Cellular Biomedicine Group Reports Third Quarter Financial Results and Recent Operational Highlights
November 08 2016 - 4:15PM
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 third quarter ended
September 30, 2016.
“In recent months, we have been diligently
preparing for the launch of our upcoming CD19 and CD20 clinical
studies and strengthening our CAR-T intellectual property
portfolio,” commented Tony (Bizuo) Liu, CBMG’s Chief Executive
Officer. “We believe that since August 2015, the China Food and
Drug Administration has been working towards formalizing a national
cell therapy policy that will lay the groundwork for the safe use
of immune cell and stem cell therapy treatments in China.
Although the PRC government is still in the process of
codifying industry regulations for such cell therapies, in
anticipation of potential future market opportunities, we have
accelerated the launch of multiple Phase I/IIb clinical studies
with CAR-T CD19 and CD20 assets to advance our immuno-oncology
pipeline. We have a strong balance sheet to finance our
current clinical studies and to further expand our translational
medicine research and development.”
Third Quarter 2016 Financial Performance
1. Cash Position: $44.1 million cash and
cash equivalents as compared to $14.9 million as of December 31,
2015. 2. Cash Used in Operating
Activities: We used $3.3 million and $12.1 million
for the three months and nine months ended September 30, 2016 in
operating activities as compared to $2.9 million and $8.6 million
for the same periods in 2015. 3. G&A
Expenses: General and administrative expenses for the
three months and nine months ended September 30, 2016 were $2.8
million and $8.6 million respectively, compared to $3.5 million and
$9.9 million for the same periods in 2015. 4. R&D
Expenses: Research and development expenses for the
three months and nine months ended September 30, 2016 were $2.9
million and $8.3 million respectively, compared to $2.2 million and
$5.0 million for the same periods in 2015.5. Net
Loss: Net loss allocable to common stock holders for
the three months ended September 30, 2016 was $10.7 million,
compared to $5.1 million for the same period in 2015. A $4.6
million impairment charge was incurred in the third quarter due to
legacy, non-core business investments.
Business and Operational Highlights for the Third
Quarter 2016 to date
- The Company signed a tenancy deposit agreement to lease a
10,500 square meters facility located in Shanghai;
- Appointment of Dr. Zhou Hansheng as a Director of the Company;
and
- Completed treatment of eighteen patients in Phase I clinical
study of AlloJoinTM haMPC therapy for Knee Osteoarthritis
(KOA).
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 twelve 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 Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
Net sales
and revenue |
|
$ |
10,012 |
|
|
$ |
624,907 |
|
|
$ |
570,102 |
|
|
$ |
1,885,256 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
9,128 |
|
|
|
443,416 |
|
|
|
835,908 |
|
|
|
1,335,707 |
|
|
General and
administrative |
|
|
2,790,305 |
|
|
|
3,467,184 |
|
|
|
8,638,877 |
|
|
|
9,915,956 |
|
|
Selling and
marketing |
|
|
124,143 |
|
|
|
190,152 |
|
|
|
342,377 |
|
|
|
500,393 |
|
|
Research and
development |
|
|
2,897,736 |
|
|
|
2,190,240 |
|
|
|
8,268,953 |
|
|
|
4,968,352 |
|
|
Impairment of
investments |
|
|
4,611,714 |
|
|
|
- |
|
|
|
4,611,714 |
|
|
|
123,428 |
|
|
Total operating
expenses |
|
|
10,433,026 |
|
|
|
6,290,992 |
|
|
|
22,697,829 |
|
|
|
16,843,836 |
|
|
Operating
loss |
|
|
(10,423,014 |
) |
|
|
(5,666,085 |
) |
|
|
(22,127,727 |
) |
|
|
(14,958,580 |
) |
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
22,338 |
|
|
|
8,386 |
|
|
|
57,678 |
|
|
|
29,417 |
|
|
Other income
(expense) |
|
|
(17,314 |
) |
|
|
492,101 |
|
|
|
6,652 |
|
|
|
502,921 |
|
|
Total other income,
net |
|
|
5,024 |
|
|
|
500,487 |
|
|
|
64,330 |
|
|
|
532,338 |
|
|
Loss before
taxes |
|
|
(10,417,990 |
) |
|
|
(5,165,598 |
) |
|
|
(22,063,397 |
) |
|
|
(14,426,242 |
) |
|
|
|
|
|
|
|
|
|
|
|
Income
taxes credit (provision) |
|
|
(243,230 |
) |
|
|
23,400 |
|
|
|
(5,218 |
) |
|
|
(29,602 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(10,661,220 |
) |
|
$ |
(5,142,198 |
) |
|
$ |
(22,068,615 |
) |
|
$ |
(14,455,844 |
) |
|
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
Cumulative translation
adjustment |
|
|
(58,824 |
) |
|
|
(225,198 |
) |
|
|
(314,189 |
) |
|
|
(163,353 |
) |
|
Unrealized gain (loss)
on investments, net of tax |
|
|
- |
|
|
|
(1,520,000 |
) |
|
|
5,300,633 |
|
|
|
6,543,460 |
|
|
Reclassification
adjustments, net of tax, in connection with other-than-temporary
impairment of investments |
|
|
(5,557,939 |
) |
|
|
- |
|
|
|
(5,557,939 |
) |
|
|
- |
|
|
Total other
comprehensive income (loss): |
|
|
(5,616,763 |
) |
|
|
(1,745,198 |
) |
|
|
(571,495 |
) |
|
|
6,380,107 |
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive gain (loss) |
|
$ |
(16,277,983 |
) |
|
$ |
(6,887,396 |
) |
|
$ |
(22,640,110 |
) |
|
$ |
(8,075,737 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share : |
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.75 |
) |
|
$ |
(0.44 |
) |
|
$ |
(1.67 |
) |
|
$ |
(1.27 |
) |
|
Diluted |
|
$ |
(0.75 |
) |
|
$ |
(0.44 |
) |
|
$ |
(1.67 |
) |
|
$ |
(1.27 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
|
14,128,465 |
|
|
|
11,622,756 |
|
|
|
13,253,290 |
|
|
|
11,399,958 |
|
|
Diluted |
|
|
14,128,465 |
|
|
|
11,622,756 |
|
|
|
13,253,290 |
|
|
|
11,399,958 |
|
|
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(UNAUDITED) |
|
|
September 30, |
|
December 31, |
|
2016 |
|
2015 |
|
|
|
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
44,115,886 |
|
|
$ |
14,884,597 |
|
Accounts receivable, less allowance
for doubtful amounts of $10,707 and $nil as of September 30,
2016 and December 31, 2015, respectively |
|
53,477 |
|
|
|
630,332 |
|
Other receivables |
|
264,802 |
|
|
|
271,344 |
|
Inventory |
|
253,173 |
|
|
|
390,886 |
|
Prepaid expenses |
|
661,144 |
|
|
|
367,050 |
|
Taxes recoverable |
|
- |
|
|
|
150,082 |
|
Total current assets |
|
45,348,482 |
|
|
|
16,694,291 |
|
|
|
|
|
Investments |
|
509,424 |
|
|
|
5,379,407 |
|
Property, plant and equipment,
net |
|
3,119,174 |
|
|
|
2,768,900 |
|
Goodwill |
|
7,678,789 |
|
|
|
7,678,789 |
|
Intangibles, net |
|
14,570,556 |
|
|
|
15,949,100 |
|
Long-term prepaid expenses and
other assets |
|
1,507,686 |
|
|
|
989,935 |
|
Total assets |
$ |
72,734,111 |
|
|
$ |
49,460,422 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
Liabilities: |
|
|
|
Accounts payable |
$ |
220,205 |
|
|
$ |
260,886 |
|
Accrued expenses |
|
663,880 |
|
|
|
845,087 |
|
Taxes payable |
|
30,000 |
|
|
|
- |
|
Other current liabilities |
|
1,015,076 |
|
|
|
1,913,284 |
|
Total current liabilities |
|
1,929,161 |
|
|
|
3,019,257 |
|
|
|
|
|
Other non-current
liabilities |
|
10,482 |
|
|
|
76,229 |
|
Total liabilities |
|
1,939,643 |
|
|
|
3,095,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
|
|
|
Preferred stock, par value $.001,
50,000,000 shares authorized; none issued and outstanding as of
September 30, 2016 and December 31, 2015, respectively |
|
- |
|
|
|
- |
|
|
|
|
|
Common stock, par value $.001,
300,000,000 shares authorized; 14,240,610 and 11,711,645 issued and
outstanding as of September 30, 2016 and December 31, 2015,
respectively |
|
14,241 |
|
|
|
11,711 |
|
Additional paid in capital |
|
150,874,763 |
|
|
|
103,807,651 |
|
Accumulated deficit |
|
(79,406,926 |
) |
|
|
(57,338,311 |
) |
Accumulated other comprehensive
income (loss) |
|
(687,610 |
) |
|
|
(116,115 |
) |
Total stockholders' equity |
|
70,794,468 |
|
|
|
46,364,936 |
|
|
|
|
|
Total liabilities and stockholders'
equity |
$ |
72,734,111 |
|
|
$ |
49,460,422 |
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
|
|
|
For the Nine Months Ended |
|
|
September 30, |
|
|
2016 |
|
2015 |
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
Net loss |
|
$ |
(22,068,615 |
) |
|
$ |
(14,455,844 |
) |
Adjustments to
reconcile net loss to net cash used in operating
activities: |
|
|
|
|
Depreciation and amortization |
|
|
2,034,411 |
|
|
|
1,537,323 |
|
Loss on disposal of assets |
|
|
1,034 |
|
|
|
- |
|
Stock based compensation
expense |
|
|
3,944,125 |
|
|
|
5,672,955 |
|
Decrease in fair value of accrued
expenses for the acquisition of intangible assets |
|
|
- |
|
|
|
(413,559 |
) |
Other than temporary impairment on
investments |
|
|
4,611,714 |
|
|
|
123,428 |
|
Realized losses from sale of
investments |
|
|
- |
|
|
|
5,178 |
|
Inventory provision |
|
|
110,145 |
|
|
|
- |
|
Allowance for doubtful account |
|
|
10,707 |
|
|
|
- |
|
Changes in operating
assets and liabilities: |
|
|
|
|
Accounts receivable |
|
|
548,268 |
|
|
|
(275,317 |
) |
Other receivables |
|
|
1,275 |
|
|
|
(176,301 |
) |
Inventory |
|
|
33,398 |
|
|
|
(49,828 |
) |
Prepaid expenses |
|
|
(307,924 |
) |
|
|
108,055 |
|
Taxes recoverable |
|
|
150,082 |
|
|
|
- |
|
Other current assets |
|
|
- |
|
|
|
110,347 |
|
Long-term prepaid expenses and
other assets |
|
|
(376,214 |
) |
|
|
(156,704 |
) |
Accounts payable |
|
|
(33,281 |
) |
|
|
(280,548 |
) |
Accrued expenses |
|
|
(167,615 |
) |
|
|
183,105 |
|
Advances payable to related
party |
|
|
- |
|
|
|
(30,216 |
) |
Other current liabilities |
|
|
(528,430 |
) |
|
|
(63,426 |
) |
Taxes payable |
|
|
30,000 |
|
|
|
(198,488 |
) |
Other non-current liabilities |
|
|
(65,449 |
) |
|
|
(212,371 |
) |
Net cash used in operating
activities |
|
|
(12,072,369 |
) |
|
|
(8,572,211 |
) |
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
Proceed from sale of investments,
net of issuance cost paid |
|
|
- |
|
|
|
1,480 |
|
Purchases of intangibles |
|
|
(11,160 |
) |
|
|
(4,577,740 |
) |
Purchases of assets |
|
|
(1,642,179 |
) |
|
|
(918,289 |
) |
Net cash used in investing
activities |
|
|
(1,653,339 |
) |
|
|
(5,494,549 |
) |
|
|
|
|
|
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 |
|
|
685,712 |
|
|
|
478,798 |
|
Net cash provided by financing
activities |
|
|
43,123,086 |
|
|
|
19,443,647 |
|
|
|
|
|
|
EFFECT OF EXCHANGE RATE
CHANGES ON CASH |
|
|
(166,089 |
) |
|
|
(41,094 |
) |
|
|
|
|
|
INCREASE IN CASH AND
CASH EQUIVALENTS |
|
|
29,231,289 |
|
|
|
5,335,793 |
|
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD |
|
|
14,884,597 |
|
|
|
14,770,584 |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD |
|
$ |
44,115,886 |
|
|
$ |
20,106,377 |
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL
CASH FLOW INFORMATION |
|
|
|
|
Cash paid for income
taxes |
|
$ |
6,705 |
|
|
$ |
99,668 |
|
|
|
|
|
|
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
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Grayling
+1 347 481-371
vivian.chen@grayling.com
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