PALO
ALTO, Calif., Nov. 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 September 30, 2022.
"We continue to execute on our comprehensive pivotal clinical
program for tarcocimab tedromer and remain on track to report
topline results for all of the ongoing Phase 3 studies in diabetic
macular edema, wet age-related macular degeneration and
non-proliferative diabetic retinopathy over the next 12 months,"
said Victor Perlroth, MD, Chief
Executive Officer of Kodiak Sciences. "The retinal vascular disease
treatment landscape continues to evolve as new data become
available on anti-VEGF therapies from incumbent players. These
Phase 3 and commercial anti-VEGF medicines do not appear to be
designed with a science of durability and currently are delivering
an every 3 to 4-month dosing interval. We remain focused on the
vision for tarcocimab, designed from the ground up with a science
of durability, to deliver strong efficacy and solid safety while
bringing a majority of patients to every 5 and 6-month dosing,
which we continue to view as a first-line profile. To this point,
in our BEACON study, tarcocimab tedromer is the only anti-VEGF
therapy that in clinical trials demonstrated non-inferior vision
outcomes in retinal vein occlusion with a doubling of the treatment
interval for all patients versus monthly aflibercept. And in our
DAZZLE study in patients with wet age-related macular degeneration,
although the study demonstrated that a minority of patients may
have benefited from treatment with tarcocimab more frequently than
every 3 months, the study also indicated that the majority of
patients receiving tarcocimab every 5 months could obtain and
maintain excellent visual outcomes. If approved, tarcocimab has the
potential to provide best in class durability thereby resulting in
improved patient outcomes and quality of life."
Recent Business Highlights
- Update on Tarcocimab tedromer Clinical Program:
We continued to advance our ongoing, fully-enrolled Phase 3 pivotal
studies, with four Phase 3 studies on track to read out topline
data in 2023:
-
- GLEAM / GLIMMER: Our paired Phase 3 long-interval
(as infrequently as every 6 months) 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 Phase 3 short-interval 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 long-interval (every 6 months)
treatment and vision loss prevention study GLOW of tarcocimab
versus sham in non-proliferative diabetic retinopathy without DME
("NPDR") is expected to report topline results in the second half
of 2023. If successful, we expect GLOW to contribute data to
support approval of tarcocimab in NPDR with the potential to be the
longest-interval intravitreal therapeutic option in this
disease.
- BEACON: The primary (6 month) efficacy and safety
results of our successful BEACON study of tarcocimab versus
aflibercept in retinal vein occlusion were reported at the 2022
EURetina and AAO scientific congresses.
- Commercial Manufacturing: We continued our
manufacturing scale up activities of tarcocimab tedromer to support
a potential commercial launch.
- Pipeline Progression: We continued progressing
our pipeline product candidates, in particular KSI-501. 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 with an inflammatory component, including DME and
uveitic macular edema. We believe we are on track to file the IND
for KSI-501 in the fourth quarter of 2022 and to begin the Phase 1
clinical study in early 2023.
Third Quarter 2022 Financial Results
Cash Position
Kodiak ended the third quarter of 2022 with $537.4 million of cash, cash equivalents and
marketable securities. This includes an unrealized loss of
$2.5 million on the investment
portfolio due to rising interest rates during the quarter.
Net Loss
The net loss for the third quarter of 2022 was $77.0 million, or $1.47 per share, on both a basic and diluted
basis, as compared to a net loss of $67.5
million, or $1.30 per share,
on both a basic and diluted basis, for the third quarter of 2021.
The net loss for the quarter ended September 30, 2022 included
non-cash stock-based compensation of $26.2
million.
R&D Expenses
Research and development (R&D) expenses were $61.7 million for the third quarter of 2022, as
compared to $56.0 million for the
third quarter of 2021. The R&D expenses for the third quarter
of 2022 included non-cash stock-based compensation of $14.9 million. The increase in R&D expenses
was primarily driven by higher non-cash stock-based
compensation.
G&A Expenses
General and administrative (G&A) expenses were $17.8 million for the third quarter of 2022, as
compared to $11.5 million for the
third quarter of 2021. The G&A expenses for the third quarter
of 2022 included non-cash stock-based compensation of $11.2 million. The increase in G&A expenses
was primarily driven by increased non-cash stock-based
compensation.
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 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 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
studies in patients with diabetic macular edema, the BEACON study
in patients with retinal vein occlusion, the DAYLIGHT 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 568
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, all patients receiving tarcocimab were
treated with two monthly loading doses followed by treatment every
8 weeks, and patients receiving aflibercept were treated monthly as
per its label. In the BEACON study, tarcocimab tedromer dosed every
two months met the primary endpoint of non-inferior visual acuity
gains compared to aflibercept dosed every month. Tarcocimab is the
first anti-VEGF therapy that in clinical trials demonstrated
non-inferiority in visual acuity gains while doubling the treatment
interval in patients with RVO. 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. In the second six months, patients in both
groups will receive treatment on an individualized basis per
protocol-specified criteria. 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 half of 2022. The primary
endpoint for both studies is at year one, 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 at one year. 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, and we expect to announce topline data in the second
half of 2023. 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 seek and potentially 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; anticipated
benefits of anti-VEGF therapies from third parties; the
potential for tarcocimab to deliver strong efficacy and solid
safety while bringing a majority of patients to every 5 and 6-month
dosing; and expectations regarding commercial manufacturing
capabilities. 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
patients as 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
September 30,
|
|
|
Nine Months
Ended
September 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
61,676
|
|
|
$
|
56,002
|
|
|
$
|
211,597
|
|
|
$
|
141,743
|
|
General and
administrative
|
|
|
17,802
|
|
|
|
11,533
|
|
|
|
55,716
|
|
|
|
32,259
|
|
Total operating
expenses
|
|
|
79,478
|
|
|
|
67,535
|
|
|
|
267,313
|
|
|
|
174,002
|
|
Loss from
operations
|
|
|
(79,478)
|
|
|
|
(67,535)
|
|
|
|
(267,313)
|
|
|
|
(174,002)
|
|
Interest
income
|
|
|
2,028
|
|
|
|
40
|
|
|
|
3,239
|
|
|
|
270
|
|
Interest
expense
|
|
|
(4)
|
|
|
|
(6)
|
|
|
|
(14)
|
|
|
|
(17)
|
|
Other income
(expense), net
|
|
|
416
|
|
|
|
(25)
|
|
|
|
713
|
|
|
|
(76)
|
|
Net loss
|
|
$
|
(77,038)
|
|
|
$
|
(67,526)
|
|
|
$
|
(263,375)
|
|
|
$
|
(173,825)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(1.47)
|
|
|
$
|
(1.30)
|
|
|
$
|
(5.04)
|
|
|
$
|
(3.36)
|
|
Weighted-average common
shares outstanding
used in computing net loss per common share,
basic and diluted
|
|
|
52,288,257
|
|
|
|
51,875,315
|
|
|
|
52,227,072
|
|
|
|
51,722,611
|
|
Kodiak Sciences
Inc.
Condensed
Consolidated Balance Sheet Data
(Unaudited)
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022
|
|
|
December 31,
2021
|
|
Cash, cash equivalents
and marketable securities
|
|
|
|
|
|
$
|
537,395
|
|
|
$
|
731,510
|
|
Working
capital
|
|
|
|
|
|
$
|
479,062
|
|
|
$
|
670,128
|
|
Total assets
|
|
|
|
|
|
$
|
723,988
|
|
|
$
|
904,220
|
|
Accumulated
deficit
|
|
|
|
|
|
$
|
(821,592)
|
|
|
$
|
(558,217)
|
|
Total stockholders'
equity
|
|
|
|
|
|
$
|
479,529
|
|
|
$
|
663,320
|
|
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SOURCE Kodiak Sciences Inc.