Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company dedicated to developing treatments that restore and
preserve vision for people with serious eye diseases, today
reported financial results for the quarter ended June 30, 2018 and
provided an update on its development programs.
“We remain on track to submit our first NDA
before the end of this year and are continuing to make significant
progress in advancing our late-stage pipeline,” said Daniel H.
White, Chief Executive Officer and President of Clearside. “At the
same time, to help us capture the large and growing market
opportunities for our proprietary suprachoroidal treatment
approach, both at home and abroad, we are also ramping up our
commercial capabilities for the United States and laying the
groundwork for our key assets in Europe and other
jurisdictions. We are excited about Clearside’s planned
transition from a clinical-stage to a commercial-stage
company.”
Update on Key Development
Programs
Suprachoroidal CLS-TA, Clearside’s first
investigational treatment program, is a proprietary suspension of
the corticosteroid triamcinolone acetonide formulated for
administration to the back of the eye via the suprachoroidal space,
or SCS®, which is the space located between the choroid and the
outer protective layer of the eye known as the sclera. Clearside’s
proprietary suprachoroidal treatment approach is designed to enable
rapid dispersion of a high amount of medicine to the back of the
eye so that adequate medicine reaches and stays at the site of
disease and has potential to act longer. This approach has
potential to provide efficacy advantages and require fewer
treatments and office visits while minimizing harm to the
surrounding healthy parts of the eye.
Macular Edema Associated with
Non-Infectious Uveitis
Clearside expects to submit a New Drug
Application (“NDA”) for suprachoroidal CLS-TA to treat macular
edema associated with non-infectious uveitis to the U.S. Food and
Drug Administration (“FDA”) by the end of 2018. In addition,
following discussions with regulatory agencies in Europe and other
jurisdictions, Clearside intends to pursue marketing authorizations
outside of the United States.
In July 2018, during a late-breaking
oral presentation at the 2018 annual meeting of the
American Society of Retina Specialists (“ASRS”), Steven Yeh, M.D.,
Louise M. Simpson Professor of Ophthalmology and Uveitis and
Vitreoretinal Surgery Director, Uveitis and Vasculitis Service at
the Emory Eye Center, Emory University, shared data from PEACHTREE,
Clearside’s pivotal Phase 3 trial of suprachoroidal CLS-TA in
patients with macular edema associated with non-infectious
uveitis.
In this first public presentation of data from
the PEACHTREE trial at a medical conference, Dr. Yeh highlighted
that, as previously reported, this 24-week study met its primary
endpoint, with 47% of patients in the treatment arm who received
suprachoroidal CLS-TA every 12 weeks gaining at least 15 letters in
best corrected visual acuity (“BCVA”), as measured using the Early
Treatment of Diabetic Retinopathy Study (“ETDRS”) scale, from
baseline at week 24, compared to 16% of patients in the control arm
who underwent a sham procedure (p<0.001). The mean change
in BCVA from baseline was better in the treatment arm than in the
sham control arm at each monthly evaluation. The mean improvement
from baseline seen at the first evaluation at week 4 was maintained
throughout the trial, with 9.6 letters gained at week 4 and 13.8
letters at week 24 in the treatment arm, compared to 1.3 letters at
week 4 and 3.0 letters at week 24 in the sham control arm. In
addition, administration of suprachoroidal CLS-TA resulted in a
mean reduction from baseline of 153 microns in central subfield
thickness (“CST”) of the retina at week 24 in the treatment arm,
compared to an 18 micron mean reduction in the sham control arm, a
result that was also statistically significant (p<0.001).
Suprachoroidal CLS-TA was generally well tolerated, with no
treatment-related serious adverse events reported in the
trial.
Dr. Yeh also presented additional highlights
from the PEACHTREE trial, which are summarized below:
- 52% of patients in the treatment arm could read 70 or more
ETDRS letters, the minimum legal limit to qualify for a driver’s
license in most states, at week 24, compared to 22% of patients in
the control arm;
- Over 85% of the patients in the treatment arm did not require
rescue therapy, compared to 28% of patients in the control arm;
and
- With respect to safety, based on an analysis which included
patients who received rescue therapy, elevated intraocular
pressure ("IOP") adverse events pertaining to corticosteroid use
were reported for 11.5% (11/96) of patients in the treatment arm,
compared to 26.3% (10/38) of patients rescued with local
corticosteroids, such as intravitreal OZURDEX® (dexamethasone
intravitreal implant) and subtenon and intravitreal triamcinolone
acetonide in the sham control arm, resulting in an overall rate of
15.6% (10/64) of patients in the sham control arm through 24
weeks.
“We were honored to share the PEACHTREE data
with researchers and clinicians at such an important forum as
ASRS,” said Mr. White. “Our confidence in the potential of
suprachoroidal CLS-TA, if approved, to become a new treatment
option for non-infectious uveitis continues to grow, and we are
beginning to build our commercial infrastructure to support
that.”
Macular Edema Associated with Retinal
Vein Occlusion (“RVO”)
While suprachoroidal CLS-TA is being studied as
a monotherapy in macular edema associated with non-infectious
uveitis, Clearside is studying suprachoroidal CLS-TA together with
an intravitreal anti-vascular endothelial growth factor
(“anti-VEGF”) agent in other retinal vascular diseases, such as RVO
and diabetic macular edema, which have a high vascular endothelial
growth factor response to disease.
RVO is a particularly aggressive eye disease
resulting from an occlusion in a vein carrying blood out of the
retina. This blockage can lead to the rapid onset of complications,
including sudden declines in vision.
In June 2018, Clearside announced the completion
of patient enrollment in SAPPHIRE, its first Phase 3 clinical trial
of suprachoroidal CLS-TA used in combination with the intravitreal
anti-VEGF agent EYLEA® (aflibercept) (“intravitreal Eylea”) in
treatment naïve patients with RVO.
The objective of the SAPPHIRE trial is to show
that suprachoroidal CLS-TA used together with an intravitreal
anti-VEGF agent may result in earlier, superior visual acuity
outcome as compared to monthly injections of an intravitreal
anti-VEGF alone in newly diagnosed branch retinal vein occlusion
(“BRVO”) and central retinal vein occlusion (“CRVO”) patients.
“Ideally, we would like to see better visual
outcomes in the early phase of the disease like we saw in our Phase
2 Tanzanite study, where 52% of patients receiving combination
treatment recovered 3 lines of vision by month 1, compared to 39%
of patients receiving Eylea alone,” said Mr. White. “If we
achieve similar results in SAPPHIRE, we believe that this Phase 3
study has the potential to demonstrate a better opportunity to
recover vision earlier and potentially preserve those vision gains
over the long term. We look forward to reporting topline
8-week primary endpoint data from the Phase 3 SAPPHIRE trial in the
fourth quarter of 2018.”
Clearside also continues to enroll patients in
SAPPHIRE’s companion Phase 3 trial, TOPAZ, of suprachoroidal CLS-TA
with one of two intravitreal anti-VEGF agents, LUCENTIS®
(ranibizumab) or AVASTIN® (bevacizumab), in treatment naïve
patients with RVO.
If the primary endpoints are met in both the
SAPPHIRE and TOPAZ trials, Clearside intends to seek a class label
in the United States, which would allow suprachoroidal CLS-TA to be
used together with any anti-VEGF agent for the treatment of
RVO. In addition, based on recent feedback from the European
Medicines Agency (“EMA”), Clearside believes that data from the RVO
phase 3 development program are sufficient to support a potential
Marketing Authorization Application (“MAA”).
Diabetic Macular Edema
(“DME”)
In May 2018, Clearside announced that TYBEE, its
Phase 2 trial to evaluate the safety and efficacy of suprachoroidal
CLS-TA used with intravitreal Eylea in 71 patients with DME over a
6-month evaluation period, met its primary endpoint.
Patients in both the combination arm receiving
suprachoroidal CLS-TA together with intravitreal Eylea and the
control arm receiving Eylea alone achieved a statistically
significant improvement in mean BCVA at week 24 from baseline
(p<0.001). The combination arm achieved a
statistically similar outcome to Eylea alone at every visit,
including at week 24, with fewer treatments.
Additionally, patients showed [statistically]
significantly better resolution of CST in the combination arm at
week 4 compared to the resolution in the Eylea alone arm
(p<0.01); the greater resolution seen in the combination arm was
sustained through the end of the study.
Suprachoroidal CLS-TA used together with
intravitreal Eylea was generally well tolerated, with no
treatment-related serious adverse events reported through the
24-week evaluation period. Elevated IOP adverse events were
reported for 8.3% (3/36) of patients in the combination arm,
compared to 2.9% (1/35) of patients in the control arm.
Cataract adverse events were reported for 5.6% (2/36) of patients
in the combination arm and 2.9% (1/35) of patients in the control
arm.
“We are pleased with the topline results of the
Phase 2 TYBEE trial, which signals the potential utility of
suprachoroidal CLS-TA to improve on the existing standard of care
in DME,” stated Mr. White. “Like in our RVO program, we
observed positive outcomes in vision, meaningful improvements in
CST and fewer incidences of elevated IOP events than typically
associated with local administration of corticosteroids. As
we receive the complete data set, we will work closely with our
scientific and medical advisors to evaluate the outcomes of the
TYBEE trial and develop a plan forward for this program.”
Pipeline and Collaborations
Clearside continues nonclinical efforts, both
internally and with multiple collaborators, in other ocular
diseases and technologies that may benefit from a suprachoroidal
treatment approach.
Second Quarter 2018 Financial
Results
Clearside’s research and development expenses
for the three months ended June 30, 2018 were $17.3 million,
compared to $11.5 million for the second quarter of 2017, an
increase of $5.9 million. This was primarily attributable to
an increase in costs related to Clearside’s clinical
programs. Costs for Clearside’s RVO program increased $5.7
million, which included purchases of Eylea for SAPPHIRE and
start-up costs and purchases of Lucentis and Avastin for TOPAZ, and
costs for its DME program increased $0.3 million. In
addition, Clearside incurred a $0.2 million increase in regulatory
costs in preparation for an NDA submission for CLS-TA for the
treatment of non-infectious uveitis and a $0.3 million increase in
employee-related costs due to an increase in headcount to support
increased clinical trial activities. These increases were
partially offset by a $0.2 million decrease in clinical costs for
Clearside’s uveitis program, as the PEACHTREE trial was completed
during the first quarter of 2018, and a $0.4 million decrease in
costs related to device and drug manufacturing.
General and administrative expenses were $3.6
million for the second quarter of 2018, compared to $2.3 million
for the same period last year, an increase of $1.3 million.
This increase was primarily attributable to an increase of $0.6
million in employee-related costs, an increase of $0.4
million in marketing-related expenses as Clearside prepares for
potential commercialization of CLS-TA and an increase of $0.1
million in patent-related expenses.
At June 30, 2018, Clearside had cash, cash
equivalents and short-term investments totaling $84.4 million,
which it believes, when combined with its anticipated available
borrowing capacity under its debt facility, is sufficient to fund
the company’s planned operations into the fourth quarter of 2019.
Net loss for the second quarter of 2018 was
$20.7 million, or $0.65 per share of common stock, compared to
$13.8 million, or $0.54 per share of common stock, for the second
quarter of 2017. The increase in net loss and net loss per
share was primarily attributable to higher research and development
expenses in the second quarter of 2018 compared to the second
quarter of 2017.
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 management will discuss the financial
results and provide an update on Clearside’s corporate
developments. To participate in this conference call, please dial
(844) 263-8310 (U.S.) or (213) 358-0959 (international), conference
ID 6390517, 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 September 9, 2018.
About Clearside
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing treatments that
restore and preserve vision for people with serious eye
diseases. Clearside’s proprietary suprachoroidal treatment
approach offers unprecedented access to the back of the eye where
sight-threatening disease often occurs. The company’s unique
platform for eye disease treatments is inherently flexible and
intended to work with established medicines, new formulations of
medicines, as well as future innovations. Clearside’s
pipeline includes advanced and preclinical product candidates in
diseases where macular edema is a common complication, including
uveitis, RVO and DME. Clearside’s most advanced program is in
non-infectious uveitis and it expects to submit an NDA to the FDA
for use of suprachoroidal CLS-TA for the treatment of macular edema
associated with non-infectious uveitis by the end of 2018.
The company is also conducting two ongoing Phase 3 trials of
suprachoroidal CLS-TA with an intravitreal anti-VEGF agent in
patients with RVO. In addition, Clearside recently announced
positive topline results from a Phase 2 clinical trial of
suprachoroidal CLS-TA used with Eylea in patients with DME and is
continuing to analyze additional data from the trial as it becomes
available. Clearside is headquartered in Alpharetta,
GA. For more information, please visit
http://www.clearsidebio.com. Follow @clearsidebio on Twitter
and Linkedin.
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
potential clinical development of Clearside’s product candidates,
the availability of data from Clearside’s clinical trials, the
timing of a potential submission of an NDA with the FDA and an MAA
to the EMA, and the potential commercialization of CLS-TA, both in
the United States and internationally. 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, 2017, filed with the U.S. Securities and
Exchange Commission (“SEC”) on March 16, 2018, 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 EndedJune
30, |
|
|
Six Months EndedJune
30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
License and
collaboration revenue |
|
$ |
— |
|
|
$ |
130 |
|
|
$ |
— |
|
|
$ |
135 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
17,343 |
|
|
|
11,478 |
|
|
|
30,722 |
|
|
|
19,068 |
|
General
and administrative |
|
|
3,561 |
|
|
|
2,290 |
|
|
|
6,635 |
|
|
|
4,961 |
|
Total
operating expenses |
|
|
20,904 |
|
|
|
13,768 |
|
|
|
37,357 |
|
|
|
24,029 |
|
Loss from
operations |
|
|
(20,904 |
) |
|
|
(13,638 |
) |
|
|
(37,357 |
) |
|
|
(23,894 |
) |
Other income (expense),
net |
|
|
203 |
|
|
|
(135 |
) |
|
|
49 |
|
|
|
(252 |
) |
Net loss |
|
$ |
(20,701 |
) |
|
$ |
(13,773 |
) |
|
$ |
(37,308 |
) |
|
$ |
(24,146 |
) |
Net loss per share of
common stock — basic and diluted |
|
$ |
(0.65 |
) |
|
$ |
(0.54 |
) |
|
$ |
(1.27 |
) |
|
$ |
(0.96 |
) |
Weighted average shares
outstanding — basic and diluted |
|
|
31,979,158 |
|
|
|
25,309,966 |
|
|
|
29,412,904 |
|
|
|
25,280,314 |
|
Balance Sheet
Data |
June 30, |
|
|
December 31, |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and short-term investments |
$ |
84,430 |
|
|
$ |
37,640 |
|
Restricted cash |
|
360 |
|
|
|
360 |
|
Total assets |
|
88,016 |
|
|
|
40,493 |
|
Long-term debt
(including current portion) |
|
9,848 |
|
|
|
8,009 |
|
Total liabilities |
|
21,344 |
|
|
|
19,078 |
|
Total stockholders’
equity |
|
66,672 |
|
|
|
21,415 |
|
Contacts:
Stephen KilmerInvestor Relations(678)
430-8206stephen.kilmer@clearsidebio.com
Charles DeignanChief Financial
Officer678-270-4005charlie.deignan@clearsidebio.com
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