U. S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
10-Q/A
☑
Quarterly report pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934For
the quarterly period ended September 30,
2016.
☐ For the transition
period from to .
Commission File Number 0-8092
OXIS INTERNATIONAL, INC.
(Exact name of small business issuer as specified in its
charter)
Delaware
(State
or other jurisdiction of incorporation
or organization)
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94-1620407
(I.R.S.
employer identification
number)
|
100
South Ashley Drive, Suite 600
Tampa,
FL 33602
(Address
of principal executive offices and zip code)
(800)
304-9888
(Registrant’s
telephone number, including area code)
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 during the preceding
12 months (or for such shorter period that 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, a non-accelerated filer, or a smaller
reporting company. See the definitions of “large
accelerated filer,” “accelerated filer” and
“smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large accelerated
filer ☐
|
Accelerated
filer ☐
|
Non-accelerated
filer ☐ (Do not check if a smaller reporting
company)
|
Smaller reporting
company ☑
|
Indicate by check mark whether the registrant is a
shell company (as defined in Rule 12b-2 of the Exchange
Act).Yes ☐·No ☑
At
November 14, 2016, the issuer had outstanding the indicated number
of shares of common stock: 30,241,305.
EXPLANATORY NOTE
GT Biopharma, Inc., formerly known as Oxis
International, Inc, (the “Company”)
is filing this Amendment No. 1 to its Quarterly Report on Form 10-Q
for its nine months ended September 30, 2016, as filed with the
Securities and Exchange Commission on November 14, 2016 (the
“Original September 2016 Form
10-Q”), primarily to
correct an error related to the non-cash calculation of warranty
liabilities.
Actual Changes in the Original
September 2016 Form 10-Q. The actual changes in the Original September 2016
Form 10-Q included in this Amendment No. 1 are amendments
to: (a) amended and restated Consolidated Statement
of Operations for the nine months ended September 30,
2016, (b) amended and restated Consolidated Statement
of Cash Flows for the nine months ended September 30, 2016, and
(c) the addition of Note
7.
Notwithstanding
that there are no changes in most of the Notes to the Consolidated
Financial Statements included in this Amendment No. 1, a complete
Form 10-Q document including a complete set of the Consolidated
Financial Statements (together with all of the Notes from the
Original September 2016 10-Q) has been included in this Amendment
No. 1, for convenient reference.
In
addition, see additional amended filings of the Company for
relevant subsequent events.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
FORM 10-Q
For the Nine Ended September 30, 2016
Table of Contents
PART
I FINANCIAL INFORMATION
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Page
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Item
1.
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Financial
Statements
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1
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Consolidated
Balance Sheets as of September 30, 2016 (Unaudited) and December
31, 2015
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1
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Consolidated
Statements of Operations for the three and nine months ended
September 30, 2016 and 2015 (Unaudited)
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2
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Consolidated
Statements of Cash Flows for the nine months ended September 30,
2016 and 2015 (Unaudited)
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3
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Condensed Notes to
Consolidated Financial Statements
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4
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Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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20
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Item
3.
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Quantitative and
Qualitative Disclosures About Market Risk
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26
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Item
4.
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Controls and
Procedures
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26
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PART
II OTHER INFORMATION
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Item
1.
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Legal
Proceedings
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28
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Item
1A.
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Risk
Factors
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28
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Item
2.
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Unregistered Sales
of Securities and Use of Proceeds
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29
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Item
3.
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Defaults Upon
Senior Securities
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30
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Item
4.
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Mine Safety
Disclosures
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30
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Item
5.
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Other
Information
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30
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Item
6.
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Exhibits
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30
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SIGNATURES
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31
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OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
As of September 30, 2016 and December 31, 2015
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ASSETS
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Current
Assets:
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Cash
and cash equivalents
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$154,000
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$47,000
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Prepaid
expenses
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2,000
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2,000
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Total
Current Assets
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156,000
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49,000
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Fixed
assets, net
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4,000
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5,000
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Total
Other Assets
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4,000
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5,000
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TOTAL
ASSETS
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$160,000
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$54,000
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LIABILITIES AND STOCKHOLDERS’ DEFICIT
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Current
Liabilities:
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Accounts
payable
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1,814,000
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893,000
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Accrued
interest
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3,480,000
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2,391,000
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Accrued
expenses
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597,000
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4,326,000
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Line
of credit
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31,000
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31,000
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Warrant
liability
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184,000
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33,266,000
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Settlement
note payable
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691,000
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691,000
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Demand
notes payable
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452,000
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452,000
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Convertible
debentures, current portion, net of discount of $1,596,000 and
$900,000
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8,678,000
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6,820,000
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Convertible
debentures
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1,039,000
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1,039,000
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Total
current liabilities
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16,966,000
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49,909,000
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Long
term liabilities:
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Convertible
debt, net of discount of $470,000 and $2,536,000
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400,000
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714,000
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Total
long term liabilities
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400,000
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714,000
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Total
liabilities
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17,366,000
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50,623,000
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Stockholders’
Deficit:
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Convertible
preferred stock - $0.001 par value; 15,000,000 shares
authorized:
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Series
C - 96,230 and 96,230 shares issued and outstanding at September
30, 2016 and December 31, 2015, respectively
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1,000
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1,000
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Series
H – 25,000 and 25,000 shares issued and outstanding at
September 30, 2016 and December 31, 2015, respectively
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-
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-
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Series
I – 1,666,667 and 1,666,667 shares issued and outstanding at
September 30, 2016 and December 31, 2015, respectively
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2,000
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2,000
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Common stock - $0.001 par value;
150,000,000 shares authorized; 28,218,365 and
2,400,000 shares
issued and outstanding at September 30, 2016 and December 31,
2015
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28,000
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2,000
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Additional
paid-in capital
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104,752,000
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84,012,000
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Accumulated
deficit
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(121,820,000)
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(134,417,000)
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Noncontrolling
interest
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(169,000)
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(169,000)
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Total
Stockholders’ Deficit
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(17,206,000)
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(50,569,000)
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TOTAL
LIABILITIES AND STOCKHOLDERS’ DEFICIT
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$160,000
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$54,000
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The
accompanying condensed notes are an integral part of these
consolidated financial statements.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
For the Nine Months Ended September 30, 2016 and 2015
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Three Months
Ended September 30,
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Nine Months Ended
September 30,
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Product
revenues
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$-
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$-
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$-
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$-
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License
revenue
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-
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-
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-
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27,000
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Total
revenue
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-
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-
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-
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27,000
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Cost of product
revenue
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-
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-
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-
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-
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Gross
profit
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-
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-
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-
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27,000
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Operating
expenses
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Research and
development
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250,000
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225,000
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725,000
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475,000
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Selling, general
and administrative expenses
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2,280,000
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2,552,000
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7,827,000
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5,571,000
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Total operating
expenses
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2,530,000
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2,777,000
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8,552,000
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6,046,000
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Loss from
operations
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(2,530,000)
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(2,777,000)
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(8,552,000)
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(6,019,000)
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Other income
(expense)
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Change in value of
warrant and derivative liabilities
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436,000
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2,809,000
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25,930,000
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20,683,000
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Interest
expense
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(1,536,000)
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(1,724,000)
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(4,781,000)
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(10,012,000)
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Total other income
(expense)
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(1,100,000)
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1,085,000
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21,149,000
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10,671,000
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Income (loss)
before minority interest and
provision for
income taxes
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(3,630,000)
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(1,692,000)
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12,597,000
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4,652,000
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Plus: net (income)
loss attributable to the noncontrolling interest
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-
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-
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-
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-
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Income (loss)
before provision for income taxes
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(3,630,000)
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(1,692,000)
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12,597,000
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4,652,000
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Provision for
income tax
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-
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-
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-
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-
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Net income
(loss)
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(3,630,000)
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(1,692,000)
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12,597,000
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4,652,000
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Weighted average
common shares outstanding – basis and diluted
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Basic
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27,462,111
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2,400,000
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22,656,666
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2,392,683
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Diluted
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27,462,111
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2,400,000
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22,656,666
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4,764,753
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Net income per
share
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Basic
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$0.13
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$0.71
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$0.56
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$1.94
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Diluted
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$0.13
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$0.71
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$0.56
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$0.98
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The
accompanying condensed notes are an integral part of these
consolidated financial statements.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
For the Nine Months Ended September 30, 2016 and 2015
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Nine
months Ended September 30,
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CASH
FLOWS FROM OPERATING ACTIVITIES:
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Net
income
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$12,597,000
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$4,652,000
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Adjustments
to reconcile net income to net cash used in operating
activities:
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Depreciation
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1,000
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1,000
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Amortization
of intangible assets
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-
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-
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Stock
compensation expense for options and warrants issued to
employees and non-employees
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5,812,000
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1,820,000
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Non-cash
interest expense
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1,697,000
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7,717,000
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Amortization
of debt discounts
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1,625,000
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1,732,000
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Change
in value of warrant and derivative liabilities
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(25,930,000)
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(20,683,000)
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Changes
in operating assets and liabilities:
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Accounts
receivable
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-
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-
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Other
assets
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-
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25,000
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Accounts
payable and accrued expenses
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2,403,000
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1,023,000
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Net
cash used in operating activities
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(1,795,000)
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(3,713,000)
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CASH
FLOWS FROM FINANCING ACTIVITIES:
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Repayment of note payable
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-
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-
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Proceeds
of notes payable
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1,902,000
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2,900,000
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Net
cash provided by financing activities
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1,902,000
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2,900,000
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Minority
interest
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-
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-
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NET
DECREASE IN CASH AND CASH EQUIVALENTS
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107,000
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(813,000)
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CASH
AND CASH EQUIVALENTS - Beginning of period
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47,000
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855,000
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CASH
AND CASH EQUIVALENTS - End of period
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$154,000
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$42,000
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Supplemental Disclosures
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Interest
paid
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$-
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$-
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Income
taxes paid
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$-
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$-
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Supplemental non-cash activities:
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Common
stock issued upon conversion of convertible notes
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$1,794,000
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$-
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Common
stock issued upon conversion of accrued interest and
penalty
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$346,000
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$247,000
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The
accompanying condensed notes are an integral part of these
consolidated financial statements.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
The Company and Summary of Significant Accounting
Policies
OXIS International,
Inc. (collectively, “OXIS” or the
“Company”) is engaged in discovering, developing
and commercializing novel therapeutics from our proprietary product
platform in a broad range of disease
areas. Currently, OXIS develops innovative drugs focused
on the treatment of cancer. OXIS' lead drug candidate,
OXS-2175, is a small molecule therapeutic candidate targeting the
treatment of triple-negative breast cancer.
In in
vitro and in
vivo models of TNBC,
OXS-2175 demonstrated the ability to inhibit metastasis.
OXIS' lead drug candidate, OXS-4235, also a small molecule
therapeutic candidate, targets the treatment of multiple myeloma
and associated osteolytic lesions.
In in
vitro and in
vivo models of
multiple myeloma, OXS-4235 demonstrated the ability to kill
multiple myeloma cells, and decrease osteolytic lesions in bone.
OXIS' lead drug candidate, OXS-1550, is a bispecific scFv
recombinant fusion protein-drug conjugate composed of the variable
regions of the heavy and light chains of anti-CD19 and anti-CD22
antibodies and a modified form of diphtheria toxin as its cytotoxic
drug payload. OXS-1550 has demonstrated success in early human
clinical trials in patients with relapsed/refractory B-cell
lymphoma or leukemia.
In
1965, the corporate predecessor of OXIS, Diagnostic Data, Inc. was
incorporated in the State of California. Diagnostic Data changed
its incorporation to the State of Delaware in 1972; and changed its
name to DDI Pharmaceuticals, Inc. in 1985. In 1994, DDI
Pharmaceuticals merged with International BioClinical, Inc. and
Bioxytech S.A. and changed its name to OXIS International,
Inc.
Basis of Presentation
The
accompanying unaudited interim condensed consolidated financial
statements have been prepared in accordance with accounting
principles generally accepted in the U.S. (“U.S. GAAP”)
and the rules and regulations of the U.S. Securities and Exchange
Commission (“SEC”). Certain information and disclosures
required by U.S. GAAP for complete consolidated financial
statements have been condensed or omitted herein. The interim
condensed consolidated financial statements should be read in
conjunction with the audited consolidated financial statements and
notes thereto included in the Company's Form 10-K for the year
ended December 31, 2015. The unaudited interim condensed
consolidated financial information presented herein reflects all
normal adjustments that are, in the opinion of management,
necessary for a fair statement of the financial position, results
of operations and cash flows for the periods presented. The Company
is responsible for the unaudited interim consolidated financial
statements included in this report. The results of operations of
any interim period are not necessarily indicative of the results
for the full year.
Going Concern
As shown in the
accompanying consolidated financial statements, the Company has
incurred an accumulated deficit of $121,820,000 through
September 30,
2016. On a consolidated basis, the Company had
cash and cash equivalents of $154,000 at September 30, 2016. The Company's plan is to raise additional capital
until such time that the Company generates sufficient revenues to
cover its cash flow needs and/or it achieves profitability.
However, the Company cannot assure that it will accomplish this
task and there are many factors that may prevent the Company from
reaching its goal of profitability.
The current rate of
cash usage raises substantial doubt about the Company’s
ability to continue as a going concern, absent any sources of
significant cash flows. In an effort to mitigate this
near-term concern the Company intends to seek additional equity or
debt financing to obtain sufficient funds to sustain
operations. However, the Company cannot provide
assurance that it will successfully obtain equity or debt or other
financing, if any, sufficient to finance its goals or that the
Company will generate future product related
revenues. The Company’s financial statements do
not include any adjustments relating to the recoverability and
classification of recorded assets, or the amounts and
classification of liabilities that might be necessary in the event
that the Company cannot continue in existence.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
Basis of Consolidation and Comprehensive Income
The
accompanying consolidated financial statements include the accounts
of OXIS International, Inc. and its subsidiaries. All intercompany
balances and transactions have been eliminated. The Company's
financial statements are prepared using the accrual method of
accounting.
Cash and Cash Equivalents
The
Company considers all highly liquid investments with original
maturities of three months or less to be cash
equivalents.
Concentrations of Credit Risk
The
Company's cash and cash equivalents, marketable securities and
accounts receivable are monitored for exposure to concentrations of
credit risk. The Company maintains substantially all of its cash
balances in a limited number of financial institutions. The
balances are each insured by the Federal Deposit Insurance
Corporation up to $250,000. The Company does not have balances in
excess of this limit at September 30, 2016.
Fair Value of Financial Instruments
The
carrying amounts of cash and cash equivalents, restricted cash,
accounts receivable, inventory, accounts payable and accrued
expenses approximate fair value because of the short-term nature of
these instruments. The fair value of debt is based upon current
interest rates for debt instruments with comparable maturities and
characteristics and approximates the carrying amount.
Stock Based Compensation to Other than Employees
The
Company accounts for equity instruments issued in exchange for the
receipt of goods or services from other than employees in
accordance with ASC 718. Costs are measured at the estimated fair
market value of the consideration received or the estimated fair
value of the equity instruments issued, whichever is more reliably
determinable. The value of equity instruments issued for
consideration other than employee services is determined on the
earlier of a performance commitment or completion of performance by
the provider of goods or services. In the case of equity
instruments issued to consultants, the fair value of the equity
instrument is recognized over the term of the consulting
agreement.
Impairment of Long Lived Assets
The
Company's long-lived assets currently consist of capitalized
patents. The Company evaluates its long-lived assets for impairment
whenever events or changes in circumstances indicate that the
carrying amount of such assets may not be recoverable. If any of
the Company's long-lived assets are considered to be impaired, the
amount of impairment to be recognized is equal to the excess of the
carrying amount of the assets over the fair value of the
assets.
Income Taxes
The
Company accounts for income taxes using the asset and liability
approach, whereby deferred income tax assets and liabilities are
recognized for the estimated future tax effects, based on current
enacted tax laws, of temporary differences between financial and
tax reporting for current and prior periods. Deferred tax assets
are reduced, if necessary, by a valuation allowance if the
corresponding future tax benefits may not be realized.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
Net Income (Loss) per Share
Basic net income (loss) per share is computed by
dividing the net loss for the period by the weighted average number
of common shares outstanding during the period. Diluted net income
(loss) per share is computed by dividing the net loss for the
period by the weighted average number of common shares outstanding
during the period, plus the potential dilutive effect of common
shares issuable upon exercise or conversion of outstanding stock
options and warrants during the period. The weighted average number
of potentially dilutive common shares excluded from the calculation
of net income (loss) per share totaled in 38,410,084 and
2,039,480 as of September 30, 2016 and 2015,
respectively.
Patents
Acquired
patents are capitalized at their acquisition cost or fair value.
The legal costs, patent registration fees and models and drawings
required for filing patent applications are capitalized if they
relate to commercially viable technologies. Commercially viable
technologies are those technologies that are projected to generate
future positive cash flows in the near term. Legal costs associated
with patent applications that are not determined to be commercially
viable are expensed as incurred. All research and development costs
incurred in developing the patentable idea are expensed as
incurred. Legal fees from the costs incurred in successful defense
to the extent of an evident increase in the value of the patents
are capitalized.
Capitalized
cost for pending patents are amortized on a straight-line basis
over the remaining twenty year legal life of each patent after the
costs have been incurred. Once each patent is issued, capitalized
costs are amortized on a straight-line basis over the shorter of
the patent's remaining statutory life, estimated economic life or
ten years.
Fixed Assets
Fixed
assets are stated at cost. Depreciation is computed on a
straight-line basis over the estimated useful lives of the assets,
which are 3 to 10 years for machinery and equipment and the
shorter of the lease term or estimated economic life for leasehold
improvements.
Fair Value
The
carrying amounts reported in the balance sheets for receivables and
current liabilities each qualify as financial instruments and are a
reasonable estimate of fair value because of the short period of
time between the origination of such instruments and their expected
realization and their current market rate of interest. The
three levels are defined as follows:
●
Level 1 inputs to
the valuation methodology are quoted prices (unadjusted) for
identical assets or liabilities in active markets. The
Company’s Level 1 assets include cash equivalents, primarily
institutional money market funds, whose carrying value represents
fair value because of their short-term maturities of the
investments held by these funds.
●
Level 2 inputs to
the valuation methodology include quoted prices for similar assets
and liabilities in active markets, and inputs that are observable
for the asset or liability, either directly or indirectly, for
substantially the full term of the financial instrument. The
Company’s Level 2 liabilities consist of liabilities arising
from the issuance of convertible securities and in accordance with
ASC 815-40: a warrant liability for detachable warrants, as well as
an accrued derivative liability for the beneficial conversion
feature. These liabilities are remeasured each reporting period.
Fair value is determined using the Black-Scholes valuation model
based on observable market inputs, such as share price data and a
discount rate consistent with that of a government-issued security
of a similar maturity.
●
Level 3 inputs to
the valuation methodology are unobservable and significant to the
fair value measurement.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
The
following table represents the Company’s assets and
liabilities by level measured at fair value on a recurring basis at
September 30, 2016.
Description
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
$—
|
$—
|
$—
|
Liabilities
|
|
|
|
Warrant
liability
|
—
|
184,000
|
—
|
Research and Development
Research
and development costs are expensed as incurred and reported as
research and development expense. Research and development costs
totaling $725,000 and $475,000 for the nine months ended September
30, 2016 and 2015, respectively.
Revenue Recognition
License Revenue
License
arrangements may consist of non-refundable upfront license fees,
exclusive licensed rights to patented or patent pending technology,
and various performance or sales milestones and future product
royalty payments. Some of these arrangements are multiple element
arrangements.
Non-refundable,
up-front fees that are not contingent on any future performance by
us, and require no consequential continuing involvement on our
part, are recognized as revenue when the license term commences and
the licensed data, technology and/or compound is
delivered. We defer recognition of non-refundable
upfront fees if we have continuing performance obligations without
which the technology, right, product or service conveyed in
conjunction with the non-refundable fee has no utility to the
licensee that is separate and independent of our performance under
the other elements of the arrangement. In addition, if we have
continuing involvement through research and development services
that are required because our know-how and expertise related to the
technology is proprietary to us, or can only be performed by us,
then such up-front fees are deferred and recognized over the period
of continuing involvement.
Payments related to
substantive, performance-based milestones in a research and
development arrangement are recognized as revenue upon the
achievement of the milestones as specified in the underlying
agreements when they represent the culmination of the earnings
process.
Use of Estimates
The financial
statements and notes are representations of the Company's
management, which is responsible for their integrity and
objectivity. These accounting policies conform to accounting
principles generally accepted in the United States of America, and
have been consistently applied in the preparation of the financial
statements. The preparation of financial statements requires
management to make estimates and assumptions that affect the
reported amounts of assets, liabilities revenues and expenses and
disclosures of contingent assets and liabilities at the date of the
financial statements. Actual results could differ from those
estimates.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
Convertible debentures
On October 25,
2006, the Company entered into a securities purchase agreement
(“2006 Purchase Agreement”) with four accredited
investors (the “2006 Purchasers”). In conjunction with
the signing of the 2006 Purchase Agreement, the Company issued
secured convertible debentures (“2006 Debentures”) and
Series A, B, C, D, and E common stock warrants (“2006
Warrants”) to the 2006 Purchasers, and the parties also
entered into a security agreement (the “2006 Security
Agreement”) pursuant to which the Company agreed to grant the
2006 Purchasers, pari passu, a security interest in substantially
all of the Company’s assets.
Pursuant to the
terms of the 2006 Purchase Agreement, the Company issued the 2006
Debentures in an aggregate principal amount of $1,694,250 to the
2006 Purchasers. The 2006 Debentures are subject to an original
issue discount of 20.318% resulting in proceeds to the Company of
$1,350,000 from the transaction. The 2006 Debentures were due on
October 25, 2008. The 2006 Debentures are convertible, at the
option of the 2006 Purchasers, at any time prior to payment in
full, into shares of common stock of the Company. As a result of
the full ratchet anti-dilution provision the current conversion
price is $2.50 per share (the “2006 Conversion Price”).
Beginning on the first of the month beginning February 1, 2007, the
Company was required to amortize the 2006 Debentures in equal
installments on a monthly basis resulting in a complete repayment
by the maturity date (the “Monthly Redemption
Amounts”). The Monthly Redemption Amounts could have been
paid in cash or in shares, subject to certain restrictions. If the
Company chose to make any Monthly Redemption Amount payment in
shares of common stock, the price per share would have been the
lesser of the Conversion Price then in effect and 85% of the
weighted average price for the 10-trading days prior to the due
date of the Monthly Redemption Amount. The Company did not make any
of the required monthly redemption payments.
Pursuant to the
provisions of the 2006 Debentures, such non-payment was an event of
default and penalty interest has accrued on the unpaid redemption
balance at an interest rate equal to the lower of 18% per annum and
the maximum rate permitted by applicable law. In addition, each of
the 2006 Purchasers has the right to accelerate the cash repayment
of at least 130% of the outstanding principal amount of the 2006
Debenture (plus accrued but unpaid liquidated damages and interest)
and to sell substantially all of the Company’s assets
pursuant to the provisions of the 2006 Security Agreement to
satisfy any such unpaid balance. On June 6, 2008, the Company
received notification from Bristol Investment Fund, Ltd
(“Bristol”), that the collateral held under the 2006
Security Agreement would be sold to the highest qualified bidder on
Thursday, June 19, 2008. On June 19, 2008, the Company received a
Notice of Disposition of Collateral from Bristol in which Bristol
notified the Company that Bristol, acting as the agent for itself
and the three other 2006 Purchasers, purchased certain assets held
as collateral under the 2006 Security Agreement. Bristol purchased
111,025 shares of common stock of BioCheck, Inc., the
Company’s majority owned subsidiary, on a credit bid of
$50,000, and Bristol also purchased 1,000 shares of the capital
stock of OXIS Therapeutics, Inc., a wholly owned subsidiary of
OXIS, for a credit bid of $10,000. In December 2005, OXIS purchased
the 111,025 shares of common stock of BioCheck, Inc. for
$3,060,000. After crediting the aggregate amount of $60,000 to the
aggregate amount due under the 2006 Debentures, plus fees and
charges due through June 19, 2008, Bristol notified the Company
that the Company remains obligated to the 2006 Purchasers in a
deficiency in an aggregate amount of $2,688,000 as of June 19,
2008. As a result of the disposition of the collateral, the Company
recorded a net loss aggregating $2,978,000.
Under the 2006
Purchase Agreement, the 2006 Purchasers also have a right of first
refusal to participate in up to 100% of any future financing
undertaken by the Company until the 2006 Debentures are no longer
outstanding. In addition, the Company is also prohibited from
effecting any subsequent financing involving a variable rate
transaction until such time as no 2006 Purchaser holds any of the
2006 Debentures. Furthermore, so long as any 2006 Purchaser holds
any of the securities issued under the 2006 Purchase Agreement, if
the Company issues or sells any common stock or instruments
convertible into common stock which a 2006 Purchaser reasonably
believes is on terms more favorable to such investors than the
terms pursuant to the 2006 Debentures or 2006 Warrants, the Company
is obligated to permit such 2006 Purchaser the benefits of such
better terms.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
Of the 2006
Warrants issued by the Company to the 2006 Purchasers, only the
Series A Warrants remain outstanding. The Series A Warrants, which
now expire in July 2019, permit the holders to purchase 9,681
shares of common stock at an original exercise price of $87.50 per
share. Such exercise price is adjustable pursuant to a full ratchet
anti-dilution provision and upon the occurrence of a stock split or
a related event.
During 2009,
Bristol converted $177,900 of the principal amount of 2006
Debentures for 71,160 shares of the Company’s common stock.
During 2010, Bristol converted an additional $401,000 of the
principal amount of 2006 Debentures for 160,400 shares of the
Company’s common stock. During 2011, an additional $605,000
of the principal amount of 2006 Debentures was converted into
242,000 shares of the Company’s common stock. During 2012, an
additional $369,625 of the principal amount of 2006 Debentures was
converted into 350,619 shares of the Company’s common
stock.
The 2006 Debentures
do not meet the definition of a “conventional convertible
debt instrument” since they are not convertible into a fixed
number of shares. The Monthly Redemption Amounts can be paid with
common stock at a conversion price that is a percentage of the
market price; therefore the number of shares that could be required
to be delivered upon “net-share settlement” is
essentially indeterminate. Therefore, the 2006 Debentures are
considered “non-conventional,” which means that the
conversion feature must be bifurcated from the debt and shown as a
separate derivative liability. This beneficial conversion liability
has been calculated to be $690,000 on October 25, 2006. In
addition, since the 2006 Debentures are convertible into an
indeterminate number of shares of common stock, it is assumed that
the Company could never have enough authorized and unissued shares
to settle the conversion of the 2006 Warrants issues in this
transaction into common stock. Therefore, the 2006 Warrants have a
fair value of $2,334,000 at October 25, 2006. The value of the 2006
Warrant was calculated using the Black-Scholes model using the
following assumptions: Discount rate of 4.5%, volatility of 158%
and expected term of 1 to 6 years. The fair value of the beneficial
conversion feature and the 2006 Warrant liability will be adjusted
to fair value on each balance sheet date with the change being
shown as a component of net loss. The fair value of the beneficial
conversion feature and the 2006 Warrants at the inception of the
2006 Debentures were $690,000 and $2,334,000, respectively. The
first $1,350,000 of these discounts was amortized over the term of
the 2006 Debenture and the excess of $1,674,000 was shown as
financing costs in statement of operations.
The Company and
Bristol entered into a Forbearance Agreement on December 3, 2015,
pursuant to which Bristol agreed to refrain and forbear from
exercising certain rights and remedies with respect the 2006
Debentures for three months. In exchange for the Forbearance
Agreement, the Company issued an allonge in the amount of $250,000
increasing the principal amount if the 2006
Debentures.
On October 1, 2009,
the Company entered into a financing arrangement with several
accredited investors (the “2009 Investors”), pursuant
to which it sold various securities in consideration of a maximum
aggregate purchase price of $2,000,000 (the “2009
Financing”). In connection with the 2009 Financing, the
Company issued the following securities to the 2009
Investors:
●
0% Convertible
Debentures in the principal amount of $2,000,000 due 24 months from
the date of issuance (the “ 2009 Debentures”),
convertible into shares of the Company’s common stock at a
per share conversion price equal to $12.50 per share;
●
Series A warrant to
purchase such number of shares of the Company’s common stock
equal to 50% of the principal amount invested by each 2009 Investor
(the “2009 Class A Warrants” ) resulting in the
issuance of Class A Warrants to purchase 80,000 shares of common
stock of the Company.
●
Series B warrant to
purchase such number of shares of the Company’s common stock
equal to 50% of the principal amount invested by each 2009 Investor
(the “2009 Class B Warrants”) resulting in the issuance
of Class B Warrants to purchase 80,000 shares of common stock of
the Company.
The Class A
Warrants and Class B Warrants (collectively, the “ 2009
Warrants”) are exercisable for up to five years from the date
of issue at a per share exercise price equal to $15.625 and $18.75
for the Class A Warrants and the Class B Warrants, respectively, on
a cash or cashless basis. The 2009 Debentures and the 2009 Warrants
are collectively referred to herein as the “2009
Securities”.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
In connection with
the sale of the 2009 Securities by the Company, the Company and
Bristol entered a Standstill and Forbearance Agreement, pursuant to
which Bristol agreed to refrain and forbear from exercising certain
rights and remedies with respect to (i) the 2006 Debentures and
(ii) certain demand notes (the “Bridge Notes”) issued
by the Company on October 8, 2008, March 19, 2009, April 7, 2009,
April 28, 2009, May 21, 2009 and June 25, 2009 and discussed under
the caption “Demand Notes” below. In connection with
the sale of the 2009 Securities by the Company, the Company and
Bristol have also entered into a waiver agreement (the
“Waiver Agreement”) pursuant to which Bristol waived
certain rights with respect to the 2006 Debentures and Bridge
Notes.
The conversion
price of the 2009 Debentures and the exercise price of the 2009
Warrants are subject to full ratchet anti-dilution adjustment in
the event that the Company thereafter issues common stock or common
stock equivalents at a price per share less than the conversion
price or the exercise price, respectively, and to other normal and
customary anti-dilution adjustment upon certain other events. So
long as the 2009 Debentures are outstanding, if the Company effects
a subsequent financing, the October 2009 Investors may elect, in
their sole discretion, to exchange all or some of the October 2009
Debentures (but not the 2009 Warrants) for any securities or units
issued in a subsequent financing on a $1.00 for $1.00 basis or to
have any particular provisions of the subsequent financing legal
documents apply to the documents utilized for the October 2009
Financing.
The Company also
agreed that if it determines to prepare and file with the
Commission a registration statement relating to an offering for its
own account or the account of others, then it shall include the
shares of common stock underlying the 2009 Securities on such
registration statement. The 2009 Investors have contractually
agreed to restrict their ability to convert the 2009 Debentures and
exercise the 2009 Warrants and receive shares of our common stock
such that the number of shares of the Company common stock held by
a 2009 Investor and its affiliates after such conversion or
exercise does not exceed 4.9% of the Company’s then issued
and outstanding shares of common stock.
During 2010, 2009
Investors converted $1,335,000 of the principal amount of 2009
Debentures for 106,800 shares of the Company’s common stock.
During 2011, 2009 Investors converted $610,000 of the principal
amount of 2009 Debentures for 48,800 shares of the Company’s
common stock.
The Company entered
into a Forbearance Agreement on December 3, 2015, pursuant to which
the remaining 2009 Debenture holder agreed to refrain and forbear
from exercising certain rights and remedies with respect the 2009
Debentures for three months. In exchange for the Forbearance
Agreement, the Company issued an allonge in the amount of $250,000
increasing the principal amount of the 2009 Debentures to $305,000
as of March 31,2016.
On June 1, 2011,
the Company entered into a financing arrangement with several
accredited investors (the “June 2011 Investors”),
pursuant to which it sold various securities in consideration of a
maximum aggregate purchase price of $500,000 (the “June 2011
Financing”). In connection with the June 2011 Financing, the
Company issued the following securities to the June 2011
Investors:
●
12% Convertible
Debentures in the principal amount of $500,000 due April 15, 2012,
convertible into shares of the Company’s common stock at a
per share conversion price equal to $25.00 per share;
and
●
Warrants to
purchase 20,000 of shares of the Company’s common stock. The
warrants are exercisable, on a cash or cashless basis, for up to
two years from the date of issue at a per share exercise price
equal to $37.50. During 2015, the exercise price was adjusted to
$1.25 and the exercise date was extended to June 2019.
In November, 2011,
the Company entered into a financing arrangement with several
accredited investors (the “November 2011 Investors”),
pursuant to which it sold various securities in consideration of a
maximum aggregate purchase price of $275,000 (the “November
2011 Financing”). In connection with the November 2011
Financing, the Company issued the following securities to the
November 2011 Investors:
●
8% Convertible
Debentures in the principal amount of $275,000 due in two years,
convertible into shares of the Company’s common stock at a
per share conversion price equal to $12.50 per share;
and
●
Warrants to
purchase 22,000 of shares of the Company’s common stock. The
Class A Warrants and Class B Warrants (collectively, the
“Warrants”) are exercisable for up to five years from
the date of issue at a per share exercise price equal to $15.625
and $18.75 for the Class A Warrants and the Class B Warrants,
respectively, on a cash or cashless basis.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
In March, 2012, the
Company entered into a financing arrangement with several
accredited investors pursuant to which it sold various securities
in consideration of a maximum aggregate purchase price of $617,500
(the “March 2012 Financing”). In connection with the
March 2012 Financing, the Company issued the following securities
to the investors:
●
8% Convertible
Debentures in the principal amount of $617,500 due in two years,
convertible into shares of the Company’s common stock at a
per share conversion price equal to $12.50 per share;
and
●
Warrants to
purchase 49,400 of shares of the Company’s common stock. The
Class A Warrants and Class B Warrants (collectively, the “
March 2012 Warrants”) are exercisable for up to five years
from the date of issue at a per share exercise price equal $15.625
and $18.75 for the Class A Warrants and the Class B Warrants,
respectively, on a cash or cashless basis.
In April 2012, the
Company agreed to an adjustment as negotiated to enable inducement
of further financing of the Company. Pursuant to the anti-dilution
provisions in the convertible instruments, the conversion price of
certain
convertible
instruments is now $2.50 (with the exception of the conversion
price of the October 2006 Debenture which is already priced at the
lesser of $2.50 and 60% of the average of the lowest three trading
prices occurring at any time during the 20 trading days preceding
conversion).
In May, 2012, the
Company entered into a financing arrangement with several
accredited investors pursuant to which it sold various securities
in consideration of a maximum aggregate purchase price of $275,000
(the “May 2012 Financing”). In connection with the May
2012 Financing, the Company issued the following securities to the
investors:
●
8% Convertible
Debentures in the principal amount of $275,000 due May 2014,
convertible into shares of the Company’s common stock at a
per share conversion price equal to $12.50 per share;
and
●
Warrants to
purchase 22,000 of shares of the Company’s common stock. The
Class A Warrants and Class B Warrants (collectively, the “
May 2012 Warrants”) are exercisable for up to five years from
the date of issue at a per share exercise price equal to $15.625
and $18.75 for the Class A Warrants and the Class B Warrants,
respectively, on a cash or cashless basis.
On August 8, 2012,
a Settlement Agreement and Mutual General Release ("Agreement") was
made by and between OXIS and Bristol Investment Fund, Ltd., in
order to settle certain claims regarding certain convertible
debentures held by Bristol.
Pursuant to the
Agreement, OXIS shall pay Bristol (half of which payment would
redound to Theorem Capital LLC (“Theorem”)) a total of
$1,119,778 as payment in full for the losses suffered and all costs
incurred by Bristol in connection with the Transaction. Payment of
such $1,119,778 shall be made as follows: OXIS shall issue
restricted common stock to each of Bristol and Merit, in an amount
such that each Bristol and Theorem shall hold no more than 9.99% of
the outstanding shares of OXIS (including any shares that each may
hold as of the date of issuance). The shares so issued represent
$417,475.65 of the $1,119,778 payment (111,327 shares at $3.75 per
share, of which 36,675 will be retained by Bristol and 74,652 will
be issued to Theorem). The remaining balance of the payment shall
be made in the form of two convertible promissory notes in the
respective amounts of $422,357.75 for Bristol and $279,944.60 for
Theorem (collectively, the “Notes”) with a maturity of
December 1, 2017 having an 8% annual interest rate, with interest
only accruing until January 1, 2013, and then level payments of
$3,750 each beginning January 1, 2013 until paid in full on
December 1, 2017. In the event a default in the monthly payments on
the Notes has occurred and is continuing each holder of the Notes
shall be permitted to convert the unpaid principal and interest of
the Notes into shares of OXIS at $2.50 cents per share. In the
absence of such continuing default no conversion of the Notes will
be permitted. OXIS will have the right to repay the Notes in full
at any time without penalty.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
Effective April,
2013 the Company entered into a securities purchase agreement with
one accredited investor to sell 10% convertible debentures with an
initial principal balance of $75,000.
In October and
November, 2013, the Company entered into a securities purchase
agreement with four accredited investors to sell 10% convertible
debentures with an initial principal balance of $172,000 and
warrants to acquire up to 98,286 shares of the Company’s
common stock at an exercise price of $2.50 per share.
In December, 2013,
the Company entered into a convertible demand promissory note with
an initial principal balance of $189,662 convertible at $1.75 per
share and warrants to acquire up to 108,378 shares of the
Company’s common stock at an exercise price of $2.50 per
share.
In January, 2014,
the Company entered into a securities purchase agreement with one
accredited investor to sell 10% convertible debentures with an
initial principal balance of $50,000 and warrants to acquire up to
28,571 shares of the Company’s common stock at an exercise
price of $2.50 per share.
In April, 2014, the
Company entered into a securities purchase agreement with three
accredited investors to sell 10% convertible debentures with an
initial principal balance of $49,000 and warrants to acquire up to
22,286 shares of the Company’s common stock at an exercise
price of $2.50 per share.
In July 2014, the
Company agreed to an adjustment as negotiated to enable inducement
of further financing of the Company. Pursuant to the anti-dilution
provisions in the convertible instruments, the conversion price of
certain
convertible
instruments is now $1.75 (with the exception of the conversion
price of the October 2006 Debenture which is already priced at the
lesser of $1.75 and 60% of the average of the lowest three trading
prices occurring at any time during the 20 trading days preceding
conversion).
On July 24, 2014,
the Company entered into a securities purchase agreement with ten
accredited investors to sell 10% convertible debentures, with an
exercise price of $1.75, with an initial principal balance of
$1,250,000 and warrants to acquire up to 714,286 shares of the
Company’s common stock at an exercise price of $2.50 per
share.
Also on July 24,
2014, the Company sold to Kenneth Eaton, the Company’s Chief
Executive Officer, a $175,000 debenture, with an exercise price of
$1.75, as payment in full for all accrued and unpaid salary and
fees owed to Mr. Eaton. This note was converted on the second
quarter of 2016.
On October 15,
2014, the Company entered into a securities purchase agreement with
three accredited investors to sell 10% convertible debentures, with
an exercise price of $2.50, with an initial principal balance of
$1,250,000 and warrants to acquire up to 400,000 shares of the
Company’s common stock at an exercise price of $5.00 per
share.
On February 23, 2015, the Company entered into a securities
purchase agreement with ten accredited investors to sell 10%
convertible debentures, with an exercise price of $6.25, with an
initial principal balance of $2,350,000 and warrants to acquire up
to 376,000 shares of the Company’s common stock at an
exercise price of $7.50 per share.
Effective July 2015, the Company entered into a securities purchase
agreement with three accredited investors to sell 10% convertible
debentures, with an exercise price of $5.00, with an initial
principal balance of $550,000 and warrants to acquire up to 111,765
shares of the Company’s common stock at an exercise price of
$6.25 per share.
Effective October 2015, the Company entered into a securities
purchase agreement with three accredited investors to sell 10%
convertible debentures, with an exercise price of $2.50, with an
initial principal balance of $500,000 and warrants to acquire up to
200,000 shares of the Company’s common stock at an exercise
price of $2.50 per share.
Effective November 2015, the Company entered into a securities
purchase agreement with two accredited investors to sell 10%
convertible debentures, with an exercise price of $2.50, with an
initial principal balance of $100,000 and warrants to acquire up to
80,000 shares of the Company’s common stock at an exercise
price of $2.50 per share.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
Effective December 2015, the Company entered into a securities
purchase agreement with two accredited investors to sell 10%
convertible debentures, with and an exercise price of $1.25, with
an initial principal balance of $350,000 and warrants to acquire up
to 280,000 shares of the Company’s common stock at an
exercise price of $1.25 per share.
In December 2015,
the Company agreed to an adjustment as negotiated to enable
inducement of further financing of the Company. Pursuant to the
anti-dilution provisions in all the convertible instruments, the
conversion price of certain convertible instruments is now $1.25
(with the exception of the conversion price of the October 2006
Debenture which is already priced at the lesser of $1.25 and 60% of
the average of the lowest three trading prices occurring at any
time during the 20 trading days preceding conversion).
In January 2016, the Company entered into a securities purchase
agreement with one accredited investor to sell 10% convertible
debentures, with and an exercise price of $1.25, with an initial
principal balance of $150,000 and warrants to acquire up to 80,000
shares of the Company’s common stock at an exercise price of
$1.25 per share.
In May 2016, the
Company agreed to an adjustment as negotiated to enable inducement
of further financing of the Company. Pursuant to the anti-dilution
provisions in all the convertible instruments, the conversion price
of certain convertible instruments is now $0.40 (with the exception
of the conversion price of the October 2006 Debenture which is
already priced at the lesser of $0.40 and 60% of the average of the
lowest three trading prices occurring at any time during the 20
trading days preceding conversion).
In May 2016, the Company entered into a securities purchase
agreement with twenty accredited investors to sell 10% convertible
debentures, with and an exercise price of $0.40, with an initial
principal balance of $1,390,044 and warrants to acquire up to
3,475,111 shares of the Company’s common stock at an exercise
price of $0.45 per share.
In July 2016, the Company entered into a securities purchase
agreement with one accredited investor to sell 10% convertible
debentures, with and an exercise price of $0.40, with an initial
principal balance of $112,135 and warrants to acquire up to 280,338
shares of the Company’s common stock at an exercise price of
$0.45 per share.
In August 2016, the Company entered into a securities purchase
agreement with one accredited investor to sell 10% convertible
debentures up $1,000,000, with and an exercise price of $0.40, with
an initial principal balance of $250,000 and warrants to acquire up
to 2,500,000 shares of the Company’s common stock at an
exercise price of $0.45 per share.
Allonges
On
August 18, 2015, the Company entered into a settlement agreement
with three noteholders. In accordance with the July 24,
2014 Security Purchase Agreements, The Company was required to
establish and maintain a reserve of shares of its common stock from
its duly authorized shares of Common Stock for issuance in an
amount equal to 150% of a required minimum by December 21, 2014
which did not occur. As compensation for the default,
the Company issued allonges to the noteholders for a total of
$837,500, increasing the principal amount of the convertible
notes.
On
October 7, 2015, the Company entered into a settlement agreement
with two noteholders. In accordance with the July 24,
2014 Security Purchase Agreements, The Company was required to
establish and maintain a reserve of shares of its common stock from
its duly authorized shares of Common Stock for issuance in an
amount equal to 150% of a required minimum by December 21, 2014
which did not occur. As compensation for the default,
the Company issued allonges to the noteholders for a total of
$537,500, increasing the principal amount of the convertible
notes.
On
November 5, 2015, the Company entered into a Second Settlement
Agreement with three noteholders. On August 18, 2015 the Company
entered into a Settlement Agreement that required the Company to
increase its authorized shares to not less 8,000,000 shares and
reserve 150% of the number of shares of its Common Stock no later
than the earlier of (1) two days after Oxis obtaining all corporate
and regulatory approvals necessary to increase it authorized
shares; or (2) September 30, 2015 which did not
occur. As compensation for the default, the Company
issued additional allonges to the noteholders for a total of
$837,500, increasing the principal amount of the convertible
notes.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
On
Dec 5, 2015, the Company entered into a Second Settlement Agreement
with three noteholders. On October 7, 2015 the Company entered into
a Settlement Agreement that required the Company to increase its
authorized shares to not less than 8,000,000 shares and reserve
150% of the number of shares of its Common Stock no later than the
earlier of (1) two days after Oxis obtaining all corporate and
regulatory approvals necessary to increase it authorized shares; or
(2) September 30, 2015 which did not occur. As
compensation for the default, the Company issued additional
allonges to the noteholders for a total of $537,500, increasing the
principal amount of the convertible notes.
On
July 15, 2015, the Company entered into a settlement agreement with
one noteholder. In accordance with a 10% Convertible
Debenture Due July 24, 2016, The Company was required pay accrued
interest in case upon a conversion of the debt within three
business days for the conversion which did not occur. As
compensation for the default, the Company issued allonges to the
noteholders for a total of $40,000, increasing the principal amount
of the convertible notes.
Demand Notes
On May 15, 2009,
the Company entered into a convertible demand promissory note with
Bristol Capital, LLC for certain consulting services totaling
$100,000. The note does not provide for any interest and is due
upon demand by the holder. The note has been converted into common
stock of the Company.
On June 22, 2009,
the Company entered into a convertible demand promissory note with
Theorem Group (“Theorem”) pursuant to which Theorem
purchased an aggregate principal amount of $31,375 of convertible
demand promissory notes for an aggregate purchase price of $25,000
(the “ 2009 Theorem Note”). The 2009 Theorem Note was
subsequently sold as described below.
Simultaneously with
the issuance of the 2009 Theorem Note, the Company issued Theorem a
seven-year warrant (the “2009 Theorem Warrant”) to
purchase 12,550 shares of common stock of the Company at a price
equal to the lower of (i) $2.50 and (ii) 60% of the average of the
three (3) lowest trading prices occurring at any time during the 20
trading days preceding the issue date of the Theorem Note (the
“Exercise Price”). The 2009 Theorem Warrant may be
exercised on a cashless basis if the shares of common stock
underlying the 2009 Theorem Warrant are not then registered
pursuant to an effective registration statement. In the event the
2009 Theorem Warrant is exercised on a cashless basis, we will not
receive any proceeds.
On December 1,
2009, Theorem sold the 2009 Theorem Note to Net Capital Partners,
Inc. (“Net Capital”). In December 2009, Net Capital
converted $24,000 of the principal for 9,600 shares of the
Company’s common stock. In January 2010, Net Capital
converted the remaining $7,375 of principal amount for an
additional 2,950 shares of the Company’s common
stock.
On February 7, 2011
the Company entered into a convertible demand promissory note with
Bristol pursuant to which Bristol purchased an aggregate principal
amount of $31,375 of convertible demand promissory notes for an
aggregate purchase price of $25,000 (the “February 2011
Bristol Note”). The February 2011 Bristol Note is convertible
into shares of common stock of the Company at a price equal to
$12.50 per share.
Simultaneously with
the issuance of the February 2011 Bristol Note, the Company issued
Bristol a Series A Warrant (the “February 2011 Bristol Series
A Warrants”) to purchase 1,255 shares of the Company’s
common stock at a per share exercise price of $15.625, and a Series
B Warrant (the “February 2011 Bristol Series B
Warrants” and, together with the February 2011 Bristol Series
A Warrants, the “February 2011 Bristol Warrants”) to
purchase 1,255 shares of the Company’s common stock at a per
share exercise price of $18.75. The February 2011 Warrants are
exercisable for up to seven years from the date of issue. The
February 2011 Warrants may be exercised on a cashless basis if the
shares of common stock underlying the February 2011 Warrants are
not then registered pursuant to an effective registration
statement. In the event the February 2011 Bristol Warrants are
exercised on a cashless basis, the Company will not receive any
proceeds.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
On February 7, 2011
the Company entered into a convertible demand promissory note with
Net Capital pursuant to which Net Capital purchased an aggregate
principal amount of $31,375 of convertible demand promissory notes
for an aggregate purchase price of $25,000 (the “February
2011 Net Capital Note”). The February 2011 Net Capital Note
is convertible into shares of common stock of the Company at a
price equal to $12.50 per share. As of September, 2012, the
February 2011 Net Capital Note had been converted into shares of
the Company’s common stock.
Simultaneously with
the issuance of the February 2011 Net Capital Note, the Company
issued Net Capital a Series A Warrant (the “February 2011 Net
Capital Series A Warrants”) to purchase 1,255 shares of the
Company’s common stock at a per share exercise price of
$15.625, and a Series B Warrant (the “February 2011 Net
Capital Series B Warrants” and, together with the February
2011 Net Capital Series A Warrants, the “February 2011 Net
Capital Warrants”) to purchase 1,255 shares of the
Company’s common stock at a per share exercise price of
$18.75. The February 2011 Net Capital Warrants are exercisable for
up to seven years from the date of issue. The February 2011 Net
Capital Warrants may be exercised on a cashless basis if the shares
of common stock underlying the February 2011 Net Capital Warrants
are not then registered pursuant to an effective registration
statement. In the event the February 2011 Net Capital Warrants are
exercised on a cashless basis, the Company will not receive any
proceeds.
On March 4, 2011
the Company entered into a convertible demand promissory note with
Bristol pursuant to which Bristol purchased an aggregate principal
amount of $31,375 of convertible demand promissory notes for an
aggregate purchase price of $25,000 (the “March 2011 Bristol
Note”). The March 2011 Bristol Note is convertible at the
option of the holder at any time into shares of common stock, at a
price equal to $12.50.
Simultaneously with
the issuance of the March 2011 Bristol Note, the Company issued
Bristol a Series A Warrant (the “March 2011 Bristol Series A
Warrants”) to purchase 1,255 shares of the Company’s
common stock at a per share exercise price of $15.625, and a Series
B Warrant (the “March 2011 Bristol Series B Warrants”
and, together with the March 2011 Bristol Series A Warrants, (the
“March 2011 Bristol Warrants”) to purchase 1,255 shares
of the Company’s common stock at a per share exercise price
of $18.75. The March 2011 Warrants are exercisable for up to seven
years from the date of issue. The March 2011 Warrants may be
exercised on a cashless basis if the shares of common stock
underlying the March 2011 Warrants are not then registered pursuant
to an effective registration statement. In the event the March 2011
Warrants are exercised on a cashless basis, the Company will not
receive any proceeds.
On April 4, 2011
the Company entered into a convertible demand promissory note with
Net Capital pursuant to which Net Capital purchased an aggregate
principal amount of $31,375 of convertible demand promissory notes
for an aggregate purchase price of $25,000 (the “April 2011
Net Capital Note”). The April 2011 Net Capital Note is
convertible into shares of common stock of the Company, at a price
equal to $12.50 per share. As of September, 2012, the April 2011
Net Capital Note had been converted into shares of the
Company’s common stock.
Simultaneously with
the issuance of the Net Capital Note, the Company issued Net
Capital a Series A Warrant (the “April 2011 Net Capital
Series A Warrants”) to purchase 1,255 shares of common stock
of the Company at a per share exercise price of $15.625, and a
Series B Warrant (the “April 2011 Net Capital Series B
Warrants” and, together with the April 2011 Net Capital
Series A Warrants, the “April 2011 Net Capital
Warrants”) to purchase 1,255 shares of common stock of the
Company at a per share exercise price of $18.75. The April 2011 Net
Capital Warrants are exercisable for up to seven years from the
date of issue. The April 2011 Net Capital Warrants may be exercised
on a cashless basis if the shares of common stock underlying the
April 2011 Net Capital Warrants are not then registered pursuant to
an effective registration statement. In the event the April 2011
Net Capital Warrants are exercised on a cashless basis, we will not
receive any proceeds.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
On October 26, 2011
the Company entered into a convertible demand promissory note with
Theorem pursuant to which Theorem purchased an aggregate principal
amount of $200,000 of convertible demand promissory notes for an
aggregate purchase price of $157,217 (the “October 2011
Theorem Note”). The October 2011 Theorem Note is convertible
into shares of common stock of the Company, at a price equal to
$12.50 per share.
Simultaneously with
the issuance of the October 2011 Theorem Note, the Company issued
Theorem a Series A Warrant (the “October 2011 Series A
Warrant”) to purchase 40,000 shares of common stock of the
Company at a per share exercise price of $15.625, and a Series B
Warrant (the “October 2011 Series B Warrants” and,
together with the October 2011 Series A Warrants, the
“October 2011 Warrants”) to purchase 40,000 shares of
common stock of the Company at a per share exercise price of
$18.75. The October 2011 Warrants are exercisable for up
to
seven years from
the date of issue. The October 2011 Warrants may be exercised on a
cashless basis if the shares of common stock underlying the October
2011 Warrants are not then registered pursuant to an effective
registration statement. In the event the October 2011 Warrants are
exercised on a cashless basis, we will not receive any
proceeds.
All of the
foregoing securities were issued in reliance upon an exemption from
the registration requirements pursuant to Section 4(2) of the
Securities Act of 1933, as amended.
On December 7,
2012, the Company entered into, and made its initial $315,000
borrowing under, a short-term loan agreement with two lenders
pursuant to which it is permitted to borrow up to an aggregate of
$350,000. The loans made under the loan agreement are evidence by
the Company’s notes and secured pursuant to a Security
Agreement, that is junior to the Company’s existing security
arrangements under the Company’s October 26, 2006 Debentures
but cover the same assets of the Company.
Interest on the
Notes is at the rate of 18% per annum, payable on the first day of
each month until maturity on May 1, 2013. On April 1, 2013, the
Company was required to pay 25.7143% of the Loan, with the
remaining balance due on May 1, 2013.
The full principal
amount of the Loans may be due upon default under the terms of the
Loan Agreement, the Notes or the Security Agreement.
Under the Loan
Agreement, the Company is required to issue 266.67 shares of its
common stock for each $1,000 of Loans made. Accordingly, on
December 7, 2012, the Company issued 84,000 shares of its common
stock. Assuming the entire amounts of Loans permitted under the
Loan Agreement are borrowed, the Company will issue 93,334 shares
in connection with the Loan Agreement.
In March 2013, the
Company entered into, and made an additional $35,000 borrowing
under, a short-term loan agreement with two lenders the Company
entered into in December 2012, pursuant to which it is permitted to
borrow up to an aggregate of $350,000. The loans made under the
loan agreement are evidence by the Company’s notes and
secured pursuant to a Security Agreement, that is junior to the
Company’s existing security arrangements under the
Company’s October 26, 2006 Debentures but cover the same
assets of the Company.
Financing Agreement
On November 8,
2010, the Company entered into a financing arrangement with Gemini
Pharmaceuticals, Inc., a product development and manufacturing
partner of the Company, pursuant to which Gemini Pharmaceuticals
made a $250,000 strategic equity investment in the Company and
agreed to make a $750,000 purchase order line of credit facility
available to the Company. The outstanding principal of all Advances
under the Line of Credit will bear interest at the rate of interest
of prime plus 2 percent per annum. There is $31,000 due on this
credit line at September 30, 2016.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
Common Stock
In January 2015, the Company agreed to issue 39,657 shares of
common stock as a price protection to a note holder that originally
converted notes at a price of $2.50 and continues to hold these
shares. These additional shares would have been issued if the
conversion shares price was $1.75. As of December 31,
2015, 33,142 shares of common stock have been issued and
$247,000 of interest expense was recorded for this issuance. During
January 2016 the remaining 6,515 share were issued and $20,000 of
interest expense was recorded.
During the nine months
ending September 30, 2016, the Company issued an
aggregate of 12,580,183 shares of
common stock to a total of 34 persons or entities in exchange of
the cancellation of warrants on a cashless basis. The
shares issued were exempt from the registration requirements of
Section 5 of the Securities Act of 1933 (the “Act”)
pursuant to Section 4(2) of the Act since
the shares were issued to persons or entities closely associated
with the Company and there was no public offering of the
shares.
During the nine months
ending September 30, 2016, the Company also issued an
aggregate of 2,022,230 shares of
common stock to a total of 17 persons as payment for consulting
services provided to the Company. The average valuation
of these shares was $2.00 per share. These shares were also exempt
from the registration requirements of Section 5 of the Act pursuant
to Section 4(2) of the Act
since the shares were also issued to persons closely associated
with the Company and there was no public offering of the
shares.
During the nine months ending September 30, 2016, the Company also
issued an aggregate of 4,612,341 shares of common stock to two
executive officers of the Company in fulfilment of contractual
rights held by the officers pursuant to their employment
agreements. These shares were also exempt from the
registration requirements of Section 5 of the Act pursuant to
Section 4(2) of the Act since the shares were also issued to
persons closely associated with the Company and there was no public
offering of the shares.
During the nine months
ending September 30, 2016, the Company also issued an
aggregate of 5,503,551 shares of
common stock to a total of 18 persons as payment for the conversion
of certain note and the related accrued interest. The
conversion price of these shares was $0.40 per share. These shares
were also exempt from the registration requirements of Section 5 of
the Act pursuant to Section 4(2) of the Act
since the shares were also issued to persons closely associated
with the Company and there was no public offering of the
shares.
In August 2016, the
Company issued 1,115,000 shares
of common stock to H.C. Wainwright and Co., LLC as payment for
investment banking services provided to the
Company.
Preferred Stock
On
January 8, 2016 the Company entered into an Exchange Agreement with
certain investors together holding 25,000 shares of Series H
Preferred Stock and 1,666,667 shares of Series I Preferred Stock
have agreed to convert all such shares of Preferred Stock into an
aggregate of 4,075,000 shares of Common Stock upon successful
completion by the Company of a $6 million financing.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
4.
Stock Options and Warrants
Stock Options
Following
is a summary of the stock option activity:
|
|
Weighted Average
Exercise Price
|
Outstanding as of
December 31, 2015
|
374,800
|
$4.88
|
Granted
|
-
|
-
|
Forfeited
|
20
|
$67.5
|
Exercised
|
-
|
-
|
Outstanding as of
September 30, 2016
|
374,780
|
$4.88
|
Warrants
Following
is a summary of the warrant activity:
|
|
Weighted Average
Exercise Price
|
Outstanding as of
December 31, 2015
|
12,525,721
|
$1.25
|
Granted
|
5,101,500
|
0.45
|
Forfeited
|
(339,932)
|
1.25
|
Exercised
|
(12,610,183)
|
1.25
|
Outstanding as of
September 30, 2016
|
4,677,106
|
$0.45
|
In October 2016 the
Company issued an aggregate of
453,431 shares of common stock to one noteholder as payment for the
conversion of certain accrued interest. The conversion
price of these shares was $0.40 per share. These shares were also
exempt from the registration requirements of Section 5 of the Act
pursuant to Section 4(2) of the Act
since the shares were also issued to persons closely associated
with the Company and there was no public offering of the
shares.
In October 2016 the
Company issued an aggregate of
594,530 shares of common stock to one noteholder as payment for the
conversion of a certain note. The conversion price of
these shares was $0.0841 per share based on 60% of the
average of the lowest three trading prices occurring at any time
during the 20 trading days preceding conversion These shares were also exempt from the
registration requirements of Section 5 of the Act pursuant
to Section 4(2) of the Act
since the shares were also issued to persons closely associated
with the Company and there was no public offering of the
shares.
In November 2016 the Company issued an aggregate of 975,039 shares
of common stock to one noteholder as payment for the
conversion of a certain note. The conversion price of these shares
was $0.0513 per share based on 60% of the
average of the lowest three trading prices occurring at any time
during the 20 trading days preceding
conversion These shares were also exempt from the registration
requirements of Section 5 of the Act pursuant to
Section 4(2) of the Act since the shares were also issued to
persons closely associated with the Company
and there was no public offering of the shares.
OXIS INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER 30, 2016
(UNAUDITED)
7.
Restatement
The Company’s
management determined that the Company needs to make adjustments to
correct errors identified in the previously issued financial
statements related to the
non-cash calculation of warranty liabilities. The error affects
the periods ending December 31,
2015, March 31, 2016, June 30, 2016, September 30, 2016 and
December 31, 2016 financial
statements.
As
a result of the error, the Company will recognize a decrease in the
Change in Warrant Liability by $11,265,000 through December 31,
2016.
This change had no net effect on the balance sheet and cash flows
from operations, investing or financing.
The following table presents the impact of the restatement
adjustment on the Company’s Consolidated Statement of
Operations for the nine months ended September 30,
2016.
Liabilities and Stockholders:
|
|
Effects of
restatement/
reclassification
|
|
|
|
|
|
Change in value of
warrants and derivative liabilities
|
$ 37,195,000
|
$ 25,930,000
|
$ (11,265,000)
|
Net
Income
|
$ 23,862,000
|
$ 12,597,000
|
$ (11,265,000)
|
Income per share
– basic
|
$ 1.05
|
$ 0.56
|
$ (0.46)
|
Income per share
–diluted
|
$ 1.05
|
$ 0.56
|
$ (0.46)
|
Item 2. Management’s Discussion
and Analysis of Financial Condition and Results of
Operations.
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
Some
of the statements in the Form 10-Q are forward-looking statements
about what may happen in the future. Forward-looking statements
include statements regarding our current beliefs, goals, and
expectations about matters such as our expected financial position
and operating results, our business strategy, and our financing
plans. The forward-looking statements in the Form 10-Q are not
based on historical facts, but rather reflect the current
expectations of our management concerning future results and
events. The forward-looking statements generally can be
identified by the use of terms such as “believe,”
“expect,” “anticipate,”
“intend,” “plan,” “foresee,”
“likely” or other similar words or phrases. Similarly,
statements that describe our objectives, plans or goals are or may
be forward-looking statements. Forward-looking statements involve
known and unknown risks, uncertainties and other factors that may
cause our actual results, performance or achievements to be
different from any future results, performance and achievements
expressed or implied by these statements. We cannot
guarantee that our forward-looking statements will turn out to be
correct or that our beliefs and goals will not change. Our actual
results could be very different from and worse than our
expectations for various reasons. You should review carefully all
information, including the discussion of risk factors under
“Item 1A: Risk Factors” and “Item 7:
Management’s Discussion and Analysis of Financial Condition
and Results of Operations” of the Form 10-K for the year
ended December 31, 2015. Any forward-looking statements
in the Form 10-Q are made only as of the date hereof and, except as
may be required by law, we do not have any obligation to publicly
update any forward-looking statements contained in this Form 10-Q
to reflect subsequent events or circumstances.
Throughout
this Quarterly Report on Form 10-Q, the terms
“OXIS,” “we,”
“us,” “our,” “the
company” and “our company” refer to OXIS
International, Inc., a Delaware corporation formerly known as DDI
Pharmaceuticals, Inc. and Diagnostic Data, Inc, together with our
subsidiaries.
Overview
OXIS International,
Inc., through its wholly owned subsidiary Oxis Biotech,
Inc, is an immuno-oncology
company with a robust technology platform consisting of bispecific
and trispecific scFv constructs, full-length antibodies,
proprietary drug payloads, proprietary antibody-drug linkers,
dual-drug payload antibody-drug conjugates (ADCs), bispecific
targeted ADCs, and NK cell and T-cell antibody directed
cell-mediated cytotoxic (ADDCs) agents.
OXS-1550
OXS-1550 is a
bispecific scFv recombinant fusion protein-drug conjugate composed
of the variable regions of the heavy and light chains of anti-CD19
and anti-CD22 antibodies and a modified form of diphtheria toxin as
its cytotoxic drug payload. CD19 is a membrane glycoprotein
present on the surface of all stages of B-lymphocyte development,
and is also expressed on most B-cell mature lymphoma cells and
leukemia cells. CD22 is a glycoprotein expressed on B-lineage
lymphoid precursors, including precursor acute lymphoblastic
leukemia, and often is co-expressed with CD19 on mature B-cell
malignancies such as lymphoma.
OXS-1550 targets
cancer cells expressing the CD19 receptor or CD22 receptor or both
receptors. When OXS-1550 binds to cancer cells, the cancer
cells internalize OXS-1550, and are killed due to the action of
drug's cytotoxic diphtheria toxin payload. OXS-1550 has
demonstrated success in a Phase 1 human clinical trial in patients
with relapsed/refractory B-cell lymphoma or leukemia.
Oxis began
enrolling patients in a Phase 1/Phase 2 trial of OXS-1550 during
the second quarter of 2016. The FDA-approved clinical trial is
being conducted at the University of Minnesota's Masonic Cancer
Center. There are currently 32 patients who have participated in
the clinical trial. The nine new patients bring to 32 the number of
patients who have participated in the clinical trial. All the new
patients are given an approved increased dosage of
OXS-1550.
Trispecific Killer Engager (TriKE) Technology
The TriKE platform is designed to address the issue of making NK
cells antigen specific by modifying a bispecific antibody platform
and adding a third signal by inserting a modified IL-15 cross
linker. IL-15 is known as a chief activator of NK cells that can
enhance an anti-cancer immune response. This new trispecific
platform is unique because it simultaneously delivers a priming,
expansion, killing, and activating signal directly to the immune
cell as it is in contact with the cancer cell. We are now working
currently working toward FDA approved clinical trials to
demonstrate TriKE safety and efficacy. Unlike standard anti-cancer
antibodies, we believe that TriKE can mediate specificity and
deliver an immune expansion signal locally (instead of
systemically) which has the potential to diminish
toxicity.
OXS-4235, p62/SQSTM1 (Sequestosome-1) Inhibitor Drug Development
Program
In
humans, the p62/SQSTM1 protein is encoded by the SQSTM1
gene. The p62/SQSTM1 protein is a multifunctional
protein involved in autophagy, cell signaling, tumorigenesis, and
plays an important role at the crossroad between autophagy and
cancer. Cell-cell interactions between multiple myeloma
cells and bone marrow stromal cells activate signaling pathways
that result in enhanced multiple myeloma cell growth, osteoclast
formation, and inhibition of osteoblast
differentiation.
Multiple
myeloma remains an incurable malignancy with systematic morbidity
and a median survival of 3-5 years. Multiple myeloma is
characterized by aberrant proliferation of terminally
differentiated plasma cells and impairment in apoptosis
capacity. Due to the interactions between myeloma cells
and cells of the bone marrow microenvironment, the osteolytic bone
disease associated with myeloma is inextricably linked with tumor
progression. High incidence of bone metastasis in
multiple myeloma patients is frequently associated with severe bone
pain and pathological bone fracture. Activated
osteoclast levels and suppressed osteoblast levels are thought to
play a role in multiple myeloma associated osteolytic bone
disease.
While
a diverse spectrum of novel agents has shown therapeutic potential
for the treatment of multiple myeloma including bortezomib,
lenalidomide and arsenic trioxide, high relapse rates and drug
resistance continue to plague these therapies. Thus,
novel targets and new therapeutics for the treatment of multiple
myeloma are of critical importance for improved patient
outcomes.
It
has been demonstrated that the ZZ domain of the p62/SQSTM1 protein
is responsible for increased multiple myeloma cell growth and
associated osteoclast mediated bone disease. Dr.
Xiang-Qun Xie and colleagues at ID4 Pharma LLC have developed novel
chemical compounds (e.g., OXS-4235) which inhibit osteoclastic bone
destruction in multiple myeloma. Oxis Biotech has
exclusively licensed rights to OXS-4235 and other compounds for the
treatment of multiple myeloma and associated osteolytic bone
disease.
OXS-2175, Triple-Negative Breast Cancer Drug Development
Program
OXS-2175 is a small molecule therapeutic candidate
which has shown promise in early-stage
preclinical in vitro and in vivo models of triple-negative breast
cancer. Oxis Biotech is investigating OXS-2175
formulated as an ADC therapy for the treatment of triple-negative
breast cancer.
Therapeutic Antibody-Drug Conjugates Drug Development
Program
Antibody-drug
conjugates (ADCs) are a new class of highly potent
biopharmaceutical drugs designed as a targeted therapy for the
treatment of cancer. By combining the unique targeting
capabilities of monoclonal antibodies with the cancer-killing
ability of cytotoxic drugs, antibody-drug conjugates allow
sensitive discrimination between healthy and diseased
tissue.
Recent Developments
Restructuring Agreements
Effective
January 8, 2016, Company entered into agreements to effect the
restructuring (the “Restructuring”) of certain
unregistered debt and equity securities of the Company that will
result in an issuance of up to 28,389,193 shares of common stock of
the Company (the “Common Stock”). In
connection with the Restructuring, the Company entered into a note
conversion agreement (the “Conversion Agreement”), a
warrant exercise agreement (the “Exercise Agreement”)
and a preferred stock exchange agreement (the “Exchange
Agreement” and, collectively with the Conversion Agreement
and the Exercise Agreement, the “Restructuring
Agreements”), pursuant to which the Company and certain of
the Company’s creditors and investors have agreed that (i)
certain outstanding debt of the Company (collectively, the
“Debt”) will be converted into shares of Common Stock;
(ii) certain outstanding warrants to purchase shares of capital
stock of the Company (collectively, the “Warrants”)
will be exercised on a cashless basis for shares of Common
Stock; and (iii) certain outstanding shares of Series H
Convertible Preferred Stock of the Company (the “Series H
Preferred Stock”) and Series I Convertible Preferred Stock of
the Company (the “Series I Preferred Stock” and
together with the Series H Preferred Stock, the “Preferred
Stock”) will be exchanged for shares of Common
Stock. The Conversion Agreement, Exercise Agreement and
Exchange Agreement and the transactions contemplated thereby are
described in further detail below.
Under the Conversion Agreement, certain creditors
of the Company holding an aggregate of approximately $15,056,000
(including accrued interest and penalties) of outstanding Debt
agreed to convert all such outstanding Debt into shares of Common
Stock at a conversion price of $1.25 per share upon successful
completion by the Company of a $6 million financing.
However, since the financing did not occur by March 15,
2016, the Conversion Agreement was terminated.
In
addition, under the Exercise Agreement, certain investors together
holding warrants to purchase 12,269,240 shares of capital stock of
the Company exchanged such warrants and received one share of
Common Stock in exchange for each share of capital stock of the
Company underlying the warrants.
Finally,
under the Exchange Agreement, certain investors together holding
25,000 shares of Series H Preferred Stock and 1,666,667 shares of
Series I Preferred Stock have agreed to convert all such shares of
Preferred Stock into an aggregate of 4,075,000 shares of Common
Stock upon successful completion by the Company of a $6 million
financing.
The
Restructuring Agreements terminated the warrants and any
anti-dilution protection thereunder. In addition, all
creditor and investor parties to the Restructuring Agreements
provided a waiver of any and all past defaults and breaches under
the Warrants and Preferred Stock, in consideration of the shares
issued pursuant to the Restructuring Agreements.
License Agreements
University of Minnesota
License Agreement. Oxis
executed an exclusive worldwide license agreement with the Regents
of the University of Minnesota, to further develop and
commercialize cancer therapies using
Trispecific Killer Engager (TriKE) technology developed by
researchers at the university to target NK cells to cancer.
Under the terms of the agreement, OXIS
receives exclusive rights to conduct research and to develop, make,
use, sell, and import TriKe technology worldwide for the treatment
of any disease, state or condition in humans. OXIS shall own all
permits, licenses, authorizations, registrations and regulatory
approvals required or granted by any governmental authority
anywhere in the world that is responsible for the regulation of
products such as the TriKe technology, including without limitation
the Food and Drug Administration in the United States and the
European Agency for the Evaluation of Medicinal Products in the
European Union. Under the agreement, the University of Minnesota
will receive an upfront license fee, royalty fees, and certain
milestone payments.
Daniel A. Vallera, Ph.D.
License Agreement. Oxis
executed an exclusive worldwide license agreement with Daniel A.
Vallera, Ph.D. and his associate (jointly "Dr. Vallera"), to
further develop and commercialize DT2219ARL (OXS-1550), a novel
therapy for the treatment of various human cancers. Under the terms
of the agreement, OXIS receives exclusive rights to conduct
research and to develop, make, use, sell, and import DT2219ARL
worldwide for the treatment of any disease, state or condition in
humans. OXIS shall own all permits, licenses, authorizations,
registrations and regulatory approvals required or granted by any
governmental authority anywhere in the world that is responsible
for the regulation of products such as DT2219ARL, including without
limitation the Food and Drug Administration in the United States
and the European Agency for the Evaluation of Medicinal Products in
the European Union. Under the agreement, Dr. Vallera will receive
an upfront license fee, royalty fees, and certain milestone
payments.
ID4 Pharma, LLC
License Agreement. Pursuant to a patent license agreement with
ID4 Pharma LLC, dated January 2, 2015 (the “ID4 License
Agreement”), we received an exclusive, worldwide license to
certain intellectual property, including intellectual property
related to treating a
p62-mediated disease including but not limited to multiple myeloma
and other cancers. The terms of
this license require us to pay ID4 Pharma royalties equal to three
percent (3%) of net sales of products and twenty-five percent
royalty of net sublicensing revenues. The license will expire upon
expiration of the last patent contained in the licensed patent
rights, unless terminated earlier. We may terminate the licensing
agreement with ID4 Pharma by providing ID4 Pharma with a 30 day
written notice. Under the agreement, ID4 Pharma LLC will receive an
upfront license fee, royalty fees, and certain milestone
payments.
MultiCell Immunotherapeutics,
Inc. (MCIT) License Agreement. Oxis licensed exclusive rights to
three antibody-drug
conjugates (ADCs) that MCIT
will prepare for further evaluation by Oxis as prospective
therapeutics for the treatment of triple-negative breast cancer,
and multiple myeloma and associated osteolytic bone
disease. Under the terms of the
agreement, MCIT will develop three ADC product candidates which
contain Oxis’ lead drug candidates OXS-2175 and
OXS-4235. Oxis paid MCIT a license fee of $500,000 and
will reimburse MCIT up to $1.125 million for its development costs
to make the three ADCs exclusively licensed to
Oxis. Assuming all clinical development milestones are
achieved and manufacturing rights to the three ADCs purchased, Oxis
will pay MCIT an additional sum of $22.75 million and pay a royalty
of 3% of net yearly worldwide sales upon marketing approval of the
ADCs.
Results of Operations
Comparison of the Three Months Ended September 30, 2016 and
2015
Research and Development Expenses
During the three
months ended September 30, 2016 and 2015, we incurred $250,000 and
$225,000 of research and development expenses.
Selling, general and administrative expenses
During the three
months ended September 30, 2016 and 2015, we incurred $2,280,000
and $2,552,000 of selling, general and administrative
expenses. The increase in selling, general and
administrative expenses is primarily attributable to an increase in
professional fees, license fees investor relations and stock
compensation.
Change in value of warrant and derivative liabilities
During the three
months ended September 30, 2016, we recorded a gain as a result of
a decrease in the fair market value of outstanding warrants and
beneficial conversion features of $436,000, compared to a gain
of $2,809,000 during the three months ended September 30, 2015.
This reduction is a result of a decrease in the fair market value
of outstanding debt and equity securities accounted for as
derivative liabilities and the conversion of warrants to common
stock.
Interest Expense
Interest expense
was $1,536,000 and $1,724,000 for the three months ended September
30, 2016 and 2015 respectively. The decrease is
primarily due to an decrease in the non-cash amortization of the
debt issuance costs associated with the convertible debentures and
demand notes payable and expenses related the issuance of
additional shares
Comparison of the Nine Months Ended September 30, 2016 and
2015
License revenue
During the nine
months ended September 30, 2016 and 2015, we received $-0- and
$27,000 of licensing revenue related to a Vitamin D producing line
of sun care and skin care products under a license from
ESLLC.
Research and Development Expenses
During the nine
months ended September 30, 2016 and 2015, we incurred $725,000 and
$475,000 of research and development expenses.
Selling, general and administrative expenses
During the nine
months ended September 30, 2016 and 2015, we incurred $7,827,000
and $5,571,000 of selling, general and administrative
expenses. The increase in selling, general and
administrative expenses is primarily attributable to an increase in
professional fees, license fees and stock
compensation.
Change in value of warrant and derivative liabilities
During the nine
months ended September 30, 2016, we recorded a gain as a result of
a decrease in the fair market value of outstanding warrants and
beneficial conversion features of
$25,930,000, compared to a gain of $20,683,000
during the nine months ended June 30, 2015.
Interest
Expense
Interest
expense was $4,781,000 and $10,012,000 for the nine months ended
September 30, 2016 and 2015 respectively. The decrease
is primarily due to a decrease in the non-cash amortization of the
debt issuance costs associated with the convertible debentures and
demand notes payable, non-cash interest related to the beneficial
conversion feature of new debt and expenses related the issuance of
additional shares
Liquidity and Capital Resources
On
a consolidated basis, we had cash and cash equivalents of $154,000
at September 30, 2016 and $16,966,000 of current liabilities (of
which $16,782,000 represented current cash obligations and $184,000
represented non-cash warrant liabilities and accrued
expenses). As a result, on a cash basis, as of September
30, 2016, we had a working capital deficit of
$16,810,000. In addition, we have an accumulated deficit
of $121,820,000 through September 30, 2016.
In
January 2016, the Company entered into convertible debentures
totaling $150,000.
In
May 2016, the Company entered into convertible debentures totaling
$1,390,044.
In July 2016, the Company entered into convertible
debentures totaling $112,135.
In August 2016, the Company entered into
convertible debentures totaling $250,000.
Critical Accounting Policies
We
consider the following accounting policies to be critical given
they involve estimates and judgments made by management and are
important for our investors’ understanding of our operating
results and financial condition.
Basis of Consolidation
The
consolidated financial statements contained in this report include
the accounts of OXIS International, Inc. and its
subsidiaries. All intercompany balances and transactions
have been eliminated.
Revenue Recognition
Product Revenue
The
Company manufactures, or has manufactured on a contract basis, fine
chemicals and nutraceutical products, which are its primary
products to be sold to customers. Revenue from the sale of its
products, including shipping fees, will be recognized when title to
the products is transferred to the customer which usually occurs
upon shipment or delivery, depending upon the terms of the sales
order and when collectability is reasonably assured. Revenue from
sales to distributors of its products will be recognized, net of
allowances, upon delivery of product to the distributors. According
to the terms of individual distributor contracts, a distributor may
return product up to a maximum amount and under certain conditions
contained in its contract. Allowances are calculated based upon
historical data, current economic conditions and the underlying
contractual terms.
License Revenue
License
arrangements may consist of non-refundable upfront license fees and
various performance or sales milestones and future product royalty
payments. Some of these arrangements are multiple
element arrangements. Non-refundable, up-front fees that
are not contingent on any future performance by us, and require no
consequential continuing involvement on our part, are recognized as
revenue when the license term commences and the licensed data,
technology and/or compound is delivered. We defer
recognition of non-refundable upfront fees if we have continuing
performance obligations without which the technology, right,
product or service conveyed in conjunction with the non-refundable
fee has no utility to the licensee that is separate and independent
of our performance under the other elements of the
arrangement. In addition, if we have continuing
involvement through research and development services that are
required because our know-how and expertise related to the
technology is proprietary to us, or can only be performed by us,
then such up-front fees are deferred and recognized over the period
of continuing involvement.
Long-Lived Assets
Our
long-lived assets include property, plant and equipment,
capitalized costs of filing patent applications and goodwill and
other assets. We evaluate our long-lived assets for
impairment in accordance with ASC 360, whenever events or changes
in circumstances indicate that the carrying amount of such assets
may not be recoverable. Estimates of future cash flows
and timing of events for evaluating long-lived assets for
impairment are based upon management’s
judgment. If any of our intangible or long-lived assets
are considered to be impaired, the amount of impairment to be
recognized is the excess of the carrying amount of the assets over
its fair value.
Applicable
long-lived assets are amortized or depreciated over the shorter of
their estimated useful lives, the estimated period that the assets
will generate revenue, or the statutory or contractual term in the
case of patents. Estimates of useful lives and periods
of expected revenue generation are reviewed periodically for
appropriateness and are based upon management’s
judgment. Goodwill and other assets are not
amortized.
Certain Expenses and Liabilities
On
an ongoing basis, management evaluates its estimates related to
certain expenses and accrued liabilities. We base our
estimates on historical experience and on various other assumptions
that we believe to be reasonable under the circumstances, the
results of which form the basis for making judgments about the
carrying values of liabilities that are not readily apparent from
other sources. Actual results may differ materially from
these estimates under different assumptions or
conditions.
Derivative Financial Instruments
During
the normal course of business, from time to time, we issue warrants
as part of a debt or equity financing. We do not enter into any
derivative contracts for speculative purposes. We recognize all
derivatives as assets or liabilities measured at fair value with
changes in fair value of derivatives reflected as current period
income or loss unless the derivatives qualify for hedge accounting
and are accounted for as such. During the nine months ended
September 30, 2016 and 2015, we issued warrants to purchase
3,475,111 and 376,000 shares of common stock, respectively, in
connection with equity transactions. In accordance with ASC Topic
815-40, “Derivatives and Hedging — Contracts in
Entity’s Own Stock” (“ASC 815-40”), the
value of these warrants is required to be recorded as a liability,
as the holders have an option to put the warrants back to us in
certain events, as defined.
Inflation
We
believe that inflation has not had a material adverse impact on our
business or operating results during the periods
presented.
Off-balance Sheet Arrangements
We
have no off-balance sheet arrangements as of September 30,
2016.
Item 3. Quantitative and Qualitative Disclosures About
Market Risk
This
company qualifies as a smaller reporting company, as defined in 17
C.F.R. §229.10(f) (1) and is not required to provide
information by this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer
evaluated the effectiveness of our “disclosure controls and
procedures” (as such term is defined in Rules 13a-15(e) and
15d-15(e) of the United States Securities Exchange Act of 1934, as
amended), as of September 30, 2016. Based on that
evaluation we have concluded that our disclosure controls and
procedures were not effective as of September 30,
2016.
Management’s Report on Internal Control over Financial
Reporting
Management
is responsible for establishing and maintaining adequate internal
control over financial reporting. Internal control over
financial reporting is defined in Rule 13a-15(f) or 15d-15(f)
promulgated under the Securities Exchange Act of 1934, as amended,
as a process designed by, or under the supervision of, a
company’s principal executive and principal financial
officers and effected by a company’s board of directors,
management and other personnel, to provide reasonable assurance
regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in
accordance with generally accepted accounting principles and
includes those policies and procedures that:
●
Pertain
to the maintenance of records that in reasonable detail accurately
and fairly reflect the transactions and dispositions of the assets
of the company;
●
Provide
reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with
generally accepted accounting principles, and that receipts and
expenditures of the company are being made only in accordance with
authorizations of management and directors of the company;
and
●
Provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the company’s
assets that could have a material effect on the financial
statements.
All
internal control systems, no matter how well designed, have
inherent limitations and can provide only reasonable, not absolute,
assurance that the objectives of the control system are
met. Further, the design of a control system must
reflect the fact that there are resource constraints, and the
benefits of controls must be considered relative to their
costs. Because of the inherent limitations in all
control systems, no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any,
within our company have been detected. Therefore, even
those systems determined to be effective can provide only
reasonable assurance with respect to financial statement
preparation and presentation.
As
of September 30, 2016, management of the company conducted an
assessment of the effectiveness of the company’s internal
control over financial reporting. In making this
assessment, it used the criteria set forth by the Committee of
Sponsoring Organizations of the Treadway Commission (COSO) in
Internal Control—Integrated Framework. In the
course of the assessment, material weaknesses were identified in
the company’s internal control over financial
reporting.
A
material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such
that there is a reasonable possibility that a material misstatement
of our annual or interim financial statements will not be prevented
or detected on a timely basis.
Management
determined that fundamental elements of an effective control
environment were missing or inadequate as of September 30,
2016. The most significant issues identified were: 1)
lack of segregation of duties due to very small staff and
significant reliance on outside consultants, and 2) risks of
executive override also due to lack of established policies, and
small employee staff. Based on the material weaknesses
identified above, management has concluded that internal control
over financial reporting was not effective as of September 30,
2016. As the company’s operations increase, the
company intends to hire additional employees in its accounting
department.
Changes in Internal Control over Financial Reporting
Other
than as described above, no changes in our internal control over
financial reporting were made during our most recent fiscal quarter
that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
In May, 2015, Aaion
Partners Inc, a consulting firm, filed a breach of contract
action against the Company in the Superior Court of California
County of Los Angeles, Case No: BC581098. The
lawsuit seeks payment under a consulting agreement. In
July, 2015, the Company filed a cross-claim against Aaion
Partners Inc. for breach of contract and tort claims. In
December 2015, we settled this claim for $150,000 to be made in
three cash payments and 11,429 shares of restricted common
stock. The Company paid
$50,000 of the cash due and issued the stock owed. As of this
filing, the Company has not made the 2 remaining cash payments and
is in default in the settlement agreement.
On June 23, 2016,
the Company was served with a complaint filed in the Circuit Court
of the 13th Judicial Circuit in
and for Hillsborough County, FL, Case No. 16-CA-004791. Suit was
brought against the Company by Lippert/Heilshorn and Associates,
Inc. who is alleging they are owed compensation for consulting
services provided to the company. They are seeking payment of
$73,898. The Company has engaged legal counsel to answer the
complaint.
Item 1A. Risk Factors
This
company qualifies as a “smaller reporting company” as
defined in 17 C.F.R. §229.10(f)(1), and is not required to
provide information by this Item.
Item 2. Unregistered Sales of Securities and Use of
Proceeds
In January 2015, the Company agreed to issue 39,657 shares of
common stock as a price protection to a note holder that originally
converted notes at a price of $2.50 and continues to hold these
shares. These additional shares would have been issued if the
conversion shares price was $1.75. As of December 31,
2015, 33,142 shares of common stock have been issued and
$247,000 of interest expense was recorded for this issuance. During
January 2016 the remaining 6,515 share were issued and $20,000 of
interest expense was recorded.
During the nine months
ending September 30, 2016, the Company issued an
aggregate of 12,580,183 shares of
common stock to a total of 34 persons or entities in exchange of
the cancellation of warrants on a cashless basis. The
shares issued were exempt from the registration requirements of
Section 5 of the Securities Act of 1933 (the “Act”)
pursuant to Section 4(2) of the Act since
the shares were issued to persons or entities closely associated
with the Company and there was no public offering of the
shares.
During the nine months
ending September 30, 2016, the Company also issued an
aggregate of 2,022,230 shares of
common stock to a total of 17 persons as payment for consulting
services provided to the Company. The average valuation
of these shares was $2.00 per share. These shares were also exempt
from the registration requirements of Section 5 of the Act pursuant
to Section 4(2) of the Act
since the shares were also issued to persons closely associated
with the Company and there was no public offering of the
shares.
During the nine months ending September 30, 2016, the Company also
issued an aggregate of 4,612,341 shares of common stock to two
executive officers of the Company in fulfilment of contractual
rights held by the officers pursuant to their employment
agreements. These shares were also exempt from the
registration requirements of Section 5 of the Act pursuant to
Section 4(2) of the Act since the shares were also issued to
persons closely associated with the Company and there was no public
offering of the shares.
During the nine months
ending September 30, 2016, the Company also issued an
aggregate of 5,301,205 shares of
common stock to a total of 18 persons as payment for the conversion
of certain note and the related accrued interest. The
conversion price of these shares was $0.40 per share. These shares
were also exempt from the registration requirements of Section 5 of
the Act pursuant to Section 4(2) of the Act
since the shares were also issued to persons closely associated
with the Company and there was no public offering of the
shares.
In July 2016, the Company entered into a securities purchase
agreement with one accredited investor to sell 10% convertible
debentures, with and an exercise price of $0.40, with an initial
principal balance of $112,135 and warrants to acquire up to 280,338
shares of the Company’s common stock at an exercise price of
$0.45 per share.
In July 2016, the
Company also issued an aggregate of 1,026,019 shares of common stock to a
total of three persons or entities as payment for the conversion of
certain note and the related accrued interest. The
conversion price of these shares was $0.40 per share. These shares
were also exempt from the registration requirements of Section 5 of
the Act pursuant to Section 4(2) of the Act
since the shares were also issued to persons closely associated
with the Company and there was no public offering of the
shares.
In August 2016, the
Company issued 1,115,000 shares
of common stock to H.C. Wainwright and Co., LLC as payment for
investment banking services provided to the
Company.
In August 2016, the Company entered into a securities purchase
agreement with one accredited investor to sell 10% convertible
debentures up $1,000,000, with and an exercise price of $0.40, with
an initial principal balance of $250,000 and warrants to acquire up
to 2,500,000 shares of the Company’s common stock at an
exercise price of $0.45 per share.
In October 2016 the
Company issued an aggregate of
453,431 shares of common stock to one noteholder as payment for the
conversion of certain accrued interest. The conversion
price of these shares was $0.40 per share. These shares were also
exempt from the registration requirements of Section 5 of the Act
pursuant to Section 4(2) of the Act
since the shares were also issued to persons closely associated
with the Company and there was no public offering of the
shares.
In October 2016 the
Company issued an aggregate of
594,530 shares of common stock to one noteholder as payment for the
conversion of a certain note. The conversion price of
these shares was $0.0841 per share based on 60% of the
average of the lowest three trading prices occurring at any time
during the 20 trading days preceding conversion These shares were also exempt from the
registration requirements of Section 5 of the Act pursuant
to Section 4(2) of the Act
since the shares were also issued to persons closely associated
with the Company and there was no public offering of the
shares.
In November 2016 the Company issued an aggregate of 975,039 shares
of common stock to one noteholder as payment for the
conversion of a certain note. The conversion price of these shares
was $0.0513 per share based on 60% of the
average of the lowest three trading prices occurring at any time
during the 20 trading days preceding
conversion These shares were also exempt from the registration
requirements of Section 5 of the Act pursuant to
Section 4(2) of the Act since the shares were also issued to
persons closely associated with the Company and there
was no public offering of the shares.
Item 3. Defaults Upon Senior Securities.
There
have been no material changes from the disclosure provided in Part
I, Item 7 of our Annual Report on Form 10-K for the year ended
December 31, 2015.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information.
None.
Item 6. Exhibits
Exhibit Number
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Description
of Exhibit
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Certification of
Principal Executive Officer pursuant to Rule 13a-14 and Rule
15d-14(a), promulgated under the Securities and Exchange Act of
1934, as amended.
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Certification of
Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d
14(a), promulgated under the Securities and Exchange Act of 1934,
as amended.
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Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 (Chief Executive
Officer).
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Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 (Chief Financial
Officer).
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101.INS
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XBRL Instance
Document
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101.SCH
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XBRL Taxonomy
Extension Schema
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101.CAL
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XBRL Taxonomy
Extension Calculation Linkbase
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101.DEF
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XBRL Taxonomy
Extension Definition Linkbase
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101.LAB
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XBRL Taxonomy
Extension Label Linkbase
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101.PRE
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XBRL Extension
Presentation Linkbase
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SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly
authorized.
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GT Biopharma, Inc.
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Dated:
February 28, 2018
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By:
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/s/ Shawn
Cross
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Shawn
Cross
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Chief Executive
Officer and Chairman of the Board
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Pursuant
to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of
the registrant and in the capacities and on the dates
indicated.
Name
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Position
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Date
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/s/ Shawn
Cross
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Chief Executive
Officer and Chairman of the Board
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February 28,
2018
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Shawn
Cross |
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/s/ Steven
Weldon
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Chief Financial
Officer (Principal Financial Officer), and
Director
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February 28,
2018
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Steven
Weldon |
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/s/ Dr. Kathleen
Clarence-Smith
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Vice Chairwoman and
Director
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February 28,
2018
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Dr. Kathleen
Clarence-Smith |
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/s/ Anthony J.
Cataldo
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Director
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February 28,
2018
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Anthony J.
Cataldo |
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/s/ Geoffrey
Davis
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Director
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February 28,
2018
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Geoffrey
Davis |
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