NEW YORK and SHANGHAI, May 6,
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 first quarter of
2020.
"We currently have six clinical assets in development. In Q1,
China's National Medical Products
Administration (NMPA) accepted our Investigational New Drug (IND)
application for B-cell maturation antigen (BCMA) Chimeric antigen
receptor (CAR) T-cell therapy for multiple myeloma (MM).
Although early in the study, we are guardedly optimistic about the
preliminary data of the 19 infused patients with only one patient
being observed to have grade 3 cytokine release syndrome (CRS). We
are excited to continue the development of this program and believe
that our competitive advantages may be partially attributable to
our proprietary manufacturing process with reduced vein-to-vein
times. We are also conducting an Investigator-Initiated Trial (IIT)
on our anti-CD19/CD20 BiCAR-T in non-Hodgkin's lymphoma (NHL) in
China and are seeing promising
early data," said Tony (Bizuo) Liu, the Company's Chief Executive
Officer.
Mr. Liu added, "Together with our new Rockville, Maryland facility coming online in
the latter part of the year, which will support the early phases of
our U.S. clinical trials, and observation of the promising data in
our China study, we are taking
small steps to explore feasibility of a U.S. clinical trial for
anti-CD19/CD20 BiCAR-T for non-Hodgkin's lymphoma (NHL) as well as
the tumor infiltrating lymphocytes (TIL) clinical trial for
Non-Small-Cell Lung Cancer (NSCLC).
"Regarding our regenerative medicine program, with the COVID-19
outbreak tapering off in China, we
have resumed patients' enrollment for our knee osteoarthritis (KOA)
Phase II allogenic (off the shelf AlloJoin®) stem-cell clinical
trial and are in the process of preparing for the Phase II
autologous (ReJoin®) trial as well.
"We are continuing to execute our vision to build a global
platform of cutting-edge process development and incisive
translational medicine, delivering innovative cell therapies to
patients via personalized bespoke manufacturing processes. These
transformative capabilities can bring not only fast vein-to-vein
delivery but also safe and effective drugs to patients suffering
with cancer and degenerative diseases. And amid the COVID-19
pandemic, we are pleased to have secured facilities to bolster our
balance sheet to fund our clinical development."
First Quarter 2020 and Other Recent Corporate
Developments
|
− Anti-BCMA
CAR-T for Relapsed or Refractory Multiple Myeloma
|
|
• National
Medical Products Administration of China (NMPA) accepted our IND
application for Phase I clinical trial;
|
|
• 19 patients
have been infused under investigator-initiated studies; 17 patients
have evaluable data for clinical efficacy with only one grade 3 CRS
observed;
|
|
−
Anti-CD19/CD20 Bi-Specific CAR-T for Non-Hodgkin's
Lymphoma
|
|
• 4 patients
have been infused under investigator-initiated studies; 3 patients
have evaluable data for clinical efficacy;
|
|
− On April 30,
2020, we received approval for CNY 30 million line of credit
(approximately USD $4.2 million).
|
First Quarter 2020 Financial Results
|
− Cash
Position: Cash, cash equivalents and restricted cash of March 31,
2020 were $21.6 million, compared to $15.4 million as of December
31, 2019;
|
|
− Research
& Development Expenses: R&D expenses were $7.8 million for
the first quarter of 2020, compared to $6.0 million for the first
quarter of 2019;
|
|
− General &
Administrative Expenses: G&A expenses were $3.4 million for the
first quarter of 2020, compared to $3.4 million for the first
quarter of 2019;
|
|
− Net loss was
$11.5 million for the first quarter of 2020, compared to $9.3
million for the first quarter of 2019;
|
|
− Executed a
bridge loan of $16 million.
|
About Cellular Biomedicine Group, Inc.
Cellular
Biomedicine Group, Inc. (NASDAQ: CBMG) develops proprietary cell
therapies for the treatment of cancer and degenerative diseases.
The company conducts immuno-oncology and stem cell clinical trials
in China using products from its
integrated GMP laboratory. The Company's GMP facilities in
China, consisting of twelve
independent cell production lines, are designed and managed
according to both China and U.S.
GMP standards. Its 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. These
partnerships focus on improving manufacturing processes for cell
therapies. CBMG currently has ongoing CAR-T Phase I clinical trials
in China. The China NMPA (formerly
CFDA) approved the Company's IND application for a Phase II trial
for AlloJoin®, CBMG's "Off-the-Shelf" allogenic haMPC therapy for
the treatment of Knee Osteoarthritis (KOA), and has accepted the
Company's IND application for a Phase II trial for ReJoin®
autologous haMPC therapy for the treatment of KOA. The NMPA has
also accepted CBMG's dossier for an IND application for clinical
trials of anti-BCMA CAR-T. CBMG is included in the broad-market
Russell 3000® Index 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 any 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, including risks relating to the impact of the COVID-19
pandemic on our operations. Generally, the words "believes,"
"anticipates," "may," "will," "should," "could," "expect," "plans,"
"intend," "estimate," "projects," "presents," "potential,"
"continue" and similar expressions or the negative thereof or
comparable terminology are intended to identify forward-looking
statements. These statements reflect our current views with respect
to future events or to our future financial performance and involve
known and unknown risks, uncertainties and other factors which may
cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. Given these uncertainties, you should not place undue
reliance on these forward-looking statements.
|
CELLULAR
BIOMEDICINE GROUP, INC.
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
2020
|
|
2019
|
|
|
|
|
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
$
21,597,360
|
|
$
15,443,649
|
|
Restricted
cash
|
-
|
|
17,000,000
|
|
Other
receivables
|
253,749
|
|
750,943
|
|
Prepaid
expenses
|
1,707,265
|
|
835,048
|
|
Total current
assets
|
23,558,374
|
|
34,029,640
|
|
|
|
|
|
|
Investments
|
-
|
|
240,000
|
|
Property, plant and
equipment, net
|
21,338,143
|
|
21,434,414
|
|
Right of
use
|
19,280,349
|
|
20,106,163
|
|
Goodwill
|
7,678,789
|
|
7,678,789
|
|
Intangibles,
net
|
7,035,420
|
|
7,376,940
|
|
Long-term prepaid
expenses and other assets
|
6,997,391
|
|
6,458,354
|
|
Total
assets
|
$
85,888,466
|
|
$
97,324,300
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
Short-term
debt
|
$
14,000,000
|
|
$
14,334,398
|
|
Accounts
payable
|
1,620,314
|
|
2,039,686
|
|
Accrued
expenses
|
2,372,410
|
|
1,904,829
|
|
Taxes
payable
|
30,420
|
|
26,245
|
|
Other current
liabilities
|
5,509,393
|
|
5,367,708
|
|
Total current
liabilities
|
23,532,537
|
|
23,672,866
|
|
|
|
|
|
Other non-current
liabilities
|
17,204,688
|
|
17,933,743
|
|
Total
liabilities
|
40,737,225
|
|
41,606,609
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock, par value $.001, 50,000,000 shares
authorized; none issued and outstanding
as of March 31, 2020 and December
31, 2019, respectively
|
-
|
|
-
|
|
|
|
|
|
Common stock, par value $.001, 300,000,000 shares
authorized; 20,427,185 and
20,359,889 issued; and 19,371,686 and 19,304,390
outstanding, as of March 31, 2020
and December 31, 2019, respectively
|
20,427
|
|
20,360
|
|
Treasury
stock at cost; 1,055,499 shares of common stock as of March 31, 2020 and December 31, 2019,
respectively
|
(14,992,694)
|
|
(14,992,694)
|
|
Additional paid in
capital
|
273,535,311
|
|
272,117,518
|
|
Accumulated deficit
|
(211,514,040)
|
|
(199,966,543)
|
|
Accumulated other comprehensive loss
|
(1,897,763)
|
|
(1,460,950)
|
|
Total stockholders'
equity
|
45,151,241
|
|
55,717,691
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
85,888,466
|
|
$
97,324,300
|
|
CELLULAR
BIOMEDICINE GROUP, INC.
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
|
|
|
|
|
|
|
|
For the Three
Months Ended
|
|
|
March
31,
|
|
|
2020
|
|
2019
|
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
|
|
|
Net
loss
|
|
$
(11,547,497)
|
|
$
(9,336,788)
|
|
Adjustments to
reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
Depreciation
and amortization
|
|
1,593,078
|
|
1,329,699
|
|
Loss on disposal of
assets
|
|
-
|
|
(23)
|
|
Stock based
compensation expense
|
|
936,062
|
|
1,124,562
|
|
Other than temporary
impairment on investments
|
|
240,000
|
|
-
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
Accounts
receivable
|
|
-
|
|
788
|
|
Other
receivables
|
|
493,853
|
|
(161,074)
|
|
Prepaid
expenses
|
|
(884,281)
|
|
(1,038,324)
|
|
Long-term prepaid
expenses and other assets
|
|
(472,222)
|
|
(378,024)
|
|
Accounts
payable
|
|
(744,090)
|
|
426,027
|
|
Accrued
expenses
|
|
486,538
|
|
12,704
|
|
Other current
liabilities
|
|
599,822
|
|
155,980
|
|
Taxes
payable
|
|
4,175
|
|
-
|
|
Other non-current
liabilities
|
|
-
|
|
(71,221)
|
|
Net cash used in operating activities
|
|
(9,294,562)
|
|
(7,935,694)
|
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
|
|
|
Proceeds
from disposal of assets
|
|
-
|
|
359
|
|
Purchases of
intangibles
|
|
(51,687)
|
|
(619,165)
|
|
Purchases of property,
plant and equipment
|
|
(1,582,479)
|
|
(3,545,355)
|
|
Net cash used in investing activities
|
|
(1,634,166)
|
|
(4,164,161)
|
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
|
|
|
Net proceeds from the
issuance of common stock
|
|
-
|
|
16,038,504
|
|
Proceeds from exercise
of stock options
|
|
481,798
|
|
109,261
|
|
Proceeds from
short-term debt
|
|
14,000,000
|
|
6,131,723
|
|
Repayment of
short-term debt
|
|
(14,315,898)
|
|
-
|
|
Repurchase of treasury
stock
|
|
-
|
|
(1,039,028)
|
|
Net cash provided by financing activities
|
|
165,900
|
|
21,240,460
|
|
|
|
|
|
|
EFFECT OF EXCHANGE
RATE CHANGES ON CASH
|
|
(83,461)
|
|
84,032
|
|
|
|
|
|
|
INCREASE (DECREASE)
IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
|
|
(10,846,289)
|
|
9,224,637
|
|
CASH, CASH
EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD
|
|
32,443,649
|
|
52,812,880
|
|
CASH, CASH
EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD
|
|
$
21,597,360
|
|
$
62,037,517
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH
FLOW INFORMATION
|
|
|
|
|
|
|
|
|
|
|
Income tax
refund
|
|
$
3,200
|
|
$
-
|
|
|
|
|
|
|
Cash paid for income
taxes
|
|
$
800
|
|
$
2,400
|
|
|
|
|
|
|
Interest expense
paid
|
|
$
99,271
|
|
$
30,506
|
|
|
|
|
|
|
Interest income from
pledged bank deposits received, netting off withholding
tax
|
|
$
460,041
|
|
$
-
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
March
31,
|
|
|
2020
|
|
2019
|
|
Reconciliation of
cash, cash equivalents and restricted cash in condensed
consolidated statements of cash flows:
|
|
|
|
|
|
Restricted
cash
|
|
$
-
|
|
$
17,000,000
|
|
Cash and cash
equivalents
|
|
21,597,360
|
|
45,037,517
|
|
|
|
|
|
|
Cash, cash equivalents
and restricted cash
|
|
$
21,597,360
|
|
$
62,037,517
|
|
CELLULAR
BIOMEDICINE GROUP, INC.
|
|
CONDENSED
CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE
LOSS
|
|
(UNAUDITED)
|
|
|
|
|
|
|
|
For the Three
Months Ended
|
|
|
March
31,
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
Net sales and
revenue
|
|
$
-
|
|
$
49,265
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Cost of
sales
|
|
-
|
|
8,087
|
|
General and
administrative
|
|
3,431,344
|
|
3,447,734
|
|
Selling and
marketing
|
|
-
|
|
42,260
|
|
Research and
development
|
|
7,759,358
|
|
5,968,096
|
|
Impairment of
investments
|
|
240,000
|
|
-
|
|
Total operating expenses
|
|
11,430,702
|
|
9,466,177
|
|
Operating
loss
|
|
(11,430,702)
|
|
(9,416,912)
|
|
|
|
|
|
|
Other (expense)
income
|
|
|
|
|
|
Interest income,
net
|
|
12,772
|
|
97,034
|
|
Other expense,
net
|
|
(127,792)
|
|
(14,510)
|
|
Total
other (expense) income
|
|
(115,020)
|
|
82,524
|
|
Loss before
taxes
|
|
(11,545,722)
|
|
(9,334,388)
|
|
|
|
|
|
|
Income taxes
provision
|
|
(1,775)
|
|
(2,400)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(11,547,497)
|
|
$
(9,336,788)
|
|
Other comprehensive
income:
|
|
|
|
|
|
Cumulative translation
adjustment
|
|
(436,813)
|
|
396,126
|
|
Total other
comprehensive income:
|
|
(436,813)
|
|
396,126
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
(11,984,310)
|
|
$
(8,940,662)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
:
|
|
|
|
|
|
Basic and
diluted
|
|
$
(0.60)
|
|
$
(0.51)
|
|
|
|
|
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
Basic and
diluted
|
|
19,340,982
|
|
18,152,429
|
Company/Investor Contact:
Derrick C. Li
Head of Strategy and Investor Relations, CBMG
Phone: 917-717-0994
Email: derrick.li@cellbiomedgroup.com
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SOURCE Cellular Biomedicine Group