8-K

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): April 1, 2019

CASI PHARMACEUTICALS, INC.

(Exact Name of Issuer as Specified in Charter)

Delaware	000-20713	58-1959440
(State or other jurisdiction	(Commission File Number)	(I.R.S. Employer
of incorporation)		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)

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 (see General Instruction A.2. below):

¨ 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))

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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On April 1, 2019, the Board of Directors (the “Board”) of CASI Pharmaceuticals, Inc. (the “Company”) restructured its senior management team in order to facilitate a transition to commercial operations, effective April 2, 2019. In connection therewith, Dr. Ken K. Ren stepped down as Chief Executive Officer and the Board appointed Dr. Wei-Wu He, the Company’s Executive Chairman, to serve as the Company’s new Chief Executive Officer. Additional information about Dr. He has been disclosed in the Company’s Proxy Statement filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 17, 2018, which is incorporated herein by reference.

Dr. He started as CEO on April 2, 2019 pursuant to the terms of an offer letter (the “Offer Letter”) from the Company, dated March 22, 2019, containing the following material terms:

· an annual base salary of $568,000;

· an expatriate allowance consisting of tuition for pre-college age children (up to $120,000 per year) and a housing allowance for an apartment in Beijing;

· subject to stockholder approval and the cancellation of his existing performance-based option, a grant of options to purchase four (4) million shares of the Company’s common stock at an exercise price of the closing price on the grant date, which will be the date the Company cancels Dr. He’s options to purchase four (4) million shares of the Company’s common stock previously awarded, vesting at the earlier of (i) the completion of a transformative event by the Company as determined in the discretion of the Compensation Committee and (ii) the second anniversary of the date of grant. In the event Dr. He is terminated without cause or resigns for good reason prior to the second anniversary of the date of grant, then the option will vest immediately upon such termination of employment.

In addition, Dr. He advised the Company that he plans to continue in his role as (1) chairman of the board of Origene Technologies, Inc. and (ii) managing partner of Emerging Technology Partners LLC, and that such roles will not materially infringe on his duties to the Company as Chief Executive Officer. The information set forth above with respect to the Offer Letter does not purport to be complete in scope and is qualified in its entirety by the full text of the Offer Letter, a copy of which will be filed with the Company’s Quarterly Report on Form 10-Q.

In connection with his departure, Dr. Ren is expected to enter into a separation agreement with the Company (the “Separation Agreement”). The Separation Agreement will provide that Dr. Ren shall receive the severance benefits set forth in his Employment Agreement for a termination without cause. The Separation Agreement also will include a general release by Dr. Ren, as well as customary covenants and acknowledgements.

There were no disagreements between Dr. Ren and the Company on any matter relating to the Company’s operations, policies or practices that resulted in his resignation. Dr. Ren will remain as a member of the Board of Directors.

In addition, as a result of the management changes described above and the Company’s focus on growing its commercial operations in China, the Company expects that Cynthia W. Hu, COO, General Counsel & Secretary, will have a reduced policy making role in the future. Ms. Hu will retain her title and continue as General Counsel and Secretary and concentrate on operational matters in the United States. Ms. Hu will not be an “officer” for purposes of Section 16 of the Securities Exchange Act of 1934, as amended.

A copy of the press release of the Company announcing the changes is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits

Exhibit No.	Description
10.1	Employment Agreement by and between EntreMed, Inc. and Ken K. Ren, dated as of April 2, 2013* (incorporated by reference to Exhibit 10.1 of our Form 10-Q filed with the Securities and Exchange Commission on May 15, 2013)
99.1	Press Release, dated April 2, 2019

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                                       

Cynthia W. Hu

COO, General Counsel & Secretary

April 5, 2019

EX-99.1

Exhibit 99.1

  www.casipharmaceuticals.com

FOR IMMEDIATE RELEASE:

CASI PHARMACEUTICALS ANNOUNCES THE APPOINTMENT OF WEI-WU HE,
PH.D., EXECUTIVE CHAIRMAN, TO THE ROLE OF CHIEF EXECUTIVE OFFICER

ROCKVILLE, Md. (April 2, 2019) – CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world, announced that Wei-Wu He, Ph.D., Executive Chairman of CASI, has been appointed Chief Executive Officer. Dr. He will continue to serve as Chairman of the Board of Directors. Dr. He succeeds Ken K. Ren, Ph.D. who for personal reasons is stepping down from his role as Chief Executive Officer but will remain on the Company’s Board of Directors.

Prior to joining CASI as CEO, Dr. He had a very successful career building companies from early to revenue and profit stages. Most recent from his track record was serving as CEO of OriGene Technologies, Inc., which he co-founded and built into a profitable life science company that later merged with a publicly traded Chinese company, VICANBIO Cell & Gene Engineering Corp., Ltd. (SHA: 600645). Dr. He will continue in his role as Chairman of the Board of OriGene, and is also the founder and general partner of Emerging Technology Partners, LLC, a life sciences focused venture fund, and has been involved in funding over 60 biotech companies. In the earlier part of his career, Dr. He was one of the first few scientists at Human Genome Sciences, and prior to that, was a research fellow at Massachusetts General Hospital and Mayo Clinic. Dr. He is an author to 30 research publications and holder of over 32 issued patents.

“We are grateful for Ken’s dedication to CASI during the Company’s transition period and his role in the Company’s growth in China, the advancement of our pipeline and our fundraising initiatives,” said Dr. He.

Dr. He continued, “This is an exciting inflection point in CASI’s history and I look forward to working with our management team to build a revenue-driven commercial company, with EVOMELA^® as the first product in our pipeline to launch this year. I am particularly excited to pursue additional products to complement our pipeline and therapeutic areas, while we concurrently advance our existing products to the market and serve our patients.”

CASI Pharmaceuticals, Inc. / 9620 Medical Center Drive / Suite 300 / Rockville, MD 20850

Phone 240.864.2600 / Fax 301.315.2437

About CASI Pharmaceuticals

CASI Pharmaceuticals (NASDAQ: CASI) is a U.S. pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world. CASI’s product pipeline features three U.S. Food and Drug Administration (FDA)-approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. (and recently transferred to Acrotech Biopharma LLC) for China regional rights. EVOMELA^® was approved by the China National Medical Products Administration (NMPA) for commercialization in China. The NMPA also approved ZEVALIN^® and MARQIBO^®’s Clinical Trial Applications (CTAs) to conduct registration trials in China. The Company also acquired a portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs), and four pipeline ANDAs that are pending FDA approval from Sandoz, and an HBV ANDA from Laurus Labs. CASI has offices in Rockville, Maryland and has a wholly owned subsidiary in Beijing, China through which substantially all of our operations are conducted. 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: risks relating to interests of our largest stockholders that differ from our other stockholders; the difficulty of executing our business strategy in China; the risk that we will not be able to effectively select, register and commercialize products from our recently acquired portfolio of abbreviated new drug applications (ANDAs);  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 National Medical Products Administration 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 our product candidates; risks associated with any early-stage products under development;  risk that results 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; 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 U.S. Securities and Exchange Commission, which are available at www.sec.gov.

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

COMPANY CONTACT: CASI Pharmaceuticals, Inc. 240.864.2643 ir@casipharmaceuticals.com INVESTOR CONTACT: Solebury Trout Jennifer Porcelli 646.378.2962 jporcelli@troutgroup.com   Brennan Doyle 617.221.9005 BDoyle@troutgroup.com

# # #