Cellular Biomedicine Group Reports Second Quarter and First Half 2016 Financial Results and Business Highlights
August 09 2016 - 6:26AM
- Ended Second Quarter with $47.5 million in Cash
-
Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), a clinical-stage biomedicine firm engaged in the
development of immunotherapies for cancer and effective stem cell
therapies for degenerative diseases, today reported financial
results and business highlights for the second quarter and six
months ended June 30, 2016.
“In the first half of 2016, we made several
significant advancements towards the operating objectives for our
dual technology platforms of immuno-oncology and stem cells,”
commented Tony (Bizuo) Liu, CBMG’s Chief Executive Officer.
“The completion of a $43.13 million strategic investment has
strengthened our capabilities to continue to invest in research and
development, optimize our clinical process and expand our focus on
the CAR-T pipeline. We anticipate in the coming quarters
launching clinical trials in China on CAR-T CD19 and CD20
constructs and to further bolster our immuno-oncology
pipeline. We have completed patient treatment in the Phase I
trial of AlloJoinTM, our off-the-shelf allogeneic adipose-derived
progenitor cell (haMPC) therapy for Knee Osteoarthritis (KOA) in
China, and are encouraged to see no serious adverse events thus
far. We continue to evaluate the feasibility of initiating a
clinical study of AlloJoinTM under IND to support the same
indication in the United States. As we look forward to the
remainder of 2016, we will continue to prioritize our
immuno-oncology and stem cell clinical pipelines for multiple
indications that serve large addressable markets while facilitating
future partnerships and collaborations that will enhance our
ability to develop safe and effective
therapies.” Second Quarter and First Half 2016
Financial Performance
1. Cash Position: Cash and
cash equivalents as of June 30, 2016 were $47.5 million compared to
$14.9 million as of December 31, 2015. This increase was due to a
private placement financing in February and April 2016 for gross
proceeds of approximately $43 million, offset by cash used in
operating and investment activities. 2. Net Cash Used in
Operating Activities: Net cash used in operating
activities for the quarter and six months ended June 30, 2016 was
$5.2 million and $8.8 million, respectively, compared to $3.3
million and $5.7 million for the same periods in 2015. 3.
G&A Expenses: General and administrative expenses
for the quarter and six months ended June 30, 2016 were $3.1
million and $5.8 million, respectively, compared to $3.8 million
and $6.4 million for the same periods in 2015. 4. R&D
Expenses: Research and development expenses for the
quarter and six months ended June 30, 2016 were $3 million and $5.4
million respectively, compared to $1.3 million and $2.8 million for
the same periods in 2015. The increase of R&D costs was
primarily attributed to:5. Net Loss: Net loss
allocable to common stock holders for the quarter and six months
ended June 30, 2016 was $7.2 million and $11.4 million
respectively, compared to $5 million and $9.3 million for the same
periods in 2015. Changes in net loss are primarily attributable to
changes in operations of our biomedicine segment, which are
described above.
Recent Business and Technology Highlights
- Completed treatment for eighteen patients in Phase I trial of
AlloJoinTM haMPC therapy for Knee Osteoarthritis (KOA);
- China Patent Office granted the Company’s patent application
on genetically engineered anti-CD20 Chimeric Antigen
Receptor-positive NKT cells, its production and application;
- Advanced the Company’s cash position following the closing of
an agreement with Wuhan Dangdai Science & Technology Industries
Group Inc. to invest an aggregate of $43.13 million for 2.27
million shares of the Company’s common stock, representing a 16.2%
post-money stake investment as of April 15, 2016;
- Appointment of Dr. Zhou Hansheng as a member of the Board of
Directors.
Pipeline Update
- Conducted single-center Phase I trial of AlloJoinTM haMPC
therapy for Knee Osteoarthritis (KOA) in China
- Eighteen patients have received two dose intra-articular
injections at three week intervals and have not been presented with
any serious adverse events thus far
- Patients will be monitored over the next 12 months for safety
and efficacy signs
- Phase I clinical research trial for AlloJoin™ is registered at
ClinicalTrials.gov under the number NCT02641860
- Anticipate announcement of sponsorship of multi-indication
clinical studies with multiple institutions using CBMG’s CD19 and
CD20 constructs and stem cell technologies by Q12017 after the
technologies are optimized and manufacturing capabilities are in
place
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.
|
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, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
Net sales and
revenue |
|
$ |
71,599 |
|
|
$ |
656,959 |
|
|
$ |
560,090 |
|
|
$ |
1,260,349 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of sales |
|
|
323,587 |
|
|
|
398,229 |
|
|
|
826,780 |
|
|
|
892,291 |
|
General and administrative |
|
|
3,072,647 |
|
|
|
3,768,535 |
|
|
|
5,848,572 |
|
|
|
6,448,772 |
|
Selling and marketing |
|
|
39,480 |
|
|
|
161,219 |
|
|
|
218,234 |
|
|
|
310,241 |
|
Research and development |
|
|
2,972,855 |
|
|
|
1,322,692 |
|
|
|
5,371,217 |
|
|
|
2,778,112 |
|
Impairment of investments |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
123,428 |
|
Total operating expenses |
|
|
6,408,569 |
|
|
|
5,650,675 |
|
|
|
12,264,803 |
|
|
|
10,552,844 |
|
Operating loss |
|
|
(6,336,970 |
) |
|
|
(4,993,716 |
) |
|
|
(11,704,713 |
) |
|
|
(9,292,495 |
) |
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
18,290 |
|
|
|
5,920 |
|
|
|
35,340 |
|
|
|
21,031 |
|
Other income (expense) |
|
|
7,646 |
|
|
|
13,523 |
|
|
|
23,966 |
|
|
|
10,820 |
|
Total other income |
|
|
25,936 |
|
|
|
19,443 |
|
|
|
59,306 |
|
|
|
31,851 |
|
Loss before taxes |
|
|
(6,311,034 |
) |
|
|
(4,974,273 |
) |
|
|
(11,645,407 |
) |
|
|
(9,260,644 |
) |
|
|
|
|
|
|
|
|
|
Income taxes credit
(provision) |
|
|
(886,248 |
) |
|
|
(52,202 |
) |
|
|
238,012 |
|
|
|
(53,002 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,197,282 |
) |
|
$ |
(5,026,475 |
) |
|
$ |
(11,407,395 |
) |
|
$ |
(9,313,646 |
) |
Other comprehensive
income (loss): |
|
|
|
|
|
|
|
|
Cumulative translation
adjustment |
|
|
(271,438 |
) |
|
|
42,236 |
|
|
|
(255,365 |
) |
|
|
61,845 |
|
Unrealized gain (loss) on
investments, net of tax |
|
|
(11,115,884 |
) |
|
|
10,631,731 |
|
|
|
5,300,633 |
|
|
|
8,063,460 |
|
Total other comprehensive income
(loss): |
|
|
(11,387,322 |
) |
|
|
10,673,967 |
|
|
|
5,045,268 |
|
|
|
8,125,305 |
|
|
|
|
|
|
|
|
|
|
Comprehensive gain
(loss) |
|
$ |
(18,584,604 |
) |
|
$ |
5,647,492 |
|
|
$ |
(6,362,127 |
) |
|
$ |
(1,188,341 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.52 |
) |
|
$ |
(0.44 |
) |
|
$ |
(0.89 |
) |
|
$ |
(0.83 |
) |
Diluted |
|
$ |
(0.52 |
) |
|
$ |
(0.44 |
) |
|
$ |
(0.89 |
) |
|
$ |
(0.83 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
13,737,722 |
|
|
|
11,531,497 |
|
|
|
12,810,894 |
|
|
|
11,286,712 |
|
Diluted |
|
|
13,737,722 |
|
|
|
11,531,497 |
|
|
|
12,810,894 |
|
|
|
11,286,712 |
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(UNAUDITED) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
Assets |
|
|
|
Cash and
cash equivalents |
$ |
47,470,196 |
|
|
$ |
14,884,597 |
|
Accounts
receivable, less allowance for doubtful amounts of $10,782
|
|
|
|
and
$nil as of June 30, 2016 and December 31, 2015, respectively |
|
330,860 |
|
|
|
630,332 |
|
Other
receivables |
|
245,073 |
|
|
|
271,344 |
|
Inventory |
|
313,837 |
|
|
|
390,886 |
|
Prepaid
expenses |
|
811,403 |
|
|
|
367,050 |
|
Taxes
recoverable |
|
- |
|
|
|
150,082 |
|
Total current
assets |
|
49,171,369 |
|
|
|
16,694,291 |
|
|
|
|
|
|
Investments |
|
11,211,137 |
|
|
|
5,379,407 |
|
Property,
plant and equipment, net |
|
3,204,157 |
|
|
|
2,768,900 |
|
Goodwill |
|
7,678,789 |
|
|
|
7,678,789 |
|
Intangibles, net |
|
15,018,223 |
|
|
|
15,949,100 |
|
Long-term
prepaid expenses and other assets |
|
1,256,973 |
|
|
|
989,935 |
|
Total assets |
$ |
87,540,648 |
|
|
$ |
49,460,422 |
|
|
|
|
|
|
Liabilities and Stockholders'
Equity |
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
Accounts payable |
$ |
136,355 |
|
|
$ |
260,886 |
|
Accrued expenses |
|
457,392 |
|
|
|
845,087 |
|
Taxes payable |
|
30,000 |
|
|
|
- |
|
Other current
liabilities |
|
1,574,592 |
|
|
|
1,913,284 |
|
Total current
liabilities |
|
2,198,339 |
|
|
|
3,019,257 |
|
|
|
|
|
|
Deferred
tax liabilities |
|
288,830 |
|
|
|
- |
|
Other
non-current liabilities |
|
25,636 |
|
|
|
76,229 |
|
Total liabilities |
|
2,512,805 |
|
|
|
3,095,486 |
|
|
|
|
|
|
Commitments
and Contingencies |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock, par
value $.001, 50,000,000 shares |
|
|
|
authorized; none issued
and outstanding as of |
|
|
|
June 30, 2016 and
December 31, 2015, respectively |
|
- |
|
|
|
- |
|
|
|
|
|
|
Common stock, par value
$.001, 300,000,000 shares authorized; |
|
|
|
14,099,228 and
11,711,645 issued and outstanding |
|
|
|
as of June 30, 2016 and
December 31, 2015, respectively |
|
14,099 |
|
|
|
11,711 |
|
Additional paid in
capital |
|
148,830,297 |
|
|
|
103,807,651 |
|
Accumulated
deficit |
|
(68,745,706 |
) |
|
|
(57,338,311 |
) |
Accumulated other
comprehensive income (loss) |
|
4,929,153 |
|
|
|
(116,115 |
) |
Total stockholders'
equity |
|
85,027,843 |
|
|
|
46,364,936 |
|
|
|
|
|
|
Total liabilities and
stockholders' equity |
$ |
87,540,648 |
|
|
$ |
49,460,422 |
|
|
|
|
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
|
|
|
|
|
|
|
For the Six Months Ended |
|
|
June 30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
Net loss |
|
$ |
(11,407,395 |
) |
|
$ |
(9,313,646 |
) |
Adjustments to reconcile net loss
to net cash |
|
|
|
|
used in operating activities: |
|
|
|
|
Depreciation and amortization |
|
|
1,349,137 |
|
|
|
928,531 |
|
Stock based compensation
expense |
|
|
2,412,261 |
|
|
|
3,618,050 |
|
Other than temporary impairment on
investments |
|
|
- |
|
|
|
123,428 |
|
Realized losses from sale of
investments |
|
|
- |
|
|
|
5,178 |
|
Inventory provision |
|
|
105,919 |
|
|
|
- |
|
Allowance for doubtful account |
|
|
10,782 |
|
|
|
- |
|
Changes in operating assets and
liabilities: |
|
|
|
|
Accounts receivable |
|
|
275,333 |
|
|
|
(304,173 |
) |
Other receivables |
|
|
20,521 |
|
|
|
(222,716 |
) |
Inventory |
|
|
(25,309 |
) |
|
|
(27,839 |
) |
Prepaid expenses |
|
|
(457,032 |
) |
|
|
(8,427 |
) |
Taxes recoverable |
|
|
150,082 |
|
|
|
- |
|
Other current assets |
|
|
- |
|
|
|
110,347 |
|
Long-term prepaid expenses and
other assets |
|
|
(259,624 |
) |
|
|
(73,031 |
) |
Accounts payable |
|
|
(124,531 |
) |
|
|
(320,305 |
) |
Accrued expenses |
|
|
(387,695 |
) |
|
|
112,026 |
|
Advances payable to related
party |
|
|
- |
|
|
|
(30,216 |
) |
Other current liabilities |
|
|
(152,605 |
) |
|
|
88,991 |
|
Taxes payable |
|
|
30,000 |
|
|
|
(173,739 |
) |
Deferred tax liabilities |
|
|
(242,267 |
) |
|
|
- |
|
Other non-current liabilities |
|
|
(50,049 |
) |
|
|
(212,265 |
) |
Net cash used in operating
activities |
|
|
(8,752,472 |
) |
|
|
(5,699,806 |
) |
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
Proceed from sale of investments,
net of issuance cost paid |
|
|
- |
|
|
|
1,480 |
|
Purchases of intangibles |
|
|
- |
|
|
|
(4,385,940 |
) |
Purchases of assets |
|
|
(1,161,568 |
) |
|
|
(224,826 |
) |
Net cash used in investing
activities |
|
|
(1,161,568 |
) |
|
|
(4,609,286 |
) |
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
Net proceeds from the issuance of
common stock |
|
|
42,437,374 |
|
|
|
18,964,849 |
|
Proceeds from exercise of stock
options |
|
|
175,399 |
|
|
|
234,599 |
|
Net cash provided by financing
activities |
|
|
42,612,773 |
|
|
|
19,199,448 |
|
|
|
|
|
|
EFFECT OF EXCHANGE RATE
CHANGES ON CASH |
|
|
(113,134 |
) |
|
|
(9,856 |
) |
|
|
|
|
|
INCREASE IN CASH AND
CASH EQUIVALENTS |
|
|
32,585,599 |
|
|
|
8,880,500 |
|
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD |
|
|
14,884,597 |
|
|
|
14,770,584 |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD |
|
$ |
47,470,196 |
|
|
$ |
23,651,084 |
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL
CASH FLOW INFORMATION |
|
|
|
|
|
|
|
|
|
Cash paid for income
taxes |
|
$ |
(6,705 |
) |
|
$ |
(226,855 |
) |
|
|
|
|
|
Non-cash investing
activities |
|
|
|
|
Acquisition of intangible assets
through issuance of the Company's stock |
|
$ |
- |
|
|
$ |
1,096,399 |
|
|
|
|
|
|
Contacts:
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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