SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): March 8, 2021 (
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|Item 1.01||Entry into a Material Definitive Agreement.|
On March 5, 2021, CASI Pharmaceuticals, Inc., a Delaware corporation (the “Company”), entered into a License and Development Agreement for CB-5339 (the “License Agreement”) by and between the Company and Cleave Therapeutics, Inc. (“Cleave”), a Delaware corporation, pursuant to which the Company obtained an exclusive license for the development and commercialization of CB-5339, a novel VCP/p97 inhibitor in Mainland China, Hong Kong, Macau and Taiwan (collectively, “Greater China”).
Pursuant to the License Agreement, the Company and Cleave will develop CB-5339 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in Greater China. Cleave will receive a $5.5 million upfront payment and is eligible to receive up to $74 million in development and commercial milestone payments, plus tiered royalties in the high-single to mid-double-digit range on net sales of CB-5339. In addition, the Company agreed to purchase from Cleave a convertible promissory note for $5.5 million, to be converted into shares of conversion stock of Cleave, in accordance with the terms and conditions of the note.
The License Agreement contains customary representations, warranties, covenants and indemnification provisions.
The foregoing description of the License 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 License Agreement that will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021.
|Item 8.01||Other Events|
On March 8, 2021, the Company issued a press release announcing the License Agreement. A copy of the press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference.
|Item 9.01||Financial Statements and Exhibits.|
|Exhibit No.||Description of Document|
|99.1||Press Release of CASI Pharmaceuticals, Inc. dated March 8, 2021|
|104||Cover Page Interactive Data File (embedded within the inline XBRL document).|
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.|
|/s/ Cynthia W. Hu|
|Cynthia W. Hu|
|COO, General Counsel and Secretary|
Date: March 8, 2021