- Commenced Phase I Trial (CALL-1) for C-CAR011 in adult patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (ALL) in China
- Strategic partnership with GE Healthcare Life Sciences China to establish joint technology laboratory to develop control processes for the manufacture of CAR-T and Stem Cell Therapies
- Completed Wuxi GMP facility expansion
- Began expansion of Shanghai GMP facility
- Awarded $2.29 million grant from the California Institute for Regenerative Medicine (CIRM) for pre-clinical studies of AlloJoinTM in the U.S.
SHANGHAI, China and CUPERTINO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- 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, today reported financial results for the first quarter ended March 31, 2017 and provided business highlights.
“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.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. (NASDAQ:CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. We conduct immuno-oncology and stem cell clinical trials in China using products from our integrated GMP laboratory. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoinTM (CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis (KOA). CBMG was recently awarded $2.29 million from the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoinTM for Knee Osteoarthritis in the United States. The Company also recently announced a strategic partnership with GE Healthcare Life Sciences China to establish a joint technology laboratory to develop control processes for the manufacture of CAR-T and stem cell therapies. To learn more about CBMG, please visit www.cellbiomedgroup.com.
Forward-Looking Statements
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy, including the devaluation of the RMB by China in August 2015 and other risks detailed from time to time in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (UNAUDITED) | ||||||||
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2017 | 2016 | |||||||
| Net sales and revenue | $ | 98,425 | $ | 488,491 | ||||
| Operating expenses: | ||||||||
| Cost of sales | 37,402 | 503,193 | ||||||
| General and administrative | 3,185,247 | 2,775,925 | ||||||
| Selling and marketing | 117,884 | 178,754 | ||||||
| Research and development | 3,044,125 | 2,398,362 | ||||||
| Total operating expenses | 6,384,658 | 5,856,234 | ||||||
| Operating loss | (6,286,233 | ) | (5,367,743 | ) | ||||
| Other income | ||||||||
| Interest income | 49,182 | 17,050 | ||||||
| Other income | 77,508 | 16,320 | ||||||
| Total other income | 126,690 | 33,370 | ||||||
| Loss before taxes | (6,159,543 | ) | (5,334,373 | ) | ||||
| Income taxes credit (provision) | (2,450 | ) | 1,124,260 | |||||
| Net loss | $ | (6,161,993 | ) | $ | (4,210,113 | ) | ||
| Other comprehensive income: | ||||||||
| Cumulative translation adjustment | 53,669 | 16,073 | ||||||
| Unrealized gain on investments, net of tax of nil and $4,514,060, for the three months ended March 31, 2017 and 2016, respectively | - | 16,416,517 | ||||||
| Total other comprehensive income: | 53,669 | 16,432,590 | ||||||
| Comprehensive income (loss) | $ | (6,108,324 | ) | $ | 12,222,477 | |||
| Net loss per share : | ||||||||
| Basic | $ | (0.43 | ) | $ | (0.35 | ) | ||
| Diluted | $ | (0.43 | ) | $ | (0.35 | ) | ||
| Weighted average common shares outstanding: | ||||||||
| Basic | 14,281,745 | 11,884,066 | ||||||
| Diluted | 14,281,745 | 11,884,066 | ||||||
| CELLULAR BIOMEDICINE GROUP, INC. | |||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
| (UNAUDITED) | |||||||||
| March 31, | December 31, | ||||||||
| 2017 | 2016 | ||||||||
| Assets | |||||||||
| Cash and cash equivalents | $ | 33,361,784 | $ | 39,252,432 | |||||
| Accounts receivable, less allowance for doubtful amounts of $10,218 | |||||||||
| and $10,163 as of March 31, 2017 and December 31, 2016, respectively | 79,602 | 39,974 | |||||||
| Other receivables | 813,077 | 412,727 | |||||||
| Prepaid expenses | 1,071,447 | 986,951 | |||||||
| Total current assets | 35,325,910 | 40,692,084 | |||||||
| Investments | 509,424 | 509,424 | |||||||
| Property, plant and equipment, net | 4,449,268 | 4,117,739 | |||||||
| Goodwill | 7,678,789 | 7,678,789 | |||||||
| Intangibles, net | 13,677,958 | 14,092,581 | |||||||
| Long-term prepaid expenses and other assets | 1,949,542 | 1,537,850 | |||||||
| Total assets | $ | 63,590,891 | $ | 68,628,467 | |||||
| Liabilities and Stockholders' Equity | |||||||||
| Liabilities: | |||||||||
| Accounts payable | $ | 782,450 | $ | 216,154 | |||||
| Accrued expenses | 325,486 | 1,168,787 | |||||||
| Taxes payable | 31,325 | 28,875 | |||||||
| Other current liabilities | 866,223 | 950,220 | |||||||
| Total current liabilities | 2,005,484 | 2,364,036 | |||||||
| Other non-current liabilities | 362,356 | 370,477 | |||||||
| Total liabilities | 2,367,840 | 2,734,513 | |||||||
| Stockholders' equity: | |||||||||
| Preferred stock, par value $.001, 50,000,000 shares | |||||||||
| authorized; none issued and outstanding as of | |||||||||
| March 31, 2017 and December 31, 2016, respectively | - | - | |||||||
| Common stock, par value $.001, 300,000,000 shares authorized; | |||||||||
| 14,286,013 and 14,281,378 issued and outstanding | |||||||||
| as of March 31, 2017 and December 31, 2016, respectively | 14,286 | 14,281 | |||||||
| Additional paid in capital | 153,980,468 | 152,543,052 | |||||||
| Accumulated deficit | (91,708,680 | ) | (85,546,687 | ) | |||||
| Accumulated other comprehensive loss | (1,063,023 | ) | (1,116,692 | ) | |||||
| Total stockholders' equity | 61,223,051 | 65,893,954 | |||||||
| Total liabilities and stockholders' equity | $ | 63,590,891 | $ | 68,628,467 | |||||
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) | ||||||||
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2017 | 2016 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (6,161,993 | ) | $ | (4,210,113 | ) | ||
| Adjustments to reconcile net loss to net cash | ||||||||
| used in operating activities: | ||||||||
| Depreciation and amortization | 669,739 | 671,649 | ||||||
| Loss on disposal of assets | 237 | - | ||||||
| Stock based compensation expense | 1,431,907 | 1,266,063 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (39,411 | ) | 50,764 | |||||
| Other receivables | (398,190 | ) | 9,705 | |||||
| Inventory | - | (96,083 | ) | |||||
| Prepaid expenses | (78,832 | ) | (274,829 | ) | ||||
| Taxes recoverable | - | 150,082 | ||||||
| Long-term prepaid expenses and other assets | 6,524 | (38,522 | ) | |||||
| Accounts payable | 565,236 | (51,992 | ) | |||||
| Accrued expenses | (844,172 | ) | 57,178 | |||||
| Other current liabilities | (2,012 | ) | 29,415 | |||||
| Taxes payable | 2,450 | 32,450 | ||||||
| Deferred tax liabilities | - | (1,128,515 | ) | |||||
| Other non-current liabilities | (10,146 | ) | (50,049 | ) | ||||
| Net cash used in operating activities | (4,858,663 | ) | (3,582,797 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchases of intangibles | (23,268 | ) | - | |||||
| Purchases of property, plant and equipment | (1,026,994 | ) | (674,736 | ) | ||||
| Net cash used in investing activities | (1,050,262 | ) | (674,736 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from the issuance of common stock | - | 4,970,002 | ||||||
| Proceeds from exercise of stock options | 5,514 | 93,249 | ||||||
| Net cash provided by financing activities | 5,514 | 5,063,251 | ||||||
| EFFECT OF EXCHANGE RATE CHANGES ON CASH | 12,763 | (22,786 | ) | |||||
| INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (5,890,648 | ) | 782,932 | |||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 39,252,432 | 14,884,597 | ||||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 33,361,784 | $ | 15,667,529 | ||||
| SUPPLEMENTAL CASH FLOW INFORMATION | ||||||||
| Cash paid for income taxes | $ | - | $ | (4,255 | ) | |||