BEIJING, Aug. 16,
2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc.
(Nasdaq: CASI) ("CASI" or the "Company"), a Cayman incorporated
biopharmaceutical company specializing in the development and
commercialization of innovative therapeutics and pharmaceutical
products, today reported business updates and financial results for
the three months ended June 30,
2024.
"The second quarter of 2024 was a period of significant progress
for CASI as we shifted our Company's strategy to the development of
therapeutics for organ transplant rejection and autoimmune
disease," said Dr. Wei-Wu He,
Chairman and CEO of CASI Pharmaceuticals. "The keystone of our
strategic pivot is CID-103, an anti-CD38 antibody that we believe
has potential for therapeutic use across multiple areas of unmet
need, including antibody-mediated rejection (AMR) and idiopathic
thrombocytopenia purpura (ITP). Ultimately, we believe CID-103 has
widespread therapeutic use in many immune-mediated diseases. We are
structuring our resources according to this expectation and will
aim to advance our anti-CD38 programs at a brisk pace."
Dr. He continued: "For both AMR and ITP, we are anticipating
clinical study initiation on an efficient timeline. We are pleased
that the U.S. FDA recently cleared our Investigational New Drug
(IND) application for CID-103 for the treatment of adults with ITP,
and we expect to initiate our planned Phase 1 study by year end. We
anticipate that we will submit an IND for CID-103 in AMR in the
fourth quarter of this year. We are especially pleased to have
recently announced a $15 million
private placement financing by Venrock Healthcare Capital Partners,
Foresite Capital, and Panacea Venture in support of our strategy
and its execution."
CASI's Board of Directors has formed a special committee to
evaluate Dr. He's proposal letter dated June
21, 2024, to acquire the entire business operations of the
Company in China, including all
license-in, distribution and related rights in Asia (excluding Japan), for an aggregate purchase price of
$40.0 million. The offer price
includes assumption of up to $20.0
million of the Company's debt.
Second Quarter 2024 Financial Highlights
- Total revenue was $4.0 million for the three months
ended June 30, 2024, compared
to $9.8 million for the three months ended June 30, 2023.
- Costs of revenues were $1.9 million for the three
months ended June 30, 2024, compared
to $4.0 million for the three months ended June 30, 2023. The decrease was in line with the
decrease of revenues.
- Research and development expenses for the three months ended
June 30, 2024, were $1.3
million, compared with $2.6 million for the three months
ended June 30, 2023.
- General and administrative expenses for the three months ended
June 30, 2024, were $5.9 million, compared with $7.7 million for the three months ended
June 30, 2023.
- Selling and marketing expenses for the three months ended
June 30, 2024, were $4.4
million, compared with $4.8 million for the three months
ended June 30, 2023.
- Net loss for the three months ended June
30, 2024, was $7.0 million, compared with $10.1
million for the three months ended June
30, 2023.
- As of June 30, 2024, CASI had
cash and cash equivalents of $9.5 million. In July 2024, the Company received gross proceeds of
$15 million from a Private
Placement.
Further information regarding the Company, including its
Quarterly Report for the quarter ended June
30, 2024, can be found at www.casipharmaceuticals.com.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company
focused on developing and commercializing innovative therapeutics
and pharmaceutical products in China, the United
States, and throughout the world. The Company is focused on
acquiring, developing, and commercializing products that augment
its focus on hematology oncology therapeutics and therapeutics for
organ transplant rejection and autoimmune disease, as well as other
areas of unmet medical need. The Company intends to execute its
plan to become a leader by launching medicines in the Greater China market, leveraging the Company's
China-based regulatory and
commercial competencies and its global drug development expertise.
The Company's operations in China
are conducted through its wholly owned subsidiary, CASI
Pharmaceuticals (China) Co., Ltd.,
located in Beijing, China. More
information on CASI is available at
www.casipharmaceuticals.com.
CASI Forward-Looking Statements:
This announcement contains forward-looking statements. These
statements are made under the "safe harbor" provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These
forward-looking statements can be identified by terminology such as
"will," "expects," "anticipates," "future," "intends," "plans,"
"believes," "estimates," "confident" and similar statements. Among
other things, the business outlook and quotations from management
in this announcement, as well as the Company's strategic and
operational plans, contain forward-looking statements. The Company
may also make written or oral forward-looking statements in its
periodic reports to the U.S. Securities and Exchange Commission
(the "SEC"), in in its annual report to shareholders, in press
releases and other written materials and in oral statements made by
its officers, directors or employees to third parties. Statements
that are not historical facts, including statements about the
Company's beliefs and expectations, are forward-looking statements.
Forward-looking statements involve inherent risks and
uncertainties. A number of factors could cause actual results to
differ materially from those contained in any forward-looking
statement, including but not limited to the following:
uncertainties related to the non-binding proposal to acquire the
Company's certain business operations in China; the risk that we may be unable to
continue as a going concern as a result of our inability to raise
sufficient capital for our operational needs; the possibility that
we may be delisted from trading on The Nasdaq Capital Market if we
fail to satisfy applicable continued listing standards; the
volatility in the market price of our ordinary shares; the risk of
substantial dilution of existing shareholders in future share
issuances; the difficulty of executing our business strategy on a
global basis including China; our
inability to enter into strategic partnerships for the development,
commercialization, manufacturing and distribution of our proposed
product candidates or future candidates; legal or regulatory
developments in China that
adversely affect our ability to operate in China, our lack of experience in manufacturing
products and uncertainty about our resources and capabilities to do
so on a clinical or commercial scale; risks relating to the
commercialization, if any, of our products and proposed products
(such as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks); our inability to predict when
or if our product candidates will be approved for marketing by the
U.S. Food and Drug Administration, European Medicines Agency, PRC
National Medical Products Administration, or other regulatory
authorities; our inability to enter into strategic partnerships for
the development, commercialization, manufacturing and distribution
of our proposed product candidates or future candidates; the risks
relating to the need for additional capital and the uncertainty of
securing additional funding on favorable terms; the risks
associated with our product candidates, and the risks associated
with our other early-stage products under development; the risk
that result in preclinical and clinical models are not necessarily
indicative of clinical results; uncertainties relating to
preclinical and clinical trials, including delays to the
commencement of such trials; our ability to protect our
intellectual property rights; the lack of success in the clinical
development of any of our products; and our dependence on third
parties; the risks related to our dependence on Juventas to conduct
the clinical development of CNCT19 and to partner with us to
co-market CNCT19; risks related to our dependence on Juventas to
ensure the patent protection and prosecution for CNCT19; the risk
related to the Company's ongoing development of and regulatory
application for CID-103 with respect to the treatment of
antibody-mediated rejection for organ transplant and the license
arrangements of CID-103; risks relating to the commercialization,
if any, of our proposed products (such as marketing, safety,
regulatory, patent, product liability, supply, competition and
other risks); risks relating to interests of our largest
shareholder and our Chairman and CEO that differ from our other
shareholders; and risks related to the development of a new
manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd.
Further information regarding these and other risks is included in
the Company's filings with the SEC. All information provided herein
is as of the date of this announcement, and the Company undertakes
no obligation to update any forward-looking statement, except as
required under applicable law.
EVOMELA® is proprietary to Acrotech
Biopharma Inc. and its
affiliates. FOLOTYN® is proprietary
to Acrotech Biopharma Inc and its affiliates.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
(Financial Table Follows)
CASI Pharmaceuticals,
Inc.
Unaudited Condensed Consolidated Balance Sheets
(In USD thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
June
30, 2024
|
|
December 31, 2023
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
9,533
|
|
$
|
17,083
|
Investment in equity
securities, at fair value
|
|
|
3,194
|
|
|
1,675
|
Short term
investments
|
|
|
—
|
|
|
12,011
|
Accounts
receivable
|
|
|
6,781
|
|
|
9,551
|
Amounts due from
related parties
|
|
|
963
|
|
|
587
|
Inventories
|
|
|
14,614
|
|
|
15,877
|
Prepaid expenses and
other
|
|
|
2,111
|
|
|
2,560
|
Total current
assets
|
|
|
37,196
|
|
|
59,344
|
|
|
|
|
|
|
|
Long-term
investments
|
|
|
1,773
|
|
|
1,686
|
Property, plant and
equipment, net
|
|
|
8,496
|
|
|
9,241
|
Intangible assets,
net
|
|
|
1,358
|
|
|
1,839
|
Right of use
assets
|
|
|
1,756
|
|
|
2,392
|
Other assets
|
|
|
692
|
|
|
766
|
Total assets
|
|
$
|
51,271
|
|
$
|
75,268
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
792
|
|
$
|
4,438
|
Accrued and other
current liabilities
|
|
|
8,791
|
|
|
12,288
|
Total current
liabilities
|
|
|
9,583
|
|
|
16,726
|
|
|
|
|
|
|
|
Long term
borrowing
|
|
|
18,465
|
|
|
18,895
|
Other
liabilities
|
|
|
14,202
|
|
|
15,482
|
Total
liabilities
|
|
|
42,250
|
|
|
51,103
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
|
|
Ordinary
shares
|
|
|
1
|
|
|
1
|
Treasury
shares
|
|
|
(9,604)
|
|
|
(9,604)
|
Subscription
Receivable
|
|
|
(2,019)
|
|
|
—
|
Additional paid-in
capital
|
|
|
699,373
|
|
|
695,785
|
Accumulated other
comprehensive loss
|
|
|
(1,420)
|
|
|
(1,200)
|
Accumulated
deficit
|
|
|
(677,310)
|
|
|
(660,817)
|
Total shareholders'
equity
|
|
|
9,021
|
|
|
24,165
|
Total liabilities and
shareholders' equity
|
|
$
|
51,271
|
|
$
|
75,268
|
CASI Pharmaceuticals,
Inc.
Unaudited Condensed Consolidated Statements of Operations and
Comprehensive Loss
(In thousands, except share and per share data)
|
|
|
Three months
ended
|
|
Six months
ended
|
|
June 30,
2024
|
June 30,
2023
|
|
June 30,
2024
|
June 30,
2023
|
|
|
|
|
|
|
Revenues
|
3,979
|
9,820
|
|
7,388
|
18,167
|
|
|
|
|
|
|
Costs of
revenues
|
1,912
|
3,986
|
|
3,515
|
7,364
|
|
|
|
|
|
|
Gross profit
|
2,067
|
5,834
|
|
3,873
|
10,803
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
1,254
|
2,614
|
|
3,730
|
5,148
|
General and
administrative
|
5,942
|
7,701
|
|
10,755
|
13,446
|
Selling and
marketing
|
4,425
|
4,820
|
|
8,161
|
8,782
|
Gain on disposal of
intangible assets
|
(500)
|
—
|
|
(500)
|
—
|
Foreign exchange loss
(gain)
|
(265)
|
44
|
|
(30)
|
(15)
|
Total operating
expense
|
10,856
|
15,179
|
|
22,116
|
27,361
|
|
|
|
|
|
|
Loss from
operations
|
(8,789)
|
(9,345)
|
|
(18,243)
|
(16,558)
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
Interest (expense)
income, net
|
(55)
|
139
|
|
(116)
|
341
|
Other
income
|
18
|
9
|
|
176
|
1,426
|
Changes in fair value
of investments
|
1,861
|
(938)
|
|
1,690
|
(1,078)
|
Loss before income tax
expense and share of net loss in an
equity investee
|
(6,965)
|
(10,135)
|
|
(16,493)
|
(15,869)
|
Income tax
benefit
|
—
|
80
|
|
—
|
—
|
Share of net loss in
an equity investee
|
—
|
(15)
|
|
—
|
(32)
|
Net loss
|
(6,965)
|
(10,070)
|
|
(16,493)
|
(15,901)
|
Less: loss attributable
to redeemable noncontrolling interest
|
—
|
(593)
|
|
—
|
(1,260)
|
accretion
to redeemable noncontrolling interest redemption value
|
—
|
762
|
|
—
|
1,607
|
Net loss attributable
to CASI Pharmaceuticals, Inc.
|
(6,965)
|
(10,239)
|
|
(16,493)
|
(16,248)
|
|
|
|
|
|
|
Weighted average number
of ordinary shares outstanding
(basic and diluted)
|
13,519,328
|
13,344,548
|
|
13,450,694
|
13,341,897
|
Net loss per share
(basic and diluted)
|
(0.52)
|
(0.77)
|
|
(1.23)
|
(1.22)
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
Net loss
|
(6,965)
|
(10,070)
|
|
(16,493)
|
(15,901)
|
Foreign currency
translation adjustment
|
(316)
|
(2,177)
|
|
(220)
|
(1,979)
|
Total comprehensive
loss
|
(7,281)
|
(12,247)
|
|
(16,713)
|
(17,880)
|
Less: comprehensive
loss attributable to redeemable
noncontrolling interest
|
—
|
(1,789)
|
|
—
|
(2,348)
|
Comprehensive loss
attributable to ordinary shareholders
|
(7,281)
|
(10,458)
|
|
(16,713)
|
(15,532)
|
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SOURCE CASI Pharmaceuticals