0001104659-22-030346.txt : 20220304 0001104659-22-030346.hdr.sgml : 20220304 20220304080302 ACCESSION NUMBER: 0001104659-22-030346 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220302 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220304 DATE AS OF CHANGE: 20220304 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CASI Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0000895051 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 581959440 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-20713 FILM NUMBER: 22712124 BUSINESS ADDRESS: STREET 1: 9620 MEDICAL CENTER DR STREET 2: STE 300 CITY: ROCKVILLE STATE: MD ZIP: 20850 BUSINESS PHONE: 240-864-2600 MAIL ADDRESS: STREET 1: 9620 MEDICAL CENTER DR STREET 2: STE 300 CITY: ROCKVILLE STATE: MD ZIP: 20850 FORMER COMPANY: FORMER CONFORMED NAME: ENTREMED INC DATE OF NAME CHANGE: 19960415 8-K 1 tm2135684-3_8k.htm FORM 8-K
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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): March 2, 2022

 

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 1.01 — Entry into a Material Definitive Agreement.

 

On March 2, 2022, CASI Pharmaceuticals, Inc., a Delaware corporation (“CASI” or the “Company”), entered into a two-year renewal Exclusive Distribution Agreement (the “Agreement”), effective as of March 2, 2022, with China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. (“CRPCGIT”), a company of limited liability, established and existing under the laws of the People’s Republic of China, and CASI Pharmaceuticals (China) Co., Ltd, (“CASI China”) a company of limited liability, incorporated and existing under the laws of the People’s Republic of China and a wholly owned subsidiary of the Company. Under the terms of the Agreement, CASI appointed CRPCGIT on an exclusive basis as its sole distributor for the sale of Melphalan Hydrochloride for Injection (EVOMELA®) (the “Product”) in the territory of the People’s Republic of China (excluding Hong Kong, Taiwan and Macau) (the “Territory”) during the term of this Agreement, subject to certain terms and conditions. CRPCGIT may appoint sub-distributors of its choice in furtherance of this goal provided that CASI has been notified in writing and received the due diligence or any other information of the sub-distributor as CASI requests. CRPCGIT agreed to use its best efforts to distribute and sell the Product to the maximum number of customers in the Territory.

 

The foregoing description of the Agreement does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the full text of the Agreement that will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022.

 

A copy of the press release of the Company announcing the Agreement is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 9.01 — Financial Statements and Exhibits.

 

(d) Exhibits

  

Exhibit No.   Description of Document
99.1 ─   Press Release of CASI Pharmaceuticals, Inc., dated March 4, 2022.
104 ─   Cover Page Interactive Data File (embedded within the inline XBRL document).

 

 

 

 

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)

 

  By: /s/ Larry Zhang  
    Larry Zhang  
    President  

 

March 4, 2022

 

 

 EX-99.1 2 tm2135684d3_ex99-1.htm EXHIBIT 99.1

 


 

 

 www.casipharmaceuticals.com

 

 

 Exhibit 99.1

 

CASI PHARMACEUTICALS ANNOUNCES

RENEWAL OF EXCLUSIVE DISTRIBUTION AGREEMENT FOR EVOMELA® IN CHINA

 

ROCKVILLE, MD. and BEIJING, China (March 4, 2022) CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced today, that the Company has entered into a renewal exclusive distribution agreement, whereby under the terms of the agreement, China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. (CRPCGIT), previously called “China Resources Guokang Pharmaceuticals Co., Ltd. (CRGK)”, will continue to be the sole distributor for the sale of EVOMELA® (melphalan) for Injection in China.

 

Larry Zhang, CASI’s Global President, commented, “EVOMELA® has shown rapid revenue growth in the past three years and reached $30 million in 2021. In combination with the efforts of all CASI employees, cooperation with CRPCGIT has been tremendously valuable in achieving long-term growth. CRPCGIT provides reliable and efficient distribution services that significantly increase accessibility to EVOMELA® for physicians and patients. We look forward to our future collaboration.”

 

About CASI Pharmaceuticals

 

CASI Pharmaceuticals, Inc. 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., which is located in Beijing, China. The Company has built a commercial team of more than 100 hematology oncology sales and marketing specialists based 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, 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.

 

EVOMELA® is proprietary to Acrotech Biopharma LLC and its affiliates.

COMPANY CONTACT:

Rui Zhang

CASI Pharmaceuticals, Inc.

240.864.2643

ir@casipharmaceuticals.com

INVESTOR CONTACT:

Xuan Yang

Solebury Trout

646.378.2975

xyang@soleburytrout.com

 

 

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Mar. 02, 2022
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Document Period End Date Mar. 02, 2022
Entity File Number 0-20713
Entity Registrant Name CASI PHARMACEUTICALS, INC.
Entity Central Index Key 0000895051
Entity Tax Identification Number 58-1959440
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 9620 Medical Center Drive
Entity Address, Address Line Two Suite 300
Entity Address, City or Town Rockville
Entity Address, State or Province MD
Entity Address, Postal Zip Code 20850
City Area Code 240
Local Phone Number 864-2600
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Title of 12(b) Security Common Stock
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