8-K

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 8, 2021 (March 5, 2021)

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 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.

(d) 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).

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.

/s/ Cynthia W. Hu

Cynthia W. Hu

COO, General Counsel and Secretary

Date: March 8, 2021

EX-99.1

Exhibit 99.1

CLEAVE THERAPEUTICS LICENSES FIRST-IN-CLASS VCP/P97 INHIBITOR

CB-5339 TO CASI PHARMACEUTICALS FOR GREATER CHINA REGION

~ CASI’s pipeline expanded to include first-in-class VCP/p97 inhibitor in Phase 1 for hematological malignancies and solid tumors ~

~ Cleave to receive $5.5 million upfront in cash payment and $5.5 million as a convertible note with potential to receive up to $74 million in milestone payments, plus tiered royalties ~

San Francisco, CA, and Rockville, MD – March 8, 2021 – Cleave Therapeutics, Inc. (“Cleave”), a clinical-stage biopharmaceutical company focused on valosin-containing protein (VCP)/p97 as a novel target in protein homeostasis, DNA damage response and other cellular stress pathways for therapeutic use in cancer, and CASI Pharmaceuticals, Inc (NASDAQ: CASI), a U.S. biopharmaceutical company with an established clinical development and commercial infrastructure in China, today announced they have entered an exclusive licensing agreement for the development and commercialization of CB-5339, a novel VCP/p97 inhibitor, in mainland China, Taiwan, Hong Kong and Macau.

Under the terms of the agreement, Cleave and CASI will develop CB-5339 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in China and associated markets. 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 to the upfront cash payment, CASI will make a $5.5 million investment in Cleave through a convertible note.

CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, is being evaluated in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), while the National Cancer Institute (NCI) is sponsoring and evaluating CB-5339 in a Phase 1 clinical trial of patients with solid tumors and lymphomas.

“Our collaboration with CASI is a strategic step to accelerate the development of CB-5339 globally by initiating trials for additional indications such as multiple myeloma in Greater China,” said Amy Burroughs, President and CEO of Cleave Therapeutics. “CASI’s development and commercial capabilities in hematology oncology and long-term commitment as an investor make them an ideal partner at this exciting time in the development of our first-in-class drug candidate.”

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, said: “Cleave’s novel approach to inhibiting VCP/p97 in hematological malignancies such as AML and MDS is supported by extensive preclinical research and early clinical data. CB-5339 represents a promising new agent for selectively targeting VCP/p97 in cancers and is a complementary addition to our growing portfolio of approved and investigational therapies for hematology oncology. We are thrilled to partner with Cleave as CB-5339 advances through clinical development.”

About Cleave Therapeutics

Cleave Therapeutics is a clinical-stage biopharmaceutical company focused on VCP/p97 as a novel target in protein homeostasis and cellular stress pathways for therapeutic use in cancer. The privately held company, based in San Francisco, is studying CB-5339, its second-generation, small molecule VCP/p97 inhibitor, in a Phase 1 clinical trial in patients with acute myeloid leukemia and myelodysplastic syndrome, while the National Cancer Institute is sponsoring and evaluating CB-5339 in a Phase 1 clinical trial of patients with solid tumors and lymphomas. Cleave investors include 5AM Ventures, Bristol-Myers Squibb, Orbimed, U.S. Venture Partners (USVP), Arcus Ventures, Astellas Venture Management, and Osage University Partners. For additional information, visit www.cleavetherapeutics.com.

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 is executing its plan to become a biopharmaceutical leader in the greater China market by leveraging the Company’s China-based clinical, 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 80 hematology and 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.

For further information, please contact:

Cleave

Susan Kinkead

susan@kinkeadcomm.com

415-509-3610

CASI

Weihao Xu, CFO	Jennifer Porcelli, Solebury Trout
ir@casipharmaceuticals.com	+1 646.378.2962
	jporcelli@troutgroup.com

XML

Cover	Mar. 05, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 05, 2021
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
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	CASI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false