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Cellular Biomedicine Group Reports First Quarter 2017 Financial Results and Provides Business Highlights

  • 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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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)

Contacts: Sarah Kelly Director of Corporate Communications, CBMG +1 408-973-7884 sarah.kelly@cellbiomedgroup.com Vivian Chen Managing Director Investor Relations, Citigate Dewe Rogerson +1 347 481-3711 vivian.chen@citigatedr.com

Source:Cellular Biomedicine Group Inc.