PALO
ALTO, Calif., Aug. 9, 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 June 30, 2022.
"We continue to meaningfully advance the tarcocimab tedromer
(KSI-301, tarcocimab) clinical program," said Victor Perlroth, MD, Chief Executive Officer of
Kodiak Sciences. "In demonstrating non-inferior visual acuity with
a doubling of the treatment interval, we achieved the goal of the
BEACON study. A successful outcome in BEACON is one of the pillars
of our original development plan, which calls for two successful
studies in one indication (GLEAM and GLIMMER in Diabetic Macular
Edema) and then individual studies in each of the other
indications. Importantly, the BEACON data provide reasons to be
optimistic about the potential for GLEAM and GLIMMER to achieve
non-inferiority in vision with best in class durability and thus
the broader success of our development strategy with tarcocimab.
Our suite of Phase 3 pivotal studies is fully enrolled and expected
to read out topline data next year. As we learn more from the
remaining Phase 3 studies, we look forward to continuing to work
with the FDA and global health authorities to bring this medicine
to patients."
Recent Business
Highlights
- BEACON Phase 3 Pivotal Study of tarcocimab tedromer
in Retinal Vein Occlusion Topline
Readout: We recently announced positive
topline results from our Phase 3 pivotal study of tarcocimab
tedromer (KSI-301, tarcocimab) in treatment-naïve patients with
macular edema due to retinal vein occlusion ("RVO"). The study met
its primary efficacy endpoint of non-inferior visual acuity gains
at week 24 for subjects dosed every 8 weeks following two monthly
loading doses with tarcocimab compared to subjects given
aflibercept every 4 weeks. Tarcocimab was safe and well tolerated
in the study with no new or unexpected safety signals identified.
We intend to include the primary results at week 24 in our
anticipated BLA filing to serve as the basis for approval of
tarcocimab in RVO.
- Update on Tarcocimab tedromer Clinical
Program: We continued to advance tarcocimab
across all ongoing Phase 3 pivotal studies:
-
- GLEAM / GLIMMER: Our paired Phase 3 studies GLEAM
and GLIMMER in diabetic macular edema ("DME") are expected to
report topline data in mid-2023 and if successful are designed to
serve as the primary basis for a licensing application and
potential regulatory approval of tarcocimab.
- DAYLIGHT: Our short-interval Phase 3 study DAYLIGHT
in wet age-related macular degeneration (wet "AMD") is expected to
report topline results in mid-2023. If successful, we expect
DAYLIGHT to contribute data to support approval of tarcocimab in
wet AMD.
- GLOW: Our Phase 3 treatment and prevention study GLOW of
tarcocimab versus sham in non-proliferative diabetic retinopathy
without DME ("NPDR" without "DME") has recently completed
enrollment ahead of schedule. The primary endpoint is at one year
with topline results expected in the second half of 2023. If
successful, we expect GLOW to contribute data to support approval
of tarcocimab in NPDR.
- Update on Tarcocimab tedromer Regulatory Plan:
With the suite of Phase 3 studies fully enrolled and anticipated to
read out their topline data mid-2023, if successful, we plan to
file a single Biologics License Application (BLA) with the data
across the program.
- Commercial Manufacturing: We continued our
manufacturing scale up and announced the grand opening of our
purpose-built bioconjugation facility with our manufacturing
partner Lonza in May 2022. The
facility will play a key role in the scaled manufacturing of
tarcocimab tedromer to support a potential global commercial
launch.
- 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 IL-6
(anti-IL-6 antibody) and VEGF (VEGF-trap) for the treatment of
retinal diseases. We are progressing the bioconjugate cGMP
manufacturing, non-clinical toxicology and other supporting
activities towards an expected IND submission in the second half of
2022.
Expected Upcoming Events /
Milestones
- Full primary results from the BEACON study are expected to be
presented by BEACON Study Investigators at upcoming ophthalmology
congresses in September 2022.
Second Quarter 2022 Financial
Results
Cash Position
Kodiak ended the second quarter of 2022 with $597.9 million of cash, cash equivalents and
marketable securities. This includes an unrealized loss of
$1.9 million on the investment
portfolio due to rising interest rates during the quarter.
Net Loss
The net loss for the second quarter of 2022 was $90.6 million, or $1.74 per share, on both a basic and diluted
basis, as compared to a net loss of $55.9
million, or $1.08 per share,
on both a basic and diluted basis, for the second quarter of 2021.
The net loss for the quarter ended June 30, 2022 included
non-cash stock-based compensation of $26.0
million, of which $15.8
million was recorded in the second quarter related to the
2021 Long-Term Performance Incentive Plan.
R&D Expenses
Research and development (R&D) expenses were $73.7 million for the second quarter of 2022, as
compared to $45.4 million for the
second quarter of 2021. The R&D expenses for the second quarter
included non-cash stock-based compensation of $14.1 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 $18.3 million for the second quarter of 2022, as
compared to $10.5 million for the
second quarter of 2021. The G&A expenses for the second quarter
included non-cash stock-based compensation of $11.9 million. The increase in G&A expenses
was primarily driven by increased non-cash stock-based compensation
expense.
About tarcocimab tedromer
(KSI-301)
Tarcocimab tedromer 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 tedromer is 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. Kodiak is developing tarcocimab to be a new first-line
agent which enables a majority of patients to be treated and
maintained on an every 5 to 6-month treatment interval and a
minority of high need patients to be treated as frequently as
monthly. The tarcocimab tedromer clinical program is designed to
assess the product'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, the DAYLIGHT pivotal
study in patients with wet AMD, and the GLOW study in patients with
NPDR are anticipated to form the basis of the Company's BLA to
support potential approval and commercialization in multiple
indications. The global tarcocimab tedromer clinical program is
being conducted at 150+ study sites in more than 10 countries.
Kodiak is developing and owns global rights to tarcocimab
tedromer.
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
tarcocimab tedromer in patients with treatment-naïve macular edema
due to retinal vein occlusion, including both branch and central
subtypes. Patients are randomized 1:1 to receive tarcocimab 5 mg or
aflibercept 2 mg. In the first six months, patients receiving
tarcocimab are treated with a proactive, fixed regimen which
includes two monthly loading doses followed by treatment every 8
weeks, and patients receiving aflibercept are treated monthly as
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 tarcocimab tedromer for an additional six months on an
individualized basis. The study completed enrollment of 568
patients worldwide in the fourth quarter of 2021 and met its
primary efficacy endpoint at six months. 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 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. 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 (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 topline 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 tarcocimab 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 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 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 the average of weeks
40, 44 and 48. The DAYLIGHT study is intended to clarify the
efficacy of tarcocimab 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. DAYLIGHT has completed enrollment
of approximately 550 patients worldwide and we expect to announce
topline 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 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 tedromer in approximately 240 patients with
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 tedromer 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. 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, tarcocimab
tedromer, 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
regulatory developments and strategy, including plans to obtain
regulatory approval, expected timing of data from studies and
submission of INDs, the bases on which regulatory approval may be
sought, and contribution of data to support approval of tarcocimab;
timing of upcoming presentations; and expectations regarding
commercial manufacturing capabilities, including the potential of
the bioconjugation facility to scale manufacturing to support a
potential product launch. 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 tedromer product
candidate may not continue or persist; the risk that tarcocimab
tedromer may not have the anti-VEGF effect or impact on the
treatment of RVO expected; cessation or delay of any of the ongoing
clinical studies and/or our development of tarcocimab tedromer 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 tarcocimab tedromer, including those
related to current and planned clinical studies, may be
insufficient to support regulatory submissions or approval; adverse
economic conditions may significantly impact our business and
operations, including our clinical trial sites, and those of our
manufacturers, contract research organizations or other 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
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
73,744
|
|
|
$
|
45,404
|
|
|
$
|
149,921
|
|
|
$
|
85,741
|
|
General and
administrative
|
|
|
18,324
|
|
|
|
10,505
|
|
|
|
37,914
|
|
|
|
20,726
|
|
Total operating
expenses
|
|
|
92,068
|
|
|
|
55,909
|
|
|
|
187,835
|
|
|
|
106,467
|
|
Loss from
operations
|
|
|
(92,068)
|
|
|
|
(55,909)
|
|
|
|
(187,835)
|
|
|
|
(106,467)
|
|
Interest
income
|
|
|
1,135
|
|
|
|
81
|
|
|
|
1,211
|
|
|
|
230
|
|
Interest
expense
|
|
|
(5)
|
|
|
|
(5)
|
|
|
|
(10)
|
|
|
|
(11)
|
|
Other income
(expense), net
|
|
|
310
|
|
|
|
(19)
|
|
|
|
297
|
|
|
|
(51)
|
|
Net loss
|
|
$
|
(90,628)
|
|
|
$
|
(55,852)
|
|
|
$
|
(186,337)
|
|
|
$
|
(106,299)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(1.74)
|
|
|
$
|
(1.08)
|
|
|
$
|
(3.57)
|
|
|
$
|
(2.06)
|
|
Weighted-average common
shares outstanding
used in computing net loss per common share,
basic and diluted
|
|
|
52,218,773
|
|
|
|
51,573,894
|
|
|
|
52,195,972
|
|
|
|
51,644,946
|
|
Kodiak Sciences
Inc.
Condensed
Consolidated Balance Sheet Data
(Unaudited)
(in
thousands)
|
|
|
|
|
|
|
|
June 30,
2022
|
|
|
December 31,
2021
|
|
Cash, cash equivalents
and marketable securities
|
|
|
|
|
|
$
|
597,876
|
|
|
$
|
731,510
|
|
Working
capital
|
|
|
|
|
|
$
|
534,536
|
|
|
$
|
670,128
|
|
Total assets
|
|
|
|
|
|
$
|
781,905
|
|
|
$
|
904,220
|
|
Accumulated
deficit
|
|
|
|
|
|
$
|
(744,554)
|
|
|
$
|
(558,217)
|
|
Total stockholders'
equity
|
|
|
|
|
|
$
|
530,931
|
|
|
$
|
663,320
|
|
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SOURCE Kodiak Sciences Inc.