Full Press Release Details
CASI PHARMACEUTICALS ANNOUNCES
SECOND QUARTER 2024 BUSINESS AND FINANCIAL RESULTS
BEIJING, China (August 16, 2024) 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
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
EVOMELA is proprietary
to Acrotech Biopharma Inc. and its affiliates. FOLOTYN is proprietary to Acrotech Biopharma Inc and its affiliates.
CASI Pharmaceuticals, Inc.
(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 | ) |