PALO
ALTO, Calif., March 28,
2023 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq:
KOD), a biopharmaceutical company committed to researching,
developing and commercializing transformative therapeutics to treat
high prevalence retinal diseases, today reported business
highlights and financial results for the fourth quarter ended
December 31, 2022.
"We are running a comprehensive development program for
tarcocimab tedromer with topline data from four Phase 3 studies
planned for 2023: two for the long-interval treatment of diabetic
macular edema (GLEAM and GLIMMER studies), one for the
long-interval treatment and prevention of worsening of
non-proliferative diabetic retinopathy (GLOW study) and one for the
short-interval treatment of wet age-related macular degeneration
(DAYLIGHT study). We are on track to announce topline primary
endpoint data from all four studies in the third quarter of this
year. Durability clearly matters to the community of retina
patients, physicians and payors, and our Phase 3 program is testing
the longest treatment intervals of any intravitreal biologic while
preserving dosing flexibility for high-need patients," said
Victor Perlroth, MD, Chief Executive
Officer of Kodiak Sciences. "We are also pleased to be screening
patients in the Phase 1 clinical study of our second ABC platform
product candidate to enter the clinic, KSI-501. KSI-501 is our
bispecific antibody biopolymer conjugate which inhibits both VEGF
and IL-6 and thus targets two important biological mechanisms in
retinal diseases - angiogenesis and inflammation - and which
represents an exciting new category of retinal medicine. As we
enter 2023, we are strongly positioned to execute on our vision for
tarcocimab, to become a true platform company as we bring KSI-501
with its bispecific mechanism of action into the clinic and to
continue our unique franchise build in retinal science and
medicines development."
Recent Business Highlights
- Tarcocimab pivotal program: The tarcocimab
pivotal program continues to make steady operational progress. In
2022, we completed enrollment in all four of our ongoing Phase 3
pivotal studies, namely our paired Phase 3 studies GLEAM/GLIMMER in
DME, our Phase 3 GLOW study in NPDR and our Phase 3 study DAYLIGHT
in wAMD. We were encouraged by the positive outcome of our Phase 3
BEACON study in RVO and by the promising safety profile tarcocimab
demonstrated in BEACON. We are currently on track to release
topline data from the four ongoing Phase 3 studies in the third
quarter of 2023.
- Commercial Manufacturing: We continue to make
substantial progress in our commercial manufacturing capabilities
in collaboration with our partner Lonza. Our custom-built
commercial scale manufacturing facility, Ursus, achieved mechanical
completion in the first half of 2022, was commissioned as a cGMP
facility in January 2023, and we
began the manufacturing of commercial scale cGMP batches in the
first quarter of 2023.
- Pipeline Progression: In 2022, we
broadened our development pipeline of product candidates built on
our ABC Platform with the filing of the Investigational New Drug
(IND) application with the US FDA for KSI-501. KSI-501 is an
investigational, first-in-class bispecific ABC that is designed to
inhibit two mechanisms implicated in retinal diseases: vascular
endothelial growth factor (VEGF) and interleukin-6 (IL-6). IL-6 is
a pro-inflammatory cytokine and growth factor implicated in the
pathophysiology of multiple retinal diseases and, in conditions for
which anti-VEGF treatment is used, elevated levels of ocular IL-6
have been associated with poor anti-VEGF treatment response.
KSI-501 is a trap-antibody fusion biopolymer conjugate designed to
provide potent inhibition of (i) VEGF-mediated angiogenesis and
vascular permeability through a soluble decoy receptor inhibiting
the binding of VEGF-A and PLGF to their cognate receptors and (ii)
IL-6 mediated inflammation through an antibody that binds soluble
interleukin-6, inhibiting its binding to both soluble and
membrane-bound IL-6 receptors. In preclinical studies KSI-501 was
found to inhibit angiogenesis and also normalize inner and outer
blood retinal barriers in primary-cell assays. Dual inhibition of
VEGF and IL-6 by KSI-501 confers superior normalization of cell
morphology and junctional biology compared to either anti-VEGF or
anti-IL-6 monotherapy in cell-based assays. We believe KSI-501 has
the potential to become a new category of retinal medicines with
greater therapeutic efficacy than existing therapies while also
benefiting from the promising long-interval durability of Kodiak's
ABC Platform. The IND for KSI-501 has been cleared by the FDA, and
the Phase 1 study in diabetic macular edema (DME) patients is now
screening patients.
- Technology Platform Development: We continued
progressing our technology development with our "triplet" platform.
The triplet science is designed to bring our
phosphorylcholine-based biopolymer, the central tenet of our ABC
platform, together with many hundreds of copies of small molecules
chemically embedded in that biopolymer, which is conjugated to an
antibody therapeutic. We believe this new antibody conjugate drug
format offers broad and important utility for multifactorial
ophthalmic diseases and also has significant relevance for systemic
diseases. We continue to advance our triplet platform towards its
initial therapeutic concepts.
- Digital Health Platform Development: We are
developing a visual engagement technology and imager ("VETi")
designed by Kodiak engineers initially to be used by eye care
professionals for vision and ophthalmic anatomical examination,
diagnosis and monitoring. Our longer-term goal with VETi, built
with semiconductor technologies, is to deliver a wearable device
for long-term health engagement and monitoring. Importantly, we
also believe the Kodiak VETi platform as a medical engagement and
imaging platform has the potential to disrupt ophthalmology
clinical trials by enabling new trial endpoints, thereby enabling
faster and more cost-effective medicines development in ophthalmic
disease, an area that historically requires lengthy and expensive
trials. VETi may also aid in market build and shaping for
undertreated or underdiagnosed diseases, such as diabetic eye
diseases where Kodiak's product candidates tarcocimab and KSI-501
are being studied and where early treatment and prevention may
allow patients to achieve better outcomes. The VETi platform is
expected to begin pilot clinical testing mid-2023 to gather initial
user input for continued innovation in the design and build of this
new hardware and software platform.
Expected Upcoming Events/Milestones
- Treatment of first subjects in Phase 1 study of KSI-501 in DME,
2Q2023
- Announce topline data for ongoing Phase 3 pivotal studies of
tarcocimab:
-
- GLEAM and GLIMMER, paired Phase 3 studies of tarcocimab in DME,
3Q2023 (expected July)
- DAYLIGHT, Phase 3 study of tarcocimab in wAMD, 3Q2023
- GLOW, Phase 3 study of tarcocimab in NPDR without DME,
3Q2023
Fourth Quarter and Full Year 2022 Financial Results
Cash Position
Kodiak ended the fourth quarter of 2022 with $478.9 million of cash, cash equivalents and
marketable securities.
Net Loss
The net loss for the fourth quarter of 2022 was $70.4 million, or $1.35 per share on both a basic and diluted
basis, as compared to a net loss of $93.2
million, or $1.79 per share on
both a basic and diluted basis, for the fourth quarter of 2021. The
net loss for the quarter ended December 31, 2022 included
non-cash stock-based compensation of $25.8
million, as compared to $28
million for the quarter ended December 31, 2021.
R&D Expenses
Research and development (R&D) expenses were $56.0 million for the quarter ended December 31, 2022, as compared to $75.6 million for the quarter ended December 31, 2021. The R&D expenses for the
fourth quarter of 2022 included non-cash stock-based compensation
of $14.3 million, as compared to
$15.6 million for the fourth quarter
of 2021. The decrease in R&D expenses for the fourth quarter of
2022 was primarily driven by the maturation of the tarcocimab
clinical program and the timing of manufacturing activities.
R&D expenses were $267.6
million for the year ended December 31, 2022, as
compared to $217.3 million for the
year ended December 31, 2021. The R&D expenses for the
full year of 2022 included non-cash stock-based compensation of
$59.3 million, as compared to
$33.2 million for the full year of
2021. The increase in R&D expenses for the full year of
2022 was primarily driven by higher clinical trial costs to support
ongoing trials, increased manufacturing activities, as well as
higher non-cash stock-based compensation expense.
G&A Expenses
General and administrative (G&A) expenses were $18.1 million for the quarter ended December 31, 2022, as compared to $17.5 million for the quarter ended December 31, 2021. The G&A expenses for the
fourth quarter of 2022 included non-cash stock-based compensation
of $11.5 million, as compared to
$12.4 million for the fourth quarter
of 2021.
G&A expenses were $73.8
million for the year ended December
31, 2022, as compared to $49.7
million for the year ended December
31, 2021. The G&A expenses for the full year of 2022
included non-cash stock-based compensation of $46.7 million, as compared to $28.1 million for the full year of 2021, which
was the primary driver for the G&A expense increase in
2022.
About tarcocimab tedromer (tarcocimab, KSI-301)
Tarcocimab is an investigational anti-VEGF therapy built on
Kodiak's Antibody Biopolymer Conjugate ("ABC") Platform and is
designed to maintain potent and effective drug levels in ocular
tissues for longer than existing available agents. Kodiak's
objective with tarcocimab is to develop a new first-line agent to
improve outcomes for patients with retinal vascular diseases and to
enable earlier treatment and prevention of vision loss for patients
with diabetic eye diseases. The tarcocimab clinical program is
designed to assess the product's durability, efficacy and safety in
major retinal vascular diseases in parallel, through the GLEAM and
GLIMMER studies in diabetic macular edema ("DME"), the BEACON study
in retinal vein occlusion ("RVO"), the GLOW study in
non-proliferative diabetic retinopathy ("NPDR") without DME and the
DAYLIGHT study in wet age-related macular degeneration ("AMD"). The
global tarcocimab clinical program is being conducted at 150+ study
sites in more than 10 countries. Kodiak is developing and owns
global rights to tarcocimab.
About the GLEAM and GLIMMER Studies
The Phase 3 GLEAM and GLIMMER studies are global, multi-center,
randomized pivotal studies designed to evaluate the durability,
efficacy and safety of tarcocimab in patients with treatment-naïve
diabetic macular edema ("DME"). In each study, patients are
randomized 1:1 to receive either tarcocimab or aflibercept. The
tarcocimab arm is treated with a proactive, individualized dosing
regimen of every 8-, 12-, 16-, 20- or 24 weeks after three monthly
loading doses. The aflibercept arm is treated with a fixed dosing
regimen of every 8-weeks after five monthly loading doses, per its
label. Both studies completed enrollment of approximately 450
patients each worldwide in the first quarter of 2022. The primary
endpoint for both studies is at year one. We expect to announce
topline data in the third quarter of 2023. If successful, we expect
that data from our GLEAM and GLIMMER studies will serve as the
primary basis for regulatory approval of tarcocimab. Additional
information about GLEAM (also called Study KS301P104) and GLIMMER
(also called Study KS301P105) can be found on
www.clinicaltrials.gov under Trial Identifiers NCT04611152 and
NCT04603937, respectively
(https://clinicaltrials.gov/ct2/show/NCT04611152 and
https://clinicaltrials.gov/ct2/show/NCT04603937).
About the GLOW Study
The Phase 3 GLOW study is a global, multi-center, randomized
pivotal superiority study designed to evaluate the efficacy and
safety of tarcocimab in treatment-naïve, moderately severe to
severe non-proliferative diabetic retinopathy ("NPDR"). Patients
are randomized to receive either tarcocimab every six months after
initiating doses given at baseline, 8 weeks and 20 weeks into the
study, or to receive sham injections. The primary endpoint is at
one year and patients will be treated and followed for two years.
Outcomes include changes in diabetic retinopathy severity, measured
on a standardized photographic grading scale, and the rate of
development of sight-threatening complications due to diabetic
retinopathy. We believe tarcocimab has the potential to be the
longest-interval intravitreal therapeutic option for patients with
diabetic retinopathy. GLOW has completed enrollment of
approximately 240 patients in August
2022, and we expect to announce topline data in the third
quarter of 2023. Additional information about GLOW (also called
Study KS301P106) can be found on www.clinicaltrials.gov under
Trial Identifier NCT05066230
(https://clinicaltrials.gov/show/NCT05066230).
About the DAYLIGHT Study
The Phase 3 DAYLIGHT study is a global, multi-center, randomized
pivotal study designed to evaluate the efficacy and safety of
high-frequency tarcocimab in patients with treatment-naïve wet
age-related macular degeneration (wet "AMD"). Patients are
randomized to receive either tarcocimab on a monthly dosing regimen
or to receive standard-of-care aflibercept on a fixed dosing
regimen of every 8-weeks after three monthly loading doses per its
label. The primary endpoint is at year one. The DAYLIGHT study is
intended to demonstrate the efficacy of tarcocimab to treat high
need patients with wet AMD. DAYLIGHT has completed enrollment of
approximately 550 patients worldwide and we expect to announce
topline data in the third quarter of 2023. Additional information
about DAYLIGHT (also called Study KS301P107) can be found on
www.clinicaltrials.gov under Trial Identifier NCT04964089
(https://clinicaltrials.gov/show/NCT04964089).
About the BEACON Study
In the Phase 3 BEACON study, tarcocimab dosed every two months
met the primary endpoint of non-inferior visual acuity gains
compared to aflibercept dosed every month in patients with macular
edema due to retinal vein occlusion ("RVO"). Tarcocimab is the
first anti-VEGF therapy to achieve non-inferiority in visual acuity
gains while doubling the treatment interval in patients with RVO.
The BEACON study is a global, multi-center, randomized study
designed to evaluate the durability, efficacy and safety of
tarcocimab in 568 patients with treatment-naïve macular edema due
to RVO, including both branch and central subtypes. Patients were
randomized 1:1 to receive tarcocimab 5 mg or aflibercept 2 mg. In
the first six months, patients who received tarcocimab were treated
with a proactive, fixed regimen which included two monthly loading
doses followed by treatment every 8 weeks, and patients receiving
aflibercept were treated monthly as per its label. In the study,
tarcocimab was well tolerated with a low rate of intraocular
inflammation and no new or unexpected safety signals. Results from
the BEACON study are intended to serve as the basis for the
potential approval of tarcocimab in RVO. Additional information
about the BEACON study (also called Study KS301P103) can be found
on www.clinicaltrials.gov under Trial Identifier NCT04592419
(https://clinicaltrials.gov/show/NCT04592419).
About Ursus
Ursus is a commercial scale manufacturing facility dedicated to
the manufacture of Kodiak's Antibody Biopolymer Conjugate ("ABC")
medicines. Ursus is designed, built and commissioned in
collaboration with Kodiak's long-term CDMO partner Lonza and is
located in the IBEX Biopark of Lonza AG in Visp, Switzerland. Ursus is custom designed to
fulfill the requirement of premium manufacturing of complex
antibody conjugate biotherapeutics and is expected to have the
capacity to supply over 10 million dose equivalents annually. Ursus
achieved mechanical completion in the first half of 2022 and was
commissioned as a cGMP facility in January
2023. Kodiak began the manufacturing of commercial scale
cGMP batches of tarcocimab tedromer, Kodiak's lead product
candidate currently being investigated in multiple Phase 3 studies
for retinal vascular diseases, in the first quarter of 2023.
About KSI-501
Also built on Kodiak's ABC Platform, KSI-501 an investigational,
first-in-class bispecific ABC that is designed to inhibit two
mechanisms implicated in retinal diseases: vascular endothelial
growth factor ("VEGF") and interleukin-6 (IL-6). IL-6 is a
pro-inflammatory cytokine and growth factor implicated in the
pathophysiology of multiple retinal diseases and, in conditions for
which anti-VEGF treatment is used, elevated levels of ocular IL-6
have been associated with poor anti-VEGF treatment response.
KSI-501 is a trap-antibody fusion biopolymer conjugate designed to
provide potent inhibition of (i) VEGF-mediated angiogenesis and
vascular permeability through a soluble decoy receptor inhibiting
the binding of VEGF-A and PLGF to their cognate receptors and (ii)
IL-6 mediated inflammation through an antibody that binds soluble
interleukin-6, inhibiting its binding to both soluble and
membrane-bound IL-6 receptors. In preclinical studies KSI-501 was
found to inhibit angiogenesis and also normalize inner and outer
blood retinal barriers in primary-cell assays. Dual inhibition of
VEGF and IL-6 by KSI-501 confers superior normalization of cell
morphology and junctional biology compared to either anti-VEGF or
anti-IL-6 monotherapy in cell-based assays. We believe KSI-501 has
the potential to become a new category of retinal medicines with
greater therapeutic efficacy than existing therapies while also
benefiting from the promising long-interval durability of Kodiak's
ABC Platform. The Investigational New Drug application ("IND") for
KSI-501 has been cleared by the FDA, and a Phase 1 study in DME
patients is on track to begin dosing patients in the second quarter
of 2023.
About Kodiak Sciences Inc.
Kodiak (Nasdaq: KOD) is a biopharmaceutical company committed to
researching, developing and commercializing transformative
therapeutics to treat high prevalence retinal diseases. Founded in
2009, we are focused on bringing new science to the design and
manufacture of next generation retinal medicines to prevent and
treat the leading causes of blindness globally. Our ABC Platform™
uses molecular engineering to merge the fields of antibody-based
and chemistry-based therapies and is at the core of Kodiak's
discovery engine. Kodiak's lead product candidate, tarcocimab, is a
novel anti-VEGF antibody biopolymer conjugate being developed for
the treatment of retinal vascular diseases including diabetic eye
diseases, the leading cause of blindness in working-age patients in
the developed world, and wet age-related macular degeneration, the
leading cause of blindness in elderly patients in the developed
world. Kodiak has leveraged its ABC Platform to build a pipeline of
product candidates in various stages of development. KSI-501 is our
dual inhibitor antibody biopolymer conjugate targeting both VEGF
(VEGF-trap) and IL-6 (anti-IL-6 antibody) for the treatment of
retinal diseases. We are expanding our early research pipeline to
include ABC Platform based triplet inhibitors for multifactorial
retinal diseases such as dry AMD and glaucoma. Kodiak is based in
Palo Alto, CA. For more
information, please visit www.kodiak.com.
Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak
logo are registered trademarks or trademarks of Kodiak Sciences
Inc. in various global jurisdictions.
Forward-Looking Statements
This release contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
not based on historical fact and include statements regarding the
potential of our ABC Platform to significantly extend treatment
intervals in retinal disorders in a safe and convenient manner, the
anti-VEGF effect of tarcocimab tedromer (tarcocimab, KSI-301), the
expected advances for treatment of diabetic eye diseases and wAMD
represented by tarcocimab, the anticipated safety profile of
tarcocimab, planned activities in connection with the development
of VETi; VETi's potential benefits, including but not limited to
the potential to disrupt ophthalmology clinical trials and shape
the market for undertreated or undiagnosed diseases; future
development plans, including clinical objectives and the timing
thereof, anticipated design and benefits of planned clinical
trials, the expected timing of clinical study readouts; the
objectives and anticipated benefits of our tarcocimab clinical
program; and expansion of our research pipeline, and the
anticipated presentation of data; the potential benefits of
KSI-501, including its potential to be a first-in-class bispecific
ABC inhibiting VEGF and IL-6; the anticipated commencement of a
Phase 1 study of KSI-501; the potential for a single BLA submission
in multiple retinal vascular disease indications; the potential for
our products to obtain a product label in multiple indications and
with a range of dosing intervals; expectations regarding commercial
manufacturing capabilities; and the results of our research and
development efforts and our ability to advance our product
candidates into later stages of development. Forward-looking
statements generally include statements that are predictive in
nature and depend upon or refer to future events or conditions, and
include words such as "may," "will," "should," "would," "could,"
"expect," "plan," "believe," "intend," "pursue," and other similar
expressions among others. Any forward-looking statements are based
on management's current expectations of future events and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to, the risk that
preliminary safety, efficacy and durability data for our tarcocimab
product candidate may not continue or persist; the risk that
tarcocimab may not have the anti-VEGF effect or impact on the
treatment of diabetic eye diseases and wAMD as expected; cessation
or delay of any of the ongoing clinical studies / our development
of tarcocimab / KSI-501 may occur; the risk that our ABC Platform
may not extend treatment intervals in retinal disorders as
anticipated, or at all; future potential regulatory milestones of
tarcocimab / KSI-501, including those related to current and
planned clinical studies, may be insufficient to support regulatory
submissions or approval; our research and development efforts and
our ability to advance our product candidates into later stages of
development may fail; the risk that KSI-501 may not inhibit VEGF
and IL-6 or have an impact on the treatment of patients as
expected; the risk that VETi is not developed as anticipated,
and/or may not have the expected benefits or capabilities; any one
or more of our product candidates may not be successfully
developed, approved or commercialized; manufacturing facilities may
not be completed when expected, or at all; adverse conditions in
the general domestic and global economic markets, which may
significantly impact our business and operations, including 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-K, as well as discussions of potential risks,
uncertainties, and other important factors in our subsequent
filings with the Securities and Exchange Commission. These
forward-looking statements speak only as of the date hereof and
Kodiak undertakes no obligation to update forward-looking
statements, and readers are cautioned not to place undue reliance
on such forward-looking statements. Kodiak®, Kodiak Sciences®,
ABC™, ABC Platform™ and the Kodiak logo are registered trademarks
or trademarks of Kodiak Sciences Inc. in various global
jurisdictions.
Kodiak Sciences Inc.
Condensed Consolidated
Statements of Operations
(Unaudited)
(in thousands, except share and per
share amounts)
|
|
Three Months
Ended
December 31,
|
|
|
Year Ended
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
55,994
|
|
|
$
|
75,597
|
|
|
$
|
267,591
|
|
|
$
|
217,340
|
|
General and
administrative
|
|
|
18,072
|
|
|
|
17,452
|
|
|
|
73,788
|
|
|
|
49,711
|
|
Total operating
expenses
|
|
|
74,066
|
|
|
|
93,049
|
|
|
|
341,379
|
|
|
|
267,051
|
|
Loss from
operations
|
|
|
(74,066)
|
|
|
|
(93,049)
|
|
|
|
(341,379)
|
|
|
|
(267,051)
|
|
Interest
income
|
|
|
3,017
|
|
|
|
28
|
|
|
|
7,071
|
|
|
|
298
|
|
Interest
expense
|
|
|
(4)
|
|
|
|
(5)
|
|
|
|
(18)
|
|
|
|
(47)
|
|
Other income
(expense), net
|
|
|
605
|
|
|
|
(139)
|
|
|
|
503
|
|
|
|
(190)
|
|
Net loss
|
|
$
|
(70,448)
|
|
|
$
|
(93,165)
|
|
|
$
|
(333,823)
|
|
|
$
|
(266,990)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(1.35)
|
|
|
$
|
(1.79)
|
|
|
$
|
(6.39)
|
|
|
$
|
(5.16)
|
|
Weighted-average shares
of common stock
outstanding used in computing net loss per
common
share, basic and diluted
|
|
|
52,316,531
|
|
|
|
51,988,910
|
|
|
|
52,249,620
|
|
|
|
51,788,918
|
|
Kodiak Sciences Inc.
Condensed Consolidated
Balance Sheet Data
(Unaudited)
(in
thousands)
|
|
|
|
|
|
December 31,
2022
|
|
|
December 31,
2021
|
|
Cash, cash equivalents
and marketable securities
|
|
|
|
|
|
$
|
478,933
|
|
|
$
|
731,510
|
|
Working
capital
|
|
|
|
|
|
$
|
433,509
|
|
|
$
|
670,128
|
|
Total assets
|
|
|
|
|
|
$
|
666,628
|
|
|
$
|
904,220
|
|
Accumulated
deficit
|
|
|
|
|
|
$
|
(892,040)
|
|
|
$
|
(558,217)
|
|
Total stockholders'
equity
|
|
|
|
|
|
$
|
436,167
|
|
|
$
|
663,320
|
|
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SOURCE Kodiak Sciences Inc.