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      Cellular Biomedicine Group Reports Second Quarter and First Half of 2019 Financial Results and Business Highlights

      - Began enrollment for the second cohort in a dose escalation clinical study in multiple myeloma for CBMG's anti-BCMA CAR-T asset. Submitted pre-IND meeting application to the NMPA.

      - Readied patients enrollment plan for the first cohort in a dose escalation study for CBMG's AFP TCR-T program targeting hepatocellular carcinoma.

      - Advanced preparation of AlloJoin® therapy for multiple-site Knee Osteoarthritis Phase II clinical trial

      Cellular Biomedicine Group logo (PRNewsfoto/Cellular Biomedicine Group)

      News provided by

      Cellular Biomedicine Group

      Aug 06, 2019, 16:10 ET

      Share this article

      Share this article


      NEW YORK and SHANGHAI, Aug. 6, 2019 /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 its financial results and business highlights for the second quarter and six months ended June 30, 2019.

      "During the second quarter of 2019, we made strides in advancing CBMG's clinical pipeline in China. This includes expansion to multiple sites, dose escalation and robust patient recruitment for our B cell maturation antigen (BCMA) CAR-T program targeting multiple myeloma (MM). We have finished enrolling patients for the first cohort in a dose escalation study and currently are enrolling patients for the second cohort. We are also expanding the study into multiple sites. We are moving the alpha-fetoprotein T-cell receptor (AFP-TCR-T) program forward and will start to screen and enroll patients in hepatocellular carcinoma (HCC). We are actively preparing for a multisite trial for our AlloJoin® therapy for Knee Osteoarthritis (KOA)," commented Tony (Bizuo) Liu, Chief Executive Officer of CBMG.

      Mr. Liu continued, "We continue to leverage the investigator initiated trial (IIT) process in China and plan to initiate these cancer clinical trials in the U.S. when we see positive proof of concept signals in the IIT studies in China. This allows us to prioritize and focus on developing clinical assets with the most potential and best chance to win both in China and globally."

      Business Highlights for the Second Quarter and First Half 2019:

      • Advanced myriad of  our immune-oncology (I/O) and regenerative medicine assets for the next stage  in the translational medicine process, comprised of fine-tuning process development, multiple sites trial, increases in patient recruitment, and dose escalation;
      • Preparing to bring our I/O assets to the U.S. market.

      Upcoming Clinical Milestones:

      • Present update of clinical data for CBMG's anti-BCMA CAR-T in the fourth quarter of 2019

      Financial Results for the Second Quarter and First Half 2019:

      • Net loss allocable to common stock holders for the quarter and six months ended June 30, 2019 was $12.1 million and $21.4 million respectively, compared to $9.2 million and $17.7 million for the same periods in 2018.
      • General and administrative expenses for the quarter and six months ended June 30, 2019 were $3.2 million and $6.6 million, respectively, compared to $3.1 million and $6.3 million for the same periods in 2018.
      • Research and development expenses for the quarter and six months ended June 30, 2019 were $9.1 million and $15 million respectively, compared $6.2 million and $11.4 million for the same periods in 2018, primarily due to the increased clinical development for our leading cell therapy targets.
      • Net cash used in operating activities for first half of 2019 was $18.7 million, compared $13.7 million for the same period in 2018.
      • Cash, cash equivalents and restricted cash was $56.7 million as of June 30, 2019, compared to $62.0 million as of March 31, 2019.

      Conference Call and Webcast Information
      The Company will host a conference call and webcast with the investment community on Tuesday, August 6th at 4:30 p.m. Eastern Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.

      Live Call:

      Toll-Free: 1-855-327-6838

      International: 1-604-235-2082



      Webcast:

      http://public.viavid.com/index.php?id=135481



      Replay:

      Toll-Free: 1-844-512-2921

      International: 1-412-317-6671

      Conference ID: 10007371

      (Available approximately two hours after the completion of the live call until 11:59 p.m. ET on August 20, 2019)

      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 and 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, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K and. 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. 

      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

      CELLULAR BIOMEDICINE GROUP, INC.

      CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS








      For the Six Months Ended



      June 30,



      2019


      2018




      CASH FLOWS FROM OPERATING ACTIVITIES:





        Net loss


      $(21,433,485)


      $(17,682,499)

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





      Depreciation and amortization


      2,659,038


      2,486,145

      Loss on disposal of assets


      92,487


      2,721

      Stock based compensation expense


      2,113,535


      2,477,614

      Other than temporary impairment on long-term investments


      -


      29,424

      Interest expense


      158,430


      -

      Interest from pledged bank deposits


      (317,696)


      -

        Changes in operating assets and liabilities:





      Accounts receivable


      785


      66,451

      Other receivables


      (19,821)


      20,006

      Prepaid expenses


      (572,978)


      (579,479)

      Long-term prepaid expenses and other assets


      (978,505)


      (649,262)

      Accounts payable


      333,463


      114,249

      Accrued expenses


      (818,327)


      (9,892)

      Deferred income


      -


      (4,515)

      Other current liabilities


      205,632


      166,870

      Other non-current liabilities


      (74,105)


      (93,732)

                Net cash used in operating activities


      (18,651,547)


      (13,655,899)






      CASH FLOWS FROM INVESTING ACTIVITIES:





         Proceeds from disposal of assets


      359


      -

         Putting six-month deposits with the banks


      -


      (10,000,000)

      Purchases of intangibles


      (752,449)


      (34,172)

      Purchases of assets


      (7,468,850)


      (2,167,527)

                Net cash used in investing activities


      (8,220,940)


      (12,201,699)






      CASH FLOWS FROM FINANCING ACTIVITIES:





      Net proceeds from the issuance of common stock


      17,166,199


      30,506,521

      Proceeds from exercise of stock options


      150,788


      1,165,763

      Proceeds from short-term debt


      14,546,035


      -

      Interest paid


      (145,159)


      -

      Repurchase of treasury stock


      (1,039,028)


      (2,536,064)

                Net cash provided by financing activities


      30,678,835


      29,136,220






      EFFECT OF EXCHANGE RATE CHANGES ON CASH


      94,518


      (61,177)






      INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH


      3,900,866


      3,217,445

      CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD


      52,812,880


      21,568,422

      CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD


      $56,713,746


      $24,785,867











      SUPPLEMENTAL CASH FLOW INFORMATION










      Cash paid for income taxes


      $3,750


      $2,400




























      June 30,


      June 30,



      2019


      2018

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





      Restricted cash


      $17,000,000


      $-

      Cash and cash equivalents


      39,713,746


      24,785,867






      Cash, cash equivalents and restricted cash


      $56,713,746


      $24,785,867







      CELLULAR BIOMEDICINE GROUP, INC.

      CONDENSED CONSOLIDATED BALANCE SHEETS

      (UNAUDITED)








      June 30,


      December 31,



      2019


      2018






       Assets




      Cash and cash equivalents

      $39,713,746


      $52,812,880

      Restricted cash

      17,000,000


      -

      Accounts receivable, less allowance for doubtful accounts of nil and $94,868 as of June 30, 2019 and December 31, 2018, respectively

      -


      787

      Other receivables

      440,847


      101,909

      Prepaid expenses

      2,262,527


      1,692,135

      Total current assets

      59,417,120


      54,607,711






      Investments

      240,000


      240,000

      Property, plant and equipment, net

      19,992,728


      15,193,761

      Right of use

      15,203,003


      15,938,203

      Goodwill

      7,678,789


      7,678,789

      Intangibles, net

      7,868,803


      7,970,692

      Long-term prepaid expenses and other assets

      7,286,803


      5,952,193

      Total assets

      $117,687,246


      $107,581,349






      Liabilities and Stockholders' Equity









      Liabilities:




      Short-term debt

      $14,546,035


      $-

      Accounts payable

      1,351,930


      422,752

      Accrued expenses

      1,058,273


      1,878,926

      Taxes payable

      28,950


      28,950

      Other current liabilities

      5,186,335


      5,710,578

      Total current liabilities

      22,171,523


      8,041,206






      Other non-current liabilities

      13,338,721


      14,321,751

      Total liabilities

      35,510,244


      22,362,957
















      Stockholders' equity:









          Preferred stock, par value $.001, 50,000,000 shares authorized; none issued and outstanding as of June 30, 2019 and December 31, 2018, respectively

      -


      -






          Common stock, par value $.001, 300,000,000 shares authorized; 20,301,425 and 19,120,781 issued; and 19,245,926 and 18,119,282 outstanding, as of June 30, 2019 and December 31, 2018, respectively

      20,301


      19,121

          Treasury stock at cost; 1,055,499 and 1,001,499 shares of common stock as of June 30, 2019 and December 31, 2018, respectively

      (14,992,694)


      (13,953,666)

      Additional paid in capital

      270,033,960


      250,604,618

          Accumulated deficit

      (171,415,974)


      (149,982,489)

          Accumulated other comprehensive loss

      (1,468,591)


      (1,469,192)

      Total stockholders' equity

      82,177,002


      85,218,392






      Total liabilities and stockholders' equity

      $117,687,246


      $107,581,349






      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,



      2019


      2018


      2019


      2018










      Net sales and revenue


      $-


      $77,313


      $49,265


      $128,274










      Operating expenses:









      Cost of sales


      -


      54,393


      8,087


      76,693

      General and administrative


      3,180,709


      3,121,695


      6,628,443


      6,310,492

      Selling and marketing


      41,252


      92,880


      83,512


      167,465

      Research and development


      9,062,526


      6,166,556


      15,030,622


      11,440,507

      Impairment of long-term investments


      -


      29,424


      -


      29,424

               Total operating expenses


      12,284,487


      9,464,948


      21,750,664


      18,024,581

      Operating loss


      (12,284,487)


      (9,387,635)


      (21,701,399)


      (17,896,307)










      Other income :









      Interest income, net


      182,017


      116,835


      279,051


      122,284

      Other income (expense), net


      7,123


      84,724


      (7,387)


      93,924

              Total other income


      189,140


      201,559


      271,664


      216,208

      Loss before taxes


      (12,095,347)


      (9,186,076)


      (21,429,735)


      (17,680,099)










      Income taxes provision


      (1,350)


      -


      (3,750)


      (2,400)



















      Net loss


      $(12,096,697)


      $(9,186,076)


      $(21,433,485)


      $(17,682,499)

      Other comprehensive income (loss):









      Cumulative translation adjustment


      (395,525)


      (1,120,722)


      601


      (302,361)

      Total other comprehensive income (loss):


      (395,525)


      (1,120,722)


      601


      (302,361)










      Comprehensive loss


      $(12,492,222)


      $(10,306,798)


      $(21,432,884)


      $(17,984,860)










      Net loss per share :









        Basic and diluted


      $(0.63)


      $(0.53)


      $(1.15)


      $(1.03)



















      Weighted average common shares outstanding:









        Basic and diluted


      19,223,113


      17,487,184


      18,690,729


      17,116,944










      SOURCE Cellular Biomedicine Group

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