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)

Exhibit 99.1 CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2024 BUSINESS AND FINANCIAL RESULTS BEIJING, 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 Chairma ...

BEIJING, Sept. 4, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI) ("CASI" or the "Company"), a Cayman incorporated biopharmaceutical company specializing in the development and commercialization of innovative therapeutics and pharmaceutical products, today announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference taking place September 9-11, 2024, at the Lotte New York Palace in New York City. Members of the CASI management team, including Chief Financial Off ...

BEIJING, Aug. 16, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI) ("CASI" or the "Company"), a Cayman incorporated biopharmaceutical company specializing in the development and commercialization of innovative therapeutics and pharmaceutical products, today reported business updates and financial results for the three months ended June 30, 2024."The second quarter of 2024 was a period of significant progress for CASI as we shifted our Company's strategy to the development of therapeutics for o ...

What could be better than viable enterprises within the biotechnology industry? Try biotech stocks under $10.Primarily, the reason why the sector is so popular among investors is its potential for addressing various diseases and conditions. Obviously, there’s the human component of lengthening life and its quality. However, economic considerations exist as well. According to one study published by the National Institutes of Health’s website, the total cost of chronic disease worldwide may reach $47 trillion ...

BEIJING, July 19, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported that it has furnished a current report on Form 6-K to disclose material development relating to its dispute with Juventas. For details, please visit below link:https://www.sec.gov/Archives/edgar/data/1962738/000110465924080958/tm2419826d1_6k.htmAbout CASI PharmaceuticalsC ...

BEIJING, July 8, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products today announces appointment of Daniel Lang, MD as Chief Financial Officer and Senior Vice President, effective July 8th, 2024.Dr. Lang has more than 30 years of experience as a physician scientist, investor, and biotech executive. He is a cardiologist by training from UCSF, followed by 20 ...

CASI Pharmaceuticals, Inc. (CASI) announced that its board of directors has received a proposal from the chairman of the company for acquiring its business operations in China. Shares of this biopharmaceutical company are soaring in pre-market trading on the news.CASI Pharmaceuticals is focused on developing and commercializing innovative drugs in China, the United States, and the rest of the world.Dr. Wei-Wu He, CASI’s chairman of the board and CEO, sent a preliminary non-binding proposal letter, dated Jun ...