BEIJING, CHINA, November 15, 2024 (Newswire.com)
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CASI Pharmaceuticals, Inc. (Nasdaq:CASI) (“CASI” or the “Company”), a biopharmaceutical entity based in the Cayman Islands, actively engaged in the creation and market introduction of groundbreaking therapeutics and pharmaceutical solutions, today announced significant business advancements and financial outcomes for the quarter ending September 30, 2024.
Dr. Wei-Wu He, Chairman and CEO of CASI, expressed enthusiasm over the milestones achieved, stating, “The third quarter of 2024 signifies a critical juncture for CASI as we persist in honing our strategic direction, primarily emphasizing the development of treatments for organ transplant rejection and various autoimmune disorders. Notably, we have recently received the green light from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for our Clinical Trial Application (CTA) to initiate a phase 1/2 clinical study of CID-103 targeting patients suffering from chronic Immune Thrombocytopenia (ITP) within China. This pivotal trial is an integral aspect of our larger global study, which had earlier garnered approval from the U.S. FDA in May. Additionally, we are advancing steadily towards submitting the Investigational New Drug (IND) application aimed at addressing Antibody-Mediated Rejection (AMR) in renal allograft patients in the U.S.
Third Quarter 2024 Financial Highlights
Recent Development for Certain Litigation
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is committed to innovating and commercializing transformative therapeutics and pharmaceutical solutions across China, the United States, and globally. The company focuses on not just acquiring, but also developing products that emphasize hematology oncology treatments and addressing unmet medical needs in organ transplant rejection and autoimmune diseases. Through strategic execution of its business plan, CASI aims to establish itself as a leader in the Greater China market by leveraging its regulatory expertise based in China alongside its adeptness in global drug development. The company’s operations in China are effectively managed by its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., situated in Beijing. For further insights into CASI’s operations and goals, visit www.casipharmaceuticals.com.
CASI Forward-Looking Statements:
EVOMELA® and FOLOTYN® are proprietary to Acrotech Biopharma Inc. and its respective affiliates.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
[email protected]
Financial Table Follows
CASI Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Balance Sheets
(In USD thousands, except share and per share data)
CASI Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
SOURCE: CASI Pharmaceuticals
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CASI Pharmaceuticals, Inc.
240.864.2643
[email protected]
Financial Table Follows
CASI Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Balance Sheets
(In USD thousands, except share and per share data)
| ASSETS | ||
|---|---|---|
| Current assets: | ||
| Cash and cash equivalents | $ 16,537 | $ 17,083 |
| Investment in equity securities, at fair value | 4,277 | 1,675 |
| Short term investments | – | 12,011 |
| Accounts receivable | 10,116 | 9,551 |
| Amounts due from related parties | 1,027 | 587 |
| Inventories | 12,925 | 15,877 |
| Prepaid expenses and other | 2,270 | 2,560 |
| Total current assets | 47,152 | 59,344 |
| Long-term investments | 2,246 | 1,686 |
| Property, plant and equipment, net | 8,488 | 9,241 |
| Intangible assets, net | 1,117 | 1,839 |
| Right of use assets | 3,911 | 2,392 |
| Other assets | 702 | 766 |
| Total assets | $ 63,616 | $ 75,268 |
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||
| Current liabilities: | ||
| Accounts payable | $ 1,764 | $ 4,438 |
| Accrued and other current liabilities | 12,975 | 12,288 |
| Total current liabilities | 14,739 | 16,726 |
| Long term borrowing | 19,123 | 18,895 |
| Other liabilities | 15,907 | 15,482 |
| Total liabilities | 49,769 | 51,103 |
| Commitments and contingencies | ||
| Shareholders’ equity: | ||
| Ordinary shares | 2 | 1 |
| Treasury shares | (9,604) | (9,604) |
| Subscription Receivable | (1,975) | – |
| Additional paid-in capital | 712,597 | 695,785 |
| Accumulated other comprehensive loss | (1,468) | (1,200) |
| Accumulated deficit | (685,705) | (660,817) |
| Total shareholders’ equity | 13,847 | 24,165 |
| Total liabilities and shareholders’ equity | $ 63,616 | $ 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 | Nine months ended | |||
|---|---|---|---|---|
| September 30, 2024 | September 30, 2023 | September 30, 2024 | September 30, 2023 | |
| Revenues | 7,793 | 8,838 | 15,181 | 27,005 |
| Costs of revenues | 3,748 | 3,648 | 7,263 | 11,012 |
| Gross profit | 4,045 | 5,190 | 7,918 | 15,993 |
| Operating expenses: | ||||
| Research and development | 1,521 | 2,399 | 5,251 | 7,547 |
| General and administrative | 5,701 | 5,521 | 16,456 | 18,967 |
| Selling and marketing | 4,908 | 2,518 | 13,069 | 11,300 |
| Other operating income | – | – | – | (1,306) |
| Gain on disposal of intangible assets | – | – | (500) | – |
