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Cellular Biomedicine Group Reports First Quarter 2019 Results and Highlights Operational Progress
  • USA - English
  • India - Hindi

-- Initiated patient recruitment for Phase I trial of anti-BCMA CAR-T therapy targeting relapsed and refractory Multiple Myeloma in China

-- AlloJoin® therapy for Knee Osteoarthritis (KOA) approved as first stem cell KOA drug application in China for a Phase II clinical trial

-- Ended quarter with $62 million in cash

Cellular Biomedicine Group logo (PRNewsfoto/Cellular Biomedicine Group)

News provided by

Cellular Biomedicine Group

Apr 30, 2019, 17:24 ET

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NEW YORK and SHANGHAI, April 30, 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 first quarter ended March 31, 2019.

"Early in 2019, we achieved the first of many milestones anticipated for this year in support of our immuno-oncology platform, as we initiated patient recruitment for our Phase I trial of anti-BCMA CAR-T therapy targeting multiple myeloma in China. We are also on track with the technology transfer from the strategic licensing and collaboration agreement that we signed during the 2018 third quarter with a global leader in CAR-T cell therapy for patients in China," commented Tony Liu, Chief Executive Officer of CBMG. "In addition to the AFP-TCR and TIL solid tumor platform, in 2019 we plan to initiate clinical development for CAR-T programs for CD22, CD20 and NKG2D for hematological cancers, and AFP TCR-T for metastatic HCC. Also during the first quarter, significant progress was made with our Stem Cell Platform as our IND application for AlloJoin® for KOA became the first stem cell drug application to be approved by China's CDE for a Phase II KOA clinical trial since the new Regulation's release*. Our broad clinical development programs and investments into our in-house research, manufacturing capabilities and our CMC platform remain a key part of our strategy to realize the potential of CAR-T cell therapies for patients suffering from various cancers."

* China NMPA (formerly CFDA) clarified Cell Therapy Regulations in December 2017 (the "Regulation") whereby all cell therapies are being treated as drug NDA/IND.

First Quarter 2019 Financial Performance

  • Cash Position: Cash position as of March 31, 2019 was $62 million (including restricted cash) compared to $52.8 million as of December 31, 2018;
  • Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2019 was $7.9 million, compared to $5.6 million for the same period in 2018, a 41% increase;
  • G&A Expenses: General and administrative expenses for the first quarter of 2019 were $3.4 million compared to $3.2 million for the same period in 2018, an 8% increase;
  • R&D Expenses: Research and development expenses for the first quarter of 2019 were $6.0 million, compared to $5.3 million for the same period a year ago, a 13% increase. The increase was primarily due the increased spending in the growth of our pipeline in both liquid tumor and solid tumor development;
  • Net Loss: Net loss allocable to common stock holders was $9.3 million, compared to $8.5 million for the same period in 2018, a 10% increase.
  • In January 2019, China Merchants Bank granted the Company a credit up to RMB 100 million (approximately $14.7 million) via revolving and/or one-time credit lines, which period runs until December 30, 2019. As of March 31, 2019, $6.1 million had been drawn down under this banking facility.

Conference Call and Webcast Information

The Company will host a conference call and webcast with the investment community on Wednesday, May 1st at 8:30 a.m. Eastern Time / 8:30 p.m. China Standard Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.

Live Call:

Toll-Free: 1-877-423-9813

International: 1-201-689-8573



Webcast:

http://public.viavid.com/index.php?id=134237 



Replay:

Toll-Free: 1-844-512-2921

International: 1-412-317-6671

Conference ID: 13690103

(Available approximately two hours after the completion of the live call until 11:59 p.m. ET on May 15, 2019)

About Cellular Biomedicine Group, Inc.

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. It conducts immuno-oncology and stem cell clinical trials in China using products from its integrated GMP laboratory. Its GMP facilities in China, consisting of 12 independent cell production lines, are designed and managed according to both China and U.S. GMP standards. 

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 our obligations under the terms of our licensing and collaboration arrangement with Novartis, 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, 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, it 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: [email protected]

Investor Contact:
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1254 / 212-896-1267
Email: [email protected]

CELLULAR BIOMEDICINE GROUP, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)








March 31,


December 31,



2019


2018






 Assets




Cash and cash equivalents

$45,037,517


$52,812,880

Restricted cash

17,000,000


$-

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

-


787

Other receivables

263,158


101,909

Prepaid expenses

2,733,614


1,692,135

Total current assets

65,034,289


54,607,711






Investments

240,000


240,000

Property, plant and equipment, net

15,157,707


15,193,761

Right of use

16,017,978


15,938,203

Goodwill

7,678,789


7,678,789

Intangibles, net

8,259,257


7,970,692

Long-term prepaid expenses and other assets

8,951,077


5,952,193

Total assets

$121,339,097


$107,581,349






Liabilities and Stockholders' Equity









Liabilities:




Short-term debt

$6,131,723


$-

Accounts payable

868,590


422,752

Accrued expenses

1,894,470


1,878,926

Taxes payable

28,950


28,950

Other current liabilities

5,762,778


5,710,578

Total current liabilities

14,686,511


8,041,206






Other non-current liabilities

14,141,557


14,321,751

Total liabilities

28,828,068


22,362,957











Stockholders' equity:









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

-


-






    Common stock, par value $.001, 300,000,000 shares authorized; 20,182,654 and 19,120,781 issued; and  19,127,155 and 18,119,282 outstanding, as of March 31, 2019 and December 31, 2018, respectively

20,183


19,121

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

(14,992,694)


(13,953,666)

Additional paid in capital

267,875,883


250,604,618

    Accumulated deficit

(159,319,277)


(149,982,489)

    Accumulated other comprehensive loss

(1,073,066)


(1,469,192)

Total stockholders' equity

92,511,029


85,218,392






Total liabilities and stockholders' equity

$121,339,097


$107,581,349

CELLULAR BIOMEDICINE GROUP, INC.

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)








For the Three Months Ended



March 31,



2019


2018






Net sales and revenue


$49,265


$50,961






Operating expenses:





Cost of sales


8,087


22,300

General and administrative


3,447,734


3,188,797

Selling and marketing


42,260


74,585

Research and development


5,968,096


5,273,951

         Total operating expenses


9,466,177


8,559,633

Operating loss


(9,416,912)


(8,508,672)






Other income





Interest income, net


97,034


5,449

Other income (expense), net


(14,510)


9,200

        Total other income


82,524


14,649

Loss before taxes


(9,334,388)


(8,494,023)






Income taxes provision


(2,400)


(2,400)











Net loss


$(9,336,788)


$(8,496,423)

Other comprehensive income:





Cumulative translation adjustment


396,126


818,361

Total other comprehensive income:


396,126


818,361






Comprehensive loss


$(8,940,662)


$(7,678,062)











Net loss per share :





  Basic and diluted


$(0.51)


$(0.51)






Weighted average common shares outstanding:





  Basic and diluted


18,152,429


16,742,591
















CELLULAR BIOMEDICINE GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS








For the Three Months Ended



March 31,



2019


2018




CASH FLOWS FROM OPERATING ACTIVITIES:





  Net loss


$(9,336,788)


$(8,496,423)

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





Depreciation and amortization


1,329,699


1,175,488

(Gain) loss on disposal of assets


(23)


935

Stock based compensation expense


1,124,562


1,134,881

Interest expense


39,619


-

Interest from pledged bank deposits


(117,370)


-

  Changes in operating assets and liabilities:





Accounts receivable


788


81,633

Other receivables


(43,704)


(4,820)

Prepaid expenses


(1,038,324)


(112,228)

Long-term prepaid expenses and other assets


(378,024)


(436,503)

Accounts payable


426,027


26,596

Accrued expenses


12,704


731,748

Other current liabilities


146,867


276,230

Taxes payable


-


2,400

Other non-current liabilities


(71,221)


8,012

          Net cash used in operating activities


(7,905,188)


(5,612,051)






CASH FLOWS FROM INVESTING ACTIVITIES:





   Proceeds from disposal of assets


359


-

Purchases of intangibles


(619,165)


-

Purchases of property, plant and equipment


(3,545,355)


(1,082,635)

          Net cash used in investing activities


(4,164,161)


(1,082,635)






CASH FLOWS FROM FINANCING ACTIVITIES:





Net proceeds from the issuance of common stock


16,038,504


30,508,670

Proceeds from exercise of stock options


109,261


769,723

Proceeds from short-term debt


6,131,723


-

Interest paid


(30,506)


-

Repurchase of treasury stock


(1,039,028)


(715,668)

          Net cash provided by financing activities


21,209,954


30,562,725






EFFECT OF EXCHANGE RATE CHANGES ON CASH


84,032


119,430






INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH


9,224,637


23,987,469

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD


52,812,880


21,568,422

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD


$62,037,517


$45,555,891











SUPPLEMENTAL CASH FLOW INFORMATION










Cash paid for income taxes


$2,400


$-













March 31,


December 31,



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


45,037,517


52,812,880






Cash, cash equivalents and restricted cash


$62,037,517


$52,812,880

SOURCE Cellular Biomedicine Group

Related Links

https://www.cellbiomedgroup.com

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