected for pivotal study
KSI-301 Phase 1b
DME Year 1 Data
BCVA ETDRSletters
12
0
4
500
450
OCT CST microns
8
16
20
24 Weeks28
32
36
40
44
48
52
400
350
300
N=32
250
3.0 | 1.0 |
Loading doses
Individualized doses
Interim data; 2.5 & 5 mg doses pooled. Observed data, includes only patients that received all (3) loading doses and reached Week 12 or later. Error bars represent standard error of the mean. Individualized doses reflect the number of injections received per patient between Week 12 and 48 inclusive. OCT CST site reported. CST= central subfield thickness.
-136
100
Percentageofpatients (%)
80
50% of patients did not requireany retreatment
60
50.0
40
20
0
0
1
2
Number of individualized doses in Year 1
Interim data; 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Individualized doses reflect the average number of injections received per patient between Week 12 and 48 inclusive. N=32
3
4
5
6+
100
Percentageofpatients (%)
80
60
69% of patients were on a 6-month or longer treatment-free interval at Year 1
40
20
68.8
9.4
3.1
0
3.1
1 month
2 months
3 months
6.3
4 months
Treatment interval at Year 1
9.4
5 months
6 months or longer
Interim data. 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Treatment interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52. N=32
0
Loading | Year 1 | Year 2 |
Overall Time on Study (weeks)
8
16
24
32
40
48
56
64
72
80
88
96
104
1
KSI-301 3
2.5 mg (n=9)
5
7
9
Interval at Year 1*
n=32
1
3
5
KSI-301 5 mg (n=24)
7
9
11
13
15
Total
17
(n=33)
19
21
23
≤2-month interval3-month interval
81% have achieved a 6-month or longer treatment-free interval at least once during follow-up
4-month interval5-month interval
≥6-month treatment-free intervalCurrent follow-up (<6 months)Discontinuation
Interim data. Includes only randomized patients that reached the first retreatment opportunity (Week 12 visit). Each bar represents an individual patient. *Treatment intervals include only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52. One patient only received one loading dose and was excluded from the calculation. Interim data as of 29 Jan 2021
DAY 1
Proliferative DR (DRSS 71)
PDR
Peripheral ischemia
KSI-301 5 mg
3 loading doses
WEEK 12
Non-Proliferative DR (DRSS 53)
Two additional doses
Regression from PDR to NPDR
Fast and substantial (3-step) improvement, sustained for 18 months with only 2 additional doses (26-week mean retreatment interval)
DR= Diabetic Retinopathy; PDR= Proliferative DR; NPDR= Non-Proliferative DR; DRSS = DR Severity Scale; DRSS 53 = Severe NPDR; DRSS 71 = High-risk PDR
WEEK 72
Non-Proliferative DR (DRSS 53)
(Pre-Treatment)
Day 1
From Phase 1b Study
OCT Images
3 total injections in Year 1
Week 12 +3 lettersWeek 32 +7 lettersWeek 56 +8 letters (20/20)
3 Loading doses
Day 1
Week 4
Week 8
1 month after 3 loading doses
6 months after 3 loading doses
12 months after 3 loading doses
Benchmarking in treatment-naïve DME: KSI-301 Phase 1b
"Generation 2.0" durability compared to Faricimab YOSEMITE / RHINE
75
Faricimab YOSEMITE / RHINEKSI-301 Phase 1b Study (Year 1)
ProportionofPatients OnEachTreatmentInterval(%)
60
45
30
15
0
4
8
12
16
20
24
Treatment Interval (Weeks)
1. Angiogenesis 2021 Presentation: Faricimab Phase 3 (YOSEMITE and RHINE) Topline Results in Diabetic Macular Edema - Charles C. Wykoff, MD, PhD
2. For KSI-301: Treatment intervals include only patients that received all (3) loading doses and received a dose before Week 52. Interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available)or the last interval before Week 52.
Benchmarking: KSI-301 Phase 1b DME data
"Generation 2.0" durability compared to Eylea
Year 1
Average number of injections required
9.2
8.0
Maintenance Doses
3.2
Monthly Loading Doses
Eylea - Mean
4.0 1.0
Maintenance Dose
3.0
Monthly Loading Doses
(N=221)1
Faricimab PTI - Median
KSI-301
(N=632)2
Phase 1b Study - Mean
(N=32)3
1. Wells JA. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema (DRCR Protocol T). N Engl J Med. 2015 Mar 26;372(13):1193-203 (supplemental data).
2. Angiogenesis 2021 Presentation: Faricimab Phase 3 (YOSEMITE and RHINE) Topline Results in Diabetic Macular Edema - Charles C. Wykoff, MD, PhD
3. Interim data; 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Individualized doses reflect the average number of injections received per patient between Week 12 and 48 inclusive. N=32
DME - Phase 1b
81% have achieved a 6-month or longer treatment- free interval at least once during follow-up
Interval at Year 1*Percentage
(n= 32)
GLEAM-GLIMMER pivotal studies evaluate individualized dosing of every 8, 12, 16, 20 or 24 weeks, after only 3 loading doses
KSI-301 injection
KSI-301 individualized treatment/Sham
Aflibercept injectionDisease Activity Assessment
Sham injection
1. After the loading phase
Interim data. Includes only randomized patients that reached the first retreatment opportunity (Week 12 visit). *Treatment intervals include only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52. One patient only received one loading dose and was excluded from the calculation
How do GLEAM & GLIMMER Studies Disease Activity
Assessment Criteria Compare to Phase 1b?
Parameters | Phase 1b Study1 | GLEAM & GLIMMER Studies | Change |
Visual and anatomical | Increase in CST ≥75 µm with a decrease in BCVA of ≥ 5 letters compared to Week 12 or the prior visit, OR | Increase in OCT CST ≥ 50 µm compared to lowest previous measurement and a decrease in BCVA of ≥ 5 letters compared to the average of the 2 best previous BCVA assessments, due to worsening of DME disease activity, or | Tighter and dynamic control of both vision and anatomy |
Visual only | Decrease in BCVA of ≥ 10 letters compared to the best prior BCVA, due to worsening DME activity | N/A | Eliminated to reduce subjectivity and unnecessary retreatments |
Anatomical only | N/A | Increase in OCT CST ≥ 75 µm compared to lowest previous measurement due to worsening of DME disease activity; or | Added two anatomical- only criteria |
N/A | New or worsening proliferative DR (PDR) |
DME = diabetic macular edema; OCT = optical coherence tomography; CST = central subfield retinal thickness; BCVA = best corrected visual acuity.
1 Clinicaltrials.gov ID: NCT03790852
GLEAM & GLIMMER Phase 3 protocol optimization
▪ Building from the exploratory Phase 1b, GLEAM & GLIMMER maintain consistency of key features while further optimizing protocol designs
1. Similar patient population - treatment naïve DME (~80% from USA)
2. Proactive tighter dosing interval ranging - from uncapped to Q8W-Q24W
3. Tighter disease control - tighter disease activity assessments to patients' determine dosing intervals
4. Decreased subjectivity - no physician discretion treatment (IRT driven)
5. High statistical power for non-inferiority (>90%)
6. High dose (5.0 mg) selected for pivotal study
KSI-301 Phase 1b
RVO Year 1 Data
BCVA ETDRSletters
OCT CST microns
12
0
4
8
16
20
750
24 Weeks28
32
650
550
450
350
250
CRVO n= 15 | -357 |
N=34
3.0 | 1.7 |
Loading doses
Individualized doses
Interim data; 2.5 & 5 mg doses pooled. Observed data, includes only patients that received all (3) loading doses and reached Week 12 or later. Error bars represent standard error of the mean. Individualized doses reflect the number of injections received per patient between Week 12 and 48 inclusive. OCT CST site reported. CST= central subfield thickness.
36
40
44
48
52
100
Percentageofpatients (%)
80
60
Only 28% of patients required more than 5 total injections in Year 1*
40
20
0
0
1
2
3
4
Number of individualized doses in Year 1
Interim data; 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Two patients were not included as they discontinued at the Week 12 and 16 visits, respectively, without receiving a retreatment dose. Individualized doses reflect the average number of injections received per patient between Week 12 and 48 inclusive. N=32
* 3 loading doses plus more than 2 individualized doses
0.0
5
6+
100
Percentageofpatients (%)
80
60
66% of patients were on a 6-month or longer treatment-free intervalat Year 1
40
65.6
20
12.5
9.4
3.1
0
1 month
2 months
3 months
6.3
4 months
Treatment interval at Year 1
3.1
5 months
6 months or longer
Interim data. 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Two patients were not included as they discontinued at the Week 12 and 16 visits, respectively, without receiving a retreatment dose. Treatment interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52. N=32
Loading | Year 1 | Year 2 |
Overall Time on Study (weeks)
0
8
16
24
32
40
48
56
64
72
80
88
96
104
1
KSI-301 3
2.5 mg (n=9)
5
7
9
1
3
5
KSI-301 5 mg
7
9
(n=25)
11
13
15
Total (n=34)
17
19
21
23
25
≤2-month interval3-month interval
69% have achieved a 6-month or longer treatment-free interval at least once during follow-up
Interval at Year 1* | n=32 |
3% | |
9% | |
3 months or longer | 87% |
4 months or longer | 75% |
5 months or longer | 69% |
6 months or longer | 66% |
4-month interval5-month interval
≥6-month treatment-free intervalCurrent follow-up (<6 months)Discontinuation
Interim data. Includes only randomized patients that reached the first retreatment opportunity (Week 12 visit). Each bar represents an individual patient. *Treatment intervals include only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Interval at Year 1 reflects the treatment interval ongoing at the Week
52 visit (where available) or the last interval before Week 52. Two patients discontinued before receiving their first retreatment and less than 6 months of follow-up after the loading phase. Interim data as of 29 Jan 2021
Is it possible to control the most severe CRVO cases with only 2 loading doses?
Case Example of KSI-301 in the Phase 1b Study
Day 1 1202 microns
Week 1 597 microns
Week 4 416 microns
Week 8 260 microns
1 week after 1 dose +14 letters
1 month after 1 dose +23 letters
1 month after 2 doses +23 letters (20/25)
Benchmarking: KSI-301 Phase 1b RVO data
"Generation 2.0" durability compared to Eylea
Year 1
Mean number of injections required
8.6
Maintenance doses
2.6
4.7
1.7
Maintenance dosesMonthly loading doses
6.0
3.0
Monthly loading doses
Eylea (n=221)1
KSI-301 Phase 1b study
(n=32)2
1. Injections averaged between the two pivotal aflibercept trials; n represents the total randomized in the aflibercept groups in both studies. Brown DM. Intravitreal Aflibercept Injection for Macular Edema Secondary to Central Retinal Vein Occlusion: 1-Year Results From the Phase 3 COPERNICUS Study. Am J Ophthalmol 2013;155:429-437.Korobelnik JF, et al. Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion. Ophthalmology 2014;121:202-208
2. Interim data; 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Two patients were not included as they discontinued at the Week 12 and 16 visits, respectively, without receiving a retreatment dose. Individualized doses reflect the average number of injections received per patient between Week 12 and 48 inclusive. N=32
KSI-301 Phase 3 RVO BEACON Study
Two loading doses with KSI-301 + every 8 weeks
RVO - Phase 1b
69% have achieved a 6-month or longer treatment-free interval at least once during follow-up
Interval at Year 1* | Percentage (n= 34) |
1 month | 3% |
2 months | 9% |
3 months or longer | 87% |
4 months or longer | 75% |
5 months or longer | 69% |
6 months or longer | 66% |
Clinicaltrials.gov ID NCT04592419, currently recruiting
BEACON pivotal study evaluates two loading doses and every 8-week dosing, followed by individualized dosing
KSI-301 injection Aflibercept injection
KSI-301 individualized treatment/Sham Aflibercept individualized treatment/ShamSham injection
Disease Activity Assessment
PE= Primary endpoint. SE= Secondary endpoints. SA= Safety assessment
Interim data. Includes only randomized patients that reached the first retreatment opportunity (Week 12 visit). *Treatment intervals include only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 32 visit). Interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52. Two patients discontinued before receiving their first retreatment and less than 6 months of follow-up after the loading phase.
How do BEACON Study Disease Activity Assessment
Criteria Compare to Phase 1b?
Parameters | Phase 1b Study1 | BEACON Study2 | Change |
Visual and anatomical | Increase in CST ≥75 µm with a decrease in BCVA of ≥ 5 letters compared to Week 12 or the prior visit, OR | Increase in OCT CST ≥ 50 µm compared to lowest previous measurement and a decrease in BCVA of ≥ 5 letters compared to the average of the 2 best previous BCVA assessments, due to worsening of RVO disease activity, or | Tighter and dynamic control of both vision and anatomy |
Visual only | Decrease in BCVA of ≥ 10 letters compared to the best prior BCVA, due to worsening RVO activity | N/A | Eliminated to reduce subjectivity and unnecessary retreatments |
Anatomical only | N/A | Increase in OCT CST ≥ 75 µm compared to lowest previous measurement due to worsening of RVO disease activity; or | Added one anatomical- only criteria |
RVO = retinal vein occlusion; OCT = optical coherence tomography; CST = central subfield retinal thickness; BCVA = best corrected visual acuity.
1 Clinicaltrials.gov ID: NCT03790852
2 Clinicaltrials.gov ID: NCT04592419
BEACON Phase 3 protocol optimization
▪ Building from the exploratory Phase 1b, BEACON maintains consistency of key features while further optimizing study protocol
1. Similar patient population - treatment naïve RVO (~80% from USA)
2. Proactive tighter dosing interval - from uncapped to fixed q2-month dosing, through 6-month primary endpoint
3. Tighter disease control - tighter disease activity assessments to determine dosing interval, in second 6 months of study
4. Decreased subjectivity - no physician discretion treatment (IRT driven)
5. High statistical power (>90%)
6. High dose (5.0 mg) selected for pivotal study
KSI-301 Phase 1b
Safety
130
710
168
+
Subjects dosed
Total dosesPatient-years
121
96
Across the Phase 1a/1b program
Completed the loading phase in
Phase 1b
Phase 1b subjects at Week 12 or later that have received all three loading doses plus at least one additional retreatment
▪ Most AEs were assessed as mild and are consistent with profile of intravitreal anti-VEGFs
▪ To date, 43 SAEs have been reported in 24 subjects - none drug related
▪ Three ocular SAEs in the study eye, not drug related, all resolved
- Worsening DME secondary to systemic fluid overload
- Worsening cataract in a diabetic patient
- Subretinal hemorrhage in a wAMD patient
▪ Only two AEs of intraocular inflammation, both trace to 1+ vitreous cells, with complete resolution
-
Rate of 0.28% (2/710 injections)
- No vasculitis or retinal artery occlusion in either patient
Includes all Phase 1a+1b patients randomized as of 26 Jan 2021, all doses administered across cohorts. Interim safety data as of 26 Jan 2021; AE: adverse event; SAE: serious adverse event Inflammation scored based on the 0 - 4+ standardized vitreous grading scale (Foster 2002)
KSI-301 CLINICAL EXPERIENCE
Clinical data from ~2,000 injections in ~500 patients representing ~350 patient-years of exposure in representative populations in wAMD, DME and RVO
▪ Safety: Tracking with current standard of care (Lucentis, Eylea)
▪ Efficacy: Vision & retinal anatomy improvements in line with current anti-VEGF agents
▪ Durability: 2 in every 3 patients going 6-months or longer between doses in wet AMD, DME and RVO
OPTIMIZED PIVOTAL STUDY PROGRAM
Objective to show disruptive durability with same safety and efficacy as Eylea
DAZZLE wet AMD study enrollment complete; BEACON RVO study and GLEAM & GLIMMER DME now enrolling - Data from all studies expected in 2022
Pivotal studies designed from phase 1b data with high dose (5.0 mg), high statistical power, tighter criteria for disease activity assessments, tighter dosing interval ranging, maintaining similar (80%+) U.S. treatment naïve population
OPERATING WITH CONVICTION
On track for a single BLA filing in the key indications of wAMD, DME, RVO treatment and with NPDR indication in a supplemental
Manufacturing investments aligned to clinical opportunity with commercial supply goal of 2.5M+ Prefilled Syringes in Year 1 of launch
Developing bispecific and triplet ABC Medicines for multi-mechanism diseases, including dry AMD and glaucoma
POISED COMMERCIAL OPPORTUNITY
Competitive landscape is clearing with competing molecules/technologies demonstrating poor risk-benefit profiles
We believe KSI-301 may be able to capture market share from standard of care agents, futurebiosimilars, and competing late-stage molecules in development
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Kodiak Sciences Inc. published this content on 13 February 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 February 2021 09:04:01 UTC.
