- Ended Second Quarter with $47.5 million in Cash -


Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a clinical-stage biomedicine firm engaged in the development of immunotherapies for cancer and effective stem cell therapies for degenerative diseases, today reported financial results and business highlights for the second quarter and six months ended June 30, 2016.

“In the first half of 2016, we made several significant advancements towards the operating objectives for our dual technology platforms of immuno-oncology and stem cells,” commented Tony (Bizuo) Liu, CBMG’s Chief Executive Officer.  “The completion of a $43.13 million strategic investment has strengthened our capabilities to continue to invest in research and development, optimize our clinical process and expand our focus on the CAR-T pipeline.  We anticipate in the coming quarters launching clinical trials in China on CAR-T CD19 and CD20 constructs and to further bolster our immuno-oncology pipeline.  We have completed patient treatment in the Phase I trial of AlloJoinTM, our off-the-shelf allogeneic adipose-derived progenitor cell (haMPC) therapy for Knee Osteoarthritis (KOA) in China, and are encouraged to see no serious adverse events thus far. We continue to evaluate the feasibility of initiating a clinical study of AlloJoinTM under IND to support the same indication in the United States. As we look forward to the remainder of 2016, we will continue to prioritize our immuno-oncology and stem cell clinical pipelines for multiple indications that serve large addressable markets while facilitating future partnerships and collaborations that will enhance our ability to develop safe and effective therapies.”  Second Quarter and First Half 2016 Financial Performance

1. Cash Position: Cash and cash equivalents as of June 30, 2016 were $47.5 million compared to $14.9 million as of December 31, 2015. This increase was due to a private placement financing in February and April 2016 for gross proceeds of approximately $43 million, offset by cash used in operating and investment activities. 2. Net Cash Used in Operating Activities: Net cash used in operating activities for the quarter and six months ended June 30, 2016 was $5.2 million and $8.8 million, respectively, compared to $3.3 million and $5.7 million for the same periods in 2015. 3. G&A Expenses: General and administrative expenses for the quarter and six months ended June 30, 2016 were $3.1 million and $5.8 million, respectively, compared to $3.8 million and $6.4 million for the same periods in 2015. 4. R&D Expenses: Research and development expenses for the quarter and six months ended June 30, 2016 were $3 million and $5.4 million respectively, compared to $1.3 million and $2.8 million for the same periods in 2015. The increase of R&D costs was primarily attributed to:5. Net Loss: Net loss allocable to common stock holders for the quarter and six months ended June 30, 2016 was $7.2 million and $11.4 million respectively, compared to $5 million and $9.3 million for the same periods in 2015. Changes in net loss are primarily attributable to changes in operations of our biomedicine segment, which are described above.

Recent Business and Technology Highlights

  • Completed treatment for eighteen patients in Phase I trial of AlloJoinTM haMPC therapy for Knee Osteoarthritis (KOA);
  • China Patent Office granted the Company’s patent application on  genetically engineered anti-CD20 Chimeric Antigen Receptor-positive NKT cells, its production and application;
  • Advanced the Company’s cash position following the closing of an agreement with Wuhan Dangdai Science & Technology Industries Group Inc. to invest an aggregate of $43.13 million for 2.27 million shares of the Company’s common stock, representing a 16.2% post-money stake investment as of April 15, 2016;
  • Appointment of Dr. Zhou Hansheng as a member of the Board of Directors.

Pipeline Update

  • Conducted single-center Phase I trial of AlloJoinTM haMPC therapy for Knee Osteoarthritis (KOA) in China
    • Eighteen patients have received two dose intra-articular injections at three week intervals and have not been presented with any serious adverse events thus far
    • Patients will be monitored over the next 12 months for safety and efficacy signs
    • Phase I clinical research trial for AlloJoin™ is registered at ClinicalTrials.gov under the number NCT02641860
  • Anticipate announcement of sponsorship of multi-indication clinical studies with multiple institutions using CBMG’s CD19 and CD20 constructs and stem cell technologies by Q12017 after the technologies are optimized and manufacturing capabilities are in place

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.

 
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
                 
    For the Three Months Ended   For the Six Months Ended
    June 30,   June 30,
      2016       2015       2016       2015  
                 
Net sales and revenue   $ 71,599     $ 656,959     $ 560,090     $ 1,260,349  
                 
Operating expenses:                
Cost of sales     323,587       398,229       826,780       892,291  
General and administrative     3,072,647       3,768,535       5,848,572       6,448,772  
Selling and marketing     39,480       161,219       218,234       310,241  
Research and development     2,972,855       1,322,692       5,371,217       2,778,112  
Impairment of investments     -       -       -       123,428  
Total operating expenses     6,408,569       5,650,675       12,264,803       10,552,844  
Operating loss     (6,336,970 )     (4,993,716 )     (11,704,713 )     (9,292,495 )
                 
Other income (expense):                
Interest income     18,290       5,920       35,340       21,031  
Other income (expense)     7,646       13,523       23,966       10,820  
Total other income     25,936       19,443       59,306       31,851  
Loss before taxes     (6,311,034 )     (4,974,273 )     (11,645,407 )     (9,260,644 )
                 
Income taxes credit (provision)     (886,248 )     (52,202 )     238,012       (53,002 )
                 
                 
Net loss   $ (7,197,282 )   $ (5,026,475 )   $ (11,407,395 )   $ (9,313,646 )
Other comprehensive income (loss):                
Cumulative translation adjustment     (271,438 )     42,236       (255,365 )     61,845  
Unrealized gain (loss) on investments, net of tax     (11,115,884 )     10,631,731       5,300,633       8,063,460  
Total other comprehensive income (loss):     (11,387,322 )     10,673,967       5,045,268       8,125,305  
                 
Comprehensive gain (loss)   $ (18,584,604 )   $ 5,647,492     $ (6,362,127 )   $ (1,188,341 )
                 
                 
Net loss per share :                
Basic   $ (0.52 )   $ (0.44 )   $ (0.89 )   $ (0.83 )
Diluted   $ (0.52 )   $ (0.44 )   $ (0.89 )   $ (0.83 )
                 
Weighted average common shares outstanding:                
Basic     13,737,722       11,531,497       12,810,894       11,286,712  
Diluted     13,737,722       11,531,497       12,810,894       11,286,712  
 
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
         
    June 30,   December 31,
      2016       2015  
         
 Assets      
Cash and cash equivalents $ 47,470,196     $ 14,884,597  
Accounts receivable, less allowance for doubtful amounts of $10,782        
  and $nil as of June 30, 2016 and December 31, 2015, respectively   330,860       630,332  
Other receivables   245,073       271,344  
Inventory   313,837       390,886  
Prepaid expenses   811,403       367,050  
Taxes recoverable   -       150,082  
Total current assets   49,171,369       16,694,291  
         
Investments   11,211,137       5,379,407  
Property, plant and equipment, net   3,204,157       2,768,900  
Goodwill   7,678,789       7,678,789  
Intangibles, net   15,018,223       15,949,100  
Long-term prepaid expenses and other assets   1,256,973       989,935  
Total assets $ 87,540,648     $ 49,460,422  
         
Liabilities and Stockholders' Equity      
         
Liabilities:      
Accounts payable $ 136,355     $ 260,886  
Accrued expenses   457,392       845,087  
Taxes payable   30,000       -  
Other current liabilities   1,574,592       1,913,284  
Total current liabilities   2,198,339       3,019,257  
         
Deferred tax liabilities   288,830       -  
Other non-current liabilities   25,636       76,229  
Total liabilities   2,512,805       3,095,486  
         
Commitments and Contingencies      
         
Stockholders' equity:      
         
Preferred stock, par value $.001, 50,000,000 shares      
authorized; none issued and outstanding as of      
June 30, 2016 and December 31, 2015, respectively   -       -  
         
Common stock, par value $.001, 300,000,000 shares authorized;      
14,099,228 and 11,711,645 issued and outstanding      
as of June 30, 2016 and December 31, 2015, respectively   14,099       11,711  
Additional paid in capital   148,830,297       103,807,651  
Accumulated deficit   (68,745,706 )     (57,338,311 )
Accumulated other comprehensive income (loss)   4,929,153       (116,115 )
Total stockholders' equity   85,027,843       46,364,936  
         
Total liabilities and stockholders' equity $ 87,540,648     $ 49,460,422  
         
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
         
    For the Six Months Ended
    June 30,
      2016       2015  
     
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net loss   $ (11,407,395 )   $ (9,313,646 )
Adjustments to reconcile net loss to net cash        
used in operating activities:        
Depreciation and amortization     1,349,137       928,531  
Stock based compensation expense     2,412,261       3,618,050  
Other than temporary impairment on investments     -       123,428  
Realized losses from sale of investments     -       5,178  
Inventory provision     105,919       -  
Allowance for doubtful account     10,782       -  
Changes in operating assets and liabilities:        
Accounts receivable     275,333       (304,173 )
Other receivables     20,521       (222,716 )
Inventory     (25,309 )     (27,839 )
Prepaid expenses     (457,032 )     (8,427 )
Taxes recoverable     150,082       -  
Other current assets     -       110,347  
Long-term prepaid expenses and other assets     (259,624 )     (73,031 )
Accounts payable     (124,531 )     (320,305 )
Accrued expenses     (387,695 )     112,026  
Advances  payable to related party     -       (30,216 )
Other current liabilities     (152,605 )     88,991  
Taxes payable     30,000       (173,739 )
Deferred tax liabilities     (242,267 )     -  
Other non-current liabilities     (50,049 )     (212,265 )
Net cash used in operating activities     (8,752,472 )     (5,699,806 )
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Proceed from sale of investments, net of issuance cost paid     -       1,480  
Purchases of intangibles     -       (4,385,940 )
Purchases of assets     (1,161,568 )     (224,826 )
Net cash used in investing activities     (1,161,568 )     (4,609,286 )
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Net proceeds from the issuance of common stock     42,437,374       18,964,849  
Proceeds from exercise of stock options     175,399       234,599  
Net cash provided by financing activities     42,612,773       19,199,448  
         
EFFECT OF EXCHANGE RATE CHANGES ON CASH     (113,134 )     (9,856 )
         
INCREASE IN CASH AND CASH EQUIVALENTS     32,585,599       8,880,500  
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD     14,884,597       14,770,584  
CASH AND CASH EQUIVALENTS, END OF PERIOD   $ 47,470,196     $ 23,651,084  
         
         
SUPPLEMENTAL CASH FLOW INFORMATION        
         
Cash paid for income taxes   $ (6,705 )   $ (226,855 )
         
Non-cash investing activities        
Acquisition of intangible assets through issuance of the Company's stock   $ -     $ 1,096,399  
         

 

Contacts:
Sarah Kelly 
Director of Corporate Communications, CBMG
+1 650 566-5064
sarah.kelly@cellbiomedgroup.com

Vivian Chen
Managing Director Investor Relations, Grayling
+1 347 481-3711
vivian.chen@grayling.com
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