Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage
biopharmaceutical company developing first-in-class drug therapies
to treat back-of-the-eye diseases, today reported financial results
for the quarter ended March 31, 2017 and provided an update on its
development programs.
“The Clearside team continues our pursuit of transformative,
elegant, precise solutions to restore and preserve vision,” said
Daniel H. White, Chief Executive Officer and President. “Together,
we continued to advance our pipeline in the first quarter of 2017
as our pivotal Phase 3 clinical trial for the treatment of macular
edema associated with non-infectious uveitis continues enrollment
with preliminary data expected in early 2018. We also
enrolled the first patient in a Phase 3 clinical trial for the
treatment of macular edema associated with retinal vein occlusion.
Additionally, we received notices of allowance of two important
U.S. patents, which are representative of a new family of patents
that protect the unique drug distribution properties of injecting
to the retinal and choroid through the suprachoroidal space.”
Update on Key Development Programs
CLS-TA for suprachoroidal administration (“suprachoroidal
CLS-TA”), Clearside’s proprietary suspension formulation of the
corticosteroid triamcinolone acetonide, used either alone or
together with an intravitreal anti-VEGF agent, is part of
Clearside’s pipeline for the treatments of unmet or underserved
blinding eye diseases where the pathologies manifest in the choroid
and retina.
Macular Edema Associated with Non-Infectious
Uveitis
In the first quarter of 2017, Clearside continued to enroll
patients in PEACHTREE, the Phase 3 trial of suprachoroidal CLS-TA
in patients with macular edema associated with non-infectious
uveitis. Clearside currently anticipates that it will report
initial results from PEACHTREE in early 2018.
Macular Edema Associated with Retinal Vein Occlusion
(“RVO”)
On February 16, 2017, Clearside announced the enrollment of the
first patient in a Phase 3 clinical trial, SAPPHIRE, of
suprachoroidal CLS-TA used together with intravitreally
administered EYLEA® (aflibercept) (“intravitreal Eylea”) for the
treatment of macular edema associated with RVO.
SAPPHIRE is a multicenter, multi-country, randomized, masked,
controlled trial designed to assess the safety and efficacy of
suprachoroidal CLS-TA used with intravitreal Eylea in subjects with
RVO. The primary objective of this trial will be to determine the
proportion of patients in each arm with best corrected visual
acuity improvement of at least 15 letters from baseline at eight
weeks after initial treatment. Several secondary efficacy and
safety outcomes will also be evaluated.
Diabetic Macular Edema (“DME”)
On April 20, 2017, Clearside announced the completion of
enrollment in an exploratory clinical trial, HULK, of
suprachoroidal CLS-TA, both with or without intravitreal Eylea, for
the treatment of DME.
HULK is an open-label, multi-center Phase 1/2 study designed to
assess the safety and efficacy of the administration of a
suprachoroidal injection of CLS-TA along with an intravitreal
injection of Eylea in patients with DME naïve to treatment, as well
as that of a suprachoroidal injection of CLS-TA alone in patients
with DME who have previously been treated with intravitreal
anti-VEGF or intravitreal corticosteroid treatment and still
require further treatment. Clearside currently expects to
report preliminary results from HULK in the second half of
2017.
Clearside is also planning a multicenter, randomized, masked,
controlled Phase 2 trial, TYBEE, to evaluate suprachoroidal CLS-TA
along with intravitreal Eylea, compared to intravitreal Eylea only,
in patients with DME, over a 6-month evaluation period. The
primary endpoint of the trial will be the change in best corrected
visual acuity from baseline in the combination treatment arm
compared to the intravitreal Eylea only arm. Clearside
currently expects to enroll the first patient in TYBEE in
mid-2017.
Wet Age-Related Macular Degeneration (“Wet
AMD”)
Clearside continues to explore potential opportunities for the
use of pharmacological therapies via suprachoroidal injection for
the treatment of wet AMD.
Collaborations
As Clearside’s development programs move further into the
clinic, opportunities have been created to collaborate with
third-party proprietary programs. In this regard, Clearside
continues preclinical efforts with multiple collaborations in gene
therapy, complement inhibition, and alternative mechanisms in the
treatment of complex retinal diseases like AMD.
First Quarter 2017 Financial Results
Clearside’s research and development expenses for the three
months ended March 31, 2017 were $7.6 million, compared to $4.6
million for the first quarter of 2016, an increase of $3.0 million.
This increase was primarily attributable to increased costs related
to Clearside’s ongoing clinical development programs for CLS-TA and
an increase in device manufacturing costs, partially offset by the
decrease in costs from completed clinical trials and Clearside’s
discontinuation of preclinical trials in its wet AMD program.
General and administrative expenses were $2.7 million for the
first quarter of 2017, compared to $1.3 million for the same period
last year, an increase of $1.4 million. This year-over-year
increase was primarily attributable to an increase of $0.5 million
in employee-related costs, a $0.2 million increase in patent and
trademark costs, a $0.2 million increase for marketing expenses and
a $0.3 million increase in the costs of operating as a public
company.
Cash, cash equivalents and short-term investments totaled $77.5
million as of March 31, 2017, compared to $83.6 million as of
December 31, 2016. The decrease reflects total operating expenses,
partially offset by $5.1 million received in January 2017 upon the
underwriters’ exercise of their option to purchase additional
shares as part of Clearside’s follow-on public offering that
initially closed in December 2016.
Net loss for the first quarter of 2017 was $10.4 million, or
$0.41 per share of common stock, compared to $5.4 million, or $2.05
per share of common stock, for the first quarter of 2016. The
increase in net loss is primarily attributable to higher research
and development expenses, while the decrease in net loss per share
of common stock is primarily due to an increase in the number of
shares of common stock outstanding resulting from Clearside’s
financing activities in 2016.
Conference Call & Webcast Details
Clearside is pleased to invite all interested
parties to participate in a conference call today at 8:30 a.m.
Eastern Time, during which the results will be discussed. To
participate in this conference call, please dial (844) 263-8310
(U.S.) or (213) 358-0959 (international), conference ID 17122858,
approximately 10 minutes prior to the start time. A live,
listen-only audio webcast of the conference call can accessed by
visiting the “Investor Relations” section at www.clearsidebio.com.
An archive of the webcast will be available until June 10,
2017.
About Clearside
Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is
a late-stage clinical ophthalmic biopharmaceutical company that
envisions a world without blindness. Clearside relentlessly
pursues transformative, elegant, precise solutions to restore and
preserve vision. Clearside is developing advanced clinical and
preclinical product candidates using a proprietary treatment
approach offering unprecedented access to the back of the eye
through the suprachoroidal space (SCS™). This offers potentially
meaningful treatment benefit to patients suffering from sight
threatening diseases like uveitis, RVO, DME and wet AMD. To
learn more about how Clearside is changing ophthalmology, please
visit us at www.clearsidebio.com.
Cautionary Note Regarding Forward-Looking
Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements may be identified by words such
as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and
similar expressions, and are based on Clearside’s current beliefs
and expectations. These forward-looking statements include
expectations regarding the clinical development of, and the
potential market for, Clearside’s product candidates and the
availability of data from Clearside’s clinical trials. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials, Clearside’s reliance on third parties over
which it may not always have full control, and other risks and
uncertainties that are described in Clearside’s Annual Report on
Form 10-K for the year ended December 31, 2016, filed with the U.S.
Securities and Exchange Commission (“SEC”) on March 16, 2017 and
Clearside’s other Periodic Reports filed with the SEC. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Clearside as of
the date of this release, and Clearside assumes no obligation to,
and does not intend to, update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
CLEARSIDE BIOMEDICAL, INC.Selected
Financial Data (in thousands, except share and per share
data)(unaudited)
|
|
|
|
Statements of Operations Data |
|
Three Months EndedMarch
31, |
|
|
|
2017 |
|
|
2016 |
|
License revenue |
|
$ |
5 |
|
|
$ |
505 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
7,590 |
|
|
|
4,589 |
|
General
and administrative |
|
|
2,671 |
|
|
|
1,273 |
|
Total
operating expenses |
|
|
10,261 |
|
|
|
5,862 |
|
Loss from
operations |
|
|
(10,256 |
) |
|
|
(5,357 |
) |
Other expense, net |
|
|
(117 |
) |
|
|
(92 |
) |
Net loss |
|
$ |
(10,373 |
) |
|
$ |
(5,449 |
) |
Net loss per share of
common stock — basic and diluted |
|
$ |
(0.41 |
) |
|
$ |
(2.05 |
) |
Weighted average shares
outstanding — basic and diluted |
|
|
25,250,333 |
|
|
|
2,660,370 |
|
|
|
|
|
|
|
Balance Sheet
Data |
March 31, |
|
|
December 31, |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and short-term investments |
$ |
77,451 |
|
|
$ |
83,631 |
|
Restricted cash |
|
360 |
|
|
|
360 |
|
Total assets |
|
81,958 |
|
|
|
84,813 |
|
Long-term debt
(including current portion) |
|
7,691 |
|
|
|
7,586 |
|
Total liabilities |
|
14,795 |
|
|
|
13,154 |
|
Total stockholders’
equity |
|
67,163 |
|
|
|
71,659 |
|
Contacts:
Stephen Kilmer
Investor Relations
(678) 270-3631
stephen.kilmer@clearsidebio.com
Charles Deignan
Chief Financial Officer
678-270-4005
charlie.deignan@clearsidebio.com
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