GAITHERSBURG, Md. and
SHANGHAI, Aug. 12, 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 second quarter and six months ended June 30, 2020.
"We held a virtual research & development day in July to
provide an update on the six clinical programs we have in
development," said Tony (Bizuo) Liu, Chief Executive Officer of
CBMG. "Amid the global pandemic, we continue to enroll
patients in investigator-initiated trials (IIT) for our
clinical programs in China. This includes C-CAR088
anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T
cells (CAR-T) for relapsed or refractory multiple myeloma (MM),
C-CAR039 anti-CD19/CD20 bi-specific CAR-T for
Non-Hodgkin's Lymphoma (NHL), and C-TCR055 alpha-fetoprotein
(AFP) TCR-T in hepatocellular carcinoma (HCC). We look forward to
the completion of our new Rockville facility later this year to support
potential U.S. clinical development for C-CAR039 and C-TIL051
tumor-infiltrating lymphocytes (TIL) for non-small cell lung cancer
(NSCLC). We also continue to enroll patients in China for our off-the-shelf
AlloJoinTM knee osteoarthritis (KOA) Phase II trial. We
plan to submit and present the C-CAR088 and C-CAR039 clinical data
at a major conference later this year. We are happy to report
that we have recently secured borrowings to support our
near-term clinical development."
Clinical Highlights for First Half of 2020 and to
Date:
- C-CAR088 for MM*:
-
- Infused 22 of the 25 enrolled patients; 17 patients with
evaluable data for safety and clinical efficacy
- No Grade 4 or higher cytokine release syndrome (CRS)
- No Grade 2 or higher neurotoxicity and dose limiting
toxicities
- Cytopenia was mostly related to Cy/Flu lymphodepletion
- 17 patients with 100% best overall response; comprised of
5 complete response, 9 very good partial response and 3
partial response
- C-CAR039 for NHL*:
-
- Infused 10 of the 16 enrolled patients
- No Grade 3 or higher CRS was observed
- No Grade 2 or higher neurotoxicity
- Cytopenia was mostly related to Cy/Flu lymphodepletion
- Observed encouraging clinical efficacy with limited number of
patients
- C-TCR055 in HCC:
-
- Initiated an early dose escalation study to evaluate the safety
and efficacy
- Conducted a poster presentation at the American Association for
Cancer Research (AACR) annual meeting: "Selecting Clinical Lead of
TCRs Targeting Alpha-Fetoprotein-Positive Liver Cancer on Balance
of Risk and Benefit"
- On July 13, 2020, the Company
hosted a virtual Research & Development Showcase to present an
overview and update on the current state of its clinical and
pre-clinical programs.
*: As of June 15,
2020
Business Highlights for First Half of 2020 and to
Date:
- Executed a one-year $25 million
convertible bridge loan
- Extended the $16 million
convertible bridge loan repayment schedule to August, 2021
- Obtained $8.6 million lines of
credit
Upcoming Milestones:
- In the next nine months, present our key clinical assets update
at major conferences
- In 2021, execute our C-TIL051 to sponsor and initiate an IIT in
the U.S. for stage IIIB and IV NSCLC patients refractory to
anti-PD1 immunotherapy
- Upon completion, qualify our Rockville facility to support U.S. clinical
development
Financial Results for the Second Quarter and First Half
2020 as compared to the same periods in 2019:
- Net loss allocable to common stockholders for the quarter and
six months ended June 30, 2020 was
$13.5 million and $25.1 million respectively, compared to
$12.1 million and $21.4 million
- General and administrative expenses for the quarter and six
months ended June 30, 2020 were
$3.3 million and $6.7 million, respectively, compared to
$3.2 million and $6.6 million
- Research and development expenses for the quarter and six
months ended June 30, 2020 were
$10.1 million and $17.8 million respectively, compared $9.1 million and $15.0
million
- Net cash used in operating activities for first half of 2020
was $19.8 million, compared to
$18.8 million
- Our cash, cash equivalents and restricted cash decreased to
$13,581,952 at June 30, 2020 compared to $32,443,649 at December
31, 2019. Subsequent to end of the second quarter, we
arranged additional borrowings of $29.3
million to fortify our balance sheet.
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 our
clinical trials, enrollment of clinical trial patients, the
presentation of key clinical assets updates, our activities with
respect to C-TIL051, and the ability of our Rockville site to support U.S. clinical
development, 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:
Derrick C. Li
Head of Strategy and Investor Relations, CBMG
Phone: 917-717-0994
Email: derrick.li@cellbiomedgroup.com
|
|
CELLULAR BIOMEDICINE
GROUP, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
June 30,
|
|
December
31,
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
$
13,581,952
|
|
$
15,443,649
|
|
Restricted
cash
|
-
|
|
17,000,000
|
|
Other
receivables
|
299,124
|
|
750,943
|
|
Prepaid
expenses
|
1,094,270
|
|
835,048
|
|
Total current
assets
|
14,975,346
|
|
34,029,640
|
|
|
|
|
|
|
|
Investments
|
-
|
|
240,000
|
|
Property, plant and
equipment, net
|
22,443,525
|
|
21,434,414
|
|
Right of
use
|
18,670,312
|
|
20,106,163
|
|
Goodwill
|
7,678,789
|
|
7,678,789
|
|
Intangibles,
net
|
6,747,628
|
|
7,376,940
|
|
Long-term prepaid
expenses and other assets
|
7,052,583
|
|
6,458,354
|
|
Total assets
(1)
|
$
77,568,183
|
|
$
97,324,300
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
Short-term
debt
|
$
19,474,822
|
|
$
14,334,398
|
|
Accounts
payable
|
1,517,144
|
|
2,039,686
|
|
Accrued
expenses
|
1,706,967
|
|
1,904,829
|
|
Taxes
payable
|
30,420
|
|
26,245
|
|
Other current
liabilities
|
5,722,765
|
|
5,367,708
|
|
Total current
liabilities
|
28,452,118
|
|
23,672,866
|
|
|
|
|
|
|
|
Other non-current
liabilities
|
16,583,514
|
|
17,933,743
|
|
Total
liabilities
|
45,035,632
|
|
41,606,609
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value $.001,
50,000,000 shares authorized; none issued and outstanding as of
June 30, 2020 and December 31, 2019, respectively
|
-
|
|
-
|
|
|
|
|
|
|
|
Common stock, par value $.001,
300,000,000 shares authorized; 20,481,791 and 20,359,889
issued; and 19,426,292 and 19,304,390 outstanding, as of June 30,
2020 and December 31, 2019, respectively
|
20,482
|
|
20,360
|
|
Treasury
stock at cost; 1,055,499 shares of common stock as of June 30, 2020
and December 31, 2019
|
(14,992,694)
|
|
(14,992,694)
|
|
Additional paid in
capital
|
274,404,670
|
|
272,117,518
|
|
Accumulated deficit
|
(225,046,129)
|
|
(199,966,543)
|
|
Accumulated other comprehensive loss
|
(1,853,778)
|
|
(1,460,950)
|
|
Total stockholders'
equity
|
32,532,551
|
|
55,717,691
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
77,568,183
|
|
$
97,324,300
|
|
|
|
|
|
|
|
|
|
|
|
CELLULAR
BIOMEDICINE GROUP, INC.
|
|
CONDENSED
CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
(UNAUDITED)
|
|
|
|
|
For the Three
Months Ended
|
|
For the Six Months
Ended
|
|
|
|
June
30,
|
|
June
30,
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
Net sales and
revenue
|
$
-
|
|
$
-
|
|
$
-
|
|
$
49,265
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
-
|
|
-
|
|
-
|
|
8,087
|
|
General and
administrative
|
3,280,529
|
|
3,180,709
|
|
6,711,873
|
|
6,628,443
|
|
Selling and
marketing
|
-
|
|
41,252
|
|
-
|
|
83,512
|
|
Research and
development
|
10,086,204
|
|
9,062,526
|
|
17,845,562
|
|
15,030,622
|
|
Impairment of
investments
|
-
|
|
-
|
|
240,000
|
|
-
|
|
Total operating expenses
|
13,366,733
|
|
12,284,487
|
|
24,797,435
|
|
21,750,664
|
|
Operating
loss
|
(13,366,733)
|
|
(12,284,487)
|
|
(24,797,435)
|
|
(21,701,399)
|
|
|
|
|
|
|
|
|
|
|
Other (expense)
income
|
|
|
|
|
|
|
|
|
Interest income,
net
|
22,797
|
|
182,017
|
|
35,569
|
|
279,051
|
|
Other expense,
net
|
(188,153)
|
|
7,123
|
|
(315,945)
|
|
(7,387)
|
|
Total
other (expense) income
|
(165,356)
|
|
189,140
|
|
(280,376)
|
|
271,664
|
|
Loss before
taxes
|
(13,532,089)
|
|
(12,095,347)
|
|
(25,077,811)
|
|
(21,429,735)
|
|
|
|
|
|
|
|
|
|
|
Income taxes
provision
|
-
|
|
(1,350)
|
|
(1,775)
|
|
(3,750)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
(13,532,089)
|
|
$
(12,096,697)
|
|
$
(25,079,586)
|
|
$
(21,433,485)
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
Cumulative translation
adjustment
|
43,985
|
|
(395,525)
|
|
(392,828)
|
|
601
|
|
Total other
comprehensive income (loss):
|
43,985
|
|
(395,525)
|
|
(392,828)
|
|
601
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
$
(13,488,104)
|
|
$
(12,492,222)
|
|
$
(25,472,414)
|
|
$
(21,432,884)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
(0.70)
|
|
$
(0.63)
|
|
$
(1.29)
|
|
$
(1.15)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
19,395,253
|
|
19,223,113
|
|
19,368,118
|
|
18,690,729
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CELLULAR
BIOMEDICINE GROUP, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
For the Six Months
Ended
|
|
|
|
June
30,
|
|
|
|
2020
|
|
2019
|
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
|
|
Net
loss
|
|
$
(25,079,586)
|
|
$
(21,433,485)
|
Adjustments to
reconcile net loss to net cash
|
|
|
|
|
used in operating
activities:
|
|
|
|
|
Depreciation and
amortization
|
|
3,157,829
|
|
2,659,038
|
Loss on disposal of
assets
|
|
149
|
|
92,487
|
Stock based
compensation expense
|
|
1,804,840
|
|
2,113,535
|
Other than temporary
impairment on long-term investments
|
|
240,000
|
|
-
|
Changes in
operating assets and liabilities:
|
|
|
|
|
Accounts
receivable
|
|
-
|
|
785
|
Other
receivables
|
|
448,649
|
|
(337,517)
|
Prepaid
expenses
|
|
(270,666)
|
|
(572,978)
|
Long-term prepaid
expenses and other assets
|
|
(829,714)
|
|
(978,505)
|
Accounts
payable
|
|
(209,527)
|
|
333,463
|
Accrued
expenses
|
|
(179,881)
|
|
(818,327)
|
Taxes
payable
|
|
4,175
|
|
-
|
Other current
liabilities
|
|
1,186,828
|
|
218,903
|
Other non-current
liabilities
|
|
(90,424)
|
|
(74,105)
|
Net cash used in operating activities
|
|
(19,817,328)
|
|
(18,796,706)
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
|
|
Proceeds
from disposal of assets
|
|
-
|
|
359
|
Purchases of
intangibles
|
|
(141,707)
|
|
(752,449)
|
Purchases of
assets
|
|
(4,483,163)
|
|
(7,468,850)
|
Net cash used in investing activities
|
|
(4,624,870)
|
|
(8,220,940)
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
|
|
Net proceeds from the
issuance of common stock
|
|
-
|
|
17,166,199
|
Proceeds from exercise
of stock options
|
|
482,434
|
|
150,788
|
Proceeds from
short-term debt
|
|
19,456,322
|
|
14,546,035
|
Repayment of
short-term debt
|
|
(14,315,898)
|
|
-
|
Repurchase of treasury
stock
|
|
-
|
|
(1,039,028)
|
Net cash provided by financing activities
|
|
5,622,858
|
|
30,823,994
|
|
|
|
|
|
EFFECT OF EXCHANGE
RATE CHANGES ON CASH
|
|
(42,357)
|
|
94,518
|
|
|
|
|
|
(DECREASE)/INCREASE
IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
|
|
(18,861,697)
|
|
3,900,866
|
CASH, CASH
EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD
|
|
32,443,649
|
|
52,812,880
|
CASH, CASH
EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD
|
|
$
13,581,952
|
|
$
56,713,746
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH
FLOW INFORMATION
|
|
|
|
|
|
|
|
|
|
Income tax
refund
|
|
$
3,200
|
|
$
-
|
|
|
|
|
|
Cash paid for income
taxes
|
|
$
800
|
|
$
3,750
|
|
|
|
|
|
Interest expense
paid
|
|
$
99,271
|
|
$
145,159
|
|
|
|
|
|
Interest income from
pledged bank deposits received, netting off withholding
tax
|
|
$
460,041
|
|
$
-
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
June
30,
|
|
|
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
|
|
13,581,952
|
|
39,713,746
|
|
|
|
|
|
Cash, cash equivalents
and restricted cash
|
|
$
13,581,952
|
|
$
56,713,746
|
|
|
|
|
|
|
|
|
|
|
|
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/cellular-biomedicine-group-cbmg-reports-q2-h1-2020-financial-results-and-business-highlights-301111326.html
SOURCE Cellular Biomedicine Group