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): September 20, 2015

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))

Item 1.01. Entry into a Material Definitive Agreement.

On September 20, 2015, CASI Pharmaceuticals, Inc. (the “Company”) entered into stock purchase agreements (the “Agreements”) with certain investors (the “Investors”), led by a China investment fund manager affiliated with the same management team of its current largest shareholder, IDG-Accel China Growth Fund III, L.P.

Pursuant to the Agreements, the Company has agreed to sell to the Investors in a private placement an aggregate of 20,658,434 shares of the Company's common stock, par value $0.01 per share (“Common Stock”), at $1.190 per share, based on the closing bid price of the Company's Common Stock on the Nasdaq Capital Market on September 18, 2015, and a total of 4,131,686 warrants, representing a 20% warrant coverage, with a purchase price of $0.125 per whole warrant share. The warrants will become exercisable three months after issuance at $1.69 per share exercise price, and will expire three years from the date the warrants become exercisable.

The offering is expected to close (the “Closing”) after satisfaction of certain regulatory and customary closing conditions, with the net proceeds being subject to payment of offering expenses, including customary finder and advisory fees to be finalized prior to the Closing.

The Company has granted registration rights to the Investors and has agreed to file a resale registration statement covering the shares of the Common Stock and the shares of Common Stock underlying the warrants within 120 days of the Closing.

The foregoing description of the Agreements is not complete and is qualified in its entirety by reference to the full text of such Agreements, a form of which the Company expects to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending September 30, 2015.

Item 3.02. Unregistered Sales of Equity Securities.

The description of the transaction contemplated by the Agreements described under Item 1.01 above is incorporated herein by reference.  The issuance of the shares and warrants pursuant to the Agreements is intended to be exempt from registration under the Securities Act of 1933, as amended, in reliance on Section 4(a)(2) thereunder.

Item 8.01. Other Information.

On September 21, 2015, the Company issued a press release with respect to entering into the Agreements described under Item 1.01 of this Current Report on Form 8-K. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	Press release dated September 21, 2015.

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
	Chief Operating Officer, General Counsel & Secretary
Date:  September 22, 2015

EX-99.1

Exhibit 99.1

www.casipharmaceuticals.com

FOR IMMEDIATE RELEASE:

CASI PHARMACEUTICALS TO RAISE $25.1 MILLION

IN PRIVATE PLACEMENT OF COMMON STOCK AND WARRANTS

ROCKVILLE, Md. (September 21, 2015) – CASI Pharmaceuticals, Inc. (the “Company”) (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that it has entered into definitive agreements for a $25.1 million financing led by a China investment fund manager affiliated with the same management team of our current largest shareholder, IDG-Accel China Growth Fund III, L.P.

The Company agreed to sell a total of 20,658,434 shares of common stock, at $1.190 per share, based on the closing bid price of the Company’s common stock on the Nasdaq Capital Market on September 18, 2015, and a total of 4,131,686 warrants, representing a 20% warrant coverage, with a purchase price of $0.125 per whole warrant share. The warrants will become exercisable three months after issuance at $1.69 per share exercise price, and will expire three years from the date the warrants become exercisable. The offering is expected to close after satisfaction of certain regulatory and customary closing conditions. The Company intends to use the net proceeds, after deduction at closing of offering expenses, including customary finder and advisory fees, primarily to accelerate its clinical and regulatory activities, expand its product pipeline, and to support its marketing and commercial planning activities. The Company also agreed to register for re-sale, following the closing, the common stock and the shares of common stock underlying the warrants.

This news release shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About CASI Pharmaceuticals, Inc.

CASI is a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China. CASI’s product pipeline includes exclusive rights to ZEVALIN^® (ibritumomab tiuxetan), MARQIBO^® (vinCRIStine sulfate LIPOSOME injection) and EVOMELA™ (CE-Melphalan HCI for injection) for greater China (including Taiwan, Hong Kong and Macau). CASI’s development pipeline also includes its proprietary drug candidate ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial) currently under reformulation development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com and in the Company’s filings with the U.S. Securities and Exchange Commission.

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

Phone 240.864.2600 /Fax 301.315.2437

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, including, without limitation, with respect to the closing of the private placement offering and the anticipated use of the net proceeds. 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: the risk that the closing of the private placement offering does not occur, that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility in the market price of our common stock; risks relating to interests of our largest stockholders that differ from our other stockholders; the risk of substantial dilution of existing stockholders in future stock issuances, including as a result of the closing of the private placement offering; the difficulty of executing our business strategy in China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidate or future candidates; 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; the risk that results in preclinical models are not necessarily indicative of 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; dependence on third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). 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.

ZEVALIN^® MARQIBO^® and EVOMELA™ are proprietary to Spectrum Pharmaceuticals, Inc. and its affiliates.

COMPANY CONTACT: CASI Pharmaceuticals, Inc. 240.864.2643 ir@casipharmaceuticals.com   INVESTOR CONTACT: Torrey Hills Capital Jim Macdonald 858.456.7300 jmacdonald@torreyhillscapital.com

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