Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a
clinical-stage biopharmaceutical drug development company focused
on advancing novel therapeutics targeting degenerative retinal
diseases that have significant unmet medical needs, today announced
its financial results for the three-months ended September 30,
2023, and provided a general business update.
“We made meaningful progress in the quarter advancing our
clinical trials for Tinlarebant and are excited by our results,”
said Dr. Tom Lin, Chairman and CEO of Belite Bio. “Results from our
Phase 2 trial of Tinlarebant in childhood-onset Stargardt Disease
showed Tinlarebant lowered retinal lesion growth versus patients in
a 24-month natural history study and visual acuity was stabilized,
all while remaining safe and well-tolerated. Additionally, in the
quarter, we completed enrollment for the DRAGON trial, dosed our
first subject and made substantial progress in the PHOENIX trial.
We remain focused on our vision to bring novel therapies to
patients suffering from degenerative retinal diseases.”
Professor John Grigg, Head Specialty of Ophthalmology at the
University of Sydney and Consultant Ophthalmologist at the Sydney
Children’s Hospitals Network at Westmead and Sydney Eye Hospital,
presented the results of the Phase 2 trial of Tinlarebant in
adolescent Stargardt disease patients at the American Association
of Ophthalmology annual meeting early this month and commented,
“The results of the Phase 2 study with 24-month treatment of
Tinlarebant in adolescents were promising. Stargardt is a
debilitating disease that may have a life-changing impact on those
diagnosed with the disease. The disease most often progresses
quickly, and vision deteriorates rapidly at a very young age. The
Phase 2 data continued to demonstrate slowing of the disease
progression in the study cohort and the stabilization in several
structural and functional parameters including stabilization of
visual acuity. We are highly encouraged by these results and the
potential to impact the lives of patients suffering from a disease
for which there currently is no FDA-approved treatment.”
Third Quarter 2023 Business Highlights and Upcoming
Milestones:
Clinical Highlights
Tinlarebant (LBS-008) is designed to be an
oral, potent, once-daily retinol binding protein 4 (RBP4)
antagonist that decreases RBP4 levels in the blood and reduces
vitamin A (retinol) delivery to the eye without disrupting systemic
retinol delivery to other tissues. Vitamin A is critical to normal
vision but can accumulate as toxic byproducts leading to retinal
cell death and vision loss diseases such as STGD1 and GA, the
advanced form of dry Age-Related Macular Degeneration (dry
AMD).
- Stargardt disease (STGD1): Accumulation of
cytotoxic bisretinoids has been implicated in the onset and
progression of STGD1. Tinlarebant has been granted Fast Track and
Rare Pediatric Disease (RPD) designations by the U.S. Food and Drug
Administration (FDA), and orphan drug designation (ODD) in the U.S.
and Europe for STGD1. There are currently no FDA-approved
treatments for STGD1.
- LBS-008-CT02 trial: Ongoing, open-label, 2-year Phase 1b/2
trial in adolescent STGD1 subjects
- A total of 12 adolescent STGD1 subjects aged 12-18 years
completed 24-months of treatment in the Phase 2 study of
Tinlarebant. Key study findings are as follows:
- Tinlarebant was safe and well-tolerated with no withdrawals due
to adverse events.
- Retinal imaging showed that 5 of 12 subjects remained free of
atrophic retinal lesions (referred to as definitely decreased
autofluorescence or DDAF) after 24 months of Tinlarebant
treatment.
- A comparison of the 24-month DDAF lesion growth between
Tinlarebant-treated subjects and ProgStar participants possessing
similar baseline characteristics (aged ≤18 years) showed a
sustained lower DDAF lesion growth in Tinlarebant-treated subjects
over the 24-month treatment period (p<0.001).
- Visual acuity was stabilized in the majority of subjects during
the study with a mean loss of five letters following 24 months of
treatment (a loss of <10 letters is not considered clinically
significant).
*Only 50 patients from ProgStar Cohort (aged ≤18 ) were included
in the analysis due to one subject having ungradable screening FAF
data.
1. Strauss RW, Ho A, Muñoz B, et al. ProgStar Report No. 1.
Ophthalmology. 2016;123(4):817-28.2. Strauss RW, Muñoz B, Ho A, et
al. ProgStar Report No. 9. JAMA Ophthalmol. 2017;
135(11):1232-1241.
- Pivotal DRAGON trial: 2-year, randomized, double-masked,
placebo-controlled, global, multi-center, pivotal Phase 3 trial in
STGD1 subjects aged 12-20 years old:
- Enrollment complete, with 104 subjects across 11 countries
worldwide including sites in the U.S., the United Kingdom, Germany,
Belgium, France, Switzerland, China, Hong Kong, Taiwan, Australia,
and the Netherlands.
- Primary efficacy endpoint is slowing of lesion growth rate;
safety and tolerability will also be assessed.
- 2H 2024: Interim efficacy and safety data expected.
Geographic Atrophy (GA): GA, the advanced form
of dry AMD, is a chronic degenerative disease of the retina that
leads to blindness in the elderly. Accumulation of toxic vitamin A
byproducts (bisretinoids) has been implicated in the progression of
GA. There are currently no FDA-approved orally administered
treatments for GA.
- Pivotal PHOENIX Trial: 2-year prospective, randomized (2:1,
active:placebo, n ~430), double-masked, placebo-controlled, global,
multi-center, Phase 3 trial in subjects with GA.
- Primary efficacy endpoint is slowing of lesion growth rate;
safety and tolerability will also be assessed.
- First subject has been dosed.
- Interim analysis expected at mid-point of the trial.
Corporate Highlights
- For the three months ended September 30, 2023, the Company
strengthened its balance sheet with $5.0 million of gross proceeds
from the exercise of warrants granted in the underwritten follow-on
offering in May 2023.
- For the three months ended September 30, 2023, the Company
raised $0.64 million of net proceeds from its at-the-market
offering program established in June 2023.
Risks and Uncertainties
Based on current business plans and financial expectations, the
Company expects that it will be a “passive foreign investment
company” within the meaning of Section 1297 of the U.S. Internal
Revenue Code of 1986, as amended (“PFIC”) for its current tax year
2023, and may be a PFIC in one or more future tax years, which may
have adverse U.S. federal income tax consequences for U.S.
securityholders.
If the Company is a PFIC for any year during a U.S. taxpayer’s
holding period of the Company’s ADSs or ordinary shares, then such
U.S. taxpayer generally will be required to treat any gain realized
upon a disposition of the Company’s ADSs, ordinary shares or
warrants or any so-called “excess distribution” received on such
ADSs, ordinary shares or warrants as ordinary income, and to pay an
interest charge on a portion of such gain or distribution. In
certain circumstances, the sum of the tax and the interest charge
may exceed the total amount of proceeds realized on the
disposition, or the amount of excess distribution received, by the
U.S. taxpayer. Subject to certain limitations, these tax
consequences may be mitigated if a U.S. taxpayer makes a timely and
effective “qualified electing fund” (“QEF”) election within the
meaning of Section 1295 of the Code (a “QEF Election”) or a
“mark-to-market election” within the meaning of Section 1296 of the
Code (a “Mark-to-Market Election”). The QEF Election is not
available with respect to warrants until those warrants are
exercised. Each investor in a warrant (and, in particular, any such
investor that holds warrants but not ADSs or ordinary shares) who
is a U.S. taxpayer should consult its own tax advisor regarding the
tax consequences of the PFIC rules and the ownership and
disposition of the warrants. The Mark-to-Market Election is only
available with respect to ADSs, ordinary shares or warrants
regularly traded on a qualified exchange or market. Subject to
certain additional limitations, such elections may be made with
respect to the Company’s ADSs or ordinary shares (and with respect
to the Mark-to-Market Election, the warrants). A U.S. taxpayer who
makes a timely and effective QEF Election generally must report on
a current basis its share of the Company’s net capital gain and
ordinary earnings for any year in which the Company is a PFIC,
whether or not the Company distributes any amounts with respect to
the ADSs or ordinary shares. However, U.S. taxpayers should be
aware that there can be no assurance that the Company will satisfy
the record keeping requirements that apply to a QEF, or that the
Company will supply U.S. taxpayers with information that such U.S.
taxpayers require to report under the QEF Election rules, in the
event that the Company is a PFIC and a U.S. taxpayer wishes to make
a QEF Election. Thus, U.S. taxpayers may not be able to make a QEF
Election with respect to their ADSs or ordinary shares. A U.S.
taxpayer who makes the Mark-to-Market Election generally must
include as ordinary income each year the excess of the fair market
value of the ADSs or ordinary shares over the taxpayer’s basis
therein. Each potential investor who is a U.S. taxpayer should
consult its own tax advisor regarding the tax consequences of the
PFIC rules and the ownership and disposition of ADSs or ordinary
shares, including the availability of and procedure for making a
QEF Election or a Mark-to-Market Election.
Third Quarter 2023 Financial Results:
Cash: As of September 30, 2023, the Company had
$54.5 million in cash.
R&D Expenses:
For the three months ended September 30, 2023, research and
development expenses were $8.7 million compared to $1.2 million for
the same period in 2022. The increase resulted primarily from
increases in (x) expenses for conducting the DRAGON and PHOENIX
trials and (y) wages and salaries due to share-based compensation
granted to our R&D team in the third quarter of 2023. For the
nine months ended September 30, 2023, research and development
expenses were $20.0 million compared to $3.6 million for the same
period in 2022. The increase in research and development expenses
was primarily attributable to increases in (i) expenses related to
conducting the DRAGON and PHOENIX trials, and (ii) wages and
salaries due to our R&D team expansion and share-based
compensation granted in the third quarter of 2023.
G&A Expenses:
For the three months ended September 30, 2023, general and
administration expenses were $2.2 million compared to $1.4 million
for the same period in 2022. The increase resulted primarily from
an increase in share-based compensation granted in the third
quarter of 2023. For the nine months ended September 30, 2023,
general and administration expenses were $4.7 million compared to
$2.5 million for the same period in 2022. The increase resulted
also primarily from an increase in share-based compensation granted
in the third quarter of 2023 and an increase in professional
service fees.
Net Loss:
For the three months ended September 30, 2023, the Company
reported a net loss of $10.9 million or ($0.40) per share compared
to $2.4 million or ($0.10) per share for the same period in 2022.
For the nine months ended September 30, 2023, the Company reported
a net loss of $24.6 million or ($0.95) per share, compared to a net
loss of $5.9 million or ($0.32) per share for the same period in
2022.
Webcast Information
Belite Bio will host a webcast on Tuesday, November
14, 2023, at 4:30 p.m. Eastern Time to discuss the Company’s
financial results and provide a business update. To join the
webcast, please visit https://wsw.com/webcast/cc/blte/1366794. A
replay will be available for approximately 90 days following the
event.
About Belite Bio
Belite Bio is a clinical-stage biopharmaceutical drug
development company focused on advancing novel therapeutics
targeting degenerative retinal diseases with significant unmet
medical needs, such as STGD1 and GA in advanced dry AMD, in
addition to specific metabolic diseases. For more information,
follow us on Twitter, Instagram, LinkedIn, Facebook or visit
us at www.belitebio.com.
Important Cautions Regarding Forward Looking
Statements
This press release contains forward-looking statements about
future expectations, plans and prospects, as well as any other
statements regarding matters that are not historical facts. These
statements include but are not limited to statements regarding the
potential implications of clinical data for patients, clinical
development, regulatory milestones of its product candidates, and
any other statements containing the words “expect”, “will”,
“believe”, and other similar expressions. Actual results may differ
materially from those indicated in the forward-looking statements
as a result of various important factors, including but not limited
to Belite Bio’s ability to demonstrate the safety and efficacy of
its drug candidates; the clinical results for its drug candidates,
which may not support further development or regulatory approval;
expectations for the timing of initiation, enrollment and
completion of, and data relating to, its clinical trials; the
content and timing of decisions made by the relevant regulatory
authorities regarding regulatory approval of Belite Bio’s drug
candidates; whether additional clinical trials may be required for
DRAGON or PHOENIX studies based on their respective data; the
potential efficacy of Tinlarebant, as well as those risks more
fully discussed in the “Risk Factors” section in Belite Bio’s
filings with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to Belite Bio, and Belite Bio undertakes no obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise, except
as may be required by law.
|
BELITE BIO, INCUNAUDITED CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(Amounts in thousands of US Dollars, except
share and per share amounts) |
|
|
|
For the Three Months |
|
|
For the Nine Months |
|
|
Ended September 30, |
|
|
Ended September 30, |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
1,185 |
|
|
8,743 |
|
|
3,643 |
|
|
19,982 |
|
General and
administrative |
|
1,355 |
|
|
2,218 |
|
|
2,457 |
|
|
4,731 |
|
Total
operating expenses |
|
2,540 |
|
|
10,961 |
|
|
6,100 |
|
|
24,713 |
|
Loss
from operations |
|
(2,540) |
|
|
(10,961) |
|
|
(6,100) |
|
|
(24,713) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Total other
income, net |
|
137 |
|
|
27 |
|
|
236 |
|
|
81 |
|
Loss
before income tax |
|
(2,403) |
|
|
(10,934) |
|
|
(5,864) |
|
|
(24,632) |
|
Income tax
expense |
|
- |
|
|
1 |
|
|
- |
|
|
10 |
|
Net
loss |
|
(2,403) |
|
|
(10,935) |
|
|
(5,864) |
|
|
(24,642)) |
|
Other comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments, net of nil tax |
|
(166) |
|
|
(55) |
|
|
(323) |
|
|
(115) |
|
Total comprehensive loss |
|
(2,569) |
|
|
(10,990) |
|
|
(6,187) |
|
|
(24,757) |
|
Weighted average number of ordinary shares used in per
share calculation: |
|
|
|
|
|
|
|
|
|
|
|
|
- Basic and
Diluted |
|
24,869,038 |
|
|
27,315,550 |
|
|
18,321,088 |
|
|
26,013,012 |
|
Net
loss per ordinary share |
|
|
|
|
|
|
|
|
|
|
|
|
- Basic and
Diluted |
$ |
(0.10) |
|
$ |
(0.40) |
|
$ |
(0.32) |
|
$ |
(0.95) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BELITE BIO, INCUNAUDITED CONDENSED
CONSOLIDATED BALANCE SHEETS(Amounts in thousands
of US Dollars, except share amounts) |
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2022 |
|
|
2023 |
|
Current assets |
$ |
42,807 |
|
$ |
56,135 |
|
Other assets |
|
1,466 |
|
|
1,463 |
|
TOTAL
ASSETS |
$ |
44,273 |
|
$ |
57,598 |
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES |
$ |
2,772 |
|
$ |
4,804 |
|
|
|
|
|
|
|
|
TOTAL SHAREHOLDERS’
EQUITY |
|
41,501 |
|
|
52,794 |
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
$ |
44,273 |
|
$ |
57,598 |
|
|
|
|
|
|
|
|
Ordinary shares
authorized |
|
492,179,086 |
|
|
400,000,000 |
|
Ordinary shares issued and
outstanding |
|
24,898,908 |
|
|
27,599,244 |
|
|
Media and Investor Relations Contact:
Jennifer Wu /ir@belitebio.comArgot
Partners /ir@belitebio.com
Photos accompanying this announcement are available
at: https://www.globenewswire.com/NewsRoom/AttachmentNg/a9faecbb-230b-4dd2-8fd7-0796ba383139https://www.globenewswire.com/NewsRoom/AttachmentNg/4c5b2dd3-8bb5-40c0-96d9-2ec4422ea4fd
Belite Bio (NASDAQ:BLTE)
Historical Stock Chart
From May 2024 to Jun 2024
Belite Bio (NASDAQ:BLTE)
Historical Stock Chart
From Jun 2023 to Jun 2024