Cellular Biomedicine Group Reports Second Quarter and First Half 2016 Financial Results and Business Highlights

Shanghai, CHINA


- Ended Second Quarter with $47.5 million in Cash -

SHANGHAI, China and CUPERTINO, Calif., Aug. 09, 2016 (GLOBE NEWSWIRE) -- 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 
     

 


        

Tags


Contact Data