Clearside Biomedical Announces Second Quarter 2021 Financial Results and Provides Corporate Update
August 10 2021 - 4:05PM
Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company dedicated to developing and delivering treatments that
restore and preserve vision for people with serious back of the eye
diseases, today reported financial results for second quarter ended
June 30, 2021.
“We continue to demonstrate our position as the
leader in the suprachoroidal space with numerous clinical trials in
multiple indications, a New Drug Application (NDA) for
XIPERE™ under regulatory review and recent positive results
from our CLS-AX clinical trial,” said George Lasezkay, Pharm.D.,
J.D., Clearside’s President and Chief Executive Officer. “We are
the first company to develop a clinically tested, non-surgical,
repeatable micro-injection technology designed to unlock the
potential clinical benefits of administering drugs into the
suprachoroidal space. We are encouraged by the Cohort 1 results of
our OASIS Phase 1/2a trial in wet AMD patients, which achieved its
safety and tolerability endpoints. We believe the Cohort 1 data
supports our hypothesis that the combination of targeted and
compartmentalized suprachoroidal delivery and the potent pan-VEGF
attributes of axitinib may facilitate an effective treatment option
for patients suffering from wet AMD. We have begun enrollment in
Cohort 2 with more than triple the dose used in Cohort 1 and look
forward to reporting results by the end of 2021.”
“Following our NDA resubmission for XIPERE for
the treatment of macular edema associated with uveitis, the U.S.
Food and Drug Administration (FDA) assigned a Prescription Drug
User Fee Act (PDUFA) action date of October 30, 2021. If approved,
XIPERE would represent the first therapy for macular edema
associated with uveitis, the first approved therapeutic delivered
into the suprachoroidal space and the first commercial product
developed by Clearside. In addition to progressing our internal
development initiatives, we continue to work closely with our
commercial and drug development partners, and expect data from
their ongoing clinical trials using our SCS Microinjector® later
this year,” concluded Dr. Lasezkay.
Key Highlights
- Patient enrollment
is underway in Cohort 2 of OASIS, Clearside’s U.S. based,
open-label, dose-escalation Phase 1/2a trial in wet AMD patients,
to assess the safety and tolerability of a 0.1 mg dose of CLS-AX
administered by suprachoroidal injection via Clearside’s SCS
Microinjector®.
- Clearside reported
positive results from Cohort 1 of OASIS in six patients (n=6) with
neovascular age-related macular degeneration (wet AMD). The primary
endpoints were achieved in Cohort 1, as the initial lowest planned
dose of 0.03 mg CLS-AX was well tolerated with no serious adverse
events and no drug related treatment emergent adverse events
observed throughout the study period.
- FDA accepted the
XIPERE NDA resubmission and assigned a PDUFA action date of October
30, 2021.
- Multiple
presentations featuring the use of Clearside’s proprietary
suprachoroidal space (SCS®) delivery platform to administer small
molecules and gene therapy were highlighted at global conferences,
including the Association for Research in Vision and Ophthalmology
(ARVO) Annual Meeting and the Wet AMD & DME Drug Development
Summit.
- Data was published
in Translational Vision Science & Technology titled “Evaluation
of Long-Lasting Potential of Suprachoroidal Axitinib Suspension Via
Ocular and Systemic Disposition in Rabbits” in June 2021.
Second Quarter 2021 Financial
Results
Clearside’s license and other revenue for the
second quarter of 2021 was $0.8 million, compared to $0.4 million
for the second quarter of 2020. This increase was primarily
attributable to higher revenue from partner licensing agreements in
the second quarter of 2021.
Research and development expenses for the second
quarter of 2021 were $4.1 million, compared to $3.3 million for the
second quarter of 2020. This increase was primarily attributable to
increased costs for continued development of pipeline programs and
employee-related expenses.
General and administrative expenses for the
second quarter of 2021 were $2.8 million, compared to $2.6 million
for the second quarter of 2020. This increase was primarily
attributable to an increase in employee-related expenses.
Net loss for the second quarter of 2021 was $6.1
million, or $0.11 per share of common stock, compared to a net loss
of $5.8 million, or $0.13 per share of common stock, for the second
quarter of 2020. This increase in net loss was primarily
attributable to higher research and development expenses in the
second quarter of 2021. The change in net loss per share was
related to the increase in shares outstanding.
As of June 30, 2021, Clearside’s cash and cash
equivalents totaled $26.4 million. The Company believes it will
have sufficient resources to fund its planned operations into the
second quarter of 2022, not including receipt of potential partner
milestone payments.
Conference Call & Webcast
Details
Clearside’s management will host a webcast and
conference call today at 4:30 p.m. Eastern Time to discuss the
financial results and provide a corporate update. The live and
archived webcast may be accessed on the Clearside website under the
Investors section: Events and Presentations. The live call can be
accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959
(international) and entering conference code: 7785213. An
archive of the webcast will be available for three months.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing and delivering
treatments that restore and preserve vision for people with serious
back of the eye diseases. Clearside’s proprietary SCS
Microinjector® targets the suprachoroidal space (SCS®) and offers
unique access to the macula, retina and choroid where
sight-threatening disease often occurs. The Company’s SCS injection
platform is an inherently flexible, in-office, non-surgical
procedure, intended to provide targeted delivery to the site of
disease and to work with both established and new formulations of
medications. For more information, please visit
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 statements regarding the clinical development,
including the timing of data from the OASIS clinical trial, the
potential benefits of XIPERE, CLS-AX and therapies using
Clearside’s SCS Microinjector®, the resubmitted NDA for and
anticipated regulatory approval of XIPERE and Clearside’s
ability to fund its operations into the second quarter of
2022. 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, uncertainties
regarding the COVID-19 pandemic and other risks and uncertainties
that are described in Clearside’s Annual Report on Form 10-K for
the year ended December 31, 2020, filed with the U.S. Securities
and Exchange Commission (“SEC”) on March 15, 2021, 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.
Investor and Media Contacts:Jenny Kobin Remy
Bernarda ir@clearsidebio.com(678) 430-8206
-Financial Tables Follow-
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, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
License and other revenue |
|
$ |
780 |
|
|
$ |
354 |
|
|
$ |
814 |
|
|
$ |
4,451 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,060 |
|
|
|
3,300 |
|
|
|
9,550 |
|
|
|
7,111 |
|
General and administrative |
|
|
2,816 |
|
|
|
2,611 |
|
|
|
5,709 |
|
|
|
5,733 |
|
Total operating expenses |
|
|
6,876 |
|
|
|
5,911 |
|
|
|
15,259 |
|
|
|
12,844 |
|
Loss from operations |
|
|
(6,096 |
) |
|
|
(5,557 |
) |
|
|
(14,445 |
) |
|
|
(8,393 |
) |
Other income |
|
|
1 |
|
|
|
— |
|
|
|
999 |
|
|
|
— |
|
Other expense |
|
|
— |
|
|
|
(197 |
) |
|
|
— |
|
|
|
(272 |
) |
Net loss |
|
$ |
(6,095 |
) |
|
$ |
(5,754 |
) |
|
$ |
(13,446 |
) |
|
$ |
(8,665 |
) |
Net loss per share of common
stock — basic and diluted |
|
$ |
(0.11 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.19 |
) |
Weighted average shares
outstanding — basic and diluted |
|
|
57,745,465 |
|
|
|
45,214,500 |
|
|
|
57,394,017 |
|
|
|
44,984,005 |
|
Balance Sheet
Data |
June 30, |
|
December 31, |
|
2021 |
|
2020 |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
26,414 |
|
$ |
17,287 |
Total assets |
|
28,592 |
|
|
19,322 |
Deferred revenue |
|
5,000 |
|
|
5,000 |
Long-term debt (including current
portion) |
|
— |
|
|
991 |
Total liabilities |
|
9,254 |
|
|
10,559 |
Total stockholders’ equity |
|
19,338 |
|
|
8,763 |
Source: Clearside Biomedical, Inc.
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