Cellular Biomedicine Group Inc. (Nasdaq:CBMG) ("CBMG" or the
"Company"), a biomedicine firm engaged in the development of
effective treatments for degenerative and cancerous diseases, today
reported full-year and fourth quarter 2014 financial results for
the period ended December 31, 2014.
"2014 laid the foundation for building a world-class
biotechnology enterprise that was marked by achieving notable
corporate and clinical milestones and meaningful acquisitions that
will drive our business momentum as we move into 2015," said
William (Wei) Cao, PhD, BM, Chief Executive Officer of Cellular
Biomedicine Group. "In addition to our successful listing on
NASDAQ, we accelerated the growth of our Immuno-Oncology platform
through the acquisition of Agreen Biotech Co. Ltd. China ("AG"),
the acquisition of third generation Chimeric Antigen Receptor T
cell (CAR-T), anti-PD-1, CD19 and aAPC cancer immunotherapy
technologies from Persongen Biotechnology Ltd., and the acquisition
of four CAR-T therapies with corresponding Phase I clinical data
and manufacturing knowledge from Chinese PLA General Hospital
("PLAGH", Beijing, also known as "301 Hospital"). The Company's
lead product candidate from our Human Adipose-Derived Mesenchymal
Progenitor Cell (haMPC) Platform, ReJoinTM for the treatment of
Knee Osteoarthritis (KOA), reported positive 12 month results from
its Phase IIa clinical trials in 2014 and we are encouraged by the
interim Phase IIb clinical data released in the first quarter of
2015 which continues to show excellent progress. We look forward to
2015 as we continue to amalgamate novel cancer technology leaders,
deliver promise from our clinical trials to serve several large
unmet medical needs in China and seek to evolve into a
leader in the biotechnology field."
Tony (Bizuo) Liu, Chief Financial Officer of the Company,
commented, "I am pleased to also announce the successful completion
of an $18 million private placement transaction in 2014 and $20
million in 2015 which fortified our cash position. We will continue
to leverage our financial resources to expand our technology
portfolio, strengthen our clinical pipeline, pursue strategic
acquisitions, add world-class scientific talent and evaluate
multi-national licensing opportunities. We believe these strategic
initiatives will further validate our vision of becoming an
innovative cell-therapy company that delivers value to our
shareholders."
Corporate and Clinical Developments of 2014 and Early
2015
During 2014 and 2015 to date, Cellular Biomedicine Group
achieved the following milestones and significant corporate
events:
Clinical Developments
1. Announced positive clinical data from Phase
I of its CAR-T immuno-oncology clinical development programs of
CAR-T CD19 for Acute Lymphocytic Leukemia (B-cell ALL) and CAR-T
CD20 for Advanced Diffuse Large B Cell Lymphoma (DLBCL)
2. Launched a clinical study on human adipose derived
mesenchymal progenitor cell (haMPC) therapy for Cartilage Damage
(CD) resulting from osteoarthritis (OA) or sports injury, which
study also serves as a supporting study of ReJoinTM for Knee
Osteoarthritis (KOA)
3. Released positive 12-month follow-up data analysis of
Phase I/IIa clinical trial for ReJoinTM human adipose-derived
mesenchymal progenitor cell (haMPC) therapy for KOA
4. Announced positive interim 24-week clinical data from
the Phase IIb trial of its ReJoinTM haMPC therapy for KOA
Corporate Developments
5. The Company successfully listed onto Nasdaq Capital
Markets as the first pure-play cell therapy company from China
6. Closed private placement transactions for total gross
proceeds of approximately $38 Million
7. Expanded Intellectual Property portfolio to 69
patents in various stages of approval in China, U.S. and
through the Patent Cooperation Treaty (PCT), including one granted
US Patent and 15 granted China patents
Fourth Quarter and 2014 Financial
Performance
1. Cash Position: Cash and liabilities
at December 31, 2014 of approximately $14.8
million and $4.5 million, respectively. (Subsequently, in
March 2015, the Company closed a private placement transaction for
total gross proceeds of approximately $20,000,000)
2. Net Cash Used in Operating
Activities: Q4 and full-year 2014 operating
cash burn of $2.2 million and $10.3 million,
respectively, compared to $1.3 million and $8.5
million for the same periods in 2013
3. Revenue: Q4 and full-year 2014 revenue
of $0.4 million and $0.6 million, respectively,
compared to $0.1 million and $0.2 million for
the same periods in 2013
4. G&A Expenses: Q4 and full-year 2014
general and administrative expenses of $3.3 million and $8.4
million, respectively, compared to $2.2 million and $9.3 million
for the same periods in 2013. Excluding the stock-based
compensation of $1.9 million and $1.5 million recorded in G&A
expenses for full-year 2014 and 2013, the G&A expenses would
have been $6.5 million and $7.8 respectively.
5. R&D Expenses: Q4 and full-year 2014
research and development expenses of $0.8 million and $2.7 million,
respectively, compared to $0.6 million and $1.9 million for the
same periods a year ago, the increase mainly attributable to
significant activities surrounding the development of our
biomedicine intellectual property, including the implementation of
Phase IIb clinical trials for KOA and launch of the clinical trial
for cartilage damage
6. Net Loss: Q4 and full-year 2014 net
loss allocable to common stock holders was $5.5
million and $15.5 million, respectively, compared
to $6.5 million and $13.8 million for the same
periods in 2013. Excluding the stock-based compensation of $1.9
million and $1.5 million recorded for full-year 2014 and 2013, the
net loss would have been $13.6 million and $12.3 million
respectively.
Primary 2015 Operating Objectives:
1. Publish CAR-T Phase I Clinical Data of CD30 for Hodgkin's
lymphoma and EGFR (HER1) for advanced lung cancer
2. Initiate CAR-T Phase II Clinical Trials of CD19, CD20, CD30
and EGFR (HER1)
3. Expand GMP facilities to 47,000 ft2
4. Release 48-week follow-up data from ReJoinTM Phase IIb
Clinical Trial
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell
therapies for the treatment of certain degenerative diseases and
cancers. Our developmental stem cell, progenitor cell, and
immune cell projects are the result of research and development by
scientists and doctors from China and the United
States. Our flagship GMP facility, consisting of eight independent
cell production lines, is 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, but are not
limited to, risk factors inherent in doing business.
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. |
(FORMERLY EASTBRIDGE
INVESTMENT GROUP CORPORATION) |
CONSOLIDATED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS |
|
|
|
|
|
|
|
For the Year
Ended |
|
December
31, |
|
2014 |
2013 |
|
|
|
Net sales and revenue |
$564,377 |
$204,914 |
|
|
|
Operating expenses: |
|
|
Cost of sales |
213,243 |
296,212 |
General and administrative |
8,413,251 |
9,314,143 |
Selling and marketing |
280,595 |
57,670 |
Research and development |
2,671,932 |
1,890,506 |
Other general expenses |
1,427,840 |
-- |
Total operating expenses |
13,006,861 |
11,558,531 |
Operating loss |
(12,442,484) |
(11,353,617) |
|
|
|
Other income (expense): |
|
|
Interest income |
15,043 |
1,294 |
Other income (expense) |
71,982 |
(6,196) |
Total other income
(expense) |
87,025 |
(4,902) |
Loss from continuing operations before
taxes |
(12,355,459) |
(11,358,519) |
|
|
|
Income tax provision |
-- |
-- |
|
|
|
Loss from continuing operations |
(12,355,459) |
(11,358,519) |
|
|
|
Loss on discontinued
operations, net of tax |
(3,119,152) |
(2,438,514) |
|
|
|
Net loss |
$(15,474,611) |
$(13,797,033) |
Other comprehensive income (loss): |
|
|
Cumulative translation
adjustment |
15,254 |
78,650 |
Unrecognized gain (loss) on
investments |
1,611,045 |
(198,200) |
Total other comprehensive
income (loss): |
1,626,299 |
(119,550) |
|
|
|
Comprehensive loss |
$(13,848,312) |
$(13,916,583) |
|
|
|
Earnings (loss) per share for continuing
operations: |
|
|
Basic |
$(1.43) |
$(1.96) |
Diluted |
$(1.43) |
$(1.96) |
|
|
|
Earnings (loss) per share discontinued
operations: |
|
|
Basic |
$(0.36) |
$(0.42) |
Diluted |
$(0.36) |
$(0.42) |
|
|
|
Earnings (loss) per share net loss: |
|
|
Basic |
$(1.79) |
$(2.38) |
Diluted |
$(1.79) |
$(2.38) |
|
|
|
Weighted average common shares
outstanding: |
|
|
Basic |
8,627,094 |
5,792,888 |
Diluted |
8,627,094 |
5,792,888 |
|
CELLULAR BIOMEDICINE
GROUP, INC. |
(FORMERLY EASTBRIDGE
INVESTMENT GROUP CORPORATION) |
CONSOLIDATED BALANCE
SHEETS |
|
|
|
|
December 31, |
December 31, |
|
2014 |
2013 |
|
|
|
Assets |
|
|
Cash and cash equivalents |
$14,770,584 |
$7,175,215 |
Accounts receivable |
141,029 |
10,581 |
Other receivable |
135,957 |
78,521 |
Inventory |
372,249 |
119,119 |
Prepaid expenses |
565,299 |
56,911 |
Other current assets |
110,347 |
134,661 |
Total current assets |
16,095,465 |
7,575,008 |
|
|
|
Investments |
6,886,033 |
5,105,891 |
Property, plant and equipment,
net |
1,280,410 |
1,014,805 |
Goodwill |
7,678,789 |
3,299,566 |
Intangibles, net |
11,156,676 |
601,456 |
Long-term prepaid expenses and
other assets |
587,729 |
-- |
Total assets |
$43,685,102 |
$17,596,726 |
|
|
|
Liabilities and Stockholders'
Equity |
|
|
|
|
|
Liabilities: |
|
|
Accounts payable |
$426,917 |
$213,891 |
Accrued expenses |
2,074,384 |
503,717 |
Tax payable |
814,288 |
1,164,747 |
Advances payable to related
party |
36,254 |
67,999 |
Other current liabilities |
724,479 |
251,299 |
Total current liabilities |
4,076,322 |
2,201,653 |
|
|
|
Other non-current
liabilities |
452,689 |
-- |
Total liabilities |
4,529,011 |
2,201,653 |
|
|
|
Commitments and Contingencies |
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
Preferred stock, par value
$.001, 50,000,000 shares |
|
|
authorized; none issued and
outstanding as of |
|
|
December 31, 2014 and 2013,
respectively |
-- |
-- |
|
|
|
Common stock, par value $.001,
300,000,000 shares authorized; |
|
|
10,990,335 and 7,382,797 issued
and outstanding |
|
|
as of December 31, 2014 and
2013, respectively |
10,990 |
7,383 |
Additional paid in capital |
75,467,316 |
37,861,593 |
Accumulated deficit |
(37,890,590) |
(22,415,979) |
Accumulated other comprehensive
income (loss) |
1,568,375 |
(57,924) |
Total stockholders' equity |
39,156,091 |
15,395,073 |
|
|
|
Total liabilities and
stockholders' equity |
$43,685,102 |
$17,596,726 |
|
|
|
|
|
|
CELLULAR BIOMEDICINE
GROUP, INC. |
(FORMERLY EASTBRIDGE
INVESTMENT GROUP CORPORATION) |
CONSOLIDATED STATEMENTS
OF CASH FLOWS |
|
|
|
|
For the Year
Ended |
|
December
31, |
|
2014 |
2013 |
|
|
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$(15,474,611) |
$(13,797,033) |
Adjustments to reconcile net loss to net
cash |
|
|
used in operating
activities: |
|
|
Depreciation and
amortization |
1,190,505 |
841,235 |
Loss on disposal of assets |
257,672 |
-- |
Stock based compensation
expense |
1,949,908 |
4,381,077 |
Other than temporary
impairment |
1,427,840 |
-- |
Impairment of goodwill |
3,299,566 |
4,258,967 |
Third party services received
in exchange for disposition of investment stock |
-- |
83,334 |
Loss recognized in excess of
cash received on disposition of investment stock |
5,913 |
138,909 |
Value of stock received for
services |
(1,610,000) |
(3,500,000) |
Deferred tax |
-- |
(76,544) |
Changes in operating assets and
liabilities: |
|
|
Accounts receivable |
20,645 |
10,102 |
Other receivable |
(25,638) |
50,160 |
Inventory |
(78,310) |
(81,878) |
Prepaid expenses |
(494,057) |
(38,793) |
Other current assets |
24,314 |
(84,661) |
Investments |
7,150 |
-- |
Long-term prepaid expenses and
other assets |
(504,678) |
134,229 |
Accounts payable |
165,517 |
40,862 |
Accrued expenses |
409,109 |
(739,839) |
Other current liabilities |
(694,131) |
186,464 |
Taxes payable |
(176,583) |
(10,121) |
Deferred revenue |
-- |
(251,834) |
Net cash used in operating
activities |
(10,299,869) |
(8,455,364) |
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Acquisition of business, net of
cash acquired |
(1,485,548) |
-- |
Purchases of intangibles |
(8,989) |
(5,828) |
Purchases of assets |
(311,625) |
(147,211) |
Net cash used in investing
activities |
(1,806,162) |
(153,039) |
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Proceeds from the issuance of
common stock |
19,700,933 |
11,561,386 |
Proceeds from exercise of stock
options |
19,383 |
-- |
Repayment of advances from
affiliate |
(31,745) |
(1,250) |
Advances from affiliate |
-- |
36,614 |
Net cash provided by financing
activities |
19,688,571 |
11,596,750 |
|
|
|
EFFECT OF EXCHANGE RATE CHANGES ON CASH |
12,829 |
41,972 |
|
|
|
INCREASE IN CASH AND CASH EQUIVALENTS |
7,595,369 |
3,030,319 |
CASH AND CASH EQUIVALENTS, BEGINNING OF
PERIOD |
7,175,215 |
4,144,896 |
CASH AND CASH EQUIVALENTS, END OF PERIOD |
$14,770,584 |
$7,175,215 |
|
|
|
SUPPLEMENTAL CASH FLOW
INFORMATION |
|
|
|
|
|
Cash paid for income taxes |
$460,924 |
$-- |
Non cash financing and investing
activities: |
|
|
Issuance of company stock for accrued
liabilities and advances |
$-- |
$149,475 |
Issuance of company stock for acquisition of
patent |
$1,442,850 |
$-- |
Issuance of company stock for acquisition of
business |
$14,496,256 |
$-- |
CONTACT: Sarah Kelly
Director of Corporate Communications, CBMG
+1 650 566-5064
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Grayling
+1 347-481-3711
vivian.chen@grayling.com
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