On May 8, 2017 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, reported financial results for the first quarter ended March 31, 2017 and provided business highlights (Press release, Cellular Biomedicine Group, MAY 8, 2017, View Source [SID1234519117]).
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"The first quarter of 2017 was very productive, with several key achievements, including the commencement of our second Phase I CAR-T clinical trial utilizing CBMG’s proprietary and optimized CD19 construct, for the treatment of adult patients with relapsed or refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL)," commented Tony Liu, Chief Executive Officer of CBMG. "The award of $2.29 million from the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoinTM in the U.S., moves forward our endeavor into the U.S. market and the development of an off-the-shelf stem cell product to treat Knee Osteoarthritis (KOA). The signing of a collaboration with GE Healthcare Life Sciences China to establish a joint laboratory within our own GMP facilities in Shanghai credits our GMP stature and capabilities. We are determined to build on our accomplishments from the first quarter to continue to strengthen our innovative pipelines and move our clinical assets into later stage development. We believe we are ahead of the competitive curve in addressing the manufacturing barriers to delivering consistent clinical grade cell therapies which have the potential to address the large cancer and knee osteoarthritis markets."
First Quarter 2017 Financial Performance
Cash Position:Cash and cash equivalents as of March 31, 2017 were $33.4 million compared to $39.3 million as of December 31, 2016.
Net Cash Used in Operating Activities:Net cash used in operating activities for the first quarter of 2017 was $4.86 million, compared to $3.58 million for the same period in 2016.
G&A Expenses:General and administrative expenses for the first quarter of 2017 were $3.2 million compared to $2.8 million for the same period in 2016. The increase is in large part attributed to the rental increase, which resulted from the new leased facilities located in the "Pharma Valley" of Shanghai from January 1, 2017.
R&D Expenses:Research and development expenses for the first quarter of 2017 were $3.0 million, compared to $2.4 million for the same period a year ago. The increase was primarily attributable to headcount increases of R&D staff and increased expenses related to advancing assets into clinical trials.
Net Loss:Net loss allocable to common stock holders was $6.2 million, compared to $4.2 million for the same period in 2016.
Business & Technology Highlights of 2017 To Date
Commenced CALL-1 ("CAR-T against Acute Lymphoblastic Leukemia") Phase I clinical trial in China utilizing its optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with relapsed or refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL);
Awarded $2.29 million by California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to support pre-clinical studies of AlloJoinTM, CBMG’s "Off-the-Shelf" Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States;
On May 4, 2017, the Company received $1.2 million from the CIRM grant, the first of four disbursements
Completed expansion of its 30,000 square foot facility in Huishan High Tech Park in Wuxi, China, with 20,000 square feet of the Wuxi GMP facility dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents;
Began construction of a new GMP facility in "Pharma Valley" in Shanghai Zhangjiang High-Tech Park, which will consist of 40,000 square feet dedicated to advanced cell manufacturing;
Established a strategic research collaboration with GE Healthcare Life Sciences China to co-develop certain high-quality industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing and to form a joint laboratory within CBMG’s new Shanghai Zhangjiang GMP-facility dedicated to the joint research and development of a functionally integrated and automated immunotherapy cell preparation system.