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 second quarter ended June 30, 2024, and
provided a corporate update.
“Our Phase 2b ODYSSEY clinical trial utilizing
CLS-AX (axitinib injectable suspension) in patients with wet AMD
continues to advance on track and on time with topline data
expected in late Q3 2024,” said George Lasezkay, PharmD, JD,
President and Chief Executive Officer. “In July, the Safety Review
Committee reviewed masked safety data and noted that there have
been no drug-related Serious Adverse Events (SAEs), including no
endophthalmitis or retinal vasculitis, and recommended the trial
continue as planned without modifying the protocol. Both arms of
the ODYSSEY trial have completed six months of treatment, with
CLS-AX being re-dosed per protocol in the CLS-AX arm. Re-dosing
with CLS-AX is an important and differentiating feature of the
ODYSSEY trial, and the re-dosing data will be valuable as we
evaluate the effects of CLS-AX in this chronic disease and plan our
Phase 3 clinical development program.”
Dr. Lasezkay continued, “Several noteworthy
events have also occurred featuring our commercial product,
XIPERE®1, for the treatment of patients with macular edema
associated with uveitis. Most importantly, our Asia-Pacific
partner, Arctic Vision, reported positive results from their Phase
3 trial for XIPERE, known as ARCATUS in China, and announced that
new drug applications (NDAs) for ARCATUS have been accepted for
review in Australia and Singapore. In addition, data presented on
the real-world use of XIPERE in the United States has shown the
product has excellent durability as 87.7% of eyes did not require
an injected or implanted corticosteroid for 6 months after a single
dose of XIPERE2.”
“In May 2024, consensus guidelines for drug
delivery by suprachoroidal administration, co-authored by 16
practicing retinal physicians, were published in the prominent
journal, RETINA®. The article describes the physicians’ best
practices for injection into the suprachoroidal space. These
valuable guidelines, combined with our progress with CLS-AX and the
promising real-world and Phase 3 data from XIPERE continue to
demonstrate the advantages of suprachoroidal administration
utilizing our proprietary SCS Microinjector® to deliver therapies
to the back of the eye for the treatment of a variety of retinal
diseases,” concluded, Dr. Lasezkay,
Key Highlights
- Topline data
expected in late third quarter of 2024 from Phase 2b ODYSSEY
clinical trial of CLS-AX using suprachoroidal delivery in
neovascular age-related macular degeneration (wet AMD).
- Clearside’s
Asia-Pacific partner, Arctic Vision, reported positive topline
results from its Phase 3 clinical trial of ARCATUS® for the
treatment of uveitic macular edema in China and announced that NDAs
for ARCATUS have been officially accepted in Australia and
Singapore.
- Clearside hosted
its Suprachoroidal Delivery Key Opinion Leader webinar highlighting
broad applicability and real-world experience with suprachoroidal
drug delivery and SCS development opportunities, including wet AMD
and geographic atrophy. The replay of this event is available on
the Clearside website under the Investors section: Events and
Presentations.
- Ophthalmology
Science published an article summarizing safety and tolerability
data from OASIS, Clearside’s Phase 1/2a Open-Label, Dose-Escalation
trial of CLS-AX (axitinib injectable suspension) in wet AMD. The
full publication can be accessed here.
- RETINA®, The
Journal of Retinal and Vitreous Diseases published consensus
guidelines for drug delivery via Suprachoroidal Space (SCS®)
injection. The full publication can be accessed here.
- Clearside’s gene
therapy partner, REGENXBIO, reported progress on their ABBV-RGX-314
programs delivered via suprachoroidal injection with Clearside’s
SCS Microinjector®. REGENEXBIO announced that they expect to
initiate a global pivotal trial in the first half of 2025 for the
treatment of diabetic retinopathy, and that their Phase 2 ALTITUDE®
trial is now enrolling a new cohort of patients with
center-involved diabetic macular edema (DME). In addition,
REGENEXBIO announced their AAVIATE® Phase 2 trial in wet AMD is
initiating enrollment in a new cohort at dose level 4.3
- Multiple data
presentations on the use of Clearside’s suprachoroidal delivery
platform were featured at prominent medical meetings, including the
Association for Research in Vision and Ophthalmology (ARVO),
Clinical Trials at the Summit and Retinal Imaging Biomarkers and
Endpoints Summit.
- Glenn Yiu, MD, PhD,
Professor of Ophthalmology at the University of California, Davis,
was appointed to Clearside’s Scientific Advisory Board (SAB) in
July 2024. Dr. Yiu, a board-certified vitreoretinal surgeon, leads
the translational research program at UC Davis studying AMD and
other retinal diseases, with focus on ocular imaging technologies,
gene editing and delivery, and animal models of retinal
disease.
- Tony Gibney was
appointed to Clearside’s Board of Directors in April 2024. Mr.
Gibney is an experienced biotechnology executive and former
investment banker who brings over 25 years of experience dedicated
to advising biotechnology companies on business strategy,
collaborations, financings, and mergers and acquisitions.
Second Quarter 2024 Financial
Results
- License and other revenue for the
second quarter of 2024 was $90,000, compared to $1.0 million for
the second quarter of 2023. The revenue primarily related to
payments pursuant to Clearside’s license agreements and revenue for
services and the sales of SCS Microinjector kits to licensees.
- Research and development expenses
for the second quarter of 2024 were $4.6 million, compared to $4.9
million for the second quarter of 2023. The decrease was primarily
related to the CLS-AX program ($0.2 million), development of the
SCS Microinjector ($0.2 million), and preclinical work ($0.1
million). This was partially offset by a $0.2 million increase in
employee related costs.
- General and administrative expenses
remained constant at $3.1 million in the second quarter of 2024 and
2023.
- Interest income for the second
quarter of 2024 was $0.4 million compared to $0.5 million for the
second quarter of 2023. The decrease was due to the lower balance
of cash, cash equivalents and short-term investments.
- Other income for the second quarter
of 2024 was $1.9 million, compared to $0 for the second quarter of
2023. Other income for the second quarter of 2024 was due to the
change in fair value of the warrant liabilities from the prior
March 31, 2024 valuation date.
- Non-cash interest expense remained
constant at $2.3 million in the second quarter of 2024 and 2023.
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 for the second quarter of
2024 was $7.6 million, or $0.10 per share of common stock, compared
to net loss of $9.1 million, or $0.15 per share of common stock,
for the second quarter of 2023.
- As of June 30, 2024, Clearside’s
cash, cash equivalents and short-term investments totaled $29.4
million. The Company believes it will have sufficient resources to
fund its planned operations into the third quarter of 2025.
Additional Information
In lieu of a second quarter 2024 conference
call, the Company hosted a Suprachoroidal Delivery Key Opinion
Leader Webinar on Wednesday, July 24, 2024. The replay of this
event is available on the Clearside website under the Investors
section: Events and Presentations. Quarterly earnings conference
calls are expected to resume with the third quarter 2024 financial
results.
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
patented 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 2b 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
clearsidebio.com and follow us on LinkedIn and X.
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, the expected timing of topline results from the ODYSSEY
clinical trial, the potential benefits of CLS-AX, Clearside’s
suprachoroidal delivery technology and Clearside’s SCS
Microinjector® and Clearside’s ability to fund its operations into
the third quarter of 2025. 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, 2023, filed with the U.S. Securities and
Exchange Commission (SEC) on March 12, 2024 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.
1XIPERE® (triamcinolone acetonide injectable
suspension) for suprachoroidal use is being commercialized by
Bausch + Lomb who has the exclusive license for the
commercialization and development of XIPERE in the United States
and Canada. Arctic Vision has the exclusive license for the
commercialization and development of XIPERE, in Greater China,
South Korea, Australia, New Zealand, India and the ASEAN Countries.
XIPERE was approved by the U.S. Food and Drug Administration in
October 2021 and is commercially available in the U.S. A link to
the full prescribing information is available at
https://www.xipere.com/hcp/#isi.
2Yiu, Glen, “Suprachoroidal Drug Delivery in the
Real World”, Clinical Trials at the Summit Meeting, June 2024
3ALTITUDE® and AAVIATE® are registered
trademarks of REGENXBIO, Inc.
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, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
License and other revenue |
|
$ |
90 |
|
|
$ |
1,018 |
|
|
$ |
320 |
|
|
$ |
1,022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
— |
|
|
|
213 |
|
|
|
— |
|
|
|
213 |
|
Research and development |
|
|
4,603 |
|
|
|
4,948 |
|
|
|
10,218 |
|
|
|
9,399 |
|
General and administrative |
|
|
3,077 |
|
|
|
3,127 |
|
|
|
5,901 |
|
|
|
6,285 |
|
Total operating expenses |
|
|
7,680 |
|
|
|
8,288 |
|
|
|
16,119 |
|
|
|
15,897 |
|
Loss
from operations |
|
|
(7,590 |
) |
|
|
(7,270 |
) |
|
|
(15,799 |
) |
|
|
(14,875 |
) |
Interest
income |
|
|
419 |
|
|
|
458 |
|
|
|
767 |
|
|
|
950 |
|
Other
income, net |
|
|
1,917 |
|
|
|
— |
|
|
|
418 |
|
|
|
— |
|
Non-cash
interest expense on liability related to the sales of future
royalties |
|
|
(2,340 |
) |
|
|
(2,294 |
) |
|
|
(4,743 |
) |
|
|
(4,461 |
) |
Net
loss |
|
$ |
(7,594 |
) |
|
$ |
(9,106 |
) |
|
$ |
(19,357 |
) |
|
$ |
(18,386 |
) |
Net loss
per share of common stock — basic and diluted |
|
$ |
(0.10 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.30 |
) |
Weighted
average shares outstanding — basic and diluted |
|
|
74,731,139 |
|
|
|
61,654,520 |
|
|
|
72,292,183 |
|
|
|
61,413,343 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet Data |
June 30, |
|
|
December 31, |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
18,238 |
|
|
$ |
28,920 |
|
Short-term investments |
|
11,122 |
|
|
|
— |
|
Total
assets |
|
33,934 |
|
|
|
34,018 |
|
Liabilities related to the sales of future royalties, net |
|
46,731 |
|
|
|
41,988 |
|
Warrant
liabilities |
|
9,121 |
|
|
|
— |
|
Total
liabilities |
|
62,219 |
|
|
|
49,930 |
|
Total
stockholders’ deficit |
|
(28,285 |
) |
|
|
(15,912 |
) |
|
|
|
|
|
|
|
|
Source: Clearside Biomedical, Inc.
Clearside Biomedical (NASDAQ:CLSD)
過去 株価チャート
から 7 2024 まで 8 2024
Clearside Biomedical (NASDAQ:CLSD)
過去 株価チャート
から 8 2023 まで 8 2024