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.
"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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SOURCE Cellular Biomedicine Group