ALD-1910

BEIJING, June 26, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI) ("CASI" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, announced today that the Company is planning to submit an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for CID-103 for the treatment of antibody-mediated rejection ("AMR") in kidney transplant recipients by the end of 2024. CID-103 is a fully 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. The Company believes that with the proceeds from the previously announced private placement financing, together with its existing cash and cash equivalents, it will have sufficient capital to complete the Phase II clinical trial for AMR. CASI also announced that its board of directors (the "Board") received a preliminary non-binding proposal letter (the "Proposal Letter") dated June 21, 2024, from Dr. Wei-Wu He, Chairman of the Board and CEO of the Company, to acquire the entire business operations of the Company in China and all license-in, distribution and related rights in Asia (excluding Japan) related to all of the Company's pipeline products, including but not limited to EVOMELA®, FOLOTYN®, CNCT19, BI-1206, CB-5339,CID-103 and Thiotepa, for an aggregate purchase price of $40.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company (the "Proposed Transaction"). On June 25, the Board has formed a special committee comprised solely of incumbent independent directors (the "Special Committee") to evaluate the transaction contemplated under the Proposal Letter and such other strategic and business alternatives available to the Company in respect of the Company's business operations in China. The Board and the Special Committee caution the Company's shareholders and others considering trading the Company's securities that no decisions have been made with respect to the Proposed Transaction or any alternative strategic option that the Company may pursue. There can be no assurance that any definitive offer will be received, that any definitive agreement will be executed relating to the Proposed Transaction or that any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to any transaction, except as required under applicable law. 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 hematology oncology therapeutic focus 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. 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 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: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; 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 FDA, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; 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 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest shareholder and our Chairman and CEO that differ from our other shareholders; and risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. COMPANY CONTACT: Rui Zhang CASI Pharmaceuticals, Inc. 240.864.2643 [email protected] SOURCE CASI Pharmaceuticals

The migraine market is expected to surge due to the increasing prevalence of the disease along with increasing awareness during the forecast period. Furthermore, the launch of various multiple-stage pipeline products will significantly revolutionize the migraine market dynamics. LAS VEGAS, June 15, 2022 /PRNewswire/ -- DelveInsight's Migraine Market Insights report includes a comprehensive understanding of current treatment practices, Migraine emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM (the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), and Japan. Key Takeaways from the Migraine Market Report As per DelveInsight analysis, the migraine market size in the 7MM was approximately USD 6.9 billion in 2021. As per the estimates, the total Migraine prevalent cases in the 7MM was approximately 118 million in 2021. Leading Migraine companies such as Lundbeck Seattle BioPharmaceutical, Eli Lilly and Company, Amgen, Novartis, Teva Pharmaceuticals, Allergan, Biohaven Pharmaceuticals, Dr. Reddy's Labs, AbbVie, Impel NeuroPharma, Zosano Pharma, Axsome Therapeutics, Aeon Biopharma Inc., Ionis Pharmaceuticals, Inc., Charleston Laboratories , and others are developing novel migraine drugs which can be available in the migraine market in the upcoming years. The migraine therapies in the pipeline include BHV-3500 (Zavegepant), Atogepant, INP104, Zolmitriptan transdermal, AXS-07, Lu AG09222, ABP-450, IONIS-PKKRx, Oral CL- H1T, LY-3451838, and others. The increased number of migraine cases and the emerging treatment are likely to contribute directly to the migraine market growth during the forecast period. Discover more about therapies set to grab major migraine market share @ Migraine Market Landscape Migraine Overview Migraine is the seventh most debilitating disease in the world (responsible for 2.9% of all years of life lost to disability/YLDs) and the leading cause of impairment among all neurological disorders. Migraine is classed as chronic or episodic based on the type of the attack and its frequency. Episodic migraine is defined as having 0–14 headache days per month, and chronic migraine is defined as having 15 or more headache days per month. Although migraine symptoms usually include severe throbbing recurring pain on one side of the head, one-third of migraine attacks are found to be affected on both sides. Among the most common migraine causes include stress, physical factors, food additives, and others. MRI and CT scans are mainly used for migraine diagnosis. Migraine Epidemiology Segmentation As per DelveInsight, there were approx 118 million Migraine prevalent cases in the 7MM in 2021. Among the EU5 countries, Germany had the highest migraine prevalence in 2021. The Migraine market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalence of Migraine Prevalent Cases of Migraine by severity Gender-specific Prevalence of Migraine Diagnosed Cases of Episodic and Chronic Migraine Download the report to understand which factors are driving migraine epidemiology trends @ Migraine Epidemiological Insights Migraine Treatment Market The key revenue-generating components of the acute migraine treatment market can be roughly characterized as triptans, NSAIDs, analgesics/opioids, and DHE (dihydroergotamine) or ergot alkaloids. Triptans continue to dominate the entire acute therapy landscape in terms of revenue generation. Some of the major migraine drugs (generics/branded) belonging to this class are eletriptan, almotriptan, sumatriptan, rizatriptan, zolmitriptan, and others. Moreover, preventive/prophylactic treatment is used to minimize the frequency, intensity, and duration of migraine attacks. Preventive migraine medicines approved by the FDA include propranolol, timolol, divalproex sodium, OnabotulinumtoxinA (botox), and topiramate; other drugs have demonstrated effectiveness but need FDA clearance. Apart from these, the other FDA approved drugs used for migraine treatment are Vyepti (Eptinezumab) (Lundbeck Seattle BioPharmaceutical), Emgality (Galcanezumab-gnlm) (Eli Lilly and Company), Aimovig (Amgen/Novartis), Ajovy (Teva Pharmaceuticals), Ubrelvy (Allergan), Rimegepant (Nurtec ODT) (Biohaven Pharmaceuticals), and others. To know more about migraine treatment, visit @ Migraine Medications Migraine Pipeline Therapies and Key Companies BHV-3500 (Zavegepant): Biohaven Pharmaceuticals Atogepant: AbbVie INP104: Impel NeuroPharma Zolmitriptan transdermal: Zosano Pharma AXS-07: Axsome Therapeutics Lu AG09222: Lundbeck ABP-450: Aeon Biopharma IONIS-PKKRx: Ionis Pharmaceuticals Oral CL- H1T: Charleston Laboratories LY-3451838: Eli Lilly and Company Learn more about the migraine medicine in clinical trials @ Migraine Treatment Migraine Market Dynamics The migraine treatment market looks promising as the market is emerging with newer treatments that have recently been approved by the FDA and are anticipated for approval in the coming years. A large number of clinical phase trials are being done to examine and evaluate promising investigational therapies and their much-awaited launch owing to a robust therapeutic treatment market and bolstering the treatment response as a whole. Moreover, the increasing disease prevalence and awareness will fuel the migraine market during the forecast period. However, some factors are hindering the growth of the migraine market. Despite the availability of standard treatment guidelines across regions and the well-entrenched presence of an array of available, mostly inexpensive options, current abortive and prophylactics, lack of biomarkers, and lack of therapies for pediatric patients exist as a high unmet need which is contrary to the popular perception. The therapies addressed in recent are not effective in all patients, have contraindications related to cardiovascular conditions in some patients, and are nonspecific or poorly tolerated in others. In addition, the undiagnosed, unreported cases and the unawareness about the disease remain the primary aspects that strive for the migraine market growth. Scope of the Migraine Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Migraine Companies: Lundbeck Seattle BioPharmaceutical, Eli Lilly and Company, Amgen, Novartis, Teva Pharmaceuticals, Allergan, Biohaven Pharmaceuticals, Dr. Reddy's Labs, AbbVie, Impel NeuroPharma, Zosano Pharma, Axsome Therapeutics, Aeon Biopharma Inc., Ionis Pharmaceuticals, Inc., Charleston Laboratories, and others Key Migraine Therapies: BHV-3500 (Zavegepant), Atogepant, INP104, Zolmitriptan transdermal, AXS-07, Lu AG09222, ABP-450, IONIS-PKKRx, Oral CL- H1T, LY-3451838, and others Therapeutic Assessment: Migraine current marketed and emerging therapies Migraine Market Dynamics: Migraine market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Migraine Market Access and Reimbursement Discover more about migraine drugs in development @ Migraine Clinical Trials Table of Contents Get in touch with our Business executive @ Healthcare Due Diligence Services Related Reports Migraine Epidemiology Migraine Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical, and forecasted Migraine epidemiology in the 7MM. Migraine Pipeline Migraine Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Migraine companies including Allergan, Biohaven Pharmaceuticals, Dr. Reddy's Labs, AbbVie, among others. Cluster Headache Market Cluster Headache Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Cluster Headache companies including Eli Lilly and Company, Teva Pharmaceuticals, Novartis, among others. Cluster Headache Epidemiology Cluster Headache Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical, and forecasted Cluster Headache epidemiology in the 7MM. Cluster Headache Pipeline Cluster Headache Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Cluster Headache companies including Eli Lilly and Company, Teva Pharmaceuticals, Novartis, among others. 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Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP