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 the fourth quarter
and year ended December 31, 2020 and provided a corporate update.
“Over the past year, our team has executed on
our key initiatives with purpose and focus,” said George Lasezkay,
Pharm.D., J.D., Clearside’s President and Chief Executive Officer.
“As the pioneers in treating back of the eye diseases through the
suprachoroidal space, we expanded the use of our first in class,
proprietary SCS Microinjector® into four clinical programs in the
U.S. based on our internal product pipeline and our collaborators’
efforts.”
“We advanced our high-potential CLS-AX program
with suprachoroidally-administered axitinib into the clinic and
have fully enrolled and completed dosing in Cohort 1 of OASIS, our
Phase 1/2a trial in patients with neovascular age-related macular
degeneration (wet AMD). We expect to report initial safety data
from Cohort 1 in mid-2021. In addition, we remain on track to
resubmit our New Drug Application for XIPERE™ in the second
quarter of 2021, which is in line with our prior guidance. With our
recently completed financings, we are well-funded to reach multiple
potential value-creating events over the next 12 months,” concluded
Dr. Lasezkay.
Key Highlights and Anticipated
Milestones
- Initiation 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 single dose of CLS-AX administered by
suprachoroidal injection via Clearside’s SCS Microinjector®.
- Completion of
patient dosing in Cohort 1 of the OASIS trial with initial safety
data expected mid-2021.
- Completion of
registered direct offering of 4.2 million shares in January 2021,
resulting in total gross proceeds of approximately $12.0
million.
- Clearside’s
adeno-associated virus (AAV)-based gene therapy partner, REGENXBIO,
expects to: report interim efficacy data in the third quarter of
2021 from Cohort 1 and complete enrollment in Cohort 2 in the
second quarter of 2021 in AAVIATE™, a Phase 2 trial for treatment
of wet AMD; and report initial data from ALTITUDE, a Phase 2 trial
for treatment of diabetic retinopathy, in 2021.
- Multiple
presentations featuring Clearside’s suprachoroidal injection
platform in a range of indications, including wet AMD, uveitis,
diabetic macular edema and ocular gene therapy, were highlighted at
global conferences, including the American Academy of Ophthalmology
Annual Meeting, the 44th Annual Meeting of The Macula Society and
the Angiogenesis, Exudation, and Degeneration 2021 Meeting.
- Data was published
in the British Journal of Ophthalmology in February 2021 titled
“Suprachoroidal CLS-TA for Non-infectious Uveitis: an Open-label,
Safety Trial (AZALEA)”.
- Data was published
in Expert Opinion on Drug Delivery in January 2021 titled
“Biomechanics of Suprachoroidal Drug Delivery: From Benchtop to
Clinical Investigation in Ocular Therapies”.
- Data was published
in Translational Vision Science & Technology, a journal of the
Association for Research in Vision and Ophthalmology, in December
2020 titled “Suprachoroidally Delivered DNA Nanoparticles Transfect
Retina and Retinal Pigment Epithelium/Choroid in Rabbits”.
Fourth Quarter 2020 Financial
Results
Clearside’s license and other revenue for the
fourth quarter of 2020 was $11,000, compared to $1.9 million for
the fourth quarter of 2019. The $1.9 million decrease was primarily
attributable to lower revenue from partner licensing agreements in
the fourth quarter of 2020.
Research and development expenses for the fourth
quarter of 2020 were $4.5 million, compared to $1.3 million for the
fourth quarter of 2019. The $3.2 million increase was primarily
attributable to increased expenses related to preparation for
initiation of the CLS-AX Phase 1/2a clinical trial and costs
related to drug manufacturing activities for XIPERE.
General and administrative expenses for the
fourth quarter of 2020 were $2.6 million, compared to $3.7 million
for the fourth quarter of 2019. The $1.0 million decrease was
primarily attributable to reduced marketing-related expenses
resulting from the out-licensing of XIPERE commercialization.
Net loss for the fourth quarter of 2020 was $7.1
million, or $0.14 per share of common stock, compared to a net loss
of $3.1 million, or $0.07 per share of common stock, for the fourth
quarter of 2019. The increase in net loss was primarily
attributable to higher research and development expenses in the
fourth quarter of 2020.
Full Year 2020 Financial
Results
Clearside’s license and other revenue for the
year ended December 31, 2020 was $7.9 million, compared to $2.2
million for the year ended December 31, 2019. The $5.7 million
increase was primarily attributable to higher revenue from partner
licensing agreements in 2020.
Research and development expenses for the year
ended December 31, 2020 were $15.1 million, compared to $15.7
million for the year ended December 31, 2019.
General and administrative expenses for the year
ended December 31, 2020 were $10.8 million, compared to $16.8
million for the year ended December 31, 2019. The $6.1 million
decrease was primarily attributable to reduced marketing-related
expenses resulting from the out-licensing of XIPERE
commercialization.
Net loss for the year ended December 31, 2020
was $18.2 million, or $0.39 per share of common stock, compared to
a net loss of $30.8 million, or $0.81 per share of common stock,
for the year ended December 31, 2019. The decrease in net loss was
primarily attributable to higher revenue from partner licensing
agreements and lower general and administrative expenses in
2020.
As of December 31, 2020, Clearside’s cash and
cash equivalents totaled $17.3 million. In January 2021, aggregate
net proceeds of $14.4 million were raised from a registered direct
offering of 4.2 million shares and issuances of 1.2 million shares
through an at-the-market agreement. The Company believes it will
have sufficient resources to fund its planned operations into the
first 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: 5286349. 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 safety data from the OASIS clinical trial,
and the potential benefits, of CLS-AX and therapies using
Clearside’s SCS Microinjector®, the timeline for resubmitting the
NDA for XIPERE and Clearside’s ability to fund its
operations into the first 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, 2019, filed with the U.S. Securities and
Exchange Commission (“SEC”) on March 13, 2020, Clearside’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2020, filed with the SEC on November 10, 2020 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 Ended December
31, |
|
|
Twelve Months Ended December
31, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
License and other revenue |
$ |
11 |
|
|
$ |
1,942 |
|
|
$ |
7,894 |
|
|
$ |
2,173 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
4,472 |
|
|
|
1,305 |
|
|
|
15,073 |
|
|
|
15,658 |
|
General and administrative |
|
2,649 |
|
|
|
3,650 |
|
|
|
10,756 |
|
|
|
16,819 |
|
Total operating expenses |
|
7,121 |
|
|
|
4,955 |
|
|
|
25,829 |
|
|
|
32,477 |
|
Loss from operations |
|
(7,110 |
) |
|
|
(3,013 |
) |
|
|
(17,935 |
) |
|
|
(30,304 |
) |
Other expense |
|
(2 |
) |
|
|
(83 |
) |
|
|
(275 |
) |
|
|
(466 |
) |
Net loss |
$ |
(7,112 |
) |
|
$ |
(3,096 |
) |
|
$ |
(18,210 |
) |
|
$ |
(30,770 |
) |
Net loss per share of common
stock — basic and diluted |
$ |
(0.14 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.81 |
) |
Weighted average shares
outstanding — basic and diluted |
|
49,048,402 |
|
|
|
42,394,959 |
|
|
|
46,506,540 |
|
|
|
38,170,830 |
|
Balance Sheet
Data |
December 31, |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
17,287 |
|
|
$ |
22,595 |
|
Total assets |
|
19,322 |
|
|
|
26,776 |
|
Deferred revenue |
|
5,000 |
|
|
|
5,000 |
|
Long-term debt (including current
portion) |
|
991 |
|
|
|
5,152 |
|
Total liabilities |
|
10,559 |
|
|
|
15,619 |
|
Total stockholders’ equity |
|
8,763 |
|
|
|
11,157 |
|
Source: Clearside Biomedical, Inc.
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