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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): December 23, 2020

 

CASI PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

  

delaware

(State or other jurisdiction  of

incorporation or organization)

0-20713

(Commission File Number)

 

58-1959440

(IRS Employer Identification

No.)

 

9620 Medical Center Drive, Suite 300

Rockville, Maryland

(Address of principal executive offices)

 

20850

(Zip Code)

 

(240) 864-2600

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of exchange on which registered
Common Stock   CASI   Nasdaq Capital Market

  

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 8.01 Other Events

   

On December 23, 2020, CASI Pharmaceuticals, Inc. announced its partner Juventas Cell Therapy Ltd. received a breakthrough therapy designation for CNCT19 in the treatment of adults with relapsed/refractory B-cell acute lymphoblastic leukemia from the Chinese Center for Drug Evaluation, a division of the China National Medical Products Association. CASI has co-commercial rights to CNCT19 and is a shareholder of Juventas.

  

Item 9.01.     Financial Statements and Exhibits.

 

(d) Exhibits

 

  Exhibit    
  Number   Description
       
  99.1   Press Release of CASI Pharmaceuticals, Inc., dated December 23, 2020
  104   Inline XBRL for the cover page of this Current Report on Form 8-K

                

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  CASI PHARMACEUTICALS, INC.
       (Registrant)  
     
  /s/ Cynthia W. Hu  
  COO, General Counsel & Secretary  

  

Date: December 23, 2020