PALO ALTO, Calif., Nov. 12, 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 third quarter
ended September 30, 2019.
"During the third quarter and into the early fourth quarter, we
presented promising safety, efficacy, and durability data from the
clinical study of our novel anti-VEGF antibody biopolymer conjugate
KSI-301 in retinal diseases and showed for the first time that it
is possible for many patients to go for as long as four to six
months before retreatment with an intravitreally-injected
biologic," said Victor Perlroth,
M.D., Chief Executive Officer of Kodiak Sciences. "KSI-301
continues to demonstrate a meaningfully differentiated durability
profile across all the diseases under study: wet age-related
macular degeneration (wet AMD), diabetic macular edema (DME), and
retinal vein occlusion (RVO). We began enrollment in DAZZLE, our
pivotal study of KSI-301 in patients with treatment-naïve wet AMD.
We completed an End of Phase 2 meeting with FDA, where we confirmed
that an approval for KSI-301 in wet AMD, DME, and RVO could
potentially be achieved with a total of only four pivotal trials.
This allows us to further accelerate the clinical development of
KSI-301 and bring DME and diabetic retinopathy (DR) into our 2022
Vision. We look forward to discussing these recent business
highlights and also reviewing the latest safety, efficacy, and
durability data from our ongoing Phase 1b trial at today's teleconference."
Recent Business Highlights:
- Initiated recruitment in our pivotal 'DAZZLE' clinical trial of
KSI-301 in patients with treatment naïve wet AMD;
- Presented promising clinical safety, efficacy, and durability
data from the ongoing Phase 1b study
of KSI-301 at the American Academy of Ophthalmology Annual Meeting
Retina Subspecialty Day;
- Announced an accelerated development and registration strategy
for KSI-301;
- Completed a Type B (End of Phase 2 or EOP) meeting with the FDA
where we discussed and agreed on:
-
- The recommended clinical, non-clinical, and manufacturing
activities to support the licensure of KSI-301, and
- The order and number of clinical studies required to support an
initial Biologics License Application (BLA) in RVO and supplemental
BLAs (sBLA) in wet AMD, DME, and DR; and
- Provided clarity on a capital efficient "2022 Vision" towards
an initial FDA approval of KSI-301 in 2022 for RVO and supplemental
BLA submissions in 2022 for wet AMD, DME and potentially DR without
DME.
Based on the emerging clinical data as well as our productive
EOP meeting with FDA, we are accelerating the clinical development
of KSI-301, with the goal of demonstrating a
meaningfully-differentiated durability profile in each of wet AMD,
RVO, DME, and DR, as compared to currently-marketed medicines and
those known to be in clinical development.
Additional details around the accelerated clinical development
strategy for KSI-301, the FDA EOP meeting, and the latest clinical
data from the ongoing Phase 1b study
can also be found in the Company's third quarter 2019 Quarterly
Report on Form 10-Q to be filed with the SEC on November 12, 2019.
Conference Call and Webcast
Kodiak will host a
business highlights conference call and webcast today at 2:00
p.m. Pacific Time. The call may be accessed by dialing 786-789-4797
and providing the passcode 5902695. The live webcast with
synchronized slides will be available on the "Investors &
Media" section of Kodiak's website
at http://ir.kodiak.com/ and will remain available for
replay following the event.
Third Quarter 2019 Financial Results and Financial
Guidance
Cash Position
Kodiak ended the third quarter of 2019 with $60.6 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 third quarter of 2019 was $12.4 million, or $0.33 per share on both a basic and diluted
basis, as compared to a net loss of $10.5
million, or $1.33 per share on
both a basic and diluted basis, for the third quarter of 2018.
R&D Expenses
Research and development (R&D) expenses were $10.1 million for the third quarter of 2019, as
compared to $4.7 million for the
third quarter of 2018.
G&A Expenses
General and administrative (G&A) expenses were $2.6 million for the third quarter of 2019, as
compared to $1.7 million for the
third quarter of 2018.
About KSI-301
KSI-301 is an investigational therapy built on Kodiak's
proprietary Antibody Biopolymer Conjugate (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.
About the DAZZLE Study
The DAZZLE study (also called Study KSI-CL-102) is a global,
multi-center, randomized study designed to evaluate the safety and
efficacy of KSI-301 in patients with treatment-naïve wet AMD.
Patients are randomized to receive either KSI-301 on an
individualized dosing regimen as infrequently as every five months
and no more often than every three months or to receive
standard-care aflibercept on its every eight-week dosing regimen,
each after three monthly initiating doses. The study is expected to
enroll at least 368 patients worldwide. The primary endpoint is at
one year and each patient will be treated and followed for two
years. Additional information about DAZZLE can be found on
www.clinicaltrials.gov under Trial Identifier
NCT04049266 (https://clinicaltrials.gov/show/NCT04049266).
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, and we
are expanding our early research pipeline to include ABC Platform
based triplet inhibitors for multifactorial retinal diseases such
as dry AMD and the neurodegenerative aspects of glaucoma. 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, but are not limited to,
statements regarding our platform technology and potential
therapies, future development plans including "2022 Vision,"
clinical and regulatory objectives and the timing thereof,
anticipated design of planned clinical trials, including the order
and number of clinical studies required to support a potential
approval for KSI-301 in wet AMD, DME, RVO and DR, expectations
regarding the potential efficacy and commercial potential of our
product candidates, including KSI-301 and its ability to reduce
treatment burden and improve vision outcomes, the anticipated
presentation of data, the results of our research and development
efforts, our ability to advance our product candidates into later
stages of development and the sufficiency of our cash, cash
equivalents and marketable securities. 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. 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 preliminary safety, efficacy
and durability data for our KSI-301 product candidate from the
Phase 1b 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; 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
September
30,
|
|
|
Nine Months
Ended
September
30,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
10,115
|
|
|
$
|
4,709
|
|
|
$
|
24,676
|
|
|
$
|
11,942
|
|
General and
administrative
|
|
|
2,617
|
|
|
|
1,671
|
|
|
|
8,330
|
|
|
|
5,075
|
|
Total operating
expenses
|
|
|
12,732
|
|
|
|
6,380
|
|
|
|
33,006
|
|
|
|
17,017
|
|
Loss from
operations
|
|
|
(12,732)
|
|
|
|
(6,380)
|
|
|
|
(33,006)
|
|
|
|
(17,017)
|
|
Interest
income
|
|
|
354
|
|
|
|
—
|
|
|
|
1,265
|
|
|
|
—
|
|
Interest
expense
|
|
|
(2)
|
|
|
|
(1,982)
|
|
|
|
(8)
|
|
|
|
(5,329)
|
|
Other income
(expense), net
|
|
|
—
|
|
|
|
(2,090)
|
|
|
|
—
|
|
|
|
(4,435)
|
|
Net loss
|
|
$
|
(12,380)
|
|
|
$
|
(10,452)
|
|
|
$
|
(31,749)
|
|
|
$
|
(26,781)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.33)
|
|
|
$
|
1.33
|
|
|
$
|
(0.85)
|
|
|
$
|
(3.45)
|
|
Weighted-average
common shares outstanding used in computing net loss per common
share, basic and
diluted
|
|
|
37,330,066
|
|
|
|
7,851,560
|
|
|
|
37,291,328
|
|
|
|
7,764,888
|
|
|
|
|
Kodiak Sciences
Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(Unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
2019
|
|
|
December 31,
2018
|
|
Cash, cash
equivalents and marketable securities
|
|
|
|
|
|
|
|
|
|
$
|
60,604
|
|
|
$
|
88,254
|
|
Working
capital
|
|
|
|
|
|
|
|
|
|
$
|
53,743
|
|
|
$
|
85,623
|
|
Total
assets
|
|
|
|
|
|
|
|
|
|
$
|
68,916
|
|
|
$
|
92,189
|
|
Accumulated
deficit
|
|
|
|
|
|
|
|
|
|
$
|
(142,515)
|
|
|
$
|
(110,766)
|
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
|
|
$
|
59,691
|
|
|
$
|
86,833
|
|
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SOURCE Kodiak Sciences Inc.