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Cellular Biomedicine Group Announces Q4 and Full Year 2019 Financial Results and Recent Operational Progress

NEW YORK and SHANGHAI, Feb. 28, 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 fourth quarter and full year ended December 31, 2019.

Cellular Biomedicine Group logo (PRNewsfoto/Cellular Biomedicine Group)

"We made significant progress in 2019 with four cancer immuno-cell therapy ("I/O") clinical studies and our allogeneic off-the-shelf, as well as autologous, stem cell assets on Knee Osteoarthritis ("KOA") clinical trials. We have also embarked on renovating a 22,000 square foot facility in Rockville to expand our research and development ("R&D") footprint in Maryland. Working with our partners, we have made substantial strides in our operation and further institutionalized our Shanghai manufacturing site," said Tony Liu, CEO of the company. "Because of our skills in tech transfer, process development and lean manufacturing, we are emboldened and plan to utilize our four cleanrooms at the Rockville site to support our U.S. clinical studies upon completion of the facility.  This month we have also started to collaborate with Shanghai Ruijin Hospital on a pilot clinical study on inhalation of mesenchymal stem cell exosomes treating severe Novel Coronavirus Pneumonia ("NCP").  We are continuing to advance our I/O and KOA drug candidates both in China and the U.S."

Mr. Liu added, "Cell therapy has been embraced by both start-ups and large pharmas with the clear clinical benefits provided to patients globally. CBMG intends to leverage our internal capabilities, namely robust vein-to-vein integrated biopharma capabilities, as well as external collaboration, to rapidly bring these therapies to patients and help cure cancer.

"We are mindful of the ongoing risks posed by the coronavirus disease, or COVID-19. The full extent to which the coronavirus will negatively impact our business operations and results is still highly uncertain and cannot be accurately predicted; however, we have experienced, and expect to continue to experience, a slowdown in patient recruitment for our clinical studies."

2019 Clinical and Business Highlights

  • Initiated recruitment and showed early data for our Anti- B-cell maturation antigen ("BCMA") Chimeric antigen receptor T-cells ("CAR-T") for relapsed or refractory Multiple Myeloma ("r/r MM")
  • Began patient enrollment for our CD19/CD20 BiCar for Non-Hodgkins Lymphoma ("NHL")
  • Dosed first patient for our Alpha-Fetoprotein T-Cell Receptor ("AFP-TCR-T") technology targeting Hepatocellular Carcinoma ("HCC")
  • Began dosing patients for our Anti-CD20 CAR-T, targeting Anti-CD19 treated, relapsed Diffuse Large B-Cell Lymphoma ("DLBCL")
  • Received China National Medical Products Administration ("NMPA") Investigational New Drug application ("IND") acceptance to move to Phase II clinical trial for both off-the-shelf AlloJoin® and ReJoin® human adipose-derived mesenchymal progenitor cell ("haMPC") therapies for KOA
  • Expanding US footprint with new facility in Rockville, Maryland to support R&D and clinical studies

Fourth Quarter and Full Year 2019 Financial Results

  • Cash Position: Cash, cash equivalents and restricted cash as of December 31, 2019 were $32.4 million, compared to $52.8 million as of December 31, 2018
  • R&D Expenses: Research and development expenses were $37.7 million for 2019 as compared to $24.2 million for 2018
  • G&A Expenses: General and administrative expenses were $13.5 million for 2019 as compared to $13.2 million for 2018
  • Net Loss: Net loss was $50 million for 2019 as compared to $38.9 million for 2018

About Cellular Biomedicine Group, Inc.

Cellular Biomedicine Group, Inc. is a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases. For more information, please visit https://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 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. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are inherently subject to risks and uncertainties that could cause actual results to differ materially from those currently anticipated, including, but not limited to, the risks of failure inherent in the development of products based on new biomedical technologies as well as the other risks detailed from time to time in CBMG's reports filed with the Securities and Exchange Commission, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-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, we 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. 


CELLULAR BIOMEDICINE GROUP, INC.

 CONSOLIDATED BALANCE SHEETS







December 31,


December 31,


2019


2018





 Assets




Cash and cash equivalents

$            15,443,649


$          52,812,880

Restricted cash

17,000,000


-

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

-


787

Other receivables

750,943


101,909

Prepaid expenses

835,048


1,692,135

Total current assets

34,029,640


54,607,711





Investments

240,000


240,000

Property, plant and equipment, net

21,434,414


15,193,761

Right of use

20,106,163


15,938,203

Goodwill

7,678,789


7,678,789

Intangibles, net

7,376,940


7,970,692

Long-term prepaid expenses and other assets

6,458,354


5,952,193

Total assets

$            97,324,300


$        107,581,349





Liabilities and Stockholders' Equity








Liabilities:




Short-term debt

$            14,334,398


$                           -

Accounts payable

2,039,686


422,752

Accrued expenses

1,904,829


1,878,926

Taxes payable

26,245


28,950

Other current liabilities

5,367,708


5,710,578

Total current liabilities

23,672,866


8,041,206





Other non-current liabilities

17,933,743


14,321,751

Total liabilities

41,606,609


22,362,957













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

-


-





     Common stock, par value $.001, 300,000,000 shares authorized; 20,359,889 and 19,120,781 issued; and 19,304,390 and 18,119,282 outstanding, as of December 31, 2019 and 2018, respectively

20,360


19,121

     Treasury stock at cost; 1,055,499 and 1,001,499 shares of common stock

(14,992,694)


(13,953,666)

    as of December 31, 2019 and December 31, 2018, respectively




   Additional paid in capital

272,117,518


250,604,618

       Accumulated deficit

(199,966,543)


(149,982,489)

       Accumulated other comprehensive loss

(1,460,950)


(1,469,192)

   Total stockholders' equity

55,717,691


85,218,392





   Total liabilities and stockholders' equity

$            97,324,300


$        107,581,349











CELLULAR BIOMEDICINE GROUP, INC.

 CONSOLIDATED STATEMENTS OF CASH FLOWS








For the Year Ended


December 31,


2019


2018


2017





CASH FLOWS FROM OPERATING ACTIVITIES:






  Net loss

$       (49,984,054)


$       (38,945,492)


$       (25,490,310)

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






Depreciation and amortization

5,638,303


5,049,523


2,985,963

Loss on disposal of assets

39,033


4,957


317

Stock based compensation expense

4,063,981


4,826,745


5,345,211

Other than temporary impairment on investments

-


29,424


-

Impairment on intangible assets

-


2,884,896


-

Interest income from six-month deposits with the banks

-


(175,479)


-

Interest income from pledged bank deposits

(500,219)


-


-

Interest expenses

481,895


-


-

Allowance for doubtful account

-


84,622


-

  Changes in operating assets and liabilities:






Accounts receivable

774


107,263


(160,628)

Other receivables

(150,222)


66,108


(467,985)

Prepaid expenses

831,686


68,435


(812,675)

Long-term prepaid expenses and other assets

(1,324,924)


(538,349)


(1,005,029)

Accounts payable

1,170,688


133,740


(814)

Accrued expenses

48,762


816,936


(118,968)

Other current liabilities

(43,401)


390,181


1,339,866

Taxes payable

(2,705)


75


-

Other non-current liabilities

80,420


83,416


(208,340)

          Net cash used in operating activities

(39,649,983)


(25,112,999)


(18,593,392)







CASH FLOWS FROM INVESTING ACTIVITIES:






   Proceeds from disposal of assets

148,393


1,625


-

   Withdrawing six-month deposits with the banks

-


10,175,479


-

   Putting six-month deposits with the banks

-


(10,000,000)


-

Purchases of intangible assets

(869,110)


(196,836)


(23,734)

Purchases of property, plant and equipment

(10,674,812)


(6,589,493)


(10,169,134)

          Net cash used in investing activities

(11,395,529)


(6,609,225)


(10,192,868)







CASH FLOWS FROM FINANCING ACTIVITIES:






Net proceeds from the issuance of common stock

17,166,199


70,351,173


14,496,040

Proceeds from exercise of stock options

283,959


2,738,866


308,371

Proceeds from short-term debt

14,546,035


-


-

Interest paid

(470,901)


-


-

Repurchase of treasury stock

(1,039,028)


(9,975,737)


(3,977,929)

          Net cash provided by financing activities

30,486,264


63,114,302


10,826,482







EFFECT OF EXCHANGE RATE CHANGES ON CASH

190,017


(147,620)


275,768







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

(20,369,231)


31,244,458


(17,684,010)

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD

52,812,880


21,568,422


39,252,432

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD

$        32,443,649


$        52,812,880


$        21,568,422







SUPPLEMENTAL CASH FLOW INFORMATION












Cash paid for income taxes

$                3,750


$                4,879


$                2,450




















December 31,


December 31,


December 31,


2019


2018


2017

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






Restricted cash

$        17,000,000


$                         -


$                         -

Cash and cash equivalents

15,443,649


52,812,880


21,568,422







Cash, cash equivalents and restricted cash

$        32,443,649


$        52,812,880


$        21,568,422











CELLULAR BIOMEDICINE GROUP, INC.

 CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS



For the Year Ended
December 31,



2019


2018


2017







Net sales and revenue

$         339,920


$               224,403


$            336,817







Operating expenses:






Cost of sales

62,378


135,761


162,218

General and administrative

13,458,151


13,220,757


12,780,483

Selling and marketing

141,597


308,830


360,766

Research and development

37,669,978


24,150,480


14,609,917

Impairment of non-current assets

-


2,914,320


-

         Total operating expenses

51,332,104


40,730,148


27,913,384

Operating loss

(50,992,184)


(40,505,745)


(27,576,567)







Other income:






Interest income

809,785


392,328


133,621

Other income

199,390


1,172,879


1,955,086

        Total other income

1,009,175


1,565,207


2,088,707

Loss before taxes

(49,983,009)


(38,940,538)


(25,487,860)







Income taxes provision

(1,045)


(4,954)


(2,450)













Net loss

$    (49,984,054)


$          (38,945,492)


$      (25,490,310)

Other comprehensive income (loss):






Cumulative translation adjustment

8,242


(1,079,689)


967,189

   Unrealized  loss on investments, net of tax

-


-


(240,000)

Total other comprehensive income (loss):

8,242


(1,079,689)


727,189







Comprehensive loss

$    (49,975,812)


$          (40,025,181)


$      (24,763,121)







Net loss per share:






  Basic and diluted

$              (2.63)


$                    (2.20)


$                 (1.78)







Weighted average common shares outstanding:






  Basic and diluted

18,983,206


17,741,104


14,345,604









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

 

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