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 first quarter ended
March 31, 2021.
“We have made meaningful, value-creating
progress over the past several months,” said George Lasezkay,
Pharm.D., J.D., Clearside’s President and Chief Executive Officer.
“In late April, we resubmitted our New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for XIPERETM for the
treatment of macular edema associated with uveitis. This milestone
is important as XIPERE would be Clearside’s first commercial
product if approved by the FDA, and it would also be the first
approved drug to be delivered into the suprachoroidal space (SCS®).
Our innovative platform represents a potential breakthrough for
delivering drugs to the back of the eye using a reliable,
non-surgical, office-based method.”
“We have also efficiently advanced our lead
development asset, CLS-AX, our proprietary small molecule
suspension of axitinib delivered via our SCS Microinjector® for the
treatment of patients with neovascular age-related macular
degeneration, commonly known as wet AMD. We completed enrollment
and dosing in Cohort 1 of our OASIS Phase 1/2a clinical trial and
expect to announce data from this cohort in June 2021. We believe
CLS-AX is attractively differentiated, combining the potential
benefits of pan-VEGF inhibition with the compartmentalized safety
of suprachoroidal administration,” concluded Dr. Lasezkay.
Key Highlights and Anticipated
Milestones
- NDA resubmission to
the FDA for XIPERE (triamcinolone acetonide suprachoroidal
injectable suspension) for the treatment of macular edema
associated with uveitis.
- Completion of
patient dosing in Cohort 1 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®, with Cohort 1 data expected in June 2021.
- Completion of
registered direct offering of 4.2 million shares in January 2021,
resulting in total gross proceeds of approximately $12.0
million.
- 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 Association for Research in
Vision and Ophthalmology (ARVO) Annual Meeting, the 44th Annual
Meeting of The Macula Society and the Angiogenesis, Exudation, and
Degeneration 2021 Meeting.
- Two manuscripts
were published in the British Journal of Ophthalmology including
“Suprachoroidal CLS-TA for Non-infectious Uveitis: an Open-label,
Safety Trial (AZALEA)” in February 2021 and “Extension Study of the
Safety and Efficacy of CLS-TA for Treatment of Macular Oedema
Associated with Non-infectious Uveitis (MAGNOLIA)” in March
2021.
- Data was published
in Expert Opinion on Drug Delivery titled “Biomechanics of
Suprachoroidal Drug Delivery: From Benchtop to Clinical
Investigation in Ocular Therapies” in January 2021.
First Quarter 2021 Financial
Results
Clearside’s license and other revenue for the
first quarter of 2021 was $34,000, compared to $4.1 million for the
first quarter of 2020. This decrease was primarily attributable to
lower revenue from partner licensing agreements in the first
quarter of 2021.
Research and development expenses for the first
quarter of 2021 were $5.5 million, compared to $3.8 million for the
first quarter of 2020. This increase was primarily attributable to
increased costs for the CLS-AX program, including costs for OASIS,
a Phase 1/2a clinical trial of CLS-AX, and costs related to drug
manufacturing for XIPERE.
General and administrative expenses for the
first quarter of 2021 were $2.9 million, compared to $3.1 million
for the first quarter of 2020. This decrease was primarily
attributable to a reduction in professional fees.
Other income for the first quarter of 2021 was
comprised of the gain on the extinguishment of debt from the
forgiveness of the Paycheck Protection Program loan and accrued
interest.
Net loss for the first quarter of 2021 was $7.4
million, or $0.13 per share of common stock, compared to a net loss
of $2.9 million, or $0.07 per share of common stock, for the first
quarter of 2020. This increase in net loss was primarily
attributable to higher research and development expenses and lower
license revenues in the first quarter of 2021.
As of March 31, 2021, Clearside’s cash and cash
equivalents totaled $26.1 million. 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: 1488886. 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 resubmitted 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, 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.
-Financial Tables Follow-
CLEARSIDE BIOMEDICAL, INC.Selected
Financial Data (in thousands, except share and per share
data)(unaudited)
Statements of
Operations Data |
Three Months EndedMarch 31, |
|
|
2021 |
|
|
2020 |
|
License and other revenue |
$ |
34 |
|
|
$ |
4,097 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
5,490 |
|
|
|
3,811 |
|
General and administrative |
|
2,893 |
|
|
|
3,122 |
|
Total operating expenses |
|
8,383 |
|
|
|
6,933 |
|
Loss from operations |
|
(8,349 |
) |
|
|
(2,836 |
) |
Other income |
|
998 |
|
|
|
— |
|
Other expense |
|
— |
|
|
|
(75 |
) |
Net loss |
$ |
(7,351 |
) |
|
$ |
(2,911 |
) |
Net loss per share of common
stock — basic and diluted |
$ |
(0.13 |
) |
|
$ |
(0.07 |
) |
Weighted average shares
outstanding — basic and diluted |
|
57,038,664 |
|
|
|
44,753,510 |
|
Balance Sheet
Data |
March 31, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
26,147 |
|
|
$ |
17,287 |
|
Total assets |
|
27,821 |
|
|
|
19,322 |
|
Deferred revenue |
|
5,000 |
|
|
|
5,000 |
|
Long-term debt (including current
portion) |
|
— |
|
|
|
991 |
|
Total liabilities |
|
10,836 |
|
|
|
10,559 |
|
Total stockholders’ equity |
|
16,985 |
|
|
|
8,763 |
|
Source: Clearside Biomedical, Inc.
Investor and Media Contacts:
Jenny Kobin
Remy Bernarda
ir@clearsidebio.com
(678) 430-8206
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