资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 8月13日，凯信远达(CASI)盘中上涨5.78%，截至01:09，报1.83美元/股，成交9.19万美元，总市值 2835.16万美元。 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 大事提醒： 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 本文源自：金融界 作者：行情君 ...

8月11日，凯信远达(CASI)盘中上涨5.25%，截至23:18，报1.716美元/股，成交11.1万美元，总市值 2657.92万美元。 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 大事提醒： 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 本文源自：金融界 作者：行情君 ...

8月11日，凯信远达(CASI)盘中上涨3.03%，截至21:38，报1.679美元/股，成交8879.0美元，总市值 2601.84万美元。 本文源自：金融界 作者：行情君 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 大事提醒： ...

资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 本文源自：金融界 8月8日，凯信远达(CASI)盘中上涨7.69%，截至21:35，报1.583美元/股，成交1.94万美元，总市值 2452.49万美元。 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 大事提醒： 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 作者：行情君 ...

资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 大事提醒： 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 本文源自：金融界 8月8日，凯信远达(CASI)开盘上涨3.4%，截至21:30，报1.52美元/股，成交9227.0美元，总市值2354.89 万美元。 作者：行情君 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 ...

本文源自：金融界 作者：行情君 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 大事提醒： 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 8月5日，凯信远达(CASI)开盘上涨51.16%，截至21:30，报1.95美元/股，成交1.33亿美元，总市值 3021.07万美元。 ...

资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 本文源自：金融界 作者：行情君 8月4日，凯信远达(CASI)盘中上涨60.5%，截至22:00，报2.07美元/股，成交2480.16万美元，总市值 3207.60万美元。 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 大事提醒： 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 ...

7月30日，凯信远达(CASI)开盘上涨2.96%，截至21:31，报1.565美元/股，成交4226.0美元，总市值 2424.60万美元。 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 本文源自：金融界 作者：行情君 大事提醒： ...

8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 7月29日，凯信远达(CASI)开盘上涨9.26%，截至21:30，报1.77美元/股，成交4.71万美元，总市值 2742.20万美元。 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 大事提醒： 本文源自：金融界 作者：行情君 ...

PART I [ITEM 3. KEY INFORMATION](index=7&type=section&id=ITEM%203.%20KEY%20INFORMATION) The company faces significant going concern risks due to recurring losses and is subject to complex PRC regulations - The company is a Cayman Islands holding company, not a Chinese operating company, with the majority of its business conducted by its subsidiaries in China[21](index=21&type=chunk) - On June 21, 2024, the company's Chairman and CEO, Dr. Wei-Wu He, submitted a non-binding proposal to acquire the company's entire China business operations and related rights for **$40.0 million**, including the assumption of up to **$20.0 million** in debt[25](index=25&type=chunk) - A special committee of independent directors was formed to evaluate this proposal[25](index=25&type=chunk) Key Financial Indicators (as of and for the year ended Dec 31, 2024) | Metric | Value (USD) | | :--- | :--- | | Accumulated Deficit | $700.1 million | | Net Loss | $39.3 million | | Cash Outflow from Operations | $29.2 million | | Net Current Assets | $3.1 million | - Recurring operating losses have raised **substantial doubt about the company's ability to continue as a going concern**, as it will require additional liquidity to fund operations over the next 12 months[27](index=27&type=chunk) - The PCAOB vacated its determination that it was unable to inspect the company's auditor in mainland China on December 15, 2022[31](index=31&type=chunk)[32](index=32&type=chunk) - Consequently, the company does not expect to be identified as a Commission-Identified Issuer under the HFCAA for the 2024 fiscal year, mitigating immediate delisting risk from this issue[31](index=31&type=chunk)[32](index=32&type=chunk) - As a company with substantial operations in the PRC, future securities offerings are subject to filing procedures with the China Securities Regulatory Commission (CSRC) under the Overseas Listing Trial Measures[41](index=41&type=chunk)[42](index=42&type=chunk)[44](index=44&type=chunk) [Risk Factors](index=11&type=section&id=D.%20Risk%20Factors) Key risks include financial instability, dependency on specific products, and complex US/China regulatory environments [ITEM 4. INFORMATION ON THE COMPANY](index=37&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) The company focuses on commercializing in-licensed oncology therapeutics in China with a dedicated commercial team - The company shifted its business strategy to China in 2012 and now conducts the majority of its operations through its subsidiaries, CASI China and CASI Wuxi, with a commercial team of 141 specialists[197](index=197&type=chunk)[198](index=198&type=chunk) - In December 2022, the company returned the land use right for its planned Wuxi manufacturing facility to the local government, shifting away from a substantial investment in GMP manufacturing facilities[200](index=200&type=chunk) - The company's business development strategy focuses on in-licensing late-stage or approved drug candidates for the China market, with a primary therapeutic focus on hematological malignancies[212](index=212&type=chunk) Core Product and Candidate Pipeline | Product/Candidate | Name/Type | Status/Indication | | :--- | :--- | :--- | | **EVOMELA®** | Melphalan for Injection | Launched in China for multiple myeloma | | **FOLOTYN®** | Pralatrexate | Launched in China for relapsed/refractory PTCL | | **CNCT19** | Inaticabtagene Autoleucel | Approved in China for r/r B-ALL | | **BI-1206** | anti-FcyRIIB antibody | Phase 1 study ongoing in China for NHL | | **CB-5339** | VCP/p97 inhibitor | CTA approved in China for multiple myeloma | | **CID-103** | anti-CD38 mAb | IND cleared by FDA for ITP; CTA approved in China for ITP | | **Thiotepa** | Chemotherapeutic agent | Applying for generic registration in China | - The company faces direct competition for its key products; **EVOMELA® competes with two domestically produced injectable melphalan products** in China, and FOLOTYN® competes with alternative treatments on the NRDL[274](index=274&type=chunk)[276](index=276&type=chunk) [ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS](index=60&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) Revenue declined 15.8% in 2024 due to competition, leading to a net loss and significant going concern doubts Consolidated Results of Operations (Years Ended December 31) | (in thousands USD) | 2024 | 2023 | 2022 | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$28,537** | **$33,879** | **$43,107** | | Gross Profit | $11,146 | $20,052 | $27,280 | | Loss from operations | ($39,621) | ($25,080) | ($34,032) | | **Net loss** | **($39,258)** | **($26,259)** | **($40,257)** | - Product sales revenue **decreased by 15.8% to $28.5 million** in 2024, primarily attributed to intensified competition for EVOMELA®[391](index=391&type=chunk) - Costs of revenues **increased by 26.1% to $17.4 million** in 2024, mainly due to a **$4.8 million write-down of inventories**[395](index=395&type=chunk) - The company's recurring operating losses and **negative cash flow of $29.2 million** in 2024 raise substantial doubt about its ability to continue as a going concern[424](index=424&type=chunk)[425](index=425&type=chunk)[426](index=426&type=chunk) Summary of Cash Flows (Years Ended December 31) | (in thousands USD) | 2024 | 2023 | 2022 | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | ($29,224) | ($19,967) | ($21,088) | | Net cash provided by (used in) investing activities | $11,244 | ($9,673) | $31,159 | | Net cash provided by (used in) financing activities | $15,434 | ($907) | ($3,267) | | **Cash and cash equivalents at end of the year** | **$13,468** | **$17,083** | **$47,112** | [ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES](index=74&type=section&id=ITEM%206.%20DIRECTORS%2C%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) The company is led by an experienced team and board, with compensation tied to long-term incentive plans - The company's leadership includes Chairman and CEO Wei-Wu He, Ph.D, Global Chief Medical Officer Alexander A. Zukiwski, MD, and Global Chief Commercial Officer Hai Huang[450](index=450&type=chunk) - For the year ended December 31, 2024, the aggregate compensation paid to directors and officers was **$4.1 million in salary and benefits**, plus **$0.8 million in share-based compensation**[463](index=463&type=chunk) - The company maintains multiple long-term incentive plans to grant equity awards, with options for **3,560,120 ordinary shares outstanding** as of March 21, 2025[465](index=465&type=chunk)[466](index=466&type=chunk)[468](index=468&type=chunk)[469](index=469&type=chunk) - The Board of Directors consists of five members and has three primary committees: Audit, Compensation, and Nominating and Corporate Governance[483](index=483&type=chunk)[487](index=487&type=chunk) Employee Count by Function (as of Dec 31, 2024) | Function | Number of Employees | | :--- | :--- | | Management and General Administration | 31 | | Medical, Clinical and Registration | 19 | | Commercial | 141 | | Manufactory, Quality Control, R&D | 42 | | **Total** | **233** | - As of March 21, 2025, Chairman and CEO Dr. Wei-Wu He beneficially owned approximately **21.5% of the company's outstanding ordinary shares**[513](index=513&type=chunk)[515](index=515&type=chunk) [ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS](index=87&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) Key related party transactions include a PIPE financing with the CEO and agreements with other affiliated entities - In the July 2024 PIPE transaction, Chairman and CEO Dr. Wei-Wu He and his family trust purchased **300,000 ordinary shares for an aggregate price of $1.5 million**[522](index=522&type=chunk)[523](index=523&type=chunk) - The company entered into a service agreement in December 2024 with Human Longevity Inc (HLI), where CASI's Chairman and CEO also serves as Executive Chairman[524](index=524&type=chunk) - The company has a sublicense agreement with PAT, from which it recognized a **$5.0 million upfront payment as revenue in 2022** and received **$4.4 million in expense reimbursements in 2023**[525](index=525&type=chunk)[526](index=526&type=chunk)[527](index=527&type=chunk) [ITEM 8. FINANCIAL INFORMATION](index=88&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) The company is engaged in significant legal arbitrations with partners Juventas and Acrotech over key product agreements - The company is in an ongoing arbitration with Juventas regarding the purported termination of the CNCT19 commercialization agreements, with **assets of both parties frozen by PRC courts**[532](index=532&type=chunk)[533](index=533&type=chunk) - Acrotech has filed a complaint in New York to enforce the termination of the EVOMELA® license agreement, which CASI disputes and plans to counter with its own arbitration[534](index=534&type=chunk) - The company has never paid cash dividends and does not intend to do so in the foreseeable future[535](index=535&type=chunk) [ITEM 10. ADDITIONAL INFORMATION](index=91&type=section&id=ITEM%2010.%20ADDITIONAL%20INFORMATION) The company operates under Cayman Islands law but is treated as a US corporation for tax purposes, facing PRC tax risks - Holders of ordinary shares are entitled to one vote per share on all matters[557](index=557&type=chunk) - The company is an exempted company incorporated under the laws of the Cayman Islands[584](index=584&type=chunk) - For U.S. federal income tax purposes, the company is **treated as a U.S. corporation** pursuant to Section 7874 of the Internal Revenue Code[631](index=631&type=chunk) - The company faces the risk of being classified as a **"resident enterprise" for PRC tax purposes**, which could subject its global income to a 25% PRC enterprise income tax[621](index=621&type=chunk)[624](index=624&type=chunk)[626](index=626&type=chunk) [ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=105&type=section&id=ITEM%2011.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) Primary market risks are foreign exchange exposure from RMB-denominated operations and minimal interest rate risk - The company's primary market risk is **foreign exchange risk**, as substantially all of its revenues and a significant portion of its expenses are denominated in RMB[655](index=655&type=chunk) - The company has not used any derivative financial instruments to hedge its exposure to foreign exchange or interest rate risk[655](index=655&type=chunk)[658](index=658&type=chunk) PART II [ITEM 15. CONTROLS AND PROCEDURES](index=107&type=section&id=ITEM%2015.%20CONTROLS%20AND%20PROCEDURES) Management concluded that both disclosure controls and internal control over financial reporting were effective as of year-end 2024 - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2024[667](index=667&type=chunk) - Based on an assessment using the COSO 2013 framework, management concluded that the company's **internal control over financial reporting was effective** as of December 31, 2024[669](index=669&type=chunk) [ITEM 16. CORPORATE GOVERNANCE AND OTHER MATTERS](index=107&type=section&id=ITEM%2016.%20CORPORATE%20GOVERNANCE%20AND%20OTHER%20MATTERS) The company follows home country governance practices and has established a cybersecurity risk management framework - The Board of Directors has determined that Thomas Folinsbee is an audit committee financial expert[671](index=671&type=chunk) Principal Accountant Fees (KPMG) | (in thousands USD) | 2024 | 2023 | | :--- | :--- | :--- | | Audit fees | $736 | $600 | | Tax fees | $0 | $5 | | **Total** | **$736** | **$605** | - As a foreign private issuer, the company follows certain home country corporate governance practices, which may afford less protection to shareholders than if it fully complied with Nasdaq rules[684](index=684&type=chunk)[685](index=685&type=chunk) - The company has implemented a cybersecurity risk management framework with oversight from the board of directors and has identified **no material cybersecurity incidents to date**[691](index=691&type=chunk)[694](index=694&type=chunk)[695](index=695&type=chunk) PART III [ITEM 18. FINANCIAL STATEMENTS](index=111&type=section&id=ITEM%2018.%20FINANCIAL%20STATEMENTS) The audited financial statements include a "Going Concern" warning from the auditor due to recurring operating losses - The Report of Independent Registered Public Accounting Firm includes a paragraph highlighting that recurring operating losses raise **substantial doubt about the company's ability to continue as a going concern**[714](index=714&type=chunk) - The auditor identified the assessment of impairment triggering events related to the manufacturing asset group as a **critical audit matter**[720](index=720&type=chunk)[721](index=721&type=chunk) Consolidated Balance Sheet Summary (as of Dec 31) | (in thousands USD) | 2024 | 2023 | | :--- | :--- | :--- | | **Total Current Assets** | **$39,576** | **$59,344** | | **Total Assets** | **$53,674** | **$75,268** | | **Total Current Liabilities** | **$36,452** | **$16,726** | | **Total Liabilities** | **$51,823** | **$51,103** | | **Total Shareholders' Equity** | **$1,851** | **$24,165** | - In July 2024, the company closed a PIPE transaction, raising **gross proceeds of $15.0 million**[895](index=895&type=chunk)