Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company revolutionizing the delivery of therapies to the back of
the eye through the suprachoroidal space (SCS®), today reported
financial results for the first quarter ended March 31, 2022 and
provided a corporate update.
“The approval and recent commercial launch of
XIPERE® in the U.S. validates delivery into the suprachoroidal
space by our proprietary SCS Microinjector®, and supports our
strategic approach focused on small molecule suspensions,” said
George Lasezkay, Pharm.D., J.D., Clearside’s
President and Chief Executive Officer. “As part of the launch
process, hundreds of retinal specialists throughout the country
have been trained on the use of our SCS Microinjector. This vast
experience and technical knowledge using our Microinjector
establishes a strong base for our platform as we expand our
internal and externally partnered therapeutic candidates.”
Dr. Lasezkay continued, “Our lead internal
suprachoroidal pipeline product candidate, CLS-AX, combines our
proprietary small molecule suspension of the tyrosine kinase
inhibitor axitinib with delivery by our SCS Microinjector. We are
progressing OASIS, our Phase 1/2a single dose escalating clinical
trial targeting patients with wet AMD. We are encouraged by the
growing interest in this trial, and as a result, we have recently
doubled the number of clinical trial sites to ten. Our Safety
Monitoring Committee reviewed one-month initial safety data from
Cohort 3 and we are pleased to report that there were no dose
limiting toxicities observed at the 0.5 mg dose. As a result, we
are now enrolling patients in Cohort 4 at the higher dose of 1.0 mg
while simultaneously continuing our Cohort 3 enrollment. We are
targeting up to 25 patients in total from all four OASIS
cohorts.”
“This expanded enrollment of Cohort 3 and the
addition of Cohort 4 will allow us to collect more CLS-AX patient
data in order to help guide our selection of the most appropriate
dosing protocol for our planned Phase 2b clinical trial. We now
expect to report safety and tolerability data from both Cohorts 3
and 4 in the fourth quarter of this year. This will allow us to
report a more comprehensive set of patient data as we will be able
to include the complete analysis from all four dosing cohorts of
the OASIS trial, in addition to the detailed individual patient
data from the final two cohorts,” concluded Dr. Lasezkay.
Key Highlights
- XIPERE®
(triamcinolone acetonide injectable suspension) for suprachoroidal
use for the treatment of macular edema associated with uveitis was
commercially launched for sale in the U.S. by Bausch + Lomb.
- Continued progress
made in OASIS, Clearside’s U.S. based, open-label, dose-escalation
Phase 1/2a trial in patients with wet AMD, to assess the safety and
tolerability of CLS-AX (axitinib injectable suspension)
administered by suprachoroidal injection via Clearside’s SCS
Microinjector.
- Benjamin R. Yerxa,
Ph.D., Chief Executive Officer of the Foundation Fighting
Blindness, the world’s leading private funding source for retinal
degenerative disease research, was appointed to Clearside’s Board
of Directors.
- Multiple
presentations and panels featuring the use of Clearside’s
proprietary suprachoroidal space injection platform were
highlighted at global conferences, including Association for
Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting,
the American Society of Cataract and Refractive Surgery (ASCRS)
Meeting, Vit Buckle Society Annual Meeting, Sonoma Eye Meeting, Wet
AMD & DME Drug Development Summit and Angiogenesis, Exudation,
and Degeneration Virtual Conference.
- Several posters were presented at ARVO
related to XIPERE® for suprachoroidal use.
- Two presentations
were delivered on REGENXBIO asset RGX-314 administered via
Clearside’s SCS Microinjector at ARVO.
First Quarter 2022 Financial
Results
Clearside’s license and other revenue for the
first quarter of 2022 was $347,000, compared to $34,000 for the
first quarter of 2021.
Research and development expenses for the first
quarter of 2022 were $4.5 million, compared to $5.5 million for the
first quarter of 2021. The $1.0 million decrease was primarily
attributable to reduced XIPERE-related expenses which offset CLS-AX
Phase 1/2a clinical trial costs.
General and administrative expenses for the
first quarter of 2022 were $3.5 million, compared to $2.9 million
for the first quarter of 2021. The $0.6 million increase was
primarily attributable to share-based compensation and higher
salary costs.
Net loss for the first quarter of 2022 was $7.6
million, or $0.13 per share of common stock, compared to a net loss
of $7.4 million, or $0.13 per share of common stock, for the first
quarter of 2021.
As of March 31, 2022, Clearside’s cash and cash
equivalents totaled $34.4 million. The Company believes it will
have sufficient resources to fund its planned operations for at
least the next twelve months.
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: 3749780. An
archive of the webcast will be available for three months.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company revolutionizing the delivery of therapies
to the back of the eye through the suprachoroidal space (SCS®).
Clearside’s SCS injection platform, utilizing the Company’s
proprietary SCS Microinjector®, enables an in-office, repeatable,
non-surgical procedure for the targeted and compartmentalized
delivery of a wide variety of therapies to the macula, retina or
choroid to potentially preserve and improve vision in patients with
sight-threatening eye diseases. Clearside is developing its own
pipeline of small molecule product candidates for administration
via its SCS Microinjector and strategically partners its SCS
injection platform with companies utilizing other ophthalmic
therapeutic innovations. Clearside’s first product, XIPERE®
(triamcinolone acetonide injectable suspension) for suprachoroidal
use, is commercially available in the U.S. 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 of
CLS-AX, including the expected timing of data from the OASIS
clinical trial and plans for the Phase 2b trial, the potential
benefits of CLS-AX and product candidates using Clearside’s SCS
Microinjector® and Clearside’s ability to fund its operations for
at least the next twelve months. 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, 2021,
filed with the U.S. Securities and Exchange Commission (SEC) on
March 11, 2022, 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 EndedMarch 31, |
|
|
|
2022 |
|
|
2021 |
|
License and other revenue |
|
$ |
347 |
|
|
$ |
34 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
4,536 |
|
|
|
5,490 |
|
General
and administrative |
|
|
3,457 |
|
|
|
2,893 |
|
Total
operating expenses |
|
|
7,993 |
|
|
|
8,383 |
|
Loss
from operations |
|
|
(7,646 |
) |
|
|
(8,349 |
) |
Other
income |
|
|
2 |
|
|
|
998 |
|
Net
loss |
|
$ |
(7,644 |
) |
|
$ |
(7,351 |
) |
Net loss
per share of common stock — basic and diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.13 |
) |
Weighted
average shares outstanding — basic and diluted |
|
|
60,064,209 |
|
|
|
57,038,664 |
|
|
|
|
|
|
|
Balance Sheet Data |
March 31, |
|
|
December 31, |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
34,372 |
|
|
$ |
30,436 |
|
Accounts
receivable |
|
̶ |
|
|
|
10,000 |
|
Total
assets |
|
36,059 |
|
|
|
42,903 |
|
Total
liabilities |
|
4,356 |
|
|
|
4,928 |
|
Total
stockholders’ equity |
|
31,703 |
|
|
|
37,975 |
|
|
|
|
|
|
|
|
|
Source: Clearside Biomedical, Inc.
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