PALO ALTO, Calif., Aug. 14, 2019 /PRNewswire/ -- Kodiak
Sciences Inc. (Nasdaq: KOD), a clinical stage biopharmaceutical
company specializing in novel therapeutics to treat chronic,
high-prevalence retinal diseases, today reported business
highlights and financial results for the second quarter ended
June 30, 2019.
"During the second quarter, we expanded enrollment in our Phase
1b study of KSI-301 across all three
major retinal vascular disease indications of wet AMD, diabetic
macular edema, and retinal vein occlusion. Last month we presented
interim safety and efficacy results on the podium at the American
Society of Retina Specialists (ASRS) 2019 Annual Meeting. Across
all three diseases under study, we observed strong improvements in
vision and retinal anatomy and encouraging signs of disease
modification," said Victor Perlroth,
M.D., Chief Executive Officer of Kodiak Sciences. "Additionally,
this quarter we look forward to initiating our pivotal Phase 2
DAZZLE study of KSI-301 head-to-head versus aflibercept in patients
with treatment-naïve wet AMD, with all patients randomized to
KSI-301 on an every 12-week or longer dosing regimen after three
monthly loading doses. We are excited by the growing body of
promising safety and efficacy data on KSI-301, the opportunities to
present evolving durability data at upcoming ophthalmology
meetings, and our expanding set of clinical studies with the
molecule."
Recent Business Highlights:
Positive Data from Ongoing Phase 1b Study of KSI-301 Presented at ASRS 2019
Meeting
The first data from the ongoing Phase 1b study of KSI-301 in patients with anti-VEGF
treatment-naïve neovascular (wet) age-related macular degeneration
(AMD), diabetic macular edema (DME), and macular edema due to
retinal vein occlusion (RVO) were presented at the American Society
of Retina Specialists (ASRS) 2019 Annual Meeting. Across all three
diseases under study, strong improvements in vision and retinal
anatomy were observed over 12 weeks. The efficacy data presented at
ASRS include outcomes from 35 patients in the study who had reached
the week 12 visit. In the study, patients are being treated with
three monthly doses of either 2.5 mg or 5 mg KSI-301 and followed
for 7 months thereafter, with additional treatments according to
protocol-specified retreatment criteria. As of the July 24, 2019 ASRS presentation's data cut-off
date, a total of 77 patients were enrolled in the Phase
1b study. Further, more than 200
injections with KSI-301 have been given to date across the Phase 1a
and Phase 1b program with no
intraocular inflammation or ocular serious adverse events reported.
Based on the positive data observed to date, Kodiak is planning for
supplemental cohorts to explore additional scientific questions
relevant to KSI-301 and its use for the treatment of retinal
diseases.
Presentation of 12-Week Phase 1a Study of KSI-301 at ARVO
2019 Annual Meeting
Data presentations at the Association
for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting
highlighted the final 12-week results of the Phase 1a clinical
study of KSI-301 with sustained responses observed after a single
dose of KSI-301, measured as improvement from baseline in vision,
retinal anatomy, or both. Through the 12-week last visit, there
were no dose-limiting toxicities, no drug-related adverse events,
and no signs of intraocular inflammation. Rapid high-magnitude and
durable treatment responses were seen at all dose levels
tested.
Expected Upcoming Milestones in 2019
- Initiate KSI-301 pivotal phase 2 DAZZLE randomized head-to-head
study against aflibercept in treatment-naïve patients with wet AMD
with all KSI-301 patients on a 12-week or longer dose regimen. For
additional details about the study, please see
https://clinicaltrials.gov/ct2/show/NCT04049266
- Present additional Phase 1b data
at the European Society of Retina Specialists EURETINA Annual
Meeting (September), the Annual Meeting of the Retina Society
(September), and the American Academy of Ophthalmology (AAO) Annual
Meeting (October)
Second Quarter 2019 Financial Results and Financial
Guidance
Cash Position
Kodiak ended the second quarter of 2019 with $68.1 million of cash, cash equivalents and
marketable securities. The Company expects that its existing cash,
cash equivalents and marketable securities will be sufficient to
fund its operations at least through the first half of 2020.
Net Loss
The net loss for the second quarter of 2019 was $11.4 million, or $0.31 per share on both a basic and diluted
basis, as compared to a net loss of $7.4
million, or $0.96 per share on
both a basic and diluted basis, for the second quarter of 2018.
R&D Expenses
Research and development (R&D) expenses were $8.8 million for the second quarter of 2019, as
compared to $3.6 million for the
second quarter of 2018.
G&A Expenses
General and administrative (G&A) expenses were $3.0 million for the second quarter of 2019, as
compared to $1.5 million for the
second quarter of 2018.
About KSI-301
KSI-301 is an investigational therapy built on the Company's 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. KSI-301 is being developed and is fully
owned globally by Kodiak Sciences Inc.
About Kodiak Sciences Inc.
Kodiak™ is a clinical-stage biopharmaceutical company
specializing in novel therapeutics to treat chronic,
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 ABC Platform™ merges 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 and diabetic eye diseases. Kodiak has
leveraged its ABC Platform to build a pipeline of product
candidates in various stages of development including KSI-501, our
bispecific anti-IL-6/VEGF biopolymer conjugate for the treatment of
neovascular retinal diseases with an inflammatory component. Kodiak
is based in Palo Alto, CA. For
more information, 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 our platform technology and potential therapies, future
development plans, clinical and regulatory objectives and the
timing thereof, expectations regarding the sufficiency of cash,
cash equivalents and marketable securities to fund operations at
least through the first half of 2020, anticipated design of planned
clinical trials, expectations regarding the potential efficacy and
commercial potential of our product candidates, including KSI-301,
the anticipated presentation of data, the results of our research
and development efforts 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," "expect,"
"plan," "believe," "intend," "pursue," and other similar
expressions among others. Statements that are not historical fact
are forward-looking statements. Forward-looking statements are
based on current beliefs and assumptions that involve risks,
uncertainties and other factors that may cause actual results,
events or developments to be materially different from those
expressed or implied by such forward-looking statements. These
risks and uncertainties, many of which are beyond our control,
include, but are not limited to: clinical trials may not
demonstrate safety and efficacy of any of our product candidates;
our assumptions regarding our planned expenditures and sufficiency
of our cash to fund operations may be incorrect; our efforts to
advance the clinical development of additional product candidates
may not be successful; any of our product candidates may fail in
development; the preliminary safety, efficacy and durability data
for our KSI-301 product candidate from the Phase 1 study will not
continue or persist; cessation or delay of any of the ongoing
clinical studies and/or our development of KSI-301 may occur;
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; 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," "ABC Platform" and the Kodiak logo are registered
trademarks or trademarks of Kodiak Sciences Inc. in various
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,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
8,838
|
|
|
$
|
3,591
|
|
|
$
|
14,561
|
|
|
$
|
7,233
|
|
General and
administrative
|
|
|
2,976
|
|
|
|
1,499
|
|
|
|
5,713
|
|
|
|
3,404
|
|
Total operating
expenses
|
|
|
11,814
|
|
|
|
5,090
|
|
|
|
20,274
|
|
|
|
10,637
|
|
Loss from
operations
|
|
|
(11,814)
|
|
|
|
(5,090)
|
|
|
|
(20,274)
|
|
|
|
(10,637)
|
|
Interest
income
|
|
|
431
|
|
|
|
76
|
|
|
|
911
|
|
|
|
124
|
|
Interest
expense
|
|
|
(2)
|
|
|
|
(1,877)
|
|
|
|
(6)
|
|
|
|
(3,347)
|
|
Other income
(expense), net
|
|
|
—
|
|
|
|
(518)
|
|
|
|
-
|
|
|
|
(2,469)
|
|
Net loss
|
|
$
|
(11,385)
|
|
|
$
|
(7,409)
|
|
|
$
|
(19,369)
|
|
|
$
|
(16,329)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.31)
|
|
|
$
|
(0.96)
|
|
|
$
|
(0.52)
|
|
|
$
|
(2.11)
|
|
Weighted-average
common shares outstanding used in
computing net loss per common share, basic and diluted
|
|
|
37,294,853
|
|
|
|
7,757,081
|
|
|
|
37,271,638
|
|
|
|
7,720,967
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kodiak Sciences
Inc.
Condensed
Consolidated Balance Sheet Data
(Unaudited)
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
2019
|
|
|
December 31,
2018
|
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
|
|
|
|
$
|
68,101
|
|
|
$
|
88,254
|
|
Working
capital
|
|
|
|
|
|
|
|
|
|
$
|
64,278
|
|
|
$
|
85,623
|
|
Total
assets
|
|
|
|
|
|
|
|
|
|
$
|
78,275
|
|
|
$
|
92,189
|
|
Accumulated
deficit
|
|
|
|
|
|
|
|
|
|
$
|
(130,135)
|
|
|
$
|
(110,766)
|
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
|
|
$
|
70,019
|
|
|
$
|
86,833
|
|
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SOURCE Kodiak Sciences Inc.