PALO ALTO, Calif., March 1, 2022 /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, 2021.
"Although our Phase 2b/3 pivotal
study in wet AMD did not meet its primary efficacy endpoint, we
believe the data served as important validation for KSI-301 and our
ABC platform in its ability to extend dosing in a compelling manner
for nearly 60% of wet AMD patients and doing so safely, which to
our knowledge no other intravitreal anti-VEGF therapy has
demonstrated to date," said Victor
Perlroth, MD, Chief Executive Officer of Kodiak Sciences.
"We do take away important learnings from this initial study, in
particular that some patients may benefit from more frequent
dosing. The designs of our other ongoing Phase 3 studies have more
proactive dosing and therefore we believe less risk of
undertreatment. We intend to continue advancing our ongoing pivotal
studies of KSI-301 in all of the major retinal vascular disorders
for which intravitreal anti-VEGF therapies are currently used,
namely our Phase 3 pivotal study BEACON in retinal vein occlusion
("RVO"), our paired Phase 3 studies GLEAM/GLIMMER in diabetic
macular edema ("DME"), our Phase 3 short-interval study DAYLIGHT in
wet AMD, and our Phase 3 pivotal study GLOW in non-proliferative
diabetic retinopathy without DME ("NPDR" without DME). Our BEACON
study is expected to have the primary endpoint visit completed in
all patients this coming June, with top-line data anticipated to
follow shortly thereafter. For our DAYLIGHT study as well as our
GLEAM and GLIMMER studies, we expect top-line data in 2023. We
remain committed to bringing potentially the longest-interval
intravitreal anti-VEGF therapy to patients with retinal vascular
diseases and, despite our disappointment in not having met the
primary endpoint in our Phase 2b/3
study, I believe we are one step closer to achieving that
goal."
Recent Business Highlights
- KSI-301 Phase 2b/3 Pivotal
Study in Wet AMD Top-line Data: We recently announced
top-line data from our Phase 2b/3
pivotal study of KSI-301 in patients with treatment-naïve wet AMD.
The study did not meet its primary efficacy endpoint of
non-inferior visual acuity gains for subjects dosed on extended
regimens every 12, 16, or 20 weeks with KSI-301 compared to
subjects given aflibercept every 8 weeks. Year 1 data showed 59% of
patients in the KSI-301 arm achieved 5-month dosing with visual
acuity gains and anatomic improvements comparable to the overall
aflibercept group. KSI-301 was safe and well tolerated in the
study, with no new safety signals identified.
- Continued Progress in Ongoing KSI-301 Pivotal
Program: We completed enrollment of over 550 patients
worldwide in 2021 for our pivotal study BEACON in RVO and expect to
announce top-line data in the third quarter of 2022. Our paired
Phase 3 studies GLEAM/GLIMMER in DME have completed enrollment of
approximately 450 patients each worldwide. Our short-interval Phase
3 study DAYLIGHT in wet AMD randomized the first patient in
June 2021 and recruitment continues
in both the U.S. and EU. We expect to complete enrollment in the
first half of 2022. We began screening patients into GLOW, our
Phase 3 study in NPDR, in 2Q 2021 and randomized the first patients
in September 2021. Our belief in the
potential of KSI-301 (and our ABC Platform) to extend treatment
intervals and improve patient outcomes in retinal vascular diseases
remains, and we are encouraged by the promising safety profile
KSI-301 demonstrated. We are pleased with the continued operational
progress across our pivotal program and plan to continue advancing
our pivotal program towards an initial BLA with a label that is
supportive of a range of indications and dosing intervals.
- Commercial Manufacturing: We continued making
substantial progress in our commercial manufacturing capabilities
in collaboration with our partner Lonza. Our custom-built
commercial scale bioconjugation facility is scheduled for
mechanical completion in the first half of 2022.
- Pipeline Progression: We continued advancing our
pipeline product candidates KSI-501 and KSI-601. KSI-501 is our
dual inhibitor antibody biopolymer conjugate targeting both VEGF
and IL-6 for the treatment of retinal diseases with an inflammatory
component. KSI-501 is being progressed towards an IND submission in
2022. KSI-601 is targeting the multifactorial nature of dry AMD,
and we continued development on KSI-601 and the triplet platform
towards an IND.
Expected Upcoming Events/Milestones
- Announce top-line data for BEACON, Phase 3 pivotal study of
KSI-301 in RVO, 3Q 2022
- Complete enrollment in DAYLIGHT, short-interval pivotal study
of KSI-301 in wet AMD, 1H 2022
- Mechanical completion of the Lonza-Kodiak Ibex Dedicate
facility in 1H 2022
- Submit IND for KSI-501, a novel bispecific antibody biopolymer
conjugate
Fourth Quarter and Full Year 2021 Financial Results
Cash Position
Kodiak ended the fourth quarter of 2021 with $731.5 million of cash and cash equivalents.
Net Loss
The net loss for the fourth quarter of 2021 was $93.2 million, or $1.79 per share on both a basic and diluted
basis, as compared to a net loss of $46.6
million, or $0.97 per share on
both a basic and diluted basis, for the fourth quarter of 2020. The
net loss for the year ended December 31,
2021 was $267.0 million, or
$5.16 per share on both a basic and
diluted basis, as compared to a net loss of $133.1 million, or $2.91 per share on both a basic and diluted
basis, for the year ended December 31,
2020. The net loss for the fourth quarter and for the year
ended December 31, 2021 included
non-cash stock-based compensation of $28.0
million and $61.4 million,
respectively, of which $14.2 million
was recorded in the fourth quarter related to the 2021 Long-Term
Performance Incentive Plan ("LTPIP").
R&D Expenses
Research and development (R&D) expenses were $75.6 million for the fourth quarter of 2021, as
compared to $37.4 million for the
fourth quarter of 2020. R&D expenses were $217.3 million for the year ended December 31, 2021, as compared to $107.4 million for the year ended December 31, 2020. The R&D expenses for the
fourth quarter and for the year ended December 31, 2021 included non-cash stock-based
compensation of $15.6 million and
$33.2 million, respectively, of which
$8.3 million was recorded in the
fourth quarter related to the LTPIP. The increase in R&D
expenses 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 $17.5 million for the fourth quarter of 2021, as
compared to $9.5 million for the
fourth quarter of 2020. G&A expenses were $49.7 million for the year ended December 31, 2021, as compared to $28.6 million for the year ended December 31, 2020. The G&A expenses for the
fourth quarter and for the year ended December 31, 2021 included non-cash stock-based
compensation of $12.4 million and
$28.1 million, respectively, of which
$5.9 million was recorded in the
fourth quarter related to the LTPIP. The increase in G&A
expenses was primarily driven by increased headcount and non-cash
stock-based compensation expense.
About KSI-301
KSI-301 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 KSI-301 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 disease. The KSI-301 clinical
program is designed to assess KSI-301's durability, efficacy and
safety in wet AMD, DME, RVO and non-proliferative DR (without DME)
through clinical studies run in parallel. The Company's GLEAM and
GLIMMER pivotal studies in patients with diabetic macular edema,
the BEACON pivotal study in patients with retinal vein occlusion
and the DAYLIGHT pivotal study in patients with wet AMD are
anticipated to form the basis of the Company's initial BLA to
support potential approval and commercialization in multiple
indications. An additional Phase 3 pivotal study, GLOW , in
patients with non-proliferative diabetic retinopathy is also
underway. The global KSI-301 clinical program is being conducted at
150+ study sites in more than 10 countries. Kodiak is developing
KSI-301 and owns global rights to KSI-301.
About the BEACON Study
The Phase 3 BEACON study is a
global, multi-center, randomized study designed to evaluate the
durability, efficacy and safety of KSI-301 in patients with
treatment-naïve macular edema due to retinal vein occlusion (RVO),
including both branch and central subtypes. Patients are randomized
1:1 to a KSI-301 arm or an aflibercept arm. In the first six
months, the KSI-301 arm is treated with a proactive, fixed regimen
which includes two monthly loading doses and then every 8-week
treatment (including treatment 4-weeks prior to the 24-week primary
endpoint). In the first six months, the aflibercept arm is treated
with a fixed monthly regimen, per its label. In the second six
months, patients in both groups will receive treatment on an
individualized basis per protocol-specified criteria. Following
this, patients can continue to receive KSI-301 for an additional
six months on an individualized basis. The study completed
enrollment of over 550 patients worldwide in 2021. The primary
endpoint is at six months, and patients will be treated and
followed for 18 months. The last patient visit for the 24-week
primary endpoint is expected in mid-June
2022. We expect to announce top-line data in the third
quarter of 2022. 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 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 KSI-301 in
patients with treatment-naïve wet AMD. Patients are randomized to
receive either KSI-301 on a monthly dosing regimen or to receive
standard-of-care aflibercept. The study is expected to enroll
approximately 500 patients worldwide. The primary endpoint is at
ten months, and the study is being planned and executed to allow
for inclusion of its results in the initial BLA for KSI-301. The
intent of this pivotal study is to broaden KSI-301's potential
product labeling, explore the potential for improved treatment
outcomes in certain patients with intensive anti-VEGF treatment,
and eliminate possible barriers to market access and insurance
reimbursement that have impeded or complicated the commercial
uptake of other anti-VEGF medications in the past. We believe that
pursuing a broad product label will provide physicians with the
flexibility, agency, and reimbursement confidence required to
consider KSI-301 treatment for all their patients. 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 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
KSI-301 in patients with treatment-naïve diabetic macular edema
(DME). In each study, patients are randomized 1:1 to receive either
KSI-301 or aflibercept. The KSI-301 arm is treated with a
proactive, individualized dosing regimen of every 8-, 12-, 16-, 20-
or 24 weeks (utilizing tight dynamic retreatment criteria) after
three loading doses. The aflibercept arm is treated with a fixed
regimen of 8-week dosing after five monthly loading doses, per its
label. Both studies have completed enrollment of approximately 450
patients each worldwide. The primary endpoint for both studies is
at one year, and patients will be treated and followed for a total
of two years. We expect to announce top-line data in the first half
of 2023. 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 study designed to evaluate
the efficacy and safety of KSI-301 in patients with
treatment-naïve, moderately severe to severe non-proliferative
diabetic retinopathy (NPDR). Patients are randomized to receive
either KSI-301 on a once every six-month dosing regimen after three
monthly initiating doses or to receive sham injection. The study is
expected to enroll approximately 240 patients worldwide. The
primary endpoint is at one year and patients will be treated and
followed for two years. 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 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, KSI-301, is a novel
anti-VEGF antibody biopolymer conjugate being developed for the
treatment of retinal vascular diseases including wet age-related
macular degeneration, the leading cause of blindness in elderly
patients in the developed world, and diabetic eye diseases, the
leading cause of blindness in working-age patients in the developed
world. Kodiak has leveraged its ABC Platform to build a pipeline of
product candidates in various stages of development including
KSI-501, our bispecific anti-IL-6/VEGF biopolymer conjugate for the
treatment of neovascular retinal diseases with an inflammatory
component, and 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.
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
KSI-301, the expected advances for treatment of wet AMD represented
by KSI-301, the anticipated safety profile for KSI-301, future
development plans, including clinical objectives and the timing
thereof, anticipated design and benefits of planned clinical
trials, and the anticipated presentation of data; potential for a
single BLA submission in wet AMD, DME and RVO; the potential for
our products to obtain a product label in multiple indications and
with a full range of labeled and reimbursable dosing frequencies in
each indication; 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 KSI-301 product candidate may
not continue or persist; the risk that KSI-301 may not have the
anti-VEGF effect or impact on the treatment of wet AMD expected;
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; the risk that our ABC Platform may not
extend treatment intervals in retinal disorders as anticipated, or
at all; 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;
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; manufacturing facilities may
not be completed when expected, or at all; adverse conditions in
the general domestic and global economic markets, including the
COVID-19 pandemic, 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,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
75,597
|
|
|
$
|
37,356
|
|
|
$
|
217,340
|
|
|
$
|
107,389
|
|
General and
administrative
|
|
|
17,452
|
|
|
|
9,486
|
|
|
|
49,711
|
|
|
|
28,618
|
|
Total operating
expenses
|
|
|
93,049
|
|
|
|
46,842
|
|
|
|
267,051
|
|
|
|
136,007
|
|
Loss from
operations
|
|
|
(93,049)
|
|
|
|
(46,842)
|
|
|
|
(267,051)
|
|
|
|
(136,007)
|
|
Interest
income
|
|
|
28
|
|
|
|
351
|
|
|
|
298
|
|
|
|
2,902
|
|
Interest
expense
|
|
|
(5)
|
|
|
|
(6)
|
|
|
|
(22)
|
|
|
|
(25)
|
|
Other income
(expense), net
|
|
|
(139)
|
|
|
|
(86)
|
|
|
|
(215)
|
|
|
|
34
|
|
Net loss
|
|
$
|
(93,165)
|
|
|
$
|
(46,583)
|
|
|
$
|
(266,990)
|
|
|
$
|
(133,096)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(1.79)
|
|
|
$
|
(0.97)
|
|
|
$
|
(5.16)
|
|
|
$
|
(2.91)
|
|
Weighted-average
common shares outstanding
used in
computing net loss per common share,
basic
and diluted
|
|
|
51,988,910
|
|
|
|
48,034,290
|
|
|
|
51,788,918
|
|
|
|
45,741,845
|
|
Kodiak Sciences
Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(Unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
|
December 31,
2021
|
|
|
December 31,
2020
|
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
$
|
731,510
|
|
|
$
|
968,974
|
|
Working
capital
|
|
|
|
|
|
$
|
670,128
|
|
|
$
|
940,583
|
|
Total
assets
|
|
|
|
|
|
$
|
904,220
|
|
|
$
|
1,067,347
|
|
Accumulated
deficit
|
|
|
|
|
|
$
|
(558,217)
|
|
|
$
|
(291,227)
|
|
Total stockholders'
equity
|
|
|
|
|
|
$
|
663,320
|
|
|
$
|
860,751
|
|
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SOURCE Kodiak Sciences Inc.