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 March 31, 2020.
☐
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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9350 Wilshire Blvd.
Suite 203
Beverly Hills, CA 90212
(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 every Interactive Data File required to be
submitted 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 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 ☐
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Accelerated
filer ☐
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Non-accelerated
filer ☐
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Smaller
reporting company ☑
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Emerging
growth company ☐
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|
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If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a
shell company (as defined in Rule 12b-2 of the Exchange
Act).Yes ☐·No ☑
At
May 12, 2020, the issuer had outstanding the indicated number of
shares of common stock: 70,699,433.
GT Biopharma, Inc. and Subsidiaries
FORM 10-Q
For the Quarter Ended March 31, 2020
Table of Contents
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Page
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20
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21
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21
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21
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23
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23
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23
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24
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25
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GT Biopharma, Inc. and Subsidiaries
as of March 31,2020 and December 31, 2019
Consolidated Balance Sheets
(in Thousands, Except Par Value and Share Data)
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ASSETS
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Current
Assets:
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Cash
and cash equivalents
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$5
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$28
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Prepaid
expenses
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183
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246
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Total
Current Assets
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188
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274
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Deposits
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12
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12
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Operating
lease right-to-use asset
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95
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110
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Total
Other Assets
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107
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122
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TOTAL
ASSETS
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$295
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$396
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LIABILITIES AND STOCKHOLDERS’ DEFICIT
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Current
Liabilities:
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Accounts
payable
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$2,370
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$1,940
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Accrued
expenses
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2,736
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2,379
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Accrued
interest
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2,651
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2,029
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Operating
lease liability
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105
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120
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Line
of credit
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31
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31
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Convertible
debentures
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13,257
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13,207
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Total
Current Liabilities
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21,150
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19,706
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Total
liabilities
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21,150
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19,706
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Commitments
and Contingencies
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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 March 31,
2020 and December 31, 2019, respectively
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1
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1
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Series
J – 2,353,548 and 2,353,548 shares issued and outstanding at
March 31, 2020 and December 31, 2019, respectively
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2
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2
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Common
stock - $0.001 par value; 750,000,000 shares authorized; and
70,599,433 and 69,784,699 shares issued and outstanding at March
31, 2020 and December 31, 2019, respectively
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71
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70
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Additional
paid-in capital
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548,280
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548,118
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Accumulated
deficit
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(569,040)
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(567,332)
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Noncontrolling
interest
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(169)
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(169)
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Total
Stockholders’ Deficit
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(20,855)
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(19,310)
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TOTAL
LIABILITIES AND STOCKHOLDERS’ DEFICIT
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$295
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$396
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The
accompanying notes are an integral part of these consolidated
financial statements.
GT Biopharma,
Inc. and Subsidiaries
March 31, 2020 and 2019
(in Thousands, Except Par Value and Share Data)
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Revenue:
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License
revenues
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$-
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$-
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TOTAL
REVENUE
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-
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-
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Cost
of License Revenue
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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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Operating
Expenses:
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Research
and development
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324
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834
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Selling,
general and administrative
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746
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3,222
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Total
operating expenses
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1,070
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4,056
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Loss
from Operations
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(1,070)
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(4,056)
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Other
income (expense)
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Interest
expense/income
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(638)
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(454)
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Total
Other Income (Expense)
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(638)
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(454)
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Loss
before minority interest and provision for income
taxes
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(1,708)
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(4,510)
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Less:
Loss attributable to the noncontrolling interests
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-
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-
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Loss
before provision for income taxes
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(1,708)
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(4,510)
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Provision
for income taxes
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-
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-
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Net
loss
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(1,708)
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(4,510)
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Loss
per share
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Basic
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$(0.02)
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$(0.09)
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Diluted
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$(0.02)
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$(0.09)
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Weighted
Average Shares Outstanding –
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Basic
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70,077,026
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51,092,886
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Diluted
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70,077,026
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51,092,886
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The
accompanying notes are an integral part of these consolidated
financial statements.
GT Biopharma, Inc. and Subsidiaries
Consolidated Statements of Cash
Flows
For the Three Months Ended March 31, 2020 and 2019
(in Thousands)
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CASH
FLOWS FROM OPERATING ACTIVITIES:
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Net
loss
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$(1,708)
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$(4,510)
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Adjustments to reconcile net loss to net cash used in operating
activities:
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Depreciation
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-
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1
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Stock
compensation expense for options and warrants issued to
employees and non-employees
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-
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2,565
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Amortization
of debt discounts
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-
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163
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Changes
in operating assets and liabilities:
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Other
assets
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63
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3
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Accounts
payable and accrued liabilities
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1,422
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817
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Net
cash used in operating activities
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(223)
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(961)
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CASH
FLOWS FROM FINANCING ACTIVITIES:
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Proceeds
from notes payable
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200
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1,052
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Loan
costs
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-
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-
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Repayment
of note payable
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-
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(100)
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Net
cash provided by financing activities
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200
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952
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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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(23)
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(9)
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CASH
AND CASH EQUIVALENTS - Beginning of period
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28
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60
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CASH
AND CASH EQUIVALENTS - End of period
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$5
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$51
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Supplemental
disclosures:
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Interest
paid
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$-
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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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$150
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$430
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Issuance
of common stock upon conversion of accrued interest
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$12
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$4
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The
accompanying condensed notes are an integral part of these
consolidated financial statements.
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
1.
The Company and Summary of Significant Accounting
Policies
Business
In
1965, the corporate predecessor of GT Biopharma, 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.
We are a clinical stage biopharmaceutical company focused on the
development and commercialization of novel immuno-oncology products
based off our proprietary Tri-specific Killer Engager
(TriKE™), Tetra-specific Killer Engager (TetraKE™) and
bi-specific ligand-directed single-chain fusion protein technology
platforms. Our TriKE and TetraKE platforms generate proprietary
therapeutics designed to harness and enhance the cancer killing
abilities of a patient’s own natural killer cells, or NK
cells. Once bound to an NK cell, our moieties are designed to
enhance the NK cell, and precisely direct it to one or more
specifically-targeted proteins expressed on a specific type of
cancer cell or virus infected cell, ultimately resulting in the
targeted cell’s death. TriKEs and TetraKEs are made up of
recombinant fusion proteins, can be designed to target any number
of tumor antigens on hematologic malignancies, sarcomas or solid
tumors and do not require patient-specific
customization.
Going Concern
The
Company’s current operations have focused on business
planning, raising capital, establishing an intellectual property
portfolio, hiring, and conducting preclinical studies and clinical
trials. The Company does not have any product candidates approved
for sale and has not generated any revenue from product sales. The
Company has sustained operating losses since inception and expects
such losses to continue over the foreseeable future.
The
financial statements of the Company have been prepared on a
goingconcern basis, which contemplates the realization of
assets and the satisfaction of liabilities in the normal course of
business. Accordingly, the financial statements do not include any
adjustments that might be necessary should the Company be unable to
continue in existence.
The
Company has incurred substantial losses and negative cash flows
from operations since its inception and has an accumulated deficit
of $569 million and cash of $5 thousand as of March 31, 2020 The
Company anticipates incurring additional losses until such time, if
ever, that it can generate significant sales of its products
currently in development. Substantial additional financing will be
needed by the Company to fund its operations and to commercially
develop its product candidates. These factors raise substantial
doubt about the Company’s ability to continue as a going
concern.
Management is currently evaluating different strategies to obtain
the required funding for future operations. These strategies may
include but are not limited to: public offerings of equity and/or
debt securities, payments from potential strategic research and
development, and licensing and/or marketing arrangements with
pharmaceutical companies. If the Company is unable to secure
adequate additional funding, its business, operating results,
financial condition and cash flows may be materially and adversely
affected.
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.
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
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.
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, 2019 filed with the SEC on March 27, 2020. 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 had no balances in excess
of this limit at March 31, 2020.
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 quarters ended March
31, 2020 and 2019, respectively
Long-Lived Assets
Our
long-lived assets include property, plant and equipment,
capitalized costs of filing patent applications and other
indefinite lived intangible assets. We evaluate our long-lived
assets for impairment, other than indefinite lived intangible
assets, 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.
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
Impairment of Long-Lived Assets
The
Company evaluates indefinite lived intangible assets for impairment
at least annually and whenever impairment indicators are present in
accordance with ASC 350. When necessary, the Company records an
impairment loss for the amount by which the fair value is less than
the carrying value of these assets. The fair value of intangible assets other than
goodwill is typically determined using the “relief from
royalty method”, specifically the discounted cash flow
method utilizing Level 3 fair value
inputs. Some of the more significant estimates and
assumptions inherent in this approach include: the amount and
timing of the projected net cash flows, which includes the expected
impact of competitive, legal and/or regulatory forces on the
projections and the impact of technological risk associated with
IPR&D assets, as well as the selection of a long-term growth
rate; the discount rate, which seeks to reflect the various risks
inherent in the projected cash flows; and the tax rate, which seeks
to incorporate the geographic diversity of the projected cash
flows.
The
Company performs impairment testing for all other long-lived assets
whenever impairment indicators are present. When necessary, the
Company calculates the undiscounted value of the projected cash
flows associated with the asset, or asset group, and compares this
estimated amount to the carrying amount. If the carrying amount is
found to be greater, we record an impairment loss for the excess of
book value over fair value.
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 87,120,470 and 22,731,781 as of
March 31, 2020 and 2019, 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.
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
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:
●
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. There were not such liabilities at March 31,
2020.
●
Level 3 inputs to
the valuation methodology are unobservable and significant to the
fair value measurement. There were no such assets or liabilities as
of March 31, 2020.
Research and Development
Research and development costs are expensed as incurred and
reported as research and development expense. Research and
development costs totaling $.3 million and $.8 million for the
three months ended March 31, 2020 and 2019,
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.
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(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. As of March 31, 2020, the Company has not generated any
licensing revenue.
Convertible Notes
On January 22, 2018, the Company entered into a Securities Purchase
Agreement (“SPA”) with fourteen accredited investors
(individually, a “Buyer” and collectively, the
“Buyers”) pursuant to which the Company agreed to issue
to the Buyers senior convertible notes in an aggregate principal
amount of $7,760,510 (the “Notes”), which Notes shall
be convertible into the Company’s common stock, par value
$0.001 per share (the “Common Stock”) at a price of
$4.58 per share, and five-year warrants to purchase the
Company’s Common Stock representing the right to acquire an
aggregate of approximately 1,694,440 shares of Common Stock (the
“Warrants”).
Pursuant to the terms of SPA the Notes were subject to an original
issue discount of 10% resulting in proceeds to the Company of
$7,055,000 from the transaction.
Upon
the purchase of the Notes, the Buyers received Warrants to purchase
1,694,440 shares of Common
Stock. Such Warrants are exercisable for (5) years from the
date the shares underlying the Warrants are freely saleable. The
initial Exercise Price is $4.58. According to the terms
of the warrant agreement, the Warrants are subject to certain
adjustments depending upon the price and structure of a subsequent
financing, including a qualified financing with gross proceeds of
at least $20 million, as defined in the
agreements.
The issuance of the Notes and Warrants were made in reliance on the
exemption provided by Section 4(a)(2) of the Securities Act of
1933, as amended (the “Securities Act”) for the offer
and sale of securities not involving a public offering, and
Regulation D promulgated under the Securities Act.
Contemporaneously with the execution and delivery of the SPA, the
Company and the Buyers executed and delivered a Registration Rights
Agreement (the “Registration Rights Agreement”)
pursuant to which the Company has agreed to provide certain
registration rights with respect to the Registrable Securities
under the 1933 Act and the rules and regulations promulgated
thereunder, and applicable state securities laws.
Senior Convertible Debentures
On August 2, 2018, GT Biopharma, Inc. (the “Company”)
entered into a Securities Purchase Agreement with the purchasers
identified on the signature pages thereto (individually, a
“Purchaser,” and collectively, the
“Purchasers”) pursuant to which the Company issued to
the Purchasers one year 10% Senior Convertible Debentures in an
aggregate principal amount of $5,140,000 (the
“Debentures”), which Debentures shall be convertible
into the Company’s common stock, par value $0.001 per share
(the “Common Stock”), at a price of $2 per share. The
Company used a portion of these proceeds to repay $4.4 million of
the notes issued on January 22, 2018. Additionally, the remaining
$3.3 million of the notes issued on January 22, 2018 were converted
into the Debentures at the same terms discussed above.
On September 7, 2018, GT Biopharma, Inc. (the
“Company”) entered into a Securities Purchase Agreement
with the purchasers identified on the signature pages thereto
(individually, a “Purchaser,” and collectively, the
“Purchasers”) pursuant to which the Company has issued
to the Purchasers one year 10% Senior Convertible Debentures in an
aggregate principal amount of $2,050,000 (the
“Debentures”), which Debentures shall be convertible
into the Company’s common stock, par value $0.001 per share
(the “Common Stock”), at an initial price of $2 per
share.
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
On September 24, 2018, GT Biopharma, Inc. (the
“Company”) entered into a Securities Purchase Agreement
with the purchasers identified on the signature pages thereto
(individually, a “Purchaser,” and collectively, the
“Purchasers”) pursuant to which the Company has issued
to the Purchasers one year 10% Senior Convertible Debentures in an
aggregate principal amount of $800,000 (the
“Debentures”), which Debentures shall be convertible
into the Company’s common stock, par value $0.001 per share
(the “Common Stock”), at an initial price of $2 per
share.
On February 4, 2019, GT Biopharma, Inc. (the “Company”)
entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with the purchasers identified on the signature
pages thereto (individually, a “Purchaser,” and
collectively, the “Purchasers”), pursuant to which the
Company issued to the Purchasers, on February 4, 2019, Secured
Convertible Notes in an aggregate principal amount of $1,352,224
(the “Notes”), consisting of gross proceeds of
$1,052,224 and settlement of existing debt of $300,000, which Notes
shall be convertible at any time after issuance into shares (the
“Conversion Shares”) of the Company’s common
stock, par value $0.001 per share (the “Common Stock”),
at an initial conversion price of $0.60 per share (the
“Conversion Price”).
The Notes accrue interest at the rate of 10% per annum and mature
on August 2, 2019. Interest on the Notes is payable in cash or, at
a Purchaser’s option, in shares of Common Stock at the
Conversion Price. Upon the occurrence of an event of default,
interest accrues at 18% per annum. The Notes contain customary
default provisions, including provisions for potential
acceleration, and covenants, including negative covenants regarding
additional indebtedness and dividends. The Conversion Price is
subject to adjustment due to certain events, including stock
dividends and stock splits, and is subject to reduction in certain
circumstances if the Company issues Common Stock or Common Stock
equivalents at an effective price per share that is lower than the
Conversion Price then in effect. The Company may only prepay the
Notes with the prior written consent of the respective Purchasers
thereof.
Contemporaneously with the execution and delivery of the Purchase
Agreement, on February 4, 2019, the Company and certain of its
wholly-owned subsidiaries entered into a Security Agreement (the
“Security Agreement”) with Alpha Capital Anstalt, as
collateral agent on behalf of the Purchasers, and with the
Purchasers, pursuant to which the Purchasers have been granted a
first-priority security interest in substantially all of the assets
of the Company and such subsidiaries securing (i) an aggregate
principal amount of $1,352,224 of Notes and (ii) an aggregate
principal amount of $9,058,962 of the Company’s 10% Senior
Convertible Debentures issued on August 2, 2018, September 7, 2018
and September 24, 2018 held by such Purchasers.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 14 days after February 4, 2019, one or more registration
statements on Form S-3 (or, if Form S-3 is not then available to
the Company, such form of registration that is then available to
effect a registration for resale of the subject securities)
covering the resale of all Conversion Shares, subject to certain
penalties set forth in the Registration Rights Agreement. The Form
S-3 was filed by the Company on February 14, 2019.
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
On May 22, 2019, GT Biopharma, Inc. (the “Company”)
entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with the ten purchasers (individually, a
“Purchaser,” and collectively, the
“Purchasers”), pursuant to which the Company issued to
the Purchasers, on May 22, 2019, Secured Convertible Notes in an
aggregate principal amount of $1,300,000 (the “Notes”),
which Notes shall be convertible at any time after issuance into
shares (the “Conversion Shares”) of the Company’s
common stock, par value $0.001 per share (the “Common
Stock”), at an initial conversion price of $0.35 per share
(the “Conversion Price”).
The Notes accrue interest at the rate of 10% per annum and mature
on November 22, 2019. Interest on the Notes is payable in cash or,
at a Purchaser’s option, in shares of Common Stock at the
Conversion Price. Upon the occurrence of an event of default,
interest accrues at 18% per annum. The Notes contain customary
default provisions, including provisions for potential
acceleration, and covenants, including negative covenants regarding
additional indebtedness and dividends. The Conversion Price is
subject to adjustment due to certain events, including stock
dividends and stock splits, and is subject to reduction in certain
circumstances if the Company issues Common Stock or Common Stock
equivalents at an effective price per share that is lower than the
Conversion Price then in effect. The Company may only prepay the
Notes with the prior written consent of the respective Purchasers
thereof.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 30 days after May 22, 2019, one or more registration
statements on Form S-3 (or, if Form S-3 is not then available to
the Company, such form of registration that is then available to
effect a registration for resale of the subject securities)
covering the resale of all Conversion Shares, subject to certain
penalties set forth in the Registration Rights Agreement. The Form
S-1 was filed by the Company on June 21, 2019 and became effective
on July 12, 2019.
Between July 31 and August 28, 2019, GT Biopharma, Inc. (the
“Company”) entered into a Securities Purchase Agreement
(the “Purchase Agreement”) with the eleven purchasers
(individually, a “Purchaser,” and collectively, the
“Purchasers”), pursuant to which the Company issued to
the Purchasers, Secured Convertible Notes in an aggregate principal
amount of $975,000 (the “Notes”), which Notes shall be
convertible at any time after issuance into shares (the
“Conversion Shares”) of the Company’s common
stock, par value $0.001 per share (the “Common Stock”),
at an initial conversion price of $0.20 per share (the
“Conversion Price”).
The Notes accrue interest at the rate of 10% per annum and mature
between January 31 and February 28, 2020. Interest on the Notes is
payable in cash or, at a Purchaser’s option, in shares of
Common Stock at the Conversion Price. Upon the occurrence of an
event of default, interest accrues at 18% per annum. The Notes
contain customary default provisions, including provisions for
potential acceleration, and covenants, including negative covenants
regarding additional indebtedness and dividends. The Conversion
Price is subject to adjustment due to certain events, including
stock dividends and stock splits, and is subject to reduction in
certain circumstances if the Company issues Common Stock or Common
Stock equivalents at an effective price per share that is lower
than the Conversion Price then in effect. The Company may only
prepay the Notes with the prior written consent of the respective
Purchasers thereof.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 30 days, one or more registration statements on Form S-3
(or, if Form S-3 is not then available to the Company, such form of
registration that is then available to effect a registration for
resale of the subject securities) covering the resale of all
Conversion Shares, subject to certain penalties set forth in the
Registration Rights Agreement. The Form S-1 was filed by the
Company on September 13, 2019 and became effective in October 2,
2019.
On December 19, 2019, GT Biopharma, Inc. (the
“Company”) entered into a Securities Purchase Agreement
(the “Purchase Agreement”) with the one purchaser
(individually, a “Purchaser,” and collectively, the
“Purchasers”), pursuant to which the Company issued to
the Purchasers, on December 19, 2019, Secured Convertible Notes in
an aggregate principal amount of $200,000 (the
“Notes”), which Notes shall be convertible at any time
after issuance into shares (the “Conversion Shares”) of
the Company’s common stock, par value $0.001 per share (the
“Common Stock”), at an initial conversion price of
$0.20 per share (the “Conversion Price”).
The Notes accrue interest at the rate of 10% per annum and mature
on August 19, 2020. Interest on the Notes is payable in cash or, at
a Purchaser’s option, in shares of Common Stock at the
Conversion Price. Upon the occurrence of an event of default,
interest accrues at 18% per annum. The Notes contain customary
default provisions, including provisions for potential
acceleration, and covenants, including negative covenants regarding
additional indebtedness and dividends. The Conversion Price is
subject to adjustment due to certain events, including stock
dividends and stock splits, and is subject to reduction in certain
circumstances if the Company issues Common Stock or Common Stock
equivalents at an effective price per share that is lower than the
Conversion Price then in effect. The Company may only prepay the
Notes with the prior written consent of the respective Purchasers
thereof.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 30 days after December 19, 2019, one or more registration
statements on Form S-3 (or, if Form S-3 is not then available to
the Company, such form of registration that is then available to
effect a registration for resale of the subject securities)
covering the resale of all Conversion Shares, subject to certain
penalties set forth in the Registration Rights
Agreement.
On January 30, 2020 GT Biopharma, Inc. (the “Company”)
entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with the one purchaser (individually, a
“Purchaser,” and collectively, the
“Purchasers”), pursuant to which the Company issued to
the Purchasers, on January 30, 2020, Secured Convertible Notes in
an aggregate principal amount of $200,000 (the
“Notes”), which Notes shall be convertible at any time
after issuance into shares (the “Conversion Shares”) of
the Company’s common stock, par value $0.001 per share (the
“Common Stock”), at an initial conversion price of
$0.20 per share (the “Conversion Price”).
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
The Notes accrue interest at the rate of 10% per annum and mature
on September 30, 2020. Interest on the Notes is payable in cash or,
at a Purchaser’s option, in shares of Common Stock at the
Conversion Price. Upon the occurrence of an event of default,
interest accrues at 18% per annum. The Notes contain customary
default provisions, including provisions for potential
acceleration, and covenants, including negative covenants regarding
additional indebtedness and dividends. The Conversion Price is
subject to adjustment due to certain events, including stock
dividends and stock splits, and is subject to reduction in certain
circumstances if the Company issues Common Stock or Common Stock
equivalents at an effective price per share that is lower than the
Conversion Price then in effect. The Company may only prepay the
Notes with the prior written consent of the respective Purchasers
thereof.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 30 days after January 30, 2020, one or more registration
statements on Form S-3 (or, if Form S-3 is not then available to
the Company, such form of registration that is then available to
effect a registration for resale of the subject securities)
covering the resale of all Conversion Shares, subject to certain
penalties set forth in the Registration Rights
Agreement.
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 March 31, 2020.
Common Stock
In the first quarter of 2020, the Company issued 814,734 shares of
common stock upon conversion of $162,943 in principal and interest
on senior convertible notes.
Preferred Stock
The 96,230 shares of Series C preferred stock are convertible into
111 shares of the Company's common stock at the option of the
holders at any time. The conversion ratio is based on the average
closing bid price of the common stock for the fifteen consecutive
trading days ending on the date immediately preceding the date
notice of conversion is given, but cannot be less than .20 or more
than .2889 common shares for each Series C preferred share. The
conversion ratio may be adjusted under certain circumstances such
as stock splits or stock dividends. The Company has the right to
automatically convert the Series C preferred stock into common
stock if the Company lists its shares of common stock on the Nasdaq
National Market and the average closing bid price of the Company's
common stock on the Nasdaq National Market for 15 consecutive
trading days exceeds $3,000.00. Each share of Series C preferred
stock is entitled to the number of votes equal to .26 divided by
the average closing bid price of the Company's common stock during
the fifteen consecutive trading days immediately prior to the date
such shares of Series C preferred stock were purchased. In the
event of liquidation, the holders of the Series C preferred stock
shall participate on an equal basis with the holders of the common
stock (as if the Series C preferred stock had converted into common
stock) in any distribution of any of the assets or surplus funds of
the Company. The holders of Series C preferred stock are entitled
to noncumulative dividends if and when declared by the Company's
board of directors. No dividends to Series C preferred stockholders
were issued or unpaid through March 31, 2020.
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
On September 1, 2017, the Company designated 2,000,000 shares of
Series J Preferred Stock. Shares of Series J Preferred Stock will
have the same voting rights as shares of common stock with each
share of Series J Preferred Stock entitled to one vote at a meeting
of the shareholders of the Corporation. Shares of Series J
Preferred Stock will not be entitled to receive any dividends,
unless and until specifically declared by our board of directors.
The holders of the Series J Preferred Stock will participate, on an
as-if-converted-to-common stock basis, in any dividends to the
holders of common stock. Each share of the Series J Preferred Stock
is convertible into one share of our common stock at any time at
the option of the holder.
On the same day, the Board issued 1,513, 548 of those shares in
exchange for the cancellation of debt. In the first quarter
of 2019, it was discovered that a certificate of designation with
respect to the Series J Preferred Stock had never been filed with
the Office of the Secretary of State for the State of
Delaware. Legal research determined that despite the fact the
Company had issued shares of Series J Preferred Stock, those shares
had, in fact, never existed.
To remedy the situation, on April 4, 2019, the Company filed a
certificate of designation with the Office of the Secretary State
for the State of Delaware designating a series of preferred stock
as Series J-1 Preferred Stock. On April 19, 2019, the Company
issued 2,353,548 of those shares. The issuance was in lieu of
the preferred stock that should have been issued on September 1,
2017, and in settlement for not receiving preferred stock until 20
months after the debt for which the stock was issued was cancelled.
The Company reflected an expense in general and administrative
costs in the year ended December 31, 2019 totaling
$1,140,000.
The Shares are convertible into shares of common stock of the
Registrant at the rate of $0.20 per share. The issuance was
exempt from the registration requirements of Section 5 of the
Securities Act of 1933 pursuant to Section 4(2) of the same Act
since the issuance of the Shares did not involve any public
offering.
4.
Stock Options and Warrants
Stock Options
The
following table summarizes stock option transactions for the
quarter ended March 31, 2020:
|
|
Weighted Average
Exercise Price
|
Outstanding,
December 31, 2019
|
40
|
$877.50
|
Granted
|
-
|
-
|
Exercised
|
-
|
-
|
Expired
|
-
|
-
|
Outstanding, March
31, 2020
|
40
|
$877.50
|
Exercisable, March
31, 2020
|
40
|
$877.50
|
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
Common Stock Warrants
Warrant
transactions for the quarter ended March 31, 2020 are as
follows:
|
|
Weighted Average
Exercise Price
|
Outstanding at
December 31, 2019:
|
1,813,053
|
$0.20
|
Granted
|
-
|
-
|
Forfeited
|
-
|
-
|
Exercised
|
-
|
-
|
Outstanding at
March 31, 2020
|
1,813,053
|
$0.20
|
Exercisable at
March 31, 2020
|
1,813,053
|
$0.20
|
5.
Commitments and Contingencies
Leases
On October 1, 2018, the Company entered into a three-year lease
agreement for its office in Westlake Village, CA. In addition to
minimum rent, certain leases require payment of real estate taxes,
insurance, common area maintenance charges and other executory
costs. The Company recognizes rent expense under such arrangements
on a straight-line basis over the effective term of each
lease.
The following table summarizes the Company’s future minimum
lease commitments as of March 31, 2020:
Year ending
December 31:
|
|
2020
|
53,000
|
2021
|
61,000
|
Total minimum lease
payments
|
$114,000
|
Rent expense for the quarters ended March 31,
2020 and 2019 was $17,200 and $17,000,
respectively.
Convertible Notes
Between April 20 and May 7, 2020, GT Biopharma, Inc. (the
“Company”) entered into a Securities Purchase Agreement
(the “Purchase Agreement”) with eight purchasers
(individually, a “Purchaser,” and collectively, the
“Purchasers”), pursuant to which the Company issued to
the Purchasers, on January 30, 2020, Secured Convertible Notes in
an aggregate principal amount of $2,067,000 (the
“Notes”), which Notes shall be convertible at any time
after issuance into shares (the “Conversion Shares”) of
the Company’s common stock, par value $0.001 per share (the
“Common Stock”), at an initial conversion price of
$0.20 per share (the “Conversion Price”).
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2020
(UNAUDITED)
The Notes accrue interest at the rate of 10% per annum and mature
between October 20 and November 7, 2020. Interest on the Notes is
payable in cash or, at a Purchaser’s option, in shares of
Common Stock at the Conversion Price. Upon the occurrence of an
event of default, interest accrues at 18% per annum. The Notes
contain customary default provisions, including provisions for
potential acceleration, and covenants, including negative covenants
regarding additional indebtedness and dividends. The Conversion
Price is subject to adjustment due to certain events, including
stock dividends and stock splits, and is subject to reduction in
certain circumstances if the Company issues Common Stock or Common
Stock equivalents at an effective price per share that is lower
than the Conversion Price then in effect. The Company may only
prepay the Notes with the prior written consent of the respective
Purchasers thereof.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 30 days after April 20, 2020, one or more registration
statements on Form S-3 (or, if Form S-3 is not then available to
the Company, such form of registration that is then available to
effect a registration for resale of the subject securities)
covering the resale of all Conversion Shares, subject to certain
penalties set forth in the Registration Rights
Agreement.
Common Stock
In April 2020, the Company issued 250,000 shares of common stock
upon conversion of $50,000 in principal on convertible
notes.
On May 1, 2020, the Company issued 1,086,429 shares of
restricted common stock for consulting services.
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, 2019. 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
“GTBP,” “we,”
“us,” “our,” “the company”
and “our company” refer to GT Biopharma, Inc., a
Delaware corporation formerly known as Oxis International, Inc.,
DDI Pharmaceuticals, Inc. and Diagnostic Data, Inc, together with
our subsidiaries.
Overview
We are a clinical stage biopharmaceutical company focused on the
development and commercialization of novel immuno-oncology products
based off our proprietary Tri-specific Killer Engager
(TriKE™), Tetra-specific Killer Engager (TetraKE™) and
bi-specific ligand-directed single-chain fusion protein technology
platforms. Our TriKE and TetraKE platforms generate proprietary
therapeutics designed to harness and enhance the cancer killing
abilities of a patient’s own natural killer cells, or NK
cells. Once bound to an NK cell, our moieties are designed to
enhance the NK cell, and precisely direct it to one or more
specifically-targeted proteins expressed on a specific type of
cancer cell or virus infected cell, ultimately resulting in the
targeted cell’s death. TriKEs and TetraKEs are made up of
recombinant fusion proteins, can be designed to target any number
of tumor antigens on hematologic malignancies, sarcomas or solid
tumors and do not require patient-specific
customization.
We are using our TriKE and TetraKE platforms with the intent to
bring to market immuno-oncology products that can treat a range of
hematologic malignancies, sarcoma and solid tumors. The platforms
are scalable, and we are putting processes in place to be able to
produce IND-ready moieties in a timely manner after a specific
TriKE or TetraKE conceptual design. After conducting market and
competitive research, specific moieties can then be advanced into
the clinic on our own or through potential collaborations with
larger companies. We are also evaluating, in conjunction with our
Scientific Advisory Board, additional moieties designed to target
different tumor antigens. We believe our TriKEs and TetraKEs may
have the ability, if approved for marketing, to be used on a
stand-alone basis, augment the current monoclonal antibody
therapeutics, be used in conjunction with more traditional cancer
therapy and potentially overcome certain limitations of current
chimeric antigen receptor, or CAR-T, therapy.
We are also using our TriKE and TetraKE platforms to develop
therapeutics useful for the treatment of infectious disease such as
for the treatment of patients infected by the human
immunodeficiency virus (HIV). While the use of anti-retroviral
drugs has substantially improved the health and increased the
longevity of individuals infected with HIV, these drugs are
designed to suppress virus replication to help modulate progression
to AIDS and to limit further transmission of the virus. Despite the
use of anti-retroviral drugs, infected individuals retain
reservoirs of latent HIV-infected cells that, upon cessation of
anti-retroviral drug therapy, can reactivate and re-establish an
active HIV infection. For a curative therapy, destruction of these
latent HIV infected cells must take place. The HIV-TriKE contains
the antigen binding fragment (Fab) from a broadly-neutralizing
antibody targeting the HIV-Env protein. The HIV-TriKE is designed
to target HIV while redirecting NK cell killing specifically to
actively replicating HIV infected cells. The HIV-TriKE induced NK
cell proliferation, and demonstrated the ability in vitro to
reactivate and kill HIV-infected T-cells. These findings indicate a
potential role for the HIV-TriKE in the reactivation and
elimination of the latently infected HIV reservoir cells by
harnessing the NK cell’s ability to mediate the
antibody-directed cellular cytotoxicity (ADCC).
We also believe our bi-specific, ligand-directed single-chain
fusion proteins are examples of the next generation of
antibody-drug conjugates (ADCs). We believe GTB-1550 has certain
properties that could result in competitive advantages over
recently FDA-approved ADC products targeting leukemias and
lymphomas and/or have utility in other niche populations. In a
Phase 1 trial, of nine patients that achieved adequate blood
levels, in two heavily pretreated patients a continuous partial
remission (PR) and complete remission (CR) were observed. One of
these patients, who had failed multiple previous treatment
regimens, has been in remission since early 2015.
Our initial work has been conducted in collaboration with the
Masonic Cancer Center at the University of Minnesota under a
program led by Dr. Jeffrey Miller, the Deputy Director. Dr. Miller
is a recognized leader in the field of NK cell and IL-15 biology
and their therapeutic potential. We have exclusive rights to the
TriKE and TetraKE platforms and are generating additional
intellectual property around specific moieties.
Recent Developments
Collaboration Agreement
On March 10, 2020 we entered into a collaboration agreement with
Cytovance® Biologics, a USA-based contract development and
manufacturing organization (CDMO) and a subsidiary of the Shenzhen
Hepalink Pharmaceutical Group Co., Ltd. (“Hepalink”),
to provide development services for a TriKE™ therapeutic for
the treatment of coronavirus infection. Under the terms of the
collaboration agreement, the companies will focus on preparing
sufficient quantities of our coronavirus TriKE drug product for
preclinical evaluation using Cytovance’s E. coli-based Keystone Expression
System™ and subsequently,
will scale-up production using Cytovance’s GMP microbial
manufacturing platform for evaluation of TriKE in humans to treat
coronavirus infection.
Financing
On January 30, 2020 GT Biopharma, Inc. (the “Company”)
entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with the one purchaser (individually, a
“Purchaser,” and collectively, the
“Purchasers”), pursuant to which the Company issued to
the Purchasers, on January 30, 2020, Secured Convertible Notes in
an aggregate principal amount of $200,000 (the
“Notes”), which Notes shall be convertible at any time
after issuance into shares (the “Conversion Shares”) of
the Company’s common stock, par value $0.001 per share (the
“Common Stock”), at an initial conversion price of
$0.20 per share (the “Conversion Price”).
The Notes accrue interest at the rate of 10% per annum and mature
on September 30, 2020. Interest on the Notes is payable in cash or,
at a Purchaser’s option, in shares of Common Stock at the
Conversion Price. Upon the occurrence of an event of default,
interest accrues at 18% per annum. The Notes contain customary
default provisions, including provisions for potential
acceleration, and covenants, including negative covenants regarding
additional indebtedness and dividends. The Conversion Price is
subject to adjustment due to certain events, including stock
dividends and stock splits, and is subject to reduction in certain
circumstances if the Company issues Common Stock or Common Stock
equivalents at an effective price per share that is lower than the
Conversion Price then in effect. The Company may only prepay the
Notes with the prior written consent of the respective Purchasers
thereof.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 30 days after January 30, 2020, one or more registration
statements on Form S-3 (or, if Form S-3 is not then available to
the Company, such form of registration that is then available to
effect a registration for resale of the subject securities)
covering the resale of all Conversion Shares, subject to certain
penalties set forth in the Registration Rights
Agreement.
Results of Operations
Comparison of the Three Months Ended March 31, 2020 and
2019
Research and Development Expenses
During the three months ended March 31, 2020 and 2019, we incurred
$324,000 and $834,000 research and development expenses.
Research and development costs decreased due primarily to the
reductions employees, consultants and preclinical expenses. We
anticipate our direct clinical costs to increase in second half of
2020 upon the continuation of a phase one clinical trial of our
most advanced TriKe product candidate, OXS-3550.
Selling, general and administrative expenses
During the three months ended March 31, 2020 and 2019, we incurred
$746,000 and $3,222,000 of selling, general and administrative
expenses. The decrease in selling, general and
administrative expenses is primarily attributable the reduction of
salaries.
Interest Expense
Interest expense was $638,000 and $454,000 for the three months
ended March 31, 2020 and 2019 respectively. The increase
is primarily due to the accrual of interest on outstanding
convertible notes.
Liquidity and Capital Resources
The
Company’s current operations have focused on business
planning, raising capital, establishing an intellectual property
portfolio, hiring, and conducting preclinical studies and clinical
trials. The Company does not have any product candidates approved
for sale and has not generated any revenue from product sales. The
Company has sustained operating losses since inception and expects
such losses to continue over the foreseeable future. During the
three months ended March 31, 2020, the Company raised $200,000
through an issuance of a convertible debenture in January 2020.
We
anticipate that cash utilized for selling, general, and
administrative expenses will range between $1 and $2 million in the
coming quarters, while research and development expenses will vary
depending on clinical activities. 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 an additional
$15 million of capital in 2020.
The
financial statements of the Company have been prepared on a
going-concern basis, which contemplates the realization of assets
and the satisfaction of liabilities in the normal course of
business. Accordingly, the financial statements do not include any
adjustments that might be necessary should the Company be unable to
continue in existence.
The
Company has incurred substantial losses and negative cash flows
from operations since its inception and has an accumulated deficit
of $569 million and cash of $5 thousand as of March 31, 2020. The
Company anticipates incurring additional losses until such time, if
ever, that it can generate significant sales or revenue from
out-licensing of its products currently in development. Substantial
additional financing will be needed by the Company to fund its
operations and to commercially develop its product candidates.
These factors raise substantial doubt about the Company’s
ability to continue as a going concern.
Management
is currently evaluating different strategies to obtain the required
funding for future operations. These strategies may include but are
not limited to: public offerings of equity and/or debt securities,
payments from potential strategic research and development,
licensing and/or marketing arrangements with pharmaceutical
companies. Management has also implemented cost saving efforts,
including reduction in executive salaries and reduced travel.
Management believes that these ongoing and planned financing
endeavors, if successful, will provide adequate financial resources
to continue as a going concern for at least the next six months
from the date the financial statements are issued; however, there
can be no assurance in this regard. If the Company is unable to
secure adequate additional funding, its business, operating
results, financial condition and cash flows may be materially and
adversely affected.
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.
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.
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 March 31,
2020.
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 March 31, 2019. Based on that evaluation
we have concluded that our disclosure controls and procedures were
not effective as of March 31, 2020.
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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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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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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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 March 31, 2020, 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 March 31,
2020. The most significant
issues identified were: 1) lack of segregation of duties due to
very small staff and significant reliance on outside consultants,
2) risks of executive override also due to lack of established
policies, and small employee staff and 3) insufficient written
policies and procedures for accounting and financial reporting for
the requirements and application of GAAP and SEC Guidelines. Based
on the material weaknesses identified above, management has
concluded that internal control over financial reporting was not
effective as of March 31, 2020. As the company’s operations
increase, the company intends to take measures to mitigate the
issues identified and implement a functional system of internal
controls over financial reporting. Such measures will include, but
not be limited to hiring of additional employees in its finance and
accounting department; preparation of risk-control matrices to
identify key risks and develop and document policies to mitigate
those risks; and identification and documentation of standard
operating procedures for key financial
activities.
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
On December 24, 2018, Empery Asset Master, Empery Tax Efficient,
LP, and Empery Tax Efficient II, LP (collectively,
“Plaintiffs) filed in the N.Y. Supreme Court, Index No.
656408/2018, alleging causes of action against the Company for
Breach of Contract, Liquidated Damages, Damages, and
Indemnification. The claims arose out of a securities purchase
agreement entered into between Plaintiffs and the Company pursuant
to which the Company issued convertible notes and warrants to
Plaintiffs in or around January 2018. Plaintiffs allege, inter
alia, that the Company failed to pay Plaintiffs’ outstanding
principal on or before the July 23, 2018 maturity date of said
notes, failed to convert a portion of said notes in response to
Plaintiffs’ conversion notice, and failed to timely adjust
the exercise price of said warrants. At issue are notes issued to
Plaintiffs in the aggregate principal amount of approximately $2.2
million and warrants representing the right of Plaintiffs to
acquire an aggregate of 480,352 shares of common stock in the
Company. The Company and Plaintiffs are in the process of
negotiating a settlement that would fully resolve Plaintiffs’
asserted claims, but no formal agreement has been
finalized.
On August 28, 2019, a complaint was filed in the Superior Court of
California, County of Los Angeles, West Judicial District, Santa
Monica Courthouse, Unlimited Civil Division by Jeffrey Lion, an
individual (“Lion”), and by Daniel Vallera, an
individual (“Vallera”). Lion and Vallera are referred
to jointly as the “Plaintiffs”. The complaint was filed
against GT Biopharma, Inc. and its subsidiary Oxis Biotech, Inc.
(either of them or jointly, the “Company”). The
Plaintiffs allege breach of a license agreement between the
Plaintiffs and the Company entered into on or about September 3,
2015. Lion alleges breach of a consulting agreement between Lion
and the Company entered into on or about September 1, 2015. Vallera
alleges breach of a consulting agreement between Vallera and the
Company entered into in or around October, 2018. The Complaint
seeks actual damages of $1,670,000, for the fair market value of
the number of shares of GT Biopharma, Inc. that at the time of
judgment represent 15,000,000 shares of such stock as of September
1, 2015, and that GT Biopharma, Inc. issue Lion the number of
common shares of GT Biopharma, Inc. that at the time of judgment
represent 15,000,000 such shares as of September 1,
2015.
Information regarding risk factors appears under “Risk
Factors” included in Item 1A, Risk Factors, of our Annual
Report on Form 10-K for the year ended December 31, 2019. There
have been no material changes from the risk factors previously
disclosed in the above-mentioned periodic report.
Item 2. Unregistered Sales of
Securities and Use of Proceeds
On December 19, 2019, GT Biopharma, Inc. (the
“Company”) entered into a Securities Purchase Agreement
(the “Purchase Agreement”) with the one purchaser
(individually, a “Purchaser,” and collectively, the
“Purchasers”), pursuant to which the Company issued to
the Purchasers, on December 19, 2019, Secured Convertible Notes in
an aggregate principal amount of $200,000 (the
“Notes”), which Notes shall be convertible at any time
after issuance into shares (the “Conversion Shares”) of
the Company’s common stock, par value $0.001 per share (the
“Common Stock”), at an initial conversion price of
$0.20 per share (the “Conversion Price”).
The Notes accrue interest at the rate of 10% per annum and mature
on August 19, 2020. Interest on the Notes is payable in cash or, at
a Purchaser’s option, in shares of Common Stock at the
Conversion Price. Upon the occurrence of an event of default,
interest accrues at 18% per annum. The Notes contain customary
default provisions, including provisions for potential
acceleration, and covenants, including negative covenants regarding
additional indebtedness and dividends. The Conversion Price is
subject to adjustment due to certain events, including stock
dividends and stock splits, and is subject to reduction in certain
circumstances if the Company issues Common Stock or Common Stock
equivalents at an effective price per share that is lower than the
Conversion Price then in effect. The Company may only prepay the
Notes with the prior written consent of the respective Purchasers
thereof.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 30 days after December 19, 2019, one or more registration
statements on Form S-3 (or, if Form S-3 is not then available to
the Company, such form of registration that is then available to
effect a registration for resale of the subject securities)
covering the resale of all Conversion Shares, subject to certain
penalties set forth in the Registration Rights
Agreement.
On January 30, 2020 GT Biopharma, Inc. (the “Company”)
entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with the one purchaser (individually, a
“Purchaser,” and collectively, the
“Purchasers”), pursuant to which the Company issued to
the Purchasers, on January 30, 2020, Secured Convertible Notes in
an aggregate principal amount of $200,000 (the
“Notes”), which Notes shall be convertible at any time
after issuance into shares (the “Conversion Shares”) of
the Company’s common stock, par value $0.001 per share (the
“Common Stock”), at an initial conversion price of
$0.20 per share (the “Conversion Price”).
The Notes accrue interest at the rate of 10% per annum and mature
on September 30, 2020. Interest on the Notes is payable in cash or,
at a Purchaser’s option, in shares of Common Stock at the
Conversion Price. Upon the occurrence of an event of default,
interest accrues at 18% per annum. The Notes contain customary
default provisions, including provisions for potential
acceleration, and covenants, including negative covenants regarding
additional indebtedness and dividends. The Conversion Price is
subject to adjustment due to certain events, including stock
dividends and stock splits, and is subject to reduction in certain
circumstances if the Company issues Common Stock or Common Stock
equivalents at an effective price per share that is lower than the
Conversion Price then in effect. The Company may only prepay the
Notes with the prior written consent of the respective Purchasers
thereof.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 30 days after January 30, 2020, one or more registration
statements on Form S-3 (or, if Form S-3 is not then available to
the Company, such form of registration that is then available to
effect a registration for resale of the subject securities)
covering the resale of all Conversion Shares, subject to certain
penalties set forth in the Registration Rights
Agreement.
Between April 20 and May 7, 2020, GT Biopharma, Inc. (the
“Company”) entered into a Securities Purchase Agreement
(the “Purchase Agreement”) with eight purchasers
(individually, a “Purchaser,” and collectively, the
“Purchasers”), pursuant to which the Company issued to
the Purchasers, on January 30, 2020, Secured Convertible Notes in
an aggregate principal amount of $2,067,000 (the
“Notes”), which Notes shall be convertible at any time
after issuance into shares (the “Conversion Shares”) of
the Company’s common stock, par value $0.001 per share (the
“Common Stock”), at an initial conversion price of
$0.20 per share (the “Conversion Price”).
The Notes accrue interest at the rate of 10% per annum and mature
between October 20 and November 7, 2020. Interest on the Notes is
payable in cash or, at a Purchaser’s option, in shares of
Common Stock at the Conversion Price. Upon the occurrence of an
event of default, interest accrues at 18% per annum. The Notes
contain customary default provisions, including provisions for
potential acceleration, and covenants, including negative covenants
regarding additional indebtedness and dividends. The Conversion
Price is subject to adjustment due to certain events, including
stock dividends and stock splits, and is subject to reduction in
certain circumstances if the Company issues Common Stock or Common
Stock equivalents at an effective price per share that is lower
than the Conversion Price then in effect. The Company may only
prepay the Notes with the prior written consent of the respective
Purchasers thereof.
The Purchase Agreement contains customary representations,
warranties and covenants, including covenants, subject to certain
exceptions, that the Company, until the date on which less than 10%
of the Notes are outstanding, shall not effect any Variable Rate
Transaction (as defined in the Purchase Agreement) and that, for as
long as a Purchaser holds any Notes or Conversion Shares, the
Company shall amend the terms and conditions of the Purchase
Agreement and the transactions contemplated thereby with respect to
such Purchaser to give such Purchaser the benefit of any terms or
conditions under which the Company agrees to issue or sell any
Common Stock or Common Stock equivalents that are more favorable to
an investor than the terms and conditions granted to such Purchaser
under the Purchase Agreement and the transactions contemplated
thereby.
In addition, the Company entered into a registration rights
agreement (the “Registration Rights Agreement”) with
the Purchasers, pursuant to which the Company has agreed to file,
within 30 days after April 20, 2020, one or more registration
statements on Form S-3 (or, if Form S-3 is not then available to
the Company, such form of registration that is then available to
effect a registration for resale of the subject securities)
covering the resale of all Conversion Shares, subject to certain
penalties set forth in the Registration Rights
Agreement.
Item 3. Defaults Upon Senior
Securities.
As of March 31, 2020, convertible notes totaling approximately
$13,257,000 are in default.
Item 4. Mine Safety
Disclosures
None.
Item 5. Other
Information.
None.
Exhibit
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Description
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Form
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SEC File No.
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Filing Date
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Certificate
of Amendment to the Certificate of Incorporation of the Registrant,
effective as of July 19, 2017.
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8-K
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000-08092
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03/15/18
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Securities
Purchase Agreement by and among the Company and the Buyers, dated
January 30, 2020.
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Form of
Registration Rights Agreement by and among the Company and the
Buyers, dated January 30, 2020.
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Form of
Note, dated January 30, 2020.
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Securities
Purchase Agreement by and among the Company and the Buyers, dated
April/May, 2020.
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Form of
Registration Rights Agreement by and among the Company and the
Buyers, dated April/May, 2020.
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Form of
Note, dated April/May, 2020.
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Clinical
Trial Agreement with University of Minnesota
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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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X
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Exhibit
No.
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Description
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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 Document.
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101.CAL
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XBRL Taxonomy Extension Calculation Linkbase Document.
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101.DEF
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XBRL Taxonomy Extension Definition Linkbase Document.
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101.LAB
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XBRL Taxonomy Extension Label Linkbase Document.
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101.PRE
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XBRL Taxonomy Extension
Presentation Linkbase Document.
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*
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This certification shall not be deemed “filed” for
purposes of Section 18 of the Securities Act of 1934, or
otherwise subject to the liability of that Section, nor shall it be
deemed to be incorporated by reference into any filing under the
Securities Act of 1933 or the Securities Exchange Act of
1934.
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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: May 15,
2020
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By:
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/s/ Anthony
Cataldo
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Anthony
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
Cataldo
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Chief Executive
Officer and Chairman of the Board
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May 15,
2020
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Anthony
Cataldo
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/s/ Steven
Weldon
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Chief Financial
Officer (Principal Financial Officer), and Director
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May 15,
2020
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Steven
Weldon
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