Blueprint
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
☒
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended June 30, 2018
OR
☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Commission File Number 001-36498
CELLULAR BIOMEDICINE GROUP, INC.
(Exact name of registrant as specified in its charter)
Delaware
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86-1032927
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State of Incorporation
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IRS Employer Identification No.
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19925 Stevens Creek Blvd., Suite 100
Cupertino, California 95014
(Address of principal
executive offices)
(408) 973-7884
(Registrant’s telephone number)
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or
15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days. Yes ☒
No ☐
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any, every
Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period than the
registrant was required to submit and post such files). Yes ☒
No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, or a non-accelerated
filer. See definition of “accelerated filer,” and
“large accelerated filer” and “smaller reporting
company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large accelerated filer
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☐
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Accelerated filer
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☒
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Non-accelerated filer
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☐
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Smaller reporting company
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☐
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Emerging growth company
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☐
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If
an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act). Yes ☐ No
☒
As of August 1, 2018, there were
17,522,772 and
16,962,004 shares of common
stock, par value $.001 per share, issued and outstanding,
respectively.
TABLE OF CONTENTS
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3
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46
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47
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PART I – FINANCIAL
INFORMATION
Item 1. Condensed Consolidated
Financial Statements (Unaudited)
CELLULAR BIOMEDICINE
GROUP, INC.
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CONDENSED CONSOLIDATED BALANCE SHEETS
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Assets
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Cash
and cash equivalents
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$24,785,867
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$21,568,422
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Short-term
investment
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10,000,000
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-
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Accounts
receivable, less allowance for doubtful amounts of
$10,655
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and
$10,789 as of June 30, 2018 and December 31, 2017,
respectively
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133,876
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202,887
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Other
receivables
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150,128
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170,842
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Prepaid
expenses
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2,409,101
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1,852,695
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Total
current assets
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37,478,972
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23,794,846
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Long-term
investments
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240,000
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269,424
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Property,
plant and equipment, net
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14,072,278
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12,973,342
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Goodwill
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7,678,789
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7,678,789
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Intangibles,
net
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11,538,905
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12,419,692
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Long-term
prepaid expenses and other assets
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4,805,996
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4,026,203
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Total
assets (1)
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$75,814,940
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$61,162,296
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Liabilities and Stockholders' Equity
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Liabilities:
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Accounts
payable
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$387,860
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$225,287
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Accrued
expenses
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1,078,584
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1,097,327
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Taxes
payable
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28,875
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28,875
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Other
current liabilities
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3,300,520
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2,324,632
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Total
current liabilities
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4,795,839
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3,676,121
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Other
non-current liabilities
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87,601
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183,649
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Total
liabilities (1)
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4,883,440
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3,859,770
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Commitments
and Contingencies (note 12)
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Stockholders'
equity:
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Preferred
stock, par value $.001, 50,000,000 shares
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authorized;
none issued and outstanding as of
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June
30, 2018 and December 31, 2017, respectively
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-
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-
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Common
stock, par value $.001, 300,000,000 shares authorized;
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17,503,238
and 15,615,558 issued; and 16,942,470 and 15,188,764
outstanding,
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as
of June 30, 2018 and December 31, 2017, respectively
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17,503
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15,616
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Treasury
stock at cost: 560,768 and 426,794 shares of common
stock
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as
of June 30, 2018 and December 31, 2017, respectively
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(6,513,993)
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(3,977,929)
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Additional
paid in capital
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206,839,350
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172,691,339
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Accumulated
deficit
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(128,719,496)
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(111,036,997)
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Accumulated
other comprehensive loss
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(691,864)
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(389,503)
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Total
stockholders' equity
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70,931,500
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57,302,526
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Total
liabilities and stockholders' equity
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$75,814,940
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$61,162,296
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(1)
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The Company’s consolidated assets as of June 30, 2018 and
December 31, 2017 included $21,776,560 and $21,775,087,
respectively, of assets of variable interest entities, or VIEs,
that can only be used to settle obligations of the VIEs. Each of
the following amounts represent the balances as of June 30, 2018
and December 31, 2017, respectively. These assets include cash and
cash equivalents of $1,030,161 and $2,337,173; accounts receivable
of $22,670 and $nil; other receivables of $62,677 and $61,735;
prepaid expenses of $2,243,855 and $1,750,509; property, plant and
equipment, net, of $13,126,061 and $12,477,315; intangibles of
$1,421,201 and $1,516,449; and long-term prepaid expenses and other
assets of $3,869,935 and $3,631,906. The Company’s
consolidated liabilities as of June 30, 2018 and December 31, 2017
included $3,437,199 and $2,688,520, respectively, of liabilities of
the VIEs whose creditors have no recourse to the Company. These
liabilities include accounts payable of $299,346 and $181,231;
other payables of $2,175,830 and $1,631,582; accrued payroll of
$854,879 and $682,248, which mainly includes bonus accrual of
$757,196 and $673,443; deferred income of $19,543 and $9,810 and
other non-current liabilities of $87,601 and $183,649. See further
description in Note 3, Variable Interest Entities.
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The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
CELLULAR BIOMEDICINE GROUP,
INC.
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CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE
LOSS
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For the Three
Months Ended
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Net sales and
revenue
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$77,313
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$62,914
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$128,274
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$161,339
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Operating
expenses:
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Cost of
sales
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54,393
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38,097
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76,693
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75,499
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General and
administrative
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3,121,695
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3,319,093
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6,310,492
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6,504,340
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Selling and
marketing
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92,880
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76,385
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167,465
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194,269
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Research and
development
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6,166,556
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3,349,509
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11,440,507
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6,393,634
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Impairment of
long-term investments
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29,424
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-
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29,424
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-
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Total
operating expenses
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9,464,948
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6,783,084
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18,024,581
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13,167,742
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Operating
loss
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(9,387,635)
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(6,720,170)
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(17,896,307)
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(13,006,403)
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Other income
:
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Interest
income
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116,835
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40,573
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122,284
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89,755
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Other
income
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84,724
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476,079
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93,924
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553,587
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Total other income
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201,559
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516,652
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216,208
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643,342
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Loss before
taxes
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(9,186,076)
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(6,203,518)
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(17,680,099)
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(12,363,061)
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Income taxes
provision
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-
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-
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(2,400)
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(2,450)
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Net
loss
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$(9,186,076)
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$(6,203,518)
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$(17,682,499)
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$(12,365,511)
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Other comprehensive
income (loss):
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Cumulative
translation adjustment
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(1,120,722)
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292,452
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(302,361)
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346,121
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Unrealized
loss on investments, net of tax
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-
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(240,000)
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-
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(240,000)
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Total other
comprehensive income (loss):
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(1,120,722)
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52,452
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(302,361)
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106,121
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Comprehensive
loss
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$(10,306,798)
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$(6,151,066)
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$(17,984,860)
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$(12,259,390)
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Net loss per share
:
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Basic
and diluted
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$(0.53)
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$(0.43)
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$(1.03)
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$(0.87)
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Weighted average
common shares outstanding:
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Basic
and diluted
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17,487,184
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14,298,973
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17,116,944
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14,211,888
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The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
CELLULAR BIOMEDICINE GROUP,
INC.
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
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CASH
FLOWS FROM OPERATING ACTIVITIES:
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Net
loss
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$(17,682,499)
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$(12,365,511)
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Adjustments
to reconcile net loss to net cash
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used
in operating activities:
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Depreciation
and amortization
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2,486,145
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1,369,168
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Loss
/ (gain) on disposal of assets
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2,721
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(49)
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Stock
based compensation expense
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2,477,614
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2,902,113
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Other
than temporary impairment on long-term investments
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29,424
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-
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Changes
in operating assets and liabilities:
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Accounts
receivable
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66,451
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(50,557)
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Other
receivables
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20,006
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(488,480)
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Prepaid
expenses
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(579,479)
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13,246
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Long-term
prepaid expenses and other assets
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(649,262)
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(237,637)
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Accounts
payable
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114,249
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949,142
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Accrued
expenses
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(9,892)
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(595,382)
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Deferred
income
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(4,515)
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1,069,515
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Other
current liabilities
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166,870
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35,542
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Other
non-current liabilities
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(93,732)
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(379,161)
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Net
cash used in operating activities
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(13,655,899)
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(7,778,051)
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CASH
FLOWS FROM INVESTING ACTIVITIES:
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Proceeds
from disposal of assets
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-
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286
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Putting
six-month deposits with the banks
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(10,000,000)
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-
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Purchases
of intangibles
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(34,172)
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(23,339)
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Purchases
of assets
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(2,167,527)
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(3,014,055)
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Net
cash used in investing activities
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(12,201,699)
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(3,037,108)
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CASH
FLOWS FROM FINANCING ACTIVITIES:
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Net
proceeds from the issuance of common stock
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30,506,521
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-
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Proceeds
from exercise of stock options
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1,165,763
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73,779
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Repurchase
of treasury stock
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(2,536,064)
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(1,357,931)
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Net
cash provided by financing activities
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29,136,220
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(1,284,152)
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EFFECT
OF EXCHANGE RATE CHANGES ON CASH
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(61,177)
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145,324
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INCREASE/(DECREASE)
IN CASH AND CASH EQUIVALENTS
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3,217,445
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(11,953,987)
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CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
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21,568,422
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39,252,432
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CASH
AND CASH EQUIVALENTS, END OF PERIOD
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$24,785,867
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$27,298,445
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SUPPLEMENTAL CASH FLOW INFORMATION
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Cash
paid for income taxes
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$2,400
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$-
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Note: Six-month deposits of $10,000,000 was recorded as short-term
investment and excluded from cash and cash equivalents as of June
30, 2018
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
CELLULAR BIOMEDICINE
GROUP, INC.
FOR THE THREE MONTHS ENDED JUNE 30, 2018 AND 2017
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
NOTE 1 – DESCRIPTION OF BUSINESS
As
used in this quarterly report, "we", "us", "our", "CBMG", "Company"
or "our company" refers to Cellular Biomedicine Group, Inc. and,
unless the context otherwise requires, all of its subsidiaries and
variable interest entities.
Overview
Cellular
Biomedicine Group, Inc. is a clinical stage biopharmaceutical
company, principally engaged in the development of therapies for
cancer and degenerative diseases utilizing proprietary cell-based
technologies. Our technology includes two major platforms: (i)
Immune cell therapy for treatment of a broad range of cancer
indications comprised of technologies in Chimeric Antigen Receptor
modified T cells (CAR-T), T-Cell Receptor (TCR), and (ii) human
adipose-derived mesenchymal progenitor cells (haMPC) for treatment
of joint diseases. CBMG’s Research & Development are
based in Gaithersburg, Maryland and Shanghai, China, and its
manufacturing facilities are based in China in the cities of
Shanghai, Wuxi, and Beijing.
We
are focused on developing and marketing safe and effective
cell-based therapies based on our cellular platforms, to treat
cancer and orthopedic diseases. We have developed proprietary
technologies and know-hows in our cell therapy platforms. We are
conducting clinical studies in China with our stem cell based
therapies to treat knee osteoarthritis (“KOA”). We have
completed a Phase IIb autologous haMPC KOA clinical study and
published its promising results. Led by Shanghai Renji Hospital,
one of the largest teaching hospitals in China, we have completed a
Phase I clinical trial of our off-the-shelf allogeneic haMPC
(AlloJoin™) therapy for treating KOA patients. We have
completed and presented the Allojoin™ Phase I 48-week data in
China and have met with the China Food and Drug Administration
(“CFDA”) in a pre-IND meeting to discuss methods to
potentially enhance development.
Our
primary target market is China. We believe that our cell-based
therapies will be able to help patients with high unmet medical
needs. We expect to carry out clinical studies leading to the
eventual CFDA approval of our products through Biologics License
Application (BLA) filings and authorized clinical centers
throughout Greater China.
We have launched clinical trials using our CAR-T
products in B-cell non-Hodgkin lymphoma
("NHL"). Diffuse large B-cell
lymphoma (“DLBCL”) and adult acute lymphoblastic
leukemia (“ALL”). We may also establish partnerships
with other companies for co-development in CAR-T, TCR-T and stem
cell based therapies. We are striving to build a highly competitive
research and development function, a translational medicine unit,
along with a well-established cellular manufacturing capability and
ample capacity, to support the development of multiple assets in
multiple indications. These efforts will allow us to boost the
Company's Immuno-Oncology presence and pave the way for additional
future partnerships.
Corporate History
Headquartered
in Cupertino, California, the Company is a Delaware
biopharmaceutical company focused on developing treatment for
cancer and orthopedic diseases for patients in China. The Company
started its regenerative medicine business in China in 2009 and
expanded to CAR-T therapies in 2014.
NOTE 2 – BASIS OF PRESENTATION AND SIGNIFICANT
ACCOUNTING POLICIES
The
accompanying unaudited Condensed Consolidated Financial Statements
have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S.
GAAP”) for interim financial information and the rules and
regulations of the Securities and Exchange Commission
(“SEC”) for reporting on Form 10-Q. Accordingly, they
do not include all the information and footnotes required by U.S.
GAAP for complete financial statements herein. The unaudited
Condensed Consolidated Financial Statements herein should be read
in conjunction with the historical consolidated financial
statements of the Company for the years ended December 31, 2017
included in our Annual Report on Form 10-K for the year ended
December 31, 2017. Operating results for the three and six months
ended June 30, 2018 are not necessarily indicative of the results
that may be expected for the year ending December 31,
2018.
Principles of Consolidation
Our
unaudited condensed consolidated financial statements reflect all
adjustments, which are, in the opinion of management, necessary for
a fair presentation of our financial position and results of
operations. Such adjustments are of a normal recurring nature,
unless otherwise noted. The balance sheet as of June 30, 2018 and
the results of operations for the three and six months ended June
30, 2018 are not necessarily indicative of the results to be
expected for any future period.
Our
unaudited condensed consolidated financial statements are prepared
in accordance with U.S. GAAP. These accounting principles require
us to make certain estimates, judgments and assumptions that affect
the reported amounts if assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during
the reporting period. We believe that the estimates, judgments and
assumptions are reasonable, based on information available at the
time they are made. Actual results could differ materially from
those estimates.
Recent Accounting Pronouncements
Accounting pronouncements adopted during the six months ended June
30, 2018
In May 2017, the Financial Accounting Standards
Board (“FASB”) issued Accounting Standards Update
(“ASU”) 2017-09, “Compensation—Stock
Compensation (Topic 718): Scope of Modification
Accounting” (“ASU
2017-09”), which provides guidance on determining which
changes to the terms and conditions of share-based payment awards
require an entity to apply modification accounting under Topic 718.
The amendments in this ASU are effective for all entities for
annual periods, and interim periods within those annual periods,
beginning after December 15, 2017. Early adoption is permitted,
including adoption in any interim period, for (1) public business
entities for reporting periods for which financial statements have
not yet been issued and (2) all other entities for reporting
periods for which financial statements have not yet been made
available for issuance. The amendments in this ASU should be
applied prospectively to an award modified on or after the adoption
date. The adoption of the ASU 2017-09 did not have a material
impact on the Company’s consolidated financial
statements.
In February 2017, the FASB issued ASU No.
2017-05, “Other
Income—Gains and Losses from the Derecognition of
Nonfinancial Assets (Subtopic 610-20): Clarifying the Scope of
Asset Derecognition Guidance and Accounting for Partial Sales of
Nonfinancial Assets” (“ASU 2017-05”), which clarifies the
scope of the nonfinancial asset guidance in Subtopic 610-20. This
ASU also clarifies that the derecognition of all businesses and
nonprofit activities (except those related to conveyances of oil
and gas mineral rights or contracts with customers) should be
accounted for in accordance with the derecognition and
deconsolidation guidance in Subtopic 810-10. The amendments in this
ASU also provide guidance on the accounting for what often are
referred to as partial sales of nonfinancial assets within the
scope of Subtopic 610-20 and contributions of nonfinancial assets
to a joint venture or other non-controlled investee. The amendments
in this ASU are effective for annual reporting reports beginning
after December 15, 2017, including interim reporting periods within
that reporting period. Public entities may apply the guidance
earlier but only as of annual reporting periods beginning after
December 15, 2016, including interim reporting periods within that
reporting period. The adoption of the ASU 2017-05 did not have a
material impact on the Company’s consolidated financial
statements.
In November 2016, the FASB issued ASU No.
2016-18, “Statement of Cash Flows
(Topic 230): Restricted Cash” (“ASU 2016-18”), which requires
that a statement of cash flows explain the change during the period
in the total of cash, cash equivalents, and amounts generally
described as restricted cash or restricted cash equivalents.
Therefore, amounts generally described as restricted cash and
restricted cash equivalents should be included with cash and cash
equivalents when reconciling the beginning-of-period and
end-of-period total amounts shown on the statement of cash flows.
The amendments in this ASU do not provide a definition of
restricted cash or restricted cash equivalents. The amendments in
this ASU are effective for public business entities for fiscal
years beginning after December 15, 2017, and interim periods within
those fiscal years. Early adoption is permitted, including adoption
in an interim period. The adoption of the ASU 2016-18 did not have
a material impact on the Company’s consolidated financial
statements.
In August 2016, the FASB issued ASU No.
2016-15, “Statement of Cash Flows
(Topic 230): Classification of Certain Cash Receipts and Cash
Payments” (“ASU 2016-15”), which addresses
the following eight specific cash flow issues: debt prepayment or
debt extinguishment costs; settlement of zero-coupon debt
instruments or other debt instruments with coupon interest rates
that are insignificant in relation to the effective interest rate
of the borrowing; contingent consideration payments made after a
business combination; proceeds from the settlement of insurance
claims; proceeds from the settlement of corporate-owned life
insurance policies (including bank-owned life insurance policies;
distributions received from equity method investees; beneficial
interests in securitization transactions; and separately
identifiable cash flows and application of the predominance
principle. The amendments in this ASU are effective for public
business entities for fiscal years beginning after December 15,
2017, and interim periods within those fiscal years. Early adoption
is permitted, including adoption in an interim period. The adoption
of the ASU 2016-15 did not have a material impact on the
Company’s consolidated financial
statements.
In January 2016, the FASB issued ASU No.
2016-01, “Financial Instruments
– Overall (Subtopic 825-10): Recognition and Measurement of
Financial Assets and Financial
Liabilities” (“ASU
2016-01”). The amendments in this update require all equity
investments to be measured at fair value with changes in the fair
value recognized through net income (other than those accounted for
under equity method of accounting or those that result in
consolidation of the investee). The amendments in this update also
require an entity to present separately in other comprehensive
income the portion of the total change in the fair value of a
liability resulting from a change in the instrument-specific credit
risk when the entity has elected to measure the liability at fair
value in accordance with the fair value option for financial
instruments. In addition, the amendments in this update eliminate
the requirement for to disclose the method(s) and significant
assumptions used to estimate the fair value that is required to be
disclosed for financial instruments measured at amortized cost on
the balance sheet for public entities. For public business
entities, the amendments in ASU 2016-01 are effective for fiscal
years beginning after December 15, 2017, including interim periods
within those fiscal years. Except for the early application
guidance discussed in ASU 2016-01, early adoption of the amendments
in this update is not permitted. The adoption of the ASU 2016-01
did not have a material impact on the Company’s consolidated
financial statements.
In May 2014, the FASB issued ASU No.
2014-09, “Revenue from Contracts
with Customers (Topic 606)” (“ASU
2014-09”), which amended the existing accounting standards
for revenue recognition. ASU 2014-09 establishes principles for
recognizing revenue upon the transfer of promised goods or services
to customers, in an amount that reflects the expected consideration
received in exchange for those goods or services. ASU 2014-09 and
its related clarifying ASUs are effective for annual reporting
periods beginning after December 15, 2017 and interim periods
within those annual periods. The Company adopted ASC Topic
606, Revenue from Contracts with
Customers, in the first quarter
of 2018 using the modified retrospective transition approach.
Because the Company’s primary source of revenues for the
six-month period ended June 30, 2018 was only from cell banking
services as well as cell therapy technology services, and the
service revenues are recognized when cell banking and cell therapy
technology services are rendered (i.e., the two performance
obligations that arise from its contracts with customers are
satisfied), the impact on its consolidated financial statements
from adoption of ASC Topic 606 is not material.
Accounting pronouncements not yet effective to adopt
In
June 2018, the FASB issued ASU 2018-07, which simplifies several
aspects of the accounting for nonemployee share-based payment
transactions resulting from expanding the scope of Topic 718,
Compensation-Stock Compensation, to include share-based payment
transactions for acquiring goods and services from non-employees.
Some of the areas for simplification apply only to nonpublic
entities. The amendments specify that Topic 718 applies to all
share-based payment transactions in which a grantor acquires goods
or services to be used or consumed in a grantor’s own
operations by issuing share-based payment awards. The amendments
also clarify that Topic 718 does not apply to share-based payments
used to effectively provide (1) financing to the issuer or (2)
awards granted in conjunction with selling goods or services to
customers as part of a contract accounted for under Topic 606,
Revenue from Contracts with Customers. The amendments in this
Update are effective for public business entities for fiscal years
beginning after December 15, 2018, including interim periods within
that fiscal year. Early adoption is permitted. We do not plan to
early adopt this ASU. We are currently evaluating the potential
impacts of this updated guidance, and do not expect the adoption of
this guidance to have a material impact on our consolidated
financial statements and related disclosures.
In February 2018, the FASB issued ASU No.
2018-02, “Income
Statement—Reporting Comprehensive Income (Topic 220):
Reclassification of Certain Tax Effects from Accumulated Other
Comprehensive Income” (“ASU 2018-02”), which provides
financial statement preparers with an option to reclassify stranded
tax effects within accumulated other comprehensive income to
retained earnings in each period in which the effect of the change
in the U.S. federal corporate income tax rate in the Tax Cuts and
Jobs Act (or portion thereof) is recorded. The amendments in this
ASU are effective for all entities for fiscal years beginning after
December 15, 2018, and interim periods within those fiscal years.
Early adoption of ASU 2018-02 is permitted, including adoption in
any interim period for the public business entities for reporting
periods for which financial statements have not yet been issued.
The amendments in this ASU should be applied either in the period
of adoption or retrospectively to each period (or periods) in which
the effect of the change in the U.S. federal corporate income tax
rate in the Tax Cuts and Jobs Act is recognized. We do not expect
the adoption of ASU 2018-02 to have a material impact on our
consolidated financial statements.
In July 2017, the FASB issued ASU No.
2017-11, “Earnings Per Share
(Topic 260); Distinguishing Liabilities from Equity (Topic 480);
Derivatives and Hedging (Topic 815): (Part I) Accounting for
Certain Financial Instruments with Down Round Features, (Part II)
Replacement of the Indefinite Deferral for Mandatorily Redeemable
Financial Instruments of Certain Nonpublic Entities and Certain
Mandatorily Redeemable Non-controlling Interests with a Scope
Exception” (“ASU
2017-11”), which addresses the complexity of accounting for
certain financial instruments with down round features. Down round
features are features of certain equity-linked instruments (or
embedded features) that result in the strike price being reduced on
the basis of the pricing of future equity offerings. Current
accounting guidance creates cost and complexity for entities that
issue financial instruments (such as warrants and convertible
instruments) with down round features that require fair value
measurement of the entire instrument or conversion option. The
amendments in Part I of this ASU are effective for public business
entities for fiscal years, and interim periods within those fiscal
years, beginning after December 15, 2018. The Company is currently
evaluating the impact of the adoption of ASU 2017-11 on its
consolidated financial statements.
In January 2017, the FASB issued ASU No.
2017-04, “Intangibles—Goodwill
and Other (Topic 350): Simplifying the Test for Goodwill
Impairment” (“ASU
2017-04”), which removes Step 2 from the goodwill impairment
test. An entity will apply a one-step quantitative test and record
the amount of goodwill impairment as the excess of a reporting
unit's carrying amount over its fair value, not to exceed the total
amount of goodwill allocated to the reporting unit. The new
guidance does not amend the optional qualitative assessment of
goodwill impairment. Public business entity that is a U.S.
Securities and Exchange Commission filer should adopt the
amendments in this ASU for its annual or any interim goodwill
impairment test in fiscal years beginning after December 15, 2019.
Early adoption is permitted for interim or annual goodwill
impairment tests performed on testing dates after January 1, 2017.
We are currently evaluating the impact of the adoption of ASU
2017-04 on our consolidated financial
statements.
In June 2016, the FASB issued ASU No.
2016-13, “Financial
Instruments—Credit Losses (Topic 326): Measurement of Credit
Losses on Financial Instruments” (“ASU 2016-13”). Financial
Instruments—Credit Losses (Topic 326) amends guideline on
reporting credit losses for assets held at amortized cost basis and
available-for-sale debt securities. For assets held at amortized
cost basis, Topic 326 eliminates the probable initial recognition
threshold in current GAAP and, instead, requires an entity to
reflect its current estimate of all expected credit losses. The
allowance for credit losses is a valuation account that is deducted
from the amortized cost basis of the financial assets to present
the net amount expected to be collected. For available-for-sale
debt securities, credit losses should be measured in a manner
similar to current GAAP, however Topic 326 will require that credit
losses be presented as an allowance rather than as a write-down.
ASU 2016-13 affects entities holding financial assets and net
investment in leases that are not accounted for at fair value
through net income. The amendments affect loans, debt securities,
trade receivables, net investments in leases, off balance sheet
credit exposures, reinsurance receivables, and any other financial
assets not excluded from the scope that have the contractual right
to receive cash. The amendments in this ASU will be effective for
fiscal years beginning after December 15, 2019, including interim
periods within those fiscal years. We are currently evaluating the
impact of the adoption of ASU 2016-13 on our consolidated financial
statements.
In February 2016, the FASB issued ASU No.
2016-02, “Leases (Topic
842)” (“ASU
2016-02”). The amendments in this update create Topic 842,
Leases, and supersede the leases requirements in Topic 840, Leases.
Topic 842 specifies the accounting for leases. The objective of
Topic 842 is to establish the principles that lessees and lessors
shall apply to report useful information to users of financial
statements about the amount, timing, and uncertainty of cash flows
arising from a lease. The main difference between Topic 842 and
Topic 840 is the recognition of lease assets and lease liabilities
for those leases classified as operating leases under Topic 840.
Topic 842 retains a distinction between finance leases and
operating leases. The classification criteria for distinguishing
between finance leases and operating leases are substantially
similar to the classification criteria for distinguishing between
capital leases and operating leases in the previous leases
guidance. The result of retaining a distinction between finance
leases and operating leases is that under the lessee accounting
model in Topic 842, the effect of leases in the statement of
comprehensive income and the statement of cash flows is largely
unchanged from previous GAAP. The amendments in ASU 2016-02 are
effective for fiscal years beginning after December 15, 2018,
including interim periods within those fiscal years for public
business entities. Early application of the amendments in ASU
2016-02 is permitted. We are currently evaluating the impact of the
adoption of ASU 2016-02 on our consolidated financial
statements.
NOTE 3 – VARIABLE INTEREST ENTITIES
VIEs are those entities
in which a company, through contractual arrangements, bears the
risk of, and enjoys the rewards normally associated with ownership
of the entity, and therefore the Company is the primary beneficiary
of the entity. Cellular Biomedicine Group Ltd (Shanghai)
(“CBMG Shanghai”) and its subsidiaries are variable
interest entities (VIEs), through which the Company conducts immune
therapy and stem cell research and clinical trials in China. The
registered shareholders of CBMG Shanghai are Lu Junfeng and Chen
Mingzhe, who together own 100% of the equity interests in CBMG
Shanghai. Lu Junfeng and Chen Mingzhe are not Board members
and do not participate in management of the Company. The initial
capitalization and operating expenses of CBMG Shanghai are funded
by our wholly foreign-owned enterprise (“WFOE”),
Cellular Biomedicine Group Ltd. (Wuxi) (“CBMG Wuxi”).
CBMG Shanghai was incorporated on October 19, 2011. Agreen Biotech
Co. Ltd. (“AG”) was acquired by CBMG Shanghai in
September 2014. AG was incorporated on April 27, 2011. In January
2017, CBMG Shanghai established two fully owned subsidiaries
- Wuxi Cellular
Biopharmaceutical Group Ltd. and Shanghai Cellular
Biopharmaceutical Group Ltd, which are located in Wuxi and Shanghai
respectively. For the period ended
June 30, 2018 and 2017, 42% and nil of the Company revenue is
derived from VIEs respectively.
As of June 30, 2018, CBMG Wuxi provided financing to CBMG Shanghai
and its subsidiaries in the amount of $24,139,241 for working
capital purposes. As of the same date CBMG Shanghai and its
subsidiary provided technology services of $21,871,753 to CBMG Wuxi
and CBMG Hong Kong and CBMG Wuxi purchased $21,889,333 of
intellectual property from CBMG Shanghai. In conjunction with the
provided financing, exclusive option agreements were executed
granting CBMG Wuxi the irrevocable and exclusive right to convert
the unpaid portion of the provided financing into equity interest
of CBMG Shanghai at CBMG Wuxi’s sole and absolute discretion.
CBMG Wuxi and CBMG Shanghai additionally executed a business
cooperation agreement whereby CBMG Wuxi is to provide CBMG Shanghai
with technical and business support, consulting services, and other
commercial services. The shareholders of CBMG Shanghai pledged 100%
of their equity interest in CBMG Shanghai as collateral in the
event CBMG Shanghai does not perform its obligations under the
business cooperation agreement.
The Company has determined it is the primary beneficiary of CBMG
Shanghai by reference to the power and benefits criterion under ASC
Topic 810, Consolidation. This determination was reached after
considering the financing provided by CBMG Wuxi to CBMG Shanghai is
convertible into equity interest of CBMG Shanghai and the business
cooperation agreement grants the Company and its officers the power
to manage and make decisions that affect the operation of CBMG
Shanghai.
There are substantial uncertainties regarding the interpretation,
application and enforcement of PRC laws and regulations, including
but not limited to the laws and regulations governing our business
or the enforcement and performance of our contractual arrangements.
See Risk Factors below regarding “Risks Related to Our
Structure”.
As the primary beneficiary of CBMG Shanghai and its subsidiaries,
the Company consolidates in its financial statements the financial
position, results of operations, and cash flows of CBMG Shanghai
and its subsidiaries, and all intercompany balances and
transactions between the Company and CBMG Shanghai and its
subsidiaries are eliminated in the consolidated financial
statements.
The
Company has aggregated the financial information of CBMG Shanghai
and its subsidiaries in the table below. The aggregate carrying
value of assets and liabilities of CBMG Shanghai and its
subsidiaries (after elimination of intercompany transactions and
balances) in the Company’s condensed consolidated balance
sheets as of June 30, 2018 and December 31, 2017 are as
follows:
|
|
|
|
|
|
|
|
|
Assets
|
|
|
Cash
|
$1,030,161
|
$2,337,173
|
Accounts
receivables
|
22,670
|
-
|
Other
receivables
|
62,677
|
61,735
|
Prepaid
expenses
|
2,243,855
|
1,750,509
|
Total
current assets
|
3,359,363
|
4,149,417
|
|
|
|
Property,
plant and equipment, net
|
13,126,061
|
12,477,315
|
Intangibles
|
1,421,201
|
1,516,449
|
Long-term
prepaid expenses and other assets
|
3,869,935
|
3,631,906
|
Total
assets
|
$21,776,560
|
$21,775,087
|
|
|
|
Liabilities
|
|
|
Accounts
payable
|
$299,346
|
$181,231
|
Other
payables
|
2,175,830
|
1,631,582
|
Accrued
payroll *
|
854,879
|
682,248
|
Deferred
income
|
19,543
|
9,810
|
Total
current liabilities
|
$3,349,598
|
$2,504,871
|
|
|
|
Other
non-current liabilities
|
87,601
|
183,649
|
Total
liabilities
|
$3,437,199
|
$2,688,520
|
|
|
|
*
Accrued payroll mainly includes bonus accrual of $757,196 and
$673,443.
|
|
|
NOTE 4 – OTHER RECEIVABLES
As
of June 30, 2018 and December 31, 2017 the amounts of other
receivables were mainly comprised of the deposits expected to be
recovered within 12 months and advances to employees for business
travel purpose.
NOTE 5 – PROPERTY, PLANT AND EQUIPMENT
As
of June 30, 2018 and December 31, 2017, property, plant and
equipment, carried at cost, consisted of the
following:
|
|
|
|
|
|
Office
equipment
|
$107,477
|
$105,114
|
Manufacturing
equipment
|
5,539,351
|
4,781,936
|
Computer
equipment
|
370,504
|
233,539
|
Leasehold
improvements
|
12,639,609
|
4,196,589
|
Construction
work in process
|
718,558
|
7,498,272
|
|
19,375,499
|
16,815,450
|
Less:
accumulated depreciation
|
(5,303,221)
|
(3,842,108)
|
|
$14,072,278
|
$12,973,342
|
For
the three and six months ended June 30, 2018, depreciation expense
was $861,084 and $1,587,702, respectively, as compared to $252,499
and $475,425 for the three and six months ended June 30, 2017,
respectively.
NOTE 6 – INVESTMENTS
Short-term Investment
The
Company’s short-term investment is six-month deposits with
banks.
Long-term Investments
The
Company’s long-term investments represent the investment in
equity securities listed in Over-The-Counter (“OTC”)
markets of the United States of America:
|
|
|
Gross Unrealized Losses more than 12 months
|
Gross Unrealized Losses less than 12 months
|
|
Equity
position in Arem Pacific Corporation
|
480,000
|
-
|
-
|
(240,000)
|
240,000
|
|
|
|
|
|
|
Total
|
$480,000
|
$-
|
$-
|
$(240,000)
|
$240,000
|
|
|
|
Gross Unrealized Losses more than 12 months
|
Gross Unrealized Losses less than 12 months
|
|
Equity
position in Alpha Lujo, Inc.
|
$251,388
|
$-
|
$(221,964)
|
$-
|
$29,424
|
Equity
position in Arem Pacific Corporation
|
480,000
|
-
|
-
|
(240,000)
|
240,000
|
Total
|
$731,388
|
$-
|
$(221,964.00)
|
$(240,000)
|
$269,424
|
The
unrealized holding gain (loss) for the investments, net of tax that
were recognized in other comprehensive income for the three and six
months ended June 30, 2018 was nil, as compared to $(240,000) for
the three and six months ended June 30, 2017,
respectively.
The
Company tracks each investment with an unrealized loss and evaluate
them on an individual basis for other-than-temporary impairments,
including obtaining corroborating opinions from third party
sources, performing trend analysis and reviewing management’s
future plans. When investments have declines determined
by management to be other-than-temporary the Company recognizes
write downs through earnings. Other-than-temporary
impairment of investments for the three and six months ended June
30, 2018 was $29,424, as compared to nil for the three and six
months ended June 30, 2017. The Company provided full impairment of
$29,424 for shares of Alpha Lujo, Inc. (“ALEV”) for the
three and six months ended June 30, 2018 as ALEV filed Form 15
(Certification and Notice of Termination of Registration under
Section 12(g) of the Securities Exchange Act of 1934 or Suspension
of Duty to File Reports) in SEC and was no longer traded in the
market in recent quarter.
NOTE 7 – FAIR VALUE ACCOUNTING
The
Company has adopted ASC Topic 820, Fair Value Measurement and
Disclosure, which defines fair value, establishes a framework for
measuring fair value in GAAP, and expands disclosures about fair
value measurements. It does not require any new fair value
measurements, but provides guidance on how to measure fair value by
providing a fair value hierarchy used to classify the source of the
information. It establishes a three-level valuation hierarchy of
valuation techniques based on observable and unobservable inputs,
which may be used to measure fair value and include the
following:
Level 1 – Quoted prices in active markets for identical
assets or liabilities.
Level 2 – Inputs other than Level 1 that are observable,
either directly or indirectly, such as quoted prices for similar
assets or liabilities; quoted prices in markets that are not
active; or other inputs that are observable or can be corroborated
by observable market data for substantially the full term of the
assets or liabilities.
Level 3 – Unobservable inputs that are supported by little or
no market activity and that are significant to the fair value of
the assets or liabilities.
Classification
within the hierarchy is determined based on the lowest level of
input that is significant to the fair value
measurement.
The
carrying value of financial items of the Company including cash and
cash equivalents, accounts receivable, other receivables, current
investment, accounts payable and accrued liabilities, approximate
their fair values due to their short-term nature and are classified
within Level 1 of the fair value hierarchy. The Company’s
non-current investments are classified within Level 2 of the fair
value hierarchy because of the liquidity challenge and limited
trading of the stocks traded in OTC market.
Assets
measured at fair value within Level 2 on a recurring basis as of
June 30, 2018 and December 31, 2017 are summarized as
follows:
|
As of June 30, 2018
|
|
Fair Value Measurements at Reporting Date Using:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
Equity
position in Arem Pacific Corporation
|
240,000
|
-
|
240,000
|
-
|
|
|
|
|
|
|
$240,000
|
$-
|
$240,000
|
$-
|
|
As of December 31, 2017
|
|
Fair Vaue Measurements at Reporting Date Using:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
Equity
position in Alpha Lujo, Inc.
|
$29,424
|
$-
|
$29,424
|
$-
|
Equity
position in Arem Pacific Corporation
|
240,000
|
-
|
240,000
|
-
|
|
$269,424
|
$-
|
$269,424
|
$-
|
No shares were acquired in the six months ended
June 30, 2018 and 2017.
As
of June 30, 2018 and December 31, 2017, the Company holds 8,000,000
shares in Arem Pacific Corporation, 2,942,350 shares in ALEV and
2,057,131 shares in Wonder International Education and Investment
Group Corporation (“Wonder”),
respectively. Full impairment has been provided for
shares of Wonder and ALEV as of June 30, 2018. All
available-for-sale investments held by the Company at June 30, 2018
and December 31, 2017 have been valued based on level 2 inputs due
to the illiquid nature of these non-reporting securities that
cannot easily be sold or exchanged for
cash.
NOTE 8 – INTANGIBLE ASSETS
Intangible
assets that are subject to amortization are reviewed for potential
impairment whenever events or circumstances indicate that carrying
amounts may not be recoverable. Assets not subject to amortization
are tested for impairment at least annually. The Company evaluates
the continuing value of the intangibles at each balance sheet date
and records write-downs if the continuing value has become
impaired. An impairment is determined to exist if the anticipated
undiscounted future cash flow attributable to the asset is less
than its carrying value. The asset is then reduced to the net
present value of the anticipated future cash flow.
As
of June 30, 2018 and December 31, 2017, intangible assets, net
consisted of the following:
Patents
& knowhow & license
|
|
|
|
|
|
Cost
basis
|
$17,649,995
|
$17,674,431
|
Less:
accumulated amortization
|
(6,201,297)
|
(5,325,113)
|
|
$11,448,698
|
$12,349,318
|
Software
|
|
|
|
|
|
Cost
basis
|
$189,397
|
$158,273
|
Less:
accumulated amortization
|
(99,190)
|
(87,899)
|
|
$90,207
|
$70,374
|
|
|
|
|
|
|
Total
intangibles, net
|
$11,538,905
|
$12,419,692
|
All
software is provided by a third party vendor, is not
internally developed, and has an estimated useful life of five
years. Patents and knowhow are amortized using an estimated useful
life of three to ten years. Amortization expense for the three and
six months ended June 30, 2018 was $449,573 and $898,443,
respectively, and amortization expense for the three and six months
ended June 30, 2017 was $446,930 and $893,743,
respectively.
Estimated
amortization expense for each of the ensuing years are as follows
for the years ending June 30:
Years
ending June 30,
|
|
2019
|
$1,792,338
|
2020
|
1,791,244
|
2021
|
1,785,464
|
2022
|
1,776,042
|
2023
and thereafter
|
4,393,817
|
|
$11,538,905
|
NOTE 9 – LEASES
The
Company leases facilities under non-cancellable operating lease
agreements. These facilities are located in the United
States, Hong Kong and China. The Company recognizes
lease expense on a straight-line basis over the life of the lease
period. Lease expense under operating leases for the
three and six months ended June 30, 2018 was approximately $981,423
and $1,948,855, respectively, as compared to $890,060 and
$1,784,945 for the three and six months ended June 30, 2017,
respectively.
As
of June 30, 2018, the Company has the following future minimum
lease payments due under the foregoing lease
agreements:
Years
ending June 30,
|
|
2019
|
$3,068,252
|
2020
|
2,782,191
|
2021
|
2,594,715
|
2022
|
2,594,715
|
2023
and thereafter
|
11,077,373
|
|
|
|
$22,117,246
|
NOTE 10 – RELATED PARTY TRANSACTIONS
As
of June 30, 2018 and December 31, 2017, accrued expenses included
unpaid director fees of nil and $25,882.
From time to time, cash advance is offered to employees for business
travel purposes. No interest is charged on the
outstanding balances. As of Jun 30, 2018 and December 31, 2017,
other receivables due from officers for business travel purposes
was nil and $8,531, respectively.
NOTE 11 – EQUITY
ASC Topic 505 Equity paragraph 505-50-30-6 establishes that
share-based payment transactions with nonemployees shall be
measured at the fair value of the consideration received or the
fair value of the equity instruments issued, whichever is more
reliably measurable.
On
December 15, 2017, the Company entered into a Share Purchase
Agreement with three of its executive officers, pursuant to which
the Company agreed to sell, and the three executive officers agreed
to purchase an aggregate of 41,667 shares of the Company’s
common stock, par value $0.001 per share at $12.00 per share, for
total gross proceeds of approximately $500,000. The transaction
closed on December 22, 2017.
On
December 26, 2017, the Company entered into a Share Purchase
Agreement with two investors, pursuant to which the Company agreed
to sell and the two investors agreed to purchase from the Company,
an aggregate of 1,166,667 shares of the Company’s common
stock, par value $0.001 per share, at $12.00 per share, for total
gross proceeds of approximately $14,000,000. The transaction closed
on December 28, 2017. Together with a private placement with three
of its executive officers on December 22, 2017, the Company raised
an aggregate of approximately $14.5 million in the two private
placements in December 2017.
On
January 30, 2018 and February 5, 2018, the Company entered into
securities purchase agreements with certain investors pursuant to
which the Company agreed to sell, and the investors agreed to
purchase from the Company, an aggregate of 1,719,324 shares of the
Company’s common stock, par value $0.001 per share, at $17.80
per share, for total gross proceeds of approximately $30.6
million. The transaction closed on February 5,
2018.
During
the three and six months ended June 30, 2018, the Company expensed
$891,163 and $1,595,706 associated with unvested option awards and
$451,570 and $881,908 associated with restricted common stock
issuances, respectively. During the three and six months ended June
30, 2017, the Company expensed $1,219,219 and $2,634,970 associated
with unvested options awards and $250,987 and $267,143 associated
with restricted common stock issuances, respectively.
During
the three and six months ended June 30, 2018, options for 29,844
and 132,274 underlying shares were exercised on a cash basis,
29,844 and 132,274 shares of the Company’s common stock were
issued accordingly. During the three and six months ended June 30,
2017, options for 32,400 and 33,000 underlying shares were
exercised on a cash basis, 32,400 and 33,000 shares of the
Company’s common stock were issued accordingly. A majority of
the option exercises during the three and six months ended June 30,
2017 were by non-executive employees of the Company pursuant to
certain 10b-5 plans.
During
the three and six months ended June 30, 2018, 19,771 and 36,082 of
the Company's restricted common stock were issued respectively.
During the three and six months ended June 30, 2017, 18,061 and
22,096 of the Company’s restricted common stock were issued
respectively.
The
Company's Board of Directors approved a stock repurchase program
granting the company authority to repurchase up to $10 million in
common shares through open market purchases pursuant to a plan
adopted in accordance with Rule 10b5-1 and 10b-18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”)
and was announced on June 1, 2017.
For
the three and six months ended June 30, 2018, the Company
repurchased 96,512 and 133,974 shares of the Company’s common
stock with the total cost of $1,820,396 and $2,536,064,
respectively. Details are as follows:
|
Total number of shares purchased
|
Average price paid per share
|
|
|
|
Treasury
stock as of December 31, 2017
|
426,794
|
$9.32
|
Repurchased
from January 1, 2018 to March 31, 2018
|
37,462
|
$19.10
|
Repurchased
from April 1, 2018 to June 30, 2018
|
96,512
|
$18.86
|
|
|
|
Treasury
stock as of June 30, 2018
|
560,768
|
$11.62
|
NOTE 12 – COMMITMENTS AND CONTINGENCIES
Capital commitments
As
of June 30, 2018, the capital commitments of the Company are
summarized as follows:
|
|
|
|
Contracts
for acquisition of equipment and facility improvement being or to
be executed
|
$3,427,067
|
NOTE 13 – STOCK BASED COMPENSATION
Our
stock-based compensation arrangements include grants of stock
options and restricted stock awards under the Stock Option Plan
(collectively, the “Plans”), and certain awards granted
outside of these plans. The compensation cost that has been charged
against income related to stock options for the three and six
months ended June 30, 2018 was $891,163 and $1,595,706,
respectively, and for the three and six months ended June 30, 2017
was $1,219,219 and $2,634,970, respectively. The compensation cost
that has been charged against income related to restricted stock
awards for the three and six months ended June 30, 2018 was
$451,570 and $881,908, respectively, and for the three and six
months ended June 30, 2017 was $250,987 and $267,143,
respectively.
As
of June 30, 2018, there was $5,220,189 of unrecognized compensation
cost related to an aggregate of 549,645 of unvested stock option
awards and $512,086 related to an aggregate of 52,102 of unvested
restricted stock awards. These costs are expected to be
recognized over a weighted-average period of 2.04 years for the
stock options awards and 1.4 years for the restricted stock
awards.
During
the three months ended June 30, 2018, the Company issued options to
purchase an aggregate of 160,089 shares of the Company’s
common stock under the Plans. The grant date fair value of these
options was $2,180,036 using Black-Scholes option valuation models
with the following assumptions: exercise price equal to the grant
date stock price or average selling prices over the 30-business day
period preceding the date of grant ranging from $17.4 to $20.65,
volatility ranging from 65.99% to 90.21%, expected life of 6.0
years, and risk-free rate ranging from 2.61% to 2.96%. The Company
is expensing these options on a straight-line basis over the
requisite service period.
During
the six months ended June 30, 2018, the Company issued options to
purchase an aggregate of 190,682 shares of the Company’s
common stock to officers, directors and employees under the Plans.
The grant date fair value of these options was $2,600,715 using
Black-Scholes option valuation models with the following
assumptions: exercise price equal to the grant date stock price or
average selling prices over the 30-business day period preceding
the date of grant ranging from $14.5 to $21.8, volatility ranging
from 65.99% to 90.43%, expected life of 6.0 years, and risk-free
rate ranging from 2.33% to 2.96%. The Company is expensing these
options on a straight-line basis over the requisite service
period.
During
the three months ended June 30, 2017, the Company issued options to
purchase an aggregate of 123,997 shares of the Company’s
common stock under the Plans. The grant date fair value of these
options was $825,134 using Black-Scholes option valuation models
with the following assumptions: exercise price equal to the grant
date stock price ranging from $5.3 to $11.15, volatility ranging
from 88.04% to 88.86%, expected life of 6.0 years, and risk-free
rate ranging from 1.86% to 1.99%. The Company is expensing these
options on a straight-line basis over the requisite service
period.
During
the six months ended June 30, 2017, the Company issued options to
purchase an aggregate of 511,738 shares of the Company’s
common stock under the Plans to officers, directors and employees.
The grant date fair value of these options was $4,349,258 using
Black-Scholes option valuation models assuming grant date stock
prices ranging from $5.3 to $13.2 volatility ranging from 88.04% to
89.62%, expected life of 6.0 years, and risk-free rate ranging from
1.86% to 2.29%. The Company is expensing these options on a
straight-line basis over the requisite service period.
The
following table summarizes stock option activity as of June 30,
2018 and December 31, 2017 and for the six months ended June 30,
2018:
|
|
Weighted- Average Exercise Price
|
Weighted- Average Remaining Contractual Term (in
years)
|
Aggregate Intrinsic Value
|
|
|
|
|
|
Outstanding
as of December 31, 2017
|
1,892,189
|
$11.54
|
7.0
|
$4,909,194
|
Grants
|
190,682
|
|
|
|
Forfeitures
|
(21,653)
|
|
|
|
Exercises
|
(132,274)
|
|
|
|
Outstanding
as of June 30, 2018
|
1,928,944
|
$12.40
|
6.9
|
$14,944,205
|
|
|
|
|
|
Vested
and exercisable as of June 30, 2018
|
1,379,299
|
$11.30
|
6.1
|
$12,320,497
|
|
|
|
|
|
|
|
|
$3.00 - $4.95
|
185,547
|
185,547
|
$5.00 - $9.19
|
486,584
|
442,400
|
$9.25 - $14.92
|
585,891
|
339,831
|
$15.35 - $20.00
|
519,222
|
295,621
|
$20.10+
|
151,700
|
115,900
|
|
1,928,944
|
1,379,299
|
|
|
|
The
aggregate intrinsic value for stock options outstanding is defined
as the positive difference between the fair market value of our
common stock and the exercise price of the stock
options.
Cash
received from option exercises under all share-based compensation
arrangements for the three and six months ended June 30, 2018 was
$396,040 and $1,165,763, respectively, as compared to $68,265 and
$73,779 for the three and six months ended June 30, 2017,
respectively.
NOTE 14 – NET LOSS PER SHARE
Basic
and diluted net loss per common share is computed on the basis of
our weighted average number of common shares outstanding, as
determined by using the calculations outlined below:
|
For the Three Months Ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$(9,186,076)
|
$(6,203,518)
|
$(17,682,499)
|
$(12,365,511)
|
|
|
|
|
|
Weighted
average shares of common stock
|
17,487,184
|
14,298,973
|
17,116,944
|
14,211,888
|
Dilutive
effect of stock options
|
-
|
-
|
-
|
-
|
Restricted
stock vested not issued
|
-
|
-
|
-
|
-
|
Common
stock and common stock equivalents
|
17,487,184
|
14,298,973
|
17,116,944
|
14,211,888
|
|
|
|
|
|
Net
loss per basic and diluted share
|
$(0.53)
|
$(0.43)
|
$(1.03)
|
$(0.87)
|
Basic
and diluted net loss per share is calculated by dividing net loss
by the weighted average number of common shares outstanding during
the period, without consideration for common stock equivalents. The
Company’s potentially dilutive shares, which include unvested
restricted stock and options to purchase common stock, are
considered to be common stock equivalents and are only included in
the calculation of diluted net loss per share when their effect is
dilutive.
NOTE 15 – INCOME TAXES
Income
taxes are accounted for under the asset and liability method.
Deferred tax assets and liabilities are recognized for the future
tax consequences attributable to differences between the financial
statement carrying amounts of existing assets and liabilities and
their respective tax bases and operating loss and tax credit
carry-forwards. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be
recovered or settled. The effect of a change in tax rates on
deferred tax assets and liabilities is recognized in income in the
period during which such rates are enacted.
The
Company considers all available evidence to determine whether it is
more likely than not that some portion or all of the deferred tax
assets will be realized. The ultimate realization of deferred tax
assets is dependent upon the generation of future taxable income
during the periods in which those temporary differences become
realizable. Management considers the scheduled reversal of deferred
tax liabilities (including the impact of available carryback and
carry-forward periods), and projected taxable income in assessing
the realizability of deferred tax assets. In making such judgments,
significant weight is given to evidence that can be objectively
verified. Based on all available evidence, in particular our
three-year historical cumulative losses, recent operating losses
and U.S. pre-tax loss for the three months ended June 30, 2017, we
recorded a valuation allowance against our U.S. net deferred tax
assets. In order to fully realize the U.S. deferred tax assets, we
will need to generate sufficient taxable income in future periods
before the expiration of the deferred tax assets governed by the
tax code.
In
each of the reporting period since inception, the Company has
recorded a valuation allowance for the full amount of net deferred
tax assets, as the realization of deferred tax assets is uncertain.
As a result, the Company has not recorded any federal or state
income tax benefit in the consolidated statements of operations and
comprehensive income (loss).
Under
the December 22, 2017 tax reform bill (Tax Cut and Jobs Act
(H.R.1)), top corporate tax rate was reduced from 35% to 21%
effective from January 1, 2018. Pursuant to this new Act,
non-operating loss (“NOL”) carry back period is
eliminated and an indefinite carry forward period is permitted. As
of June 30, 2018, US federal and state NOL was $19.6 million and
$14.0 million respectively. As of June 30, 2018, the Company had
net operating loss carryforwards of $6 million and $20 million for
Chinese income tax purposes, such losses are set to expire in 2028
(for advanced and new technology enterprises and small and middle
technology enterprises) and 2023 (for other Chinese enterprises)
for Chinese income tax purposes, respectively. All deferred income
tax expense is offset by changes in the valuation allowance
pertaining to the Company's existing net operating loss
carryforwards due to the unpredictability of future profit streams
prior to the expiration of the tax losses. The Company's
effective tax rate differs from statutory rates of 21% for U.S.
federal income tax purposes, 15%, 20% and 25% for Chinese income
tax purpose and 16.5% for Hong Kong income tax purposes due to the
effects of the valuation allowance and certain permanent
differences as it pertains to book-tax differences in the value of
client shares received for services.
Pursuant
to the PRC Corporate Income Tax Law, all of the Company’s PRC
subsidiaries are liable to PRC Corporate Income Taxes
(“CIT”) at a rate of 25% except for CBMG
Shanghai” and AG. According to Guoshuihan 2009 No. 203, if an
entity is certified as an “advanced and new technology
enterprise”, it is entitled to a preferential income tax rate
of 15%. CBMG Shanghai obtained the certificate of “advanced
and new technology enterprise” dated October 30, 2015 with an
effective period of three years and the provision for PRC corporate
income tax for CBMG Shanghai is calculated by applying the income
tax rate of 15% from 2015. The October 2015 issued certificate
expires in October, 2018 and the Company plans to renew the
certificate for another three years. CBMG Shanghai is re-applying
for the certificate of “advanced and new technology
enterprise”. AG was certified as “small and micro
enterprise” in 2017 annual tax filing and enjoyed the
preferential income tax rate of 20%.
NOTE 16 – SEGMENT INFORMATION
The
Company is engaged in the development of new treatments for
cancerous and degenerative diseases utilizing proprietary
cell-based technologies, which have been organized as one reporting
segment as they have substantially similar economic characteristic
since they have similar nature and economic characteristics. The
Company’s principle operating decision maker, the Chief
Executive Officer, receives and reviews the result of the operation
for all major cell platforms as a whole when making decisions about
allocating resources and assessing performance of the Company. In
accordance with FASB ASC 280-10, the Company is not required to
report the segment information.
NOTE 17 – COMPARATIVE FIGURES
Lease
deposits of $750,604 might be recovered over one year considering
the lease term, the Company recorded it in other long-term assets.
Comparative figures of $732,098 have been reclassified to conform
with the current period’s presentation to facilitate
comparison.
ITEM 2. MANAGEMENT’S DISCUSSION
AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The following discussion and analysis summarizes the significant
factors affecting our results of operations, financial condition
and liquidity position for the three and six months ended June 30,
2018 and 2017, and should be read in conjunction with our unaudited
condensed consolidated financial statements and related notes
included elsewhere in this filing.
This report contains forward-looking statements. These statements
relate to future events or to our future financial performance and
involve known and unknown risks, uncertainties and other factors
which may cause our actual results, performance or achievements to
be materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements.
Factors that might affect our forward-looking statements include,
among other things:
●
|
overall economic and business conditions;
|
●
|
the demand for our products and services;
|
●
|
competitive factors in the market in which we compete;
|
●
|
the emergence of new technologies which compete with our product
and service offerings;
|
●
|
our cash position and cash burn rate;
|
●
|
other capital market conditions, including availability of funding
sources;
|
●
|
the strength of our intellectual property portfolio;
and
|
●
|
changes in government regulations in China and in the
U.S. related to our industries.
|
In some cases, you can identify forward-looking statements by terms
such as “may”, “will”,
“should”, “could”, “would”,
“expects”, “plans”,
“anticipates”, “believes”,
“estimates”, “projects”,
“predicts”, “potential” and similar
expressions. These statements reflect our current views with
respect to future events and are based on assumptions and are
subject to risks and uncertainties. Given these uncertainties, you
should not place undue reliance on these forward-looking
statements. We discuss many of these risks in greater detail under
the heading “Risk Factors” included in other reports we
file with the Securities and Exchange Commission. Also, these
forward-looking statements represent our estimates and assumptions
only as of the date of the document containing the applicable
statement.
Unless required by law, we undertake no obligation to update or
revise any forward-looking statements to reflect new information or
future events or developments. Thus, you should not assume that our
silence over time means that actual events are bearing out as
expressed or implied in such forward-looking
statements.
OVERVIEW
The “Company”, “CBMG”, “we”,
“us”, “our” and similar terms refer to
Cellular Biomedicine Group, Inc. (a Delaware corporation) as a
combined entity including each of its subsidiaries and deemed
controlled companies, unless the context otherwise
requires.
Recent Developments
On
January 3, 2017, we announced the signing of a ten-year lease
of an 113,038-square foot building located in the
“Pharma Valley” in Shanghai Zhangjiang High-Tech Park.
The new facility designed and built to GMP standards has
approximately 40,000 square feet dedicated to advanced cell
manufacturing. We invested approximately $10 million to
transform the Zhangjiang GMP facility and leasehold improvement. At
the end of 2017, the combination of new Zhangjiang facility, an
expanded Wuxi, and Beijing facilities, have an aggregate of
approximately 70,000 square feet for cell manufacturing. The
Company expects that it will be capable of supporting clinical
trials for five different CAR-T and stem cell products
simultaneously, or the ability to produce products to
treat approximately 10,000 cancer patients and 10,000 KOA
patients per year. To reach this capacity, we continue to
acquire talented scientists and technicians with relevant
experience and will continue to expand our equipment acquisition by
earmarking $3.4 million in systems and equipment
purchases.
On
January 9, 2017, we announced the commencement of patient
enrollment in China for our CALL-1 (“CAR-T against Acute
Lymphoblastic Leukemia”) Phase I clinical trial of CD19 CAR-T
therapy utilizing our optimized proprietary C-CAR011 construct for
the treatment of patients with relapsed or refractory (r/r) CD19+
B-cell ALL. We have been enrolling patients and working with the
China Center for Drug Evaluation (“CDE”) of the CFDA to
obtain approval of the Company’s IND application.
On
May 15, 2017, we announced the addition of a new independent
Phase I clinical trial of the Company’s ongoing CARD-1 study
in patients with chemorefractory or refractory B cell Non-Hodgkin
Lymphoma (NHL). The Company and Shanghai Tongji Hospital (Tongji)
are conducting a single arm, non-randomized study to evaluate the
safety and efficacy of C-CAR011 (Anti-CD19 single-chain variable
fragment (scFv) (41BB-CD3zeta)) therapy in relapsed or refractory B
cell NHL patients. We have been enrolling patients and working with
CDE to obtain approval of the Company’s IND
application.
On
June 1, 2017, we announced that our Board of Directors approved a
new stock repurchase program granting the company authority to
repurchase up to $10 million in common shares through
open market purchases pursuant to a plan adopted in accordance with
Rule 10b5-1 and Rule 10b-15 of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”). The program
contemplates repurchase shares of the Company’s common stock
in the open market in accordance with all applicable securities
laws and regulations. From June 2017 to June 2018 the Company
repurchased a total of 560,768 shares at a total price of
$6,513,993, or an average of $11.62 per share.
On
June 20, 2017, we announced the establishment of an External
Advisory Board and the appointment of Michael A. Caligiuri, MD,
then President of the AACR and director of The Ohio State
University Comprehensive Cancer Center and CEO of the Arthur G.
James Cancer Hospital and Richard J. Solove Research Institute in
Columbus, Ohio, as Chair of the External Advisory Board to bring
together experts from diverse disciplines to provide knowledge and
insight to help CBMG fulfill its mission and build a network for
development opportunities. Dr. Caligiuri is president of City of
Hope National Medical Center and physician-in-chief.
On
June 26, 2017, we announced the appointment of Dr. Xia Meng as
Chief Operating Officer for the Company. On February 6, 2018,
driven by the Company’s strategic move to expand its business
operations in early diagnosis and cancer intervention, Meng Xia
transitioned from the role of Chief Operating Officer to Head of
the Early Diagnosis & Intervention for the
Company.
On
November 4, 2017, we announced the grand opening of our Zhangjiang
facility. On the same day, we announced the signing of a strategic
partnership with Thermo Fisher Scientific (China) Ltd. to build a
joint Cell Therapy Technology Innovation and Application Center
(Center) at CBMG’s newly opened Shanghai Zhangjiang
facility.
On
December 28, 2017, the Company announced the closing of two private
placement transactions pursuant to which we sold an aggregate of
1,208,333 shares of the Company’s common stock to select key
executives and private investors at $12.00 per share, for total
aggregate gross proceeds of approximately $14.5
million.
On
January 30, 2018 and February 5, 2018, the Company entered into
securities purchase agreements with certain investors pursuant to
which the Company agreed to sell, and the investors agreed to
purchase from the Company, an aggregate of 1,719,324 shares (the
“February 2018 Private Placement”) of the
Company’s common stock, par value $0.001 per share, at $17.80
per share, for total gross proceeds of approximately $30.6
million. The transaction closed on February 5, 2018.
Pursuant to the purchase agreement, the Investors have the right to
nominate one director to the board of directors of the Company to
stand for election at the 2018 Annual Meeting of Stockholders.
Effective as of the closing of the February 2018 Private Placement,
Bosun S. Hau was appointed as a non-executive Class III director of
the Company and his appointment was subsequent ratified by the
shareholders during the Annual Shareholders Meeting on April 27,
2018,
On
February 15, 2018, the Company obtained a 36 months exclusive
option with Augusta University to negotiate a royalty-bearing,
exclusive license to the patent rights owned by the Augusta
University relating to an invention to identify novel alpha
fetoprotein (“AFP”) specific T-cell receptors (TCR) for
a hepatocellular carcinoma ("HCC") immunotherapy. The Company is
evaluating the feasibility and opportunities of this novel alpha
fetoprotein TCR to redirect T Cells for the HCC indication. We are
evaluating the efficacy and specificity of the AFP TCR to identity
the most appropriate candidate for first time in human (FTIH)
study. In addition, human CD8+ T cells will be redirected with the
AFP TCRs and their anti-tumor activity will be evaluated by in
vitro cytokine release assay and cytotoxicity assay. Concurrently,
potential on/off-target toxicity including allo-reactivity will
also be evaluated and the best candidate TCRs for clinical use will
be further tested in humanized mouse models. We plan to exercise
our exclusive right to license the technology from Augusta
University if and when the FTIH proof of mechanism study shows
promising clinical efficacy signal and manageable safety
profile.
On
March 16, 2018, we issued a press release announcing the
presentation of the Allojoin™ Phase I 48-week data in China,
as well as the termination of the Company’s U.S.
Allojoin™ program with CIRM to focus the clinical development
in China. Prior to termination, the Company had received $1.2
million of the potential $2.29 million available under the CIRM
grant.
On
April 18, 2018 and April 21, 2018, the CFDA CDE posted on its
website acceptance of the IND application for CAR-T cancer
therapies in treating patients with NHL and ALL submitted by two of
the wholly-owned subsidiaries of the Company, respectively.
Thus far, a total of three Chinese companies that submitted
their IND application ahead of the Company have received approval
of their IND application for CAR-T cancer therapies.
On
June 22, 2018, the Company announced the grand opening of its new
research and development center in Gaithersburg,
Maryland.
In
the next 12 months, we aim to accomplish the following, though
there can be no assurances that we will be able to accomplish any
of these goals:
●
File
Allojoin™, Rejoin™ and KOA IND application with the
CFDA’s CDE and
initiate clinical studies to support the BLA applications in
China;
●
Bolster R&D
resources to fortify our intellectual properties portfolio and
scientific development. Continue to develop a competitive immune
cell therapy pipeline for CBMG. Seek opportunities to file new
patent applications in potentially the rest of the world
and
in China
;
●
Leveraging our
quality system and our strong scientific expertise to develop a
platform as preferred parties for international pharmaceutical
companies to co-develop cell therapies in China by implementing our
quality strategies and leveraging the experience and expertise of
our strong scientific team in the U.S. and in China;
●
Continue to
identify and evaluate advanced technologies and seek partnerships
to bolster our competitive edge in the cell therapy field in
China;
●
Confirm the safety
and efficacy profile of C-CAR011 in China in refractory aggressive
DLBCL and to initiate a larger Phase II clinical trial when
feasible;
●
Confirm the safety
and efficacy 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;
●
Initiate an
investigator sponsored phase I trial of anti-BCMA CART in adults
with relapsed/refractory multiple myeloma;
●
Implement our GE
Joint Technology Laboratory’s integrated and automated cell
manufacturing system to enable robust, scalable and cost effective
processes for the manufacturing of CAR-T and Stem Cell
Therapies;
●
Implement the
digital tracking system of our Thermo Fisher Joint Cell Therapy
Technology Innovation and Application Center and develop a fully
chemically-defined culture medium for improved virus production and
assess Next-Generation Sequencing (NGS) technology to accelerate
our research and development;
●
Evaluate new
regenerative medicine technology platform for other indications and
review recent development in the competitive
landscape;
●
Evaluate our
corporate development strategy on maintaining the CAR-T and
regenerative medicine dual technology platform;
●
Advance the
evaluation on feasibility and opportunities of novel Alpha
Fetoprotein Specific T Cell Receptors (TCR) to redirect T Cells for
a HCC Immunotherapy;
●
Develop the new
cancer diagnostics and intervention business;
●
Reassess the return
of investment to develop GVAX for cancer therapeutics in the
current competitive market;
●
Advance our Quality
Management System (QMS), Validation Master
Plan(VMP) and quality assurance
automation;
●
Improve liquidity
and fortify our balance sheet by courting institutional investors;
and
●
Evaluate
possibility of dual listing on the Hong Kong Stock Exchange to
expand investor base in Asia.
Corporate History
Please refer to Note1 of unaudited condensed consolidated financial
statements for the corporate history.
BIOPHARMACEUTICAL BUSINESS
The
biopharmaceutical business was founded in 2009 by a team of
seasoned Chinese-American executives, scientists and doctors. In
2010, we established a facility designed and built to GMP standards
in Wuxi, China and in 2012 we established a U.S. Food and Drug
Administration (“FDA”) GMP standard protocol-compliant
manufacturing facility in Shanghai. In October 2015, we opened a
facility designed and built to GMP standards in Beijing. In
November 2017, we opened our Zhangjiang facility in Shanghai, of
which 40,000 square feet was designed and built to GMP standards
and dedicated to advanced cell manufacturing. Our focus has been to
serve the rapidly growing health care market in China by marketing
and commercializing immune cell and stem cell therapeutics, related
tools and products from our patent-protected homegrown and acquired
cell technology, as well as by utilizing in-licensed and other
acquired intellectual properties.
Our
current treatment focal points are KOA, cancer and we are
evaluating companion diagnostics that can benefit personalized
cancer treatment.
Cancer. We are prioritizing our clinical efforts on
CAR-T and TCR, with the recent build-up of multiple cancer
therapeutic technologies, we have prioritized our clinical efforts
on CAR-T. On November 29, 2016, we announced the approval and
commencement of patient enrollment in China for its CARD-1
(“CAR-T Against DLBCL”) Phase I clinical trial
utilizing its optimized proprietary C-CAR011 construct of CD19
chimeric antigen receptor T-cell (CAR-T) therapy for the treatment
of patients with refractory Diffuse Large B-cell Lymphoma (DLBCL).
The CARD-1 trial has begun enrollment
and awaiting CFDA CDE’s approval of our IND
application. On January 9, 2017 we announced the approval
and commencement of patient enrollment in China for its CALL-1
(“CAR-T against Acute Lymphoblastic Leukemia”) Phase I
clinical trial utilizing its optimized proprietary C-CAR011
construct of CD19 chimeric antigen receptor T-cell
(“CAR-T”) therapy for the treatment of patients with
relapsed or refractory (r/r) CD19+ B-cell Acute Lymphoblastic
Leukemia (“ALL”). The CALL-1 trial has begun enrollment
with more data expected to be released shortly after the
CDE’s approval of the Company’s IND application. On
April 21, 2018, the CDE posted on its website acceptance of the IND
application for CAR-T cancer therapies in treating patients with
adult ALL submitted by us. Depending on the Phase I CARD-1 and
CALL-1 results, we expect to initiate larger trials to confirm the
safety and efficacy profile and support BLA submission as soon as
practicable. Leveraging our quality system and our strong
scientific expertise to develop a platform as preferred parties for
international pharmaceutical companies to co-develop cell therapies
with the Company in China by implementing our quality strategies
and leveraging the experience and expertise of our strong
scientific team in China and the U.S.
KOA. In 2013, we completed a Phase I/IIa
clinical study, in China, for our KOA therapy named Re-Join®.
The trial tested the safety and efficacy of intra-articular
injections of autologous haMPCs in order to reduce inflammation and
repair damaged joint cartilage. The 6-month follow-up clinical data
showed Re-Join® therapy to be both safe and
effective.
In
Q2 of 2014, we completed patient enrollment for the Phase IIb
clinical trial of Re-Join® for KOA. The multi-center study
enrolled 53 patients to participate in a randomized, single blind
trial. We published 48 weeks follow-up data of Phase I/IIa on
December 5, 2014. The 48 week data indicated that
patients have reported a decrease in pain and a significant
improvement in mobility and flexibility, while the clinical data
shows our Re-Join® regenerative medicine treatment to be
safe. We announced the interim 24 week results for
Re-Join® on March 25, 2015 and released positive
Phase IIb 48 week follow-up data in January 2016, which shows the
primary and secondary endpoints of Re-Join® therapy group
having all improved significantly compared to their baseline, which
has confirmed some of the Company’s Phase I/IIa results. Our
Re-Join® human adipose-derived mesenchymal progenitor cell
(haMPC) therapy for KOA is an interventional therapy using
proprietary process, culture and medium.
Our
process is distinguishable from sole Stromal Vascular Fraction
(SVF) therapy. The immunophenotype of our haMPCs exhibited multiple
biomarkers such as CD29+, CD73+, CD90+, CD49d+, HLA-I+, HLA-DR-,
Actin-, CD14-, CD34-, and CD45-. In contrast, SVF is
merely a heterogeneous fraction including preadipocytes,
endothelial cells, smooth muscle cells, pericytes, macrophages,
fibroblasts, and adipose-derived stem cells (ASCs).
In
January 2016, we launched the Allogeneic KOA Phase I Trial in China
to evaluate the safety and efficacy of AlloJoin™, an off-the
shelf allogeneic adipose derived progenitor cell (haMPC) therapy
for the treatment of KOA. On August 5, 2016 we completed patient
treatment for the Allogeneic KOA Phase I trial, and on December 9,
2016 we announced interim 3-month safety data from the Allogenic
KOA Phase I Trial in China. The interim analysis of the trial has
preliminarily demonstrated a safety and tolerability profile of
AlloJoin™ in the three doses tested, and no serious adverse
events (SAE) have been observed. On March 16, 2018, we announced
the positive 48-week Allojoin™ Phase I data in China, which
demonstrated good safety and early efficacy for the prevention of
cartilage deterioration. We plan to file an IND application for
AlloJoin™ with CDE of the CFDA in the near
future.
The
unique lines of adult adipose-derived progenitor cells and the
immune cell therapies enable us to create multiple cell
formulations in treating specific medical conditions and diseases.
The quality management systems of CBMG Shanghai were issued a
Certificate of ISO-9001:2015 in 2018 and to be updated to 9001:2015
in this year. (i)The cleanrooms in our new facility are ISO 14644
certified and in compliance with China’s Good Manufacture
Practice (GMP) requirement (2010 edition); (ii) the equipment in
the new Shanghai facility has been calibrated and qualified, and
the biological safety cabinets were also qualified. The quality
management systems of CBMG Wuxi were certified as meeting the
requirement of ISO-9001:2015, and the facility and equipment were
also qualified.
Our
proprietary processes and procedures include (i) banking of
allogenic cellular product and intermediate product; (ii)
manufacturing procedures of GMP-grade viral vectors; (iii)
manufacturing procedures of GMP-grade cellular product; (iv)
analytical testing to ensure the safety, identity, purity and
potency of cellular product.
Recent Developments in Cancer Cell Therapy
According
to the U.S. National Cancer Institute’s 2013 cancer topics
research update on CAR-T-Cells, excitement is growing for
immunotherapy—therapies that harness the power of a
patient’s immune system to combat their disease, or what some
in the research community are calling the “fifth
pillar” of cancer treatment.
One
approach to immunotherapy involves engineering patients’
own immune cells to recognize and attack their tumors. This
approach is called adoptive cell transfer (ACT). ACT’s
building blocks are T cells, a type of immune cell collected
from the patient’s own blood. One of the well-established ACT
approaches is CAR-T cancer therapy. After collection, the T
cells are genetically engineered to produce special
receptors on their surface called chimeric antigen receptors
(CARs). CARs are proteins that allow the T cells to recognize
a specific protein (antigen) on tumor cells. These engineered
CAR-T cells are then grown until they number in the billions.
The expanded population of CAR-T cells is then infused into
the patient. After the infusion, if all goes as planned, the T
cells multiply in the patient’s body and, with guidance
from their engineered receptor, recognize and kill cancer
cells that harbor the antigen on their surfaces. This process
builds on a similar form of ACT pioneered from
NCI’s Surgery Branch for patients with advanced
melanoma. According to www.cancer.gov/.../research-updates/2013/CAR-T-Cells,
in 2013 NCI’s Pediatric Oncology Branch commented that
the CAR-T cells are much more potent than anything they can
achieve with other immune-based treatments being
studied. Although investigators working in this field caution
that there is still much to learn about CAR T-cell therapy,
the early results from trials like these have generated
considerable optimism.
CAR-T
cell therapies, such as anti-CD19 CAR-T and anti-BCMA CAR-T, have
been tested in several hematological indications on patients
that are refractory/relapsing to chemotherapy, and many of
them have relapsed after stem cell transplantation. All
of these patients had very limited treatment option prior
to CAR-T therapy. CAR-T has shown encouraging clinical
efficacy in many of these patients, and some of them have durable
clinical response for years. However, some adverse effects, such as
cytokine release syndrome (CRS) and neurological toxicity, have
been observed in patients treated with CAR-T cells. For example, in
July 2016, Juno Therapeutics, Inc. reported the death of
patients enrolled in the U.S. Phase II clinical trial of
JCAR015 (anti-CD19 CAR-T) for the treatment of relapsed or
refractory B cell acute lymphoblastic leukemia (B-ALL). The US
FDA put the trial on hold and lifted the hold within a
week after Juno provided satisfactory explanation and
solution. Juno believes that the patient deaths were caused by
the use of Fludarabine preconditioning and they will use only
cyclophosphamide pre-conditioning in future
enrollment.
In
August 2017, the U.S. FDA approved Novartis’ CAR-T
therapy on relapsed or refractory (r/r) acute lymphoblastic
leukemia (ALL), the most common cancer in children.
Current treatments show a rate of 80% remission using
intensive chemotherapy. However, there are almost no
conventional treatments to help patients who have relapsed or
are refractory to traditional treatment. Novartis’
Tisagenlecleucel (Kymriah), a CD19-targeted CAR-T therapy for
children and adolescents with r/r ALL has shown results
of complete and long lasting remission, which led the
FDA to approve the drug funded by Novartis and as first CAR-T
therapy. In
October 2017, the U.S. FDA approved Kite
Pharmaceuticals’ (Gilead) CAR-T therapy for diffuse large
B-cell lymphoma (DLBCL), the most common type of NHL in
adults. The initial results of axicabtagene ciloleucel
(Yescarta), the prognosis of high-grade chemo refractory NHL
is dismal with a medium survival time of a few weeks.
Yescarta is a therapy for patients who have not responded
to or who have relapsed after at least two other kinds of
treatment.
In
May 2018, the FDA approved Novartis’ Kymriah for intravenous
infusion for its second indication - the treatment of adult
patients with relapsed or refractory (r/r) large B-cell lymphoma
after two or more lines of systemic therapy including diffuse large
B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL
arising from follicular lymphoma. Kymriah is now the only CAR-T
cell therapy to receive FDA approval for two distinct indications
in non-Hodgkin lymphoma (NHL) and B-cell ALL.
Besides
anti-CD19 CAR-Ts, anti-BCMA (b-cell maturation antigen), CAR-Ts
have shown very promising clinical outcomes in treatment of
multiple myeloma. For example, bb2121, a CAR-T therapy targeting
BCMA, has been developed by Bluebird bio, Inc. and Celgene for
previously treated patients with multiple myeloma. Based on
preliminary clinical data from the ongoing phase 1 study CRB-401,
bb2121 has been granted Breakthrough Therapy Designation by the
U.S. FDA and PRIME eligibility by the European Medicines Agency
(EMA) in November 2017.
Recent
progress in Universal Chimeric Antigen Receptor (UCAR) T-cells
showed benefits such as ease of use, availability and the drug
pricing challenge. Currently, most therapeutic UCAR products have
been developed with gene editing platforms such as CRISPR or TALEN.
For example, UCART19 is an allogeneic CAR T-cell product candidate
developed by Cellectis for treatment of CD19-expressing
hematological malignancies. UCART19 Phase I clinical trials started
in adult and pediatric patients in Europe in June 2016 and in the
U.S. in 2017. The use of UCAR may has the potential to overcome the
limitation of the current autologous approach by providing an
allogeneic, frozen, “off-the-shelf” T cell product for
cancer treatment.
While
CAR-T cell therapy has been proven successful in treatment of
several hematological malignancies, other cell therapy approaches,
including Tumor Infiltrating Lymphocytes (TIL) and T Cell Receptor
engineered T cells (TCR-Ts) are being developed to treat solid
tumors. For example, Iovance Biotherapeutics is focused on the
development of autologous tumor-directed TILs for treatments of
patients with various solid tumor indications. Iovance
is conducting four Phase 2 clinical trials to assess the efficacy
and safety of autologous TIL for treatment of patients with
Metastatic Melanoma, Squamous Cell Carcinoma of the Head and Neck,
Non-Small Cell Lung Cancer (NSCLC) and Cervical Cancer in the US
and Europe.
Adaptimmune
is partnering with GlaxoSmithKline to develop TCR-T therapy
targeting the NY-ESO-1 peptide, which is present across multiple
cancer types. Their NY-ESO SPEAR T-cell has been used in multiple
Phase 1/2 clinical trials in patients with solid tumors and
haematological malignancies, including synovial sarcoma, myxoid
round cell liposarcoma, multiple myeloma, melanoma, NSCLC and
ovarian cancer. The initial data suggested positive clinical
responses and evidence of tumor reduction in patients. NY-ESO
SPEART T-cell has been granted breakthrough therapy designation by
the U.S. FDA and PRIME regulatory access in Europe.
Adaptimmune’s other TCR-T product, AFP SPEAR T-cell targeting
AFP peptide, is aimed at the treatment of patients with
hepatocellular carcinoma (HCC). AFP SPEAR T-cell is in a Phase I
study and enrolling HCC patients in the U.S.
In
December 2017, the Chinese government issued trial guidelines
concerning the development and testing of cell therapy products in
China. Although these trial guidelines are not yet codified as
mandatory regulation, we believe they provide a measure of clarity
and a preliminary regulatory pathway for our cell therapy
operations in a still uncertain regulatory environment. On April 18
and April 21, 2018, the CDE posted on its website acceptance of the
IND application for CAR-T cancer therapies in treating patients
with NHL and adult ALL submitted by the Company’s
wholly-owned subsidiaries Cellular Biomedicine Group (Shanghai)
Ltd. and Shanghai Cellular Biopharmaceutical Group
Ltd.
With
the acceptance of our CD 19 IND applications and the U.S.
FDA’s approval on Novartis, Kite and Juno’s proof
of efficacy indications have shown in the U.S. clinical
trials, management believes that CBMG is well positions and poised
to apply its CAR-T therapies to other indications via
self-development or collaborations.
Market for Stem Cell-Based Therapies
The
forecast is that in the United States, shipments of treatments with
stem cells or instruments which concentrate stem cell preparations
for injection into painful joints will fuel an overall increase in
the use of stem cell based treatments and an increase to $5.7
billion in 2020, with key growth areas being Spinal Fusion, Sports
Medicine and Osteoarthritis of the joints. According to Centers for
Disease Control and Prevention. Prevalence of doctor-diagnosed
arthritis and arthritis-attributable activity limitation United
States. 2010-2012, Osteoarthritis (OA) is a chronic disease that is
characterized by degeneration of the articular cartilage,
hyperosteogeny, and ultimately, joint destruction that can affect
all of the joints. According to Dillon CF, Rasch EK, Gu Q et al.
Prevalence of knee osteoarthritis in the United States: Arthritis
Data from the Third National Health and Nutrition Examination
Survey 1991-94. J Rheumatol. 2006, the incidence of OA is 50% among
people over age 60 and 90% among people over age 65. KOA accounts
for the majority of total OA conditions and in adults, OA is the
second leading cause of work disability and the disability
incidence is high (53%). The costs of OA management have grown
exponentially over recent decades, accounting for up to 1% to 2.5%
of the gross national product of countries with aging populations,
including the U.S., Canada, the UK, France, and Australia.
According to the American Academy of Orthopedic Surgeons (AAOS),
the only pharmacologic therapies recommended for OA symptom
management are non-steroidal anti-inflammatory drugs (NSAIDs) and
tramadol (for patients with symptomatic osteoarthritis). Moreover,
there is no approved disease modification therapy for OA in the
world. Disease progression is a leading cause of hospitalization
and ultimately requires joint replacement surgery. In 2009, the
U.S. spent over $42 billion on replacement surgery for hip and knee
joints alone. International regulatory guidelines on clinical
investigation of medicinal products used in the treatment of OA
were updated in 2015, and clinical benefits (or trial outcomes) of
a disease modification therapy for KOA has been well defined and
recommended. Medicinal products used in the treatment of
osteoarthritis need to provide both a symptom relief effect for at
least 6 months and a structure modification effect to slow
cartilage degradation by at least 12 months. Symptom relief is
generally measured by a composite questionnaire Western Ontario and
McMaster Universities Osteoarthritis Index (WOMAC) score, and
structure modification is measured by MRI, or radiographic image as
accepted by international communities. The Company uses the WOMAC
as primary end point to demonstrate symptom relief, and MRI to
assess structure and regeneration benefits as a secondary
endpoint.
According
to the Foundation for the National Institutes of Health, there are
27 million Americans with Osteoarthritis (OA), and symptomatic Knee
Osteoarthritis (KOA) occurs in 13% of persons aged 60 and older.
The International Journal of Rheumatic Diseases, 2011 reports that
approximately 57 million people in China suffer from KOA. Currently
no treatment exists that can effectively preserve knee joint
cartilage or slow the progression of KOA. Current common drug-based
methods of management, including anti-inflammatory medications
(NSAIDs), only relieve symptoms and carry the risk of side effects.
Patients with KOA suffer from compromised mobility, leading to
sedentary lifestyles; doubling the risk of cardiovascular diseases,
diabetes, and obesity; and increasing the risk of all causes of
mortality, colon cancer, high blood pressure, osteoporosis, lipid
disorders, depression and anxiety. According to the Epidemiology of
Rheumatic Disease (Silman AJ, Hochberg MC. Oxford Univ. Press,
1993:257), 53% of patients with KOA will eventually become
disabled.
Our Strategy
We
have submitted our IND application for our own proprietary CD 19
technologies in April 2018, which was subsequently accepted by the
CFDA. We have been conducting clinical studies of CD19 for DLBCL
and ALL at hospitals in China. In addition to CD 19, we are also
actively developing and evaluating other therapies comprised of
TCR-T and other CAR-T. We plan to submit our KOA IND applications
for Allojoin™ and Rejoin™ with the CFDA in the near
future.
In
addition to our development efforts, we also actively seek
co-development opportunities with international partners. We
believe that such partnership will enable us to take advantage of
the technologies of our partners such as international
pharmaceutical companies while leveraging our quality control and
manufacturing infrastructure and further expand our pipelines in a
relatively rapid fashion.
Our
goal is to develop safe and effective cellular medicine therapies
for indications that represent a large unmet need in China, based
on technologies developed both in-house and obtained through
acquisition, licensing and collaboration arrangements with
other companies. We intend to use our first-mover advantage in
China, against a backdrop of enhanced regulation by the central
government, to differentiate ourselves from the competition and
establish a leading position in the China cell therapeutic
market. We believe that few competitors in
China are as well-equipped as we are in the clinical trial
development, diversified international standard protocol compliant
manufacturing facilities, quality assurance and control processes,
regulatory compliance vigor, as well as continuous process
improvement to speed up manufacturing timelines for its cell
therapy clinical trials and commercial launch.
In
order to expedite fulfillment of patient treatment, we have been
actively developing technologies and products with a strong
intellectual properties protection, including haMPC, derived from
fat tissue, for the treatment of KOA and other indications.
CBMG’s acquisition of a 36-month exclusive option to license
the patent rights owned by the Augusta University relating to an
invention to identify novel alpha fetoprotein specific T-cell
receptors (TCR) for a hepatocellular carcinoma ("HCC")
immunotherapy provides an enlarged opportunity to expand the
application of CBMG’s cancer therapy-enabling technologies
and to initiate clinical trials with leading cancer
hospitals.
Our
proprietary and patent-protected production processes enable us to
produce raw material, manufacture cells, and conduct cell banking
and distribution. Our clinical protocols include medical assessment
to qualify each patient for treatment, evaluation of each patient
before and after a specific therapy, cell transplantation
methodologies including dosage, frequency and the use of adjunct
therapies, potential adverse effects and their proper management.
Applying our proprietary intellectual property, we plan to
customize specialize formulations to address complex diseases and
debilitating conditions.
We
operate our manufacturing facilities under the design of the
standard good manufacturing practice ("GMP") conditions in the ISO
accredited laboratories standard. We employ institutionalized and
proprietary process and quality management system to optimize
reproducibility and to hone our efficiency. Our Beijing, Shanghai
and Wuxi facilities are designed and built to meet international
GMP standards. With our integrated Plasmid, Viral Vectors, and
CAR-T cells Chemistry, Manufacturing, and Controls processes
and expanding capacity, we are highly distinguishable from other
companies in the cellular medicine space.
In
total, our facilities have approximately 70,000 square feet of
space and are expected to have a capacity to provide therapies that
can treat approximately 10,000 cancer patients and 10,000 patients
per year.
Most
importantly, our seasoned cell therapy team members have decades of
highly-relevant experience in the United States, China, and
European Union. We believe that these are the primary factors that
make CBMG a high quality cell products manufacturer in
China.
Our Targeted Indications and Potential Therapies
The chart below illustrates CBMG’s pipelines:
Immuno-oncology (I/o)
Our
CAR-T platform is built on lenti-virial vector and
second-generation CAR design, which is used by most of the current
trials and studies. We rigorously select the patient population for
each asset and indication to allow the optimal path forward for
regulatory approval. We also fully integrate the state of art
translational medicine effort into each clinical study to aid in
dose selection, to confirm the mechanism of action and proof of
concept, and to identify the optimal targeting patient population
whenever appropriate. We plan to continue to grow our translational
medicine team and engage key opinion leaders to meet the
demand.
Solid
tumors pose more challenges than hematological
cancers. The patients are more heterogeneous, making it
difficult to have one drug to work effectively in the majority of
the patients in any cancer indication. The duration of
response is most likely shorter and patients are likely to relapse
even after initial positive clinical response. We will
continue our effort in developing cell based therapies to target
both hematological cancers and solid tumors.
Knee Osteoarthritis (KOA)
We
are currently pursuing two primary therapies for the treatment of
KOA: our Re-Join® therapy and our
AlloJoin™ therapy.
We completed the Phase I/IIa clinical
trial for the treatment of KOA. The trial tested the safety and
efficacy of intra-articular injections of autologous haMPCs in
order to reduce inflammation and repair damaged joint cartilage.
The 6-month follow-up clinical data showed
Re-Join® therapy to be both safe and
effective.
In
the second quarter of 2014, we completed patient enrollment for the
Phase IIb clinical trial of Re-Join® for KOA. The multi-center
study has enrolled 53 patients to participate in a randomized,
single blind trial. We published 48 weeks follow-up data of Phase
I/IIa on December 5, 2014. The 48 weeks data indicated
that patients have reported a decrease in pain and a significant
improvement in mobility and flexibility, while the clinical data
shows our Re-Join® regenerative medicine treatment to be safe.
We announced positive Phase IIb 48-week follow-up data in January
2016, with statistical significant evidence that Re-Join®
enhanced cartilage regeneration, which concluded the planned phase
IIb trial.
In
January 2016, we launched the Allogeneic KOA Phase I Trial in
China to evaluate the safety and efficacy of AlloJoin™,
an off-the shelf haMPC therapy for the treatment of KOA. On August
5, 2016 we completed patient treatment for the Allogeneic KOA
Phase I trial. On August 5, 2016 we completed patient treatment for
the Allogenic KOA Phase I Trial, and on December 9, 2016, we
announced interim 3-month safety data from the Allogenic KOA Phase
I Trial in China. The interim analysis of the trial has
preliminarily demonstrated a safety and tolerability profile of
AlloJoin™ in the three doses tested, and no SAEs have been
observed. On March 16, 2018, we announced the positive 48-week
Allojoin™ Phase I data in China, which demonstrated good
safety and early efficacy for the prevention of cartilage
deterioration.
Osteoarthritis
is a degenerative disease of the joints. KOA is one of the most
common types of osteoarthritis. Pathological manifestation of
osteoarthritis is primarily local inflammation caused by immune
response and subsequent damage of joints. Restoration of immune
response and joint tissues are the objective of
therapies.
According to International Journal of
Rheumatic Diseases, 2011, 53%
of KOA patients will degenerate to the point of disability.
Conventional treatment usually involves invasive surgery with
painful recovery and physical therapy. As drug-based methods of
management are ineffective, the same journal estimates that some
1.5 million patients with this disability will degenerate to the
point of requiring artificial joint replacement surgery every year.
However, only 40,000 patients will actually be able to undergo
replacement surgery, leaving the majority of patients to suffer
from a life-long disability due to lack of effective
treatment.
Adult
mesenchymal stem cells can currently be isolated from a variety of
adult human sources, such as liver, bone marrow, and adipose (fat)
tissue. We believe the advantages in using adipose tissue (as
opposed to bone marrow or blood) are that it is one of the richest
sources of pluripotent cells in the body, the easy and repeatable
access to fat via liposuction, and the simple cell isolation
procedures that can begin to take place even on-site with minor
equipment needs. The procedure we are testing for autologous KOA
involves extracting a very small amount of fat using a minimally
invasive extraction process which takes up to 20 minutes and leaves
no scarring. The haMPC cells are then processed and isolated on
site, and injected intra articularly into the knee joint with
ultrasound guidance. For allogeneic KOA we use donor haMPC
cells.
These
haMPC cells are capable of differentiating into bone, cartilage,
tendon, skeletal muscle, and fat under the right conditions. As
such, haMPCs are an attractive focus for medical research and
clinical development. Importantly, we believe both allogeneic and
autologously sourced haMPCs may be used in the treatment of
disease. Numerous studies have provided preclinical data that
support the safety and efficacy of allogeneic and autologously
derived haMPC, offering a choice for those where factors such as
donor age and health are an issue.
Additionally,
certain disease treatment plans call for an initial infusion of
these cells in the form of SVF, an initial form of cell isolation
that can be completed and injected within ninety minutes of
receiving lipoaspirate. The therapeutic potential conferred by the
cocktail of ingredients present in the SVF is also evident, as it
is a rich source for preadipocytes, mesenchymal stem cells,
endothelial progenitor cells, T regulatory cells and
anti-inflammatory macrophages.
haMPCs
are currently being considered as a new and effective treatment for
osteoarthritis, with a huge potential
market. Osteoarthritis is one of the ten most disabling
diseases in developed countries. Worldwide estimates are that 9.6%
of men and 18.0% of women aged over 60 years have symptomatic
osteoarthritis. It is estimated that the global OA therapeutics
market was worth $4.4 billion in 2010 and is forecast to grow at a
compound annual growth rate (“CAGR”) of 3.8% to reach
$5.9 billion by 2018.
In
order to bring haMPC-based KOA therapy to market, our market
strategy is to: (a) establish regional laboratories that comply
with cGMP standards in Shanghai and Beijing that meet Chinese
regulatory approval; and (b) submit to the CFDA an IND package for
Allojoin™ to treat patients with donor haMPC cells, and (c)
file joint applications with Class AAA hospitals to use
Re-Join® to treat patients with their own haMPC
cells.
Our
competitors are pursuing treatments for osteoarthritis with knee
cartilage implants. However, unlike their approach, our
KOA therapy is not surgically invasive – it uses a small
amount (30ml) of adipose tissue obtained via liposuction from the
patient, which is cultured and re-injected into the patient. The
injections are designed to induce the body’s secretion of
growth factors promoting immune response and regulation, and
regrowth of cartilage. The down-regulation of the patient’s
immune response is aimed at reducing and controlling inflammation
which is a central cause of KOA.
We
believe our proprietary method, subsequent haMPC proliferation and
processing know-how will enable haMPC therapy to be a low cost and
relatively safe and effective treatment for KOA. Additionally,
banked haMPCs can continue to be stored for additional use in the
future.
AFP TCR-T
We
are evaluating the efficacy and specificity of the AFP TCR to
identity the most appropriate candidate for first time in human
(FTIH) study. In addition, human CD8+ T cells will be redirected
with the AFP TCRs and their anti-tumor activity will be evaluated
by in vitro cytokine release assay and cytotoxicity assay.
Concurrently, potential on/off-target toxicity including
allo-reactivity will be also evaluated and the best candidate TCRs
for clinical use will be further tested in humanized mouse models.
We plan to exercise our exclusive right to license the technology
from Augusta University if and when the FTIH proof of mechanism
study shows promising clinical efficacy signal and manageable
safety profile. Based on current estimates, we expect our
biopharmaceutical business to generate revenues primarily through
the development of therapies for the treatment of DLBCL, ALL and
KOA within the next three to four years although we cannot assure
you that we will be successful at all or within the foregoing
timeframe.
NKG2D CAR
Early
studies on CAR-T therapy targeting NK cell signaling has shown
promising clinical benefits. We are developing novel generation
CARs using NKG2D extracellular fragment as antigen binding domain.
These CARs can recognize targets tumor cells expressing NKG2D
ligands. We plan to initiate first in human investigator
initiated trial with R/R AML patients in the next couple of
quarters.
TIL
CBMG
plans to develop tumor infiltrating lymphocytes (TIL) based
therapies in the near future. In the early stages of cancer, the
immune system tries to fight cancer by mobilizing lymphocytes to
attack the tumor. Lymphocytes has the capacity to recognize and
attack the tumor traffic to, and infiltrate into the tumor. These
cells are known as TIL. TIL based therapies have shown some
encouraging promises in early development. For example, in Phase-2
clinical studies in patients with metastatic melanoma performed by
Dr. Rosenberg at NCI, TIL therapy demonstrated robust efficacy in
patients with metastatic melanoma with objective response rates of
56% and complete response rates of 24%. We plan to start our
development with NSCLC, and eventually expand into other cancer
indications.
Competition
Many
companies operate in the cellular biopharmaceutical
field. Currently there are several approved stem cell
therapies on the market including Canada’s pediatric
graft-versus-host disease and the European Commission’s
approval in March 2018 for the treatment of complex perianal
fistulas in adult Crohn’s disease. There are several
public and private cellular biopharmaceutical focused companies
outside of China with varying phases of clinical trials addressing
a variety of diseases. We compete with these companies in
bringing cellular therapies to the market. However, our
focus is to develop a core business in the China market. This
difference in focus places us in a different competitive
environment from other western companies with respect to fund
raising, clinical trials, collaborative partnerships, and the
markets in which we compete.
The
PRC central government has a focused strategy to enable China to
compete effectively in certain designated areas of biotechnology
and the health sciences. Because of the aging population in
China, China’s Ministry of Science and Technology
(“MOST”) has targeted stem cell development as high
priority field, and development in this field has been intense in
the agencies under MOST. For example, the 973 Program has
funded a number of stem cell research projects such as
differentiation of human embryonic germ cells and the plasticity of
adult stem cells. To the best of our knowledge, none of the
companies in China are utilizing our proposed international
manufacturing protocol and our unique technologies in conducting
what we believe will be fully compliant CFDA-sanctioned clinical
trials to commercialize cell therapies in China. Our
management believes that it is difficult for most of these Chinese
companies to turn their results into translational stem cell
science or commercially successful therapeutic products using
internationally acceptable standards.
We
compete globally with respect to the discovery and development of
new cell-based therapies, and we also compete within China to bring
new therapies to market. In the biopharmaceutical
specialty segment, namely in the areas of cell processing and
manufacturing, clinical development of cellular therapies and cell
collection, processing and storage, are characterized by rapidly
evolving technology and intense competition. Our
competitors worldwide include pharmaceutical, biopharmaceutical and
biotechnology companies, as well as numerous academic and research
institutions and government agencies engaged in drug discovery
activities or funding, in the U.S., Europe and Asia. Many of these
companies are well-established and possess technical, research and
development, financial, and sales and marketing resources
significantly greater than ours. In addition, many of our smaller
potential competitors have formed strategic collaborations,
partnerships and other types of joint ventures with larger, well
established industry competitors that afford these companies
potential research and development and commercialization advantages
in the technology and therapeutic areas currently being pursued by
us. Academic institutions, governmental agencies and
other public and private research organizations are also conducting
and financing research activities which may produce products
directly competitive to those being commercialized by us. Moreover,
many of these competitors may be able to obtain patent protection,
obtain government (e.g. FDA) and other regulatory approvals and
begin commercial sales of their products before
us.
Our
primary competitors in the field of stem cell therapy for
osteoarthritis, and other indications include Cytori Therapeutics
Inc., Caladrius Biosciences, Inc. and others. Among our
competitors, to our knowledge, the only ones based in and operating
in Greater China are Lorem Vascular, which has partnered with
Cytori to commercialize Cytori Cell Therapy for the cardiovascular,
renal and diabetes markets in China and Hong Kong, and
OLife Bio, a Medi-Post joint venture with JingYuan Bio in Taian,
Shandong Province, who planned to initiate clinical trial in China
in 2016. To our knowledge, none of the aforementioned
companies have made any progress or advancement in the clinical
development in China.
Our
primary competitors in the field of cancer immune cell therapies
include pharmaceutical, biotechnology companies such as Novartis,
Juno Therapeutics, Inc. (Celgene), Kite Pharma, Inc.(Gilead),
CARSgen, Sorrento Therapeutics, Inc. and others. Among
our competitors, the ones based in and operating in Greater China
are CARsgen, Hrain Biotechnology, Nanjing Legend Biotechnology,
Galaxy Biomed, Persongen and Anke Biotechnology, Shanghai Minju
Biotechnology, Unicar Therapy, Immuno China Biotech, Chongqing
Precision Biotech, SiDanSai Biotechnology and China Oncology Focus
Limited, which has licensed Sorrento’s anti-PD-L1 monoclonal
antibody for Greater China. Other western big pharma and biotech
companies in the cancer immune cell therapies space have made
inroads in China by partnering with local companies. For example,
in April, 2016, Seattle-based Juno Therapeutics, Inc (Celgene)
started a new company with WuXi AppTec in China named JW
Biotechnology (Shanghai) Co., Ltd. by leveraging Juno's CAR-T and
TCR technologies together with WuXi AppTec's R&D and
manufacturing platform and local expertise to develop novel
cell-based immunotherapies for patients with hematologic and solid
organ cancers. In January 2017, Shanghai Fosun Pharmaceutical
created a joint venture with Santa Monica-based Kite Pharma
Inc.(Gilead) to develop, manufacture and commercialize CAR-T and
TCR products in China. In late 2017 Gilead acquired Kite Pharma for
$11.9 billion. On January 22, 2018 Celgene announced that it had
agreed to buy Juno Therapeutics for approximately $9
billion.
The
CFDA has received IND applications for CD19 chimeric antigen
receptor T cells cancer therapies from many companies and have
granted the initial phase of acceptance to three companies thus
far.
Additionally,
in the general area of cell-based therapies for knee osteoarthritis
ailments, we potentially compete with a variety of companies, from
big pharma to specialty medical products or biotechnology
companies. Some of these, such as Abbvie, Merck KGaA, Sanofi, Teva,
GlaxosmithKline, Baxter, Johnson & Johnson, Sanumed, Medtronic
and Miltenyi Biotech, are well-established and have substantial
technical and financial resources compared to
ours. However, as cell-based products are only just
emerging as viable medical therapies, many of our more direct
competitors are smaller biotechnology and specialty medical
products companies comprised of Vericel Corporation, Regeneus Ltd.,
Advanced Cell Technology, Inc., Nuo Therapeutics, Inc., Arteriocyte
Medical Systems, Inc., ISTO technologies, Inc., Ember Therapeutics,
Athersys, Inc., Bioheart, Inc., Cytori Therapeutics, Inc., Harvest
Technologies Corporation, Mesoblast, Pluristem, Inc., TissueGene,
Inc. Medipost Co. Ltd. and others. There are also several
non-cell-based, small molecule and peptide clinical trials
targeting knee osteoarthritis, and several other FDA approved
treatments for knee pain.
Certain
CBMG competitors also work with adipose-derived stem
cells. To the best of our knowledge, none of these
companies are currently utilizing the same technologies as ours to
treat KOA, nor to our knowledge are any of these companies
conducting government-approved clinical trials in
China.
Some
of our targeted disease applications may compete with drugs from
traditional pharmaceutical or Traditional Chinese Medicine
companies. We believe that our chosen targeted disease
applications are not effectively in competition with the products
and therapies offered by traditional pharmaceutical or Traditional
Chinese Medicine companies.
We
believe we have a strategic advantage over our competitors based on
our outstanding quality management system, robust and efficient
manufacturing capability which we believe is possessed by few to
none of our competitors in China, in an industry in which meeting
exacting standards and achieving extremely high purity levels is
crucial to success. In addition, in comparison to the
broader range of cellar biopharmaceutical firms, we believe we have
the advantages of cost and expediency, and a first mover advantage
with respect to commercialization of cell therapy products and
treatments in the China market.
Critical Accounting Policies
The
discussion and analysis of our financial condition and results of
operations are based on our consolidated financial statements,
which have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S.
GAAP”). The preparation of these financial statements
requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of revenue and
expenses during the reporting period. On an ongoing basis, our
management evaluates the estimates, including those related to
revenue recognition, accounts receivable, long-lived assets,
goodwill and other intangibles, investments, stock-based
compensation, and income taxes. Of the accounting estimates we
routinely make relating to our critical accounting policies, those
estimates made in the process of determining the valuation of
accounts receivable, long-lived assets, and goodwill and other
intangibles, measuring share-based compensation expense, preparing
investment valuations, and establishing income tax valuation
allowances and liabilities are the estimates most likely to have a
material impact on our financial position and results of
operations. The Company bases its estimates on historical
experience and on various other assumptions that are believed to be
reasonable under the circumstances. However, because these
estimates inherently involve judgments and uncertainties, there can
be no assurance that actual results will not differ materially from
those estimates.
ASC
Topic 606, Revenue from Contracts
with Customers, was effective during the three months ended
March 31, 2018. ASC Topic 606 amended the existing accounting
standards for revenue recognition (ASC Topic 605, Revenue Recognition) and established
principles for recognizing revenue upon the transfer of promised
goods or services to customers, in an amount that reflects the
expected consideration received in exchange for those goods or
services. The Company adopted ASC Topic 606 in the first quarter of
2018 using the modified retrospective transition approach. Because
the Company’s primary source of revenues for the three-month period ended June 30, 2018 was
only from cell banking services as well as cell therapy
technology services, and the service revenues are recognized when
the cell banking and cell therapy
technology services are rendered (i.e., the two performance
obligations that arise from its contracts with customers are
satisfied), the impact on its consolidated financial
statements from adoption of ASC Topic 606 is not
material.
Other
than as discussed above, during the three months ended June 30,
2018, we believe that there have been no significant changes to the
items that we disclosed as our critical accounting policies and
estimates in the “Critical Accounting Policies and
Estimates” section of Item 7 - Management’s Discussion
and Analysis of Financial Condition and Results of Operations in
our Annual Report on Form 10-K for the fiscal year ended December
31, 2017.
Results of
Operations
Below is a discussion of
the results of our operations for the
three and six months ended June 30, 2018 and 2017. These
results are not necessarily indicative
of result that may be
expected in any future period. Our prospects
should be considered in light of the risks, expenses
and difficulties that we may encounter. We may not be successful in addressing
these risks and difficulties.
Comparison of Three Months Ended June 30, 2018 to Three Months
Ended June 30, 2017
The descriptions in the results of operations below reflect our
operating results as set forth in our Consolidated Statement of
Operations filed herewith.
|
Three Months Ended June 30, 2018
|
Three Months Ended June 30, 2017
|
|
|
|
Net
sales and revenue
|
$77,313
|
$62,914
|
|
|
|
Operating
expenses:
|
|
|
Cost
of sales
|
54,393
|
38,097
|
General
and administrative
|
3,121,695
|
3,319,093
|
Selling
and marketing
|
92,880
|
76,385
|
Research
and development
|
6,166,556
|
3,349,509
|
Impairment
of long-term investments
|
29,424
|
-
|
Total
operating expenses
|
9,464,948
|
6,783,084
|
Operating
loss
|
(9,387,635)
|
(6,720,170)
|
|
|
|
Other
income
|
|
|
Interest
income
|
116,835
|
40,573
|
Other
income
|
84,724
|
476,079
|
Total
other income
|
201,559
|
516,652
|
Loss
before taxes
|
(9,186,076)
|
(6,203,518)
|
|
|
|
Income
taxes provision
|
-
|
-
|
|
|
|
Net
loss
|
$(9,186,076)
|
$(6,203,518)
|
Other
comprehensive income (loss):
|
|
|
Cumulative
translation adjustment
|
(1,120,722)
|
292,452
|
Unrealized
loss on investments, net of tax
|
-
|
(240,000)
|
Total
other comprehensive income (loss):
|
(1,120,722)
|
52,452
|
Comprehensive
loss
|
$(10,306,798)
|
$(6,151,066)
|
|
|
|
|
|
|
Net
loss per share:
|
|
|
Basic
and diluted
|
$(0.53)
|
$(0.43)
|
|
|
|
Weighted
average common shares outstanding:
|
|
|
Basic
and diluted
|
17,487,184
|
14,298,973
|
|
|
|
|
|
|
* These
line items include the following amounts of non-cash, stock-based
compensation expense for the periods indicated:
|
|
Three Months
Ended June 30, 2018
|
Three Months Ended June 30,
2017
|
|
|
|
Cost
of sales
|
-
|
11,777
|
General
and administrative
|
538,582
|
828,528
|
Selling
and marketing
|
22,788
|
16,079
|
Research
and development
|
781,363
|
613,822
|
|
1,342,733
|
1,470,206
|
|
|
|
Results of Operations
Net sales and revenue
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$77,313
|
$62,914
|
$14,399
|
23%
|
Revenue for three months period ended June 30, 2018 was mainly
derived from cell banking services as well as cell therapy
technology service. Whereas revenue for three months period ended
June 30, 2017 was mainly derived from cell therapy technology
service.
Cost of Sales
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$54,393
|
$38,097
|
$16,296
|
43%
|
The cost of sales in the three months ended June 30, 2018 was
commensurate with the sales volume and the changing distribution of
the cell banking service business and cell therapy technology
service business, which have different gross profit
ratio.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$3,121,695
|
$3,319,093
|
$(197,398)
|
(6)%
|
Decreased expenses in 2018 was primarily attributed to the
following:
o
A decrease in
stock-based compensation expense of $305,000, which primarily
resulted from the decline in volume of unvested
options;
o
A decrease in
rental expense of $466,000, which mainly resulted from the opening
of our facility located in the “Pharma Valley” of
Shanghai in November 2017. Following the opening, the majority of
the rental expense was absorbed in research and development
expenses;
o
An increase in
depreciation of $55,000, which mainly resulted from opening and
depreciation of our facility located in the “Pharma
Valley” of Shanghai;
o
An increase in
legal, audit and other professional fees of $121,000, a majority of
which is attributable to the increase of recruitment fees;
and
o
An increase in
payroll of $332,000 due to headcount increase and retention bonuses
to employees in 2018.
Selling and Marketing Expenses
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$92,880
|
$76,385
|
$16,495
|
22%
|
Sales and marketing expenses increased by approximately $16,000 in
the three months ended June 30, 2018 as compared to the three
months ended June 30, 2017, primarily as a result of an increase in
salary of $6,000 and an increase in stock-based compensation
expense of $7,000.
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$6,166,556
|
$3,349,509
|
$2,817,047
|
84%
|
Research and development costs increased by approximately
$2,817,000 in the three months ended June 30, 2018 as compared to
the three months ended June 30, 2017. The increase was primarily
attributed to the pick-up in our development work and new talents
recruited for anti-BCMA target for multiple myeloma, and other
solid tumor indications at our newly operating state of the art GMP
facility.
Impairment of Investments
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$29,424
|
$-
|
$29,424
|
N/A
|
The impairment of investments for the three months ended June 30,
2018 is attributed to the recognition of other than temporary
impairment on the value of shares in one stock, no such expense
existed in the same period in 2017. The Company provided full
impairment of $29,424 for shares of ALEV for the three months ended
June 30, 2018 as ALEV filed Form 15 in SEC and was no longer traded
in the market during the period.
Operating Loss
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$(9,387,635)
|
$(6,720,170)
|
$(2,667,465)
|
40%
|
The increase in the operating loss for the three months ended June
30, 2018 as compared to the same period in 2017 is primarily due to
changes in general and administration expenses and research and
development expenses, each of which is described
above.
Total Other Income
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$201,559
|
$516,652
|
$(315,093)
|
(61)%
|
Other income for the three months ended June 30, 2018 was primarily
interest income of $117,000, government subsidy income of $27,000
and foreign currency exchange gain of $59,000 netting of equipment
disposal loss of $2,000. Other income for the three months ended
June 30, 2017 was primarily interest income of $41,000 and
government subsidy income of $512,000.
Net Loss
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$(9,186,076)
|
$(6,203,518)
|
$(2,982,558)
|
48%
|
Changes in net loss are primarily attributable to changes in
operations which are described above.
Comprehensive Loss
|
|
|
|
|
|
|
|
|
|
For the three
months ended June 30,
|
$(10,306,798)
|
$(6,151,066)
|
$(4,155,732)
|
68%
|
Comprehensive loss for three months ended June 30, 2018 includes a
currency translation net loss of approximately $1,121,000 combined
with the changes in net income. Comprehensive loss for three months
ended June 30, 2017 includes unrealized net loss on investments of
$240,000 and a currency translation net gain of approximately
$292,000 combined with the changes in net income.
Comparison of Six Months Ended June 30, 2018 to Six Months Ended
June 30, 2017
The descriptions in the results of operations below reflect our
operating results as set forth in our Consolidated Statement of
Operations filed herewith.
|
Six Months Ended
June 30, 2018
|
Six Months Ended
June 30, 2017
|
|
|
|
Net sales and
revenue
|
$128,274
|
$161,339
|
|
|
|
Operating
expenses:
|
|
|
Cost of
sales
|
76,693
|
75,499
|
General and
administrative
|
6,310,492
|
6,504,340
|
Selling and
marketing
|
167,465
|
194,269
|
Research and
development
|
11,440,507
|
6,393,634
|
Impairment of
long-term investments
|
29,424
|
-
|
Total
operating expenses
|
18,024,581
|
13,167,742
|
Operating
loss
|
(17,896,307)
|
(13,006,403)
|
|
|
|
Other
income
|
|
|
Interest
income
|
122,284
|
89,755
|
Other
income
|
93,924
|
553,587
|
Total
other income
|
216,208
|
643,342
|
Loss before
taxes
|
(17,680,099)
|
(12,363,061)
|
|
|
|
Income taxes
provision
|
(2,400)
|
(2,450)
|
|
|
|
Net
loss
|
$(17,682,499)
|
$(12,365,511)
|
Other comprehensive
income (loss):
|
|
|
Cumulative
translation adjustment
|
(302,361)
|
346,121
|
Unrealized loss on
investments, net of tax
|
-
|
(240,000)
|
Total other
comprehensive income:
|
(302,361)
|
106,121
|
Comprehensive
loss
|
$(17,984,860)
|
$(12,259,390)
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
Basic
and diluted
|
$(1.03)
|
$(0.87)
|
|
|
|
Weighted average
common shares outstanding:
|
|
|
Basic
and diluted
|
17,116,944
|
14,211,888
|
|
|
|
* These line items
include the following amounts of non-cash, stock-based compensation
expense for the periods indicated:
|
|
|
|
Six Months Ended
June 30, 2018
|
Six Months Ended
June 30, 2017
|
|
|
|
Cost of
sales
|
-
|
22,916
|
General and
administrative
|
1,100,903
|
1,696,113
|
Selling and
marketing
|
43,780
|
13,697
|
Research and
development
|
1,332,931
|
1,169,387
|
|
2,477,614
|
2,902,113
|
Results of Operations
Net sales and revenue
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$128,274
|
$161,339
|
$(33,065)
|
(20)%
|
Revenue for six months period ended June 30, 2018 was mainly
derived from cell banking services as well as cell therapy
technology service. Whereas revenue for six months period ended
June 30, 2017 was mainly derived from cell therapy technology
service.
Cost of Sales
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$76,693
|
$75,499
|
$1,194
|
2%
|
The cost of sales fluctuated mainly due to the changing
distribution of the cell banking service business and cell therapy
technology service business, which have different gross profit
ratio.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$6,310,492
|
$6,504,340
|
$(193,848)
|
(3)%
|
Decreased expenses in 2018 was primarily attributed to below
facts:
o
A decrease in
stock-based compensation expense of $595,000, which primarily
resulted from the decline in volume of unvested
options;
o
A decrease in
rental expense of $1,008,000, which mainly resulted from the
opening of our facility located in the “Pharma Valley”
of Shanghai in November 2017. Following the opening, the majority
of the rental expense was absorbed in research and development
expenses;
o
An increase in
depreciation of $127,000, which mainly resulted from opening and
depreciation of our facility located in the “Pharma
Valley” of Shanghai;
o
An increase in
legal, audit and other professional fees of $445,000, a majority of
which is attributable to a new capital market advisory expense
incurred in the first quarter 2018 and an increase in recruitment
fees; and
o
An increase in
payroll of $690,000 due to due to an increase in headcount and
retention bonuses to employees in 2018.
Selling and Marketing Expenses
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$167,465
|
$194,269
|
$(26,804)
|
(14)%
|
The selling and marketing expenses decreased by approximately $27,000 in the six months ended June
30, 2018 as compared to the six months ended June 30, 2017,
primarily as a result of a severance payment in
2017.
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$11,440,507
|
$6,393,634
|
$5,046,873
|
79%
|
Research and development costs increased by approximately
$5,047,000 in the six months ended June 30, 2018 as compared to the
six months ended June 30, 2017. The increase was primarily
attributed to the pick-up in our development work and new talents
recruited for anti-BCMA target for multiple myeloma, and other
solid tumor indications at our newly operating state of the art GMP
facility.
Impairment of Investments
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$29,424
|
$-
|
$29,424
|
N/A
|
The impairment of investments for the six months ended June 30,
2018 is attributed to the recognition of other than temporary
impairment on the value of shares in one stock, no such expense
existed in the same period in 2017. The Company provided full
impairment of $29,424 for shares of ALEV for the six months ended
June 30, 2018 as ALEV filed Form 15 in SEC and was no longer traded
in the market in recent quarter.
Operating Loss
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$(17,896,307)
|
$(13,006,403)
|
$(4,889,904)
|
38%
|
The increase in the operating loss for the six months ended June
30, 2018 as compared to the same period in 2017 is primarily due to
changes in general and administrative expenses and research and
development expenses, each of which is described
above.
Total Other Income
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$216,208
|
$643,342
|
$(427,134)
|
(66)%
|
Other income for the six months ended June 30, 2018 was primarily
interest income of $122,000, government subsidy income of $42,000
and foreign currency exchange gain of $55,000 netting of equipment
disposal loss of $3,000. Other income for the six months ended June
30, 2017 was primarily interest income of $90,000 and government
subsidy income of $592,000.
Income Taxes Provision
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$(2,400)
|
$(2,450)
|
$50
|
(2)%
|
While we have optimistic plans for our business strategy, we
determined that a valuation allowance was necessary given the
current and expected near term losses and the uncertainty with
respect to our ability to generate sufficient profits from our
business model. Therefore, we established a valuation allowance for
deferred tax assets other than the extent of the benefit from other
comprehensive income. Income tax expense for six months ended June
30, 2018 and 2017 all represent US state tax.
Net Loss
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$(17,682,499)
|
$(12,365,511)
|
$(5,316,988)
|
43%
|
Changes in net loss are primarily attributable to changes in
operations of our biomedicine segment which are described
above.
Comprehensive Loss
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
$(17,984,860)
|
$(12,259,390)
|
$(5,725,470)
|
47%
|
Comprehensive net loss for six months ended June 30, 2018 includes
a currency translation net loss of approximately $302,000 combined
with the changes in net income. Comprehensive net loss for six
months ended June 30, 2017 includes unrealized net loss on
investments of approximately $240,000 and a currency translation
net gain of approximately $346,000 combined with the changes in net
income.
Liquidity and Capital Resources
We had working capital of $32,683,133 as of June 30, 2018 compared
to $20,118,725 as of December 31, 2017. Our cash position increased
to $24,785,867 at June 30, 2018 compared to $21,568,422 at December
31, 2017, primarily due to an increase in cash provided by
financing activities, offset by cash used in operating and
investment activities, as further described below.
Net cash provided by or used in operating, investing and financing
activities from continuing operations was as follows:
Net cash used in operating activities was approximately $13,656,000
and $7,778,000 for the six months ended June 30, 2018 and 2017,
respectively. The following table reconciles net loss to net cash
used in operating activities:
For the six months
ended June 30,
|
|
|
|
Net
loss
|
$(17,682,499)
|
$(12,365,511)
|
$(5,316,988)
|
Non cash
transactions
|
4,995,904
|
4,271,232
|
724,672
|
Changes in
operating assets, net
|
(969,304)
|
316,228
|
(1,285,532)
|
Net cash used in
operating activities
|
$(13,655,899)
|
$(7,778,051)
|
$(5,877,848)
|
The 2018 change in non-cash transaction was primarily due to the
increase in depreciation and amortisation of $1,117,000 netting of
the decline in share based compensation of $424,000 compared with
same period in 2017.
Net cash used in investing activities was approximately $12,202,000
and $3,037,000 in the six months ended June 30, 2018 and 2017,
respectively.
The $12,202,000 includes a $10,000,000 short-term deposits
and the $3,037,000 is capital expenditures for new equipment
and facility improvement.
Net cash (used in) provided by financing activities was
approximately $29,136,000 and $(1,284,000) in the six months ended
June 30, 2018 and 2017, respectively. Net cash inflow in the
financing activities in 2018 was mainly attributed to the proceeds
received from the issuance of common stock and exercise of options
netting of the repurchase of the Company’s common
stock. Net
cash used in the financing activities in 2017 was mainly attributed
to repurchase of the Company’s common
stock.
Liquidity and Capital Requirements Outlook
We
anticipate that the Company will require approximately $35 million
in cash to operate as planned in the coming 12 months. Of this
amount, approximately $28 million will be used in daily operation
and approximately $7 million will be used as capital expenditure,
although we may revise these plans depending on the changing
circumstances of our biopharmaceutical business.
We
expect to rely on current cash balances on hand and additional
equity financing to provide for these capital requirements. We do
not intend to use, and will not rely on our holdings in these
illiquid securities to fund our operations. One of our stocks
held, Arem Pacific Corporation, has a declared effective S-1
prospectus which relates to the resale of up to 13,694,711 shares
of common stock, inclusive of the 8,000,000 shares held by the
Company. However, the shares offered by this filing may only be
sold by the selling stockholders at $0.05 per share until the
shares are quoted on the OTCQB® tier of OTC Markets or an
exchange. Other two of our stocks held, Alpha Lujo, Inc.
(“ALEV”) and Wonder International Education &
Investment Group Corporation (“Wonder”), are no longer
traded on any stock market. We do not know whether we can
liquidate our 8,000,000 shares of Arem Pacific stock or the
2,942,350 shares of ALEV stock and the 2,057,131 shares of Wonder
stock, or if liquidated, whether the realized amount will be
meaningful at all. As a result, we have written down above stocks
to their fair value.
On
April 15, 2016, the Company completed the second and final closing
of a financing transaction with Wuhan Dangdai Science &
Technology Industries Group Inc., pursuant to which the Company
sold to the Investor 2,006,842 shares of the Company’s common
stock, par value $0.001 per share, for approximately $38,130,000 in
gross proceeds. As previously disclosed in a Current Report on Form
8-K filed on February 10, 2016, the Company conducted the initial
closing of the financing on February 4, 2016. The aggregate gross
proceeds from both closings in the financing totaled approximately
$43,130,000. In the aggregate, 2,270,000 shares of Common Stock
were issued in the financing. On March 22, 2016, the Company filed
a registration statement on Form S-3 to offer and sell from time to
time, in one or more series, any of the securities of the Company,
for total gross proceeds up to $150,000,000. On June 17, 2016, the
SEC declared the S-3 effective; we have yet to utilize any of the
$150,000,000 registered under the S-3. On December 26, 2017, the
Company entered into a Share Purchase Agreement with two investors,
pursuant to which the Company agreed to sell and the two investors
agreed to purchase from the Company, an aggregate of 1,166,667
shares of the Company’s common stock, par value $0.001 per
share, at $12.00 per share, for total gross proceeds of
approximately $14,000,000. The transaction closed on December 28,
2017. Together with a private placement with three of its executive
officers on December 22, 2017, the Company raised an aggregate of
approximately $14.5 million in the two private placements in
December 2017. On January 30, 2018 and February 5, 2018, the
Company entered into Securities Purchase Agreements with certain
investors, pursuant to which the Company agreed to sell, and the
Investors agreed to purchase from the Company, an aggregate of
1,719,324 shares of the Company’s common stock, par value
$0.001 per share, at $17.80 per share, for total gross proceeds of
approximately $30.6 million. The February 2018 Private
Placement closed on February 5, 2018. On March 5, 2018, the
Company filed a registration statement on Form S-3 for resale of up
to 2,927,658 shares acquired on three private placement financing
on December, 2017 and on February 2018. On April 9, 2018, the SEC
declared the S-3 effective; and on April 11, 2018 we filed the
requisite resale prospectus. As we continue to incur losses,
achieving profitability is dependent upon the successful
development of our cell therapy business and commercialization of
our technology in research and development phase, which is a number
of years in the future. Once that occurs, we will have to achieve a
level of revenues adequate to support our cost structure. We may
never achieve profitability, and unless and until we do, we will
continue to need to raise additional capital. Management intends to
fund future operations through additional debt or equity offerings,
and may seek additional capital through arrangements with strategic
partners or from other sources.
Our
medium to long term capital needs involve the further development
of our biopharmaceutical business, and may include, at
management’s discretion, new clinical trials for other
indications, strategic partnerships, joint ventures, acquisition of
licensing rights from new or current partners and/or expansion of
our research and development programs. Furthermore, as our
therapies pass through the clinical trial process and if they gain
regulatory approval, we expect to expend significant resources on
sales and marketing of our future products, services and
therapies.
In
order to finance our medium to long-term plans, we intend to rely
upon external financing. This financing may be in the form of
equity and or debt, in private placements and/or public offerings,
or arrangements with private lenders. Due to our short operating
history and our early stage of development, particularly in our
biopharmaceutical business, we may find it challenging to raise
capital on terms that are acceptable to us, or at all. Furthermore,
our negotiating position in the capital raising process may worsen
as we consume our existing resources. Investor interest in a
company such as ours is dependent on a wide array of factors,
including the state of regulation of our industry in China (e.g.
the policies of MOH and the CFDA), the U.S. and other countries,
political headwinds affecting our industry, the investment climate
for issuers involved in businesses located or conducted within
China, the risks associated with our corporate structure, risks
relating to our partners, licensed intellectual property, as well
as the condition of the global economy and financial markets in
general. Additional equity financing may be dilutive to our
stockholders; debt financing, if available, may involve significant
cash payment obligations and covenants that restrict our ability to
operate as a business; our stock price may not reach levels
necessary to induce option or warrant exercises; and asset sales
may not be possible on terms we consider acceptable. If we are
unable to raise the capital necessary to meet our medium- and
long-term liquidity needs, we may have to delay or discontinue
certain clinical trials, the licensing, acquisition and/or
development of cell therapy technologies, and/or the expansion of
our biopharmaceutical business; or we may have to raise funds on
terms that we consider unfavorable.
Off Balance Sheet Transactions
CBMG
does not have any off-balance sheet arrangements except the lease
and capital commitment disclosed in the unaudited condensed
consolidated financial statements.
Contractual Obligations
We
have various contractual obligations that will affect our
liquidity. The following table sets forth our contractual
obligations as of June 30, 2018.
|
|
Contractual Obligations
|
|
|
|
|
|
|
|
|
|
|
|
Capital
Commitment
|
$3,427,067
|
$3,414,069
|
12,998
|
-
|
-
|
Operating
Lease Obligations
|
22,117,246
|
3,068,252
|
5,376,906
|
5,189,429
|
8,482,659
|
Total
|
$25,544,313
|
$6,482,321
|
$5,389,904
|
$5,189,429
|
$8,482,659
|
ITEM 3. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
Exposure
to credit, liquidity, interest rate and currency risks arises in
the normal course of the Company’s business. The
Company’s exposure to these risks and the financial risk
management policies and practices used by the Company to manage
these risks are described below.
Credit Risk
Credit
risk is the risk that one party to a financial instrument will
cause a financial loss for the other party by failing to discharge
an obligation. The Company’s credit risk is primarily
attributable to cash at bank, current investment and receivables
etc. Exposure to these credit risks are monitored by management on
an ongoing basis.
The
Company’s cash and current investment is mainly held with
well-known or state owned financial institutions, such as HSBC,
Bank of China, CITIC Bank and China Merchant Bank etc. Management
does not foresee any significant credit risks from these
deposits/investments and does not expect that these financial
institutions may default and cause losses to the
Company.
In
respect of receivables, the Company does not obtain collateral from
customers. The Company’s exposure to credit risk is
influenced mainly by the individual characteristics of each
customer rather than the industry, country or area in which the
customers operate and therefore significant concentrations of
credit risk arise primarily when the Group has significant exposure
to individual customers. As of June 30, 2018, 82% of the total
accounts receivable was due from the largest customer of the
Company.
The
maximum exposure to credit risk is represented by the carrying
amount of each financial asset in the balance sheet.
Interest Rate Risk
The
Company’s interest rate risk arises primarily from cash
deposited at banks and the Company doesn’t have any
interest-bearing long-term payable/ borrowing, therefore its
exposure to interest rate risk is limited.
Currency Risk
The
Company is exposed to currency risk primarily from sales and
purchases which give rise to receivables, payables that are
denominated in a foreign currency (mainly RMB). The Company has
adopted USD as its functional currency, thus the fluctuation of
exchange rates between RMB and USD exposes the Company to currency
risk.
The
following table details the Company’s exposure as of June 30,
2018 to currency risk arising from recognised assets or liabilities
denominated in a currency other than the functional currency of the
entity to which they relate. For presentation purposes, the amounts
of the exposure are shown in USD translated using the spot rate as
of June 30, 2018. Differences resulting from the translation of the
financial statements of entities into the Company’s
presentation currency are excluded.
|
Exposure to
foreign currencies (Expressed in USD)
|
|
|
|
|
|
Cash and cash
equivalents
|
2,693
|
185,302
|
|
|
|
Net exposure
arising from recognised assets and liabilities
|
2,693
|
185,302
|
The
following table indicates the instantaneous change in the
Company’s net loss that would arise if foreign exchange rates
to which the Company has significant exposure at the end of the
reporting period had changed at that date, assuming all other risk
variables remained constant.
|
|
|
|
|
|
increase/(decrease)
in foreign exchange rates
|
Effect on
net loss (Expressed in USD)
|
RMB (against
USD)
|
5%
|
(9,130)
|
|
|
|
|
-5%
|
9,130
|
Results
of the analysis as presented in the above table represent an
aggregation of the instantaneous effects on each of the
Company’s subsidiaries’ net loss measured in the
respective functional currencies, translated into USD at the
exchange rate ruling at the end of the reporting period for
presentation purposes.
The
sensitivity analysis assumes that the change in foreign exchange
rates had been applied to re-measure those financial instruments
held by the Company which expose the Company to foreign currency
risk at the end of the reporting period, including inter-company
payables and receivables within the Company which are denominated
in a currency other than the functional currencies of the lender or
the borrower. The analysis excludes differences that would result
from the translation of the financial statements of subsidiaries
into the Company’s presentation currency.
ITEM 4. CONTROLS AND
PROCEDURES
Disclosure Controls and Procedures
Disclosure
controls and procedures include, without limitation, controls and
procedures designed to ensure that information required to be
disclosed by an issuer in the reports that it files or submits
under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”) is recorded, processed, summarized and
reported within the time periods specified in the Securities and
Exchange Commission’s rules and forms. It should be
noted that the design of any system of controls is based in part
upon certain assumptions about the likelihood of future events, and
there can be no assurance that any design will succeed in achieving
its stated goals under all potential future conditions, regardless
of how remote.
We
carried out an evaluation, under the supervision and with the
participation of our management, including our Chief Executive
Officer and Chief Financial Officer, of the effectiveness of our
disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)). Based upon that evaluation, our
Chief Executive Officer and Chief Financial Officer concluded that,
as of the end of the period covered in this report, our disclosure
controls and procedures were effective to ensure that information
required to be disclosed in reports filed under the Exchange Act is
recorded, processed, summarized and reported within the required
time periods and is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer,
as appropriate to allow timely decisions regarding required
disclosure.
Changes in Internal Control over Financial Reporting
During
the three months ended June 30, 2018, there was no change in our
internal control over financial reporting (as such term is defined
in Rule 13a-15(f) under the Exchange Act) that has materially
affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
PART II – OTHER
INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
During the three months ended June 30, 2018, there were no material
changes to the risk factors disclosed in Item 1A of our Annual
Report on Form 10-K for the year ended December 31, 2017 except the
risks set forth below.
Litigation and other proceedings relating to intellectual property
is expensive, time consuming and uncertain, and we may be
unsuccessful in our efforts to protect against infringement by
third parties or defend ourselves against claims of infringement or
otherwise.
To protect our intellectual property, we may initiate litigation or
other proceedings. Third parties may also initiate proceedings to
challenge our intellectual property rights. For instance, in
April 2018, a company based in Hangzhou, China, submitted a
petition with the PRC Trademark Office to challenge our
Rejoin™ trademark on the basis of a lack of use. Upon such
petition, the PRC Trademark Office has issued a notice, requesting
us to provide evidence of use by August 30, 2018. We have
been collecting evidence in response to such notice and intend to
submit a response to refute the claim by August 30, 2018. Although
we are dedicated to protecting our intellectual property in such
proceedings and believe that we have resources to do so, there is
no assurance that we will succeed in each of these matters.
The loss or narrowing of our intellectual property protection, the
inability to secure or enforce our intellectual property rights or
a finding that we have infringed the intellectual property rights
of a third party could limit our ability to develop or market our
products and services in the future or adversely affect our
revenues. In addition, intellectual property litigation and other
adverse proceedings are costly and time-consuming in general,
divert the attention of management and technical personnel and
could result in substantial uncertainty regarding our future
viability, even if we ultimately prevail. Furthermore, any
public announcements related to such litigation or regulatory
proceedings could adversely affect the price of our common
stock.
Third parties may allege that the research, development and
commercialization activities we conduct infringe patents or other
proprietary rights owned by such parties. This may turn out to be
the case even though we have conducted a search and analysis of
third-party intellectual property rights and have determined that
certain aspects of our research and development and proposed
products activities apparently do not infringe on any third-party
Chinese intellectual property rights. If we are found to have
infringed the intellectual property of a third party, we may be
required to pay substantial damages; we also may be required to
seek from such party a license, which may not be available on
acceptable terms, if at all, to continue our activities. A judicial
finding or infringement or the failure to obtain necessary licenses
could prevent us from commercializing our products, which would
have a material adverse effect on our business, operating results
and financial condition.
ITEM 2. UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS
As previously disclosed on a Current Report on Form 8-K filed on
June 1, 2017, the Company authorized a share repurchase program
(the “Share Repurchase Program”), pursuant to which the
Company may, from time to time, purchase shares of its common stock
for an aggregate purchase price not to exceed $10 million. The
table below summarizes purchases made by or on behalf of the
Company or affiliated purchasers as defined in Regulation S-K under
the Share Purchase Program during the six months ended June 30,
2018.
Period
|
Total number of
shares purchased
|
Average price paid
per share
|
Total number of
shares purchased as part of publicly announced plans or
programs
|
Maximum dollar
value of shares that may yet be purchased under the plans or
programs
|
|
|
|
|
|
Prior to
2018
|
426,794
|
$9.32
|
426,794
|
|
January 1, 2018 ~
January 31, 2018
|
-
|
$-
|
-
|
|
February 1, 2018 ~
February 28, 2018
|
-
|
$-
|
-
|
|
March 1, 2018 ~
March 31, 2018
|
37,462
|
$19.10
|
37,462
|
|
April 1, 2018 ~
April 30, 2018
|
17,984
|
$19.84
|
17,984
|
|
May 1, 2018 ~ May
31, 2018
|
47,006
|
$18.97
|
47,006
|
|
June 1, 2018 ~ June
30, 2018
|
31,522
|
$18.14
|
31,522
|
|
|
|
|
|
|
Total
|
560,768
|
$11.62
|
560,768
|
3,486,007
|
ITEM 3. DEFAULTS UPON SENIOR
SECURITIES
None.
ITEM 4. MINE SAFETY
DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Not applicable.
ITEM 6. EXHIBITS
Exhibits
Exhibit Number
|
|
Description
|
|
|
Certificaton Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 - Chief Executive Officer and Chief Financial
Officer.
|
|
|
Certifications Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase
|
In accordance with Section 13 or 15(d) of the Securities
Exchange Act of 1934, as amended, the registrant caused this report
to be signed on its behalf by the undersigned, thereunto duly
authorized.
|
CELLULAR BIOMEDICINE GROUP, INC.
|
|
|
(Registrant)
|
|
|
|
|
Date: August 7, 2018
|
By:
|
/s/ Bizuo (Tony) Liu
|
|
|
|
Bizuo (Tony) Liu
|
|
|
|
Chief Executive Officer and Chief Financial Officer
|
|
|
|
(Principal Executive Officer and Principal Financial and
Accounting Officer)
|
|
|
|
|
|