Annual Report for Fiscal Year Ending December 31, 2025 (Form 20-F)

OPERATING AND FINANCIAL REVIEW AND PROSPECTS

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and the related notes included elsewhere in this annual report on Form 20-F. This discussion may contain forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under "Item 3. Key Information-D. Risk Factors" or in other parts of this annual report on Form 20-F.

Overview

We are a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. We are focused on acquiring, developing and commercializing products that augment our hematology oncology, autoimmune and organ transplant rejection therapeutic area focus as well as other unmet medical need. The Company is executing its plan to become a biopharmaceutical leader by launching medicines in the greater China market, leveraging its China-based regulatory, clinical and commercial competencies and its global drug development expertise.

We launched our first commercial product, EVOMELA^® (Melphalan for Injection) in China in August 2019. In China, EVOMELA^® is approved for use as a conditioning treatment prior to stem cell transplantation and as a palliative treatment for patients with multiple myeloma. EVOMELA^®, was originally licensed from Spectrum Pharmaceuticals, Inc. ("Spectrum"). We had a supply agreement with Spectrum to support our application for import drug registration and for commercialization purposes. Spectrum

completed the sale of its portfolio of FDA-approved hematology/oncology products including EVOMELA^® to Acrotech on March 1, 2019. The original supply agreement with Spectrum was assumed by Acrotech, and Spectrum agreed to continue with a short-term supply agreement for EVOMELA^® for the initial commercial product supply in connection with the launch, with the long-term supply assumed by Acrotech. Beginning in December 2024, we had a dispute with Acrotech concerning the agreement. In April 2026, we resolved the dispute with Acrotech through an amicable settlement and entered into a binding term sheet. The parties are currently negotiating a longer-form settlement agreement. See "Item 8 - Financial Information - A. Consolidated Statements and Other Financial Information - Legal Proceedings".

In July 2023, we entered into a tripartite assignment agreement with MICL, MMCo and Acrotech, pursuant to which, MICL's rights and obligations under that certain License, Development and Commercialization Agreement (as amended and restated) dated as of May 29, 2013 for the commercialization of FOLOTYN^® (Pralatrexate) in China, with certain terms of such rights and obligations amended as agreed to by the parties, is assigned to us. FOLOTYN^® 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 US FDA and China's NMPA for PTCL. We also entered into a supply agreement with Acrotech. pursuant to which Acrotech. will supply to the Company FOLOTYN^® subject to terms and on the conditions. On August 27, 2025, the Company received verbal communication from the CDE of the NMPA that the renewal application for the original Import Drug Registration License for FOLOTYN^® had not been granted and that, as a result, the current Import Drug Registration License for FOLOTYN^® expired as of August 25, 2025. Later, the Company received a formal notice from the NMPA that the Company's renewal application was not approved. As a result, the Company ceased the sale of FOLOTYN^® in China pursuant to the relevant regulations and rules. In the meantime, the Company may continue FOLOTYN^® clinical trial activities in China as permitted by relevant governmental authorities. The Company will continue to monitor relevant developments and take commercially reasonable measures with respect to the commercialization plan of FOLOTYN^® in China.

In May 2025, we received NMPA marketing approval for MAFALAN^® (generic melphalan), our first self-manufactured commercial product in China. MAFALAN^® is approved for high-dose conditioning treatment prior to hematopoietic stem cell transplantation in patients with multiple myeloma and for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. Manufactured at our own cGMP facility in the Wuxi Huishan Economic Development Zone, MAFALAN^® is positioned as a domestically produced alternative to the imported originator product, EVOMELA^®, leveraging localized production to achieve competitive cost structure while maintaining international quality standards. We will continue to invest our time, resources, and efforts in the commercialization of MAFALAN^® in China, and, over time, in global markets, including hospital formulary inclusions, physician engagement, and reimbursement opportunities.

In February 2026, we received NMPA's approval for thiotepa, we intend to advance and commercialize this product in China. The Company has an exclusive China license and distribution rights to a novel formulation of thiotepa, a chemotherapeutic agent, which has multiple indications including as a conditioning treatment for use prior to certain allogeneic haemopoietic stem cell transplants. Thiotepa has a long history of established use in the hematology/oncology setting.

Other core hematology/oncology assets in our pipeline include:

As part of the long-term strategy to support our future clinical and commercial manufacturing needs and to manage our supply chain for certain products, on December 26, 2018, we established CASI Wuxi, between the Company and Wuxi LP, to develop a future GMP manufacturing facility that will be located in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. In November 2019, CASI Wuxi entered into a lease agreement for the right to use a state-owned land in China for the construction of a manufacturing facility. Pursuant to this agreement, CASI Wuxi intended to invest in land use rights and property, plant and equipment of RMB 1 billion by August 2022. Construction of the manufacturing facility began in the fourth quarter of 2020. Since our business focus has been shifted from ANDAs to the hematology-oncology therapeutic area, a substantial investment in GMP manufacturing facilities does not fit the current business focus. Therefore, in December 2022, we returned the land to the local Wuxi government for an amount of RMB 44.42 million, equivalent to the payment for land use right. Meanwhile, all construction in progress on the land was

disposed. The Company recorded a total disposal loss amounted to US$2.2 million. Since we failed to meet the land development milestone, the local land administration authority requested CASI Wuxi to pay a land vacancy fee equivalent to 20% of the price for the land use rights according to the PRC Land Administration Law. We paid such fee in the amount of RMB 8.88 million to the local land administration authority in December 2022. Additionally, the Company received a government grant for the land development in April 2020 and November 2021 respectively, in the total amount of RMB 18.9 million. We are currently in negotiation with the local Wuxi government on the further treatment of the grant. The Wuxi government may require the Company to fully or partially return the grant and the Company may incur further losses.

In November 2023, CASI Wuxi obtained the Drug Manufacture Permit from local NMPA. In December 2023, the Company entered into a series of agreements, including a capital reduction agreement, a long term borrowing agreement, and four guarantee agreements, with Wuxi LP, CASI China and CASI Wuxi, pursuant to which, (i) CASI Wuxi will reduce its registered capital and return to Wuxi LP the investment principal made by Wuxi LP in CASI Wuxi in the amount of RMB134.2 million (equivalent to its original investment of US$20 million, the "Investment Principal"), together with certain investment return in the amount of RMB26.2 million to be paid in instalments, and Wuxi LP shall cease to be a shareholder of CASI Wuxi, (ii) Wuxi LP shall reinvest the Investment Principal into a three-year long term borrowing to CASI Wuxi (the "Long term borrowing"), which shall have a non-compounding annual interest rate of 4.05% and can, from the beginning date of the Long term borrowing term till the six month anniversary after the maturity of the Long term borrowing, be partially or fully converted into the equity interest of any subsidiaries of the Company at the conversion date fair value, solely at Wuxi LP's discretion, and (iii) each of the Company and CASI China will provide irrevocable joint and several liability guarantees on the above-mentioned payment obligations. The term of the Long term borrowing started on December 25, 2023 and will end on December 31, 2026.

On May 12, 2025, the Company entered into a definitive equity and assets transfer agreement with Kaixin Pharmaceuticals Inc. ("Kaixin Pharmaceuticals"), a Cayman Islands incorporated entity wholly-owned by Dr. Wei-Wu He, the chairman of the board of directors and then CEO of the Company and two direct wholly-owned subsidiaries of the Company in China (the "Target Companies"), pursuant to which the Company shall sell and transfer, and Kaixin Pharmaceuticals shall purchase and acquire, 100% equity interests in both Target Companies (the "Target Equity Interests"), and all licensing rights, distribution rights, supply arrangements and related rights related to BI-1206 (in China), CID-103(in Asia excluding Japan) and Thiotepa (in China excluding Hong Kong, Macau and Taiwan) (the "Target Pipeline Products") for an aggregate purchase price of $20.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company (the "Transaction"). The closing of the Transaction shall be subject to certain customary conditions, including resolution of certain judicial freeze on the Target Equity Interests issued in connection with certain ongoing legal dispute of the Company. As part of the Transaction, the Company and Kaixin Pharmaceuticals plan to enter into certain novation and/or assignment agreements with relevant licensors to effect the transfer of rights related to the Target Pipeline Products, which is expected to be completed concurrently with the transfer of the Target Equity Interests. After the closing of the Transaction, the Company expects to retain the rights related to CID-103 (in Japan and non-Asian regions), EVOMELA®, FOLOTYN®, CNCT19 and CB-5339, and remain firmly committed to progressing CID-103 at an accelerated pace. The Company believes this initiative aligns with its strategic pivot toward developing CID-103 for the treatment of organ transplant rejection and autoimmune diseases.

On January 7, 2026, the Company's board of directors received from Dr. Wei-Wu He, one of the Company's board of directors, a preliminary non-binding proposal, which was further amended by an updated preliminary non-binding proposal dated January 9, 2026 (the "Proposal"), to acquire all of the outstanding ordinary shares that are not already beneficially owned by Dr. He for a proposed purchase price of US$1.15 per Ordinary Share. As of the date of this report, no decisions have been made with respect to the Proposal.

Key Factors Affecting Our Results of Operations

Key factors affecting our results of operations include the following:

Funding for Our Operations

Historically, we funded our operations primarily from financing through the issuance and sale of common stocks or ordinary shares. In recent years, we were also able to fund our operations in part with revenues generated from sales of our successfully commercialized products. However, with the continuing expansion of our business and our product pipeline, we may require further funding through public or private offerings, debt financing, collaboration, and licensing arrangements or other sources. Any fluctuation in our ability to fund our operations will impact our cash flow plan and our results of operations.

Our Ability to Commercialize Our Drug Candidates

Our business and results of operations depend on our ability to commercialize our drug candidates, once and if those candidates are approved for marketing by the respective health authority. Currently, our pipeline consists of drug candidates ranging in development status from pre-clinical to late-stage clinical programs. Although we currently have only two products approved for commercial sale, we expect to generate revenue from sales of other drug candidates after we complete the clinical development, obtain regulatory approval, and successfully commercialize such drug candidates.

Supply and distribution of EVOMELA^® and FOLOTYN^®

We currently rely on a single source for the supply of both EVOMELA^® and FOLOTYN^®. The political and economic factors may affect the economies and financial markets of many countries, which may result in a period of economic slowdown or recessions. In such an event, our ability to continue to commercialize and expand distribution of EVOMELA^® and FOLOTYN^® could be adversely affected if the supplier refuses or is unable to provide products for any reason (including the occurrence of an event that makes delivery impractical). We would have to work with Acrotech to negotiate an agreement with a substitute supplier, which, assuming a substitute supplier was available, would likely interrupt the manufacturing of EVOMELA^® and FOLOTYN^®, cause supply chain delays and increase costs. On December 13, 2024, we received a termination process letter from Acrotech of the relevant exclusive license agreement. Acrotech alleged in such letter that we materially breached the license agreement and failed to cure such breach, and the license agreement was therefore terminated. Pursuant to the license agreement, we can continue to distribute and sell EVOMELA^® for a reasonable wind-down period not to exceed 24 months, so we do not expect any disruption to its current distribution plan for EVOMELA^® during such period.

We rely on one single distributor, CRPCGIT for the distribution of EVOMELA^® and CNMC for the distribution of FOLOTYN^®. Our ability to maintain and grow our business will depend on our ability to maintain an effective distribution channel that ensures the timely delivery of our medicines. However, we have relatively limited control over our distributors, who may fail to distribute our drugs in the manner we contemplate. If price controls or other factors substantially reduce the margins our distributors can obtain through the resale of our medicines to hospitals, medical institutions and sub-distributors, they may terminate their relationship with us. While we believe alternative distributors are readily available, there is a risk that, if the distribution of our medicines is interrupted, our sales volumes and business prospects could be adversely affected.

On August 27, 2025, the Company received verbal communication from the CDE of the NMPA that the renewal application for the original Import Drug Registration License for FOLOTYN^® had not been granted and that, as a result, the current Import Drug Registration License for FOLOTYN^® expired as of August 25, 2025. Later, the Company received a formal notice from the NMPA that the Company's renewal application was not approved. As a result, the Company ceased the sale of FOLOTYN^® in China pursuant to the relevant regulations and rules. In the meantime, the Company may continue FOLOTYN^® clinical trial activities in China as permitted by relevant governmental authorities. The Company will continue to monitor relevant developments and take commercially reasonable measures with respect to the commercialization plan of FOLOTYN^® in China.

Key Line Items of Our Results of Operations

Revenues

In the reporting period, we generated revenue primarily from the product sales.

Operating Costs and Expenses

Costs of revenues. Costs of revenues consists primarily of the cost of inventories, sales-based royalties related to the sale of EVOMELA^® and FOLOTYN^®, amortization of the intangible asset (License of FOLOTYN^®) and write down of inventories to their net realizable value.

Research and Development Expenses. Research and development (R&D) expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with internal and contract pre-clinical testing and clinical trials of our product candidates, including the costs of drug substance and drug product, regulatory maintenance costs of ANDAs, facilities expenses, and amortization expense of acquired ANDAs.

General and Administrative Expenses. General and administrative expenses include compensation and other expenses related to executive, finance, business development and administrative personnel, professional services, investor relations and facilities, and amortization expense of acquired license right of FOLOTYN^® before its launch.

Selling and Marketing Expenses. Selling and marketing expenses are the direct costs related to the sales of EVOMELA^® and FOLOTYN^®, such as sales force salaries, bonuses, advertising, and other marketing efforts.

Taxation

Cayman Islands

We are an exempted company incorporated in the Cayman Islands. The Cayman Islands currently levy no taxes on individuals or corporations based upon profits, income, gains or appreciations and there is no taxation in the nature of inheritance tax or estate duty. There are no other taxes likely to be material to our Company levied by the government of the Cayman Islands save certain stamp duties which may be applicable, from time to time, on certain instruments executed in or brought within the jurisdiction of the Cayman Islands. The Cayman Islands are not party to any double tax treaties that are applicable to any payments made by or to our Company. There are no exchange control regulations or currency restrictions in the Cayman Islands. In addition, the Cayman Islands does not impose withholding tax on dividend payments.

United States

In March 2023, we completed a Redomicile Merger, pursuant to which CASI Delaware merged with and into CASI Cayman, with CASI Cayman surviving the merger. Notwithstanding CASI Cayman's organization under the laws of the Cayman Islands, pursuant to Section 7874 of the Code, CASI Cayman is treated for U.S. federal income tax purposes as a U.S. corporation, including with respect to any dividends paid by it. The U.S. federal corporate income tax rate is currently 21%.

China

Generally, our PRC subsidiaries and their respective subsidiaries, which are considered PRC resident enterprises under PRC tax law, are subject to enterprise income tax on their worldwide taxable income as determined under PRC tax laws at a rate of 25%.

We are subject to value added tax, or VAT, at a rate of 13% thereafter on the sales of products, at a rate of 6% on the services rendered by us, less any deductible VAT we have already paid or borne. We are also subject to surcharges on VAT payments in accordance with PRC law.

Dividends paid by our wholly foreign-owned subsidiaries in China to us will be subject to a withholding tax rate of 10%, unless they qualify for a special exemption.

If our holding company in the Cayman Islands or any of our subsidiaries outside of China were deemed to be a "resident enterprise" under the PRC Enterprise Income Tax Law, it would be subject to enterprise income tax on its worldwide income at a rate of 25%.

Hong Kong

Under the current Hong Kong Inland Revenue Ordinance, our subsidiary incorporated in Hong Kong are subject to Hong Kong profits tax at the rate of 16.5% on their taxable income generated from the operations in Hong Kong. A two-tiered profits tax rates regime was introduced in 2018 where the first HK$2 million of assessable profits earned by a company will be taxed at half of the current tax rate (8.25%), whilst the remaining profits will continue to be taxed at 16.5%. There is an anti-fragmentation measure where each group will have to nominate only one company in the group to benefit from the progressive rates.

Critical Accounting Estimates

The preparation of our financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and

accompanying notes. Actual results could differ materially from those estimates. We consider an accounting estimate to be critical if: (1) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (2) changes in the estimate that are reasonably likely to occur from period to period, or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations. There are other items within our financial statements that require estimation but are not deemed critical, as defined above. Changes in estimates used in these and other items could have a material impact on our financial statements. For a detailed discussion of our significant accounting policies and related judgments, please see "Note 2-Summary of Significant Accounting Policies" to our consolidated financial statements included elsewhere in this annual report. You should read the following description of critical accounting estimates in conjunction with our consolidated financial statements and other disclosures included in this annual report.

Impairment of Long-Lived Assets

Long-lived assets, including property, plant and equipment, right of use ("ROU") assets and intangible assets subject to amortization, are reviewed for impairment whenever events or changes in circumstances ("triggering events") indicate that the carrying amount of an asset or asset group may not be recoverable. We identify triggering events and performs impairment testing at asset group level which represents the lowest level for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities. As of December 31, 2025, our asset groups consist of manufacturing asset group and non-manufacturing asset group.

Triggering events include, but are not limited to, significant decrease of market price of the asset group, significant adverse change of an asset group's use or physical condition, significant adverse changes in the industry conditions, significantly excessive accumulated cost compared with original expectation, expected continuing losses or negative cash flow associated with the use of the asset group, and expected significant early disposal of asset group.

When identifying triggering events for the manufacturing asset group, the assessment of expected operating results associated with the use of asset group and changes in the industry conditions may represent a triggering event required critical estimates and judgments. We consider historical information and currently available public information, including industry reports and publicly available market data for competitive products

If circumstances require an asset group be tested for possible impairment, we first compare undiscounted cash flows expected to be generated by that asset group to its carrying value. If the carrying value of the asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary.

Results of Operations

The following table sets forth a summary of our consolidated results of operations for the periods presented, both in absolute amount and as a percentage of our total net revenue for the periods presented. This information should be read together with our consolidated financial statements and related notes included elsewhere in this annual report.

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Revenues

Product Sales

Revenue was US$20.7 million for the year ended December 31, 2025, compared to US$28.5 million for the year ended December 31, 2024. Revenues decreased by 27.3% in the year ended December 31, 2025, as compared to 2024. The decrease was mainly attributable to the decrease of US$9.3 million for sales of EVOMELA^®.

Revenue was US$28.5 million for the year ended December 31, 2024, compared to US$33.9 million for the year ended December 31, 2023. Revenues decreased by 15.9% in the year ended December 31, 2024, as compared to 2023. In 2024, the Company's business faced a challenging external environment, especially more intensified competition from a domestically produced injectable melphalan product, which is the direct competitor of the Company's main product and led to the decrease in the Company's sales revenue.

Operating Expenses

Costs of Revenues

Costs of revenues were US$10.6 million for the year ended December 31, 2025, as compared to US$17.4 million for the year ended December 31, 2024, representing a decrease of 39.1%. The decrease in costs of revenues was mainly attributable to decrease of US$2.4 million royalty costs for EVOMELA^® and FOLOTYN^® which is in line with the decrease of revenues, and decrease of US$3.6 million in write-down of inventories.

Costs of revenues were US$17.4 million for the year ended December 31, 2024, as compared to US$13.8 million for the year ended December 31, 2023, representing an increase of 26.1%. The increase in costs of revenues was mainly attributable to (i) US$4.8 million increase in write-down of inventories; and (ii) US$0.8 million increase in amortization of FOLOTYN^® license right. Direct costs of revenues as a percentage of EVOMELA^® sales for 2024 and 2023 were 41% and 41%, respectively, which were stable. Direct costs of revenues as a percentage of FOLOTYN^® sales for 2024 was 76%. The higher cost of revenues as a percentage of FOLOTYN^® sales was mainly attributed to that the market is relatively small and that the Company faced a fierce competition from certain local competitors.

Research and Development Expenses

Research and development expenses for the year ended December 31, 2025 were US$6.3 million, compared with US$8.9 million for the year ended December 31, 2024. The decrease in R&D expenses was primarily attributable to decreased expense of $0.8 million for CID-103, $0.7 million for six ANDAs that were sold in 2024, and $0.4 million for BI-1206.

Research and development expenses for the year ended December 31, 2024 were US$8.9 million, compared with US$9.9 million for the year ended December 31, 2023. The decrease in R&D expenses was primarily attributable to decreased amortization expenses of six ANDAs that were fully amortized as of December 31, 2023.

General and administrative expenses

General and administrative expenses for the year ended December 31, 2025 were US$28.3 million, compared with US$23.6 million for the year ended December 31, 2024. The increase in general and administrative expenses was primarily attributable to increased legal fees of $7.6 million in relation with the ongoing arbitrations we have, partially offset by a decrease of US$1.8 million in personnel cost and US$0.6 million in depreciation cost.

General and administrative expenses for the year ended December 31, 2024 were US$23.6 million, compared with US$25.4 million for the year ended December 31, 2023. The decrease in general and administrative expenses was primarily attributable to lower share-based compensation expenses.

Selling and Marketing Expenses

Selling and marketing expenses for the year ended December 31, 2025, were US$18.3 million, compared with US$17.9 million for the year ended December 31, 2024.

Selling and marketing expenses for the year ended December 31, 2024, were US$17.9 million, compared with US$16.5 million for the year ended December 31, 2023. The increase was primarily due to increased labor cost.

Other Operating Income

Other operating income for the year ended December 31, 2025 and 2024 were nil and US$2,000, respectively.

Other operating income for the year ended December 31, 2023, were US$6.4 million, mainly consisted of a US$4.4 million reimbursement from PAT for certain labor cost and certain pre-clinical and clinical service incurred in previous years, a US$1.3 million refund from Pharmathen Global BV with respect to the termination of the exclusive distribution license agreement of product Octreotide LAI, and a US$0.6 million reimbursement from ESTEVE for certain costs of clinical trials for the registration of Thiotepa in China.

(Gain) loss on disposal of long-lived assets

There was no gain or loss on disposal of long-lived assets for the years ended December 31, 2025 and 2023.

Gain on disposal of assets for the year ended December 31, 2024 was US$0.5 million. The gain was mainly attributable to the sale of our six ANDAs, which were fully amortized as of December 31, 2023.

Foreign exchange gain (loss)

The Company had a foreign exchange loss of US$2.2 million, US$0.2 million, and a foreign exchange gain of US$0.2 million for the years ended December 31, 2025, 2024, and 2023, respectively. The foreign exchange gain (loss) was primarily attributed to accounts receivable with CRPCGIT and CNMC, and USD denominated cash accounts that are held by our Chinese subsidiaries and RMB denominated cash accounts that are held by CASI Cayman. The fluctuation is mainly due to the exchange rate of RMB against USD fluctuation.

Impairment of intangible assets

There was no impairment of intangible assets for the years ended December 31, 2025 and 2023.

In the fourth quarter of 2024, due to lower-than-expected market condition of FOLOTYN^®, the Company determined that the carrying value of the intangible asset of FOLOTYN^® license was not recoverable and should be impaired. The Company recognized an impairment loss of $0.7 million in its consolidated statements of operations and comprehensive loss for the year ended December 31, 2024.

Non-Operating Items

Interest Expense and Interest Income

Interest expense for the year ended December 31, 2025, 2024, and 2023 was US$0.8 million, US$0.9 million and US$15,000, respectively. The amounts in 2025 and 2024 were mainly attributed to the interest expenses generated from Wuxi LP's borrowing.

Interest income for the year ended December 31, 2025, 2024, and 2023 was US$0.1 million, US$0.5 million and US$0.6 million respectively. Interest income was mainly consisted of interest earned for cash and cash equivalents.

Other income

Other income for the year ended December 31, 2025 was US$20,000, compared with US$0.2 million for the year ended December 31, 2024.

Other income for the year ended December 31, 2024 was US$0.2 million, compared with US$0.7 million for the year ended December 31, 2023. Other income in 2024 was mainly consisted of local tax refund and local government grant.

Other income for the year ended December 31, 2023 was US$0.7 million, compared with US$44,000 for the year ended December 31, 2022. The increase was mainly attributable to a US$0.5 million income recognized from the repayment and termination of the convertible promissory note issued by Cleave to us, and a US$0.3 million government grant.

Change in fair value of investments

The change in fair value of investments for the years ended December 31, 2025, 2024 and 2023 was a loss of US$0.2 million, a gain of US$1.7 million and a loss of US$0.6 million, respectively. The changes were mainly attributable to the fluctuations in the market price of ordinary shares of BioInvent, a publicly traded companies invested by us.

Impairment loss of long-term investments

There was no impairment loss of long-term investments during the years ended December 31, 2025 and 2024.

Impairment loss of long-term investments for the year ended December 31, 2023 was US$2.0 million relating to the investment in PAT.

Income tax expense

There was no income tax expense during the year ended December 31, 2025 and 2024.

The Company had an income tax benefit of US$81,000 for the year ended December 31, 2023, which was attributable to the difference between the income tax provision for the year ended December 31, 2022 and the final tax return.

Share of net loss in equity investee

In May 2022, CASI China entered into an agreement for the investment in PAT in the amount of RMB 20.0 million (approximately $3.0 million) in cash during PAT's first equity financing. CASI China has paid all the consideration in June 2022. Upon consummation of such equity financing, CASI China held 15% equity interests of PAT and one of the three board seats. CASI China recognized losses of US$48,000 and US$0.8 million for the years ended December 31, 2023 and 2022, respectively.

In July 2024, CASI China entered into an agreement to purchase 19.8876% equity interests of PAT held by a third-party investor. The total consideration is RMB 28.4 million (approximately $4.1 million) plus interest and will be paid in three installments. CASI China paid the first installment of RMB 10.0 million (approximately $1.4 million) in August 2024 and obtained 5.17% equity interests of PAT, the second installment of RMB 10.0 million (approximately $1.4 million) plus interest in April 2025 and obtained 10.04% equity interests of PAT. As PAT has not established its own business and operation team and therefore does not qualify as a business. CASI China allocated the cost of the equity interests of $1.2 million and $2.2 million, respectively, for the years ended December 31, 2024 and 2025, to in-process research and development ("IPR&D") under the asset acquisition principles and immediately recorded the same amount in the share of net loss in an equity investee in its consolidated statements of operations and comprehensive loss as the IPR&D has no alternative future use.

The Financial Statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. However, our recurring operating losses raise substantial doubt about our ability to continue as a going concern.

Since our inception in 1991, we have incurred significant losses from operations and, as of December 31, 2025, had incurred an accumulated deficit of $748.1 million. For the year ended December 31, 2025, we had a net loss of $48.1 million and a cash outflow for operating activities of $20.8 million. As of December 31, 2025, we had net current liabilities of $36.2 million. We also entered into agreements with Precision Autoimmune Therapeutics Co., Ltd., ("PAT") and two investors of PAT, respectively, to purchase each of their 19.8876% equity interest of PAT. The total consideration is RMB 56.8 million (approximately US$ 8.1 million) plus interest and will be paid in installments. CASI China has paid RMB 35.4 million (approximately US$5.1 million) plus interest in total, the remaining consideration is due by June 30, 2026. Therefore, we will require additional liquidity to continue our operations over the next 12 months.

Historically, we have relied principally on proceeds from equity financing and bank borrowings to finance our operations and business expansion. We have evaluated plans to continue as a going concern which include, but are not limited to, (i) exploring opportunities for further equity financing (ii) reducing discretionary capital and operating expenses (iii) negotiate with creditor to ease the credit terms (iv) obtaining additional facilities from banks or other financial institutions, and (v) sale of assets or licenses on hand. Notwithstanding this, we may be unable to access further equity or debt financing when needed. As such, there can be no assurance that we will be able to obtain additional liquidity when needed or under acceptable terms, if at all.

The Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.

The following table sets forth a summary of our cash flows for the periods indicated:

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Operating activities

Our net cash used in operating activities was US$20.8 million in 2025. In 2025, the principal items accounting for the difference between our net cash used in operating activities and our net loss of US$48.1 million, resulted from (i) changes in operating assets and liabilities in the total amount of US$18.5 million, which mainly attributable to changes in accounts receivables of US$11.3 million and in payable to professional service of US$6.2 million, and (ii) adjustments for non-cash items totaled US$8.8 million, which mainly consisted of share-based compensation of US$3.0 million, and share of net loss in an equity investee of $2.2 million.

Our net cash used in operating activities was US$29.2 million in 2024. In 2024, the principal items accounting for the difference between our net cash used in operating activities and our net loss of US$39.3 million, resulted from adjustments for non-cash items totaled US$9.3 million, which mainly consisted of write-down of inventories and impairment of intangible asset of US$5.5 million, depreciation and amortization expenses of US$2.3 million, and share-based compensation expense of US$1.3 million.

Our net cash used in operating activities was US$20.0 million in 2023. The decrease in operating cash flow in amount of US$1.1 million compared to 2022 was mainly attributable to decreased research and development expenditures as we incurred less laboratory tests for our pipeline products and generic pharmaceuticals. In 2023, the principal items accounting for the difference between our net cash used in operating activities and our net loss of US$26.3 million, resulted from (i) adjustments for non-cash items totaled US$14.1 million, which mainly consisted of share-based compensation of US$7.2 million, depreciation and amortization expenses of US$3.7 million, and impairment of a long term investment of US$2.0 million, and partially offset by (ii) changes in operating assets and liabilities in the total amount of US$7.8 million.

Investing activities

Net cash provided by investing activities was US$1.0 million in 2025. This was primarily attributable to net proceeds of US$2.6 million from sales of BioInvent ordinary shares, which is partially offset by payment of US$1.6 million made for repurchase of PAT's equity interest.

Net cash provided by investing activities was US$11.2 million in 2024, which was primarily attributable to net proceeds from sales or maturity of short term investments of US$11.9 million.

Net cash used in investing activities was US$9.7 million in 2023, which was primarily attributable to purchase of short term investments of US$51.8 million, and purchase of long lived assets of US$2.2 million, offset by proceeds from sales or maturity of short term investments of US$43.3 million, and proceeds of US$1.0 million from the repayment and termination of the convertible promissory note issued by Cleave to CASI.

Financing activities

Net cash provided by financing activities was US$11.3 million in 2025, which was attributable to the proceeds from issuance of ordinary shares of US$5.9 million, issuance of a convertible note of US$5.0 million, and bank borrowings of US$1.0 million.

Net cash provided by financing activities was US$15.4 million in 2024, which was attributable to the proceeds from issuance of ordinary shares of US$15.0 million.

Net cash used in financing activities was US$0.9 million in 2023, which was attributable to the payment of dividends to Wuxi LP of US$0.7 million, and repurchase of our ordinary shares of US$0.3 million, and offset by proceeds from exercise of share options of US$0.1 million.

Capital Expenditures

We had capital expenditures of US$29,000, US$0.2 million and US$2.2 million in 2025, 2024 and 2023, respectively.

Contractual Obligations and Commercial Commitments

The following table sets forth our contractual obligations as of December 31, 2025:

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* Represents the principal of a convertible note. As of December 31, 2025, the Company failed to satisfy certain financial covenants associated with a Long term borrowing, which constituted an event of default under the terms of the convertible note (see Note 18 in page F-38), therefore, the holder of the note has the right to request immediate repayment of all of the outstanding balances. The Company classified the balance of the convertible note to current liability.

In conjunction with various license agreements entered into by the Company, the Company is responsible for certain milestones and royalty payments. The Company has no unrecognized obligations or commitments that are probable to be paid in relation with these certain milestones and royalty payments. Please see Note 19 for details in the consolidated financial statements and notes to consolidated financial statements included in this annual report.

Other than those shown above, we did not have any significant capital and other commitments, long-term obligations, or guarantees as of December 31, 2025.

Warrants

The Company issued certain shares of common stock with accompanying warrants to certain institutional investors, accredited investors and existing stockholders. All those warrants were equity classified and expired in March 2023.

On June 26, 2024, the Company entered into Subscription and Purchase Agreements with certain investors. On July 15, 2024, the transaction contemplated under such agreements closed, pursuant to which the Company issued pre-funded warrants to purchase 1,980,000 ordinary shares to two investors at an issuance price of US$4.9999 (with an exercise price of US$0.0001). Such warrants can be held until exercised in full, for which a net exercise is allowed. In August 2025, one of the warrant holder net exercised their pre-funded warrants to purchase 980,000 ordinary shares with the exercise price of US$0.0001.

Convertible Notes

On December 11, 2025, we entered into a convertible note purchase agreement (the "Purchase Agreement") with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He (the "Purchaser"), pursuant to which the Company would issue and sell convertible notes in an aggregate principal amount of US $20 million to the Purchaser through a private placement transaction. This

investment was planned to provide runway to fund the Company through a Phase 1 study in China in renal allograft anti-body-mediated rejection (AMR) as well as development toward a stable, high concentration protein solution for subcutaneous formulation. The sale of the convertible notes was in tranches and subject to multiple closings with certain closing conditions, including Purchaser being satisfied with the business results and financials status of the Company and the use of proceeds upon each closing. Each convertible note issued pursuant to the Purchase Agreement will mature in 36 months, bearing interest of 12% per annum from the issuance date. Upon maturity, each note may, at the Company's option, be convertible into ordinary shares of the Company, par value US $0.0001 per share (the "Shares"), at a conversion price of the volume weighted average closing price of the Company's Shares during the five consecutive trading days immediately preceding the maturity date. The Purchaser also has the right to convert each note into Shares at any time from and including the 91st day after the issuance thereof to and including the maturity date at a conversion price of the volume weighted average closing price of the Company's Shares during the five consecutive trading days immediately preceding the date of conversion notice by the Purchaser. In no event shall the conversion price be higher than US $2 per ordinary Share or lower than US $1 per Share. As of the date of this annual report, notes with an aggregate principal amount of US $20 million in four tranches has been issued.

Off-balance Sheet Arrangements

We have not entered into any material financial guarantees or other commitments to guarantee the payment obligations of any third parties and do not assume credit risk in loans facilitated through our platform. We have not entered into any derivative contracts that are indexed to our shares and classified as shareholder's equity or that are not reflected in our consolidated financial statements. Furthermore, we do not have any retained or contingent interest in assets transferred to an unconsolidated entity that serves as credit, liquidity or market risk support to such entity. We do not have any variable interest in any unconsolidated entity that provides financing, liquidity, market risk or credit support to us or engages in leasing, hedging or product development services with us.

Our success has benefited from our continuous efforts in building our technologies and protecting our intellectual property, including patents, trademarks, copyrights and trade secrets. See "Item 4. Information on the Company - B. Business Overview - Intellectual Property" for a description on the protection of our intellectual property.

The following table summarizes our research and development expenses by product candidates for the year of 2025:

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In 2025, the Company's business faced a challenging external environment, there is new undifferentiated generic formulation of melphalan for injection product coming out in China. The Company's remaining inventories of EVOMELA^® are close to expiration dates and may not be sold, and the renewal application for FOLOTYN^® was not granted so the Company ceased the sale of FOLOTYN^® in China pursuant to the relevant regulations and rules. The Company's strategy will shift to generic melphalan products in future. Other than as disclosed elsewhere in this annual report, we are not aware of any trends, uncertainties, demands, commitments or events since

January 1, 2026 that are reasonably likely to have a material adverse effect on our net revenues, income, profitability, liquidity or capital resources, or that caused the disclosed financial information to be not necessarily indicative of future operating results or financial condition.

See "Item 5. Operating and Financial Review and Prospects - B. Operating Results - Critical Accounting Estimates."