PALO
ALTO, Calif., May 15, 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 quarter ended March 31, 2023.
"We are on the cusp of four Phase 3 study readouts in major
indications, starting with results of our GLEAM, GLIMMER and
DAYLIGHT studies expected in July and our GLOW study in September.
Following our successful pivotal study readout in retinal vein
occlusion last year, we look forward to unmasking the primary
endpoint data in these next four studies shortly," said
Victor Perlroth, MD, Chief Executive
Officer of Kodiak Sciences. "Our regulatory strategy for tarcocimab
tedromer is built on meeting the primary endpoint in two studies in
diabetic eye disease (our GLEAM and GLIMMER studies in diabetic
macular edema) and then meeting the primary endpoint in a single
study in each of the other major retinal vascular diseases."
Dr. Perlroth continued, "Durability clearly matters to the
community of retina patients, physicians and payers, and especially
so in diabetic eye disease where many patients are working age and
require good vision to maintain their livelihood. One third of
anti-VEGF treated diabetic patients discontinue treatment each
year, and so the promise of the anti-VEGF mechanism is not
realized. Three out of our four ongoing Phase 3 studies of
tarcocimab tedromer (tarcocimab, KSI-301) are in diabetic eye
disease and are exploring 6-month dosing, the longest treatment
interval that has been studied by any intravitreal biologic. If
successful, we believe tarcocimab can be an important medicine for
the 37 million people living with diabetes in the U.S. who are at
risk of developing diabetic eye disease and losing vision."
Recent Business Highlights
- Tarcocimab pivotal program: We continued our
ongoing Phase 3 studies of tarcocimab towards their primary
endpoint readouts. The tarcocimab clinical program explores the
potential for 6-month durability in patients with diabetic eye
disease through the GLEAM and GLIMMER Phase 3 studies in diabetic
macular edema ("DME") and the GLOW Phase 3 study in
non-proliferative diabetic retinopathy ("NPDR") without DME. The
tarcocimab clinical program is also exploring the product's
durability, efficacy and safety in retinal vein occlusion ("RVO")
via the BEACON Phase 3 study and in wet age-related macular
degeneration ("wet AMD") via the ongoing DAYLIGHT Phase 3 study.
The BEACON study met its primary endpoint in 2022, and we expect to
announce topline data for the four ongoing Phase 3 clinical studies
in the third quarter of 2023. If successful, we expect to file a
single Biologics Licensing Applications ("BLA") for tarcocimab in
the four major retinal vascular disease indications, with the
potential for flexible dosing regimens from every month to every 6
months.
- Clinical pipeline expansion: We expanded our
development pipeline with the dosing of patients in the Phase 1
study of KSI-501, a first-in-class bispecific ABC designed to
inhibit both VEGF-mediated angiogenesis and vascular permeability
and IL-6-mediated inflammation. The Phase 1 study is an open-label,
multiple ascending dose study and is initially enrolling patients
with DME. The primary objectives of the Phase 1 study are to
evaluate ocular and systemic safety, to establish a maximum
tolerated dose and to explore bioactivity of KSI-501.
- Recent scientific presentations: We shared
scientific presentations on our clinical and research pipeline
programs at the ARVO 2023 Annual Meeting in April, including
presentations on tarcocimab's nonclinical pharmacokinetics,
distribution and excretion, and on KSI-501's molecular and
biological characterization.
- Commercial Manufacturing: Our custom-built
commercial scale manufacturing facility, Ursus, 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.
Expected Upcoming Events/Milestones
- Announce topline data for ongoing Phase 3 pivotal studies of
tarcocimab:
-
- GLEAM and GLIMMER, paired Phase 3 studies of tarcocimab in
diabetic eye disease (treatment of diabetic macular edema),
expected July 2023
- DAYLIGHT, Phase 3 study of tarcocimab in wAMD, expected
July 2023
- GLOW, Phase 3 study of tarcocimab in diabetic eye disease
(treatment and prevention of worsening in non-proliferative
diabetic retinopathy without DME), expected September 2023
First Quarter 2023 Financial Results
Cash Position
Kodiak ended the first quarter of 2023 with $421.2 million of cash, cash equivalents and
marketable securities.
Net Loss
The net loss for the first quarter of 2023 was $70.8 million, or $1.35 per share on both a basic and diluted
basis, as compared to a net loss of $95.7
million, or $1.83 per share on
both a basic and diluted basis, for the first quarter of 2022. The
net loss for the quarter ended March 31, 2023 included
non-cash stock-based compensation of $26.0
million, as compared to $28.1
million for the quarter ended March 31, 2022.
R&D Expenses
Research and development (R&D) expenses were $56.5 million for the first quarter of 2023, as
compared to $76.2 million for the
first quarter of 2022. The R&D expenses for the first quarter
of 2023 included non-cash stock-based compensation of $14.7 million, as compared to $16.0 million for the first quarter of 2022. The
decrease in R&D expenses for the first quarter of 2023 was
primarily driven by the maturation of the tarcocimab clinical
program and the timing of manufacturing activities.
G&A Expenses
General and administrative (G&A) expenses were $18.1 million for the first quarter of 2023, as
compared to $19.6 million for the
first quarter of 2022. The G&A expenses for the first quarter
of 2023 included non-cash stock-based compensation of $11.3 million, as compared to $12.1 million for the first quarter of
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 enable earlier treatment and
prevention of vision loss for patients with diabetic eye disease
and to develop a new durability agent to improve outcomes for
patients with retinal vascular diseases as a whole. The tarcocimab
clinical program is designed to explore 6-month durability in
patients with diabetic eye disease through the GLEAM and GLIMMER
Phase 3 studies in diabetic macular edema ("DME") and the GLOW
Phase 3 study in non-proliferative diabetic retinopathy ("NPDR")
without DME. The tarcocimab clinical program is also exploring the
product's durability, efficacy and safety in retinal vein occlusion
("RVO") via the BEACON Phase 3 study and in wet age-related macular
degeneration ("wet AMD") via the DAYLIGHT Phase 3 study. The BEACON
study met its primary endpoint in 2022, and four Phase 3 clinical
studies are expected to announce topline data in 3Q2023. If
successful, Kodiak plans to file a single Biologics Licensing
Applications ("BLA") for tarcocimab in the four major retinal
vascular disease indications. 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. The primary endpoint for both studies is at year one. We
expect to announce topline data from GLEAM and GLIMMER in
July 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 patients with 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. 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. We
expect to announce topline data from GLOW in September 2023. If successful, results from the
study are intended to serve as the basis for the potential approval
of tarcocimab in NPDR. 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 evaluate the safety and efficacy of tarcocimab in
treating high need patients with wet AMD. We expect to announce
topline data from DAYLIGHT in July
2023. If successful, results from the study are intended to
serve as the basis for the potential approval of tarcocimab in wet
AMD. 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.
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 was 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 in Ursus in the first quarter of 2023.
About KSI-501
Also built on Kodiak's ABC Platform, KSI-501 is an
investigational, first-in-class bispecific ABC 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 cell-based assays, KSI-501
inhibits angiogenesis and also normalizes inner and outer blood
retinal barriers; 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. 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. A Phase 1 study of KSI-501 is
currently dosing patients in the United
States to evaluate the safety, tolerability and bioactivity
of KSI-501 in DME patients.
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. 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 antibody biopolymer conjugate
platform, or 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
investigational medicine, tarcocimab tedromer, is a novel anti-VEGF
antibody biopolymer conjugate being developed for the treatment of
retinal vascular diseases including diabetic eye disease, 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. The
tarcocimab clinical program is designed to assess the product
candidate's durability, efficacy and safety in major retinal
vascular diseases in parallel, through the GLEAM and GLIMMER
studies in diabetic macular edema, the BEACON study in retinal vein
occlusion, the GLOW study in non-proliferative diabetic retinopathy
and the DAYLIGHT study in wet age-related macular degeneration.
Phase 3 data across the tarcocimab clinical program are expected in
3Q2023. 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) and is being
investigated in a Phase 1 clinical study initially in patients with
diabetic macular edema. We are expanding our early research
pipeline to include ABC Platform based triplet inhibitors for
multifactorial diseases. 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
expected timing of clinical study readouts; the objectives and
anticipated benefits of our tarcocimab clinical program and the
regulatory strategy for tarcocimab; the potential benefits of
tarcocimab for people with diabetic eye diseases and to improve
outcomes for patients with retinal vascular diseases as a whole;
the potential for a single BLA submission in multiple retinal
vascular disease indications, with the potential for flexible
dosing regimens from every month to every 6 months; the potential
benefits of KSI-501, including its potential to be a first-in-class
bispecific ABC inhibiting both VEGF and IL-6; expectations
regarding our commercial manufacturing capabilities; and planned
expansion of our research pipeline. . 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
cessation or delay of any of the ongoing clinical studies and our
development of tarcocimab or KSI-501 may occur; 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 impact on the treatment of
diabetic eye diseases or improve outcomes for patients with retinal
vascular diseases as expected; future potential regulatory
milestones of tarcocimab or 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; any one or more of our product
candidates may not be successfully developed, approved or
commercialized; our manufacturing facilities may not operate as
expected; 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
March 31,
|
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses
|
|
|
|
|
|
|
Research and
development
|
|
$
|
56,520
|
|
|
$
|
76,177
|
|
General and
administrative
|
|
|
18,095
|
|
|
|
19,590
|
|
Total operating
expenses
|
|
|
74,615
|
|
|
|
95,767
|
|
Loss from
operations
|
|
|
(74,615)
|
|
|
|
(95,767)
|
|
Interest
income
|
|
|
3,617
|
|
|
|
76
|
|
Interest
expense
|
|
|
(4)
|
|
|
|
(5)
|
|
Other income
(expense), net
|
|
|
222
|
|
|
|
(13)
|
|
Net loss
|
|
$
|
(70,780)
|
|
|
$
|
(95,709)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(1.35)
|
|
|
$
|
(1.83)
|
|
Weighted-average shares
of common stock
outstanding used in computing net loss
per
common share, basic and diluted
|
|
|
52,337,603
|
|
|
|
52,172,918
|
|
Kodiak Sciences
Inc.
Condensed
Consolidated Balance Sheet Data
(Unaudited)
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2023
|
|
|
December 31,
2022
|
|
Cash, cash equivalents
and marketable securities
|
|
|
|
|
|
$
|
421,191
|
|
|
$
|
478,933
|
|
Working
capital
|
|
|
|
|
|
$
|
362,180
|
|
|
$
|
433,509
|
|
Total assets
|
|
|
|
|
|
$
|
640,334
|
|
|
$
|
666,628
|
|
Accumulated
deficit
|
|
|
|
|
|
$
|
(962,820)
|
|
|
$
|
(892,040)
|
|
Total stockholders'
equity
|
|
|
|
|
|
$
|
392,587
|
|
|
$
|
436,167
|
|
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SOURCE Kodiak Sciences Inc.