Cellular Biomedicine Group Reports Full-Year 2015 Financial Results and Recent Operational Progress
March 14 2016 - 7:00AM
- Achieved first clinical milestones for
CD19, CD20, CD30 and EGFR CAR-T cell assets-
Expanded Immuno-Oncology platform with key
acquisitions- Expanded Stem Cell platform with the
launch of new autologous and allogeneic clinical
trials- Reported positive clinical data from Phase
IIb trial of ReJoin® haMPC therapy- Commenced
revenue-generating technology consulting services to hospitals in
several provinces in China- Solid 2015 year-end
cash position of $14.8 million
Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), a clinical-stage biomedicine firm engaged in the
development of effective treatments for degenerative and cancerous
diseases, today reported business highlights and financial results
for the full year ended December 31, 2015.
“2015 proved to be a transformative year for
Cellular Biomedicine Group with the Company’s entrance into the
dynamic field of immuno-oncology. We now operate under dual
technology platforms: Immuno-oncology (I/O) and Stem
Cells. We expect to advance several of our CAR-T candidates
including CBM.CD19 and CBM.CD20 into multiple indications of
hematological cancer. Eventually, our effort to sponsor
multi-center clinical trials in the near future should lead to
servicing the large cancer market in China. We also reported
encouraging Phase IIb data from our most advanced stem cell program
for Knee Osteoarthritis (KOA), and we will explore the possibility
of entrance into the U.S. market,” commented Tony (Bizou) Liu,
CBMG’s Chief Executive Officer. “The expansion of our GMP
facilities into Beijing allows us to prepare for anticipated
manufacturing demands from our immuno-oncology and stem cell
platforms for clinical trials and future commercialization
opportunities. We strengthened our operating and management
capabilities with the addition of key talents, which will better
position the Company to monetize our growing cell therapy pipeline.
We look forward to an exciting 2016 as we leverage these strengths
to execute on our clinical milestones, build an innovative pipeline
and move our clinical assets into later stage clinical
development.”
2015 and Recent Clinical Developments
Immuno-Oncology Platform
- Announced positive clinical data from Phase I of its CAR-T
immuno-oncology clinical development programs of:
- CBM-CD19.1 for Acute Lymphoblastic Leukemia (B-cell
ALL)
- CBM-CD20.1 for Advanced Diffuse Large B Cell Lymphoma
(DLBCL)
- CBM-CD30.1 for Stage III and IV Hodgkin's lymphoma
- CBM-EGFR.1 for the treatment of patients with EGFR expressing
advanced relapsed/refractory solid tumors.
- In all trials the assets were shown to be safe, feasible and
efficacious.
- The participants enrolled in the studies were advanced,
relapsed, and/or refractory to other standard-of-care therapies.
This patient population has substantial unmet medical needs.
Stem Cell Therapies Platform
- Announced encouraging 48-week clinical data from the Phase IIb
trial of its ReJoin® haMPC therapy for Knee Osteoarthritis (KOA),
revealing increase of patient’s knee cartilage volume and relief of
pain;
- Launched an investigator initiated Phase I clinical trial of an
off-the-shelf allogeneic adipose-derived mesenchymal progenitor
cell (haMPC) AlloJoinTM therapy for KOA patients in
China;
- Recruited patients for a clinical study on ReJoin® therapy for
Cartilage Damage (CD) resulting from sports injury, which also
serves as a supporting study of ReJoin® for KOA with
arthroscopic evidences. We plan to release results from this study
in 1H 2017.
2015 and Recent Corporate Highlights
- Completed two acquisitions, which
substantially increased CBMG’s immuno-oncology platform, including:
- PLA General Hospital’s (“PLAGH”, Beijing, also known as “301
Hospital”) Chimeric Antigen Receptor T cell (CAR-T) therapies,
redirected T cells against CD19, CD20, CD30 and Human Epidermal
Growth Factor Receptor (EGFR or HER1), their patents (all pending),
and Phase I/II clinical data of the aforementioned therapies and
manufacturing knowledge;
- Blackbird Bio Finance and University of South Florida’s
(“Licensor”) next generation GVAX vaccine’s (“CD40LGVAX”) related
technologies, technical knowledge and FDA IND approved
clinical trial protocol
- Expanded the Company’s cell manufacturing
capabilities with the opening of the Company’s third GMP
facility, a 15,000 square feet site in Beijing, China,
approximately half of which has been designed as a GMP equipped
facility to support clinical batch production and commercial scale
manufacturing;
- Commenced revenue generation through the
Company’s T Cells Receptor (“TCR”) clonality analysis and
CentrixTTM adoptive cell transfer technology services provided to 9
cooperative hospitals located in Beijing, Shandong and Anhui
provinces in China;
- Strengthened the leadership team with the
appointments of Richard L. Wang, Ph.D., MBA, PMP, formerly with
GSK, as Chief Operating Officer and Yihong Yao, Ph.D., B.S.,
formerly with Astrazeneca/Medimmune as Chief Scientific
Officer;
- Formed a Scientific Advisory Board (SAB) with
the appointment of Alan List, M.D. as Chair of the SAB, the
appointment of Scott J. Antonia, M.D., Ph.D. to advise the company
on immuno-oncology and Guoping Fan, Ph.D. to advise the Company on
stem cell technology and its applications;
- Continued to demonstrate good corporate governance
by meeting the required higher listing standards to
successfully upgrade the listing of the Company’s securities from
the NASDAQ Capital Market to the NASDAQ Global Market and being
selected into the broad-market Russell 3000® Index;
- Advanced the Company’s cash position:
- Total private placement transactions of approximately $19.6
Million in 2015
- Announced agreement of Wuhan Dangdai Science &
Technology Industries Group Inc. to invest up to $43.13 million for
2.27 million shares of the Company’s common stock, representing a
19.4% stake investment in Q1 2016 with an initial closing of $5
million in February 2016, and the remaining $38.13 million by April
15, 2016.
Full Year 2015 Financial Results
Cash Position: The Company had working
capital of $13.7 million as of December 31, 2015 compared to $12.0
million as of December 31, 2014. Cash position increased to $14.9
million at December 31, 2015 compared to $14.8 million at December
31, 2014, due to an increase in cash generated from financing
activities as a result of a private placement financing in 2015 for
aggregate net proceeds of approximately $19.0 million, partially
offset by an increase in cash used in operating and investing
activities.
Net Cash Used in Operating
Activities: Full-year 2015 net cash used in operating
activities was $11.8 million compared to $9.7 million in 2014.
The change in operating assets and liabilities was primarily due to
an increase in accounts receivables, long-term prepaid expenses
combined with decreases in tax payables and non-current
liabilities, partially offset by an increase in accrued
expenses.
Revenue: Full-year 2015 revenue
was $2.5 million compared to $0.6 million in 2014. All
revenue for the year ended December 31, 2015 was derived from TCR
technology services.
G&A Expenses: Full-year 2015 general
and administrative expenses were $13.1 million compared $7.9
million in 2014. Increased expenses in 2015 were associated
with increased corporate activities related to the management and
the development of the Company’s biomedicine business, which were
primarily attributed to:
- An increase in stock-based compensation expense of $3.7
million, which primarily resulted from the new grants and higher
fair value of unvested options in 2015 after the Company listed on
Nasdaq in June 2014 compared with those unvested options as of
December 31, 2014;
- An increase in payroll of $0.3 million in line with the
headcount increase in management in 2015;
- An increase in depreciation and amortization of $0.2 million,
which was mainly attributed to the technical knowledge and patents
obtained from the acquisition of AG in the third quarter 2014;
R&D Expenses: Full-year 2015 research
and development expenses were $7.6 million compared to $3.1 million
in 2014, the increase mainly attributable to the increase of our
immunotherapy research and development team, which resulted in an
increase in payroll expenses of $1.2 million and an increase in
stock-based compensation expenses of $1.8 million.
Net Loss: Full-year 2015 net loss
allocable to common stock holders was $19.4 million compared
to $15.5 million in 2014. Changes in net loss were
primarily attributable to changes in operations of our biomedicine
segment.
Primary 2016 Operating Objectives
The Company’s key 2016 operational objectives are to seek early
possibilities of conducting multi-center Phase IIb trials with its
CAR-T constructs after confirming their safety and tolerability
profile, to evaluate feasibility of sponsoring a registration
trial-like clinical study to support a New Drug Application (NDA)
for an allogeneic haMPC Knee Osteoarthritis therapy (“Allo KOA”)
study in the United States, and continue to build a pipeline of
advanced technologies to bolster the Company’s CAR-T China market
position.
About Cellular Biomedicine
GroupCellular 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
StatementsStatements 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. |
CONSOLIDATED STATEMENT OF OPERATIONS AND
COMPREHENSIVE LOSS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year
EndedDecember 31, |
|
|
|
|
2015 |
|
|
2014 |
|
|
2013 |
|
|
|
|
|
|
|
Net sales and
revenue |
|
|
$ |
2,505,423 |
|
$ |
564,377 |
|
$ |
204,914 |
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Cost of sales |
|
|
|
1,880,331 |
|
|
242,215 |
|
|
296,212 |
|
General and administrative |
|
|
|
13,068,255 |
|
|
7,875,413 |
|
|
9,162,172 |
|
Selling and marketing |
|
|
|
709,151 |
|
|
314,894 |
|
|
58,275 |
|
Research and development |
|
|
|
7,573,228 |
|
|
3,146,499 |
|
|
2,041,872 |
|
Impairment of investments |
|
|
|
123,428 |
|
|
1,427,840 |
|
|
- |
|
Total operating expenses |
|
|
|
23,354,393 |
|
|
13,006,861 |
|
|
11,558,531 |
|
Operating loss |
|
|
|
(20,848,970 |
) |
|
(12,442,484 |
) |
|
(11,353,617 |
) |
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
Interest income |
|
|
|
42,220 |
|
|
15,043 |
|
|
1,294 |
|
Other income (expense) |
|
|
|
630,428 |
|
|
71,982 |
|
|
(6,196 |
) |
Total other income (expense) |
|
|
|
672,648 |
|
|
87,025 |
|
|
(4,902 |
) |
Loss from continuing
operations before taxes |
|
|
|
(20,176,322 |
) |
|
(12,355,459 |
) |
|
(11,358,519 |
) |
|
|
|
|
|
|
Income taxes (expense)
credit |
|
|
|
728,601 |
|
|
- |
|
|
- |
|
|
|
|
|
|
|
Loss from continuing
operations |
|
|
|
(19,447,721 |
) |
|
(12,355,459 |
) |
|
(11,358,519 |
) |
|
|
|
|
|
|
Loss on discontinued
operations, net of taxes |
|
|
|
- |
|
|
(3,119,152 |
) |
|
(2,438,514 |
) |
|
|
|
|
|
|
Net loss |
|
|
$ |
(19,447,721 |
) |
$ |
(15,474,611 |
) |
$ |
(13,797,033 |
) |
Other comprehensive
income (loss): |
|
|
|
|
|
Cumulative translation
adjustment |
|
|
|
(307,950 |
) |
|
15,254 |
|
|
78,650 |
|
Unrecognized gain (loss) on
investments |
|
|
|
(1,376,540 |
) |
|
1,611,045 |
|
|
(198,200 |
) |
Total other comprehensive income
(loss): |
|
|
|
(1,684,490 |
) |
|
1,626,299 |
|
|
(119,550 |
) |
|
|
|
|
|
|
Comprehensive loss |
|
|
$ |
(21,132,211 |
) |
$ |
(13,848,312 |
) |
$ |
(13,916,583 |
) |
|
|
|
|
|
|
Loss per share for
continuing operations: |
|
|
|
|
|
Basic |
|
|
$ |
(1.70 |
) |
$ |
(1.43 |
) |
$ |
(1.96 |
) |
Diluted |
|
|
$ |
(1.70 |
) |
$ |
(1.43 |
) |
$ |
(1.96 |
) |
|
|
|
|
|
|
Loss per share for
discontinued operations: |
|
|
|
|
|
Basic |
|
|
$ |
- |
|
$ |
(0.36 |
) |
$ |
(0.42 |
) |
Diluted |
|
|
$ |
- |
|
$ |
(0.36 |
) |
$ |
(0.42 |
) |
|
|
|
|
|
|
Net loss per share
: |
|
|
|
|
|
Basic |
|
|
$ |
(1.70 |
) |
$ |
(1.79 |
) |
$ |
(2.38 |
) |
Diluted |
|
|
$ |
(1.70 |
) |
$ |
(1.79 |
) |
$ |
(2.38 |
) |
|
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
|
Basic |
|
|
|
11,472,306 |
|
|
8,627,094 |
|
|
5,792,888 |
|
Diluted |
|
|
|
11,472,306 |
|
|
8,627,094 |
|
|
5,792,888 |
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
Assets |
|
|
|
Cash and cash
equivalents |
$ |
14,884,597 |
|
|
$ |
14,770,584 |
|
Accounts
receivable |
|
630,332 |
|
|
|
141,029 |
|
Other receivables |
|
271,344 |
|
|
|
135,957 |
|
Inventory |
|
390,886 |
|
|
|
372,249 |
|
Prepaid expenses |
|
367,050 |
|
|
|
565,299 |
|
Taxes recoverable |
|
150,082 |
|
|
|
- |
|
Other current
assets |
|
- |
|
|
|
110,347 |
|
Total current
assets |
|
16,694,291 |
|
|
|
16,095,465 |
|
|
|
|
|
|
Investments |
|
5,379,407 |
|
|
|
6,886,033 |
|
Property, plant and
equipment, net |
|
2,768,900 |
|
|
|
1,280,410 |
|
Goodwill |
|
7,678,789 |
|
|
|
7,678,789 |
|
Intangibles, net |
|
15,949,100 |
|
|
|
11,156,676 |
|
Long-term prepaid
expenses and other assets |
|
989,935 |
|
|
|
587,729 |
|
Total assets |
$ |
49,460,422 |
|
|
$ |
43,685,102 |
|
|
|
|
|
|
Liabilities and Stockholders'
Equity |
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
Accounts payable |
$ |
260,886 |
|
|
$ |
426,917 |
|
Accrued expenses |
|
845,087 |
|
|
|
2,074,384 |
|
Taxes payable |
|
- |
|
|
|
814,288 |
|
Advances payable to
related party |
|
- |
|
|
|
36,254 |
|
Other current
liabilities |
|
1,913,284 |
|
|
|
724,479 |
|
Total current
liabilities |
|
3,019,257 |
|
|
|
4,076,322 |
|
|
|
|
|
|
Other non-current
liabilities |
|
76,229 |
|
|
|
452,689 |
|
Total liabilities |
|
3,095,486 |
|
|
|
4,529,011 |
|
|
|
|
|
|
Commitments
and Contingencies |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock, par
value $.001, 50,000,000 shares |
|
|
|
authorized; none issued
and outstanding as of |
|
|
|
December 31, 2015 and
2014, respectively |
|
- |
|
|
|
- |
|
|
|
|
|
|
Common stock, par value
$.001, 300,000,000 shares authorized; |
|
|
|
11,711,645 and
10,990,335 issued and outstanding |
|
|
|
as of December 31, 2015
and 2014, respectively |
|
11,711 |
|
|
|
10,990 |
|
Additional paid in
capital |
|
103,807,651 |
|
|
|
75,467,316 |
|
Accumulated
deficit |
|
(57,338,311 |
) |
|
|
(37,890,590 |
) |
Accumulated other
comprehensive income (loss) |
|
(116,115 |
) |
|
|
1,568,375 |
|
Total stockholders'
equity |
|
46,364,936 |
|
|
|
39,156,091 |
|
|
|
|
|
|
Total liabilities and
stockholders' equity |
$ |
49,460,422 |
|
|
$ |
43,685,102 |
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONSOLIDATED STATEMENTS OF CASH
FLOWS |
|
|
|
|
|
For the Year Ended |
|
December 31, |
|
|
2015 |
|
|
2014 |
|
|
2013 |
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
Net loss |
$ |
(19,447,721 |
) |
$ |
(15,474,611 |
) |
$ |
(13,797,033 |
) |
Adjustments to reconcile net loss
to net cash used in operating activities: |
|
|
|
Depreciation and amortization |
|
2,094,644 |
|
|
1,190,505 |
|
|
841,235 |
|
Loss on disposal of assets |
|
1,444 |
|
|
257,672 |
|
|
- |
|
Stock based compensation
expense |
|
7,592,438 |
|
|
2,528,885 |
|
|
4,381,077 |
|
Other than temporary impairment on
investments |
|
123,428 |
|
|
1,427,840 |
|
|
- |
|
Realized losses from sale of
investments |
|
5,178 |
|
|
5,913 |
|
|
138,909 |
|
Value of stock received for
services |
|
- |
|
|
(1,610,000 |
) |
|
(3,500,000 |
) |
Impairment of goodwill |
|
- |
|
|
3,299,566 |
|
|
4,258,967 |
|
Inventory provision |
|
123,848 |
|
|
- |
|
|
- |
|
Decrease in fair value of accrued
expenses for the acquisition of intangible assets |
|
(345,882 |
) |
|
- |
|
|
- |
|
Third party services received in
exchange for disposition of investment stock |
|
- |
|
|
- |
|
|
83,334 |
|
Deferred tax |
|
- |
|
|
- |
|
|
(76,544 |
) |
Changes in operating assets and
liabilities: |
|
|
|
Accounts receivable |
|
(497,937 |
) |
|
20,645 |
|
|
10,102 |
|
Other receivables |
|
(143,711 |
) |
|
(25,638 |
) |
|
50,160 |
|
Inventory |
|
(142,486 |
) |
|
(78,310 |
) |
|
(81,878 |
) |
Prepaid expenses |
|
181,679 |
|
|
(494,057 |
) |
|
(38,793 |
) |
Taxes recoverable |
|
(150,082 |
) |
|
- |
|
|
- |
|
Other current assets |
|
110,347 |
|
|
24,314 |
|
|
(84,661 |
) |
Investments |
|
- |
|
|
7,150 |
|
|
- |
|
Long-term prepaid expenses and
other assets |
|
(384,432 |
) |
|
(504,678 |
) |
|
134,229 |
|
Accounts payable |
|
(166,032 |
) |
|
165,517 |
|
|
40,862 |
|
Accrued expenses |
|
396,557 |
|
|
409,109 |
|
|
(739,839 |
) |
Advance payable to related
party |
|
(30,216 |
) |
|
- |
|
|
- |
|
Other current liabilities |
|
113,919 |
|
|
(694,131 |
) |
|
186,464 |
|
Taxes payable |
|
(814,288 |
) |
|
(176,583 |
) |
|
(10,121 |
) |
Other non-current liabilities |
|
(371,793 |
) |
|
- |
|
|
(251,834 |
) |
Net cash used in operating
activities |
|
(11,751,098 |
) |
|
(9,720,892 |
) |
|
(8,455,364 |
) |
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
Acquisition of business, net of
cash acquired |
|
(1,568,627 |
) |
|
(1,485,548 |
) |
|
- |
|
Proceed from sale of investments,
net of transaction costs |
|
1,480 |
|
|
- |
|
|
- |
|
Purchases of intangible assets |
|
(4,260,420 |
) |
|
(8,989 |
) |
|
(5,828 |
) |
Purchases of property, plant and
equipment |
|
(1,874,538 |
) |
|
(311,625 |
) |
|
(147,211 |
) |
Net cash used in investing
activities |
|
(7,702,105 |
) |
|
(1,806,162 |
) |
|
(153,039 |
) |
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
Net proceeds from the issuance of
common stock |
|
18,964,849 |
|
|
19,121,956 |
|
|
11,561,386 |
|
Proceeds from exercise of stock
options |
|
682,303 |
|
|
19,383 |
|
|
- |
|
Advance from affiliates |
|
- |
|
|
- |
|
|
36,614 |
|
Repayment of advance from
affiliate |
|
- |
|
|
(31,745 |
) |
|
(1,250 |
) |
Net cash provided by financing
activities |
|
19,647,152 |
|
|
19,109,594 |
|
|
11,596,750 |
|
|
|
|
|
EFFECT OF EXCHANGE RATE
CHANGES ON CASH |
|
(79,936 |
) |
|
12,829 |
|
|
41,972 |
|
|
|
|
|
INCREASE IN CASH AND
CASH EQUIVALENTS |
|
114,013 |
|
|
7,595,369 |
|
|
3,030,319 |
|
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD |
|
14,770,584 |
|
|
7,175,215 |
|
|
4,144,896 |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD |
$ |
14,884,597 |
|
$ |
14,770,584 |
|
$ |
7,175,215 |
|
|
|
|
|
SUPPLEMENTAL
CASH FLOW INFORMATION |
|
|
|
|
|
|
|
Cash paid for income
taxes |
$ |
108,075 |
|
$ |
460,924 |
|
$ |
- |
|
|
|
|
|
Non-cash investing
activities |
|
|
|
Acquisition of intangible assets
through issuance of the Company's stock |
$ |
1,481,462 |
|
$ |
1,442,850 |
|
$ |
- |
|
Acquisition of business through
issuance of the Company's stock |
$ |
- |
|
$ |
14,496,256 |
|
$ |
- |
|
Issuance of company stock for
accrued liabilities and advances |
$ |
- |
|
$ |
- |
|
$ |
149,475 |
|
|
|
|
|
Contacts: Sarah Kelly Director of
Corporate Communications, CBMG+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
Vivian ChenManaging Director Investor Relations, Grayling+1 347
481-3711vivian.chen@grayling.com
Cellular Biomedicine (NASDAQ:CBMG)
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Cellular Biomedicine (NASDAQ:CBMG)
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