CASI PHARMACEUTICALS, INC. (NASDAQ:CASI) Files An 8-K Other Events
Item 8.01 Other Items.
Registration statements filed by CASI Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, and any prospectuses of prospectus supplements thereto include specific risk factors. In addition to those risk factors, we incorporate by reference the risks discussed under the section captioned “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K, as well as any updates to those risk factors or new risk factors contained in our subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC. We are filing this Current Report on Form 8-K to update and restate the Risk Factors in those previously filed SEC reports. The updated and restated risk factors are filed herewith as Exhibit 99.1 and incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K, including Exhibit 99.1 hereto contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook or expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including: the difficulty of executing our business strategy 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, NMPA, 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 volatility in the market price of our common stock; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with CID-103, CNCT19, and our product candidates; risks associated with CID-103, CNCT19, and our other early-stage products under development; risks that result in preclinical and early clinical models are not necessarily indicative of later 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. Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 | Updated and Restated Risk Factors |
CASI Pharmaceuticals, Inc. Exhibit
EX-99.1 2 tv528182_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 RISK FACTORS Investing in our securities involves a high degree of risk and uncertainty. Before making an investment decision,…
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About CASI PHARMACEUTICALS, INC. (NASDAQ:CASI)
CASI Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on the acquisition, development and commercialization of therapeutics for cancer and other medical needs. It operates through the development of targeted therapeutics for the treatment of cancer segment. Its product pipeline includes internal development of its lead drug candidate, ENMD-2076; MARQIBO, ZEVALIN and EVOMELA, and early-stage candidates in preclinical development. Its ENMD-2076 is an orally active, Aurora A/angiogenic kinase inhibitor with a kinase selectivity profile and multiple mechanisms of action. Its Marqibo is a sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate. Its ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is a CD20-directed radiotherapeutic antibody. Its EVOMELA is an intravenous formulation of melphalan being investigated by Spectrum in the multiple myeloma transplant setting. Its pipeline also includes 2ME2 (2-methoxyestradial).