Cellular Biomedicine Group Reports Third Quarter 2015 Financial Results and Provides Business Highlights

SHANGHAI, China and CUPERTINO, Calif., Nov. 13, 2015 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today reported financial results for the quarter ended September 30, 2015 and provided business highlights.

Dr. William Wei Cao, Chief Executive Officer, commented, “We achieved pivotal milestones in the third quarter that redefined CBMG’s business and strategically positioned the Company as an emerging, bifurcated and world-class immuno-oncology and cell therapy contender with international aspirations through the advancement of key infrastructure and clinical milestones. We are encouraged by the positive clinical development of our therapeutic platforms in the third quarter. The Chinese PLA General Hospital (“PLAGH”) CAR-T Phase I clinical trial for the treatment of patients with EGFR expressing advanced relapsed/refractory solid tumors in Non-Small Cell Lung Cancer (“NSCLC”) and cholangiocarcinoma, and the Phase IIa CD20 Non-Hodgkin’s Lymphoma (“NHL”) clinical trial have inspired us to accelerate their development to treat these terminal conditions. We are planning to launch multi-site CAR-T and Dendristim vaccine (previously called GVax) clinical trials in China and are evaluating options to further develop this prospective treatment in the U.S. In addition, we continued to strengthen our scientific team with the appointments of Alan List, M.D., as Chair of the Scientific Advisory Board and Yihong Yao, Ph.D., as Chief Scientific Officer.”

“In terms of infrastructure, in addition to our Shanghai and Wuxi sites, we opened a new GMP facility in Beijing, and now operate three GMP facilities in China housing nine independent production lines to address increasing manufacturing demands.”

“We believe we are one of the few emerging and versatile biotech companies with a growing revenue-generating T cell technical service. We have proven our ability to make acquisitions and expand globally recognized therapies addressing large and critical markets. We believe we are in an enviable position for the future in carrying out our mission to deliver evolutionary science and serving large patient populations,” concluded Dr. William Wei Cao, Chief Executive Officer of Cellular Biomedicine Group.

Third Quarter 2015 Financial Performance

  1. Cash Position: Cash and cash equivalents as of September 30, 2015 were $20.1 million compared to $14.8 million as of December 31, 2014
  2. Net Cash Used in Operating Activities: Net cash used in operating activities for the third quarter of 2015 was $2.9 million, compared to $3.4 million for the same period in 2014
  3. Revenue: Revenues in the third quarter of 2015 were $0.6 million compared to nil for the same period in 2014. All of the revenue has resulted from our acquisition of Agreen Biotech Ltd. that provides T cell technical services, and we are continuing to expand our network of hospitals to grow our revenue.
  4. G&A Expenses: General and administrative expenses for the third quarter of 2015 were $3.5 million compared to $1.9 million for the same period in 2014. Increased expenses in 2015 were primarily attributed to the hiring of senior technical leaders, expanded GMP facility expenses, and amortization of the IP expenses associated with previous acquisitions.
  5. R&D Expenses: Research and development expenses for the third quarter of 2015 were $2.2 million, compared to $0.8 million for the same period in 2014. Approximately two thirds of the increase resulted from the addition of scientific talent to our immunotherapy research and development team, while the remaining increase stems from increased clinical trial expenditures in CAR-T, Tcm, and automated production techniques.
  6. Net Loss: Net loss allocable to common stock holders was $5.1 million, compared to $2.8 million for the same period in 2014. Changes in net loss are primarily attributable to an increase in share-based compensation and clinical trial expenses.

During and since the third quarter of 2015, Cellular Biomedicine Group achieved the following milestones and significant events:

Business Highlights

  • Appointed Alan List, MD as Chair of the Scientific Advisory Board
  • Appointed former MedImmune/AstraZeneca Director, Yihong Yao, Ph.D., B.S., as Chief Scientific Officer
  • Opened new GMP facility in Beijing
  • Evaluating options for U.S. clinical trials on NSCLC and Dendristim vaccine immune-cell therapy

Technology Achievements

  • Received two new certifications from the China Food and Drug Administration (the “CFDA”) for its proprietary cell and tissue preservation media kits respectively, in accordance with the CFDA’s new regulations announced on June 1, 2015
  • Expanded our intellectual property portfolio from 70 to 77 patents in various stages of approval
  • Announced preliminary Phase I clinical results of CAR-T EGFR-HER1 (“CBM-EGFR.1”) for the treatment of patients with EGFR expressing advanced relapsed/refractory solid tumors, with overall disease control rate (DCR) of 79% (19 of 24). 100% DCR in cholangiocarcinoma (5/5), 71% DCR in NSCLC (12/17)

Upcoming Public Events

Management is scheduled to participate in the following upcoming industry and investor conferences:

  • November 18-19, Jefferies 2015 Global Healthcare Conference, London, UK
  • December 1-2, Piper Jaffray Annual Healthcare Conference, New York, NY

September 30, December 31,
2015 2014
Cash and cash equivalents$20,106,377 $14,770,584
Accounts receivable 410,761 141,029
Other receivables 319,211 135,957
Inventory 422,077 372,249
Prepaid expenses 439,657 565,299
Other current assets - 110,347
Total current assets 21,698,083 16,095,465
Investments 13,299,407 6,886,033
Property, plant and equipment, net 1,726,418 1,280,410
Goodwill 7,678,787 7,678,789
Intangibles, net 16,323,642 11,156,676
Long-term prepaid expenses and other assets 1,150,296 587,729
Total assets$61,876,633 $43,685,102
Liabilities and Stockholders' Equity
Accounts payable$146,369 $426,917
Accrued expenses 2,574,829 2,074,384
Taxes payable 615,800 814,288
Advances payable to related party - 36,254
Other current liabilities 1,382,798 724,479
Total current liabilities 4,719,796 4,076,322
Other non-current liabilities 231,085 452,689
Total liabilities 4,950,881 4,529,011
Stockholders' equity:
Preferred stock, par value $.001, 50,000,000 shares
authorized; none issued and outstanding as of
September 30, 2015 and December 31, 2014, respectively - -
Common stock, par value $.001, 300,000,000 shares authorized;
11,656,857 and 10,990,335 issued and outstanding
as of September 30, 2015 and December 31, 2014, respectively 11,657 10,990
Additional paid in capital 101,312,047 75,467,316
Accumulated deficit (52,346,434) (37,890,590)
Accumulated other comprehensive income (loss) 7,948,482 1,568,375
Total stockholders' equity 56,925,752 39,156,091
Total liabilities and stockholders' equity$61,876,633 $43,685,102

For the Three Months Ended For the Nine Months Ended
September 30, September 30,
2015 2014 2015 2014
Net sales and revenue $624,907 $- $1,885,256 $179,120
Operating expenses:
Cost of sales 443,416 - 1,335,707 92,553
General and administrative 3,467,184 1,946,909 9,915,956 4,901,670
Selling and marketing 190,152 21,311 500,393 86,806
Research and development 2,190,240 812,227 4,968,352 2,100,271
Impairment of investments - - 123,428 -
Total operating expenses 6,290,992 2,780,447 16,843,836 7,181,300
Operating loss (5,666,085) (2,780,447) (14,958,580) (7,002,180)
Other income (expense):
Interest income 8,386 698 29,417 1,263
Other income (expense) 492,101 (260) 502,921 94,357
Total other income 500,487 438 532,338 95,620
Loss from continuing operations before taxes (5,165,598) (2,780,009) (14,426,242) (6,906,560)
Income taxes (expense) credit 23,400 - (29,602) -
Loss from continuing operations (5,142,198) (2,780,009) (14,455,844) (6,906,560)
Loss on discontinued operations, net of taxes - (43,271) - (3,037,514)
Net loss $(5,142,198) $(2,823,280) $(14,455,844) $(9,944,074)
Other comprehensive income (loss):
Cumulative translation adjustment (225,198) (1,838) (163,353) (8,673)
Unrecognized gain (loss) on investments (1,520,000) (1,005,455) 6,543,460 2,515,894
Total other comprehensive income (loss): (1,745,198) (1,007,293) 6,380,107 2,507,221
Comprehensive loss $(6,887,396) $(3,830,573) $(8,075,737) $(7,436,853)
Loss per share for continuing operations:
Basic $(0.44) $(0.30) $(1.27) $(0.85)
Diluted $(0.44) $(0.30) $(1.27) $(0.85)
Loss per share for discontinued operations:
Basic $- $- $- $(0.37)
Diluted $- $- $- $(0.37)
Net loss per share :
Basic $(0.44) $(0.31) $(1.27) $(1.22)
Diluted $(0.44) $(0.31) $(1.27) $(1.22)
Weighted average common shares outstanding:
Basic 11,622,756 9,131,576 11,399,958 8,155,213
Diluted 11,622,756 9,131,576 11,399,958 8,155,213

For the Nine Months Ended
September 30,
2015 2014
Net loss$(14,455,844) $(9,944,074)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization 1,537,323 660,836
Loss on disposal of assets - 12,313
Stock based compensation expense 5,672,955 1,151,404
Amortization of deferred stock compensation - 85,671
Other than temporary impairment on investments 123,428 -
Realized losses from sale of investments 5,178 5,913
Value of stock received for services - (1,610,000)
Impairment of goodwill - 3,299,566
Decrease in fair value of accrued expenses for the acquisition of intangible assets (413,559) -
Changes in operating assets and liabilities:
Accounts receivable (275,317) (13,419)
Other receivables (176,301) (53,332)
Inventory (49,828) (53,857)
Prepaid expenses 108,055 (439,437)
Other current assets 110,347 22,779
Investments - 7,150
Long-term prepaid expenses and other assets (156,704) (458,058)
Accounts payable (280,548) (36,988)
Accrued expenses 183,105 371,578
Advance payable to related party (30,216) -
Other current liabilities (63,426) (1,135,151)
Taxes payable (198,488) -
Other non-current liabilities (212,371) -
Net cash used in operating activities (8,572,211) (8,127,106)
Acquisition of business, net of cash acquired - (190,698)
Proceed from sale of investments, net of transaction costs 1,480 -
Purchases of intangible assets (4,577,740) (1,953)
Purchases of property, plant and equipment (918,289) (129,096)
Net cash used in investing activities (5,494,549) (321,747)
Net proceeds from the issuance of common stock 18,964,849 11,121,956
Proceeds from exercise of stock options 478,798 -
Repayment of advance from affiliate - (33,468)
Net cash provided by financing activities 19,443,647 11,088,488
Cash paid for income taxes$99,668 $-
Non-cash investing activities
Acquisition of intangible assets through issuance of the Company's stock$1,096,399 $1,442,850
Acquisition of business through issuance of the Company's stock$- $14,496,256

About Cellular Biomedicine Group

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative and cancerous diseases. Our developmental stem cell and Immuno-Oncology projects are the result of research and development by scientists and doctors from China and the United States. Our GMP facilities in China, consisting of nine independent cell production lines, are designed, certified and managed according to U.S. standards. 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.

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

Source:Cellular Biomedicine Group Inc.