Cellular Biomedicine Group Reports Third Quarter 2015 Financial Results and Provides Business Highlights
November 13 2015 - 9:21AM
Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), a biomedicine firm engaged in the development of
effective stem cell therapies for degenerative diseases and
immunotherapies for cancer, today reported financial results for
the quarter ended September 30, 2015 and provided business
highlights.
Dr. William Wei Cao, Chief Executive Officer,
commented, “We achieved pivotal milestones in the third quarter
that redefined CBMG’s business and strategically positioned the
Company as an emerging, bifurcated and world-class immuno-oncology
and cell therapy contender with international aspirations through
the advancement of key infrastructure and clinical
milestones. We are encouraged by the positive clinical
development of our therapeutic platforms in the third quarter. The
Chinese PLA General Hospital (“PLAGH”) CAR-T Phase I clinical trial
for the treatment of patients with EGFR expressing advanced
relapsed/refractory solid tumors in Non-Small Cell Lung Cancer
(“NSCLC”) and cholangiocarcinoma, and the Phase IIa CD20
Non-Hodgkin’s Lymphoma (“NHL”) clinical trial have inspired us to
accelerate their development to treat these terminal conditions.
We are planning to launch multi-site CAR-T and Dendristim
vaccine (previously called GVax) clinical trials in China and are
evaluating options to further develop this prospective treatment in
the U.S. In addition, we continued to strengthen our scientific
team with the appointments of Alan List, M.D., as Chair of the
Scientific Advisory Board and Yihong Yao, Ph.D., as Chief
Scientific Officer.”
“In terms of infrastructure, in addition to our
Shanghai and Wuxi sites, we opened a new GMP facility in Beijing,
and now operate three GMP facilities in China housing nine
independent production lines to address increasing manufacturing
demands.”
“We believe we are one of the few emerging and
versatile biotech companies with a growing revenue-generating T
cell technical service. We have proven our ability to make
acquisitions and expand globally recognized therapies addressing
large and critical markets. We believe we are in an enviable
position for the future in carrying out our mission to deliver
evolutionary science and serving large patient populations,”
concluded Dr. William Wei Cao, Chief Executive Officer of Cellular
Biomedicine Group.
Third Quarter 2015 Financial
Performance
- Cash Position: Cash and cash equivalents
as of September 30, 2015 were $20.1 million compared
to $14.8 million as of December 31, 2014
- Net Cash Used in Operating
Activities: Net cash used in operating activities for
the third quarter of 2015 was $2.9 million, compared
to $3.4 million for the same period in 2014
- Revenue: Revenues in the third quarter
of 2015 were $0.6 million compared to nil for the same
period in 2014. All of the revenue has resulted from our
acquisition of Agreen Biotech Ltd. that provides T cell technical
services, and we are continuing to expand our network of hospitals
to grow our revenue.
- G&A Expenses: General and
administrative expenses for the third quarter of 2015 were $3.5
million compared to $1.9 million for the same period in 2014.
Increased expenses in 2015 were primarily attributed to the hiring
of senior technical leaders, expanded GMP facility expenses, and
amortization of the IP expenses associated with previous
acquisitions.
- R&D Expenses: Research and
development expenses for the third quarter of 2015 were $2.2
million, compared to $0.8 million for the same period in 2014.
Approximately two thirds of the increase resulted from the addition
of scientific talent to our immunotherapy research and development
team, while the remaining increase stems from increased clinical
trial expenditures in CAR-T, Tcm, and automated production
techniques.
- Net Loss: Net loss allocable to common
stock holders was $5.1 million, compared to $2.8 million for
the same period in 2014. Changes in net loss are primarily
attributable to an increase in share-based compensation and
clinical trial expenses.
During and since the third quarter of 2015,
Cellular Biomedicine Group achieved the following milestones and
significant events:
Business Highlights
- Appointed Alan List, MD as Chair of the Scientific Advisory
Board
- Appointed former MedImmune/AstraZeneca Director, Yihong Yao,
Ph.D., B.S., as Chief Scientific Officer
- Opened new GMP facility in Beijing
- Evaluating options for U.S. clinical trials on NSCLC and
Dendristim vaccine immune-cell therapy
Technology Achievements
- Received two new certifications from the China Food and Drug
Administration (the “CFDA”) for its proprietary cell and tissue
preservation media kits respectively, in accordance with the CFDA’s
new regulations announced on June 1, 2015
- Expanded our intellectual property portfolio from 70 to 77
patents in various stages of approval
- Announced preliminary Phase I clinical results of CAR-T
EGFR-HER1 (“CBM-EGFR.1”) for the treatment of patients with EGFR
expressing advanced relapsed/refractory solid tumors, with overall
disease control rate (DCR) of 79% (19 of 24). 100% DCR in
cholangiocarcinoma (5/5), 71% DCR in NSCLC (12/17)
Upcoming Public Events
Management is scheduled to participate in the
following upcoming industry and investor conferences:
- November 18-19, Jefferies 2015 Global Healthcare Conference,
London, UK
- December 1-2, Piper Jaffray Annual Healthcare Conference, New
York, NY
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(UNAUDITED) |
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
Assets |
|
|
|
Cash and
cash equivalents |
$ |
20,106,377 |
|
|
$ |
14,770,584 |
|
Accounts
receivable |
|
410,761 |
|
|
|
141,029 |
|
Other
receivables |
|
319,211 |
|
|
|
135,957 |
|
Inventory |
|
422,077 |
|
|
|
372,249 |
|
Prepaid
expenses |
|
439,657 |
|
|
|
565,299 |
|
Other
current assets |
|
- |
|
|
|
110,347 |
|
Total current
assets |
|
21,698,083 |
|
|
|
16,095,465 |
|
|
|
|
|
|
Investments |
|
13,299,407 |
|
|
|
6,886,033 |
|
Property,
plant and equipment, net |
|
1,726,418 |
|
|
|
1,280,410 |
|
Goodwill |
|
7,678,787 |
|
|
|
7,678,789 |
|
Intangibles, net |
|
16,323,642 |
|
|
|
11,156,676 |
|
Long-term
prepaid expenses and other assets |
|
1,150,296 |
|
|
|
587,729 |
|
Total assets |
$ |
61,876,633 |
|
|
$ |
43,685,102 |
|
|
|
|
|
|
Liabilities and Stockholders'
Equity |
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
Accounts payable |
$ |
146,369 |
|
|
$ |
426,917 |
|
Accrued expenses |
|
2,574,829 |
|
|
|
2,074,384 |
|
Taxes payable |
|
615,800 |
|
|
|
814,288 |
|
Advances payable to
related party |
|
- |
|
|
|
36,254 |
|
Other current
liabilities |
|
1,382,798 |
|
|
|
724,479 |
|
Total current
liabilities |
|
4,719,796 |
|
|
|
4,076,322 |
|
|
|
|
|
|
Other non-current
liabilities |
|
231,085 |
|
|
|
452,689 |
|
Total liabilities |
|
4,950,881 |
|
|
|
4,529,011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock, par
value $.001, 50,000,000 shares |
|
|
|
authorized; none issued
and outstanding as of |
|
|
|
September 30, 2015 and
December 31, 2014, respectively |
|
- |
|
|
|
- |
|
|
|
|
|
|
Common stock, par value
$.001, 300,000,000 shares authorized; |
|
|
|
11,656,857 and
10,990,335 issued and outstanding |
|
|
|
as of September 30,
2015 and December 31, 2014, respectively |
|
11,657 |
|
|
|
10,990 |
|
Additional paid in
capital |
|
101,312,047 |
|
|
|
75,467,316 |
|
Accumulated
deficit |
|
(52,346,434 |
) |
|
|
(37,890,590 |
) |
Accumulated other
comprehensive income (loss) |
|
7,948,482 |
|
|
|
1,568,375 |
|
Total stockholders'
equity |
|
56,925,752 |
|
|
|
39,156,091 |
|
|
|
|
|
|
Total liabilities and
stockholders' equity |
$ |
61,876,633 |
|
|
$ |
43,685,102 |
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
|
|
|
|
Net sales
and revenue |
|
$ |
624,907 |
|
|
$ |
- |
|
|
$ |
1,885,256 |
|
|
$ |
179,120 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of sales |
|
|
443,416 |
|
|
|
- |
|
|
|
1,335,707 |
|
|
|
92,553 |
|
General and
administrative |
|
|
3,467,184 |
|
|
|
1,946,909 |
|
|
|
9,915,956 |
|
|
|
4,901,670 |
|
Selling and
marketing |
|
|
190,152 |
|
|
|
21,311 |
|
|
|
500,393 |
|
|
|
86,806 |
|
Research and
development |
|
|
2,190,240 |
|
|
|
812,227 |
|
|
|
4,968,352 |
|
|
|
2,100,271 |
|
Impairment of
investments |
|
|
- |
|
|
|
- |
|
|
|
123,428 |
|
|
|
- |
|
Total operating
expenses |
|
|
6,290,992 |
|
|
|
2,780,447 |
|
|
|
16,843,836 |
|
|
|
7,181,300 |
|
Operating
loss |
|
|
(5,666,085 |
) |
|
|
(2,780,447 |
) |
|
|
(14,958,580 |
) |
|
|
(7,002,180 |
) |
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
8,386 |
|
|
|
698 |
|
|
|
29,417 |
|
|
|
1,263 |
|
Other income
(expense) |
|
|
492,101 |
|
|
|
(260 |
) |
|
|
502,921 |
|
|
|
94,357 |
|
Total other income |
|
|
500,487 |
|
|
|
438 |
|
|
|
532,338 |
|
|
|
95,620 |
|
Loss from continuing operations
before taxes |
|
|
(5,165,598 |
) |
|
|
(2,780,009 |
) |
|
|
(14,426,242 |
) |
|
|
(6,906,560 |
) |
|
|
|
|
|
|
|
|
|
Income
taxes (expense) credit |
|
|
23,400 |
|
|
|
- |
|
|
|
(29,602 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Loss from
continuing operations |
|
|
(5,142,198 |
) |
|
|
(2,780,009 |
) |
|
|
(14,455,844 |
) |
|
|
(6,906,560 |
) |
|
|
|
|
|
|
|
|
|
Loss on
discontinued operations, net of taxes |
|
|
- |
|
|
|
(43,271 |
) |
|
|
- |
|
|
|
(3,037,514 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(5,142,198 |
) |
|
$ |
(2,823,280 |
) |
|
$ |
(14,455,844 |
) |
|
$ |
(9,944,074 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
Cumulative translation
adjustment |
|
|
(225,198 |
) |
|
|
(1,838 |
) |
|
|
(163,353 |
) |
|
|
(8,673 |
) |
Unrecognized gain
(loss) on investments |
|
|
(1,520,000 |
) |
|
|
(1,005,455 |
) |
|
|
6,543,460 |
|
|
|
2,515,894 |
|
Total other
comprehensive income (loss): |
|
|
(1,745,198 |
) |
|
|
(1,007,293 |
) |
|
|
6,380,107 |
|
|
|
2,507,221 |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(6,887,396 |
) |
|
$ |
(3,830,573 |
) |
|
$ |
(8,075,737 |
) |
|
$ |
(7,436,853 |
) |
|
|
|
|
|
|
|
|
|
Loss per
share for continuing operations: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.44 |
) |
|
$ |
(0.30 |
) |
|
$ |
(1.27 |
) |
|
$ |
(0.85 |
) |
Diluted |
|
$ |
(0.44 |
) |
|
$ |
(0.30 |
) |
|
$ |
(1.27 |
) |
|
$ |
(0.85 |
) |
|
|
|
|
|
|
|
|
|
Loss per
share for discontinued operations: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(0.37 |
) |
Diluted |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
|
|
Net loss
per share : |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.44 |
) |
|
$ |
(0.31 |
) |
|
$ |
(1.27 |
) |
|
$ |
(1.22 |
) |
Diluted |
|
$ |
(0.44 |
) |
|
$ |
(0.31 |
) |
|
$ |
(1.27 |
) |
|
$ |
(1.22 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
11,622,756 |
|
|
|
9,131,576 |
|
|
|
11,399,958 |
|
|
|
8,155,213 |
|
Diluted |
|
|
11,622,756 |
|
|
|
9,131,576 |
|
|
|
11,399,958 |
|
|
|
8,155,213 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
|
|
|
|
|
For the Nine Months Ended |
|
September 30, |
|
|
2015 |
|
|
|
2014 |
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
Net loss |
$ |
(14,455,844 |
) |
|
$ |
(9,944,074 |
) |
Adjustments to reconcile net loss
to net cash |
|
|
|
used in operating activities: |
|
|
|
Depreciation and amortization |
|
1,537,323 |
|
|
|
660,836 |
|
Loss on disposal of assets |
|
- |
|
|
|
12,313 |
|
Stock based compensation
expense |
|
5,672,955 |
|
|
|
1,151,404 |
|
Amortization of deferred stock
compensation |
|
- |
|
|
|
85,671 |
|
Other than temporary impairment on
investments |
|
123,428 |
|
|
|
- |
|
Realized losses from sale of
investments |
|
5,178 |
|
|
|
5,913 |
|
Value of stock received for
services |
|
- |
|
|
|
(1,610,000 |
) |
Impairment of goodwill |
|
- |
|
|
|
3,299,566 |
|
Decrease in fair value of accrued
expenses for the acquisition of intangible assets |
|
(413,559 |
) |
|
|
- |
|
Changes in operating assets and
liabilities: |
|
|
|
Accounts receivable |
|
(275,317 |
) |
|
|
(13,419 |
) |
Other receivables |
|
(176,301 |
) |
|
|
(53,332 |
) |
Inventory |
|
(49,828 |
) |
|
|
(53,857 |
) |
Prepaid expenses |
|
108,055 |
|
|
|
(439,437 |
) |
Other current assets |
|
110,347 |
|
|
|
22,779 |
|
Investments |
|
- |
|
|
|
7,150 |
|
Long-term prepaid expenses and
other assets |
|
(156,704 |
) |
|
|
(458,058 |
) |
Accounts payable |
|
(280,548 |
) |
|
|
(36,988 |
) |
Accrued expenses |
|
183,105 |
|
|
|
371,578 |
|
Advance payable to related
party |
|
(30,216 |
) |
|
|
- |
|
Other current liabilities |
|
(63,426 |
) |
|
|
(1,135,151 |
) |
Taxes payable |
|
(198,488 |
) |
|
|
- |
|
Other non-current liabilities |
|
(212,371 |
) |
|
|
- |
|
Net cash used in operating
activities |
|
(8,572,211 |
) |
|
|
(8,127,106 |
) |
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
Acquisition of business, net of
cash acquired |
|
- |
|
|
|
(190,698 |
) |
Proceed from sale of investments,
net of transaction costs |
|
1,480 |
|
|
|
- |
|
Purchases of intangible assets |
|
(4,577,740 |
) |
|
|
(1,953 |
) |
Purchases of property, plant and
equipment |
|
(918,289 |
) |
|
|
(129,096 |
) |
Net cash used in investing
activities |
|
(5,494,549 |
) |
|
|
(321,747 |
) |
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
Net proceeds from the issuance of
common stock |
|
18,964,849 |
|
|
|
11,121,956 |
|
Proceeds from exercise of stock
options |
|
478,798 |
|
|
|
- |
|
Repayment of advance from
affiliate |
|
- |
|
|
|
(33,468 |
) |
Net cash provided by financing
activities |
|
19,443,647 |
|
|
|
11,088,488 |
|
|
|
|
|
EFFECT OF EXCHANGE RATE
CHANGES ON CASH |
|
(41,094 |
) |
|
|
1,112 |
|
|
|
|
|
INCREASE IN CASH AND
CASH EQUIVALENTS |
|
5,335,793 |
|
|
|
2,640,747 |
|
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD |
|
14,770,584 |
|
|
|
7,175,215 |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD |
$ |
20,106,377 |
|
|
$ |
9,815,962 |
|
|
|
|
|
SUPPLEMENTAL
CASH FLOW INFORMATION |
|
|
|
|
|
|
|
Cash paid for income
taxes |
$ |
99,668 |
|
|
$ |
- |
|
|
|
|
|
Non-cash investing
activities |
|
|
|
Acquisition of intangible assets
through issuance of the Company's stock |
$ |
1,096,399 |
|
|
$ |
1,442,850 |
|
Acquisition of business through
issuance of the Company's stock |
$ |
- |
|
|
$ |
14,496,256 |
|
|
|
|
|
|
|
|
|
About Cellular Biomedicine
Group
Cellular Biomedicine Group, Inc. develops
proprietary cell therapies for the treatment of certain
degenerative and cancerous diseases. Our developmental stem
cell and Immuno-Oncology projects are the result of research and
development by scientists and doctors
from China and the United States. Our GMP facilities
in China, consisting of nine independent cell production lines, are
designed, certified and managed according to U.S. standards.
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.
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Grayling
+1 347 481-3711
vivian.chen@grayling.com
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