CASI Pharmaceuticals announces net loss of $21.5M in third quarter 2014

CASI Pharmaceuticals, Inc. (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 primary focus on China, today reported financial results for the three and nine months ended September 30, 2014.

CASI reported a net loss for the third quarter of 2014 of ($21.5 million), or ($0.77) per share, which includes non-cash expense of $19.7 million associated with the September 2014 in-license agreements with Spectrum Pharmaceuticals. Excluding this non-cash expense, the net loss for the third quarter was ($1.9 million), or ($0.07) per share, compared with a net loss of ($1.4 million), or ($0.05) per share, for the same period last year.

CASI reported a net loss for the first nine months of 2014 of ($24.6 million), or ($0.90) per share, which includes the above non-cash expense associated with the in-license agreements with Spectrum Pharmaceuticals. Excluding this non-cash expense, the net loss for the first nine months of 2014 was ($4.9 million), or ($0.18) per share, compared with a net loss of ($4.4 million), or ($0.17) per share, for the first nine months of 2013. The increase in reported net loss for the quarter and nine months is primarily due to the Company's acquisition of greater China rights for three late-stage products from Spectrum Pharmaceuticals, which were acquired primarily with equity and no cash up front, and resulted in the transformation of the Company's product pipeline.

As of September 30, 2014, CASI had cash and cash equivalents of approximately $11.8 million.

Commenting on these results, Sara B. Capitelli, CASI's Vice President, Finance, said, "Our third quarter 2014 financial results were in line with expectations. Research and development expenses decreased compared with the previous year primarily due to costs associated with our crossover bioavailability and food effect study of ENMD-2076 incurred during the 2013 period that were not present in the 2014 period, offset by higher non-cash stock-based compensation expense of $0.2 million and increased personnel costs associated with new employees in China in the 2014 period. The increase in general and administrative expenses compared with the previous year primarily reflects higher non-cash stock-based compensation expense of $0.4 million. As we continue to execute our regulatory, clinical and business development plan, we expect operating expenses to increase for the remainder of 2014."

Ken K. Ren, Ph.D., CASI's Chief Executive Officer, stated, "We are excited about the additions of greater China rights to ZEVALIN^®, MARQIBO^® and CE melphalan to our pipeline and are pleased with our investment in the three products. Also we are satisfied with our financial position overall and will continue to manage expenditures conservatively as we advance the development of these products as well as ENMD-2076."

Commenting further on the Company's development progress, Dr. Ren added, "We are currently working on our commercialization plan initially for ZEVALIN^® in Hong Kong and on regulatory filings for ZEVALIN^® in China and Taiwan, as well as regulatory filings for MARQIBO^® in the greater China territory. Development activities will be initiated for CE melphalan once it receives approval by the U.S. Food and Drug Administration (FDA). We are also advancing the development of ENMD-2076 as we finalize plans for an advanced late-stage clinical trial in fibrolamellar carcinoma patients, following the recent receipt of IND allowance by the FDA. We are also expanding our ongoing trials in triple-negative breast cancer, soft tissue sarcoma and ovarian clear cell carcinoma into China as we execute on our cost-effective drug development strategy."