Cellular Biomedicine Group Reports Third Quarter Financial Results and Recent Operational Highlights
November 09 2017 - 8:30AM
Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), a clinical-stage biopharmaceutical company 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, 2017.
“In line with our progress towards patient
advocacy, recently we built out our new Shanghai facility, which we
believe has one of the largest cell therapy capacities in the
world. It houses the newly launched CBMG-GE Joint Laboratory of
Cell Therapy and CBMG-Thermo Fisher Scientific Joint Innovation
& Application Center. We believe the GE and Thermo Fisher
strategic partnerships will further enhance our automation,
efficiency and quality systems,” commented Tony (Bizuo) Liu,
CBMG’s Chief Executive Officer. “We expect to release topline data
readout from our Phase I clinical trials for CARD-1 and CALL-1
Chimeric Antigen Receptor (CAR) T-cell treatment for Diffuse Large
B-Cell Lymphoma (DLBCL) and Acute Lymphoblastic Leukemia (ALL), and
final data readout from our AlloJoin™ Phase I clinical trial for
off-the-shelf Knee Osteoarthritis (KOA) therapy in China in the
first half of 2018. And we remain optimistic that the U.S. FDA’s
recent approval of certain CAR-T therapies for leukemia and
lymphoma and last month’s China State Council’s guidelines on
clinical trial reform will accelerate the review and approval
process and migration to fast-track designation for credible and
compliant CAR-T therapies in China, our addressable CAR-T
market.”
Third Quarter 2017 Financial Performance
1. Cash Position: $16.3 million cash and cash
equivalents as of September 30, 2017 as compared to $27.3 million
as of June 30, 2017. In the third quarter of 2017 we used $11
million, which mainly comprised of $4 million for capital
expenditure, $1 million in stock repurchase and $6 million for
operations. We used $3.3 million for the same periods in 2016 for
operations. 2. G&A Expenses: General and
administrative expenses for the three months and nine months ended
September 30, 2017 were $3.0 million and $9.5 million respectively,
compared to $2.8 million and $8.6 million for the same periods in
2016. 3. R&D Expenses: Research and
development expenses for the three months and nine months ended
September 30, 2017 were $4.1 million and $10.5 million
respectively, compared to $2.9 million and $8.3 million for the
same periods in 2016. 4. Net Loss: Net loss
allocable to common stock holders for the three months ended
September 30, 2017 was $6.2 million, compared to $10.7 million for
the same period in 2016. The decline in net loss mainly derived
from the recognition of other than temporary impairment on stock
investment of $4.6 million in 2016, which was one-off loss and
there was no such case in 2017.
Business and Operational Highlights for the Third
Quarter 2017 to date
- Opened new Shanghai facility in “Pharma Valley” in Zhangjiang
High-Tech Park
- Established a strategic partnership with Thermo Fisher
Scientific (China) Ltd. to build “CBMG-Thermo Fisher Scientific
Joint Innovation & Application Center” in CBMG’s new Shanghai
facility
- Launched “CBMG-GE Joint Laboratory of Cell Therapy” with GE
Healthcare Life Sciences China in CBMG’s new Shanghai facility
In the next 12 months, we aim to accomplish the following,
though there can be no assurances that we will be able to
accomplish these goals:
- Confirm the safety and tolerability profile in an
investigator-sponsored Phase I trial of C-CAR011 in China in
refractory aggressive DLBCL and to initiate a larger Phase II
clinical trial as soon as practicable;
- Confirm the safety and tolerability profile in an
investigator-sponsored phase I trial of C-CAR011 in relapsed and
refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) in
China, and to prepare for a follow up multicenter Phase IIb
trial;
- Submit to the CFDA an IND package for C-CAR011 in treating
patients with CD19+ B-cell malignancies;
- Seek opportunities to file new CAR-T and other patents in China
and potentially the rest of the world;
- Continue to seek advanced technologies and partnerships to
bolster our position in the CAR-T market in China;
- Bolster R&D resources to fortify our intellectual
properties portfolio and scientific development. Continue to
develop a competitive Immuno-oncology pipeline for CBMG;
- Assess the changes in the cell therapy competitive landscape
and revise our corporate development strategy;
- Complete Chemistry, Manufacturing and Controls (CMC),
non-clinical and preclinical study data package to prepare for
Allogeneic KOA IND filing in the United States;
- Initiate clinical study to support the Biological License
Application (BLA) for Allogeneic KOA study in the United
States;
- Bolster R&D resources to fortify our intellectual
properties portfolio and scientific development;
- Improve liquidity and fortify our balance sheet by courting
institutional investors;
- Evaluate new regenerative medicine technology platform for
other indications and review recent development in the competitive
landscape;
- Explore new CAR-T opportunities for international collaboration
and /or partnership;
- Expand our cell manufacturing capacity and
capabilities;
- Evaluate the feasibility of sponsoring a multi-site Phase I/II
NSCLC clinical study to support the Biological license
application (BLA) for the U.S. and China CD40L GVAX trial in
combination with anti-PD1;
- Implement our GE Joint Technology Laboratory to develop control
processes for the manufacture of CAR-T and Stem Cell
Therapies;
- Implement steps to advance our Thermo Fisher joint Cell Therapy
Technology Innovation and Application Center; and
- Elevate our corporate development strategy on maintaining the
CAR-T and regenerative medicine dual technology platform.
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 currently has ongoing CAR-T
Phase I clinical trials in China; CARD-1 for Diffuse Large B-cell
Lymphoma (DLBCL) and Non-Hodgkin Lymphoma (NHL) and CALL-1 for
adult Acute Lymphoblastic Leukemia (ALL), utilizing CBMG’s
proprietary and optimized CD19 construct, as well as an ongoing
Phase I trial in China for AlloJoin™ (CBMG’s “Off-the-Shelf”
Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the
treatment of Knee Osteoarthritis (KOA). 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, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales and
revenue |
|
$ |
106,787 |
|
|
$ |
10,012 |
|
|
$ |
268,126 |
|
|
$ |
570,102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
55,294 |
|
|
|
9,128 |
|
|
|
130,793 |
|
|
|
835,908 |
|
|
General
and administrative |
|
|
3,023,390 |
|
|
|
2,790,305 |
|
|
|
9,527,730 |
|
|
|
8,638,877 |
|
|
Selling
and marketing |
|
|
85,742 |
|
|
|
124,143 |
|
|
|
280,011 |
|
|
|
342,377 |
|
|
Research
and development |
|
|
4,076,186 |
|
|
|
2,897,736 |
|
|
|
10,469,820 |
|
|
|
8,268,953 |
|
|
Impairment of investments |
|
|
- |
|
|
|
4,611,714 |
|
|
|
- |
|
|
|
4,611,714 |
|
|
Total
operating expenses |
|
|
7,240,612 |
|
|
|
10,433,026 |
|
|
|
20,408,354 |
|
|
|
22,697,829 |
|
|
Operating loss |
|
|
(7,133,825 |
) |
|
|
(10,423,014 |
) |
|
|
(20,140,228 |
) |
|
|
(22,127,727 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income : |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
23,933 |
|
|
|
22,338 |
|
|
|
113,688 |
|
|
|
57,678 |
|
|
Other
income (expense) |
|
|
907,678 |
|
|
|
(17,314 |
) |
|
|
1,461,265 |
|
|
|
6,652 |
|
|
Total
other income |
|
|
931,611 |
|
|
|
5,024 |
|
|
|
1,574,953 |
|
|
|
64,330 |
|
|
Loss before taxes |
|
|
(6,202,214 |
) |
|
|
(10,417,990 |
) |
|
|
(18,565,275 |
) |
|
|
(22,063,397 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes
provision |
|
|
- |
|
|
|
(243,230 |
) |
|
|
(2,450 |
) |
|
|
(5,218 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,202,214 |
) |
|
$ |
(10,661,220 |
) |
|
$ |
(18,567,725 |
) |
|
$ |
(22,068,615 |
) |
|
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
Cumulative translation adjustment |
|
|
291,665 |
|
|
|
(58,824 |
) |
|
|
637,786 |
|
|
|
(314,189 |
) |
|
Unrealized gain (loss) on investments, net of tax |
|
|
- |
|
|
|
- |
|
|
|
(240,000 |
) |
|
|
5,300,633 |
|
|
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): |
|
|
291,665 |
|
|
|
(5,616,763 |
) |
|
|
397,786 |
|
|
|
(571,495 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(5,910,549 |
) |
|
$ |
(16,277,983 |
) |
|
$ |
(18,169,939 |
) |
|
$ |
(22,640,110 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.43 |
) |
|
$ |
(0.75 |
) |
|
$ |
(1.30 |
) |
|
$ |
(1.67 |
) |
|
Diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.75 |
) |
|
$ |
(1.30 |
) |
|
$ |
(1.67 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
14,349,569 |
|
|
|
14,128,465 |
|
|
|
14,310,344 |
|
|
|
13,253,290 |
|
|
Diluted |
|
|
14,349,569 |
|
|
|
14,128,465 |
|
|
|
14,310,344 |
|
|
|
13,253,290 |
|
|
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(UNAUDITED) |
|
|
|
|
|
September 30, |
|
December 31, |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
16,292,031 |
|
|
$ |
39,252,432 |
|
Accounts
receivable, less allowance for doubtful amounts of $10,622 |
|
|
|
|
|
|
|
and
$10,163 as of September 30, 2017 and December 31, 2016,
respectively |
|
145,384 |
|
|
|
39,974 |
|
Other
receivables |
|
935,106 |
|
|
|
412,727 |
|
Prepaid
expenses |
|
1,696,082 |
|
|
|
986,951 |
|
Total
current assets |
|
19,068,603 |
|
|
|
40,692,084 |
|
|
|
|
|
|
|
|
|
Investments |
|
269,424 |
|
|
|
509,424 |
|
Property,
plant and equipment, net |
|
11,045,150 |
|
|
|
4,117,739 |
|
Goodwill |
|
7,678,789 |
|
|
|
7,678,789 |
|
Intangibles, net |
|
12,844,078 |
|
|
|
14,092,581 |
|
Long-term
prepaid expenses and other assets |
|
2,720,582 |
|
|
|
1,537,850 |
|
Total
assets |
$ |
53,626,626 |
|
|
$ |
68,628,467 |
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
$ |
1,236,257 |
|
|
$ |
216,154 |
|
Accrued
expenses |
|
728,908 |
|
|
|
1,168,787 |
|
Taxes
payable |
|
28,875 |
|
|
|
28,875 |
|
Deferred
income |
|
510,419 |
|
|
|
- |
|
Other
current liabilities |
|
1,357,952 |
|
|
|
950,220 |
|
Total
current liabilities |
|
3,862,411 |
|
|
|
2,364,036 |
|
|
|
|
|
|
|
|
|
Other non-current
liabilities |
|
- |
|
|
|
370,477 |
|
Total
liabilities |
|
3,862,411 |
|
|
|
2,734,513 |
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock, par value $.001, 50,000,000 shares |
|
|
|
|
|
|
|
authorized; none issued and outstanding as of |
|
|
|
|
|
|
|
September
30, 2017 and December 31, 2016, respectively |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Common
stock, par value $.001, 300,000,000 shares authorized; |
|
|
|
|
|
|
|
14,375,506 and 14,281,378 issued; and 14,091,181 and 14,281,378
outstanding, |
|
|
|
|
|
|
|
as of
September 30, 2017 and December 31, 2016, respectively |
|
14,376 |
|
|
|
14,281 |
|
Treasury
stock at cost; 284,325 and nil shares of common stock |
|
|
|
|
|
|
|
as of
September 30, 2017 and December 31, 2016, respectively |
|
(2,443,122 |
) |
|
|
- |
|
Additional paid in capital |
|
157,026,279 |
|
|
|
152,543,052 |
|
Accumulated deficit |
|
(104,114,412 |
) |
|
|
(85,546,687 |
) |
Accumulated other comprehensive income (loss) |
|
(718,906 |
) |
|
|
(1,116,692 |
) |
Total
stockholders' equity |
|
49,764,215 |
|
|
|
65,893,954 |
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
$ |
53,626,626 |
|
|
$ |
68,628,467 |
|
|
|
|
|
|
|
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
|
|
|
|
|
|
|
For the Nine Months Ended |
|
|
September 30, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(18,567,725 |
) |
|
$ |
(22,068,615 |
) |
Adjustments to reconcile net loss to net cash |
|
|
|
|
|
|
|
|
used in
operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
2,125,391 |
|
|
|
2,034,411 |
|
Loss on
disposal of assets |
|
|
317 |
|
|
|
1,034 |
|
Stock
based compensation expense |
|
|
4,240,822 |
|
|
|
3,944,125 |
|
Other
than temporary impairment on investments |
|
|
- |
|
|
|
4,611,714 |
|
Inventory
provision |
|
|
- |
|
|
|
110,145 |
|
Allowance
for doubtful account |
|
|
- |
|
|
|
10,707 |
|
Changes
in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts
receivable |
|
|
(103,701 |
) |
|
|
548,268 |
|
Other
receivables |
|
|
(496,229 |
) |
|
|
1,275 |
|
Inventory |
|
|
- |
|
|
|
33,398 |
|
Prepaid
expenses |
|
|
(669,592 |
) |
|
|
(307,924 |
) |
Taxes
recoverable |
|
|
- |
|
|
|
150,082 |
|
Long-term
prepaid expenses and other assets |
|
|
(936,168 |
) |
|
|
(376,214 |
) |
Accounts
payable |
|
|
1,012,693 |
|
|
|
(33,281 |
) |
Accrued
expenses |
|
|
(475,274 |
) |
|
|
(167,615 |
) |
Deferred
income |
|
|
510,419 |
|
|
|
- |
|
Other
current liabilities |
|
|
(206,196 |
) |
|
|
(528,430 |
) |
Taxes
payable |
|
|
- |
|
|
|
30,000 |
|
Other
non-current liabilities |
|
|
(386,504 |
) |
|
|
(65,449 |
) |
Net cash
used in operating activities |
|
|
(13,951,747 |
) |
|
|
(12,072,369 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds
from disposal of assets |
|
|
286 |
|
|
|
- |
|
Purchases
of intangibles |
|
|
(23,562 |
) |
|
|
(11,160 |
) |
Purchases
of assets |
|
|
(6,978,348 |
) |
|
|
(1,642,179 |
) |
Net cash
used in investing activities |
|
|
(7,001,624 |
) |
|
|
(1,653,339 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net
proceeds from the issuance of common stock |
|
|
- |
|
|
|
42,437,374 |
|
Proceeds
from exercise of stock options |
|
|
232,910 |
|
|
|
685,712 |
|
Repurchase of treasury stock |
|
|
(2,443,122 |
) |
|
|
- |
|
Net cash
provided by financing activities |
|
|
(2,210,212 |
) |
|
|
43,123,086 |
|
|
|
|
|
|
|
|
|
|
EFFECT OF EXCHANGE RATE
CHANGES ON CASH |
|
|
203,182 |
|
|
|
(166,089 |
) |
|
|
|
|
|
|
|
|
|
INCREASE IN CASH AND
CASH EQUIVALENTS |
|
|
(22,960,401 |
) |
|
|
29,231,289 |
|
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD |
|
|
39,252,432 |
|
|
|
14,884,597 |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD |
|
$ |
16,292,031 |
|
|
$ |
44,115,886 |
|
|
|
|
|
|
Contacts: Sarah Kelly Director of
Corporate Communications, CBMG+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
Cellular Biomedicine (NASDAQ:CBMG)
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