GAITHERSBURG, Md. and
SHANGHAI, Nov. 9, 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 its financial results and
business highlights for the third quarter of 2020.
Tony (Bizuo) Liu, Chief Executive Officer, commented on Q3's
progress:
"I'm excited to share our progress in our China Phase I
Investigator Initiated Trial (IIT) assessing the safety and
efficacy of an anti-CD20/19 bispecific CAR-T, C-CAR039, a
2nd generation novel bi-specific CAR-T therapy targeting
both CD19 and CD20 antigens in the treatment of patients with
relapsed or refractory non-Hodgkin lymphoma (r/r NHL). C-CAR039's
objective is to improve both the response rate and duration of
response while limiting antigen escape of CD19 following anti-CD19
CAR-T therapy. C-CAR039 is manufactured in a proprietary process
with serum free, semi-automated, and functionally closed platform
with reduced vein-to-vein time. Thus far we have seen a
complete manufacturing success rate. As of October 30, 2020, 18 of the 21 enrolled patients
received single dose C-CAR039 intravenous infusion with a dose
range of 1.0 x 106 to 5.0 x 106 CAR-T
cells/kg of body weight. 17 patients, including 15 patients with
DLBCL, 1 with follicular lymphoma (FL) and 1 with transformed
follicular lymphoma (tFL) are evaluable for safety (evaluated by
CTCAE V5.0) and 16 patients have one month or longer efficacy
data utilizing the 2014 Lugano Classification for the
assessment of lymphoma. The median age of evaluable, infused
patients was 60 years (range: 28–71 years). The median number of
lines of prior therapies was 3 (range: 1-5). 11 of the 17 patients
were stage III or IV patients (64.7%).
C-CAR039 treatment was well tolerated with no grade 3 or higher
cytokine release syndrome (CRS), and with one grade 1 neurotoxicity
event. Reversible grade 1 or 2 CRS was observed in 15/17 (88.2%) of
patients. At the one-month efficacy evaluation, 15/16 patients
showed clinical improvement with an objective response rate (ORR)
of 94%. The best overall response (BOR) includes 14 CR (87.5%, 12
DLBCL, 1 FL and 1 tFL) and 1 partial response (PR). Cytopenia was
mostly related to Cy/Flu lymphodepletion. 12 patients have at least
3-months follow-up data. The overall survival (OS) at 3 months is
100%. The median follow-up was 156 days (39-345 days), and the
median duration of response (DOR) has not yet been reached.
Furthermore, positive correlation between the expansion of C-CAR039
CAR-T cells detected in the peripheral blood of treated patients
and tumor regression was observed. We remain optimistic that
C-CAR039 shows a potentially competitive safety and a promising
efficacy profile. We are planning further development in a
multicenter Phase Ib trial in China and in the U.S.
Regarding our C-CAR088 anti-BCMA drug development for multiple
myeloma (MM), to date we have infused 26 of the 28 patients
enrolled in the IIT study in China. Our abstract for this
study has been accepted for an oral presentation on Saturday, December 5, 2020, 1:15pm at the 62nd American Society of Hematology
(ASH) Annual Meeting and Exposition.
(https://ash.confex.com/ash/2020/webprogram/Paper138734.html)
We have been utilizing lung cancer tumor specimens for
pre-clinical development and manufacturing in China and in the U.S. Upon completion of the
Rockville, Maryland site in late
Q4, we plan to conduct knowledge transfer from China to the U.S. and utilize our Rockville facility to support early stage U.S.
clinical development for C-TIL051 tumor-infiltrating lymphocytes
(TIL) for non-small cell lung cancer (NSCLC) and C-CAR039 for
NHL.
We are also enrolling patients in China for our off-the-shelf AlloJoin® Phase II
trial in the treatment of knee osteoarthritis (KOA). To date
we have seen fewer than expected adverse events (AE) and AEs are
limited to grades 1 and 2 in the trial participants. We also
initiated development in acute respiratory distress syndrome (ARDS)
and Alzheimer's disease (AD) using allogeneic human adipose
mesenchymal stem cell exosomes (haMSC-Exos) and extracellular
vesicles, respectively, in Shanghai,
China.
We are happy to report that we secured $25 million and $20
million in financing in August and October, respectively, to
support our near-term clinical development and ongoing
operations."
Financial Results for the Third Quarter of 2020
- Net loss allocable to common stockholders for the quarter and
nine months ended September 30, 2020
was $17.0 million and $42.1 million respectively, compared to
$15.9 million and $37.3 million for the same periods in 2019.
- General and administrative expenses for the quarter and nine
months ended September 30, 2020 were
$5.1 million and $11.8 million, respectively, compared to
$3.3 million and $10.0 million for the same periods in 2019.
- Research and development expenses for the quarter and nine
months ended September 30, 2020 were
$12.6 million and $30.5 million respectively, compared $13.1 million and $28.2
million for the same periods in 2019.
- Net cash used in operating activities for the nine months ended
September 30, 2020 was $33.2 million, compared to $28.4 million for the same period in 2019.
- Cash and cash equivalents were $26
million as of September 30,
2020, compared to $13.6
million as of June 30,
2020.
- Short-term debt was $47.9 million
as of September 30, 2020, compared to
$19.5 million as of June 30, 2020.
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,
specific activities, and other statements that are not descriptions
of historical facts, including our statements regarding enrollment
of clinical trial patients and expectations relating to the
development, safety and efficacy of our drugs, 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, including risks associated with the evolving
COVID-19 pandemic and actions taken in response to it. 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 activities and
involve known and unknown risks, uncertainties and other factors
which may cause our actual activities, actions or achievements to
be materially different from any future activities, actions or
achievements expressed or implied by the forward-looking
statements. Given these uncertainties, you should not place undue
reliance on these forward-looking statements.
Company/Investor Contact:
Sarah Kelly
Director of Corporate Communications, CBMG
Phone: (301) 825-5320
Email: sarah.kelly@cellbiomedgroup.com
CELLULAR
BIOMEDICINE GROUP, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
$
26,028,897
|
|
$
15,443,649
|
|
Restricted
cash
|
-
|
|
17,000,000
|
|
Accounts
receivable
|
32,295
|
|
-
|
|
Other
receivables
|
297,919
|
|
750,943
|
|
Prepaid
expenses
|
1,512,172
|
|
835,048
|
|
Total current
assets
|
27,871,283
|
|
34,029,640
|
|
|
|
|
|
|
|
Investments
|
-
|
|
240,000
|
|
Property, plant and
equipment, net
|
24,686,304
|
|
21,434,414
|
|
Right of
use
|
18,521,996
|
|
20,106,163
|
|
Goodwill
|
7,678,789
|
|
7,678,789
|
|
Intangibles,
net
|
6,447,085
|
|
7,376,940
|
|
Long-term prepaid
expenses and other assets
|
7,880,917
|
|
6,458,354
|
|
Total
assets
|
$
93,086,374
|
|
$
97,324,300
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
Short-term
debt
|
$
47,870,256
|
|
$
14,334,398
|
|
Accounts
payable
|
2,747,583
|
|
2,039,686
|
|
Accrued
expenses
|
1,726,200
|
|
1,904,829
|
|
Taxes
payable
|
30,420
|
|
26,245
|
|
Other current
liabilities
|
6,922,762
|
|
5,367,708
|
|
Total current
liabilities
|
59,297,221
|
|
23,672,866
|
|
|
|
|
|
|
|
Other non-current
liabilities
|
16,465,553
|
|
17,933,743
|
|
Total
liabilities
|
75,762,774
|
|
41,606,609
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value $.001, 50,000,000 shares
|
|
|
|
|
authorized; none issued and outstanding as of
|
|
|
|
|
September 30, 2020 and December 31, 2019, respectively
|
-
|
|
-
|
|
|
|
|
|
|
|
Common stock, par value $.001, 300,000,000 shares
authorized;
|
|
|
|
|
20,505,852 and 20,359,889 issued; and 19,450,353 and
19,304,390 outstanding,
|
|
|
|
|
as
of September 30, 2020 and December 31, 2019,
respectively
|
20,506
|
|
20,360
|
|
Treasury
stock at cost; 1,055,499 shares of common stock
|
(14,992,694)
|
|
(14,992,694)
|
|
as
of September 30, 2020 and December 31, 2019,
respectively
|
|
|
|
|
Additional paid in
capital
|
275,338,906
|
|
272,117,518
|
|
Accumulated deficit
|
(242,084,133)
|
|
(199,966,543)
|
|
Accumulated other comprehensive loss
|
(958,985)
|
|
(1,460,950)
|
|
Total stockholders'
equity
|
17,323,600
|
|
55,717,691
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
93,086,374
|
|
$
97,324,300
|
|
CELLULAR
BIOMEDICINE GROUP, INC.
CONDENSED
CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE
LOSS
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
For the Three
Months Ended
|
|
For the Nine
Months Ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
Net sales and
revenue
|
|
$
32,295
|
|
$
-
|
|
$
32,295
|
|
$
49,265
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
7,618
|
|
-
|
|
7,618
|
|
8,087
|
General and
administrative
|
|
5,100,189
|
|
3,326,630
|
|
11,812,062
|
|
9,955,073
|
Selling and
marketing
|
|
-
|
|
38,267
|
|
-
|
|
121,779
|
Research and
development
|
|
12,611,853
|
|
13,126,699
|
|
30,457,415
|
|
28,157,321
|
Impairment of
investments
|
|
-
|
|
-
|
|
240,000
|
|
-
|
Total operating expenses
|
|
17,719,660
|
|
16,491,596
|
|
42,517,095
|
|
38,242,260
|
Operating
loss
|
|
(17,687,365)
|
|
(16,491,596)
|
|
(42,484,800)
|
|
(38,192,995)
|
|
|
|
|
|
|
|
|
|
Other
income
|
|
|
|
|
|
|
|
|
Interest income,
net
|
|
2,774
|
|
352,935
|
|
38,343
|
|
631,986
|
Other income,
net
|
|
646,587
|
|
274,430
|
|
330,642
|
|
267,043
|
Total
other income
|
|
649,361
|
|
627,365
|
|
368,985
|
|
899,029
|
Loss before
taxes
|
|
(17,038,004)
|
|
(15,864,231)
|
|
(42,115,815)
|
|
(37,293,966)
|
|
|
|
|
|
|
|
|
|
Income taxes credit
(provision)
|
|
-
|
|
325
|
|
(1,775)
|
|
(3,425)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(17,038,004)
|
|
$
(15,863,906)
|
|
$
(42,117,590)
|
|
$
(37,297,391)
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
Cumulative translation
adjustment
|
|
894,793
|
|
(303,821)
|
|
501,965
|
|
(303,220)
|
Total other
comprehensive income (loss):
|
|
894,793
|
|
(303,821)
|
|
501,965
|
|
(303,220)
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
(16,143,211)
|
|
$
(16,167,727)
|
|
$
(41,615,625)
|
|
$
(37,600,611)
|
|
|
|
|
|
|
|
|
|
Net loss per share
:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
(0.88)
|
|
$
(0.82)
|
|
$
(2.17)
|
|
$
(1.98)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
19,433,988
|
|
19,256,129
|
|
19,390,235
|
|
18,881,266
|
CELLULAR
BIOMEDICINE GROUP, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
For the Nine
Months Ended
|
|
|
September
30,
|
|
|
2020
|
|
2019
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
|
|
Net
loss
|
|
$
(42,117,590)
|
|
$
(37,297,391)
|
Adjustments to
reconcile net loss to net cash
|
|
|
|
|
used in operating
activities:
|
|
|
|
|
Depreciation and
amortization
|
|
4,850,349
|
|
4,099,029
|
Loss on disposal of
assets
|
|
150
|
|
32,236
|
Stock based
compensation expense
|
|
2,695,850
|
|
3,109,410
|
Other than temporary
impairment on long-term investments
|
|
240,000
|
|
-
|
Changes in
operating assets and liabilities:
|
|
|
|
|
Accounts
receivable
|
|
(32,295)
|
|
763
|
Other
receivables
|
|
458,119
|
|
(491,974)
|
Prepaid
expenses
|
|
(658,723)
|
|
55,519
|
Long-term prepaid
expenses and other assets
|
|
(1,076,037)
|
|
(1,920,077)
|
Accounts
payable
|
|
1,021,393
|
|
4,695,220
|
Accrued
expenses
|
|
(207,542)
|
|
(359,332)
|
Other current
liabilities
|
|
1,735,950
|
|
(297,512)
|
Taxes
payable
|
|
4,175
|
|
(325)
|
Other non-current
liabilities
|
|
(84,093)
|
|
13,035
|
Net cash used in operating activities
|
|
(33,170,294)
|
|
(28,361,399)
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
|
|
Proceeds
from disposal of assets
|
|
-
|
|
172,007
|
Purchases of
intangibles
|
|
(175,632)
|
|
(804,042)
|
Purchases of
assets
|
|
(7,057,292)
|
|
(8,645,724)
|
Net cash used in investing activities
|
|
(7,232,924)
|
|
(9,277,759)
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
|
|
Net proceeds from the
issuance of common stock
|
|
-
|
|
17,166,199
|
Proceeds from exercise
of stock options
|
|
525,684
|
|
195,731
|
Proceeds from
short-term debt
|
|
47,851,757
|
|
14,546,035
|
Repayment of
short-term debt
|
|
(14,315,898)
|
|
-
|
Repurchase of treasury
stock
|
|
-
|
|
(1,039,028)
|
Net cash provided by financing activities
|
|
34,061,543
|
|
30,868,937
|
|
|
|
|
|
EFFECT OF EXCHANGE
RATE CHANGES ON CASH
|
|
(73,077)
|
|
(6,982)
|
|
|
|
|
|
DECREASE IN CASH,
CASH EQUIVALENTS AND RESTRICTED CASH
|
|
(6,414,752)
|
|
(6,777,203)
|
CASH, CASH
EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD
|
|
32,443,649
|
|
52,812,880
|
CASH, CASH
EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD
|
|
$
26,028,897
|
|
$
46,035,677
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH
FLOW INFORMATION
|
|
|
|
|
|
|
|
|
|
Income tax
refund
|
|
$
3,200
|
|
$
-
|
|
|
|
|
|
Cash paid for income
taxes
|
|
$
800
|
|
$
3,750
|
|
|
|
|
|
Interest expense
paid
|
|
$
110,982
|
|
$
309,410
|
|
|
|
|
|
Interest income from
pledged bank deposits received, netting off withholding
tax
|
|
$
460,041
|
|
$
-
|
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SOURCE Cellular Biomedicine Group