PALO ALTO, Calif., May 10, 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 quarter
ended March 31, 2022.
"We learned in February that our Phase 2b/3 study in wet AMD did not meet its primary
endpoint," said Victor Perlroth, MD,
Chief Executive Officer of Kodiak Sciences. "We have continued to
analyze the data from this study and continue to believe that our
two primary observations were correct: (a) not allowing treatment
more frequent than every 12 weeks (q12w) was a fundamental flaw in
the study design and resulted in critical undertreatment in a
minority of patients, and (b) the durability with nearly 60% of
KSI-301 patients sustained on every five-month dosing while
achieving excellent visual and anatomic outcomes is real and
represents an important advance in the field. The learnings from
this initial study are enabling us to improve the probability of
success of the ongoing KSI-301 Phase 3 program, with the
anticipation of four Phase 3 study readouts in 2022 and 2023. We
remain optimistic that KSI-301 can demonstrate best-in-class
durability and meaningfully improve outcomes for patients with
common retinal diseases."
Recent Business Highlights
- KSI-301 Clinical Program: As part of the
learnings from our initial Phase 2b/3
study in wet AMD, we are implementing changes to our ongoing Phase
3 studies of KSI-301 including changes in the DME program that we
believe will mitigate the potential risk of undertreatment in
high-need patients and improve the probability of success of these
studies. Our regulatory strategy remains intact, and we intend to
include data from the BEACON, GLEAM, GLIMMER and DAYLIGHT studies
in a single initial BLA, if successful, and would seek labeling at
launch that is supportive of a range of indications and dosing
intervals.
-
- BEACON – Phase 3 Study in Patients with Treatment-Naïve Retinal
Vein Occlusion (RVO)
The BEACON study design remains unchanged and compares four doses
of KSI-301 versus six doses of aflibercept over the 6-month
duration to the primary endpoint. The last patient visit for the
24-week primary endpoint is expected in June
2022, and we expect to announce top-line data in
August 2022.
- DAYLIGHT – Phase 3 Study in Patients with Treatment-Naïve Wet
AMD
The DAYLIGHT study will further clarify the efficacy of KSI-301 in
treating high-need patients with wet AMD and, if successful,
is intended to serve as the basis for approval in wet AMD with
monthly dosing. Consistent with this intent to serve as a
registrational study worldwide, we are extending the length of
this study by eight weeks to 48 weeks with the primary endpoint,
mean change in BCVA from baseline, measured at the average of
weeks 40, 44 and 48. DAYLIGHT has completed enrollment of
approximately 550 patients worldwide, and we expect to announce
top-line data in mid-2023.
- GLEAM and GLIMMER – Paired Phase 3 Studies in Patients with
Treatment-Naïve Diabetic Macular Edema (DME)
We have modified the study protocols to decrease the risk of
undertreatment in high need patients by 1) triggering
retreatment earlier in disease reactivation, 2) triggering
retreatment in the presence of persistent disease, and 3)
removing subjectivity in the application of the criteria. We are
also extending the primary endpoint by twelve weeks to allow two
full cycles of every 24-week dosing for patients receiving KSI-301,
so that the durability, efficacy, and safety of the longer dosing
intervals can be more fully evaluated. The primary endpoint for
both studies is the average of weeks 60 and 64, and patients will
continue to be treated and followed for a total of two years. We
expect to announce top-line data in mid-2023. If successful, we
expect that data from our GLEAM and GLIMMER studies will serve as
the primary basis for approval of KSI-301 in our anticipated
BLA submission.
- Commercial Manufacturing: We continued our
manufacturing scale up and in March
2022 achieved mechanical completion of our purpose-built
bioconjugation facility in Visp, Switzerland.
- Pipeline Progression: We continued progressing
our pipeline product candidates KSI-501 and KSI-601. 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 progressing the bioconjugate
cGMP manufacturing, non-clinical toxicology and other
supporting activities towards expected IND submission in 2H
2022.
Expected Upcoming Events/Milestones
- Announce top-line data for BEACON, Phase 3 pivotal study of
KSI-301 in RVO, in 3Q 2022
- Complete enrollment for GLOW, Phase 3 pivotal study of KSI-301
in non-proliferative diabetic retinopathy (NPDR), in 3Q 2022
- Submit IND for KSI-501, a novel bispecific antibody biopolymer
conjugate, in 2H 2022
First Quarter 2022 Financial Results
Cash Position
Kodiak ended the first quarter of 2022 with $671.7 million of cash and cash equivalents.
Net Loss
The net loss for the first quarter of 2022 was $95.7 million, or $1.83 per share, on both a basic and diluted
basis, as compared to a net loss of $50.4
million, or $0.98 per share,
on both a basic and diluted basis, for the first quarter of 2021.
The net loss for the quarter ended March 31, 2022 included
non-cash stock-based compensation of $28.1
million, of which $16.0
million was recorded in the first quarter related to the
2021 Long-Term Performance Incentive Plan.
R&D Expenses
Research and development (R&D) expenses were $76.2 million for the first quarter of 2022, as
compared to $40.3 million for the
first quarter of 2021. The R&D expenses for the first quarter
included non-cash stock-based compensation of $16.0 million. 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 $19.6 million for the first quarter of 2022, as
compared to $10.2 million for the
first quarter of 2021. The G&A expenses for the first quarter
included non-cash stock-based compensation of $12.1 million. The increase in G&A expenses
was primarily driven by increased 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, 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 four 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 the fourth
quarter of 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
June 2022, and we expect to announce
top-line data in August 2022. If
successful, data from the BEACON study are intended to serve as the
basis for approval 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 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 on a
fixed dosing regimen of every 8-weeks after three monthly loading
doses per its label. The DAYLIGHT study is intended to clarify the
efficacy of KSI-301 to treat high need patients with wet AMD and,
if successful, is intended to serve as the basis for approval in
wet AMD with monthly dosing. Consistent with this intent to serve
as an approval study, we are extending the length of DAYLIGHT,
specifically extending the primary endpoint to the average of weeks
40, 44 and 48. DAYLIGHT has completed enrollment of approximately
550 patients worldwide, and we expect to announce top-line data in
mid-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 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. 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 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 the average of weeks
60 and 64, and patients will be treated and followed for a total of
two years. We expect to announce top-line data in mid-2023. If
successful, we expect that data from our GLEAM and GLIMMER studies
will serve as the primary basis for approval of KSI-301 in our
anticipated BLA submission. 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 initiating doses 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
randomized the first patients into GLOW in September 2021 and expect to complete enrollment
of approximately 240 patients worldwide in 2022. We believe KSI-301
has the potential to be a longest-interval therapeutic option for
patients with diabetic retinopathy. If successful, we intend to
include the results of the GLOW study in a supplemental BLA
following our planned initial BLA submission. 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.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.
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 or
milestones and the timing thereof or the evaluation of durability,
efficacy, and safety of dosing interval, anticipated design and
benefits of planned clinical trials, and the anticipated
announcement or presentation of data; potential for a single BLA
submission in wet AMD, DME and RVO or other approval (or basis
thereof); the timing for enrollment in our studies; the timing of
submission of an IND for KSI-501; 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; the results of our research and development efforts
and our ability to advance our product candidates into later stages
of development; our observations about the data from our Phase
2b/3 study in wet AMD; the impact of
changes to our ongoing Phase 3 studies of KSI-301 to mitigate the
potential risk of undertreatment. 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
March 31,
|
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses
|
|
|
|
|
|
|
Research
and development
|
|
$
|
76,177
|
|
|
$
|
40,337
|
|
General
and administrative
|
|
|
19,590
|
|
|
|
10,221
|
|
Total operating expenses
|
|
|
95,767
|
|
|
|
50,558
|
|
Loss from
operations
|
|
|
(95,767)
|
|
|
|
(50,558)
|
|
Interest
income
|
|
|
76
|
|
|
|
149
|
|
Interest
expense
|
|
|
(5)
|
|
|
|
(6)
|
|
Other
income (expense), net
|
|
|
(13)
|
|
|
|
(32)
|
|
Net loss
|
|
$
|
(95,709)
|
|
|
$
|
(50,447)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(1.83)
|
|
|
$
|
(0.98)
|
|
Weighted-average common
shares outstanding
used in computing net loss per common share,
basic and diluted
|
|
|
52,172,918
|
|
|
|
51,573,909
|
|
|
|
Kodiak Sciences
Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(Unaudited)
|
(in
thousands)
|
|
|
|
March 31,
2022
|
|
|
December 31,
2021
|
|
Cash and cash
equivalents
|
|
$
|
671,727
|
|
|
$
|
731,510
|
|
Working
capital
|
|
$
|
605,853
|
|
|
$
|
670,128
|
|
Total assets
|
|
$
|
850,288
|
|
|
$
|
904,220
|
|
Accumulated
deficit
|
|
$
|
(653,926)
|
|
|
$
|
(558,217)
|
|
Total stockholders'
equity
|
|
$
|
597,384
|
|
|
$
|
663,320
|
|
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SOURCE Kodiak Sciences Inc.