PALO
ALTO, Calif., Aug. 14,
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 June 30, 2023.
"We experienced a significant setback with the recently
announced topline data for our Phase 3 GLEAM and GLIMMER studies in
diabetic macular edema patients," said Victor Perlroth, MD, Chief Executive Officer of
Kodiak Sciences. "Tarcocimab demonstrated what we see as
industry-leading durability together with solid potency, but an
unexpected increased rate of cataracts appears to have been the
main driver to missing the primary efficacy endpoint in both
studies. In our concurrent DAYLIGHT study in age-related macular
degeneration where we dosed patients on a high-exposure regimen of
12 monthly doses of tarcocimab, fewer tarcocimab treated patients
had a finding of cataract than did aflibercept treated patients.
Notwithstanding the negative primary results in GLEAM and GLIMMER,
we have two positive Phase 3 studies with tarcocimab: the BEACON
study in patients with retinal vein occlusion and the DAYLIGHT
study in patients with wet AMD. Following the recent presentation
of the GLEAM and GLIMMER data at the American Society of Retina
Specialists (ASRS) annual meeting, we have heard encouraging
feedback from the retina community that tarcocimab's 6-month
durability profile might be compelling and important for many
patients, especially in pseudophakic patients who have already had
cataract surgery and make up as many as 40% of anti-VEGF treated
patients. While Kodiak has made the business decision to wind down
ongoing studies of tarcocimab as previously communicated, we are
still evaluating a variety of future options for the tarcocimab
program.
"We have also communicated that Kodiak will be advancing the
KSI-501 clinical program," continued Dr. Perlroth. "We are
fortunate to have the active KSI-501 clinical program in our
pipeline. KSI-501 is a first-in-class anti-IL-6 and anti-VEGF
bispecific molecule, and we have completed enrollment of the
multiple dose escalation Phase 1 study. The obvious question is why
are we confident in advancing KSI-501 if it is based on the same
platform as tarcocimab, and the answer is multiple. First, KSI-501
has the potential for both better anti-VEGF potency as it is a
VEGF-trap as well as enhanced efficacy due to its dual mechanism of
action, as compared to tarcocimab. Second, we believe we can
deliver a tailored clinical development plan based on the learnings
from the tarcocimab clinical program and the ABC platform itself.
Third, we may explore an accelerated development pathway through
orphan and/or breakthrough therapy designation applications with
KSI-501. And fourth, we are planning to explore development of
KSI-501 in its two therapeutic forms, both as its unconjugated
protein which is itself a novel bispecific protein and as its
bioconjugate form. We believe that exploring both therapeutic forms
may result in a higher probability of success of the program and
also provide us with a better understanding of the ABC
platform."
Recent Business Highlights
- Tarcocimab pivotal program: We recently announced
that our Phase 3 GLEAM and GLIMMER studies of tarcocimab in
diabetic macular edema (DME) did not meet their primary efficacy
endpoints of non-inferior visual acuity gains for tarcocimab dosed
every 8 to 24 weeks after 3 monthly loading doses compared to
aflibercept given every 8 weeks after 5 monthly loading doses.
Tarcocimab demonstrated strong durability with half of tarcocimab
treated patients achieving every 24-week dosing at the primary
endpoint. An unexpected increase in cataract adverse events was
reported over time in the tarcocimab arms of both GLEAM and GLIMMER
and contributed meaningfully to the failure of each study. We also
announced that the Phase 3 DAYLIGHT study of tarcocimab in wet
age-related macular degeneration (wet AMD) did meet the primary
efficacy endpoint of non-inferior visual acuity gains for
tarcocimab dosed monthly compared to aflibercept dosed every 8
weeks following 3 monthly loading doses. No imbalance in cataracts
was observed between the tarcocimab arm and the aflibercept arm in
this study. In light of these clinical trial outcomes, we have made
the business decision to wind down on-going clinical studies of
tarcocimab.
- KSI-501 clinical program: Our Phase 1 study of
KSI-501 has completed enrollment of patients across all dose
levels. KSI-501 is our first-in-class bispecific investigational
medicine designed to inhibit both IL-6-mediated immune inflammation
and VEGF-mediated angiogenesis and vascular permeability. The Phase
1 study is an open-label, multiple ascending dose study to evaluate
ocular and systemic safety, to establish a maximum tolerated dose
and to explore bioactivity of KSI-501, initially in patients with
DME. We are planning to explore development of KSI-501 both as (i)
its unconjugated protein which is itself a novel bispecific
anti-IL-6 antibody / anti-VEGF trap fusion protein and (ii) its
bioconjugate form.
Second Quarter 2023 Financial Results
Cash Position
Kodiak ended the second quarter of 2023 with $378.7 million of cash and cash equivalents.
Net Loss
The net loss for the second quarter of 2023 was $80.2 million, or $1.53 per share on both a basic and diluted
basis, as compared to a net loss of $90.6
million, or $1.74 per share on
both a basic and diluted basis, for the second quarter of 2022. The
net loss for the quarter ended June 30, 2023 included non-cash
stock-based compensation of $25.8
million, as compared to $26.0
million for the quarter ended June 30, 2022.
R&D Expenses
Research and development (R&D) expenses were $67.0 million for the second quarter of 2023, as
compared to $73.7 million for the
second quarter of 2022. The R&D expenses for the second quarter
of 2023 included non-cash stock-based compensation of $14.7 million, as compared to $14.1 million for the second quarter of 2022. The
decrease in R&D expenses for the second 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 $17.9 million for the second quarter of 2023, as
compared to $18.3 million for the
second quarter of 2022. The G&A expenses for the second quarter
of 2023 included non-cash stock-based compensation of $11.1 million, as compared to $11.9 million for the second quarter of
2022.
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. 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
potential benefits of KSI-501, including its potential to be a
first-in-class bispecific investigational medicine inhibiting both
VEGF and IL-6; our ability to apply tailored clinical development
plan to KSI-501 based on the learnings from the tarcocimab clinical
program and the ABC platform itself; expectations regarding our
ability to seek an accelerated development pathway through orphan
and/or breakthrough therapy designation applications with KSI-501;
planned expansion of our research pipeline; and potential future
options for the tarcocimab program. 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 KSI-501 may occur; 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
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
66,961
|
|
|
$
|
73,744
|
|
|
$
|
123,481
|
|
|
$
|
149,921
|
|
General and
administrative
|
|
|
17,871
|
|
|
|
18,324
|
|
|
|
35,966
|
|
|
|
37,914
|
|
Total operating
expenses
|
|
|
84,832
|
|
|
|
92,068
|
|
|
|
159,447
|
|
|
|
187,835
|
|
Loss from
operations
|
|
|
(84,832)
|
|
|
|
(92,068)
|
|
|
|
(159,447)
|
|
|
|
(187,835)
|
|
Interest
income
|
|
|
4,683
|
|
|
|
1,494
|
|
|
|
8,300
|
|
|
|
1,570
|
|
Interest
expense
|
|
|
(4)
|
|
|
|
(5)
|
|
|
|
(8)
|
|
|
|
(10)
|
|
Other income
(expense), net
|
|
|
(35)
|
|
|
|
(49)
|
|
|
|
187
|
|
|
|
(62)
|
|
Net loss
|
|
$
|
(80,188)
|
|
|
$
|
(90,628)
|
|
|
$
|
(150,968)
|
|
|
$
|
(186,337)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(1.53)
|
|
|
$
|
(1.74)
|
|
|
$
|
(2.88)
|
|
|
$
|
(3.57)
|
|
Weighted-average shares
of common stock
outstanding used in computing net loss
per
common share, basic and diluted
|
|
|
52,378,729
|
|
|
|
52,218,773
|
|
|
|
52,358,279
|
|
|
|
52,195,972
|
|
Kodiak Sciences
Inc.
Condensed
Consolidated Balance Sheet Data
(Unaudited)
(in
thousands)
|
|
|
|
|
|
|
|
|
|
June 30,
2023
|
|
|
December 31,
2022
|
|
Cash, cash equivalents
and marketable securities
|
|
|
|
|
|
$
|
378,670
|
|
|
$
|
478,933
|
|
Working
capital
|
|
|
|
|
|
$
|
312,717
|
|
|
$
|
433,509
|
|
Total assets
|
|
|
|
|
|
$
|
589,659
|
|
|
$
|
666,628
|
|
Accumulated
deficit
|
|
|
|
|
|
$
|
(1,043,008)
|
|
|
$
|
(892,040)
|
|
Total stockholders'
equity
|
|
|
|
|
|
$
|
338,478
|
|
|
$
|
436,167
|
|
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SOURCE Kodiak Sciences Inc.