Full Press Release Details
CASI PHARMACEUTICALS ANNOUNCES
FOURTH QUARTER AND FULL-YEAR 2024 BUSINESS AND
China (March 31, 2025) CASI Pharmaceuticals, Inc. (Nasdaq: CASI, "CASI"), a Cayman incorporated
biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported
business and financial results for the fourth quarter ended December 31, 2024, and provided an update on key highlights for 2024.
Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive
Officer, commented, "2024 was a transformative year for CASI as we strategically pivoted our company toward the development of CID-103
for organ transplant rejection and autoimmune disease. CID-103 is an anti-CD38 antibody with the potential to be a best-in-class treatment
for a myriad of autoimmune diseases as well as antibody mediated rejection (AMR). We are encouraged by our clinical progress, achieving
a milestone with the first ITP patient dosed in January 2025. Simultaneously, we are diligently working towards resolution of the
FDA renal allograft AMR clinical hold."
Dr. He continued, "As we advance into
2025, we remain firmly committed to progressing CID-103 at an accelerated pace. We expect to reach multiple important milestones this
year. Our focused approach and prudent capital allocation position CASI to deliver sustainable long-term value creation for both patients
Key Business Highlights
Pipeline and Program Updates
Product and Pipeline Highlights
CID-103 (Anti-CD38 antibody)
CID 103 is a full human IgG1 anti-CD38 monoclonal
antibody recognizing a unique epitope that has demonstrated an encouraging preclinical efficacy and safety profile compared to other anti-CD38
monoclonal antibodies, and which we have exclusive global rights. CID 103 is being developed for the treatment of patients with chronic
immune thrombocytopenic purpura (ITP), renal allograft antibody mediated rejection AMR).. In May 2024, we announced the clearance
of IND application with the US FDA for the initiation of a phase 1/2 study of CID-103 in adults with ITP. In October 2024, the Center
for Drug Evaluation (CDE) approved the Clinical Trial Application (CTA) for a phase 1/2 study of CID-103 in patients with chronic ITP
in China. The Chinese ITP study is part of the global development program which has been approved by the US FDA in May 2024. In January 2025,
CASI announced the first patient was enrolled and dosed in the ITP clinical study. Furthermore, we are making steady progress towards
resolution of the FDA clinical hold.
EVOMELA (melphalan for injection)
On December 3, 2018, CASI received the NMPA
approval for importation, marketing and sales in China for EVOMELA , and on August 12, 2019, CASI announced the commercial
launch of EVOMELA in China. Prior to EVOMELA's entry into the Chinese market, an average of 800 stem cell transplants
per year were conducted in the multiple myeloma (MM) treatment setting. Following EVOMELA's launch in August of 2019, CASI
worked closely with KOLs to improve market awareness and expedite adoption in the Chinese market. In 2023, nearly 10,000 patients were
treated with EVOMELA. In 2024, the launch of an undifferentiated generic formulation of melphalan for injection product by a Chinese domestic
manufacture has presented challenges, resulting in a decline of EVOMELA sales.
FOLOTYN (Pralatrexate)
July 31, 2023, CASI entered into a tripartite assignment agreement with Mundipharma International Corporation Limited ("MICL"),
Mundipharma Medical Company (MMCo), and Acrotech Biopharma Inc. (Acrotech) for the commercialization of FOLOTYN (Pralatrexate)
in China. FOLOTYN (Pralatrexate) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed
or refractory peripheral T-cell lymphoma (PTCL). This product was approved by both the FDA and China's NMPA for PTCL. CASI announced
the first patient was dosed with FOLOTYN in China on February 15, 2024.
Fourth Quarter and Full-Year 2024 Financial Results
for the fourth quarter of 2024 was $13.4 million, representing a 94% increase compared to $6.9 million in the same period last
year. The quarterly growth reflects a successful execution of commercial strategy implemented in the second half of the year. Full-year
revenue was $28.5 million, compared to $33.9 million in 2023, a decrease of 16%. The annual performance was impacted by intensified competition
following the market entry of domestically produced injectable melphalan, which created pricing pressure throughout the year.
expenses for the fourth quarter was $3.7 million, a 61% increase from $2.3 million in the same period last year. The increase is
primarily for the development of CID-103, supporting the company's focused pivot toward opportunities in organ transplant rejection and
autoimmune indications. Full-year R&D expenses was $8.9 million, compared to $9.9 million in 2023, representing a decrease of 10%.
The reduction primarily resulted from lower amortization expenses following the decision to write off generic portfolio at the end of
expenses for the fourth quarter of 2024 was $7.1 million, compared to $6.4 million in the same period in 2023, a 11% increase.
This quarter-over-quarter increase is primarily attributable to legal expenses associated with ongoing arbitration proceedings with Juventas.
Full-year G&A expenses was $23.6 million, compared to $25.4 million in 2023, representing a decrease of 7%. This year-over-year improvement
demonstrates the effectiveness of our operational efficiency initiatives and cost control measures, reinforcing our commitment to disciplined
financial management.
loss for the year ended December 31, 2024 was $39.3 million compared to $26.3 million for the year ended December 31,
As of December 31, 2024, CASI had cash and
cash equivalents of $13.5 million compared to cash and cash equivalents plus short term investments of $29.1 million as of December 31,
Further information regarding the Company, including
its Annual Report on Form 20-F for the year ended December 31, 2024, can be found at www.casipharmaceuticals.com. The Company
will provide a hard copy of its annual report containing the audited consolidated financial statements, free of charge, to its shareholders
upon request. Requests should be directed to Investor Relations Department, CASI Pharmaceuticals, Inc., Rm 1701-1702, China Central
Office Tower 1, No.81 Jianguo Road Chaoyang District, Beijing, 100025, China.
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 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; our recurring operating losses have raised substantial doubt regarding our ability to continue as a going
concern; 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 receive approval for renewal of license of our existing products; 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