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Cellular Biomedicine Group Reports Second Quarter and First Half 2018 Financial Results and Business Highlights

SHANGHAI, China and CUPERTINO, Calif., Aug. 08, 2018 (GLOBE NEWSWIRE) --

  • China Food and Drug Administration (CFDA) Accepts the Company’s Investigational New Drug (IND) Applications for anti-CD19 CAR-T Therapy Targeting NHL and ALL
  • Moved to New R&D Center in Gaithersburg, Maryland, USA

Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today reported financial results and business highlights for the second quarter and six months ended June 30, 2018.

“The acceptance of CBMG’s IND application for “C-CAR011” anti-CD19 chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with B-cell Non-Hodgkin’s lymphoma (NHL) and acute lymphoblastic leukemia (ALL) reinforces the strength of our immuno-oncology platform. We look forward to working with the CFDA to obtain approval to move to the next phase of development,” commented Tony (Bizuo) Liu, Chief Executive Officer of CBMG. “We continue to deploy our working capital to pursue and develop a robust non-CD19 pipeline targeting other liquid and solid tumors. We are also advancing our quality systems and automated manufacturing capabilities by utilizing digital technologies with the goal of becoming a premier international biopharma company and a preferred collaborator for cell therapy development in China. With the expansion and relocation of our U.S. R&D center to Gaithersburg, Maryland, we are committed to leverage our talented team to develop the latest technology in cancer cell therapy.  Being in the heart of this renowned research hub presents us with opportunities to collaborate with leading experts in this ecosystem to bridge new therapies developed in the U.S. into our clinical development in China, ultimately leading to serve the China market.”

Second Quarter and First Half 2018 Financial Performance

  1. G&A Expenses: General and administrative expenses remain relatively flat for the six months ended June 30, 2018 compared to the same period in 2017 due to the efficient management and utilization of resources.  General and administrative expenses for the quarter and six months ended June 30, 2018 were $3.1 million and $6.3 million, respectively, compared to $3.3 million and $6.4 million for the same periods in 2017.
  2. R&D Expenses: Research and development expenses grew substantially for the six months ended June 30, 2018 compared to the same period in 2017 due to the expanded commitment to research and development, process improvement and anticipated clinical activities. Research and development expenses for the quarter and six months ended June 30, 2018 were $6.2 million and $11.4 million respectively, compared to $3.3 million and $6.4 million for the same periods in 2017.
  3. Net Loss: Net loss allocable to common stock holders for the quarter and six months ended June 30, 2018 was $9.2 million and $17.7 million respectively, compared to $6.2 million and $12.4 million for the same periods in 2017.

Business & Technology Highlights First Half 2018

  • MOVED TO NEW R&D CENTER IN GAITHERSBURG: In May 2018, the Company moved its Maryland lab to a larger research and development center in Gaithersburg to accelerate the Company’s robust oncology research pipeline, to attract new recruits and to work closely with potential collaborating partners; 
  • SUBMITTED IND APPLICATIONS TO CFDA: In April 2018, the CFDA accepted the IND applications for anti-CD19 CAR-T therapy “C-CAR011” targeting NHL and ALL and the Company is working with the CFDA for approval to move to the next phase of development;
  • PUBLISHED KOA DATA: In March 2018, the Company presented its allogeneic adipose-derived mesenchymal progenitor cell off-the-shelf therapy AlloJoinTM for Knee Osteoarthritis (KOA) 48-week clinical data from the Phase I clinical trial in China, which demonstrated good safety and early efficacy for the prevention of cartilage deterioration;
  • OBTAINED OPTION TO LICENSE PATENT ON AFP TCR-T for HEPATOCELLULAR CARCINOMA: In February 2018, CBMG’s wholly-owned subsidiary entered into an agreement with Augusta University to take a three-year option to license technology for Alpha fetoprotein (AFP) T Cell Receptor (TCR), targeting Hepatocellular Carcinoma (HCC) (patent pending);
  • COMPLETED PRIVATE EQUITY FINANCING: In February 2018, Sailing Capital invested $30.6 million in CBMG.  Sailing Capital is a global private equity firm focused on disruptive technologies from innovative global companies in the healthcare, technology and consumer sectors.

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.  Our Shanghai facility includes a ”Joint Laboratory of Cell Therapy” with GE Healthcare and a “Joint Cell Therapy Technology Innovation and Application Center” with Thermo Fisher Scientific, which partnerships focus on improving manufacturing processes for cell therapies. CBMG currently has ongoing CAR-T Phase I clinical trials in China; CARD-1 for Diffuse Large B-cell Lymphoma (DLBCL) and Non-Hodgkin Lymphoma (NHL) and CALL-1 for adult Acute Lymphoblastic Leukemia (ALL), utilizing CBMG’s proprietary and optimized CD19 construct, a Phase IIb trial in China for Rejoin®  autologous Human Adipose-derived Mesenchymal Progenitor Cell (haMPC) for the treatment of Knee Osteoarthritis (KOA) as well as a Phase I trial in China for AlloJoin™ (CBMG’s “Off-the-Shelf” haMPC) for the treatment of KOA. CBMG is included in the broad-market Russell 3000® Index and the small-cap Russell 2000® Index, and the Loncar China BioPharma index. 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 and 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 those regarding our ability to implement our plans, strategies and objectives for future operations, including regulatory approval of our IND applications, our plan to configure part of our Shanghai facility with GE Healthcare’s FlexFactory platform, our ability to execute on proposed new products, services or development thereof, results of our clinical research and development, regulatory infrastructure governing cell therapy and cellular biopharmaceuticals, our ability to enter into agreements with any necessary manufacturing, marketing and/or distribution partners for purposes of commercialization, our ability to seek intellectual property rights for our product candidates, competition in the industry in which we operate, overall market conditions, any statements or assumptions underlying any of the foregoing 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 STATEMENTS OF CASH FLOWS
     
  For the Six Months Ended
  June 30,
   2018   2017 
         
CASH FLOWS FROM OPERATING ACTIVITIES:    
  Net loss $ (17,682,499) $ (12,365,511)
  Adjustments to reconcile net loss to net cash    
  used in operating activities:    
Depreciation and amortization   2,486,145    1,369,168 
Loss / (gain) on disposal of assets   2,721    (49)
Stock based compensation expense   2,477,614    2,902,113 
Other than temporary impairment on long-term investments   29,424    -  
  Changes in operating assets and liabilities:    
Accounts receivable   66,451    (50,557)
Other receivables   20,006    (488,480)
Prepaid expenses   (579,479)   13,246 
Long-term prepaid expenses and other assets   (649,262)   (237,637)
Accounts payable   114,249    949,142 
Accrued expenses   (9,892)   (595,382)
Deferred income   (4,515)   1,069,515 
Other current liabilities   166,870    35,542 
Other non-current liabilities   (93,732)   (379,161)
  Net cash used in operating activities   (13,655,899)   (7,778,051)
     
CASH FLOWS FROM INVESTING ACTIVITIES:    
  Proceeds from disposal of assets   -     286 
  Putting six-month deposits with the banks   (10,000,000)   -  
Purchases of intangibles   (34,172)   (23,339)
Purchases of assets   (2,167,527)   (3,014,055)
  Net cash used in investing activities   (12,201,699)   (3,037,108)
     
CASH FLOWS FROM FINANCING ACTIVITIES:    
Net proceeds from the issuance of common stock   30,506,521    -  
Proceeds from exercise of stock options   1,165,763    73,779 
Repurchase of treasury stock   (2,536,064)   (1,357,931)
  Net cash provided by financing activities   29,136,220    (1,284,152)
     
EFFECT OF EXCHANGE RATE CHANGES ON CASH   (61,177)   145,324 
     
INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS   3,217,445    (11,953,987)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD   21,568,422    39,252,432 
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 24,785,867  $ 27,298,445 
     


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,
   2018   2017   2018   2017 
         
Net sales and revenue $ 77,313  $ 62,914  $ 128,274  $ 161,339 
         
Operating expenses:        
Cost of sales   54,393    38,097    76,693    75,499 
General and administrative   3,121,695    3,319,093    6,310,492    6,504,340 
Selling and marketing   92,880    76,385    167,465    194,269 
Research and development   6,166,556    3,349,509    11,440,507    6,393,634 
Impairment of long-term investments   29,424    -     29,424    -  
  Total operating expenses   9,464,948    6,783,084    18,024,581    13,167,742 
Operating loss   (9,387,635)   (6,720,170)   (17,896,307)   (13,006,403)
         
Other income :        
Interest income   116,835    40,573    122,284    89,755 
Other income   84,724    476,079    93,924    553,587 
  Total other income   201,559    516,652    216,208    643,342 
Loss before taxes   (9,186,076)   (6,203,518)   (17,680,099)   (12,363,061)
         
Income taxes provision   -     -     (2,400)   (2,450)
         
         
Net loss $ (9,186,076) $ (6,203,518) $ (17,682,499) $ (12,365,511)
Other comprehensive income (loss):        
Cumulative translation adjustment   (1,120,722)   292,452    (302,361)   346,121 
  Unrealized loss on investments, net of tax   -     (240,000)   -     (240,000)
Total other comprehensive income (loss):   (1,120,722)   52,452    (302,361)   106,121 
         
Comprehensive loss $ (10,306,798) $ (6,151,066) $ (17,984,860) $ (12,259,390)
         
Net loss per share :        
  Basic and diluted $ (0.53) $ (0.43) $ (1.03) $ (0.87)
         
         
Weighted average common shares outstanding:        
  Basic and diluted  17,487,184   14,298,973   17,116,944   14,211,888 
                 


 
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
     
  June 30, December 31,
   2018   2017 
     
 Assets   
Cash and cash equivalents$ 24,785,867  $ 21,568,422 
Short-term investment  10,000,000    -  
Accounts receivable, less allowance for doubtful amounts of $10,655   
 and $10,789 as of June 30, 2018 and December 31, 2017, respectively  133,876    202,887 
Other receivables  150,128    170,842 
Prepaid expenses  2,409,101    1,852,695 
Total current assets  37,478,972    23,794,846 
     
Long-term investments  240,000    269,424 
Property, plant and equipment, net  14,072,278    12,973,342 
Goodwill  7,678,789    7,678,789 
Intangibles, net  11,538,905    12,419,692 
Long-term prepaid expenses and other assets  4,805,996    4,026,203 
Total assets$ 75,814,940  $ 61,162,296 
     
Liabilities and Stockholders' Equity   
     
Liabilities:   
Accounts payable$ 387,860  $ 225,287 
Accrued expenses  1,078,584    1,097,327 
Taxes payable  28,875    28,875 
Other current liabilities  3,300,520    2,324,632 
Total current liabilities  4,795,839    3,676,121 
     
Other non-current liabilities  87,601    183,649 
Total liabilities  4,883,440    3,859,770 
     
     
     
Stockholders' equity:   
     
  Preferred stock, par value $.001, 50,000,000 shares   
  authorized; none issued and outstanding as of   
  June 30, 2018 and December 31, 2017, respectively  -     -  
     
  Common stock, par value $.001, 300,000,000 shares authorized;   
 17,503,238 and 15,615,558 issued; and 16,942,470 and 15,188,764 outstanding,  
  as of June 30, 2018 and December 31, 2017, respectively  17,503    15,616 
  Treasury stock at cost:  560,768 and 426,794 shares of common stock   
  as of June 30, 2018 and December 31, 2017, respectively  (6,513,993)   (3,977,929)
Additional paid in capital  206,839,350    172,691,339 
  Accumulated deficit  (128,719,496)   (111,036,997)
  Accumulated other comprehensive loss  (691,864)   (389,503)
Total stockholders' equity  70,931,500    57,302,526 
     
Total liabilities and stockholders' equity$ 75,814,940  $ 61,162,296 
     

Contacts:
Sarah Kelly 
Director of Corporate Communications, CBMG

+1 408-973-7884
sarah.kelly@cellbiomedgroup.com

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/f9b2bd6d-579b-4b5a-8b0c-4c2a3794d6c0

Wednesday, August 8, 2018 - 07:31