CASI CASI Pharmaceuticals Inc.

1.52
0  0%
Previous Close 1.52
Open
52 Week Low 1.15
52 Week High 3.67
Market Cap $188,394,620
Shares 123,943,829
Float 86,389,373
Enterprise Value $142,572,620
Volume 0
Av. Daily Volume 597,801
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Upcoming Catalysts

Drug Stage Catalyst Date
CNCT19
Non-Hodgkin Lymphoma (NHL) / Acute lymphoblastic leukemia (ALL)
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
CID-103
Multiple myeloma
Phase 1
Phase 1
Phase 1 trial to commence 1Q 2021.

Latest News

  1. ROCKVILLE, Md. and BEIJING, Sept. 11, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced that Dr. Wei-Wu He, Chairman and Chief Executive Officer of CASI Pharmaceuticals, will be presenting at the following upcoming virtual conferences in September. Details for the virtual conferences are as follows.

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Monday, September 14th

    Time: 12:30 PM (EDT)

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date: Wednesday, September 23rd

    Time: 1:40 PM (EDT)

    Webcast or external link of the company presentations will be available under "Events & Presentations" in the "Investors Relations" section of CASI's website. Archived replays will be available for approximately 90 days following the event.

    About CASI Pharmaceuticals

    CASI Pharmaceuticals, Inc. ("CASI" or the "Company") is a U.S. 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. ("CASI China"), which is located in Beijing, China. The Company has built a commercial team of over 70 hematology and oncology sales and marketing specialists based in China. More information on CASI is available at www.casipharmaceuticals.com.

    COMPANY CONTACT:

    CASI Pharmaceuticals, Inc.

    240.864.2643

    INVESTOR CONTACT:

    Solebury Trout

    Jennifer Porcelli

    646.378.2962

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/casi-pharmaceuticals-inc-to-participate-in-two-upcoming-september-conferences-301128032.html

    SOURCE CASI Pharmaceuticals, Inc.

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  2. ROCKVILLE, Md. and BEIJING, Aug. 10, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported financial results and business highlights for the second quarter of 2020.

    Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "One of the positive developments with respect to EVOMELA this quarter was the successful transition to a new manufacturer for the commercial supply in China. This was a key accomplishment as we expect it to significantly reduce our cost of revenue. Despite the impact of COVID-19 and manufacturer change in the second quarter, we expect EVOMELA revenue to reach at least $10 million for the full year 2020.  We also expect significant improvement in our margins for EVOMELA for the second half of 2020."

    Dr. He continued, "The current Phase 1 trials for CNCT19, a CD19 CAR-T therapy, conducted by our development partner, Juventas, are well underway. Juventas expects to complete trials in B-NHL and B-ALL and initiate registration trials in the first quarter 2021, followed by NDA filing in China in early 2022. As Juventas' exclusive commercial partner, we expect that with a locally developed and manufactured CD19 CAR-T, we will be able to offer a much lower price point than imported therapies and thus be able to make this important cell-based therapy available to significantly more patients in China."

    "With regard to CID-103, our anti-CD38 monoclonal antibody, we recently submitted our IMPD application with MHRA, the British health authority, to initiate our Phase 1 clinical study in the UK. Clinical centers in the EU continue to be impacted by COVID-19; however, we expect to initiate our study in the first quarter 2021 assuming the centers open back up for clinical trial activities."

    "And finally, we were pleased to report our recent closing of an underwritten public offering for gross proceeds of $43.7 million. This successful financing attracted a number of new, fundamentally-driven, long-term oriented, healthcare-dedicated investors to the CASI story, as well as continued investment by our management. We look forward to continuing to expand our U.S. investor base, and importantly, positioning CASI to accelerate long-term value creation for our shareholders."

    Second Quarter 2020 Financial Results

    • Revenues consisted primarily of product sales of EVOMELA that launched in August of 2019. Revenues were $2.7 million for the three months ended June 30, 2020. The decrease in the second quarter revenue figures, compared to those in the first quarter was primarily due to a manufacturer change and the effects caused by the global COVID-19 pandemic. We have since received shipment of EVOMELA from the new, lower-cost supplier and expect the product to be released into our distribution chain this month. We expect our revenue from EVOMELA will resume its original projected course in the second half of 2020.
    • Costs of revenues were $2.5 million for the quarter ended June 30, 2020. Costs of revenues have been impacted by a previous supply arrangement which has since been replaced by a current lower-cost supplier. We expect that the unit cost of inventories of EVOMELA will be considerably lower in the second half of 2020.
    • Research and development expenses for the second quarter ended June 30, 2020 were $1.9 million, compared with $3.0 million for the same period in 2019. The decrease in R&D expenses is primarily due to reduced regulatory costs associated with our ANDAs and lower costs associated with preclinical development activities, offset by an increase in R&D expenses incurred related to the development of CID-103.
    • General and administrative expenses for the second quarter of 2020 were $4.1 million, compared with $7.0 million for the same period in 2019. The decrease in G&A expenses was primarily because the 2019 period included costs related to sales and marketing efforts to prepare for the August 2019 launch of EVOMELA, as well as lower professional fees and travel costs incurred during the 2020 period.
    • Selling and marketing expenses for the second quarter 2020 were $1.6 million. The increase is due to selling costs related to commercial sales of EVOMELA that began in August of 2019.
    • Acquired in-process R&D expenses for the three months ended June 30, 2020 were $0 million, compared with $5.8 million for the same period in 2019, relating to the acquisition of the Black Belt license in April 2019.
    • Net loss for the second quarter of 2020 was $8.5 million compared to $15.3 million for the same period in 2019.
    • As of June 30, 2020, the Company had cash and cash equivalents of $44.9 million compared to $53.9 million as of March 31, 2020. As reported, the Company consummated an underwritten public offering in July 2020 generating gross proceeds of approximately $43.7 million.

    Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, can be found at www.casipharmaceuticals.com.

    Conference Call

    The Company will host a conference call reviewing the second quarter highlights today at 4:30 p.m. ET. The conference call can be accessed by dialing (833) 647-4459 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), 800933597 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5223239. Participants dialing in via International Toll-Free Service (ITFS) numbers will be required to provide the following passcode to join the conference call: 8336474459, 6025859887.

    This call will be recorded and available for replay by dialing (800) 585-8367 (U.S.) or (404)-537-3406 (international) and enter 5223239 to access the replay.

    About CASI Pharmaceuticals

    CASI Pharmaceuticals, Inc. ("CASI" or the "Company") is a U.S. 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. ("CASI China"), which is located in Beijing, China. The Company has built a commercial team of over 70 hematology and oncology sales and marketing specialists based in China. In August 2019, the Company launched its first commercial product, EVOMELA® (Melphalan for Injection). Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma and also indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. Other core hematology/oncology assets in the Company's pipeline include: (i) An autologous CD19 CAR-T investigative product (CNCT19) being developed by Juventas Cell Therapy Ltd ("Juventas") as a treatment for patients with B-cell acute lymphoblastic leukemia ("B-ALL") and B-cell non-Hodgkin lymphoma ("B-NHL") for which the Company has exclusive commercialization rights. The Company expects Juventas to complete its Phase 1 study of CNCT19 and initiate its registration trials in the first quarter of 2021; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of patients with multiple myeloma. The Company intends to initiate the Phase 1 study of CID-103 in the first quarter of 2021; and (iii) ZEVALIN® (Ibritumomab Tiuxetan), a CD20-directed radiotherapeutic antibody, that is approved in the U.S. to treat patients with non-Hodgkin lymphoma ("NHL"). The Company intends to begin the China registration study of ZEVALIN in 2021. Other assets in the Company's pipeline for which the Company have exclusive rights in China are (i) Octreotide Long Acting Injectable ("LAI"), and (ii) a novel formulation of Thiotepa. Octreotide LAI formulations, which are approved in various European countries, are considered a standard of care for the treatment of acromegaly and the control of symptoms associated with certain neuroendocrine tumors. The Company plans to begin the China registration study for Octreotide LAI in 2020.  Thiotepa is a conditioning treatment for allogeneic haemopoietic stem cell transplants. The Company's partner for the novel formulation of Thiotepa plans to begin the China registration study in 2021. More information on CASI is available at www.casipharmaceuticals.com.

    Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, revenue growth, 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 we assume no duty to update forward-looking statements. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of factors, including: the outbreak of the COVID-19 pandemic and its effects on global markets and supply chains; the risk of substantial dilution of existing stockholders in future stock issuances; the difficulty of executing our business strategy in China; our ability to design and implement a development plan for our ANDAs held by CASI Wuxi; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms, if at all; the risk that we may be unable to continue as a going concern if we are unable to raise sufficient capital for our operational needs; the volatility in the market price of our common stock; the possibility that we may be delisted from trading on The Nasdaq Capital Market;  risks associated with our product candidates; risks associated with any early-stage products under development; the risk that results in preclinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; dependence on third parties; risks related to our dependence on Juventas to conduct the clinical development of 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 stockholders and our Chairman and CEO that differ from our other stockholders; and risks related to the development of a new manufacturing facility by CASI (Wuxi). 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.

    EVOMELA® and  Zevalin® are proprietary to Acrotech Biopharma LLC and its affiliates.

    COMPANY CONTACT:

    CASI Pharmaceuticals, Inc.

    240.864.2643

    INVESTOR CONTACT:

    Solebury Trout

    Jennifer Porcelli

    646.378.2962

    (Financial Table Follows)

     

    CASI Pharmaceuticals, Inc.











    Unaudited Condensed Consolidated Balance Sheets













    (In thousands, except share and per share data)





























    June 30, 2020



    December 31, 2019

    ASSETS











    Current assets:



























    Cash and cash equivalents

    $

    44,888



    $

    53,621



    Investment in equity securities, at fair value



    934





    625



    Accounts receivable, net of $0 allowance for doubtful accounts



    2,604





    1,293



    Loan receivable from a related party



    4,267







    Inventories



    430





    4,542



    Prepaid expenses and other



    1,407





    1,420



    Assets held-for-sale



    1,250





    1,496

    Total current assets



    55,780





    62,997















    Property and equipment, net



    809





    985

    Intangible assets, net



    13,143





    15,399

    Long-term investments



    13,563





    14,038

    Right of use assets 



    7,964





    8,708

    Other assets



    310





    504

    Total assets

    $

    91,569



    $

    102,631















    LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST AND STOCKHOLDERS' EQUITY











    Current liabilities:













    Accounts payable

    $

    1,825



    $

    5,113



    Accrued and other current liabilities



    2,354





    2,834

    Total current liabilities



    4,179





    7,947















    Deferred income



    2,196





    Other liabilities



    781





    1,019

    Total liabilities



    7,156





    8,966















    Commitments and contingencies (Note 19)

























    Redeemable noncontrolling interest, at redemption value (Note 11)



    21,074





    20,670















    Stockholders' equity:













    Preferred stock, $1.00 par value: 5,000,000 shares authorized and 0 shares issued and outstanding 









    Common stock, $0.01 par value: 250,000,000 shares authorized at June 30, 2020 and December 31,

    2019; 101,008,374 shares and 97,851,243 shares issued at June 30, 2020 and December 31, 2019,

    respectively; 100,928,829 shares and 97,771,698 shares outstanding at June 30, 2020 and December

    31, 2019, respectively



    1,010





    979



    Additional paid-in capital



    614,617





    606,686



    Treasury stock, at cost:  79,545 shares held at June 30, 2020 and December 31, 2019



    (8,034)





    (8,034)



    Accumulated other comprehensive loss



    (3,890)





    (2,728)



    Accumulated deficit



    (540,364)





    (523,908)

    Total stockholders' equity



    63,339





    72,995

    Total liabilities, redeemable noncontrolling interest and stockholders' equity

    $

    91,569



    $

    102,631

     

     

    CASI Pharmaceuticals, Inc.









    Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss









    (In thousands, except per share data)

































































    Three Months Ended 



    Six Months Ended 





    June 30, 2020



    June 30, 2019



    June 30, 2020



    June 30, 2019

    Revenues:

























    Product sales



    $

    2,638



    $



    $

    6,010



    $

    Lease income





    33









    67





    Total revenues





    2,671









    6,077































    Costs and expenses:

























        Costs of revenues





    2,517









    5,728





        Research and development





    1,862





    2,979





    4,879





    5,545

        General and administrative





    4,085





    6,982





    8,143





    12,693

        Selling and marketing 





    1,557









    2,817





        (Gain) loss on disposal of intangible assets













    (450)





    48

        Impairment of intangible assets





    1,537









    1,537





        Acquired in-process research and development









    5,849





    1,081





    5,849

    Total costs and expenses





    11,558





    15,810





    23,735





    24,135



























    Loss from operations





    (8,887)





    (15,810)





    (17,658)





    (24,135)

    Non-operating income/(expense):

























    Interest income, net





    153





    320





    343





    369

    Other income





    27









    27





    Foreign exchange (losses) gains





    (115)





    480





    248





    551

    Change in fair value of investment in equity securities





    324





    (241)





    309





    (196)

    Net loss





    (8,498)





    (15,251)





    (16,731)





    (23,411)

    Less: (loss)/ income attributable to redeemable noncontrolling interest





    (166)





    62





    (275)





    76

    Accretion to redeemable noncontrolling interest redemption value





    362





    158





    679





    161

    Net loss attributable to CASI Pharmaceuticals, Inc.



    $

    (8,694)



    $

    (15,471)



    $

    (17,135)



    $

    (23,648)



























    Net loss per share (basic and diluted)



    $

    (0.09)



    $

    (0.16)



    $

    (0.17)



    $

    (0.25)

    Weighted average number of common shares outstanding (basic and diluted)





    100,921





    95,717





    99,847





    95,684



























    Comprehensive loss:

























    Net loss



    $

    (8,498)



    $

    (15,251)



    $

    (16,731)



    $

    (23,411)

    Foreign currency translation adjustment





    (336)





    (1,112)





    (1,162)





    (800)

    Total comprehensive loss



    $

    (8,834)



    $

    (16,363)



    $

    (17,893)



    $

    (24,211)

    Less: Comprehensive (loss)/income attributable to redeemable

    noncontrolling interest 





    (166)





    62





    (275)





    76

    Comprehensive loss attributable to common stockholders



    $

    (8,668)



    $

    (16,425)



    $

    (17,618)



    $

    (24,287)

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/casi-pharmaceuticals-announces-second-quarter-2020-financial-results-301108897.html

    SOURCE CASI Pharmaceuticals, Inc.

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  3. ROCKVILLE, Md. and BEIJING, Aug. 3, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced the Company will host a conference call reviewing the second quarter highlights at 4:30 p.m. ET on Monday, August 10th, 2020.

    On the call, CASI's Chairman & CEO will provide an update on the Company's business and upcoming milestones. The conference call can be accessed by dialing (833) 647-4459 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), 800933597 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5223239. Participants dialing in via International Toll-Free Service (ITFS) numbers will be required to provide the following passcode to join the conference call: 8336474459, 6025859887.

    This call will be recorded and available for replay by dialing (800) 585-8367 (U.S.) or (404)-537-3406 (international) and enter 5223239 to access the replay.

    About CASI Pharmaceuticals

    CASI is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, with a product portfolio that includes approved and investigational assets. In August 2019, the Company launched its first commercial product, EVOMELA® (Melphalan for Injection), in China that is approved for use as a conditioning treatment prior to stem cell transplantation in the multiple myeloma setting.  The Company's other core hematology/oncology assets in its  pipeline include (i) an autologous CD19 CAR-T investigative product (CNCT19) being developed as a treatment for patients with B-ALL and B-NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of patients with multiple myeloma; and (iii) greater China rights to ZEVALIN® (Ibritumomab Tiuxetan), a CD20-directed radiotherapeutic antibody that is approved in the U.S. to treat patients with NHL.  The Company's oncology assets also include China rights to (i) octreotide long acting injectable (LAI) microsphere formulation indicated for the treatment of certain symptoms associated with particular neuroendocrine cancers and acromegaly, and (ii) a novel formulation of thiotepa, which has multiple potential therapeutic uses and a long history of established use in the hematology/oncology setting, both of which are being developed for import registration and market approval in China. More information on CASI is available at www.casipharmaceuticals.com.

    COMPANY CONTACT:

    CASI Pharmaceuticals, Inc.

    240.864.2643

    INVESTOR CONTACT:

    Solebury Trout

    Jennifer Porcelli

    646.378.2962

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/casi-pharmaceuticals-to-report-second-quarter-2020-financial-results-and-host-conference-call-august-10-2020-301104480.html

    SOURCE CASI Pharmaceuticals, Inc.

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  4. ROCKVILLE, Md. and BEIJING, July 22, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a price to the public of $1.90 per share. CASI has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of its common stock. The offering is expected to close on or about July 24, 2020, subject to satisfaction of customary closing conditions. The gross proceeds to CASI from the offering, excluding any exercise by the underwriters of their 30-day option to purchase additional shares…

    ROCKVILLE, Md. and BEIJING, July 22, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a price to the public of $1.90 per share. CASI has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of its common stock. The offering is expected to close on or about July 24, 2020, subject to satisfaction of customary closing conditions. The gross proceeds to CASI from the offering, excluding any exercise by the underwriters of their 30-day option to purchase additional shares, are expected to be approximately $38.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by CASI.

    Oppenheimer & Co. Inc. is acting as the sole bookrunning manager, and Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-manager, for the offering.

    CASI intends to use the net proceeds of the offering for working capital and general corporate purposes, which include, but are not limited to advancing our product portfolio, acquiring the rights to new product candidates and general and administrative expenses. 

    The securities described above are being offered by CASI pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed on December 13, 2017 and declared effective by the U.S. Securities and Exchange Commission ("SEC") on December 22, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at .

    Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that CASI has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about CASI and the offering. 

    This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

    About CASI Pharmaceuticals

    CASI Pharmaceuticals is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, with a product portfolio that includes approved and investigational assets.  In August 2019, the Company launched its first commercial product, EVOMELA® (Melphalan for Injection), in China that is approved for use as a conditioning treatment prior to stem cell transplantation in the multiple myeloma setting.  The Company's other core hematology/oncology assets in its  pipeline include (i) an autologous CD19 CAR-T investigative product (CNCT19) being developed as a treatment for patients with B-ALL and B-NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of patients with multiple myeloma; and (iii) ZEVALIN® (Ibritumomab Tiuxetan), a CD20-directed radiotherapeutic antibody that is approved in the U.S. to treat patients with NHL, and being developed for China.  The Company's oncology assets also include China rights to (i) octreotide long acting injectable (LAI) microsphere formulation indicated for the treatment of certain symptoms associated with particular neuroendocrine cancers and acromegaly, and (ii) a novel formulation of thiotepa, which has multiple indications and a long history of established use in the hematology/oncology setting, both of which are being developed for import registration and market approval in China. More information on CASI is available at www.casipharmaceuticals.com

    Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for 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 ability to design and implement a development plan for our ANDAs; the development of major public health concerns, including the coronavirus or other pandemics arising in China or elsewhere; 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 CNCT19, CID-103, 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 SEC, including, but not limited to, our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q, which are available at www.sec.gov.

    EVOMELA® and ZEVALIN® are proprietary to Acrotech Biopharma LLC and its affiliates.

    COMPANY CONTACT:

    CASI Pharmaceuticals, Inc.

    240.864.2643

    INVESTOR CONTACT:

    Solebury Trout

    Jennifer Porcelli

    646.378.2962

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    SOURCE CASI Pharmaceuticals, Inc.

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  5. ROCKVILLE, Md. and BEIJING, July 21, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the offering, CASI expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. There can be no assurances as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock in the offering…

    ROCKVILLE, Md. and BEIJING, July 21, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the offering, CASI expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. There can be no assurances as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock in the offering will be sold by CASI.

    Oppenheimer & Co. Inc. is acting as the sole bookrunning manager, and Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-manager, for the offering.

    CASI intends to use the net proceeds of the offering for working capital and general corporate purposes, which include, but are not limited to advancing our product portfolio, acquiring the rights to new product candidates and general and administrative expenses. 

    The securities described above are being offered by CASI pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed on December 13, 2017 and declared effective by the U.S. Securities and Exchange Commission ("SEC") on December 22, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at .

    Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that CASI has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about CASI and the offering. 

    This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

    About CASI Pharmaceuticals

    CASI Pharmaceuticals is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, with a product portfolio that includes approved and investigational assets.  In August 2019, the Company launched its first commercial product, EVOMELA® (Melphalan for Injection), in China that is approved for use as a conditioning treatment prior to stem cell transplantation in the multiple myeloma setting.  The Company's other core hematology/oncology assets in its  pipeline include (i) an autologous CD19 CAR-T investigative product (CNCT19) being developed as a treatment for patients with B-ALL and B-NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of patients with multiple myeloma; and (iii) ZEVALIN® (Ibritumomab Tiuxetan), a CD20-directed radiotherapeutic antibody that is approved in the U.S. to treat patients with NHL, and being developed for China.  The Company's oncology assets also include China rights to (i) octreotide long acting injectable (LAI) microsphere formulation indicated for the treatment of certain symptoms associated with particular neuroendocrine cancers and acromegaly, and (ii) a novel formulation of thiotepa, which has multiple indications and a long history of established use in the hematology/oncology setting, both of which are being developed for import registration and market approval in China. More information on CASI is available at www.casipharmaceuticals.com

    Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for 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 ability to design and implement a development plan for our ANDAs; the development of major public health concerns, including the coronavirus or other pandemics arising in China or elsewhere; 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 CNCT19, CID-103, 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 SEC, including, but not limited to, our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q, which are available at www.sec.gov.

    EVOMELA® and ZEVALIN® are proprietary to Acrotech Biopharma LLC and its affiliates.

    COMPANY CONTACT:

    CASI Pharmaceuticals, Inc.

    240.864.2643

    INVESTOR CONTACT:

    Solebury Trout

    Jennifer Porcelli

    646.378.2962

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/casi-pharmaceuticals-announces-proposed-public-offering-of-common-stock-301097384.html

    SOURCE CASI Pharmaceuticals, Inc.

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