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www.casipharmaceuticals.com CASI PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2023 FINANCIAL RESULTS BEIJING, China (

Key Takeaway: CASI PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2023 FINANCIAL RESULTS BEIJING, China (May 17, 2023) CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman Islands incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceu

Full Press Release Details

CASI PHARMACEUTICALS ANNOUNCES
FIRST QUARTER 2023 FINANCIAL RESULTS
BEIJING, China (May 17, 2023) CASI Pharmaceuticals,
Inc. (Nasdaq: CASI), a Cayman Islands incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics
and pharmaceutical products, today reported financial results for the three months ended March 31, 2023.
Wei-Wu He, Ph.D., CASI's Chairman and Chief
Executive Officer, commented, "Revenue for EVOMELA was $8.3 million in the first quarter of 2023, down 8% from the
same period in 2022. This decline is primarily due to the enhanced impact of the COVID-19 restrictions in major cities in China since
fourth quarter 2022. We are also facing competition from a generic melphalan for injection product with lower cost and undifferentiated
formulation in China market. CASI's commercial and medical marketing team has implemented a strategy to defend our market leadership
position. CASI has a strong foundation for our commercial franchise in the oncology malignant hematology therapeutic area. We will continue
to grow our commercial franchise throughout 2023 and beyond."
Dr. He continued, "Advancement, development,
and commercialization of the portfolio remains our strategic focus. We have achieved a major milestone with our partner Juventas Biotechnology
(Tianjin) ("Juventas") on the CNCT-19 CART cell therapy. CNCT-19's New Drug Application (NDA) was accepted by National
Medical Products Administration (NMPA) in December 2022. We are now diligently preparing for the anticipated CNCT-19 launch in China.
We are advancing the clinical development of BI-1206 in combination with rituximab and presently undertaking the enrollment of patients
for the second cohort of the phase I trial in China. CB-5339 also received Clinical Trial Application approval from the NMPA in January
2023. We are transitioning the development of CID-103 into China for the malignant hematology indications and have submitted the multiple
myeloma IND to the Chinese Health Authority. We plan to build on the momentum to drive our portfolio forward by executing on several milestones
as well as bringing in new potential opportunities for synergy in the quarters ahead."
First Quarter 2023 Financial Highlights
Revenues consist primarily of product sales of
EVOMELA. Revenue was $8.3 million for the three months ended March 31, 2023, compared to $9.0 million for the three months ended March
Costs of revenues were $3.4 million for the three
months ended March 31, 2023, compared to $3.8 million for the three months ended March 31, 2022.
Research and development expenses for the three
months ended March 31, 2023 were $2.5 million, compared with $4.0 million for the three months ended March 31, 2022. The decrease was
mainly due to reduced R&D expenses on CID-103.
General and administrative expenses for the three
months ended March 31, 2023 were $5.7 million, compared with $5.3 million for the three months ended March 31, 2022.
Selling and marketing expenses for the three months
ended March 31, 2023 were $4.0 million, compared with $3.3 million for the three months ended March 31, 2022. The increase was mainly
due to increased marketing activities.
Other income for the three months ended
March 31, 2023 were $1.3 million, compared with $0.04 million for the three months ended March 31, 2022. The increase was mainly
attributed to the $1.3 million refund from Pharmathen Global BV with respect to the termination of the exclusive distribution
license agreement of product Octreotide LAI.
Net loss for the three months ended March 31,
2023 were $5.8 million, compared with $8.4 million for the three months ended March 31, 2022.
As of March 31, 2023, CASI had cash, cash equivalents,
short term investments and long-term deposit of $44.8 million compared to $51.6 million as of December 31, 2022. Cash and cash equivalents
are expected to fund current operations beyond the first quarter of 2024.
Further information regarding the Company, including
its Quarterly Report for the quarter ended March 31, 2023, 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 hematology oncology
therapeutic focus 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.
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: 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; 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 LLC and its affiliates.
CASI Pharmaceuticals, Inc.
(Financial Table Follows)
CASI Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Balance
(In USD thousands, except share and per share
March 31, 2023 December 31, 2022
Current assets:
Cash and cash equivalents 16,593 47,112
Short-term investments 25,111 1,462
Investment in equity securities, at fair value 2,585 2,763
Accounts receivable 11,108 12,973
Inventories 8,565 6,138
Prepaid expenses and other 2,632 2,975
Total current assets 66,594 73,423
Term deposit, non current 3,106 3,065
Property and equipment, net 11,249 11,831
Intangible assets, net 812 1,063
Long-term investments 4,329 4,398
Right of use assets 1,160 1,398
Other assets 1,146 1,056
Total assets 88,396 96,234
Current liabilities:
Accounts payable 2,825 3,289
Accrued and other current liabilities 10,532 11,816
Income tax payable 680 1,900
Total current liabilities 14,037 17,005
Other liabilities 12,135 12,297
Total liabilities 26,172 29,302
Redeemable noncontrolling interest, at redemption value 22,644 22,358
Shareholders' equity:
Ordinary shares 1 1
Additional paid-in capital 692,120 691,766
Treasury shares (9,604 ) (9,330 )
Accumulated other comprehensive loss (613 ) (703 )
Accumulated deficit (642,324 ) (637,160 )
Total shareholders' equity 39,580 44,574
Total liabilities, redeemable noncontrolling interest and shareholders' equity 88,396 96,234
CASI Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Statements
of Operations and Comprehensive Loss
Last updated: May 17, 2023