Cellular Biomedicine Group Announces Q4 and Full Year 2019 Financial Results and Recent Operational Progress

NEW YORK and SHANGHAI, Feb. 28, 2020 /PRNewswire/ -- Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019.

"We made significant progress in 2019 with four cancer immuno-cell therapy ("I/O") clinical studies and our allogeneic off-the-shelf, as well as autologous, stem cell assets on Knee Osteoarthritis ("KOA") clinical trials. We have also embarked on renovating a 22,000 square foot facility in Rockville to expand our research and development ("R&D") footprint in Maryland. Working with our partners, we have made substantial strides in our operation and further institutionalized our Shanghai manufacturing site," said Tony Liu, CEO of the company. "Because of our skills in tech transfer, process development and lean manufacturing, we are emboldened and plan to utilize our four cleanrooms at the Rockville site to support our U.S. clinical studies upon completion of the facility. This month we have also started to collaborate with Shanghai Ruijin Hospital on a pilot clinical study on inhalation of mesenchymal stem cell exosomes treating severe Novel Coronavirus Pneumonia ("NCP"). We are continuing to advance our I/O and KOA drug candidates both in China and the U.S."

Mr. Liu added, "Cell therapy has been embraced by both start-ups and large pharmas with the clear clinical benefits provided to patients globally. CBMG intends to leverage our internal capabilities, namely robust vein-to-vein integrated biopharma capabilities, as well as external collaboration, to rapidly bring these therapies to patients and help cure cancer.

"We are mindful of the ongoing risks posed by the coronavirus disease, or COVID-19. The full extent to which the coronavirus will negatively impact our business operations and results is still highly uncertain and cannot be accurately predicted; however, we have experienced, and expect to continue to experience, a slowdown in patient recruitment for our clinical studies."

2019 Clinical and Business Highlights

    --  Initiated recruitment and showed early data for our Anti- B-cell
        maturation antigen ("BCMA") Chimeric antigen receptor T-cells ("CAR-T")
        for relapsed or refractory Multiple Myeloma ("r/r MM")
    --  Began patient enrollment for our CD19/CD20 BiCar for Non-Hodgkins
        Lymphoma ("NHL")
    --  Dosed first patient for our Alpha-Fetoprotein T-Cell Receptor
        ("AFP-TCR-T") technology targeting Hepatocellular Carcinoma ("HCC")
    --  Began dosing patients for our Anti-CD20 CAR-T, targeting Anti-CD19
        treated, relapsed Diffuse Large B-Cell Lymphoma ("DLBCL")
    --  Received China National Medical Products Administration ("NMPA")
        Investigational New Drug application ("IND") acceptance to move to Phase
        II clinical trial for both off-the-shelf AlloJoin® and ReJoin® human
        adipose-derived mesenchymal progenitor cell ("haMPC") therapies for KOA
    --  Expanding US footprint with new facility in Rockville, Maryland to
        support R&D and clinical studies

Fourth Quarter and Full Year 2019 Financial Results

    --  Cash Position: Cash, cash equivalents and restricted cash as of December
        31, 2019 were $32.4 million, compared to $52.8 million as of December
        31, 2018
    --  R&D Expenses: Research and development expenses were $37.7 million for
        2019 as compared to $24.2 million for 2018
    --  G&A Expenses: General and administrative expenses were $13.5 million for
        2019 as compared to $13.2 million for 2018
    --  Net Loss: Net loss was $50 million for 2019 as compared to $38.9 million
        for 2018

About Cellular Biomedicine Group, Inc.

Cellular Biomedicine Group, Inc. is a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases. For more information, please visit https://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. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are inherently subject to risks and uncertainties that could cause actual results to differ materially from those currently anticipated, including, but not limited to, the risks of failure inherent in the development of products based on new biomedical technologies as well as the other risks detailed from time to time in CBMG's reports filed with the Securities and Exchange Commission, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-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, we 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.


                                                                                                 
            
               CONSOLIDATED BALANCE SHEETS






                                                                                                                                                    
     December 31,                
       December 31,


                                                                                                                                                                           2019                            2018





                                                                              
            
               Assets



     Cash and cash equivalents                                                                                                                                     $15,443,649                     $52,812,880



     Restricted cash                                                                                                                                                17,000,000                               -


                                                                                                                                                                              -                            787


     Accounts receivable, less allowance for doubtful amounts of nil and  $94,868 as of December 31, 2019 and December 31, 2018, respectively



     Other receivables                                                                                                                                                 750,943                         101,909



     Prepaid expenses                                                                                                                                                  835,048                       1,692,135



     Total current assets                                                                                                                                           34,029,640                      54,607,711





     Investments                                                                                                                                                       240,000                         240,000



     Property, plant and equipment, net                                                                                                                             21,434,414                      15,193,761



     Right of use                                                                                                                                                   20,106,163                      15,938,203



     Goodwill                                                                                                                                                        7,678,789                       7,678,789



     Intangibles, net                                                                                                                                                7,376,940                       7,970,692



     Long-term prepaid expenses and other assets                                                                                                                     6,458,354                       5,952,193



     Total assets                                                                                                                                                  $97,324,300                    $107,581,349

                                                                                                                                                                                                           ===



                                                               
            
              Liabilities and Stockholders' Equity





     Liabilities:



     Short-term debt                                                                                                                                               $14,334,398 
       $                         -



     Accounts payable                                                                                                                                                2,039,686                         422,752



     Accrued expenses                                                                                                                                                1,904,829                       1,878,926



     Taxes payable                                                                                                                                                      26,245                          28,950



     Other current liabilities                                                                                                                                       5,367,708                       5,710,578




     Total current liabilities                                                                                                                                      23,672,866                       8,041,206





     Other non-current liabilities                                                                                                                                  17,933,743                      14,321,751



     Total liabilities                                                                                                                                              41,606,609                      22,362,957








           Preferred stock, par value $.001, 50,000,000 shares authorized; none issued and outstanding as of December 31, 2019 and 2018,
            respectively                                                                                                                                                      -




           Common stock, par value $.001, 300,000,000 shares authorized; 20,359,889 and 19,120,781 issued; and 19,304,390 and 18,119,282
            outstanding, as of December 31, 2019 and 2018, respectively                                                                                                  20,360                          19,121



          Treasury stock at cost; 1,055,499 and 1,001,499 shares of common stock                                                                                  (14,992,694)                   (13,953,666)



         as of December 31, 2019 and December 31, 2018, respectively



        Additional paid in capital                                                                                                                                 272,117,518                     250,604,618



            Accumulated deficit                                                                                                                                  (199,966,543)                  (149,982,489)



            Accumulated other comprehensive loss                                                                                                                   (1,460,950)                    (1,469,192)



        Total stockholders' equity                                                                                                                                  55,717,691                      85,218,392






        Total liabilities and stockholders' equity                                                                                                                 $97,324,300                    $107,581,349

                                                                                                                                                                                                           ===







                                                                              
             
             CELLULAR BIOMEDICINE GROUP, INC.


                                                                            
            
              CONSOLIDATED STATEMENTS OF CASH FLOWS




                                                                                              
             
                For the Year Ended


                                                                                                
              
                December 31,



                                                                                         2019                                                                 2018                               2017






     CASH FLOWS FROM OPERATING ACTIVITIES:



       Net loss                                                                $(49,984,054)                                               $(38,945,492)               $(25,490,310)


        Adjustments to reconcile net loss to net cash used in operating
         activities:


      Depreciation and
       amortization                                                                 5,638,303                                                            5,049,523                          2,985,963


      Loss on disposal of assets                                                       39,033                                                                4,957                                317


      Stock based compensation
       expense                                                                      4,063,981                                                            4,826,745                          5,345,211


      Other than temporary
       impairment on investments                                                                                                                           29,424                                  -


      Impairment on intangible
       assets                                                                                                                                           2,884,896                                  -


      Interest income from six-
       month deposits with the
       banks                                                                                                                                             (175,479)                                 -


      Interest income from pledged
       bank deposits                                                                (500,219)                                                                                       -



     Interest expenses                                                               481,895                                                                                        -


      Allowance for doubtful
       account                                                                                                                                             84,622                                  -



       Changes in operating assets and liabilities:


      Accounts receivable                                                                 774                                                              107,263                          (160,628)



     Other receivables                                                             (150,222)                                                              66,108                          (467,985)



     Prepaid expenses                                                                831,686                                                               68,435                          (812,675)


      Long-term prepaid expenses
       and other assets                                                           (1,324,924)                                                            (538,349)                       (1,005,029)



     Accounts payable                                                              1,170,688                                                              133,740                              (814)



     Accrued expenses                                                                 48,762                                                              816,936                          (118,968)


      Other current liabilities                                                      (43,401)                                                             390,181                          1,339,866



     Taxes payable                                                                   (2,705)                                                                  75                                  -


      Other non-current
       liabilities                                                                     80,420                                                               83,416                          (208,340)


                Net cash used in operating
                 activities                                                      (39,649,983)                                                         (25,112,999)                      (18,593,392)






     CASH FLOWS FROM INVESTING ACTIVITIES:


         Proceeds from disposal of
          assets                                                                      148,393                                                                1,625                                  -


         Withdrawing six-month
          deposits with the banks                                                                                                                      10,175,479                                  -


         Putting six-month deposits
          with the banks                                                                                                                              (10,000,000)                                 -


      Purchases of intangible
       assets                                                                       (869,110)                                                            (196,836)                          (23,734)


      Purchases of property, plant
       and equipment                                                             (10,674,812)                                                          (6,589,493)                      (10,169,134)


                Net cash used in investing
                 activities                                                      (11,395,529)                                                          (6,609,225)                      (10,192,868)






     CASH FLOWS FROM FINANCING ACTIVITIES:


      Net proceeds from the
       issuance of common stock                                                    17,166,199                                                           70,351,173                         14,496,040


      Proceeds from exercise of
       stock options                                                                  283,959                                                            2,738,866                            308,371


      Proceeds from short-term
       debt                                                                        14,546,035                                                                                        -



     Interest paid                                                                 (470,901)                                                                                       -


      Repurchase of treasury stock                                                (1,039,028)                                                          (9,975,737)                       (3,977,929)


                Net cash provided by
                 financing activities                                              30,486,264                                                           63,114,302                         10,826,482





      EFFECT OF EXCHANGE RATE
       CHANGES ON CASH                                                                190,017                                                             (147,620)                           275,768




      INCREASE/(DECREASE) IN
       CASH, CASH EQUIVALENTS AND
       RESTRICTED CASH                                                           (20,369,231)                                                          31,244,458                       (17,684,010)


      CASH, CASH EQUIVALENTS AND
       RESTRICTED CASH, BEGINNING
       OF PERIOD                                                                   52,812,880                                                           21,568,422                         39,252,432



      CASH, CASH EQUIVALENTS AND
       RESTRICTED CASH, END OF
       PERIOD                                                                     $32,443,649                                                  $52,812,880                  $21,568,422






     
                SUPPLEMENTAL CASH FLOW INFORMATION




      Cash paid for income taxes                                                       $3,750                                                       $4,879                       $2,450









                                                                        
     
          December 31,                                           
     
     December 31,                December 31,


                                                                                         2019                                                                 2018                               2017



      Reconciliation of cash, cash equivalents and  restricted cash in
       condensed consolidated statements of cash flows:



     Restricted cash                                                             $17,000,000                                           
     $              -          
     $              -


      Cash and cash equivalents                                                    15,443,649                                                           52,812,880                         21,568,422




      Cash, cash equivalents and
       restricted cash                                                            $32,443,649                                                  $52,812,880                  $21,568,422





                                                      
     
                CELLULAR BIOMEDICINE GROUP, INC.


                                                  
     
       CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS




                                                              
              
                
                  For the Year Ended
                                                                                     December 31,




                                                                     2019                                                         2018            2017






     Net sales and revenue                                      $339,920                                                     $224,403        $336,817





     Operating expenses:



     Cost of sales                                                62,378                                                      135,761         162,218



     General and administrative                               13,458,151                                                   13,220,757      12,780,483



     Selling and marketing                                       141,597                                                      308,830         360,766



     Research and development                                 37,669,978                                                   24,150,480      14,609,917


      Impairment of non-current assets                                                                                      2,914,320               -


               Total operating expenses                        51,332,104                                                   40,730,148      27,913,384




     Operating loss                                         (50,992,184)                                                (40,505,745)   (27,576,567)






     Other income:



     Interest income                                             809,785                                                      392,328         133,621



     Other income                                                199,390                                                    1,172,879       1,955,086




             Total other income                                1,009,175                                                    1,565,207       2,088,707




     Loss before taxes                                      (49,983,009)                                                (38,940,538)   (25,487,860)





     Income taxes provision                                      (1,045)                                                     (4,954)        (2,450)







     Net loss                                              $(49,984,054)                                               $(38,945,492)  $(25,490,310)




     Other comprehensive income (loss):


      Cumulative translation adjustment                             8,242                                                  (1,079,689)        967,189


         Unrealized  loss on investments, net
          of tax                                                                                                                           (240,000)


      Total other comprehensive income
       (loss):                                                      8,242                                                  (1,079,689)        727,189





     Comprehensive loss                                    $(49,975,812)                                               $(40,025,181)  $(24,763,121)






     Net loss per share:



       Basic and diluted                                         $(2.63)                                                     $(2.20)        $(1.78)






     Weighted average common shares outstanding:



       Basic and diluted                                      18,983,206                                                   17,741,104      14,345,604

For more information, please contact:
Company Contact:
Derrick C. Li
Head of Strategy and Investor Relations, CBMG
Phone: 917-717-0994
Email: derrick.li@cellbiomedgroup.com

Investor Contact:
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1254 / 212-896-1267
Email: cellbiomed@kcsa.com

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SOURCE Cellular Biomedicine Group