Attached files
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 March 31, 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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☐
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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 April 30, 2018, there were 17,488,377 and 17,006,137 shares
of common stock, par value $.001 per share, issued and outstanding,
respectively.
TABLE OF CONTENTS
PART I FINANCIAL INFORMATION
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Item 1.
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Condensed
Consolidated Financial Statements (unaudited)
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3
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Condensed
Consolidated Balance Sheets (unaudited)
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3
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Condensed
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
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4
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Condensed
Consolidated Statements of Cash Flows (unaudited)
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5
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Condensed Notes
to Consolidated Financial Statements (unaudited)
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6
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Item 2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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20
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Item 3.
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Quantitative and
Qualitative Disclosures About Market Risk
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39
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Item 4.
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Controls and
Procedures
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40
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PART II OTHER INFORMATION
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Item 1.
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Legal
Proceedings
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41
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Item 1A.
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Risk
Factors
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41
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Item 2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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41
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Item 3.
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Defaults Upon
Senior Securities
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41
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Item 4.
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Mine
Safety Disclosures
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41
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Item 5.
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Other
Information
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41
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Item 6.
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Exhibits
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42
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SIGNATURES
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43
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2
PART I – FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
(Unaudited)
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
AS OF MARCH 31, 2018 AND DECEMBER 31, 2017
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March 31,
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December 31,
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2018
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2017
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Assets
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Cash
and cash equivalents
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$45,555,891
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$21,568,422
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Accounts
receivable, less allowance for doubtful accounts of
$11,212and $10,789 as of March 31, 2018 and December 31,
2017, respectively
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128,879
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202,887
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Other
receivables
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937,447
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902,940
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Prepaid
expenses
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2,033,836
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1,852,695
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Total
current assets
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48,656,053
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24,526,944
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Investments
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269,424
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269,424
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Property,
plant and equipment, net
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14,600,398
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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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12,029,782
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12,419,692
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Long-term
prepaid expenses and other assets
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3,491,710
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3,294,105
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Total
assets (1)
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$86,726,156
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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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$331,753
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$225,287
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Accrued
expenses
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1,855,508
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1,097,327
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Taxes
payable
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31,275
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28,875
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Other
current liabilities
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2,986,701
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2,324,632
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Total
current liabilities
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5,205,237
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3,676,121
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Other
non-current liabilities
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198,849
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183,649
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Total
liabilities (1)
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5,404,086
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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 authorized; none
issued and outstanding as of March 31, 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;
17,453,623 and 15,615,558 issued; and 16,989,367 and 15,188,764
outstanding, as of March 31, 2018 and December 31, 2017,
respectively
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17,454
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15,616
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Treasury
stock at cost; 464,256 and 426,794 shares of common stock as
of March 31, 2018 and December 31, 2017, respectively
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(4,693,597)
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(3,977,929)
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Additional
paid in capital
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205,102,775
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172,691,339
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Accumulated
deficit
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(119,533,420)
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(111,036,997)
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Accumulated
other comprehensive loss
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428,858
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(389,503)
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Total
stockholders' equity
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81,322,070
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57,302,526
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Total
liabilities and stockholders' equity
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$86,726,156
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$61,162,296
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_______________
(1)
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The Company’s consolidated assets as of March 31, 2018 and
December 31, 2017 included $22,653,860 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 March 31, 2018
and December 31, 2017, respectively. These assets include cash and
cash equivalents of $1,559,223 and $2,337,173; other receivables of
$832,490 and $773,384; prepaid expenses of $1,817,395 and
$1,750,509; property, plant and equipment, net, of $14,128,478 and
$12,477,315; intangibles of $1,520,386 and $1,516,449; and
long-term prepaid expenses and other assets of $2,795,888 and
$2,920,257. The Company’s consolidated liabilities as of
March 31, 2018 and December 31, 2017 included $4,074,260 and
$2,688,520, respectively, of liabilities of the VIEs whose
creditors have no recourse to the Company. These liabilities
include accounts payable of $256,485 and $181,231; other payables
of $2,295,143 and $1,631,582; payroll accrual of $1,318,687 and
$682,248; deferred income of $5,097 and $9,810; and other
non-current liabilities of $198,848 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.
3
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
INCOME (LOSS)
(UNAUDITED)
FOR THE THREE MONTHS ENDED MARCH 31, 2018 AND 2017
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For the Three Months Ended
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March 31,
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2018
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2017
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Net
sales and revenue
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$50,961
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$98,425
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Operating
expenses:
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Cost
of sales
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22,300
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37,402
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General
and administrative
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3,188,797
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3,185,247
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Selling
and marketing
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74,585
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117,884
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Research
and development
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5,273,951
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3,044,125
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Total
operating expenses
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8,559,633
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6,384,658
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Operating
loss
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(8,508,672)
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(6,286,233)
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Other
income
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Interest
income
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5,449
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49,182
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Other
income
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9,200
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77,508
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Total
other income
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14,649
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126,690
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Loss
before taxes
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(8,494,023)
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(6,159,543)
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Income
taxes provision
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(2,400)
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(2,450)
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Net
loss
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$(8,496,423)
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$(6,161,993)
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Other
comprehensive income:
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Cumulative
translation adjustment
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818,361
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53,669
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Total
other comprehensive income:
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818,361
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53,669
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Comprehensive
loss
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$(7,678,062)
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$(6,108,324)
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Net
loss per share :
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Basic
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$(0.51)
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$(0.43)
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Diluted
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$(0.51)
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$(0.43)
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Weighted
average common shares outstanding:
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Basic
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16,742,591
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14,281,745
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Diluted
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16,742,591
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14,281,745
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The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
4
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
FOR THE THREE MONTHS ENDED MARCH 31, 2018 AND 2017
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For the Three Months Ended
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March 31,
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2018
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2017
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CASH
FLOWS FROM OPERATING ACTIVITIES:
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Net
loss
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$(8,496,423)
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$(6,161,993)
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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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1,175,488
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669,739
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Loss
on disposal of assets
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935
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237
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Stock
based compensation expense
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1,134,881
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1,431,907
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Changes
in operating assets and liabilities:
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Accounts
receivable
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81,633
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(39,411)
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Other
receivables
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(4,820)
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(398,190)
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Prepaid
expenses
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(112,228)
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(78,832)
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Long-term
prepaid expenses and other assets
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(436,503)
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6,524
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Accounts
payable
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26,596
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565,236
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Accrued
expenses
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731,748
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(844,172)
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Other
current liabilities
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276,230
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(2,012)
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Taxes
payable
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2,400
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2,450
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Other
non-current liabilities
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8,012
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(10,146)
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Net
cash used in operating activities
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(5,612,051)
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(4,858,663)
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CASH
FLOWS FROM INVESTING ACTIVITIES:
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Purchases
of intangibles
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-
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(23,268)
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Purchases
of property, plant and equipment
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(1,082,635)
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(1,026,994)
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Net
cash used in investing activities
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(1,082,635)
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(1,050,262)
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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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30,508,670
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-
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Proceeds
from exercise of stock options
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769,723
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5,514
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Repurchase
of treasury stock
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(715,668)
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-
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Net
cash provided by financing activities
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30,562,725
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5,514
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EFFECT
OF EXCHANGE RATE CHANGES ON CASH
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119,430
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12,763
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INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
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23,987,469
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(5,890,648)
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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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$45,555,891
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$33,361,784
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SUPPLEMENTAL CASH FLOW INFORMATION
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Cash
paid for income taxes
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$-
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$-
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The accompanying notes are an integral part of these
unaudited condensed consolidated financial statements.
5
CELLULAR BIOMEDICINE GROUP, INC.
FOR THE THREE MONTHS ENDED MARCH 31, 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), cancer vaccine,
and (ii) human adipose-derived mesenchymal progenitor cells (haMPC)
for treatment of joint and autoimmune diseases. CBMG’s
Research& Development are based in China and the U.S., 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, orthopedic diseases and metabolic 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 also completed a Phase I clinical trial of our
off-the-shelf allogeneic haMPC (AlloJoin™) therapy for
treating KOA patients. We have also
completed and presented the Allojoin™ Phase I 48-week data in
China.
Our
primary target market is Greater 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
Cellular
Biomedicine Group, Inc., was originally incorporated in the State
of Arizona on June 25, 2001 and changed its corporate headquarters
to California in March 2013. At the end of September 2015, the
Company moved its corporate headquarters to 19925 Stevens Creek
Blvd., Suite 100 in Cupertino, California. The Company is a
biopharmaceutical company focused on developing therapies to
improve the health of patients in China.
6
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 months ended
March 31, 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 March 31, 2018 and
the results of operations for the three months ended March 31, 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 three months ended
March 31, 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.
7
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 three-month
period ended March 31, 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.
Accounting pronouncements not yet effective to adopt
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.
8
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.
9
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 all of its subsidiaries are
variable interest entities (VIEs), through which the Company
conducts stem cell and immune therapy 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. 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”). The registered capital
of CBMG Shanghai is ten million RMB and was incorporated on October
19, 2011. Agreen Biotech Co. Ltd. (“AG”) was 100%
acquired by CBMG Shanghai in September 2014. AG was incorporated on
April 27, 2011 and its registered capital is five million RMB. 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
March 31, 2018 and 2017, 52% and nil of the Company revenue is
derived from VIEs respectively.
In February 2012, CBMG Wuxi provided financing to CBMG Shanghai in
the amount of $1,587,075 for working capital purposes. 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 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”. The Company has not provided any guarantees
related to VIEs and no creditors of VIEs have recourse to the
general credit of the Company.
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.
10
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 March 31, 2018 and December 31, 2017 are as
follows:
|
March 31,
|
December 31,
|
|
2018
|
2017
|
Assets
|
|
|
Cash
|
$1,559,223
|
$2,337,173
|
Other
receivables
|
832,490
|
773,384
|
Prepaid
expenses
|
1,817,395
|
1,750,509
|
Total
current assets
|
4,209,108
|
4,861,066
|
|
|
|
Property,
plant and equipment, net
|
14,128,478
|
12,477,315
|
Intangibles
|
1,520,386
|
1,516,449
|
Long-term
prepaid expenses and other assets
|
2,795,888
|
2,920,257
|
Total
assets
|
$22,653,860
|
$21,775,087
|
|
|
|
Liabilities
|
|
|
Accounts
payable
|
$256,485
|
$181,231
|
Other
payables
|
2,295,143
|
1,631,582
|
Payroll
accrual
|
1,318,687
|
682,248
|
Deferred
income
|
5,097
|
9,810
|
Total
current liabilities
|
$3,875,412
|
$2,504,871
|
|
|
|
Other
non-current liabilities
|
198,848
|
183,649
|
Total
liabilities
|
$4,074,260
|
$2,688,520
|
NOTE 4 – OTHER RECEIVABLES
The
Company pays deposits on various items relating to office expenses.
Management has classified these deposits as other receivables as
the intention is to recover these deposits in less than 12 months.
As of March 31, 2018 and December 31, 2017 the amounts of other
receivables was $937,447 and $902,940, respectively.
11
NOTE 5 – PROPERTY, PLANT AND EQUIPMENT
As
of March 31, 2018 and December 31, 2017, property, plant and
equipment, carried at cost, consisted of the
following:
|
March 31,
2018
|
December 31,
2017
|
|
|
|
Office
equipment
|
$108,874
|
$105,114
|
Manufacturing
equipment
|
5,543,187
|
4,781,936
|
Computer
equipment
|
272,033
|
233,539
|
Leasehold
improvements
|
13,177,467
|
4,196,589
|
Construction
work in process
|
193,803
|
7,498,272
|
|
19,295,364
|
16,815,450
|
Less:
accumulated depreciation
|
(4,694,966)
|
(3,842,108)
|
|
$14,600,398
|
$12,973,342
|
For the three months ended March 31, 2018 and
2017, depreciation expense was $726,618 and $222,926,
respectively.
NOTE 6 – INVESTMENTS
The
Company’s investments represent the investment in equity
securities listed in Over-The-Counter (“OTC”) markets
of the United States of America:
March 31, 2018 and December 31, 2017
|
Cost
|
Gross Unrealized Gains/(losses)
|
Gross Unrealized Losses more than 12 months
|
Gross Unrealized Losses less than 12 months
|
Market or Fair Value
|
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)
|
$(240,000)
|
$269,424
|
There
is no unrealized holding gains or losses for the investments that
recognized in other comprehensive income for the three months ended
March 31, 2018 and 2017.
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. There is no
other-than-temporary impairment of investments for the three months
ended March 31, 2018 and 2017.
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:
12
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, 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 investments are
classified within Level 2 of the fair value hierarchy because of
the limited trading of the three stocks traded in OTC
market.
Assets
measured at fair value within Level 2 on a recurring basis as of
March 31, 2018 and December 31, 2017 are summarized as
follows:
|
As of March 31, 2018 and December 31, 2017
|
|||
|
Fair Value Measurements at Reporting Date Using:
|
|||
|
|
Quoted Prices in
|
Significant Other
|
Significant
|
|
|
Active Markets for
|
Observable
|
Unobservable
|
|
|
Identical Assets
|
Inputs
|
Inputs
|
|
Total
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
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 three months ended
March 31, 2018 and 2017.
As
of March 31, 2018 and December 31, 2017, the Company holds
8,000,000 shares in Arem Pacific Corporation, 2,942,350 shares in
Alpha Lujo, Inc. and 2,057,131 shares in Wonder International
Education and Investment Group Corporation (“Wonder”),
respectively. Full impairment has been provided for
shares of Wonder. All available-for-sale investments held by the
Company at March 31, 2018 and December 31, 2017 have been valued
based on level 2 inputs due to the limited trading of these
companies.
13
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 March 31, 2018 and December 31, 2017, intangible assets, net
consisted of the following:
Patents & knowhow & license
|
March 31,
2018
|
December 31,
2017
|
Cost
basis
|
$17,751,228
|
$17,674,431
|
Less:
accumulated amortization
|
(5,788,742)
|
(5,325,113)
|
|
$11,962,486
|
$12,349,318
|
Software
|
March 31,
2017
|
December 31,
2016
|
Cost
basis
|
$164,468
|
$158,273
|
Less:
accumulated amortization
|
(97,172)
|
(87,899)
|
|
$67,296
|
$70,374
|
Total
intangibles, net
|
$12,029,782
|
$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
months ended March 31, 2018 and 2017 was $448,870 and $446,813,
respectively.
Estimated
amortization expense for each of the ensuing years are as follows
for the years ending March 31:
Years ending March 31,
|
Amount
|
2019
|
$1,796,957
|
2020
|
1,796,181
|
2021
|
1,791,184
|
2022
|
1,783,466
|
2023
and thereafter
|
4,861,994
|
|
$12,029,782
|
14
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
rental expense on a straight-line basis over the life of the lease
period. Rent expense under operating leases for the
three months ended March 31, 2018 and 2017 was approximately
$967,432 and $894,885, respectively.
As
of March 31, 2018, the Company has the following future minimum
lease payments due under the foregoing lease
agreements:
Years ending March 31,
|
Amount
|
2019
|
$3,112,005
|
2020
|
2,958,850
|
2021
|
2,658,663
|
2022
|
2,647,712
|
2023
and thereafter
|
12,456,024
|
|
$23,833,254
|
NOTE 10 – RELATED PARTY TRANSACTIONS
As
of March 31, 2018 and December 31, 2017, accrued expenses included
director fees of $31,582 and $25,882 due to independent director
Mr. Gang Ji.
The
Company advanced petty cash to officers for business travel
purpose. As of March 31, 2018 and December 31, 2017,
other receivables due from officers for business travel purpose 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 months ended March 31, 2018 and 2017, the Company
expensed $704,543 and $1,415,751 associate with unvested options
awards, $430,338 and $16,156 associated with restricted common
stock, respectively.
15
During
the three months ended March 31, 2018 and 2017, options for 102,430
and 600 underlying shares were exercised, 102,430 and 600 shares of
the Company’s common stock were issued
accordingly.
During
the three months ended March 31, 2018 and 2017, 16,311 and 4,035
shares of the Company's restricted common stock were issued to
directors, employees and advisors respectively.
The
Company's Board of Directors has approved a new stock repurchase
program granting the company authority to repurchase up to $10
million in common shares (the "2017 Stock Repurchase Program")
through open market purchases pursuant to a plan adopted in
accordance with Rule 10b5-1 of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”) and in accordance with
Rule 10b-18 of the Exchange Act and was announced on June 1,
2017.
From
June 1, 2017 to March 31, 2018 and January 1, 2018 to March 31,
2018, the Company repurchased 464,256 and 37,462 shares of the
Company’s common stock with the total cost of $4,693,597
and $715,668,
respectively. There was no repurchase of stock
in 2016. Details are as follows:
|
Total number of shares purchased
|
Average price paid per share
|
|
|
|
Treasury
stock at December 31, 2017
|
426,794
|
$9.32
|
Repurchased
during January 1, 2018 to March 31, 2018
|
37,462
|
$19.10
|
|
|
|
Treasury
stock at March 31, 2018
|
464,256
|
$10.11
|
NOTE 12 – COMMITMENTS AND CONTINGENCIES
Capital commitments
As
of March 31, 2018, the capital commitments of the Company are
summarized as follows:
|
March 31,
2018
|
|
|
Contracts
for acquisition of plant and equipment being or to be
executed
|
$3,088,581
|
NOTE 13 – STOCK BASED COMPENSATION
Our
stock-based compensation arrangements include grants of stock
options and restricted stock awards under the Stock Option Plan
(the “2009 Plan”,“2011 Plan”, “2013
Plan” and the “2014 Plan”), and certain awards
granted outside of these plans. The compensation cost that has been
charged against income related to stock options for the three
months ended March 31, 2018 and 2017 was $704,543 and $1,415,751,
respectively. The compensation cost that has been charged against
income related to restricted stock awards for the three months
ended March 31, 2018 and 2017 was $430,338 and $16,156,
respectively.
As
of March 31, 2018, there was $4,061,162 all unrecognized
compensation cost related to an aggregate of 526,949 of non-vested
stock option awards and $351,930 related to an aggregate of 39,103
of non-vested restricted stock awards. These costs are
expected to be recognized over a weighted-average period of 1.9
years for the stock options awards and 1.3 years for the restricted
stock awards.
During the three months ended March 31, 2018, the
Company issued options under the 2011 Plan, 2013 Plan and 2014 Plan
of an aggregate of 30,593 shares of the Company’s common
stock. The grant date fair value of these options was
$420,679 using Black-Scholes option valuation models
with the following assumptions: exercise price equal to the grant
date stock price of $14.5 to $21.8, volatility 90.06% to 90.43%,
expected life 6.0 years, and risk-free rate of 2.33% to 2.71%. The
Company is expensing these options on a straight-line basis over
the requisite service period.
16
During
the three months ended March 31, 2017, the Company issued options
under the 2011 Plan, 2013 Plan and 2014 Plan of an aggregate of
387,741 shares of the Company’s common stock. The grant date
fair value of these options was $3,524,124 using Black-Scholes
option valuation models with the following assumptions: exercise
price equal to the grant date stock price of $11.05 to $13.2,
volatility 89.05% to 89.23%, expected life 6.0 years, and risk-free
rate of 1.96% 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 March 31,
2018 and December 31, 2017 and for the three months ended March 31,
2017:
|
Number of Options
|
Weighted- Average Exercise Price
|
Weighted- Average Remaining Contractual Term (in
years)
|
Aggregate Intrinsic Value
|
Outstanding
at December 31, 2017
|
1,892,189
|
$11.54
|
7.0
|
$4,909,194
|
Grants
|
30,593
|
|
|
|
Forfeitures
|
(5,400)
|
|
|
|
Exercises
|
(102,430)
|
|
|
|
Outstanding
at March 31, 2018
|
1,814,952
|
$11.90
|
6.8
|
$12,051,569
|
|
|
|
|
|
Vested
and exercisable at March 31, 2018
|
1,288,003
|
$10.99
|
6.1
|
$9,622,751
|
Exercise
|
Number of Options
|
|
Price
|
Outstanding
|
Exercisable
|
|
|
|
$3.00
- $4.95
|
185,547
|
185,547
|
$5.00
- $9.19
|
493,654
|
439,474
|
$11.05+
|
1,135,751
|
662,982
|
|
1,814,952
|
1,288,003
|
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 payment
arrangements for the three months ended March 31, 2018 and 2017 was
$769,723 and $5,514.
17
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
|
|
|
March 31,
|
|
|
2018
|
2017
|
Net
loss
|
$(8,496,423)
|
$(6,161,993)
|
|
|
|
Weighted
average shares of common stock
|
16,742,591
|
14,281,745
|
Dilutive
effect of stock options
|
-
|
-
|
Restricted
stock vested not issued
|
-
|
-
|
Common
stock and common stock equivalents
|
16,742,591
|
14,281,745
|
|
|
|
Net
loss per basic share
|
$(0.51)
|
$(0.43)
|
Net
loss per diluted share
|
$(0.51)
|
$(0.43)
|
For
the three months ended March 31, 2018 and 2017, the effect of
conversion and exercise of the Company’s outstanding options
are excluded from the calculations of dilutive net income (loss)
per share as their effects would have been anti-dilutive since the
Company had generated loss for the three months ended March 31,
2018 and 2017.
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 March 31, 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 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).
On
December 22, 2017, US President signed tax reform bill (Tax Cut and
Jobs Act (H.R.1)) and reduced top corporate tax rate from 35% to
21% effective from January 1, 2018. Pursuant to this new Act,
non-operating loss carry back period is eliminated and an
indefinite carry forward period is permitted. As of March 31, 2018,
the Company had net operating loss carryforwards of $13.9 million
for Chinese income tax purposes, such losses are set to expire in
2023 for Chinese income tax purposes. 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% to 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.
18
Pursuant
to the Corporate Income Tax Law of the PRC, all of the
Company’s PRC subsidiaries are liable to PRC Corporate Income
Taxes (“CIT”) at a rate of 25% except for Cellular
Biomedicine Group Ltd. (Shanghai) (“CBMG Shanghai”).
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. CBMG Shanghai plans to re-apply for the certificate of
“advanced and new technology enterprise” before the
October 2015 issued certificate expires in October,
2018.
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 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 ASC Topic 280-10,
the Company is not required to report the segment
information.
NOTE 17 – SUBSEQUENT EVENTS
On April 18, 2018 and April 21, 2018, the China
Food and Drug Administration (CFDA) Center for Drug Development
(CDE) posted on its website acceptance of the Investigative New
Drug (IND) application for CAR-T cancer therapies in treating
patients with B-cell non- Hodgkin lymphoma (NHL) and adult acute
lymphoblastic leukemia (ALL) submitted by two of the wholly-owned subsidiaries
of the Company, respectively.
19
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 months ended March
31, 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 industries 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 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 controlled
companies, unless the context otherwise requires.
20
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 will
consist of 40,000 square feet dedicated to advanced cell
manufacturing. We plan to invest an aggregate of approximately
$35 million into the Zhangjiang facility, of which $10 million
will be spent to bring the facility into compliance with
current GMP standards and around $25 million will be spent on
lease of this real estate. 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 are hiring an additional 60 R&D
and Manufacturing personnel by end of 2018.
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. The CALL-1 trial began enrollment with more data
expected to be available in the first half of 2018. Depending on
the Phase I CALL-1 results, CBMG expects to initiate a larger Phase
II clinical trial as soon as possible.
On
February 27, 2017 we announced the Company received a $2.29 million
grant from California Institute of Regenerative Medicine (CIRM) to
fund our off-the-shelf AlloJoin™ Allogeneic Stem Cell Therapy
for KOA in the United States. On May 4, 2017, the Company received
$1.2 million from the CIRM grant, the first of four disbursement
totaling $2.29 million to fund our off-the-shelf AlloJoin™
Allogeneic Stem Cell Therapy for KOA in the United
States.
On
March 30, 2017 we announced the completion of our newly expanded
30,000-square foot facility in Huishan High Tech Park in Wuxi,
China. 20,000 square feet of the Wuxi facility will be dedicated to
advanced stem cell culturing, centralized plasmid and viral
vector production, cell banking and development of
reagents.
On
April 10, 2017, we announced a strategic research collaboration to
co-develop certain high-quality industrial control processes in
CAR-T and stem cell manufacturing with GE Healthcare Life Science.
In connection with the collaboration, a joint laboratory within
CBMG’s new Shanghai Zhangjiang facility designed and built to
GMP standards will be established and dedicated to the joint
research and development of a functionally integrated and automated
immunotherapy cell manufacturing system.
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. The trial will enroll 15 patients comprised of
DLBCL, Primary Mediastinal Large B-Cell Lymphoma (PMBCL) and
Follicular Lymphoma (FL).
On
June 1, 2017, we announced our Board of Directors approved a new
stock repurchase program granting the company authority to
repurchase up to $10 million in common shares (the
“2017 Stock Repurchase Program”) through open market
purchases pursuant to a plan adopted in accordance with Rule 10b5-1
of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”) and in accordance with Rule 10b-18 of
the Exchange Act. The 2017 Stock Repurchase 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 March 2018 the Company repurchased a
total of 464,256 shares at a total cost of $4,693,597, or an
average of $10.11/share.
On
June 20, 2017, we announced the establishment of an External
Advisory Board and the appointment of Michael A. Caligiuri, MD, 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.
On
June 26, 2017, we announced the appointment of Dr. Xia Meng as
Chief Operating Officer for the Company.
21
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.
On
February 6, 2018, driven primarily by the Company’s strategy
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
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 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.
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. 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.
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™ IND application with the CFDA’s CDE in
China;
●
Continue to
evaluate the path to the Rejoin™
commercialization based on China’s autologous stem cell
therapy regulatory development;
●
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 China and potentially the rest of the
world;
●
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 whenever
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;
22
●
Implement our GE
Joint Technology Laboratory to develop control processes for the
manufacturing of CAR-T and Stem Cell Therapies;
●
Implement steps to
advance our Thermo Fisher Joint Cell Therapy Technology
Innovation and Application Center;
●
Initiate clinical
study to support the BLA for Autologous and Allogeneic KOA study in
China;
●
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; and
●
Improve liquidity
and fortify our balance sheet by courting institutional
investors.
Corporate History
Please
refer to Note 1 of unaudited condensed consolidated financial
statements for the corporate history.
BIOPHARMACEUTICAL BUSINESS
Our
biopharmaceutical business was founded in 2009 as a newly formed
specialty biomedicine company 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,
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 announced the grand opening of 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 stem cell and immune cell
therapeutics, related tools and products from our patent-protected
homegrown and acquired cell technology, as well as by utilizing
exclusively in-licensed and other acquired intellectual
properties.
Our
current treatment focal points are cancer and other degenerative
diseases such as KOA.
Cancer. In the cancer field, with the recent
build-up of multiple cancer therapeutic technologies, we have
prioritized our clinical efforts on CAR-T. We are not actively
pursuing the fragmented Tcm technical services opportunities. 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 with final data expected to be available in
the second half of 2018. 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 final data expected to be commensurate with 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 our wholly-owned subsidiaries, Cellular Biomedicine
Group (Shanghai) Ltd. and Shanghai Cellular Biopharmaceutical Group
Ltd. 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.
23
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 and aggressive DLBCL. Recruitment has
started on patients comprised of DLBCL, Primary Mediastinal Large
B-Cell Lymphoma (PMBCL) and Follicular Lymphoma (FL). Final data
for this single arm, non-randomized study to evaluate the safety
and efficacy of C- CAR011 (Anti-CD19 single-chain variable fragment
(scFv) (41BB-CD3f)) therapy in relapsed or refractory B cell
Non-Hodgkin Lymphoma (NHL) is expected commensurate with the
CDE’s approval of the Company’s IND application. On
April 18, 2018, the CDE posted on its website acceptance of the IND
application for CAR-T cancer therapies in treating patients with
NHL submitted by our wholly-owned subsidiaries, Cellular
Biomedicine Group (Shanghai) Ltd. and Shanghai Cellular
Biopharmaceutical Group Ltd.
KOA. In 2013, we completed a Phase I/IIa
clinical study, in China, for our Knee Osteoarthritis
(“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 device, process, culture and medium:
●
Obtain adipose
(fat) tissue from the patient using our CFDA approved medical
device, the A-Stromal™ Kit;
●
Expand haMPCs using
our proprietary culture medium (serum-free and antibiotics-free);
and
●
Formulated for
ReJoin therapy using our proprietary formulation.
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.
In
January 2015, we initiated patient recruitment in a phase II
clinical study, in China, of ReJoin (human adipose derived
mesenchymal progenitor cell or “haMPC”) in Cartilage
Damaged (“CD”) patients resulting from osteoarthritis
(“OA”) or sports injury, in further support of KOA
indication. The study is based on the same technology that has
shown significant efficacy in the treatment of Knee Osteoarthritis
(“KOA”), but requires two arthroscopic examinations and
the use of magnetic resonance imaging (“MRI”) to
further demonstrate the regenerative efficacy of ReJoin. Upon
further review of the protocol and the difficulty of getting
patients back for a second arthroscopic examination, we determined
to terminate the study.
The
unique lines of adult adipose-derived stem 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-9001:2008 and to be updated to 9001:2015 in this year. (i)The
cleanrooms in our new facility are ISO certified and in compliance
with China’s Good Manufacture Practice of Medical Products;
(ii) the equipment in the new Shanghai facility has been calibrated
and qualified, and the biological safety cabinets were ISO
certified. The quality management systems of CBMG Wuxi were issued
a Certificate of ISO-9001 and we are in the process of qualifying
the new Wuxi site.
24
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. And although
this approach, called adoptive cell transfer (ACT), has been
restricted to small clinical trials so far, treatments using these
engineered immune cells have generated some remarkable responses in
patients with advanced cancer. For example, in several early-stage
trials testing ACT in patients with ALL who had few if any
remaining treatment options, many patients’ cancers have
disappeared entirely. Several of these patients have remained
cancer free for extended periods.
Equally
promising results have been reported in several small clinical
trials involving patients with lymphoma. Although the lead
investigators cautioned that much more research is needed, the
results from the trials performed thus far indicate that
researchers can successfully alter patients’ T cells so that
they attack their cancer cells. As an example, we look
to Spectrum Pharmaceutical’s Folotyn approved in September
2009 for treatment of R/R peripheral T-cell lymphoma with approval
supported by a single arm trial observing an overall response rate
of 27% and median duration of response of 9.4 months. In addition,
CTI Therapeutics Pixuvri received a complete response letter in
April 2010 in R/R aggressive NHL in which a 37% overall response
rate and 5.5 month duration of response was observed.
ACT’s
building blocks are T cells, a type of immune cell collected from
the patient’s own blood. 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 in the
laboratory 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. Researchers opined that CAR
T-cell therapy eventually may become a standard therapy for some
B-cell malignancies like ALL and chronic lymphocytic
leukemia.
So
far, chimeric antigen receptor T cell therapy such as CD19 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 positive clinical efficacy in
many of these patients. Some of have them lived for years post
CAR-T treatment.
Management
believes the remaining risk in monetizing cancer immune cell
therapies is concentrated in late stage clinical studies,
speed-to-approval, manufacturing and process
optimization.
On
July 2016, Juno Therapeutics, Inc. reported the death of patients
enrolled in the U.S. Phase II clinical trial of JCAR015 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 the future enrollment. The
trial was halted in November of 2016 after two more deaths occurred
after the trial resumed. The Company believes that its product and
study are distinguishable from Juno Therapeutics and plans to
continue to monitor any toxicities associated with the
study.
25
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 as the 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), Kite Pharma’s drug for
non-Hodgkin’s lymphoma, showed four out of seven patients
treated achieved complete remission, which continued after 12
months. 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
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.
Market for Cell-Based Therapies
In
2013, U.S. sales of products which contain stem cells or progenitor
cells or which are used to concentrate autologous blood, bone
marrow or adipose tissues to yield concentrations of stem cells for
therapeutic use were, conservatively, valued at $236 million at the
hospital level. It is estimated that the orthopedics industry used
approximately 92% of the stem cell products.
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.
26
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.
The
number of cell therapy companies that are currently in Phase 2 and
Phase 3 trials has been gathering momentum, and we anticipate that
new cellular therapy products will appear on the market within the
next several years.
Our Strategy
The
majority of our biopharmaceutical business is in the development
stage. We intend to concentrate our business on cell therapies and
in the near-term, carrying our KOA stem cell therapy and cancer
immune cell therapies to commercialization.
We
are developing our business in cell therapeutics and capitalizing
on the increasing importance and promise that adult stem cells have
in regenerative medicine. Our most advanced candidate involves
adipose-derived mesenchymal stem cells to treat KOA. Based on
current estimates, we expect our biopharmaceutical business to
generate revenues primarily through the development of therapies
for the treatment of KOA within the next three to four
years.
Presently
we have two completed KOA cell therapy clinical studies in China, a
Phase IIb autologous study and a Phase I allogeneic study. If and
when either therapy obtains regulatory approval in the PRC, we will
be able to market and offer the therapy for clinical use in
China.
Our
strategy 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. Our near term objective is to pursue
successful clinical trials in China for our KOA
application. We intend to utilize our comprehensive cell
platform to support multiple cell lines to pursue multiple
therapies, both allogeneic and autologous. We intend to apply U.S.
Standard Operating Procedures ("SOPs") and protocols while
complying with Chinese regulations, while owning, developing and
executing our own clinical trial protocols. We plan to establish
domestic and international joint ventures or partnerships to set up
cell laboratories and/or research facilities, acquire technology or
in-license technology from outside of China, and build affiliations
with hospitals, to develop a commercialization path for our
therapies, once approved. 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 also intend to out-license our
technologies to interested parties.
Since
the acquisition of Beijing Agreen Biotechnology Co. Ltd.
(“AG”) in 2014, we have been engaging in efforts to
monetize AG’s U.S. and Chinese intellectual property for
immune cell therapy preparation methodologies and patient immunity
assessment by engaging with prominent hospitals to conduct
pre-clinical and clinical studies in specific cancer indications.
The T Cell clonality analysis technology patent, together with
AG’s other know-how for immunity analysis, will enable the
Company to establish an immunoassay platform that is crucial for
immunity evaluation of patients with immune disorders as well as
cancerous diseases that are undergoing therapy. We will continue to
seek to empower hospitals' immune cell cancer therapy development
programs that help patients improve their quality of life and
improve their survival rate.
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 stemming from our strategic
alliance with General Electric Healthcare’s
FlexFactory™ platform which is expected to be designed to
speed up manufacturing timelines for its cell therapy clinical
trials and commercial launch, and Thermo Fisher Scientific
(China)’s automated cell therapy manufacturing
system.
We
intend to continue our business development efforts by adding other
proven domestic and international biotechnology partners to
monetize the China health care market.
27
In
order to expedite fulfillment of patient treatment CBMG has 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.
CBMG's
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 will be able 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 an institutionalized
and proprietary process and quality management system to optimize
reproducibility and to hone our efficiency. Our four China
facilities are designed and built to meet international GMP
standards in Beijing, Shanghai and Wuxi. With our integrated
Plasmid, Viral Vectors, and CAR-T cells
Chemistry, Manufacturing, and Controls processes and expanding
capacity, we are highly distinguishable with 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 China, European Union, and the United
States. 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
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.
28
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.
Immuno-oncology (I/o)
We
continue to fortify our cancer breakthrough technology platform
with I/o, programmed cell death and vaccine
technology.
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.
29
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.
Tumor Cell Specific Dendritic Cells (TC-DC)
Recent
scientific findings indicate the presence of special cells in
tumors that are responsible for cancer metastases and relapse.
Referred to as “cancer stem cells”, these cells make up
only a small portion of the tumor mass. The central concept behind
TC-DC therapy is to immunize against these cells. TC-DC therapy
takes a sample of the patient’s own purified and irradiated
cancer cells and combines them with specialized immune cells,
thereby ‘educating’ the immune cells to destroy the
cancer stem cells from which tumors arise. We believe
the selective targeting of cells that drive tumor growth would
allow for effective cancer treatment without the risks and side
effects of current therapies that also destroy healthy cells in the
body.
Our
strategy is, through the acquisition of AG and the technologies and
pre-clinical and clinical data of University of the South Florida
and PLAGH, to become an immune cell business leader in the China
cancer therapy market and specialty pharmaceutical market by
utilizing CBMG’s attractiveness as a Nasdaq listed company to
consolidate key China immune cell technology leaders with fortified
intellectual property and ramp up revenue with first mover’s
advantage in a safe and efficient manner. The Company
plans to accelerate cancer trials in China by using the knowledge
and experience gained from the Company’s ongoing KOA trials
and the recent, CAR-T and Tcm technologies. However, it remains
unclear whether our clinical trials will qualify for CFDA’s
priority review, which is granted to high-quality innovative
medicine as maintenance therapy in subjects with advanced cancer
who have limited options following surgery and front-line
platinum/taxane chemotherapy to improve their progression-free
survival. By applying U.S. SOP and protocols and following
authorized treatment plans in China, we believe we are
differentiated from our competition as we believe we have first
mover’s advantage in manufacturing.
Competition
Many
companies operate in the cellular biopharmaceutical
field. In 2010, the FDA approved the first cell therapy
for Dendreon Corporation to apply an autologous cellular
immunotherapy for the treatment of a certain type of prostate
cancer. In May 2012 the Canadian authorities approved the
first stem cell drug and granted Osiris Therapeutics’
manufactured stem cell product for use in the pediatric
graft-versus-host disease. To date there are many publicly
listed and several 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. Notwithstanding such governmental support,
China has had a highly fragmented cellular medicine
landscape. Shenzhen Beike Biotechnology Co. Ltd.
(“Beike”) and Union Stem Cell & Gene Engineering
Co., Ltd. (“Union Stem Cell”) are two large stem cell
companies in China. To the best of our knowledge, none of the
Chinese companies 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.
30
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. The biotechnology industry,
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 Beike,
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 Beike, 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.
Our primary competitors
in the field of cancer immune cell therapies include
pharmaceutical, biotechnology companies such as Novartis, Juno
Therapeutics, Inc., Kite Pharma, Inc., CARSgen, Sorrento
Therapeutics, Inc. and others. Among our competitors,
the ones based in and operating in Greater China are BeiGene,
Limited, 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 are starting to make inroads into China by partnering or
seeking to partner with local companies. For example, in April,
2016, Seattle-based Juno Therapeutics, Inc started a new company
with WuXi AppTec in China named JW Biotechnology (Shanghai) Co.,
Ltd. Its mission is to build China's leading cell therapy company
by leveraging Juno's chimeric antigen receptor (CAR) and T cell
receptor (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. to
develop, manufacture and commercialize axicabtagene ciloleucel
CAR-T product in China with the option to include additional
products, including two T cell receptor (TCR) product candidates
from Kite. Axicabtagene ciloleucel is Kite's lead product candidate
and is an investigational chimeric antigen receptor (CAR) T-cell
therapy under development for the treatment of B-cell lymphomas and
leukemias. 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 applications for CD19 chimeric antigen receptor T
cells cancer therapies from companies comprised of the Company,
Nanjing Legend Biotechnology, Chengdu Yinhe Biological Medicine,
Shanghai HRAIN Biotechnology, Carsgene Biomedicine (Shanghai),
Biogene ANKE Cell Technology and Shanghai Mingju
Biotechnology.
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 Biotec, 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 treatment for
knee pain.
Some
of our 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.
31
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 ability to meet cGMP regulatory requirements, a 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 Greater 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 March 31, 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 March 31,
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.
32
Results of Operations
Below is a discussion of
the results of our operations for the
three months ended March 31, 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 March 31, 2018 to Three Months
Ended March 31, 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
March 31,
2018
|
Three Months Ended
March 31,
2017
|
|
As stated
|
As stated
|
Net
sales and revenue
|
$50,961
|
$98,425
|
|
|
|
Operating
expenses:
|
|
|
Cost
of sales
|
22,300
|
37,402
|
General
and administrative
|
3,188,797
|
3,185,247
|
Selling
and marketing
|
74,585
|
117,884
|
Research
and development
|
5,273,951
|
3,044,125
|
Impairment
of investments
|
-
|
-
|
Total
operating expenses
|
8,559,633
|
6,384,658
|
Operating
loss
|
(8,508,672)
|
(6,286,233)
|
|
|
|
Other
income
|
|
|
Interest
income
|
5,449
|
49,182
|
Other
income
|
9,200
|
77,508
|
Total
other income
|
14,649
|
126,690
|
Loss
before taxes
|
(8,494,023)
|
(6,159,543)
|
|
|
|
Income
taxes provision
|
(2,400)
|
(2,450)
|
|
|
|
Net
loss
|
$(8,496,423)
|
$(6,161,993)
|
Other
comprehensive income:
|
|
|
Cumulative
translation adjustment
|
818,361
|
53,669
|
Total
other comprehensive income:
|
818,361
|
53,669
|
Comprehensive
loss
|
$(7,678,062)
|
$(6,108,324)
|
|
|
|
|
|
|
Net
loss per share:
|
|
|
Basic
|
$(0.51)
|
$(0.43)
|
Diluted
|
$(0.51)
|
$(0.43)
|
|
|
|
Weighted
average common shares outstanding:
|
|
|
Basic
|
16,742,591
|
14,281,745
|
Diluted
|
16,742,591
|
14,281,745
|
____________________________
* These line items include the following amounts of non-cash,
stock-based compensation expense for the periods
indicated:
|
Three Months Ended
March 31,
2018
|
Three Months Ended
March 31,
2017
|
|
As stated
|
As stated
|
Cost
of sales
|
-
|
11,139
|
General
and administrative
|
562,321
|
867,585
|
Selling
and marketing
|
20,992
|
(2,382)
|
Research
and development
|
551,568
|
555,565
|
|
1,134,881
|
1,431,907
|
33
Results of Operations
Net sales and revenue
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$50,961
|
$98,425
|
$(47,464)
|
(48)%
|
Revenue for three months period ended March 31, 2018 was mainly
derived from cell banking services as well as cell therapy
technology service. Whereas revenue for three months period ended
March 31, 2017was derived only from cell therapy technology
service.
Cost of Sales
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$22,300
|
$37,402
|
$(15,102)
|
(40)%
|
The cost of sales in the three months ended March 31, 2018 was
commensurate with the sales volume.
General and Administrative Expenses
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$3,188,797
|
$3,185,247
|
$3,550
|
0%
|
General and administrative expense did not fluctuate significantly
from the three months ended March 31, 2017 to the comparable period
in 2018, and changes were 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 $543,000, 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 $72,000, 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 $324,000, a majority of
which is attributable to a new capital market advisory expense
incurred in the first quarter 2018; and
o
An increase in
payroll of $357,000 due to retention bonuses to employees in
2018.
Selling and Marketing Expenses
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$74,585
|
$117,884
|
$(43,299)
|
(37)%
|
Sales and marketing expenses decreased by approximately $43,000 in
the three months ended March 31, 2018 as compared to the three
months ended March 31, 2017, primarily as a result of a severance
payment in 2017.
34
Research and Development Expenses
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$5,273,951
|
$3,044,125
|
$2,229,826
|
73%
|
Research and development costs increased by approximately
$2,230,000 in the three months ended March 31, 2018 as compared to
the three months ended March 31, 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.
Operating Loss
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$(8,508,672)
|
$(6,286,233)
|
$(2,222,439)
|
35%
|
The increase in the operating loss for the three months ended March
31, 2018 as compared to the same period in 2017 is primarily due to
changes in revenues, general and administration expenses and
research and development expenses, each of which is described
above.
Total Other Income
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$14,649
|
$126,690
|
$(112,041)
|
(88)%
|
Other income for the three months ended March 31, 2018 was
primarily interest income of $5,000 and subsidy income of $15,000,
netting of foreign currency exchange loss of $4,000 and equipment
disposal loss of $1,000. Other income for the three months ended
March 31, 2017 was primarily interest income of $49,000 and subsidy
income of $80,000.
Income Taxes Provision
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$(2,400)
|
$(2,450)
|
$50
|
N/A
|
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 three months ended
March 31, 2018 and 2017 all represent US state tax.
35
Net Loss
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$(8,496,423)
|
$(6,161,993)
|
$(2,334,430)
|
38%
|
Changes in net loss are primarily attributable to changes in
operations which are described above.
Comprehensive Loss
|
2018
|
2017
|
Change
|
Percent
|
For
the three months ended March 31,
|
$(7,678,062)
|
$(6,108,324)
|
$(1,569,738)
|
26%
|
Comprehensive loss for the three months ended March 31, 2018
includes a currency translation net gain of approximately $818,000
combined with the changes in net loss. Comprehensive income for the
three months ended March 31, 2017 includes a currency translation
net gain of approximately $54,000 combined with the changes in net
loss.
Liquidity and Capital Resources
We had working capital of $43,450,816 as of March 31, 2018 compared
to $20,850,823 as of December 31, 2017. Our cash position increased
to $45,555,891 at March 31, 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 $5,612,000
and $4,859,000 for the three months ended March 31, 2018 and 2017,
respectively. The following table reconciles net loss to net cash
used in operating activities:
For the
three months ended March 31,
|
2018
|
2017
|
Change
|
Net
loss
|
$(8,496,423)
|
$(6,161,993)
|
$(2,334,430)
|
Non
cash transactions
|
2,311,304
|
2,101,883
|
209,421
|
Changes
in operating assets, net
|
573,068
|
(798,553)
|
1,371,621
|
Net
cash used in operating activities
|
$(5,612,051)
|
$(4,858,663)
|
$(753,388)
|
The 2018 change in non-cash transaction was primarily due to the
increase in depreciation and amortization of $506,000 netting of
the decline in share based compensation of $297,000 compared with
same period in 2017.
Net cash used in investing activities was approximately $1,083,000
and $1,050,000 in the three months ended March 31, 2018 and 2017,
respectively. These amounts were primarily the result of
additional new equipment and facility improvement.
Cash provided by financing activities was approximately $30,563,000
and $6,000 in the three months ended March 31, 2018 and 2017,
respectively. Net cash inflow in the financing activities in 2017
was mainly attributed to the proceeds received from the issuance of
common stock and exercise of options net of the repurchase of the
Company’s common stock.
Liquidity and Capital Requirements Outlook
We
anticipate that the Company will require approximately $42 million
in cash to operate as planned in the coming 12 months. Of this
amount, approximately $30 million will be used in daily operation and
approximately $12 million will be used as capital
expenditure, although we may revise these plans depending on the
changing circumstances of our biopharmaceutical
business.
36
We
expect to rely on current cash balances that we hold to provide for
these capital requirements. We do not intend to use, and will not
rely on our holdings in 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. Another one of our stocks held, Wonder
International Education & Investment Group Corporation
(“Wonder”), is 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 2,057,131 shares of Wonder stock or
any of our other portfolio securities, 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 private or public 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.
37
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 March 31, 2018.
|
Payments due by period
|
||||
Contractual Obligations
|
Total
|
Less than
|
2-3
|
4-5
|
More than
|
|
|
1 year
|
years
|
years
|
5 years
|
Capital
Commitment
|
$3,088,581
|
$3,088,581
|
$-
|
$-
|
$-
|
Operating
Lease Obligations
|
23,833,254
|
3,112,005
|
5,617,513
|
5,295,424
|
9,808,312
|
Total
|
$26,921,835
|
$6,200,586
|
$5,617,513
|
$5,295,424
|
$9,808,312
|
38
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 and receivables etc. Exposure to these
credit risks are monitored by management on an ongoing
basis.
The
Company's cash is mainly held with well-known or state owned
financial institutions, such as HSBC, Bank of China and China
Merchant Bank etc. Management does not foresee any significant
credit risks from these deposits 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 March 31, 2018, 90% 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 March
31, 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 March 31, 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)
|
|
|
As of March 31, 2018
|
|
|
RMB
|
USD
|
Cash
and cash equivalents
|
2,630
|
3,374,633
|
|
|
|
Net
exposure arising from recognised assets and
liabilities
|
2,630
|
3,374,633
|
39
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.
|
As of March 31, 2018
|
|
|
increase/(decrease) in foreign exchange rates
|
Effect on net loss (Expressed in USD)
|
RMB
(against USD)
|
5%
|
(168,600)
|
|
|
|
|
-5%
|
168,600
|
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 March 31, 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.
40
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
During the three months ended March 31, 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.
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 three months ended March 31,
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
|
|
Total
|
464,256
|
$10.11
|
464,256
|
5,306,403
|
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Not applicable.
41
ITEM 6. EXHIBITS
Exhibits
Exhibit Number
|
|
Description
|
|
Certification 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
|
42
SIGNATURES
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: May 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)
|
|
|
|
|
|
43