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

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










 

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SOURCE Cellular Biomedicine Group