Cellular Biomedicine Group Reports First Quarter 2019 Results and Highlights Operational Progress

-- 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

News provided by

Cellular Biomedicine Group

Apr 30, 2019, 17:24 ET

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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