On March 29, 2018 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients, reported financial results for the fourth quarter and year ended December 31, 2017 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, MAR 29, 2018, View Source [SID1234525060]).

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Wei-Wu He, Ph.D., Executive Chairman of CASI Pharmaceuticals, commented, "2017 was an exciting year for CASI and we have entered 2018 with the same strong momentum. We raised $50 million from new and existing investors, which leaves us well-positioned to launch EVOMELA after the CFDA’s priority review is concluded."

Dr. He continued, "We are incredibly excited by our recent acquisition of a portfolio of ANDAs from Sandoz. We saw an opportunity to acquire medicines already approved in the U.S. and delivering them to the large patient population in China seeking high quality medicines from abroad. We think this is an important new direction for the company and allows CASI the opportunity to commercialize a greater number of both high quality and innovative medicines to Chinese patients. We will prioritize the order in which we plan to introduce these medicines based on the commercial opportunity each present and intend to tap into our local networks and potential partners to accelerate commercialization and market penetration. The rapid change and improvement of the regulatory environment in China for drug development coincides with our strategic mission in both the U.S. and China. Going forward, we plan to leverage our development, regulatory, and commercial infrastructure in China by continuing to add safe and effective medicines to our pipeline."

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

Phone 240.864.2600 / Fax 301.315.2437

Full Year and Recent Business Highlights

·Announced $50 million private placement to new and existing investors – In March 2018, the Company announced a $50 million private placement led by existing shareholders, ETP Global Fund LP and IDG-Accel China. Robert W. Duggan, former Chairman and CEO of Pharmacyclics Inc. participated as a new investor in CASI. The Company had previously closed on a $23.8 million registered direct offering in October 2017.

·Acquired portfolio of 25 US FDA-approved ANDAs from Sandoz Inc. – In January 2018, the Company announced the acquisition of a portfolio of 25 US FDA-approved ANDAs, and one that the FDA tentatively approved and three that are pending FDA approval. CASI intends to select and commercialize certain products from the portfolio that it believes have a unique market opportunity and can be manufactured cost-effectively in China and/or in the U.S.

·EVOMELA granted priority review by the CFDA; MARQIBO and ZEVALIN CFDA review in progress – In September 2017, the Company announced that the CFDA granted priority review for CASI’s import drug registration clinical trial application (CTA) for EVOMELA (melphalan) for injection. The CFDA cited the following reasons as grounds for granting priority review (1) multiple myeloma is a rare disease, (2) there is no melphalan in any formulation available in China to address the unmet medical need, and (3) EVOMELA has clear therapeutic advantages to currently available therapeutics. The CFDA review of CTAs for both MARQIBO and ZEVALIN is underway and progressing on schedule.

Financial Results for the Year ended December 31, 2017

Cash Position: As of December 31, 2017, CASI had cash and cash equivalents of approximately $43.5 million.

R&D Expenses: Research and development (R&D) expenses for the year ended December 31, 2017 were $7.6 million compared to $4.6 million in 2016, an increase of $3.0 million. The increase in 2017 R&D spending primarily reflects $2.8 million in higher costs associated with the quality testing phase of the CFDA regulatory review of ZEVALIN and EVOMELA in 2017, as well as $0.2 million in additional personnel costs related to our preclinical activities in China.

G&A Expenses: General and administrative (G&A) expenses for the year ended December 31, 2017 were $3.2 million compared to $4.8 million in 2016. The increase of $1.6 million in G&A over the prior year primarily reflects an increase of $1.8 million in non-cash stock compensation offset by a $0.2 million increase in additional personnel costs related to business development activities.

Net Loss: The net loss for the year ended December 31, 2017 was ($10.8 million), or ($0.18) per share, compared with a net loss of ($9.5 million) or ($0.17) per share in 2016. The larger net loss in 2017 can be attributed to costs associated with CFDA quality testing in support of CASI’s application for import drug registration of ZEVALIN and EVOMELA, offset by less non-cash stock compensation expense during 2017.

Financial Results for the Quarter ended December 31, 2017

R&D Expenses: R&D expenses for the quarter ended December 31, 2017 were $3.8 million compared to $1.3 million in 2016, an increase of $2.5 million. The increase in R&D expenses primarily reflects continued investment in CASI’s development of approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. in China.

G&A Expenses: G&A expenses for the quarter ended December 31, 2017 were $1.2 million compared to $1.4 million in 2016. The decrease in G&A over the prior year primarily reflects the decrease in non-cash stock compensation expense offset by increases due to additional personnel within our business development function and higher professional fees. G&A expenses include non-cash share-based compensation of $0.1 million in the fourth quarter 2017 compared to $0.6 million in the fourth quarter 2016.

Net Loss: The Company reported a net loss of ($5.0 million), or ($0.08) per share, for the quarter ended December 31, 2017. This compares with a net loss of ($2.7 million), or ($0.05) per share for the fourth quarter of 2016. The increase in net loss is primarily due to costs associated with CFDA quality testing in support of CASI’s application for import drug registration of ZEVALIN.

Further information regarding the Company, including its Annual Report on Form 10-K for the year ended December 31, 2017, can be found at www.casipharmaceuticals.com.