Clearside Biomedical Announces First Quarter 2023 Financial Results and Provides Corporate Update
May 11 2023 - 6:05AM
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, 2023 and
provided a corporate update.
“We have delivered a productive start to 2023 as
we continue executing on our near-term plan to advance CLS-AX
(axitinib injectable suspension) for the treatment of wet AMD,”
said George Lasezkay, Pharm.D., J.D., Clearside’s President and
Chief Executive Officer. “In February, we announced positive data
from the OASIS Phase 1/2a Extension Study demonstrating an
excellent safety profile for CLS-AX with promising duration and
biologic effect over 6 months in treatment-experienced, anti-VEGF
sub-responder wet AMD participants. This data was recently
presented at the ARVO Annual Meeting in New Orleans.”
“We are now looking to build upon the OASIS
results in ODYSSEY, our Phase 2b clinical trial of CLS-AX in wet
AMD patients, which will open for enrollment this quarter, with
topline results expected in Q3 2024. The recently announced ODYSSEY
trial design was based on input from our enhanced Scientific
Advisory Board and other experienced retinal physicians, while
taking into account the recent FDA draft guidance for wet AMD drug
development. In conducting the ODYSSEY trial, we believe that
CLS-AX has the potential to demonstrate an important reduction in
treatment burden while maintaining stable visual acuity in patients
with wet AMD. Importantly, we also believe that the number of
participants, the duration, and the outcome measures of the ODYSSEY
trial will provide the necessary clinical data to inform the design
of a CLS-AX Phase 3 program,” concluded Dr. Lasezkay.
Key Highlights
- Clearside announced
plans for ODYSSEY, its randomized, double-masked, parallel-group,
active-controlled, multi-center Phase 2b clinical trial of CLS-AX
(axitinib injectable suspension) using suprachoroidal delivery in
neovascular age-related macular degeneration (wet AMD).
- Favorable safety
data, duration and biologic effect over 6 months in
treatment-experienced anti-VEGF sub-responders was reported from
Cohorts 3 and 4 of the Extension Study of OASIS, Clearside’s
U.S.-based, open-label, dose-escalation Phase 1/2a clinical trial
of CLS-AX in wet AMD.
- Clearside’s
Scientific Advisory Board (SAB) was enhanced with the additions of
Thomas A. Ciulla, M.D., M.B.A. as Chair, Arshad M. Khanani, M.D.,
M.A. and Lejla Vajzovic, M.D. The SAB is comprised of industry
leading retinal physicians who provide medical and scientific
expertise and input on the Company’s research and development
programs.
- Clinical data was
presented at The Association for Research in Vision and
Ophthalmology (ARVO) 2023 Annual Meeting, which highlighted that
SCS delivery of small molecule suspensions offered targeted,
compartmentalized, and durable drug delivery to the chorioretina.
In addition, a poster presentation based on OASIS Phase 1/2a trial
data showed that CLS-AX had an excellent safety profile and that
Extension Study participants with wet AMD maintained visual acuity
while experiencing a meaningful reduction in treatment burden over
6 months.
- Presentations
featuring Clearside’s proprietary suprachoroidal space injection
platform were highlighted at the Macula Society Annual Meeting and
the Angiogenesis, Exudation, and Degeneration Virtual
Conference.
First Quarter 2023 Financial
Results
- License Revenue: Clearside’s
license and other revenue for the first quarter of 2023 was $4,000,
compared to $347,000 for the first quarter of 2022.
- Research and Development (R&D)
Expenses: R&D expenses for the first quarter
of 2023 and the first quarter of 2002 were $4.5 million.
- General and Administrative
(G&A) Expenses: G&A expenses for the first
quarter of 2023 were $3.2 million, compared to $3.5 million for the
first quarter of 2022.
- Other Income: Other income for the
first quarter of 2023 was $492,000, compared to $2,000 for the
first quarter of 2022. Other income in both periods was comprised
of interest income from cash and cash equivalents.
- Other Expense:
Non-cash interest expense for the first quarter of 2023 was $2.2
million, compared to $0 in the first quarter of 2022. Non-cash
interest expense was comprised of imputed interest on the liability
related to the sales of future royalties and the amortization of
the associated issuance costs.
- Net Loss: Net loss for the first
quarter of 2023 was $9.3 million, or $0.15 per share of common
stock, compared to net loss of $7.6 million, or $0.13 per share of
common stock, for the first quarter of 2022.
- Cash Position: As
of March 31, 2023, Clearside’s cash and cash equivalents totaled
$41.4 million. The Company believes it will have sufficient
resources to fund its planned operations into the second quarter of
2024.
Conference Call & Webcast
Details
Clearside’s management will host a webcast and
conference call today at 8:30 a.m. Eastern Time to discuss the
financial results and provide a corporate update. Registration for
the live and archived webcast may be accessed on the Clearside
website under the Investors section: Events and Presentations. To
participate via telephone, please register in advance using the
link provided in the event listing. The Company suggests
participants log in 15 minutes in advance of the event.
About Clearside Biomedical,
Inc.
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. The Company’s lead program, CLS-AX
(axitinib injectable suspension), for the treatment of neovascular
age-related macular degeneration (wet AMD), is in Phase 2 clinical
testing. Clearside developed and gained approval for its first
product, XIPERE® (triamcinolone acetonide injectable suspension)
for suprachoroidal use, which is available in the U.S. through a
commercial partner. Clearside also strategically partners its SCS
injection platform with companies utilizing other ophthalmic
therapeutic innovations. 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, timeline for initiating the ODYSSEY Phase 2b clinical trial
for CLS-AX, the expected timing of topline results from the ODYSSEY
clinical trial, the potential benefits of CLS-AX and other product
candidates using Clearside’s SCS Microinjector® and Clearside’s
ability to fund its operations into the second quarter of 2024.
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, 2022, filed with the U.S.
Securities and Exchange Commission (SEC) on March 14, 2023 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, |
|
|
|
2023 |
|
|
2022 |
|
License and other revenue |
|
$ |
4 |
|
|
$ |
347 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
4,451 |
|
|
|
4,536 |
|
General and administrative |
|
|
3,158 |
|
|
|
3,457 |
|
Total operating expenses |
|
|
7,609 |
|
|
|
7,993 |
|
Loss from operations |
|
|
(7,605 |
) |
|
|
(7,646 |
) |
Other income |
|
|
492 |
|
|
|
2 |
|
Non-cash interest expense on
liability related to the sales of future royalties |
|
|
(2,167 |
) |
|
|
— |
|
Net loss |
|
$ |
(9,280 |
) |
|
$ |
(7,644 |
) |
Net loss per share of common
stock — basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.13 |
) |
Weighted average shares
outstanding — basic and diluted |
|
|
61,169,486 |
|
|
|
60,064,209 |
|
Balance Sheet
Data |
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
41,419 |
|
|
$ |
48,258 |
|
Total assets |
|
|
44,695 |
|
|
|
51,303 |
|
Liabilities related to the sales
of future royalties, net |
|
|
36,144 |
|
|
|
33,977 |
|
Total liabilities |
|
|
41,995 |
|
|
|
40,696 |
|
Total stockholders’ equity |
|
|
2,700 |
|
|
|
10,607 |
|
|
|
|
|
|
|
|
|
|
Source: Clearside Biomedical, Inc.
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