GT Biopharma, Inc. - Quarter Report: 2017 June (Form 10-Q)
U. S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
☑ Quarterly report pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
For the quarterly period ended June 30, 2017.
☐ For the transition
period from to .
Commission File Number 0-8092
GT BIOPHARMA, 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)
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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 ☐
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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
August 11, 2017, the issuer had outstanding the indicated number of
shares of common stock: 496,441.
GT BIOPHARMA, INC. AND SUBSIDIARIES
FORM 10-Q
For the Six Months Ended June 30, 2017
Table of Contents
PART
I FINANCIAL INFORMATION
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Page
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Item
1. Financial
Statements
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3
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Consolidated
Balance Sheets as of June 30, 2017 (Unaudited) and December 31,
2016
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3
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Consolidated
Statements of Operations for the three and six months ended June
30, 2017 and 2016 (Unaudited)
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4
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Consolidated
Statements of Cash Flows for the six months ended June 30, 2017 and
2016 (Unaudited)
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5
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Condensed Notes to
Consolidated Financial Statements
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6
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Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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15
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Item
3. Quantitative and
Qualitative Disclosures About Market Risk
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20
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Item
4. Controls and
Procedures
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20
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PART
II OTHER INFORMATION
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Item
1. Legal
Proceedings
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22
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Item
1A. Risk
Factors
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22
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Item
2. Unregistered Sales
of Securities and Use of Proceeds
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22
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Item
3. Defaults Upon
Senior Securities
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23
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Item
4. Mine Safety
Disclosures
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23
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Item
5. Other
Information
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23
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Item
6. Exhibits
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23
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SIGNATURES
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24
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2
GT Biopharma, Inc. and Subsidiaries
as of June 30,2017 and December 31, 2016
Consolidated Balance Sheets
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June 30,
2017
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December 31,
2016
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ASSETS
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(unaudited)
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Current
Assets:
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Cash
and cash equivalents
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$39,000
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$19,000
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Prepaid
expenses
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-
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2,000
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Total
Current Assets
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39,000
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21,000
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Fixed
assets, net
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3,000
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4,000
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Total
Other Assets
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3,000
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4,000
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TOTAL
ASSETS
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$42,000
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$25,000
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LIABILITIES AND STOCKHOLDERS’ DEFICIT
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Current
Liabilities:
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Accounts
payable
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$2,347,000
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$2,100,000
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Accrued
interest
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4,339,000
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3,800,000
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Accrued
expenses
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57,000
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219,000
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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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964,000
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417,000
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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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190,000
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452,000
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Convertible
debentures, net of discount of $215,000 and $794,000, current
portion
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10,663,000
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10,350,000
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Convertible
debentures
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844,000
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889,000
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Total
Current Liabilities
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20,126,000
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18,949,000
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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 June 30,
2017 and December 31, 2016, 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 June
30, 2017 and December 31, 2016, respectively
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—
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—
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Series
I – 1,666,667 shares issued and outstanding at June 30, 2017
and December 31, 2016, respectively
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2,000
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2,000
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Common
stock - $0.001 par value; 750,000,000 shares authorized; and
496,441 and 104,218 shares issued and outstanding at June 30, 2017
and December 31, 2016, respectively
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0
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0
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Additional
paid-in capital
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109,876,000
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105,891,000
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Accumulated
deficit
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(129,794,000)
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(124,649,000)
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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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(20,084,000)
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(18,924,000)
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TOTAL
LIABILITIES AND STOCKHOLDERS’ DEFICIT
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$42,000
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$25,000
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The accompanying notes are an integral part of these consolidated
financial statements.
3
GT BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
For the Six Months Ended June 30, 2017 and 2016
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Three Months
Ended June 30,
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Six Months Ended
June 30,
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||
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2017
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2016
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2017
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2016
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Product
revenues
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$-
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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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-
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Total
revenue
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-
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-
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-
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-
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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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-
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Operating
expenses
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Research and
development
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241,000
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250,000
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385,000
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475,000
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Selling, general
and administrative expenses
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1,044,000
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1,871,000
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2,438,000
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5,547,000
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Total operating
expenses
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1,285,000
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2,121,000
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2,823,000
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6,022,000
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Loss from
operations
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(1,285,000)
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(2,121,000)
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(2,823,000)
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(6,022,000)
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Other income
(expense)
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Change in value of
warrant and derivative liabilities
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(367,000)
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5,263,000
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2,376,000
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36,759,000
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Interest
expense
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(1,178,000)
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(1,599,000)
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(4,698,000)
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(3,245,000)
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Total other income
(expense)
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(1,545,000)
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3,664,000
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(2,322,000)
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33,514,000
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Income (loss)
before minority interest and provision for
income taxes
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(2,830,000)
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1,543,000
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(5,145,000)
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27,492,000
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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 before
provision for income taxes
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(2,830,000)
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1,543,000
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(5,145,000)
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27,492,000
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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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(2,830,000)
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1,543,000
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(5,145,000)
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27,492,000
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Weighted average
common shares outstanding – basis and diluted
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Basic
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479,053
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77,785
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335,450
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67,918
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Diluted
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479,053
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84,690
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335,450
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67,918
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Net income (loss)
per share
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Basic
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$(5.91)
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$19.84
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$(15.34)
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$404.78
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Diluted
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$(5.91)
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$18.22
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$(15.34)
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$404.78
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The accompanying condensed notes are an integral part of these
consolidated financial statements.
4
GT BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
For the Six Months Ended June 30, 2017 and 2016
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2017
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2016
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(unaudited)
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(unaudited)
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CASH
FLOWS FROM OPERATING ACTIVITIES:
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Net
(loss)/income
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$( 5,145,000)
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$27,492,000
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Adjustments
to reconcile net (loss)/income to net cash used in operating
activities:
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Depreciation
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1,000
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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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1,524,000
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4,051,000
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Amortization
of debt discounts
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1,376,000
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972,000
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Note
allonge
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100,000
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-
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Non-cash
interest expense
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2,197,000
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1,504,000
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Change
in value of warrant and derivative liabilities
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( 2,376,000)
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( 36,759,000)
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Changes
in operating assets and liabilities:
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Other
assets
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-
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0
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Accounts
payable and accrued liabilities
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1,282,000
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1,508,000
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Net
cash used in operating activities
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( 1,041,000)
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( 1,232,000)
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CASH
FLOWS FROM INVESTING ACTIVITIES:
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Acquisition
of fixed assets
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0
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0
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Net
cash used by investing activities
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0
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0
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CASH
FLOWS FROM FINANCING ACTIVITIES:
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Proceeds
from notes payable
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1,061,000
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1,540,000
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Repayment
of note payable
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-
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-
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Net
cash provided by financing activities
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1,061,000
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1,540,000
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Minority
interest
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-
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-
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NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
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20,000
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308,000
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CASH
AND CASH EQUIVALENTS - Beginning of period
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19,000
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47,000
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CASH
AND CASH EQUIVALENTS - End of period
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$39,000
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$355,000
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Supplemental
disclosures:
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Interest
paid
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$-
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$-
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Income
taxes paid
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$-
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$-
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Supplemental
disclosures:
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Issuance
of common stock upon conversion of convertible notes
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$2,025,000
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$1,429,000
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Issuance
of common stock upon conversion of accrued interest
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$486,000
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$270,000
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The accompanying condensed notes are an integral part of these
consolidated financial statements.
5
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
1.
The Company and Summary of Significant Accounting
Policies
GT Biopharma, 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. In
July 2017, the Company changed its name to GT Biopharma,
Inc.
Going Concern
As
shown in the accompanying consolidated financial statements, the
Company has incurred an accumulated deficit of $129,794,000 through
June 30, 2017. On a
consolidated basis, the Company had cash and cash equivalents of
$39,000 at June 30, 2017.
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.
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.
Basis of Consolidation and Comprehensive Income
The accompanying consolidated financial statements include the
accounts of GT Biopharma, 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.
6
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
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, 2016. 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.
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 June 30, 2017.
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 Employees
The
Company accounts for its stock-based compensation for employees in
accordance with Accounting Standards Codification
(“ASC”) 718. The Company recognizes in the
statement of operations the grant-date fair value of stock options
and other equity-based compensation issued to employees and
non-employees over the related vesting period.
The
Company granted no stock options during the six months ended June
30, 2017 and 2016, respectively
Recent Accounting Pronouncement
In July
2017, The Financial Accounting Standards Board issued Accounting
Standards Update 2017-11 “Earnings per Share (Topic 260),
Distinguishing Liabilities from Equity (Topic 480), Derivatives and
Hedging (Topic 815)” (“ASU 2017-11”) to address
narrow issues identified as a result of the complexity associated
with applying generally accepted accounting principles (GAAP) for
certain financial instruments with characteristics of liabilities
and equity. Part I of the amendment change the classification
analysis of certain equity-linked financial instruments (or
embedded features) with down round features. The amendments also
clarify existing disclosure requirements for equity-classified
instruments. Part II of the update recharacterize the indefinite deferral
of certain provisions of
Topic 480 that now are presented as pending content in the
Codification, to a scope exception. Those amendments do not have an
accounting effect. Part I of ASU 2017-11 is effective for public
business entities for fiscal years, and interim period within those
fiscal years, beginning after December 15, 2018, with early
adoption permitted. The Company has a number of equity linked
financial instruments with down round provisions and is currently
evaluating the impact of adopting ASU-2017-11.
7
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
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.
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 1,030,951 and 43,002 as of June
30, 2017 and 2016, 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 is 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:
8
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
●
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.
The following table represents the Company’s assets and
liabilities by level measured at fair value on a recurring basis at
June 30, 2017.
Description
|
Level 1
|
Level 2
|
Level 3
|
|
|
|
|
Assets
|
|
|
|
|
$—
|
$—
|
$—
|
Liabilities
|
|
|
|
Warrant
liability
|
—
|
964,000
|
—
|
Research and Development
Research and development costs are expensed as incurred and
reported as research and development expense. Research and
development costs totaling $385,000 and $475,000 for the six months
ended June 30, 2017 and 2016, 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.
9
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
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.
2.
Debt
Senior secured 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 the lesser of $120.00 or 60% of the average of the lowest
three trading prices occurring at any time during the 20 trading
days preceding conversion (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.
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 $350,000 increasing the principal amount of the 2006
Debentures.
During the six months ended June 30, 2017 the Company converted a
total of $45,000 of the 2006 Debentures into common stock of the
Company. As of June 30, 2017, the balance of the 2006
Debentures is $844,000.
10
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
Convertible debentures
From
October 2009 to September 2016, the Company has entered into
multiple convertible debenture arrangements with several accredited
investors (“Convertible Debentures”). Interest on the
Convertible Debentures ranges for 0% to 18% with a default rate of
18%. The Convertible Debentures are either two year or six month
notes.
The
conversion price of the Convertible Debentures is 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. As a result of
the full ratchet anti-dilution provision, the current conversion
price is the lesser of (i) $15.00 or (ii) the average of the three
(3) lowest intra-day trading prices of the Common Stock during the
20 Trading Days immediately prior to the date on which the Notice
of Conversion is delivered to the Company and the default
conversion price is 65% of the average of the lowest three trading
prices occurring at any time during the 20 trading days preceding
conversion.
The
holders of the Convertible Debentures have contractually agreed to
restrict their ability to convert their Convertible Debentures and
receive shares of our common stock such that the number of shares
of the Company common stock held by holders and its affiliates
after such conversion or exercise does not exceed 4.9% or 9.9% of
the Company’s then issued and outstanding shares of common
stock.
Note
Agreement
|
Balance
at
June
30,
2017
|
Balance
at
December
31,
2016
|
|
|
|
2009
Debentures
|
$305,000
|
$305,000
|
June 2011
Debentures
|
45,000
|
64,000
|
November 2011
Debentures
|
125,000
|
125,000
|
March 2012
Debentures
|
40,000
|
140,000
|
May 2012
Debentures
|
95,000
|
225,000
|
December 2012
Debentures
|
390,000
|
425,000
|
November 2013
Debentures
|
149,000
|
172,000
|
July 2014
Debentures
|
2,590,000
|
3,140,000
|
October 2014
Debentures
|
1,221,000
|
1,250,000
|
March 2015
Debentures
|
1,689,000
|
2,175,000
|
July 2015
Debentures
|
500,000
|
500,000
|
October 2015
Debentures
|
300,000
|
330,000
|
November 2015
Debentures
|
150,000
|
190,000
|
December 2015
Debentures
|
200,000
|
200,000
|
January 2016
Debentures
|
-
|
150,000
|
May 2016
Debentures
|
1,503,000
|
1,503,000
|
September 2016
Debentures
|
225,000
|
250,000
|
January 2017
Debentures
|
924,000
|
-
|
March 2017
Debentures
|
232,000
|
|
April 2017
Debentures
|
195,000
|
-
|
|
|
|
Total convertible
debentures
|
$10,878,000
|
$11,144,000
|
Less:
discount
|
(215,000)
|
(794,000)
|
Total convertible
debentures, net of discount
|
$10,663,000
|
$10,350,000
|
|
|
|
Total short term
convertible debentures, net of discount
|
$10,663,000
|
$10,350,000
|
11
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
Settlement Note Payable
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 Theorem, 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 (371 shares at
$1,125.00 per share, of which 122 will be retained by Bristol and
249 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 $15 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. This settlement note payable is
currently in default and has a balance of $691,000 as of June 30,
2017.
Demand Notes
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 the lesser of (i) $15.00 or (ii) the
average of the three (3) lowest intra-day trading prices of the
Common Stock during the 20 Trading Days immediately prior to the
date on which the Notice of Conversion is delivered to the Company.
During the
quarter ended March 31, 2017 the Company converted the entire
balance of $31,375 into common stock of the
Company.
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 the lesser of (i) $15.00 or
(ii) the average of the three (3) lowest intra-day trading prices
of the Common Stock during the 20 Trading Days immediately prior to
the date on which the Notice of Conversion is delivered to the
Company. During the quarter
ended March 31, 2017 the Company converted the entire balance of
$31,375 into common stock of the Company.
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 the lesser of (i) $15.00 or (ii) the average of
the three (3) lowest intra-day trading prices of the Common Stock
during the 20 Trading Days immediately prior to the date on which
the Notice of Conversion is delivered to the Company. During the quarter
ended March 31, 2017 the Company converted the entire balance of
$200,000 into common stock of the
Company.
In
December, 2013, the Company entered into a convertible demand
promissory note with an initial principal balance of $189,662
convertible at a price equal to the lesser of (i) $15.00 or (ii)
the average of the three (3) lowest intra-day trading prices of the
Common Stock during the 20 Trading Days immediately prior to the
date on which the Notice of Conversion is delivered to the
Company.
12
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
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 June 30, 2017.
3.
Stockholders' Equity
Common Stock
During the six months ended June 30, 2017 the Registrant has issued
a total of 418,448 shares of common stock to a total of eleven
entities or individuals in exchange for the cancellation of debt in
the total amount of $2,025,000 and interest in the total amount of
$486,000.
The Registrant also issued 1,944 shares of common stock to one
entity upon the exercise of warrants on a cashless
basis.
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 4.9% of the fully diluted shares of Common Stock upon
successful completion by the Company of a $6 million
financing.
4.
Stock Options and Warrants
Stock Options
Following is a summary of the stock option activity:
|
Options
Outstanding
|
Weighted Average
Exercise Price
|
Outstanding as of
December 31, 2016
|
1,246
|
$1,428.12
|
Granted
|
-
|
-
|
Forfeited
|
-
|
-
|
Exercised
|
-
|
-
|
Outstanding as of
June 30, 2017
|
1,246
|
$1,428.12
|
13
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2017
(UNAUDITED)
Warrants
Following is a summary of the warrant activity:
|
Warrants
Outstanding
|
Weighted Average
Exercise Price
|
Outstanding as of
December 31, 2016
|
15,550
|
$15.00
|
Granted
|
175,968
|
15.00
|
Forfeited
|
-
|
-
|
Exercised
|
(1,944)
|
15.00
|
Outstanding as of
June 30, 2017
|
189,574
|
$15.00
|
6.
Subsequent Events
Convertible Notes
In July
2017, the Company entered into a securities purchase agreement with
three accredited investors to sell 10% convertible debentures with
an exercise price of the lesser of (i) $15.00 or (ii) the average
of the three (3) lowest intra-day trading prices of the Common
Stock during the 20 Trading Days immediately prior to the date on
which the Notice of Conversion is delivered to the Company, with an
initial principal balance of $650,000 and warrants to acquire up to
43,333 shares of the Company's common stock at an exercise price of
$15.00 per share.
Stock Split
In July 2017, the Company approved a one for three hundred reverse
stock split. The Company has reported the effect of the split
retroactively for all periods presented.
Common Shares
In July 2017, the Company amended its articles of incorporation to
change the number of authorized common shares to 750,000,000 shares
of $.001 par value stock.
Agreements
Oxis International, Inc. has engaged EMLL Group, LLC to provide
public relations/investor relations services to Oxis for a six
month period beginning on July 17, 2017. EMLL Group, LLC will
provide exposure and communications of Oxis corporate plans and
developments to current and potential investors.
14
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, 2016. 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 GT Biopharma, Inc., a
Delaware corporation formerly known as DDI Pharmaceuticals, Inc.,
Diagnostic Data, Inc and Oxis International, Inc, together with our
subsidiaries.
Overview
GT Biopharma, 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 six 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.
Oxis began enrolling patients in Phase 2 trial of OXS-1550 during
the first quarter of 2017. at the University of Minnesota's Masonic
Cancer Center. The first patient began dosing in April
2017.
15
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.
U.S. Patent and Trademark Office approved and issued Patent No.
9,580,382 for drug candidate OXIS-4235 for the treatment of myeloma
in July 2017.
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
TriKE Agreements
In March 2017, we entered a new one-year Sponsored Research
Agreement with the University of Minnesota. The purpose of this
agreement is to determine toxicities and in vivo behavior in
our Trispecific Killer
Engager (TriKE) technology licensed by Oxis from the University of
Minnesota.
16
In June
2017, we entered into a
co-development partnership agreement with Altor BioScience Corp. in
which the companies will collaborate exclusively in the clinical
development of a novel 161533 TriKE fusion protein for cancer
therapies using Oxis' trispecific killer engager (TriKE)
technology.
Financing
In
January 2017, the Company entered into a securities purchase
agreement with eight accredited investors to sell 10% convertible
debentures with and an exercise price of the lesser of (i)
$15.00 or (ii) the average of the three (3) lowest intra-day
trading prices of the Common Stock during the 20 Trading Days
immediately prior to the date on which the Notice of Conversion is
delivered to the Company, with an initial principal balance
of $633,593 and warrants to acquire up to 42,239 shares of the
Company's common stock at an exercise price of $15.00 per
share.
In
March 2017, the Company entered into a securities purchase
agreement with two accredited investors to sell 10% convertible
debentures with and an exercise price of the lesser of (i)
$15.00 or (ii) the average of the three (3) lowest intra-day
trading prices of the Common Stock during the 20 Trading Days
immediately prior to the date on which the Notice of Conversion is
delivered to the Company, with an initial principal balance
of $232,313 and warrants to acquire up to 15,487 shares of the
Company's common stock at an exercise price of $15.00 per
share.
In
April 2017, the Company entered into a securities purchase
agreement with two accredited investors to sell 10% convertible
debentures with and an exercise price of the lesser of (i) $15.00
or (ii) the average of the three (3) lowest intra-day trading
prices of the Common Stock during the 20 Trading Days immediately
prior to the date on which the Notice of Conversion is delivered to
the Company, with an initial principal balance of $70,000 and
warrants to acquire up to 4,666 shares of the Company's common
stock at an exercise price of $15.00 per share.
In May
2017, the Company entered into a securities purchase agreement with
two accredited investors to sell 10% convertible debentures with
and an exercise price of the lesser of (i) $15.00 or (ii) the
average of the three (3) lowest intra-day trading prices of the
Common Stock during the 20 Trading Days immediately prior to the
date on which the Notice of Conversion is delivered to the Company,
with an initial principal balance of $125,000 and warrants to
acquire up to 8,333 shares of the Company's common stock at an
exercise price of $15.00 per share.
In July
2017, the Company entered into a securities purchase agreement with
three accredited investors to sell 10% convertible debentures with
and an exercise price of the lesser of (i) $15.00 or (ii) the
average of the three (3) lowest intra-day trading prices of the
Common Stock during the 20 Trading Days immediately prior to the
date on which the Notice of Conversion is delivered to the Company,
with an initial principal balance of $650,000 and warrants to
acquire up to 43,333 shares of the Company's common stock at an
exercise price of $15.00 per share.
Letter of Intent
In July 2017 the Company announced that the it agreed to acquire
Georgetown Translational Pharmaceuticals, Inc. (GTP) and hire a new
Chief Executive Officer and Chief Medical Officer. The Company has
agreed to pay 33 percent of its outstanding shares to GTP to
complete the transaction, which is expected to close on or before
90 days as per the agreement. GTP is a privately-owned
biotechnology company focused on acquiring or discovering and
patenting late-stage, de-risked, and close-to-market improved
treatments for CNS disease (Neurology and Pain) and shepherding the
products through the FDA approval process to the NDA. GTP products
currently include treatment for neuropathic pain, refractory
epilepsies, the symptoms of myasthenia gravis, and motion
sickness.
17
Results of Operations
Comparison of the Three Months Ended June 30, 2017 and
2016
Research and Development Expenses
During the three months ended June 30, 2017 and 2016, we incurred
$241,000 and $250,000 of research and development
expenses.
Selling, general and administrative expenses
During the three months ended June 30, 2017 and 2016, we incurred
$1,044,000 and $1,871,000 of selling, general and administrative
expenses. The decrease in selling, general and
administrative expenses is primarily attributable to an decrease in
professional fees and stock compensation.
Change in value of warrant and derivative liabilities
During the three months ended June 30, 2017, we recorded a loss as
a result of an increase in the fair market value of outstanding
warrants and beneficial conversion features of
$367,000, compared to a gain of $5,263,000 during the three
months ended June 31, 2016. We recorded a loss as a result of an
increase in the fair market value of outstanding debt and equity
securities accounted for as derivative liabilities.
Interest Expense
Interest expense was $1,178,000 and $1,599,000 for the three months
ended June 30, 2017 and 2016 respectively. The increase
is primarily due to an increase in the non-cash amortization of the
debt issuance costs associated with the convertible debentures and
demand notes payable.
Comparison of the Six Months Ended June 30, 2017 and
2016
Research and Development Expenses
During the six months ended June 30, 2017 and 2016, we incurred
$385,000 and $475,000 of research and development
expenses.
Selling, general and administrative expenses
During the six months ended June 30, 2017 and 2016, we incurred
$2,438,000 and $5,547,000 of selling, general and administrative
expenses. The decrease in selling, general and
administrative expenses is primarily attributable to an decrease in
professional fees and stock compensation.
Change in value of warrant and derivative liabilities
During the six months ended June 30, 2017, we recorded a gain as a
result of a decrease in the fair market value of outstanding
warrants and beneficial conversion features of
$2,376,000, compared to a gain of $36,759,000 during the six
months ended June 31, 2016. We recorded a gain as a result of a
decrease in the fair market value of outstanding debt and equity
securities accounted for as derivative liabilities.
Interest Expense
Interest expense was $4,698,000 and $3,245,000 for the six months
ended June 30, 2017 and 2016 respectively. The increase
is primarily due to an increase in the non-cash amortization of the
debt issuance costs associated with the convertible debentures and
demand notes payable.
18
Liquidity and Capital
Resources
As of
June 30, 2017, we had cash and cash equivalents of $39,000. This
cash and cash equivalents is in part the result of the proceeds
from borrowings in 2017. On the same day we had total current
assets of $39,000, and a working capital deficit of $20,087,000.
Based upon
the cash position, it is necessary to raise additional capital by
the end of the next quarter in order to continue to fund current
operations. The Company is pursuing several alternatives to address
this situation, including the raising of additional funding through
equity or debt financings. In order to finance existing operations
and pay current liabilities over the next twelve months, the
Company will need to raise approximately $4-5 million of
capital.
During the six months ending June 30, 2017, the Company entered
into convertible debentures totaling $1,351,000.
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 GT Biopharma, 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.
19
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 six
months ended June 30, 2017 and 2016, we issued warrants to purchase
175,968 and 11,584 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 June 30,
2017.
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 June 30, 2017. Based on that evaluation
we have concluded that our disclosure controls and procedures were
not effective as of June 30, 2017.
20
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:
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●
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Pertain
to the maintenance of records that in reasonable detail accurately
and fairly reflect the transactions and dispositions of the assets
of the company;
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●
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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
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●
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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.
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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 June 30, 2017, 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 June 30,
2017. 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 June 30,
2017. 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.
21
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 sought 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. The remaining two payments were not made
timely but settlement was finally and fully resolved upon payment
by the Company of an additional $132,231. The case was then
dismissed in January 2017.
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.
On or immediately before February 15, 2017, MultiCell
Immunotherapeutics filed an arbitration proceeding against the
Company with the American Health Lawyers Association, Claim
#3821. In its statement of claim, MultiCell is seeking
$207,783 plus interest and costs of arbitration pursuant to alleged
contract rights against the Company under a research agreement
between the parties. The Company has entered its appearance
and is preparing its answer to the statement of
claim.
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 2017, the Company entered into a securities purchase
agreement with eight accredited investors to sell 10% convertible
debentures with and an exercise price of the lesser of (i)
$15.00 or (ii) the average of the three (3) lowest intra-day
trading prices of the Common Stock during the 20 Trading Days
immediately prior to the date on which the Notice of Conversion is
delivered to the Company, with an initial principal balance
of $633,593 and warrants to acquire up to 42,240 shares of the
Company's common stock at an exercise price of $15.00 per
share.
In
March 2017, the Company entered into a securities purchase
agreement with two accredited investors to sell 10% convertible
debentures with and an exercise price of the lesser of (i)
$15.00 or (ii) the average of the three (3) lowest intra-day
trading prices of the Common Stock during the 20 Trading Days
immediately prior to the date on which the Notice of Conversion is
delivered to the Company, with an initial principal balance
of $232,313 and warrants to acquire up to 15,487 shares of the
Company's common stock at an exercise price of $15.00 per
share.
In
April 2017, the Company entered into a securities purchase
agreement with two accredited investors to sell 10% convertible
debentures with and an exercise price of the lesser of (i) $15.00
or (ii) the average of the three (3) lowest intra-day trading
prices of the Common Stock during the 20 Trading Days immediately
prior to the date on which the Notice of Conversion is delivered to
the Company, with an initial principal balance of $70,000 and
warrants to acquire up to 46,666 shares of the Company's common
stock at an exercise price of $15.00 per share.
In May
2017, the Company entered into a securities purchase agreement with
two accredited investors to sell 10% convertible debentures with
and an exercise price of the lesser of (i) $15.00 or (ii) the
average of the three (3) lowest intra-day trading prices of the
Common Stock during the 20 Trading Days immediately prior to the
date on which the Notice of Conversion is delivered to the Company,
with an initial principal balance of $125,000 and warrants to
acquire up to 8,333 shares of the Company's common stock at an
exercise price of $15.00 per share.
22
In July
2017, the Company entered into a securities purchase agreement with
one accredited investors to sell 10% convertible debentures with
and an exercise price of the lesser of (i) $15.00 or (ii) the
average of the three (3) lowest intra-day trading prices of the
Common Stock during the 20 Trading Days immediately prior to the
date on which the Notice of Conversion is delivered to the Company,
with an initial principal balance of $650,000 and warrants to
acquire up to 43,333 shares of the Company's common stock at an
exercise price of $15.00 per share.
These convertible debentures 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, 2016.
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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License Agreement with ID4 Pharma LLC
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License Agreement with MultiCell Immunotherapeutics,
Inc.
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License Agreement with the University of
Minnesota
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License Agreement
with Daniel A. Vallera, Ph.D.
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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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23
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:
August 11, 2017
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By:
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/s/ Anthony
J. Cataldo
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Anthony
J. Cataldo
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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/
Anthony J. Cataldo
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Chairman
of the Board, Chief Executive Officer and President of Oxis
Biotech
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August
11, 2017
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Anthony
J. Cataldo
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/s/
Steven Weldon
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Chief
Financial Officer (Principal Accounting Officer), President and
Director
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August
11, 2017
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Steven
Weldon
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24