PALO ALTO, Calif., Nov. 9, 2021 /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 third
quarter ended September 30, 2021.
"We are pleased with the operational progress across our pivotal
clinical program," said Victor
Perlroth, MD, Chief Executive Officer of Kodiak Sciences.
"We believe we are on track for a series of KSI-301 topline data
readouts beginning in early 2022, with the DAZZLE study in wet AMD
expected to read out in the first quarter of 2022 and our BEACON
study in retinal vein occlusion shortly thereafter in mid-2022.
GLEAM and GLIMMER, our paired long-interval DME studies, are more
than two-thirds and three-quarters enrolled, respectively and
should complete enrollment in the first quarter of 2022. And
DAYLIGHT, our short-interval wet AMD study, is showing robust
enrollment and, based on current trends may read out ahead of GLEAM
and GLIMMER. In the third quarter, we also began recruitment in
GLOW, our study evaluating every six-month dosing of KSI-301 for
preventing sight-threatening complications in diabetic retinopathy
patients."
KSI-301 Clinical Program Highlights
We are engaged in a broad development program for KSI-301 with
concurrent late-stage development activities across all of the
major disease indications for which intravitreal anti-VEGF
therapies are used and have made considerable progress in advancing
the KSI-301 pivotal study program over this past quarter. We expect
to include the results of all our pivotal clinical trials in wet
AMD, DME and RVO in a single initial BLA. The ambitious program for
KSI-301 reflects our conviction in KSI-301 (and our ABC Platform)
and seeks labeling at launch that is supportive of a broad range of
individualized dosing intervals, from every 4-week dosing up to
once every 20-week dosing for wet AMD patients; from every 4-week
dosing up to once every 24-week dosing for DME patients; and from
every 4-week dosing up to once every 8-week dosing for RVO
patients.
- DAZZLE – Phase 2b/3 Study
in Patients with Treatment-Naïve Wet Age-Related Macular
Degeneration (Wet AMD)
The Phase 2b/3 DAZZLE study is a global, multi-center,
randomized pivotal study designed to evaluate the durability
efficacy and safety of KSI-301 in patients with treatment-naïve wet
AMD. Patients are randomized to receive either KSI-301 on an
individualized dosing regimen as infrequently as every five months
and no more often than every three months or to receive aflibercept
on its labeled every eight-week dosing regimen, each after three
monthly initiating doses.
We initiated the DAZZLE pivotal
study in October 2019 and completed
enrollment in November 2020 with over
550 patients enrolled globally. We expect the last patient's
primary endpoint visit to occur in the fourth quarter of 2021 and
to announce topline data in the first quarter of 2022.
- BEACON – Phase 3 Study in Patients with Treatment-Naïve
Retinal Vein Occlusion (RVO)
We began enrolling patients into
BEACON in the third quarter of 2020. With over 475 patients
randomized, we believe we are on track to complete enrollment into
BEACON before the end of this year. Based on the 24-week primary
endpoint for BEACON, we expect to announce topline data in
mid-2022.
- GLEAM / GLIMMER – Paired Phase 3 Studies in Patients with
Treatment-Naïve Diabetic Macular Edema (DME)
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 to receive either intravitreal
KSI-301 on an individualized dosing regimen every eight to 24 weeks
after only three loading doses or intravitreal aflibercept every
eight weeks after five loading doses per its label. Each study is
expected to enroll approximately 450 patients 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 initiated GLEAM and GLIMMER in
the third quarter of 2020. Continued elevated COVID-19 transmission
rates globally have impacted enrollment rates for patients with
treatment naïve DME. With GLEAM more than two-thirds enrolled and
GLIMMER more than three-quarters enrolled, we expect to complete
enrollment in the first quarter of 2022.
- DAYLIGHT – Phase 3 Study in Patients with Treatment-Naïve
Wet AMD
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 40 weeks, and the
study is being planned and executed to allow for inclusion of its
results in the initial BLA for KSI-301.
In June
2021, we randomized the first patients into DAYLIGHT. Study
enrollment has been strong with recruitment now underway both in
the US and EU. Additional global study sites will be activated
through the fourth quarter of 2021, and we believe we can complete
enrollment in the first half of 2022.
- GLOW – Phase 3 Study in Patients with Non-Proliferative
Diabetic Retinopathy without DME
We began screening patients into
GLOW in the second quarter of 2021 and randomized the first
patients in September. We are not planning for this study and
indication to be included in our initial BLA filing given our
expectations for a longer recruitment timeframe. We are excited to
be recruiting patients in this chronic, more preventive disease
indication and believe KSI-301 can be a new longest-interval
therapeutic option for patients with diabetic retinopathy.
To date, we are pleased with the continued operational progress
across our pivotal program. We believe we are on track for a series
of KSI-301 topline data readouts beginning in early 2022 with
DAZZLE in the first quarter of 2022, BEACON in mid-2022 and then
DAYLIGHT and GLEAM/GLIMMER tracking towards early 2023.
Expected Upcoming Events/Milestones
- Announce topline data for DAZZLE, pivotal study of KSI-301 in
wet AMD (long-interval dosing), 1Q 2022.
- Announce topline data for BEACON, pivotal study of KSI-301 in
RVO, mid-2022.
- Complete enrollment in GLEAM and GLIMMER, pivotal studies of
KSI-301 in DME (long-interval dosing), 1Q 2022.
- Complete enrollment in DAYLIGHT, pivotal study of KSI-301 in
wet AMD (short-interval dosing), 1H 2022
Third Quarter 2021 Financial Results
Cash Position
Kodiak ended the third quarter of 2021 with $799.2 million of cash and cash equivalents.
Net Loss
The net loss for the third quarter of 2021 was $67.5 million, or $1.30 per share on both a basic and diluted
basis, as compared to a net loss of $36.1
million, or $0.80 per share on
both a basic and diluted basis, for the third quarter of 2020.
R&D Expenses
Research and development (R&D) expenses were $56.0 million for the third quarter of 2021, as
compared to $29.3 million for the
third quarter of 2020. The increase in R&D expenses was
primarily driven by higher clinical trial and manufacturing costs
for KSI-301 as well as increased headcount and stock-based
compensation expense.
G&A Expenses
General and administrative (G&A) expenses were $11.5 million for the third quarter of 2021, as
compared to $7.4 million for the
third quarter of 2020. The increase in G&A expenses was
primarily driven by increased headcount and stock-based
compensation expenses.
About KSI-301
KSI-301 is an investigational anti-VEGF therapy built on the
Kodiak's Antibody Biopolymer Conjugate (ABC) Platform and is
designed to maintain potent and effective drug levels in ocular
tissues for longer than existing 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 Phase 2b/3
DAZZLE pivotal study in patients with treatment-naïve wet AMD was
initiated in October 2019 and
completed enrollment in November
2020, and Kodiak initiated the Phase 3 GLEAM, GLIMMER and
BEACON pivotal studies of KSI-301 in diabetic macular edema and
retinal vein occlusion in September
2020. The Company initiated the Phase 3 DAYLIGHT pivotal
study of monthly KSI-301 in wet AMD patients in June 2021. These pivotal studies are anticipated
to form the basis of the Company's initial BLA to support potential
approval and commercialization in multiple indications and with a
full range of labeled and reimbursable dosing frequencies in each
indication. The Phase 3 pivotal study in patients with
non-proliferative diabetic retinopathy (the GLOW study) was
initiated in August 2021. The global
KSI-301 clinical program is being conducted at 150+ study sites in
more than 10 countries. Kodiak Sciences Inc. is developing KSI-301
and owns global rights to KSI-301.
About the DAZZLE Study
The Phase 2b/3 DAZZLE study is a
global, multi-center, randomized pivotal study designed to evaluate
the durability efficacy and safety of KSI-301 in patients with
treatment-naïve wet AMD. Patients are randomized to receive either
KSI-301 on an individualized dosing regimen as infrequently as
every five months and no more often than every three months or to
receive aflibercept on its labeled every eight-week dosing regimen,
each after three monthly initiating doses. The study has enrolled
over 550 patients worldwide. The primary endpoint is at one year,
and the Last Patient Last Visit (LPLV) for the primary endpoint is
expected to occur in the fourth quarter of 2021. Each patient will
be treated and followed for two years. Additional information about
DAZZLE (also called Study KSI-CL-102) can be found on
www.clinicaltrials.gov under Trial Identifier NCT04049266
(https://clinicaltrials.gov/show/NCT04049266).
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 to receive either intravitreal
KSI-301 every eight weeks after only two loading doses or monthly
intravitreal aflibercept per its label, for the first six months.
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
is expected to enroll approximately 550 patients worldwide. The
primary endpoint is at six months, and patients will be treated and
followed for 18 months. 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 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 to receive either intravitreal KSI-301 on an
individualized dosing regimen every eight to 24 weeks after only
three loading doses or intravitreal aflibercept every eight weeks
after five loading doses per its label. Each study is expected to
enroll approximately 450 patients worldwide. The primary endpoint
for both studies is at one year, and patients will be treated and
followed for two years. 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 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 along with the DAZZLE, BEACON, GLEAM and
GLIMMER studies. 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 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, Kodiak is 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. Kodiak's 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
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, Kodiak's bispecific anti-IL-6/VEGF biopolymer
conjugate for the treatment of neovascular retinal diseases with an
inflammatory component, and Kodiak is expanding its 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 a
single BLA submission in wet AMD, DME and RVO; the sufficiency of
our cash, cash equivalents and marketable securities to fund our
operations; our platform technology and potential therapies; future
development plans; the potential for KSI-301 to obtain a broad
product label and reduce barriers to reimbursement; planned KSI-301
dosing regimens; our ability to complete patient enrollment in
clinical studies; clinical and regulatory objectives and the timing
thereof, anticipated design of planned clinical trials,
expectations regarding the potential efficacy and commercial
potential of our product candidates; and the anticipated
presentation of data; the results of our research and development
efforts (including any announcement of topline data) 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 preliminary safety, efficacy and
durability data for our KSI-301 product candidate will 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 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. 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
September 30,
|
|
|
Nine Months
Ended
September 30,
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
56,002
|
|
|
$
|
29,306
|
|
|
$
|
141,743
|
|
|
$
|
70,033
|
General and
administrative
|
|
|
11,533
|
|
|
|
7,357
|
|
|
|
32,259
|
|
|
|
19,132
|
Total operating
expenses
|
|
|
67,535
|
|
|
|
36,663
|
|
|
|
174,002
|
|
|
|
89,165
|
Loss from
operations
|
|
|
(67,535)
|
|
|
|
(36,663)
|
|
|
|
(174,002)
|
|
|
|
(89,165)
|
Interest
income
|
|
|
40
|
|
|
|
645
|
|
|
|
270
|
|
|
|
2,551
|
Interest
expense
|
|
|
(6)
|
|
|
|
(6)
|
|
|
|
(17)
|
|
|
|
(19)
|
Other income
(expense), net
|
|
|
(25)
|
|
|
|
(98)
|
|
|
|
(76)
|
|
|
|
120
|
Net loss
|
|
$
|
(67,526)
|
|
|
$
|
(36,122)
|
|
|
$
|
(173,825)
|
|
|
$
|
(86,513)
|
Net loss per common
share, basic and diluted
|
|
$
|
(1.30)
|
|
|
$
|
(0.80)
|
|
|
$
|
(3.36)
|
|
|
$
|
(1.92)
|
Weighted-average
common shares outstanding
used in
computing net loss per common share,
basic
and diluted
|
|
|
51,875,315
|
|
|
|
45,119,885
|
|
|
|
51,722,611
|
|
|
|
44,972,085
|
|
|
|
|
Kodiak Sciences
Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(Unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2021
|
|
|
December 31,
2020
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
|
|
|
|
$
|
799,247
|
|
|
$
|
968,974
|
Working
capital
|
|
|
|
|
|
|
|
|
|
$
|
751,110
|
|
|
$
|
940,583
|
Total
assets
|
|
|
|
|
|
|
|
|
|
$
|
958,206
|
|
|
$
|
1,067,347
|
Accumulated
deficit
|
|
|
|
|
|
|
|
|
|
$
|
(465,052)
|
|
|
$
|
(291,227)
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
|
|
$
|
726,320
|
|
|
$
|
860,751
|
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SOURCE Kodiak Sciences Inc.