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, 2017
OR
☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Commission File Number 001-36498
CELLULAR BIOMEDICINE GROUP, INC.
(Exact name of registrant as specified in its charter)
Delaware
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86-1032927
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State of Incorporation
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IRS Employer Identification No.
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19925 Stevens Creek Blvd., Suite 100
Cupertino, California 95014
(Address of principal
executive offices)
(408) 973-7884
(Registrant’s telephone number)
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or
15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days.
Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any, every
Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period than the
registrant was required to submit and post such files).
Yes ☑ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, or a non-accelerated
filer. See definition of “accelerated filer,” and
“large accelerated filer” and “smaller reporting
company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large accelerated filer
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☐
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Accelerated filer
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☑
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Non-accelerated filer
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☐
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Smaller reporting company
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☐
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Emerging growth company
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☐
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If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended
transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the
Exchange Act. ☐
Indicate by check mark whether the registrant is a
shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☑
As of April 30, 2017, there were 14,290,668
shares of common stock, par value $.001 per share issued and
outstanding.
PART I FINANCIAL INFORMATION
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Item 1.
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Condensed
Consolidated Financial Statements (unaudited)
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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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25
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Item 3.
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Quantitative and
Qualitative Disclosures About Market Risk
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45
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Item 4.
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Controls and
Procedures
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45
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PART II OTHER INFORMATION
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Item 1.
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Legal
Proceedings
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46
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Item 1A.
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Risk
Factors
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46
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Item 2.
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Unregistered Sales
of Equity Securities and Use of Proceeds
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61
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Item 3.
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Defaults Upon
Senior Securities
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46
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Item 4.
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Mine
Safety Disclosures
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Item 5.
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Other
Information
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61
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Item 6.
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Exhibits
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61
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SIGNATURES
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62
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2
PART I – FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
(Unaudited)
CELLULAR
BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
AS OF MARCH 31, 2017 AND DECEMBER 31, 2016
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March 31,
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December 31,
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2017
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2016
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Assets
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Cash
and cash equivalents
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$33,361,784
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$39,252,432
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Accounts
receivable, less allowance for doubtful amounts of
$10,218
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and
$10,163 as of March 31, 2017 and December 31, 2016,
respectively
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79,602
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39,974
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Other
receivables
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813,077
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412,727
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Prepaid
expenses
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1,071,447
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986,951
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Total
current assets
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35,325,910
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40,692,084
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Investments
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509,424
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509,424
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Property,
plant and equipment, net
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4,449,268
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4,117,739
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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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13,677,958
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14,092,581
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Long-term
prepaid expenses and other assets
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1,949,542
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1,537,850
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Total
assets (1)
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$63,590,891
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$68,628,467
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Liabilities and Stockholders' Equity
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Liabilities:
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Accounts
payable
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$782,450
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$216,154
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Accrued
expenses
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325,486
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1,168,787
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Taxes
payable
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31,325
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28,875
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Other
current liabilities
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866,223
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950,220
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Total
current liabilities
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2,005,484
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2,364,036
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Other
non-current liabilities
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362,356
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370,477
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Total
liabilities (1)
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2,367,840
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2,734,513
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Commitments
and Contingencies (note 12)
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Stockholders'
equity:
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Preferred
stock, par value $.001, 50,000,000 shares
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authorized;
none issued and outstanding as of
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March
31, 2017 and December 31, 2016, respectively
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-
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-
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Common
stock, par value $.001, 300,000,000 shares authorized;
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14,286,013
and 14,281,378 issued and outstanding
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as
of March 31, 2017 and December 31, 2016, respectively
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14,286
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14,281
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Additional
paid in capital
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153,980,468
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152,543,052
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Accumulated
deficit
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(91,708,680)
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(85,546,687)
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Accumulated
other comprehensive loss
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(1,063,023)
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(1,116,692)
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Total
stockholders' equity
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61,223,051
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65,893,954
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Total
liabilities and stockholders' equity
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$63,590,891
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$68,628,467
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_______________
(1)
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The Company’s consolidated assets as of March 31, 2017 and
December 31, 2016 included $9,517,425 and $$9,626,171,
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, 2017
and December 31, 2016, respectively. These assets include cash and
cash equivalents of $2,861,822 and $4,021,992; other receivables of
$772,628 and $370,702; prepaid expenses of $933,709 and $777,445;
property, plant and equipment, net, of $2,322,433 and $2,398,576;
intangibles of $1,592,961 and $1,613,582; and long-term prepaid
expenses and other assets of $1,033,872 and $443,874. The
Company’s consolidated liabilities as of March 31, 2017 and
December 31, 2016 included $1,277,632 and $1,372,391, respectively,
of liabilities of the VIEs whose creditors have no recourse to the
Company. These liabilities include accounts payable of $702,318 and
$161,825; other payables of $426,413 and $407,769; payroll accrual
of $148,901 and $792,706; and other non-current liabilities of $nil
and $10,091. 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, 2017 AND 2016
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For the Three Months Ended
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March 31,
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2017
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2016
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Net
sales and revenue
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$98,425
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$488,491
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Operating
expenses:
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Cost
of sales
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37,402
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503,193
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General
and administrative
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3,185,247
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2,775,925
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Selling
and marketing
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117,884
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178,754
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Research
and development
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3,044,125
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2,398,362
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Total
operating expenses
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6,384,658
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5,856,234
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Operating
loss
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(6,286,233)
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(5,367,743)
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Other
income
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Interest
income
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49,182
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17,050
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Other
income
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77,508
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16,320
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Total
other income
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126,690
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33,370
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Loss
before taxes
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(6,159,543)
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(5,334,373)
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Income
taxes credit (provision)
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(2,450)
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1,124,260
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Net
loss
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$(6,161,993)
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$(4,210,113)
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Other
comprehensive income:
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Cumulative
translation adjustment
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53,669
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16,073
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Unrealized
gain on investments, net of tax of nil and $4,514,060, for the
three months ended march 31, 2017 and 2016,
respectively
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16,416,517
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Total
other comprehensive income:
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53,669
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16,432,590
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Comprehensive
income (loss)
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$(6,108,324)
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$12,222,477
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Net
loss per share :
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Basic
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$(0.43)
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$(0.35)
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Diluted
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$(0.43)
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$(0.35)
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Weighted
average common shares outstanding:
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Basic
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14,281,745
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11,884,066
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Diluted
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14,281,745
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11,884,066
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The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
4
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
FOR THE THREE MONTHS ENDED MARCH 31, 2017 AND 2016
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For the Three Months Ended
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March 31,
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2017
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2016
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CASH
FLOWS FROM OPERATING ACTIVITIES:
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Net
loss
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$(6,161,993)
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$(4,210,113)
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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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669,739
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671,649
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Loss
on disposal of assets
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237
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-
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Stock
based compensation expense
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1,431,907
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1,266,063
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Changes
in operating assets and liabilities:
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Accounts
receivable
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(39,411)
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50,764
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Other
receivables
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(398,190)
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9,705
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Inventory
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-
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(96,083)
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Prepaid
expenses
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(78,832)
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(274,829)
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Taxes
recoverable
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-
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150,082
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Long-term
prepaid expenses and other assets
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6,524
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(38,522)
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Accounts
payable
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565,236
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(51,992)
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Accrued
expenses
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(844,172)
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57,178
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Other
current liabilities
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(2,012)
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29,415
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Taxes
payable
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2,450
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32,450
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Deferred
tax liabilities
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-
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(1,128,515)
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Other
non-current liabilities
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(10,146)
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(50,049)
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Net
cash used in operating activities
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(4,858,663)
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(3,582,797)
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CASH
FLOWS FROM INVESTING ACTIVITIES:
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Purchases
of intangibles
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(23,268)
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-
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Purchases
of property, plant and equipment
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(1,026,994)
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(674,736)
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Net
cash used in investing activities
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(1,050,262)
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(674,736)
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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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-
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4,970,002
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Proceeds
from exercise of stock options
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5,514
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93,249
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Net
cash provided by financing activities
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5,514
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5,063,251
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EFFECT
OF EXCHANGE RATE CHANGES ON CASH
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12,763
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(22,786)
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INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
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(5,890,648)
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782,932
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CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
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39,252,432
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14,884,597
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CASH
AND CASH EQUIVALENTS, END OF PERIOD
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$33,361,784
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$15,667,529
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SUPPLEMENTAL CASH FLOW INFORMATION
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Cash
paid for income taxes
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$-
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$(4,255)
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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, 2017 AND 2016
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 biomedicine company, principally
engaged in the development of new treatments for cancerous 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 cancers using
: Chimeric Antigen Receptor T cell (CAR-T), cancer vaccine, and T
Central Memory Cell (Tcm) technology, and (ii) human
adipose-derived mesenchymal progenitor cells (haMPC) for treatment
of joint and autoimmune diseases, with primary research and
manufacturing facilities in China.
We are focused on developing and marketing safe
and effective cell-based therapies based on our cellular platforms,
to treat serious diseases such as cancer, orthopedic diseases,
various inflammatory diseases and metabolic diseases. We have
developed proprietary practical knowledge in the use of cell-based
therapeutics that we believe could be used to help a great number
of people suffering from cancer and other serious chronic diseases.
We are conducting clinical studies in China for stem cell based
therapies to treat knee osteoarthritis (“KOA”). We have
completed 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 launched Phase I
clinical trial of an off-the-shelf allogeneic haMPC
(AlloJoinTM)
therapy for KOA. We have completed patient recruitment and
treatment for Phase I clinical studies of KOA on August 5, 2016.
With the California Institute of Regenerative Medicine’s
(CIRM) $2.29 million grant we have started manufacturing
AlloJoinTMproduct
for KOA preclinical and clinical studies in the United
States.
Our
primary target market is Greater China. We believe that the results
of our research, the acquired knowhow and clinical study results
will help to cure or alleviate illness and suffering of the
patients. We expect to carry out the clinical studies leading to
eventual CFDA approval through IND filings and authorized treatment
centers throughout Greater China.
With
the acquisition of the University of South Florida’s license
on the next generation GVAX vaccine (CD40LGVAX) and its related
standard operational procedures (SOPs), we have expanded our
immuno-oncology portfolio significantly. We plan to use the
knowledge we obtained from the previous phase l clinical study
conducted in the U.S. by the Moffitt Cancer center to support an
investigator sponsored trial to evaluate the potential synergistic
effect of the combination of CD40LGVAX with anti-PD1 checkpoint
inhibitor, to treat a selected segment of late stage non-small cell
lung cancer (NSCLC) adenocarcinoma patients. We may also seek
approval to conduct clinical trials with leading non-U.S. medical
centers or seek partnership for CD40LGVAX sub-license
opportunities.
With
our recent build-up of multiple cancer therapeutic technologies, we
have prioritized our clinical efforts on launching multiple trials
for CAR-Ts in several indications and not actively pursuing the
fragmented technical services opportunities. We are striving to
build a highly competitive research and development function, a
translational medicine team, along with a well-established cellular
manufacturing capability for clinical grade materials, to support
the development of multiple assets in several cancer indications.
These efforts will allow us to boost the Company's Immuno-Oncology
presence and pave the way for 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, 2016
included in our Annual Report on Form 10-K for the year ended
December 31, 2016. Operating results for the three months ended
March 31, 2017 are not necessarily indicative of the results that
may be expected for the year ending December 31, 2017.
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, 2017 and
the results of operations for the three months ended March 31, 2017
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
Recent
accounting pronouncements that the Company has adopted or may be
required to adopt in the future are summarized below.
In
February 2017, the Financial Accounting Standards Board
(“FASB”) issued Accounting Standards Update
(“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 noncontrolled 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.
We do not expect the adoption of ASU 2017-05 to have a material
impact on our 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
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. We do not expect the
adoption of ASU 2016-18 to have a material impact on our
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. We do not
expect the adoption of ASU 2016-15 to have a material impact 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
April 2016, the FASB issued ASU No. 2016-09,
“Compensation—Stock Compensation (Topic 718):
Improvements to Employee Share-Based Payment Accounting”
(“ASU 2016-09”), which simplifies several aspects of
the accounting for employee share-based payment transactions. The
areas for simplification in ASU 2016-09 include the income tax
consequences, classification of awards as either equity or
liabilities, and classification on the statement of cash flows. The
amendments in this ASU will be effective for annual periods
beginning after December 15, 2016 and interim periods within those
annual periods. Early adoption is permitted. ASU 2016-09 has been
adopted in our current consolidated financial statements for the
three months ended March 31, 2017 and does not have a material
impact.
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.
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. We do
not expect the adoption of ASU 2016-01 to have a material impact on
our consolidated financial statements.
8
In
May 2014, the FASB issued ASU No. 2014-09, “Revenue from
Contracts with Customers (Topic 606)” (“ASU
2014-09”). ASU 2014-09 supersedes the revenue recognition
requirements in “Revenue Recognition (Topic 605)”, and
requires entities to recognize revenue when it transfers promised
goods or services to customers in an amount that reflects the
consideration to which the entity expects to be entitled to in
exchange for those goods or services. The FASB issued ASU No.
2015-14, “Revenue from Contracts with Customers (Topic 606):
Deferral of the Effective Date” (“ASU 2015-14”)
in August 2015. The amendments in ASU 2015-14 defer the effective
date of ASU 2014-09. Public business entities, certain
not-for-profit entities, and certain employee benefit plans should
apply the guidance in ASU 2014-09 to annual reporting periods
beginning after December 15, 2017, including interim reporting
periods within that reporting period. Earlier adoption is permitted
only as of annual reporting periods beginning after December 15,
2016, including interim reporting periods within that reporting
period. Further to ASU 2014-09 and ASU 2015-14, the FASB issued ASU
No. 2016-08, “Revenue from Contracts with Customers (Topic
606): Principal versus Agent Considerations (Reporting Revenue
Gross versus Net)” (“ASU 2016-08”) in March 2016,
ASU No. 2016-10, “Revenue from Contracts with Customers
(Topic 606): Identifying Performance Obligations and
Licensing” (“ASU 2016-10”) in April 2016, ASU No.
2016-12, “Revenue from Contracts with Customers (Topic 606):
Narrow-Scope Improvements and Practical Expedients”
(“ASU 2016-12”), and ASU No. 2016-20, “Technical
Corrections and Improvements to Topic 606, Revenue from Contracts
with Customers” (“ASU 2016-20”), respectively.
The amendments in ASU 2016-08 clarify the implementation guidance
on principal versus agent considerations, including indicators to
assist an entity in determining whether it controls a specified
good or service before it is transferred to the customers. ASU
2016-10 clarifies guideline related to identifying performance
obligations and licensing implementation guidance contained in the
new revenue recognition standard. The updates in ASU 2016-10
include targeted improvements based on input the FASB received from
the Transition Resource Group for Revenue Recognition and other
stakeholders. It seeks to proactively address areas in which
diversity in practice potentially could arise, as well as to reduce
the cost and complexity of applying certain aspects of the guidance
both at implementation and on an ongoing basis. ASU 2016-12
addresses narrow-scope improvements to the guidance on
collectability, non-cash consideration, and completed contracts at
transition. Additionally, the amendments in this ASU provide a
practical expedient for contract modifications at transition and an
accounting policy election related to the presentation of sales
taxes and other similar taxes collected from customers. The
amendments in ASU 2016-20 represents changes to make minor
corrections or minor improvements to the Codification that are not
expected to have a significant effect on current accounting
practice or create a significant administrative cost to most
entities. The effective date and transition requirements for ASU
2016-08, ASU 2016-10, ASU 2016-12 and ASU 2016-20 are the same as
ASU 2014-09. We are currently in the process of evaluating the
impact of the adoption of ASU 2014-09, ASU 2016-08, ASU 2016-10,
ASU 2016-12 and ASU 2016-20 on our consolidated financial
statements.
NOTE 3 – VARIABLE INTEREST ENTITIES
VIEs are those entities
in which a company, through contractual arrangements, bears the
risk of, and enjoys the rewards normally associated with ownership
of the entity, and therefore the Company is the primary beneficiary
of the entity. Cellular Biomedicine Group Ltd (Shanghai)
(“CBMG Shanghai”) and its subsidiaries are variable
interest entities (VIEs), through which the Company conducts 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, 2017 and 2016, nil and 60% 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.
9
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.
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, 2017 and December 31, 2016 are as
follows:
10
|
March 31,
|
December 31,
|
|
2017
|
2016
|
Assets
|
|
|
Cash
|
$2,861,822
|
$4,021,992
|
Other
receivables
|
772,628
|
370,702
|
Prepaid
expenses
|
933,709
|
777,445
|
Total
current assets
|
4,568,159
|
5,170,139
|
|
|
|
Property,
plant and equipment, net
|
2,322,433
|
2,398,576
|
Intangibles
|
1,592,961
|
1,613,582
|
Long-term
prepaid expenses and other assets
|
1,033,872
|
443,874
|
Total
assets
|
$9,517,425
|
$9,626,171
|
|
|
|
Liabilities
|
|
|
Accounts
payable
|
$702,318
|
$161,825
|
Other
payables
|
426,413
|
407,769
|
Payroll
accrual
|
148,901
|
792,706
|
Total
current liabilities
|
$1,277,632
|
$1,362,300
|
|
|
|
Other
non-current liabilities
|
-
|
10,091
|
Total
liabilities
|
$1,277,632
|
$1,372,391
|
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, 2017 and December 31, 2016 the amounts of other
receivables was $813,077 and $412,727, respectively.
NOTE 5 – PROPERTY, PLANT AND EQUIPMENT
As
of March 31, 2017 and December 31, 2016, property, plant and
equipment, carried at cost, consisted of the
following:
|
March 31,
2017
|
December 31,
2016
|
|
|
|
Office
equipment
|
$79,762
|
$80,485
|
Manufacturing
equipment
|
3,392,211
|
3,347,458
|
Computer
equipment
|
170,127
|
162,769
|
Leasehold
improvements
|
1,923,024
|
1,912,573
|
Construction
work in process
|
1,618,925
|
1,172,433
|
|
7,184,049
|
6,675,718
|
Less:
accumulated depreciation
|
(2,734,781)
|
(2,557,979)
|
|
$4,449,268
|
$4,117,739
|
For the three months ended March 31, 2017 and
2016, depreciation expense was $222,926 and $217,738,
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:
11
March 31, 2017 and December 31, 2016
|
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
|
-
|
-
|
-
|
480,000
|
Total
|
$731,388
|
$-
|
$-
|
$(221,964)
|
$509,424
|
The
unrealized holding gains for the investments that recognized in
other comprehensive income for the three months ended March 31,
2017 and 2016 was $nil and $20,930,577, respectively.
The
Company tracks each investment with an unrealized loss and evaluate
them on an individual basis for other-than-temporary impairments,
including obtaining corroborating opinions from third party
sources, performing trend analysis and reviewing management’s
future plans. When investments have declines determined
by management to be other-than-temporary the Company recognizes
write downs through earnings. There is no
other-than-temporary impairment of investments for the three months
ended March 31, 2017 and 2016.
NOTE 7 – FAIR VALUE ACCOUNTING
The
Company has adopted ASC Topic 820, Fair Value Measurement and
Disclosure, which defines fair value, establishes a framework for
measuring fair value in GAAP, and expands disclosures about fair
value measurements. It does not require any new fair value
measurements, but provides guidance on how to measure fair value by
providing a fair value hierarchy used to classify the source of the
information. It establishes a three-level valuation hierarchy of
valuation techniques based on observable and unobservable inputs,
which may be used to measure fair value and include the
following:
Level 1 – Quoted prices in active markets for identical
assets or liabilities.
Level 2 – Inputs other than Level 1 that are observable,
either directly or indirectly, such as quoted prices for similar
assets or liabilities; quoted prices in markets that are not
active; or other inputs that are observable or can be corroborated
by observable market data for substantially the full term of the
assets or liabilities.
Level 3 – Unobservable inputs that are supported by little or
no market activity and that are significant to the fair value of
the assets or liabilities.
Classification
within the hierarchy is determined based on the lowest level of
input that is significant to the fair value
measurement.
The
carrying value of financial items of the Company including cash and
cash equivalents, accounts receivable, other receivables, 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, 2017 and December 31, 2016 are summarized as
follows:
|
As of March 31, 2017 and December 31, 2016
|
|||
|
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
|
480,000
|
-
|
480,000
|
-
|
|
$509,424
|
$-
|
$509,424
|
$-
|
No shares were acquired in the three months ended
March 31, 2017 and 2016.
As
of March 31, 2017 and December 31, 2016, 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, 2017 and December 31, 2016 have been valued
based on level 2 inputs due to the limited trading of all two
of these companies.
12
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, 2017 and December 31, 2016, intangible assets, net
consisted of the following:
Patents
& knowhow & license
|
|
|
|
March 31,
2017
|
December 31,
2016
|
Cost
basis
|
$17,570,593
|
$17,560,496
|
Less:
accumulated amortization
|
(3,980,482)
|
(3,539,617)
|
|
$13,590,111
|
$14,020,879
|
Software
|
|
|
|
March 31,
2017
|
December 31,
2016
|
Cost
basis
|
$149,898
|
$125,964
|
Less:
accumulated amortization
|
(62,051)
|
(54,262)
|
|
$87,847
|
$71,702
|
|
|
|
|
|
|
Total
intangibles, net
|
$13,677,958
|
$14,092,581
|
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, 2017 and 2016 was $446,813 and $453,911,
respectively.
Estimated
amortization expense for each of the ensuing years are as follows
for the years ending March 31:
Years ending
March 31,
|
Amount
|
2018
|
$1,783,572
|
2019
|
1,776,959
|
2020
|
1,776,252
|
2021
|
1,771,697
|
2022
and thereafter
|
6,569,478
|
|
$13,677,958
|
13
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, 2017 and 2016 was approximately
$894,885 and $298,799, respectively.
As
of March 31, 2017, the Company has the following future minimum
lease payments due under the foregoing lease
agreements:
Years
ending March 31,
|
Amount
|
2018
|
$3,087,257
|
2019
|
2,784,856
|
2020
|
2,673,360
|
2021
|
2,423,135
|
2022
and thereafter
|
13,765,716
|
|
|
|
$24,734,324
|
NOTE 10 – RELATED PARTY TRANSACTIONS
As
of March 31, 2017 and December 31, 2016, accrued expenses included
director fees of $8,782 and $3,082 due to independent director Mr.
Gang Ji.
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
February 4, 2016, the Company conducted an initial closing of a
financing transaction (the “Financing”), pursuant to
which it sold an aggregate of 263,158 shares of the Company’s
common stock, par value $0.001 per share to Wuhan Dangdai Science
& Technology Industries Group Inc. (the “Investor”)
at $19.00 per share, for total gross proceeds of approximately
$5,000,000. The Investor agreed to purchase, in one or more
subsequent closings, up to an additional 2,006,842 shares on or
before April 15, 2016, for a potential aggregate additional raise
of $38,130,000. The Company had received the proceeds of $5,000,000
on February 4, 2016.
On
April 15, 2016, the Company completed the second and final closing
of the Financing with the Investor, pursuant to which the Company
sold to the Investor 2,006,842 shares of the Company’s Common
Stock, for approximately $38,130,000 in gross proceeds. 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.
In
connection with the above Financing, the Company agreed to pay a
finder’s fee equal to 5% of the gross proceeds comprised of
(i) $657,628 from the gross proceeds of the Financing and (ii)
78,888 restricted shares of Common Stock based on the per share
purchase price in the Financing of $19 per share. On April 28,
2016, 78,888 shares of common stock were issued to the finder,
which was recorded against the equity.
During
the three months ended March 31, 2017 and 2016, the Company
expensed $1,415,751 and $1,092,034 associate with unvested options
awards, $16,156 and $174,029 associated with restricted common
stock, respectively.
During
the three months ended March 31, 2017 and 2016, options for 600 and
26,385 underlying shares were exercised, 600 and 26,385 shares of
the Company’s common stock were issued
accordingly.
14
During
the three months ended March 31, 2017 and 2016, 4,035 and nil
shares of the Company's restricted common stock were issued to
directors, employees and advisors respectively.
NOTE 12 – COMMITMENTS AND CONTINGENCIES
Capital commitments
As
of March 31, 2017, the capital commitments of the Company are
summarized as follows:
|
March 31,
2017
|
|
|
Contracts
for acquisition of plant and equipment being or to be
executed
|
$6,478,371
|
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, 2017 and 2016 was $1,415,751 and $1,092,034,
respectively. The compensation cost that has been charged against
income related to restricted stock awards for the three months
ended March 31, 2017 and 2016 was $16,156 and $174,029,
respectively.
As
of March 31, 2017, there was $7,484,814 all unrecognized
compensation cost related to an aggregate of 804,334 of non-vested
stock option awards and $610,045 related to an aggregate of 36,805
of non-vested restricted stock awards. These costs are
expected to be recognized over a weighted-average period of 2.24
years for the stock options awards and 1.06 years for the
restricted stock awards.
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.
During
the three months ended March 31, 2016, the Company issued options
under the 2013 Plan and 2014 Plan of an aggregate of 50,743 shares
of the Company’s common stock. The grant date fair value of
these options was $542,901 using Black-Scholes option valuation
models with the following assumptions: exercise price equal to the
grant date stock price of $14.14 to $40.00, volatility 89.66% to
89.91%, expected life 6.0 years, and risk-free rate of 1.31% to
1.65%. 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,
2017 and December 31, 2016 and for the three months ended March 31,
2017:
15
|
Number of Options
|
Weighted- Average Exercise Price
|
Weighted- Average Remaining Contractual Term (in
years)
|
Aggregate Intrinsic Value
|
|
|
|
|
|
Outstanding
at December 31, 2016
|
1,607,815
|
$12.59
|
7.3
|
$6,355,072
|
Grants
|
387,741
|
12.24
|
|
|
Forfeitures
|
(57,013)
|
22.57
|
|
|
Exercises
|
(600)
|
9.19
|
|
|
Outstanding
at March 31, 2017
|
1,937,943
|
$12.22
|
7.6
|
$5,396,233
|
|
|
|
|
|
Vested
and exercisable at March 31, 2017
|
1,133,609
|
$9.34
|
6.7
|
$5,245,859
|
Exercise
|
Number of Options
|
|
Price
|
Outstanding
|
Exercisable
|
|
|
|
$3.00 - $4.95
|
185,547
|
185,547
|
$5.00 - $9.19
|
566,104
|
546,704
|
$11.05+
|
1,186,292
|
401,358
|
|
1,937,943
|
1,133,609
|
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, 2017 and 2016 was
$5,514 and $93,249.
16
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,
|
|
|
2017
|
2016
|
|
|
|
Net
loss
|
$(6,161,993)
|
$(4,210,113)
|
|
|
|
Weighted
average shares of common stock
|
14,281,745
|
11,884,066
|
Dilutive
effect of stock options
|
-
|
-
|
Restricted
stock vested not issued
|
-
|
-
|
Common
stock and common stock equivalents
|
14,281,745
|
11,884,066
|
|
|
|
Net
loss per basic share
|
$(0.43)
|
$(0.35)
|
Net
loss per diluted share
|
$(0.43)
|
$(0.35)
|
For
the three months ended March 31, 2017 and 2016, 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,
2017 and 2016.
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).
As
of March 31, 2017, the Company had net operating loss carryforwards
of $13.2 million for U.S. federal purposes, $12.8 million for U.S.
state purposes, and $6.6 million for Chinese income tax purposes,
such losses will begin to expire in 2034, 2034, and 2022 for U.S.
federal, U.S. state and Chinese income tax purposes, respectively.
Deferred income tax expense is a result of recognizing tax benefit
of current period loss due to other comprehensive income recorded
this quarter. The Company's effective tax rate differs
from statutory rates of 35% 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.
17
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 calendar year 2015.
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 FASB ASC 280-10, the
Company is not required to report the segment
information.
NOTE 17 – SUBSEQUENT EVENTS
On April 10, 2017, Cellular
Biomedicine Group, Inc. (the “Company”) issued a press
release announcing a strategic collaboration with GE Healthcare
Life Sciences China to co-develop certain automated control
processes for manufacture of chimeric antigen receptor T-cell
(“CART”) and stem cell therapies.
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 Knee
Osteoarthritis (KOA) in the U.S.
On May 4, 2017, the Company entered into a Use Agreement with
Children's Hospital Los Angeles, using its GMP facility for
Company's KOA application in the U.S., which will be effective as
of June 1, 2017 and terminates on December 31,
2017.
18
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, 2017 and 2016, 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.
19
Recent Developments
In
January 2016, we launched a Phase I clinical trial of an
off-the-shelf allogeneic haMPC AlloJoin™ therapy for KOA (the
“Allogenic KOA Phase I Trial”) 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
March 23, 2016, the Company filed a Form S-3 Registration Statement
(the “S-3 Registration Statement”) with the SEC, which
was declared effective on June 17, 2016. The S-3 Registration
Statement contains three prospectuses:
●
Offering
Prospectus. A base prospectus which covers the offering, issuance
and sale by us of up to $150,000,000 of our common stock, preferred
stock, debt securities, warrants, rights and/or units;
●
Resale Prospectus.
A prospectus to be used for the resale by the selling stockholders
of up to 3,824,395 shares of the Common Stock; and
●
Sales Agreement
Prospectus. A sales agreement prospectus covering the offering,
issuance and sale by the registrant of up to a maximum aggregate
offering price of $50,000,000 of the Common Stock that may be
issued and sold under a sales agreement with Cantor Fitzgerald
& Co.
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
AlloJoinTM
in the three doses tested, and no
serious adverse events (SAE) have been observed. The trial is on
schedule to be completed by the third quarter of
2017.
On
November 29, 2016 we announced the approval and commencement of
patient enrollment in China for our CARD-1 (“CAR-T Against
DLBCL”) Phase I clinical trial utilizing our 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 2017.
On
December 9, 2016 we announced interim 3-month safety data from our
Phase I clinical trial in China for
AlloJoin™ off-the-shelf allogeneic stem cell therapy for
KOA. The preliminary data was presented on December 2016 at the
World Stem Cell Summit in West Palm Beach, Florida. The interim
analysis of the trial has preliminarily demonstrated a safety and
tolerability profile of AlloJoin™ in the three doses tested,
and adverse events (AE) are similar to that of our prior autologous
trials. No serious adverse events (SAE) have been observed. The
trial is on schedule to be completed by the third quarter of
2017.
On
January 3, 2017, we announced the signing of a ten-year lease of a
113,038 square feet building located in the “Pharma
Valley” in Shanghai Zhangjiang High-Tech Park. The new
facility
designed and built to GMP standards that will be built on
these premises will consist of 40,000 square feet dedicated to
advanced cell manufacturing. We plan to invest an
aggregate of approximately 32 million USD into Zhangjiang
GMP
standards
facility, of which $6.5 million will be spent on GMP
standards
facility and around 25 million will be spent on lease of this real
estate. By the end of 2017, the Company anticipates that the new
Zhangjiang, an expanded Wuxi, and Beijing GMP
standards
facilities combined will have 70,000 square feet, and the Company
expects that it will be capable of supporting simultaneous clinical
trials for five different CAR-T and stem cell products, or the
ability to treat approximately 10,000 cancer patients and 10,000
stem cell patients per year. With this capacity, we plan to boost
our head account on researchers and technicians for additional 50
personnel by the end of 2017.
On
January 9, 2017, we announced the 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 available at the end of 2017. Depending on the
Phase I CALL-1 results, CBMG expects to initiate a larger Phase II
clinical trial as soon as practicable.
On
February 27, 2017 we announced the Company received a $2.29 million
grant from California Institute of RegenerativeMedicine (CIRM)
to fund our off-the-shelf AlloJoinTM Allogeneic Stem Cell
Therapy for Knee Osteoarthritis (KOA) in the United States. The
grant will allow the company to perform pre-clinical manufacturing
studies at Children’s Hospital Los Angeles (CHLA) and to
prepare AlloJoin™ for a U.S. Phase I clinical trial with
C. Thomas Vangsness, Jr., as the principal investigator and
the Keck School of Medicine of USC as a trial site.
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 Knee
Osteoarthritis (KOA) in the U.S.
On
March 30, 2017 we announced the completion of its newly expanded
30,000 square foot facility in Huishan High Tech Park in Wuxi,
China. 20,000 square feet of the Wuxi GMP 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
Chimeric Antigen Receptor T-cell (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 preparation
system.
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:
20
●
Confirm the safety
and tolerability profile in an investigator sponsored phase I trial
of C-CAR011 in China in refractory aggressive DLBCL and to initiate
a larger Phase II clinical trial as soon as
practicable.
●
Confirm the safety
and tolerability profile in an investigator sponsored phase I trial
of C-CAR011 in refractory (r/r) CD19+ B-cell Acute Lymphoblastic
Leukemia (ALL) in China, and to prepare for a follow up multicenter
phase IIb trial.
●
Submit to the CFDA
an IND package for C-CAR011 in CD19+ B-cell
malignancies.
●
Initiate an
investigator sponsored phase I trial of CBM-CD20 in CLL patients in
China;
●
Seek opportunities
to file new CAR-T and other patents in China and potentially the
rest of the world;
●
Continue to seek
advanced technologies and partnerships to bolster our CAR-T China
market position;
●
Bolster R&D
resources to fortify our intellectual properties portfolio and
scientific development. Continue to develop a competitive
Immuno-oncology pipeline for CBMG;
●
Complete the
Allogeneic KOA Phase I Trial in China;
●
Complete CMC and
other required preclinical study data package to prepare for
Allogeneic KOA IND filing in the United States;
●
Initiate clinical
study to support the New Drug Application (NDA) for Allogeneic KOA
study in the United States;
●
Bolster R&D
resources to fortify our intellectual properties portfolio and
scientific development;
●
Improve liquidity
and fortify our balance sheet by courting institutional
investors;
●
Evaluate new
regenerative medicine technology platform for other
indications;
●
Explore new CAR-T
opportunities for international collaboration and /or
partnership;
●
Expand our cell
manufacturing capacity and capabilities;
●
Evaluate the
feasibility of sponsoring a multi-sites Phase I/II NSCLC clinical
study to support the New Drug
Application (NDA) for the U.S. and China CD40L GVAX
trial in combination with anti-PD1; and
●
Implement our GE
Joint Technology Laboratory to develop control processes for the
manufacture of CAR-T and Stem Cell Therapies.
Corporate History
Please refer to Note 1 of unaudited condensed consolidated
financial statements for the corporate history.
BIOPHARMACEUTICAL BUSINESS
Our
biomedicine 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. 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, Asthma, COPD and Cartilage
Defects.
Cancer. In the cancer field, with the recent
build-up of multiple cancer therapeutic technologies, we have
prioritized our clinical efforts on CAR-T, technologies, Vaccine,
Tcm and TCR clonality technologies, and are not actively pursuing
the fragmented Tcm technical services opportunities. We are
integrating CBMG's state-of-the art infrastructure and clinical
platform with the technologies platform to boost the Company's
immuno-oncology presence and pave the way for future partnerships.
We plan to initiate certain cancer clinical trials in China upon
receiving acceptance of the clinical trial designs with the
principal investigator and obtaining the requisite regulatory
approval. 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 2017. 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 available at the end of 2017.
Depending on the Phase I CARD-1 and CALL-1 results, we expect to
initiate larger Phase II clinical trials as soon as
practicable.
21
KOA. In 2013, we completed a Phase I/IIa
clinical study, in China, for our Knee Osteoarthritis
(“KOA”) therapy named ReJoin®. 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 ReJoin®
therapy to be both safe and effective.
In
Q2 of 2014, we completed patient enrollment for the Phase IIb
clinical trial of ReJoin® 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 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 ReJoin® regenerative medicine treatment to be
safe. We announced interim 24 week results for
ReJoin® 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 ReJoin® therapy group
having all improved significantly compared to their baseline, which
has confirmed some of the Company’s Phase I/IIa results. Our
ReJoin® 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. The trial is on schedule to be
completed by the third quarter of 2017.
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, as well as
applying single cell types in a specific treatment protocol.
Management believes that our adult adipose-derived line will become
commercially viable and market-ready in China within three to four
years. In addition, we plan to assess and initiate cancer clinical
trials leading to commercialization using safe and most effective
therapy or combination therapies. The quality management systems of
CBMG Shanghai and CBMG Wuxi were issued a Certificate of
ISO-9001:2008 by SGS /ANAB (ANSI-ASQ National Accreditation Board).
Our facility in Shanghai was issued a Certificate of Compliance by
ENV Services, Inc., and ISO Inspection Service Provider that (i)
its rooms 1-7, 10 are certified to ISO Class 7 per ISO-14644 in
accordance with cGMP; (ii) its biological safety cabinets are
certified per NSF/ANSI 49 and to ISO Class 5;and (iii) its
instrumentation calibration has been certified to perform in
accordance with ANS/NCSL Z-540-1 and document in accordance with
10CFR21.Our facility in Shanghai was issued a Testing Report by
Shanghai Food and Drug Packaging Material Control Center concluding
that some testing items of the cleanrooms are in compliance with
the Good Manufacturing Practice for Drugs (2010 Revision) of China.
The cleanrooms in Beijing are certified to meet the standard of
CNAS L1669; and Wuxi has been certified to meet the CNAS L0221
standard.
In
addition to standard protocols, we use proprietary processes and
procedures for manufacturing our cell lines, comprised
of:
●
Banking processes
that ensure cell preservation and viability;
●
DNA identification
for stem cell ownership; and
●
Bio-safety testing
at independently certified laboratories.
22
Regenerative Medicine and Cell Therapy
Regenerative
medicine is the “process of replacing or regenerating human
cells, tissues or organs to restore or establish normal
function”. Cell therapy as applied to regenerative medicine
holds the promise of regenerating damaged tissues and organs in the
body by rejuvenating damaged tissue and by stimulating the
body’s own repair mechanisms to heal previously irreparable
tissues and organs. Medical cell therapies are classified into two
types: allogeneic (cells from a third-party donor) or autologous
(cells from one’s own body), with each offering its own
distinct advantages. Allogeneic cells are beneficial when the
patient’s own cells, whether due to disease or degeneration,
are not as viable as those from a healthy donor. Similarly, in
cases such as cancer, where the disease is so unique to the
individual, autologous cells can offer true personalized
medicine.
Regenerative
medicine can be categorized into major subfields as
follows:
●
Cell Therapy. Cell
therapy involves the use of cells, whether derived from adults,
third party donors or patients, from various parts of the body, for
the treatment of diseases or injuries. Therapeutic applications may
include cancer vaccines, cell based immune-therapy, arthritis,
heart disease, diabetes, Parkinson’s and Alzheimer’s
diseases, vision impairments, orthopedic diseases and brain or
spinal cord injuries. This subfield also includes the development
of growth factors and serums and natural reagents that promote and
guide cell development.
●
Tissue Engineering.
This subfield involves using a combination of cells with
biomaterials (also called “scaffolds”) to generate
partially or fully functional tissues and organs, or using a
mixture of technology in a bioprinting process. Some natural
materials, like collagen, can be used as biomaterial, but advances
in materials science have resulted in a variety of synthetic
polymers with attributes that would make them uniquely attractive
for certain applications. Therapeutic applications may include
heart patch, bone re-growth, wound repair, replacement neo-urinary
conduits, saphenous arterial grafts, inter-vertebral disc and
spinal cord repair.
●
Diagnostics and Lab
Services. This subfield involves the production and derivation of
cell lines that may be used for the development of drugs and
treatments for diseases or genetic defects. This sector also
includes companies developing devices that are designed and
optimized for regenerative medicine techniques, such as specialized
catheters for the delivery of cells, tools for the extraction of
stem cells and cell-based diagnostic tools.
All
living complex organisms start as a single cell that replicates,
differentiates (matures) and perpetuates in an adult through its
lifetime. Cell therapy is aimed at tapping into the power of cells
to prevent and treat disease, regenerate damaged or aged tissue and
provide cosmetic applications. The most common type of cell therapy
has been the replacement of mature, functioning cells such as
through blood and platelet transfusions. Since the 1970s, bone
marrow and then blood and umbilical cord-derived stem cells have
been used to restore bone marrow and blood and immune system cells
damaged by chemotherapy and radiation used to treat many cancers.
These types of cell therapies have been approved for use world-wide
and are typically reimbursed by insurance.
Over
the past number of years, cell therapies have been in clinical
development to attempt to treat an array of human diseases. The use
of autologous (self-derived) cells to create vaccines directed
against tumor cells in the body has been demonstrated to be
effective and safe in clinical trials. Researchers around the globe
are evaluating the effectiveness of cell therapy as a form of
replacement or regeneration of cells for the treatment of numerous
organ diseases or injuries, including those of the brain and spinal
cord. Cell therapies are also being evaluated for safety and
effectiveness to treat heart disease, autoimmune diseases such as
diabetes, inflammatory bowel disease, joint diseases and cancerous
diseases. While no assurances can be given regarding future medical
developments, we believe that the field of cell therapy is a subset
of biotechnology that holds promise to improve human health, help
eliminate disease and minimize or ameliorate the pain and suffering
from many common degenerative diseases relating to
aging.
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 advanced acute lymphoblastic
leukemia ("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.
23
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.
The
traditional cancer treatment includes surgery, chemotherapy, and
radiation therapy. In the last decade, we witnessed a boom in
targeted therapies including monoclonal antibody and small molecule
therapies, such as Iressa and Tarciva that targets EGFR activating
mutations in the NSCLC, Herceptin that treats breast cancer
patients with HER2 overexpression, Crizotinib that targets NSCLC
patients with positive ALK fusion gene.
So
far, chimeric antigen receptor T cell therapy (“CAR-T”)
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.
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.
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.
24
According
to an October 2010 article from the Foundation for the National
Institutes of Health, there are approximately 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
current data on CAR T-cell therapies, presented from various
institutions including MSKCC, University of Pennsylvania, National
Cancer Institute, and Fred Hutchinson Cancer Center, Novartis and
Kite Pharma, Inc have been very positive. Novartis
CAR-T technology has made breakthroughs in treating B cell lymphoma
using genetically modified T cell technology. Both Kite and
Novartis are on track to submit their respective CAR-T registration
trial data to the US FDA for BLA in the near future.
Approved
cell therapies have been appearing on the market in recent years.
In 2011, however, the industry was dealt two setbacks when Geron
Corporation discontinued its embryonic program, and when
Sanofi-Aventis acquired Genzyme Corporation and did not acquire the
product rights relating to the allogeneic cell technology of Osiris
Therapeutics, Inc., a partner of Genzyme and a leader in the field.
In both cases there were difficulties navigating the U.S.
regulatory requirements for product approval. Inadequate trial
designs were cited in the executive summary of the 2012 New York
Stem Cell Summit Report as contributing to these
failures.
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.
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.
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 KOA cell therapy clinical studies in China, a completed
Phase IIb autologous study and an on-going 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. Our focus is on the latest translational stages of
product development, principally from the pre-clinical stage to
regulatory approval and commercialization of new
therapies.
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, followed by our CD and Asthma
therapies. We also
initiated multiple dose preclinical studies in Chronic Pulmonary
Disease (“COPD”) animal model. At this time we have
maintained our focus on the knee osteoarthritis trials and have not
prioritized the COPD pre clinical study. 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 and are exploring the feasibility of a U.S.
allogeneic KOA clinical study with the FDA.
CBMG
initially plans to use its centralized manufacturing facility
located in Shanghai to service multiple hospitals within 200 km of
the facility. We aim to complete clinical trials for our
KOA therapy candidate as soon as practicable. Our goal is to first
obtain regulatory permission for commercial use of the therapies
for the respective hospitals in which the trials are being
conducted. CBMG plans to scale up its customer base by qualifying
multiple additional hospitals for the post-trial use of therapies,
once approved, by following regulatory guidelines. Based
on current regulation and estimates we expect our biopharmaceutical
business to generate revenues primarily from the development of
therapies for the treatment of KOA within the next four to six
years.
25
With
the AG acquisition we intend 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
believe that few competitors in China are as well-equipped as we
are in the clinical trial development, diversified U.S. FDA
protocol compliant manufacturing facilities, regulatory compliance
and policy making participation, as well as a long-term presence in
the U.S. with U.S.-based management and investor base.
We
intend to continue our business development efforts by adding other
proven domestic and international biotechnology partners to
monetize the China health care market.
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 AG provides an enlarged opportunity to
expand the application of its cancer therapy-enabling technologies
and to initiate clinical trials with leading cancer
hospitals. With the AG acquisition, 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.
CBMG's
proprietary and patent-protected production processes and clinical
protocols enable us to produce raw material, manufacture cells, and
conduct cell banking and distribution. Applying our proprietary
intellectual property, we will be able to customize specialize
formulations to address complex diseases and debilitating
conditions.
CBMG
has been developing disease-specific clinical treatment protocols.
These protocols are designed for each of these proprietary cell
lines to address patient-specific medical conditions. These
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.
The protocol of allogeneic haMPC therapy for KOA
has been approved by Shanghai Renji Hospital’s Institutional
Review Board for clinical studies. Once the studies are completed,
the clinical data will be analyzed by qualified third party
statisticians and reports will be published.
We
operate our manufacturing facilities under 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. Three facilities designed and built to GMP in
Beijing, Shanghai and Wuxi, China meet international standards. In
any precision setting, it is vital that all controlled-environment
equipment meet certain design standards. To achieve this goal, our
Shanghai cleanroom facility underwent rigorous cleanroom
certification. Our facility in Shanghai was issued a Certificate of
Compliance by ENV Services, Inc., and ISO Inspection Service
Provider that (i) its rooms 1-7, 10 are certified to ISO Class 7
per ISO-14644 in accordance with cGMP; (ii) its biological safety
cabinets are certified per NSF/ANSI 49 and to ISO Class 5; and
(iii) its instrumentation calibration has been certified to perform
in accordance with ANS/NCSL Z-540-1 and document in accordance with
10CFR21. The cleanrooms in Beijing are certified to meet the
standard of CNAS L1669; and Wuxi has been certified to meet the
CNAS L0221 standard. With our integrated Plasmid, Viral Vectors,
and CAR-T cells Chemistry, Manufacturing, and Controls process
as well as planned capacity expansion, we are highly
distinguishable with other companies in the cellular medicine
space.
In
total, our facilities
operating under cGMP have over 47,300 sq. ft. of space with
the capacity for 19 independent cell production lines. We are
expanding our facilities
designed and built to GMP standards to approximately 70,000
sq. ft. of space and aim to be able to treat approximately 10,000
cancer patients and 10,000 patients per year by the end of
2017.
Most
importantly, our most experienced team members have more than 20
years of relevant experience in China, European Union, and the
United States. All of these factors 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 ReJoin ® therapy and
our AlloJoinTM therapy.
26
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
ReJoinTM
therapy to be both safe and
effective.
In
the second quarter of 2014, we completed patient enrollment for the
Phase IIb clinical trial of ReJoin® 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 ReJoin® regenerative medicine treatment to be safe.
We announced positive Phase IIb 48-week follow-up data in January
2016, with statistical significant evidence that ReJoin®
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 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. 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 serious adverse events (SAE) have been observed. The trial
is on schedule to be completed by the third quarter of
2017.
Osteoarthritis
is a degenerative disease of the joints. KOA is one of the most
common types of osteoarthritis. Pathological manifestation of
osteoarthritis is primarily local inflammation caused by immune
response and subsequent damage of joints. Restoration of immune
response and joint tissues are the objective of
therapies.
According to International Journal of
Rheumatic Diseases, 2011, 53%
of KOA patients will degenerate to the point of disability.
Conventional treatment usually involves invasive surgery with
painful recovery and physical therapy. As drug-based methods of
management are ineffective, the same journal estimates that some
1.5 million patients with this disability will degenerate to the
point of requiring artificial joint replacement surgery every year.
However, only 40,000 patients will actually be able to undergo
replacement surgery, leaving the majority of patients to suffer
from a life-long disability due to lack of effective
treatment.
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) file joint applications with Class AAA
hospitals to use haMPCs to treat KOA in a clinical trial
setting.
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 well-studied 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.
27
Because
there are many differences between hematological and solid tumors,
drug penetration or infiltration into solid tumors sites is more
challenging than hematological cancer. Antibody dependent
cell-mediated (“ADCC”) toxicity works much better in
hematological cancers. Hematological cancers usually carry fewest
mutations among all cancers and are usually less molecularly
heterogeneous than that of solid tumors. As such,
routinely hematological cancers respond better to therapeutic
interventions, there are more complete, as well as partial
responses. And the duration of response is usually
longer.
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
believe that CAR-T therapy can successfully treat hematopoietic
cancers because the therapy can deplete all B cells or T cells
including normal and cancer cells in leukemia and lymphoma. When
the stem cells are not targeted these stem cells can regenerate
normal B and T cells. In contrast, effective tumor specific
antigens found to be less to target in solid
tumors. When the drugs kill tumor cells, they also kill
the normal cells to a certain degree, leading to different degrees
of toxicity. We will continue to make an effort to
develop CAR-T or other cell based therapies to target solid
tumors.
Human Adipose-Derived Mesenchymal Progenitor Cells
(haMPC)
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 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.
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.
Immune Cell Therapy, Adoptive T cell
Adoptive
T cell therapy for cancer is a form of transfusion therapy
consisting of the infusion of various mature T cell subsets with
the goal of eliminating a tumor and preventing its
recurrence. In cases such as cancer, where the disease
is unique to the individual, the adoptive T cell therapy is a
personalized treatment.
We
believe that an increasing portion of healthcare spending both in
China and worldwide will be directed to immune cell therapies,
driven by an aging population, and the potential for immune cell
therapy treatments to become a safe, effective, and cost-effective
method for treating millions of cancer patients.
Cancer
is a major threat to public health and the solvency of health
systems worldwide. Current treatments for these diseases
cannot meet medical needs. We believe that immune cell therapy is a
new technology that has the potential to alleviate much of the
burden of these chronic and degenerative diseases in a
cost-effective manner.
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.
28
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 by using the knowledge and
experience gained from the Company’s ongoing KOA trials and
the recent, CAR-T and Tcm technologies. Immune
cell therapies have not been codified by any of the Chinese
regulatory agencies. On December 16, 2016, the CFDA issued
solicited feedback on its draft "Technical Guidelines for Research
and Evaluation of Cellular Products”, signaling near term
clarification and codification/of the cell therapy regulation. We
believe this will create substantial barrier-to-entry for newcomers
in China. However, it remains unclear if any of our clinical trials
will qualify for U.S.FDA-liked Fast Track designation 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 and
a fortified barrier to entry. In addition, encouraged by
the recent CIRM grant of $2.29 million for our preclinical trial to
replicate and validate the manufacturing process and control system
at the cGMP facility located at Children’s Hospital Los
Angeles to support the filing of an IND with the FDA, we have begun
to review the feasibility of performing a synergistic U.S. KOA
clinical trial.
Competition
The biotechnology and pharmaceutical industries,
including the gene therapy field, are characterized by rapidly
advancing technologies, intense competition and a strong emphasis
on intellectual property. We face substantial competition from many
different sources, including large biopharmaceutical companies,
midsize/smaller public and privately-held biotechnology firms,
academic research institutions, governmental agencies, and public
and private research institutions
We
compete with companies in the space of immunotherapy, as well as
companies developing novel targeted therapies for cancer. We
anticipate substantial direct competition from other organizations
developing advanced T cell therapies. In particular, we expect to
compete with genetically engineering T cell therapies that are
being pursued by multiple companies, including Kite, Novartis, Juno
Therapeutics, Amgen,as well as a number of China-based companies.
In particular, the Chinese JV Fosun Kite is in the process of
research and development of its own versions of Kite C-19 T cell
therapies and the JV BeiGene Biologic has just announced their
high-quality large scale manufacturing project in
Guangzhou.
We
also face competition in the degenerative osteoarthritis from
non-immunotherapy based treatments offered by companies such as
TissueGene and Mitsubishi pharma, which has completed U.S phase 2
trials and received a Special Protocol Assessment designation for
Phase 3 trials scheduled to begin in the second quarter of
2017.
Many
of our competitors, either alone or with their strategic partners,
have substantially greater financial, technical and human
resources. Accordingly, our competitors may be more successful than
us in obtaining approval for treatments and achieving widespread
market acceptance and may render our treatments obsolete or
non-competitive. Mergers and acquisitions in the biotechnology and
pharmaceutical industries may result in even more resources being
concentrated among a smaller number of our competitors. These
competitors also compete with us in recruiting and retaining
qualified scientific and management personnel and establishing
clinical study sites and patient registration for clinical studies,
as well as in acquiring technologies complementary to, or necessary
for, our programs. Smaller or early-stage companies may also prove
to be significant competitors, particularly through collaborative
arrangements with large and established companies.
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, inventory, 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, inventory, 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.
During
the three months ended March 31, 2017, 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, 2016.
29
Results of Operations
Below is a discussion of
the results of our operations for the
three months ended March 31, 2017 and 2016. 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, 2017 to Three Months
Ended March 31, 2016
The descriptions in the results of operations below reflect our
operating results as set forth in our Consolidated Statement of
Operations filed herewith.
|
For the Three Months Ended
|
|
|
March 31,
|
|
|
2017
|
2016
|
|
|
|
Net
sales and revenue
|
$98,425
|
$488,491
|
|
|
|
Operating
expenses:
|
|
|
Cost
of sales
|
37,402
|
503,193
|
General
and administrative
|
3,185,247
|
2,775,925
|
Selling
and marketing
|
117,884
|
178,754
|
Research
and development
|
3,044,125
|
2,398,362
|
Total
operating expenses
|
6,384,658
|
5,856,234
|
Operating
loss
|
(6,286,233)
|
(5,367,743)
|
|
|
|
Other
income
|
|
|
Interest
income
|
49,182
|
17,050
|
Other
income
|
77,508
|
16,320
|
Total
other income
|
126,690
|
33,370
|
Loss
before taxes
|
(6,159,543)
|
(5,334,373)
|
|
|
|
Income
taxes credit (provision)
|
(2,450)
|
1,124,260
|
|
|
|
|
|
|
Net
loss
|
$(6,161,993)
|
$(4,210,113)
|
Other
comprehensive income:
|
|
|
Cumulative
translation adjustment
|
53,669
|
16,073
|
Unrealized
gain on investments, net of tax of nil and $4,514,060, for the
three months ended march 31, 2017 and
2016,respectively
|
-
|
16,416,517
|
Total
other comprehensive income:
|
53,669
|
16,432,590
|
|
|
|
Comprehensive
income (loss)
|
$(6,108,324)
|
$12,222,477
|
|
|
|
|
|
|
Net
loss per share :
|
|
|
Basic
|
$(0.43)
|
$(0.35)
|
Diluted
|
$(0.43)
|
$(0.35)
|
|
|
|
Weighted
average common shares outstanding:
|
|
|
Basic
|
14,281,745
|
11,884,066
|
Diluted
|
14,281,745
|
11,884,066
|
* These line items include the following amounts of non-cash,
stock-based compensation expense for the periods
indicated:
|
Three Months Ended
March 31,
2017
|
Three Months Ended
March 31,
2016
|
|
CBMG
|
CBMG
|
|
As stated
|
As stated
|
|
|
|
Cost
of sales
|
11,139
|
37,039
|
General
and administrative
|
867,585
|
449,781
|
Selling
and marketing
|
(2,382)
|
47,761
|
Research
and development
|
555,565
|
731,482
|
|
1,431,907
|
1,266,063
|
30
Results of Operations
Net sales and revenue
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$98,425
|
$488,491
|
$(390,066)
|
(80)%
|
All the revenue was derived from cell therapy technology service
for three months period ended March 31, 2017 and 2016. The decrease
in revenue is the result of prioritizing cancer therapeutic
technologies and focusing our clinical efforts on developing CART
technologies, Vaccine, Tcm and TCR clonality technologies. As a
result of not focusing on the cell therapy technology service
revenue, in the second quarter of 2016 the Company ceased its
cooperation with the Jihua Hospital and several other agents, which
resulted in decreased revenue in 2017.
Cost of Sales
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$37,402
|
$503,193
|
$(465,791)
|
(93)%
|
The cost of sales decreased in line with the sales.
General and Administrative Expenses
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$3,185,247
|
$2,775,925
|
$409,322
|
15%
|
Increased expenses in 2017 was primarily attributed to the
following:
o
An increase in
stock-based compensation expense of $418,000, as compared to a
lower stock-based compensation expense in 2016 resulting from
forfeiture of the options due to Wei Cao who resigned as the CEO of
the Company in February 2016;
o
An increase in
rental expense of $596,000, which mainly resulted from the new
leased plant located in the “Pharma Valley” of Shanghai
from January 1, 2017;
o
A decrease in
legal, audit and other professional fee of $228,000;
and
o
A decrease in
salary of $211,000;
o
An decrease in
insurance fee of $39,000, which mainly resulted from the decrease
in premium for director and officer liability and Company
reimbursement insurance; and
o
A decrease in
director fees of $28,000.
Selling and Marketing Expenses
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$117,884
|
$178,754
|
$(60,870)
|
(34)%
|
Sales and marketing expenses decreased by approximately $61,000 in
the three months ended March 31, 2017 as compared to the three
months ended March 31, 2016, primarily as a result of a decrease in
stock-based compensation expense of $50,000 for forfeiture of the
options due to a sales manager leaving.
31
Research and Development Expenses
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$3,044,125
|
$2,398,362
|
$645,763
|
27%
|
Research and development costs increased by approximately $645,000
in the three months ended March 31, 2017 as compared to the three
months ended March 31, 2016. The increase was primarily attributed
to below facts:
o
An increase in
payroll expenses of $145,000 in line with the increase of our
immunotherapy research and development team. Total headcount of our
R&D team increased from 48 as of March 31, 2016 to 74 as of
March 31, 2017;
o
An increase in raw
material consumption of $391,000;
o
An increase in
rental expenses of $138,000, which was mainly attributed to the
launching of R&D activities at our Beijing GMP facility in the
2nd
quarter of 2016;
o
An increase in
depreciation and amortization of $131,000, which was mainly
attributed to the purchase of our new equipment for immunotherapy
research and development; and
o
A decrease in
stock-based compensation expense of $176,000 due to the lack of any
options vesting in the reporting period as compared to the same
period in 2016.
Operating Loss
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$(6,286,233)
|
$(5,367,743)
|
$(918,490)
|
17%
|
The increase in the operating loss for the three months ended March
31, 2017 as compared to the same period in 2016 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
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$126,690
|
$33,370
|
$93,320
|
280%
|
Other income for the three months ended March 31, 2017 was
primarily interest income of $49,000 and subsidy income of $80,000.
Other income for the three months ended March 31, 2016 was
primarily interest income
of $17,000, foreign exchange gain of
$15,000 and subsidy income of $1,000.
Income Taxes Credit (Provision)
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$(2,450)
|
$1,124,260
|
$(1,126,710)
|
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, 2016 mainly represents deferred income tax as a result of
recognizing tax benefit of current period loss due to other
comprehensive income recorded this quarter. Income tax expense for
three months ended March 31, 2017 all represent US state
tax.
32
Net Loss
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$(6,161,993)
|
$(4,210,113)
|
$(1,951,880)
|
46%
|
Changes in net loss are primarily attributable to changes in
operations which are described above.
Comprehensive Income (Loss)
|
2017
|
2016
|
Change
|
Percent
|
|
|
|
|
|
For
the three months ended March 31,
|
$(6,108,324)
|
$12,222,477
|
$(18,330,801)
|
(150)%
|
Comprehensive loss for three months ended March 31, 2017 includes a
currency translation net gain of approximately $54,000 combined
with the changes in net income. Comprehensive income for three
months ended March 31, 2016 includes unrealized net gain on
investments of approximately $16,416,517 and a currency translation
net gain of approximately $16,000 combined with the changes in net
income. The unrealized gain on investments was primarily attributed
to the valuation gain for the stock investment in Arem Pacific
Corporation. The stock of Arem Pacific Corporation (ARPC) held by
us is illiquid restricted shares. ARPC is a very thinly traded OTC
company.
Liquidity and Capital Resources
We had working capital of $33,320,426 as of March 31, 2017 compared to $38,328,048 as of
December 31, 2016. Our cash position decreased to $33,361,784 at
March 31, 2017 compared to $39,252,432 at December 31, 2016 for the
cash used in operating and investment
activities.
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 $4,859,000
and $3,583,000 for the three months ended March 31, 2017 and 2016,
respectively. The following table reconciles net loss to net cash
used in operating activities:
For
the three months ended March 31,
|
2017
|
2016
|
Change
|
Net
loss
|
$(6,161,993)
|
$(4,210,113)
|
$(1,951,880)
|
Non
cash transactions
|
2,101,883
|
1,937,712
|
164,171
|
Changes
in operating assets, net
|
(798,553)
|
(1,310,396)
|
511,843
|
Net
cash used in operating activities
|
$(4,858,663)
|
$(3,582,797)
|
$(1,275,866)
|
The 2017 change in non-cash transaction was primarily due to the
increase in share based compensation of $166,000 compared with same
period in 2016.
Net cash used in investing activities was approximately $1,050,000
and $675,000 in the three months ended March 31, 2017 and 2016,
respectively. These amounts were primarily the result of
purchases of fixed assets.
Cash provided by financing activities was approximately $6,000 and
$5,063,000 in the three months ended March 31, 2017 and 2016,
respectively. These amounts were mainly attributable to the
proceeds received from exercise of options and the issuance of
common stock.
Liquidity and Capital Requirements Outlook
Excluding any potential sponsorship of a CD40LGVAX Trial in the
U.S. and other regions outside of China CD40LGVAX Trial, we
anticipate that the Company will require approximately $32 million
in cash to operate as planned in the coming 12 months. Of this
amount, approximately $23 million will be used to operate our
facilities and offices, including but not limited to payroll
expenses, rent and other operating costs, and to fund our research
and development as we continue to develop our products through the
clinical study process. Approximately $9 million will be used as
capital expenditure in machinery, equipment and facilities to
expand our immune cell therapy business and CAR-T research and
development, although we may revise these plans depending on the
changing circumstances of our biopharmaceutical
business.
33
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 an 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 has delisted.
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. As we continue to incur
losses, achieving profitability is dependent upon the successful
development of our immune 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
lack of codified cell therapy regulation for clinical trial IND
filing in China, 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 increased competition on both domestic and foreign companies
launching immune cell therapies in China, the increased hurdle for
Chinese investors to transfer CNY to U.S. dollars for
investment, the risks associated with our corporate
structure, risks relating to our partners, licensed intellectual
property, as well as the condition of the global economy and
financial markets in general. Additional equity financing may be
dilutive to our stockholders; debt financing, if available, may
involve significant cash payment obligations and covenants that
restrict our ability to operate as a business; our stock price may
not reach levels necessary to induce option or warrant exercises;
and asset sales may not be possible on terms we consider
acceptable. If we are unable to raise the capital necessary to meet
our medium- and long-term liquidity needs, we may have to delay or
discontinue certain clinical trials, the licensing, acquisition
and/or development of cell therapy technologies, and/or the
expansion of our biopharmaceutical business; or we may have to
raise funds on terms that we consider unfavorable.
Off Balance Sheet Transactions
CBMG does not have any off-balance sheet arrangements except the
lease and capital commitment disclosed in the unaudited condensed
consolidated financial statements.
34
Contractual Obligations
We have various contractual obligations that will affect our
liquidity. The following table sets forth our contractual
obligations as of March 31, 2017.
|
Payments due by period
|
||||
Contractual Obligations
|
|
Less than
|
2-3
|
4-5
|
More than
|
|
Total
|
1 year
|
years
|
years
|
5 years
|
Capital
Commitment
|
$6,478,371
|
$6,107,555
|
$370,816
|
$-
|
$-
|
Operating
Lease Obligations
|
24,734,324
|
3,087,257
|
5,458,216
|
4,836,290
|
11,352,561
|
Total
|
$31,212,695
|
$9,194,812
|
$5,829,032
|
$4,836,290
|
$11,352,561
|
35
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.
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, 2017 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, 2017. 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, 2017
|
|
|
RMB
|
USD
|
Cash
and cash equivalents
|
847
|
2,113,575
|
|
|
|
Net
exposure arising from recognised assets and
liabilities
|
847
|
2,113,575
|
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, 2017
|
|
|
increase/(decrease)
in foreign exchange rates
|
Effect on net loss (Expressed in USD)
|
|
|
|
RMB
(against USD)
|
5%
|
(105,636)
|
|
|
|
|
-5%
|
105,636
|
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.
36
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, 2017, 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.
37
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
During the three months ended March 31, 2017, 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,
2016.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
All unregistered sales and issuances of equity securities for the
three months ended March 31, 2017 that are required to be disclosed
herein were previously disclosed in a Current Report on Form 8-K
filed with the SEC.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
On May 4, 2017, the Company
entered into a Use Agreement (the “Use Agreement”) with
Children's Hospital Los Angeles (“CHLA”) to use
CHLA’s GMP facility to prepare for the Company's KOA IND for
phase I trials in the United States. The agreement is effective for
a seven-month period, from June 1, 2017 through December 31, 2017.
As consideration for use of CHLA’s facilities and resources,
the Company has agreed to pay a usage fee of $2,500 per room per
day, for an aggregate of up to $960,000, subject to $75,000
security deposit and a 1.5% daily penalty for late payments.
Additionally, the Company agreed to share certain intellectual
property developed by the Company in the course of its pre-clinical
activities at CHLA. Specifically, the Company agreed to grant CHLA
an irrevocable, non-transferable, royalty-free, fully paid-up
non-exclusive limited license to use, for certain non-commercial
activities, any Intellectual Property (as such term is defined in
the Use Agreement) that the Company develops using CHLA facilities
or resources. Additionally, to the extent that a CHLA
representative assists and jointly invents or contributes to the
development of any Intellectual Property in the course of the
Company’s pre-clinical activities at CHLA, such Intellectual
Property shall be jointly owned.
The
foregoing description of the Use Agreement does not purport to be
complete and is qualified in its entirety by reference to such
agreement, which is filed as Exhibit 99.1 hereto and incorporated
herein by reference.
ITEM 6. EXHIBITS
Exhibits
Exhibit Number
|
|
Description
|
31.1
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 - Chief Executive Officer.
|
31.2
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 - Chief Financial Officer.
|
32.1
|
|
Certifications Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
99.1
|
|
Use Agreement, dated May 4, 2017, by and between the Company and
Children's Hospital Los Angeles
|
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
|
38
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 8, 2017
|
By:
|
/s/ Bizuo (Tony) Liu
|
|
|
|
Bizuo (Tony) Liu
|
|
|
|
Chief Executive Officer and Chief Financial Officer
|
|
|
|
(Principal Executive Officer and Principal Financial and
Accounting Officer)
|
|
|
|
|
|
39