Cellular Biomedicine Group Reports Q1 2020 Financial Results and Business Highlights

NEW YORK and SHANGHAI, May 6, 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 first quarter of 2020.

"We currently have six clinical assets in development. In Q1, China's National Medical Products Administration (NMPA) accepted our Investigational New Drug (IND) application for B-cell maturation antigen (BCMA) Chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma (MM). Although early in the study, we are guardedly optimistic about the preliminary data of the 19 infused patients with only one patient being observed to have grade 3 cytokine release syndrome (CRS). We are excited to continue the development of this program and believe that our competitive advantages may be partially attributable to our proprietary manufacturing process with reduced vein-to-vein times. We are also conducting an Investigator-Initiated Trial (IIT) on our anti-CD19/CD20 BiCAR-T in non-Hodgkin's lymphoma (NHL) in China and are seeing promising early data," said Tony (Bizuo) Liu, the Company's Chief Executive Officer.

Mr. Liu added, "Together with our new Rockville, Maryland facility coming online in the latter part of the year, which will support the early phases of our U.S. clinical trials, and observation of the promising data in our China study, we are taking small steps to explore feasibility of a U.S. clinical trial for anti-CD19/CD20 BiCAR-T for non-Hodgkin's lymphoma (NHL) as well as the tumor infiltrating lymphocytes (TIL) clinical trial for Non-Small-Cell Lung Cancer (NSCLC).

"Regarding our regenerative medicine program, with the COVID-19 outbreak tapering off in China, we have resumed patients' enrollment for our knee osteoarthritis (KOA) Phase II allogenic (off the shelf AlloJoin®) stem-cell clinical trial and are in the process of preparing for the Phase II autologous (ReJoin®) trial as well.

"We are continuing to execute our vision to build a global platform of cutting-edge process development and incisive translational medicine, delivering innovative cell therapies to patients via personalized bespoke manufacturing processes. These transformative capabilities can bring not only fast vein-to-vein delivery but also safe and effective drugs to patients suffering with cancer and degenerative diseases. And amid the COVID-19 pandemic, we are pleased to have secured facilities to bolster our balance sheet to fund our clinical development."

?First Quarter 2020 and Other Recent Corporate Developments

             -  Anti-BCMA CAR-T for Relapsed or
              Refractory Multiple Myeloma


                        --  National Medical Products
                         Administration of China (NMPA)
                         accepted our IND application for
                         Phase I clinical trial;


                       --  19 patients have been infused
                         under investigator-initiated
                         studies; 17 patients have
                         evaluable data for clinical
                         efficacy with only one grade 3 CRS
                         observed;


             -  Anti-CD19/CD20 Bi-Specific CAR-T for
              Non-Hodgkin's Lymphoma


                        --  4 patients have been infused
                         under investigator-initiated
                         studies; 3 patients have evaluable
                         data for clinical efficacy;


             -  On April 30, 2020, we received approval
              for CNY 30 million line of credit
              (approximately USD $4.2 million).

First Quarter 2020 Financial Results

               -  Cash Position: Cash, cash
                equivalents and restricted cash of
                March 31, 2020 were $21.6 million,
                compared to $15.4 million as of
                December 31, 2019;


               -  Research & Development Expenses:
                R&D expenses were $7.8 million for
                the first quarter of 2020,
                compared to $6.0 million for the
                first quarter of 2019;


               -  General & Administrative
                Expenses: G&A expenses were $3.4
                million for the first quarter of
                2020, compared to $3.4 million for
                the first quarter of 2019;


               -  Net loss was $11.5 million for
                the first quarter of 2020,
                compared to $9.3 million for the
                first quarter of 2019;


               -  Executed a bridge loan of $16
                million.

About Cellular Biomedicine Group, Inc.
Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. The company conducts immuno-oncology and stem cell clinical trials in China using products from its integrated GMP laboratory. The Company's GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. Its 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. These partnerships focus on improving manufacturing processes for cell therapies. CBMG currently has ongoing CAR-T Phase I clinical trials in China. The China NMPA (formerly CFDA) approved the Company's IND application for a Phase II trial for AlloJoin®, CBMG's "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and has accepted the Company's IND application for a Phase II trial for ReJoin® autologous haMPC therapy for the treatment of KOA. The NMPA has also accepted CBMG's dossier for an IND application for clinical trials of anti-BCMA CAR-T. CBMG is included in the broad-market Russell 3000® Index 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 any risks detailed from time to time in CBMG's reports filed with the Securities and Exchange Commission, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, including risks relating to the impact of the COVID-19 pandemic on our operations. Generally, the words "believes," "anticipates," "may," "will," "should," "could," "expect," "plans," "intend," "estimate," "projects," "presents," "potential," "continue" and similar expressions or the negative thereof or comparable terminology are intended to identify forward-looking statements. These statements reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

                
              
                CELLULAR BIOMEDICINE GROUP, INC.


              
              
                CONDENSED CONSOLIDATED BALANCE SHEETS


                           
              
                (UNAUDITED)




                                                          
              March 31,            December 31,


                                                                                    2020           2019





                         
              
                 Assets


      Cash and cash equivalents                                              $21,597,360    $15,443,649



     Restricted cash                                                                  -    17,000,000



     Other receivables                                                          253,749        750,943



     Prepaid expenses                                                         1,707,265        835,048


      Total current assets                                                    23,558,374     34,029,640





     Investments                                                                      -       240,000


      Property, plant and
       equipment, net                                                         21,338,143     21,434,414



     Right of use                                                            19,280,349     20,106,163



     Goodwill                                                                 7,678,789      7,678,789



     Intangibles, net                                                         7,035,420      7,376,940


      Long-term prepaid expenses
       and other assets                                                        6,997,391      6,458,354



     Total assets                                                           $85,888,466    $97,324,300

                                                                                                   ===



           
              
                Liabilities and Stockholders' Equity





     Liabilities:



     Short-term debt                                                        $14,000,000    $14,334,398



     Accounts payable                                                         1,620,314      2,039,686



     Accrued expenses                                                         2,372,410      1,904,829



     Taxes payable                                                               30,420         26,245


      Other current liabilities                                                5,509,393      5,367,708



      Total current liabilities                                               23,532,537     23,672,866




      Other non-current
       liabilities                                                            17,204,688     17,933,743



     Total liabilities                                                       40,737,225     41,606,609









     Stockholders' equity:




          Preferred stock, par value
           $.001, 50,000,000 shares
                   authorized; none
                   issued and outstanding as
           of 
              March 31,
           2020 and December 31, 2019,
           respectively                                                                -




          Common stock, par value
           $.001, 300,000,000 shares
           authorized;
           20,427,185 and 20,359,889
           issued; and 19,371,686 and
           19,304,390 outstanding,
                  as of March 31, 2020
                  and December 31, 2019,
           respectively                                                           20,427         20,360


         Treasury stock at cost;
          1,055,499 shares of common
          stock 
              as of
          March 31, 2020 and December
          31, 2019, respectively                                            (14,992,694)  (14,992,694)


      Additional paid in capital                                             273,535,311    272,117,518


          Accumulated deficit                                              (211,514,040) (199,966,543)


          Accumulated other
           comprehensive loss                                                (1,897,763)   (1,460,950)


      Total stockholders' equity                                              45,151,241     55,717,691





      Total liabilities and
       stockholders' equity                                                  $85,888,466    $97,324,300

                                                                                                   ===

               
              
                CELLULAR BIOMEDICINE GROUP, INC.


      
         
                CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)




                                                                                      For the Three Months Ended


                                                                        
              
               March 31,



                                                                                 2020                                     2019





        CASH FLOWS FROM OPERATING
         ACTIVITIES:



         Net loss                                                      $(11,547,497)                            $(9,336,788)


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


        Depreciation and amortization                                       1,593,078                                1,329,699


        Loss on disposal of assets                                                                                       (23)


        Stock based compensation expense                                      936,062                                1,124,562


        Other than temporary impairment
         on investments                                                       240,000


          Changes in operating assets and
           liabilities:



       Accounts receivable                                                                                               788



       Other receivables                                                     493,853                                (161,074)



       Prepaid expenses                                                    (884,281)                             (1,038,324)


        Long-term prepaid expenses and
         other assets                                                       (472,222)                               (378,024)



       Accounts payable                                                    (744,090)                                 426,027



       Accrued expenses                                                      486,538                                   12,704


        Other current liabilities                                             599,822                                  155,980



       Taxes payable                                                           4,175


        Other non-current liabilities                                                                                (71,221)


                  Net cash used in operating
                   activities                                             (9,294,562)                             (7,935,694)





        CASH FLOWS FROM INVESTING
         ACTIVITIES:


           Proceeds from disposal of assets                                                                               359


        Purchases of intangibles                                             (51,687)                               (619,165)


        Purchases of property, plant and
         equipment                                                        (1,582,479)                             (3,545,355)


                  Net cash used in investing
                   activities                                             (1,634,166)                             (4,164,161)





        CASH FLOWS FROM FINANCING
         ACTIVITIES:


        Net proceeds from the issuance
         of common stock                                                                                           16,038,504


        Proceeds from exercise of stock
         options                                                              481,798                                  109,261


        Proceeds from short-term debt                                      14,000,000                                6,131,723


        Repayment of short-term debt                                     (14,315,898)


        Repurchase of treasury stock                                                                              (1,039,028)


                  Net cash provided by financing
                   activities                                                 165,900                               21,240,460





        EFFECT OF EXCHANGE RATE CHANGES
         ON CASH                                                             (83,461)                                  84,032




        INCREASE (DECREASE) IN CASH,
         CASH EQUIVALENTS AND RESTRICTED
         CASH                                                            (10,846,289)                               9,224,637


        CASH,  CASH EQUIVALENTS AND
         RESTRICTED CASH, BEGINNING OF
         PERIOD                                                            32,443,649                               52,812,880



        CASH,  CASH EQUIVALENTS AND
         RESTRICTED CASH, END OF PERIOD                                   $21,597,360                              $62,037,517







                     SUPPLEMENTAL CASH FLOW
                      INFORMATION





       Income tax refund                                                      $3,200              
              $              -





        Cash paid for income taxes                                               $800                                   $2,400






       Interest expense paid                                                 $99,271                                  $30,506





        Interest income from pledged
         bank deposits received, netting
         off withholding tax                                                 $460,041              
              $              -







                                                                            March 31,                               March 31,


                                                                                 2020                                     2019



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



       Restricted cash                               
              $                  -                             $17,000,000


        Cash and cash equivalents                                          21,597,360                               45,037,517




        Cash, cash equivalents and
         restricted cash                                                  $21,597,360                              $62,037,517


                                           
          
                CELLULAR BIOMEDICINE GROUP, INC.


                              
              
       CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS


                                                  
              
                (UNAUDITED)




                                                                     For the Three Months Ended


                                                      
              
                March 31,



                                                                                           2020                             2019






     Net sales and revenue                                 
              $                      -                         $49,265





     Operating expenses:



     Cost of sales                                                                                                       8,087



     General and administrative                                                      3,431,344                        3,447,734



     Selling and marketing                                                                                              42,260



     Research and development                                                        7,759,358                        5,968,096



     Impairment of investments                                                         240,000


               Total operating expenses                                              11,430,702                        9,466,177




     Operating loss                                                               (11,430,702)                     (9,416,912)






     Other (expense) income



     Interest income, net                                                               12,772                           97,034



     Other expense, net                                                              (127,792)                        (14,510)



              Total other (expense) income                                            (115,020)                          82,524




     Loss before taxes                                                            (11,545,722)                     (9,334,388)





     Income taxes provision                                                            (1,775)                         (2,400)







     Net loss                                                                    $(11,547,497)                    $(9,336,788)




     Other comprehensive income:


      Cumulative translation adjustment                                               (436,813)                         396,126


      Total other comprehensive income:                                               (436,813)                         396,126





     Comprehensive loss                                                          $(11,984,310)                    $(8,940,662)








     Net loss per share :



       Basic and diluted                                                               $(0.60)                         $(0.51)





      Weighted average common shares
       outstanding:



       Basic and diluted                                                            19,340,982                       18,152,429


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

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SOURCE Cellular Biomedicine Group