Cellular Biomedicine Group Reports First Quarter 2017 Financial Results and Provides Business Highlights
09 May 2017 - 6:01AM
Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), clinical-stage biopharmaceutical firm engaged in the
development of effective immunotherapies for cancer and stem cell
therapies for degenerative diseases, today reported financial
results for the first quarter ended March 31, 2017 and provided
business highlights.
“The first quarter of 2017 was very productive,
with several key achievements, including the commencement of our
second Phase I CAR-T clinical trial utilizing CBMG’s proprietary
and optimized CD19 construct, for the treatment of adult patients
with relapsed or refractory CD19+ B-cell Acute Lymphoblastic
Leukemia (ALL),” commented Tony Liu, Chief Executive Officer of
CBMG. “The award of $2.29 million from the California Institute for
Regenerative Medicine (CIRM) to support pre-clinical studies of
AlloJoinTM in the U.S., moves forward our endeavor into the
U.S. market and the development of an off-the-shelf stem cell
product to treat Knee Osteoarthritis (KOA). The signing of a
collaboration with GE Healthcare Life Sciences China to establish a
joint laboratory within our own GMP facilities in Shanghai credits
our GMP stature and capabilities. We are determined to build on our
accomplishments from the first quarter to continue to strengthen
our innovative pipelines and move our clinical assets into later
stage development. We believe we are ahead of the competitive
curve in addressing the manufacturing barriers to delivering
consistent clinical grade cell therapies which have the potential
to address the large cancer and knee osteoarthritis markets.”
First Quarter 2017 Financial
Performance
- Cash Position: Cash and cash equivalents
as of March 31, 2017 were $33.4 million compared to
$39.3 million as of December 31, 2016.
- Net Cash Used in Operating
Activities: Net cash used in operating activities for
the first quarter of 2017 was $4.86 million, compared
to $3.58 million for the same period in 2016.
- G&A Expenses: General and
administrative expenses for the first quarter of 2017 were $3.2
million compared to $2.8 million for the same period in 2016.
The increase is in large part attributed to the rental increase,
which resulted from the new leased facilities located in the
“Pharma Valley” of Shanghai from January 1, 2017.
- R&D Expenses: Research and
development expenses for the first quarter of 2017 were $3.0
million, compared to $2.4 million for the same period a year ago.
The increase was primarily attributable to headcount increases of
R&D staff and increased expenses related to advancing assets
into clinical trials.
- Net Loss: Net loss allocable to common
stock holders was $6.2 million, compared to $4.2 million for
the same period in 2016.
Business & Technology Highlights of
2017 To Date
- Commenced CALL-1 (“CAR-T against Acute Lymphoblastic Leukemia”)
Phase I clinical trial in China utilizing its optimized proprietary
C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T)
therapy for the treatment of patients with relapsed or refractory
(r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL);
- Awarded $2.29 million by California Institute for Regenerative
Medicine (CIRM), California’s stem cell agency, to support
pre-clinical studies of AlloJoinTM, CBMG’s “Off-the-Shelf”
Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the
treatment of Knee Osteoarthritis in the United States;• On
May 4, 2017, the Company received $1.2 million from the CIRM grant,
the first of four disbursements
- Completed expansion of its 30,000 square foot facility in
Huishan High Tech Park in Wuxi, China, with 20,000 square feet of
the Wuxi GMP facility dedicated to advanced stem cell culturing,
centralized plasmid and viral vector production, cell banking and
development of reagents;
- Began construction of a new GMP facility in “Pharma Valley” in
Shanghai Zhangjiang High-Tech Park, which will consist of 40,000
square feet dedicated to advanced cell manufacturing;
- Established a strategic research collaboration with GE
Healthcare Life Sciences China to co-develop certain high-quality
industrial control processes in Chimeric Antigen Receptor T-cell
(CAR-T) and stem cell manufacturing and to form a joint laboratory
within CBMG’s new Shanghai Zhangjiang GMP-facility dedicated
to the joint research and development of a functionally integrated
and automated immunotherapy cell preparation system.
About Cellular Biomedicine Group Cellular
Biomedicine Group, Inc. (NASDAQ:CBMG) develops proprietary cell
therapies for the treatment of cancer and degenerative diseases. We
conduct immuno-oncology and stem cell clinical trials in China
using products from our integrated GMP laboratory. Our GMP
facilities in China, consisting of twelve independent cell
production lines, are designed and managed according to both China
and U.S. GMP standards. CBMG recently commenced two Phase I
human clinical trials in China using CAR-T to treat
relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL)
and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an
ongoing Phase I trial in China for AlloJoinTM (CBMG’s
“Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem
Cell) for the treatment of Knee Osteoarthritis (KOA). CBMG was
recently awarded $2.29 million from the California Institute for
Regenerative Medicine (CIRM) to support pre-clinical studies of
AlloJoinTM for Knee Osteoarthritis in the United States. The
Company also recently announced a strategic partnership with GE
Healthcare Life Sciences China to establish a joint technology
laboratory to develop control processes for the manufacture of
CAR-T and stem cell therapies. 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 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 risks inherent in doing business, trends affecting the
global economy, including the devaluation of the RMB by China in
August 2015 and other risks detailed from time to time in CBMG’s
reports filed with the Securities and Exchange Commission,
quarterly reports on form 10-Q, current reports on form 8-K and
annual reports on form 10-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, they 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. |
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
AND COMPREHENSIVE LOSS |
(UNAUDITED) |
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
March 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
Net sales and
revenue |
|
$ |
98,425 |
|
|
$ |
488,491 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
Cost of
sales |
|
|
37,402 |
|
|
|
503,193 |
|
General
and administrative |
|
|
3,185,247 |
|
|
|
2,775,925 |
|
Selling
and marketing |
|
|
117,884 |
|
|
|
178,754 |
|
Research
and development |
|
|
3,044,125 |
|
|
|
2,398,362 |
|
Total operating
expenses |
|
|
6,384,658 |
|
|
|
5,856,234 |
|
Operating loss |
|
|
(6,286,233 |
) |
|
|
(5,367,743 |
) |
|
|
|
|
|
Other income |
|
|
|
|
Interest
income |
|
|
49,182 |
|
|
|
17,050 |
|
Other
income |
|
|
77,508 |
|
|
|
16,320 |
|
Total other income |
|
|
126,690 |
|
|
|
33,370 |
|
Loss before taxes |
|
|
(6,159,543 |
) |
|
|
(5,334,373 |
) |
|
|
|
|
|
Income taxes credit
(provision) |
|
|
(2,450 |
) |
|
|
1,124,260 |
|
|
|
|
|
|
Net loss |
|
$ |
(6,161,993 |
) |
|
$ |
(4,210,113 |
) |
Other comprehensive
income: |
|
|
|
|
Cumulative translation adjustment |
|
|
53,669 |
|
|
|
16,073 |
|
Unrealized gain on
investments, net of tax of nil and $4,514,060, for the three months
ended March 31, 2017 and 2016, respectively |
|
|
- |
|
|
|
16,416,517 |
|
Total
other comprehensive income: |
|
|
53,669 |
|
|
|
16,432,590 |
|
|
|
|
|
|
Comprehensive income
(loss) |
|
$ |
(6,108,324 |
) |
|
$ |
12,222,477 |
|
|
|
|
|
|
Net loss per share
: |
|
|
|
|
Basic |
|
$ |
(0.43 |
) |
|
$ |
(0.35 |
) |
Diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.35 |
) |
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
Basic |
|
|
14,281,745 |
|
|
|
11,884,066 |
|
Diluted |
|
|
14,281,745 |
|
|
|
11,884,066 |
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(UNAUDITED) |
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
Assets |
|
|
|
|
Cash and cash equivalents |
$ |
33,361,784 |
|
|
|
$ |
39,252,432 |
|
Accounts receivable, less allowance for doubtful amounts of
$10,218 |
|
|
|
|
and $10,163 as of March 31, 2017 and December 31, 2016,
respectively |
|
79,602 |
|
|
|
|
39,974 |
|
Other receivables |
|
813,077 |
|
|
|
|
412,727 |
|
Prepaid expenses |
|
1,071,447 |
|
|
|
|
986,951 |
|
Total current assets |
|
35,325,910 |
|
|
|
|
40,692,084 |
|
|
|
|
|
|
|
Investments |
|
509,424 |
|
|
|
|
509,424 |
|
Property, plant and equipment, net |
|
4,449,268 |
|
|
|
|
4,117,739 |
|
Goodwill |
|
7,678,789 |
|
|
|
|
7,678,789 |
|
Intangibles, net |
|
13,677,958 |
|
|
|
|
14,092,581 |
|
Long-term prepaid expenses and other assets |
|
1,949,542 |
|
|
|
|
1,537,850 |
|
Total assets |
$ |
63,590,891 |
|
|
|
$ |
68,628,467 |
|
|
|
|
|
|
|
Liabilities and Stockholders'
Equity |
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
Accounts payable |
$ |
782,450 |
|
|
|
$ |
216,154 |
|
Accrued expenses |
|
325,486 |
|
|
|
|
1,168,787 |
|
Taxes payable |
|
31,325 |
|
|
|
|
28,875 |
|
Other current liabilities |
|
866,223 |
|
|
|
|
950,220 |
|
Total current liabilities |
|
2,005,484 |
|
|
|
|
2,364,036 |
|
|
|
|
|
|
|
Other
non-current liabilities |
|
362,356 |
|
|
|
|
370,477 |
|
Total liabilities |
|
2,367,840 |
|
|
|
|
2,734,513 |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value $.001, 50,000,000 shares |
|
|
|
|
authorized; none issued and outstanding as of |
|
|
|
|
March 31, 2017 and December 31, 2016, respectively |
|
- |
|
|
|
|
- |
|
|
|
|
|
|
|
Common stock, par value $.001, 300,000,000 shares
authorized; |
|
|
|
|
14,286,013 and 14,281,378 issued and outstanding |
|
|
|
|
as of March 31, 2017 and December 31, 2016, respectively |
|
14,286 |
|
|
|
|
14,281 |
|
Additional paid in capital |
|
153,980,468 |
|
|
|
|
152,543,052 |
|
Accumulated deficit |
|
(91,708,680 |
) |
|
|
|
(85,546,687 |
) |
Accumulated other comprehensive loss |
|
(1,063,023 |
) |
|
|
|
(1,116,692 |
) |
Total stockholders' equity |
|
61,223,051 |
|
|
|
|
65,893,954 |
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
63,590,891 |
|
|
|
$ |
68,628,467 |
|
|
|
|
|
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS(UNAUDITED) |
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
March 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
Net
loss |
|
$ |
(6,161,993 |
) |
|
$ |
(4,210,113 |
) |
Adjustments to reconcile net loss to net cash |
|
|
|
|
used in
operating activities: |
|
|
|
|
Depreciation and amortization |
|
|
669,739 |
|
|
|
671,649 |
|
Loss on
disposal of assets |
|
|
237 |
|
|
|
- |
|
Stock
based compensation expense |
|
|
1,431,907 |
|
|
|
1,266,063 |
|
Changes
in operating assets and liabilities: |
|
|
|
|
Accounts
receivable |
|
|
(39,411 |
) |
|
|
50,764 |
|
Other
receivables |
|
|
(398,190 |
) |
|
|
9,705 |
|
Inventory |
|
|
- |
|
|
|
(96,083 |
) |
Prepaid
expenses |
|
|
(78,832 |
) |
|
|
(274,829 |
) |
Taxes
recoverable |
|
|
- |
|
|
|
150,082 |
|
Long-term
prepaid expenses and other assets |
|
|
6,524 |
|
|
|
(38,522 |
) |
Accounts
payable |
|
|
565,236 |
|
|
|
(51,992 |
) |
Accrued
expenses |
|
|
(844,172 |
) |
|
|
57,178 |
|
Other
current liabilities |
|
|
(2,012 |
) |
|
|
29,415 |
|
Taxes
payable |
|
|
2,450 |
|
|
|
32,450 |
|
Deferred
tax liabilities |
|
|
- |
|
|
|
(1,128,515 |
) |
Other
non-current liabilities |
|
|
(10,146 |
) |
|
|
(50,049 |
) |
Net cash
used in operating activities |
|
|
(4,858,663 |
) |
|
|
(3,582,797 |
) |
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
Purchases
of intangibles |
|
|
(23,268 |
) |
|
|
- |
|
Purchases
of property, plant and equipment |
|
|
(1,026,994 |
) |
|
|
(674,736 |
) |
Net cash
used in investing activities |
|
|
(1,050,262 |
) |
|
|
(674,736 |
) |
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
Net
proceeds from the issuance of common stock |
|
|
- |
|
|
|
4,970,002 |
|
Proceeds
from exercise of stock options |
|
|
5,514 |
|
|
|
93,249 |
|
Net cash
provided by financing activities |
|
|
5,514 |
|
|
|
5,063,251 |
|
|
|
|
|
|
EFFECT OF EXCHANGE RATE
CHANGES ON CASH |
|
|
12,763 |
|
|
|
(22,786 |
) |
|
|
|
|
|
INCREASE (DECREASE) IN
CASH AND CASH EQUIVALENTS |
|
|
(5,890,648 |
) |
|
|
782,932 |
|
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD |
|
|
39,252,432 |
|
|
|
14,884,597 |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD |
|
$ |
33,361,784 |
|
|
$ |
15,667,529 |
|
|
|
|
|
|
SUPPLEMENTAL
CASH FLOW INFORMATION |
|
|
|
|
|
|
|
|
|
Cash paid for income
taxes |
|
$ |
- |
|
|
$ |
(4,255 |
) |
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Citigate Dewe Rogerson
+1 347 481-3711
vivian.chen@citigatedr.com
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