Cellular Biomedicine Group Reports Second Quarter and First Half 2018 Financial Results and Business Highlights
August 08 2018 - 7:31AM
- China Food and Drug
Administration (CFDA) Accepts the Company’s Investigational New
Drug (IND) Applications for anti-CD19 CAR-T
Therapy Targeting NHL and ALL
- Moved to New R&D Center in Gaithersburg, Maryland,
USA
Cellular Biomedicine Group Inc. (NASDAQ:
CBMG) (“CBMG” or the “Company”), a clinical-stage
biopharmaceutical firm engaged in the development of
immunotherapies for cancer and stem cell therapies for degenerative
diseases, today reported financial results and business highlights
for the second quarter and six months ended June 30, 2018.
“The acceptance of CBMG’s IND application for
“C-CAR011” anti-CD19 chimeric antigen receptor T cell (CAR-T)
therapy, for the treatment of adult patients with B-cell
Non-Hodgkin’s lymphoma (NHL) and acute lymphoblastic leukemia (ALL)
reinforces the strength of our immuno-oncology platform. We look
forward to working with the CFDA to obtain approval to move to the
next phase of development,” commented Tony (Bizuo) Liu, Chief
Executive Officer of CBMG. “We continue to deploy our working
capital to pursue and develop a robust non-CD19 pipeline targeting
other liquid and solid tumors. We are also advancing our quality
systems and automated manufacturing capabilities by utilizing
digital technologies with the goal of becoming a premier
international biopharma company and a preferred collaborator for
cell therapy development in China. With the expansion and
relocation of our U.S. R&D center to Gaithersburg, Maryland, we
are committed to leverage our talented team to develop the latest
technology in cancer cell therapy. Being in the heart of this
renowned research hub presents us with opportunities to collaborate
with leading experts in this ecosystem to bridge new therapies
developed in the U.S. into our clinical development in China,
ultimately leading to serve the China market.”
Second Quarter and First Half 2018
Financial Performance
- G&A
Expenses: General and administrative expenses remain
relatively flat for the six months ended June 30, 2018 compared to
the same period in 2017 due to the efficient management and
utilization of resources. General and administrative expenses
for the quarter and six months ended June 30, 2018 were $3.1
million and $6.3 million, respectively, compared to $3.3 million
and $6.4 million for the same periods in 2017.
- R&D Expenses:
Research and development expenses grew substantially for the six
months ended June 30, 2018 compared to the same period in 2017 due
to the expanded commitment to research and development, process
improvement and anticipated clinical activities. Research and
development expenses for the quarter and six months ended June 30,
2018 were $6.2 million and $11.4 million respectively, compared to
$3.3 million and $6.4 million for the same periods in 2017.
- Net Loss: Net
loss allocable to common stock holders for the quarter and six
months ended June 30, 2018 was $9.2 million and $17.7 million
respectively, compared to $6.2 million and $12.4 million for the
same periods in 2017.
Business & Technology Highlights First Half
2018
- MOVED TO NEW R&D CENTER IN GAITHERSBURG:
In May 2018, the Company moved its Maryland lab to a larger
research and development center in Gaithersburg to accelerate the
Company’s robust oncology research pipeline, to attract new
recruits and to work closely with potential collaborating
partners;
- SUBMITTED IND APPLICATIONS TO CFDA: In April
2018, the CFDA accepted the IND applications for anti-CD19 CAR-T
therapy “C-CAR011” targeting NHL and ALL and the Company is working
with the CFDA for approval to move to the next phase of
development;
- PUBLISHED KOA DATA: In March 2018, the Company
presented its allogeneic adipose-derived mesenchymal progenitor
cell off-the-shelf therapy AlloJoinTM for Knee Osteoarthritis (KOA)
48-week clinical data from the Phase I clinical trial in China,
which demonstrated good safety and early efficacy for the
prevention of cartilage deterioration;
- OBTAINED OPTION TO LICENSE PATENT ON AFP TCR-T for
HEPATOCELLULAR CARCINOMA: In February 2018, CBMG’s
wholly-owned subsidiary entered into an agreement with Augusta
University to take a three-year option to license technology for
Alpha fetoprotein (AFP) T Cell Receptor (TCR), targeting
Hepatocellular Carcinoma (HCC) (patent pending);
- COMPLETED PRIVATE EQUITY FINANCING: In
February 2018, Sailing Capital invested $30.6 million in CBMG.
Sailing Capital is a global private equity firm focused on
disruptive technologies from innovative global companies in the
healthcare, technology and consumer sectors.
About Cellular Biomedicine GroupCellular
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. Our Shanghai facility includes a
”Joint Laboratory of Cell Therapy” with GE Healthcare and a “Joint
Cell Therapy Technology Innovation and Application Center” with
Thermo Fisher Scientific, which partnerships focus on improving
manufacturing processes for cell therapies. 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, a Phase IIb trial
in China for Rejoin® autologous Human Adipose-derived
Mesenchymal Progenitor Cell (haMPC) for the treatment of Knee
Osteoarthritis (KOA) as well as a Phase I trial in China for
AlloJoin™ (CBMG’s “Off-the-Shelf” haMPC) for the treatment of KOA.
CBMG is included in the broad-market Russell 3000® Index and the
small-cap Russell 2000® Index, and the Loncar China BioPharma
index. 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 and 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 those regarding our ability to implement our plans,
strategies and objectives for future operations, including
regulatory approval of our IND applications, our plan to configure
part of our Shanghai facility with GE Healthcare’s FlexFactory
platform, our ability to execute on proposed new products, services
or development thereof, results of our clinical research and
development, regulatory infrastructure governing cell therapy and
cellular biopharmaceuticals, our ability to enter into agreements
with any necessary manufacturing, marketing and/or distribution
partners for purposes of commercialization, our ability to seek
intellectual property rights for our product candidates,
competition in the industry in which we operate, overall market
conditions, any statements or assumptions underlying any of the
foregoing 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 STATEMENTS OF CASH
FLOWS |
|
|
|
|
|
|
|
For the Six Months Ended |
|
|
June 30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
Net loss |
|
$ |
(17,682,499 |
) |
|
$ |
(12,365,511 |
) |
Adjustments to
reconcile net loss to net cash |
|
|
|
|
used in
operating activities: |
|
|
|
|
Depreciation and amortization |
|
|
2,486,145 |
|
|
|
1,369,168 |
|
Loss /
(gain) on disposal of assets |
|
|
2,721 |
|
|
|
(49 |
) |
Stock
based compensation expense |
|
|
2,477,614 |
|
|
|
2,902,113 |
|
Other
than temporary impairment on long-term investments |
|
|
29,424 |
|
|
|
- |
|
Changes in
operating assets and liabilities: |
|
|
|
|
Accounts
receivable |
|
|
66,451 |
|
|
|
(50,557 |
) |
Other
receivables |
|
|
20,006 |
|
|
|
(488,480 |
) |
Prepaid
expenses |
|
|
(579,479 |
) |
|
|
13,246 |
|
Long-term
prepaid expenses and other assets |
|
|
(649,262 |
) |
|
|
(237,637 |
) |
Accounts
payable |
|
|
114,249 |
|
|
|
949,142 |
|
Accrued
expenses |
|
|
(9,892 |
) |
|
|
(595,382 |
) |
Deferred
income |
|
|
(4,515 |
) |
|
|
1,069,515 |
|
Other
current liabilities |
|
|
166,870 |
|
|
|
35,542 |
|
Other
non-current liabilities |
|
|
(93,732 |
) |
|
|
(379,161 |
) |
Net cash used in
operating activities |
|
|
(13,655,899 |
) |
|
|
(7,778,051 |
) |
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
Proceeds from
disposal of assets |
|
|
- |
|
|
|
286 |
|
Putting
six-month deposits with the banks |
|
|
(10,000,000 |
) |
|
|
- |
|
Purchases
of intangibles |
|
|
(34,172 |
) |
|
|
(23,339 |
) |
Purchases
of assets |
|
|
(2,167,527 |
) |
|
|
(3,014,055 |
) |
Net cash used in
investing activities |
|
|
(12,201,699 |
) |
|
|
(3,037,108 |
) |
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
Net
proceeds from the issuance of common stock |
|
|
30,506,521 |
|
|
|
- |
|
Proceeds
from exercise of stock options |
|
|
1,165,763 |
|
|
|
73,779 |
|
Repurchase of treasury stock |
|
|
(2,536,064 |
) |
|
|
(1,357,931 |
) |
Net cash
provided by financing activities |
|
|
29,136,220 |
|
|
|
(1,284,152 |
) |
|
|
|
|
|
EFFECT OF EXCHANGE RATE
CHANGES ON CASH |
|
|
(61,177 |
) |
|
|
145,324 |
|
|
|
|
|
|
INCREASE/(DECREASE) IN
CASH AND CASH EQUIVALENTS |
|
|
3,217,445 |
|
|
|
(11,953,987 |
) |
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD |
|
|
21,568,422 |
|
|
|
39,252,432 |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD |
|
$ |
24,785,867 |
|
|
$ |
27,298,445 |
|
|
|
|
|
|
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, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
Net sales and
revenue |
|
$ |
77,313 |
|
|
$ |
62,914 |
|
|
$ |
128,274 |
|
|
$ |
161,339 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
54,393 |
|
|
|
38,097 |
|
|
|
76,693 |
|
|
|
75,499 |
|
General
and administrative |
|
|
3,121,695 |
|
|
|
3,319,093 |
|
|
|
6,310,492 |
|
|
|
6,504,340 |
|
Selling
and marketing |
|
|
92,880 |
|
|
|
76,385 |
|
|
|
167,465 |
|
|
|
194,269 |
|
Research
and development |
|
|
6,166,556 |
|
|
|
3,349,509 |
|
|
|
11,440,507 |
|
|
|
6,393,634 |
|
Impairment of long-term investments |
|
|
29,424 |
|
|
|
- |
|
|
|
29,424 |
|
|
|
- |
|
Total operating
expenses |
|
|
9,464,948 |
|
|
|
6,783,084 |
|
|
|
18,024,581 |
|
|
|
13,167,742 |
|
Operating loss |
|
|
(9,387,635 |
) |
|
|
(6,720,170 |
) |
|
|
(17,896,307 |
) |
|
|
(13,006,403 |
) |
|
|
|
|
|
|
|
|
|
Other income : |
|
|
|
|
|
|
|
|
Interest
income |
|
|
116,835 |
|
|
|
40,573 |
|
|
|
122,284 |
|
|
|
89,755 |
|
Other
income |
|
|
84,724 |
|
|
|
476,079 |
|
|
|
93,924 |
|
|
|
553,587 |
|
Total other
income |
|
|
201,559 |
|
|
|
516,652 |
|
|
|
216,208 |
|
|
|
643,342 |
|
Loss before taxes |
|
|
(9,186,076 |
) |
|
|
(6,203,518 |
) |
|
|
(17,680,099 |
) |
|
|
(12,363,061 |
) |
|
|
|
|
|
|
|
|
|
Income taxes
provision |
|
|
- |
|
|
|
- |
|
|
|
(2,400 |
) |
|
|
(2,450 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(9,186,076 |
) |
|
$ |
(6,203,518 |
) |
|
$ |
(17,682,499 |
) |
|
$ |
(12,365,511 |
) |
Other comprehensive
income (loss): |
|
|
|
|
|
|
|
|
Cumulative translation adjustment |
|
|
(1,120,722 |
) |
|
|
292,452 |
|
|
|
(302,361 |
) |
|
|
346,121 |
|
Unrealized loss
on investments, net of tax |
|
|
- |
|
|
|
(240,000 |
) |
|
|
- |
|
|
|
(240,000 |
) |
Total
other comprehensive income (loss): |
|
|
(1,120,722 |
) |
|
|
52,452 |
|
|
|
(302,361 |
) |
|
|
106,121 |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(10,306,798 |
) |
|
$ |
(6,151,066 |
) |
|
$ |
(17,984,860 |
) |
|
$ |
(12,259,390 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share
: |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
(0.53 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.03 |
) |
|
$ |
(0.87 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
17,487,184 |
|
|
|
14,298,973 |
|
|
|
17,116,944 |
|
|
|
14,211,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(UNAUDITED) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
24,785,867 |
|
|
$ |
21,568,422 |
|
Short-term investment |
|
10,000,000 |
|
|
|
- |
|
Accounts receivable, less allowance for doubtful amounts of
$10,655 |
|
|
|
and $10,789 as of June 30, 2018 and December 31, 2017,
respectively |
|
133,876 |
|
|
|
202,887 |
|
Other receivables |
|
150,128 |
|
|
|
170,842 |
|
Prepaid expenses |
|
2,409,101 |
|
|
|
1,852,695 |
|
Total current assets |
|
37,478,972 |
|
|
|
23,794,846 |
|
|
|
|
|
|
Long-term investments |
|
240,000 |
|
|
|
269,424 |
|
Property, plant and equipment, net |
|
14,072,278 |
|
|
|
12,973,342 |
|
Goodwill |
|
7,678,789 |
|
|
|
7,678,789 |
|
Intangibles, net |
|
11,538,905 |
|
|
|
12,419,692 |
|
Long-term prepaid expenses and other assets |
|
4,805,996 |
|
|
|
4,026,203 |
|
Total assets |
$ |
75,814,940 |
|
|
$ |
61,162,296 |
|
|
|
|
|
|
Liabilities and Stockholders'
Equity |
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
Accounts payable |
$ |
387,860 |
|
|
$ |
225,287 |
|
Accrued expenses |
|
1,078,584 |
|
|
|
1,097,327 |
|
Taxes payable |
|
28,875 |
|
|
|
28,875 |
|
Other current liabilities |
|
3,300,520 |
|
|
|
2,324,632 |
|
Total current liabilities |
|
4,795,839 |
|
|
|
3,676,121 |
|
|
|
|
|
|
Other
non-current liabilities |
|
87,601 |
|
|
|
183,649 |
|
Total liabilities |
|
4,883,440 |
|
|
|
3,859,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock, par value $.001, 50,000,000 shares |
|
|
|
authorized; none issued and outstanding as of |
|
|
|
June
30, 2018 and December 31, 2017, respectively |
|
- |
|
|
|
- |
|
|
|
|
|
|
Common stock, par value $.001, 300,000,000 shares authorized; |
|
|
|
17,503,238 and 15,615,558 issued; and 16,942,470 and
15,188,764 outstanding, |
|
|
as
of June 30, 2018 and December 31, 2017, respectively |
|
17,503 |
|
|
|
15,616 |
|
Treasury stock at cost: 560,768 and 426,794 shares of common
stock |
|
|
|
as
of June 30, 2018 and December 31, 2017, respectively |
|
(6,513,993 |
) |
|
|
(3,977,929 |
) |
Additional paid in capital |
|
206,839,350 |
|
|
|
172,691,339 |
|
Accumulated deficit |
|
(128,719,496 |
) |
|
|
(111,036,997 |
) |
Accumulated other comprehensive loss |
|
(691,864 |
) |
|
|
(389,503 |
) |
Total stockholders' equity |
|
70,931,500 |
|
|
|
57,302,526 |
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
75,814,940 |
|
|
$ |
61,162,296 |
|
|
|
|
|
|
Contacts: Sarah Kelly Director of
Corporate Communications, CBMG+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/f9b2bd6d-579b-4b5a-8b0c-4c2a3794d6c0
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