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, ~~2018.~~2019.

☐ 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)	94-1620407 (I.R.S. employer identification number)
~~1825 K Street,~~310 N. Westlake Blvd, Suite ~~510~~206 ~~Washington, DC 20006~~Westlake Village, CA 91362 (Address of principal executive offices and zip code) (800) 304-9888 (Registrant’s telephone number, including area code)

100 South Ashley Drive

Suite 600

Tampa, FL 33602

(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit ~~and post~~ such files). Yes ☑ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☐ ~~(Do not check if a smaller reporting company)~~	Smaller reporting company ☑
Emerging growth company ☐

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 11, ~~2018,~~2019, the issuer had outstanding the indicated number of shares of common stock: ~~50,117,977.~~51,374,417.

GT Biopharma, Inc. and Subsidiaries

FORM 10-Q

For the Quarter Ended March 31, ~~2018~~2019

Table of Contents

PART I FINANCIAL INFORMATION		Page

Item 1.	Financial Statements
	Consolidated Balance Sheets as of March 31, ~~2018~~2019 (Unaudited) and December 31, ~~2017~~2018		1
	Consolidated Statements of Operations for the three months ended March 31, 2019 and 2018 ~~and 2017~~ (Unaudited)		2
	Consolidated Statements of Cash Flows for the three months ended March 31, 2019 and 2018 ~~and 2017~~ (Unaudited)		3
	Condensed Notes to Consolidated Financial Statements		4
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		12 14
Item 3.	Quantitative and Qualitative Disclosures About Market Risk		15 17
Item 4.	Controls and Procedures		15 17
PART II OTHER INFORMATION
Item 1.	Legal Proceedings		16 18
Item 1A.	Risk Factors		16 18
Item 2.	Unregistered Sales of Securities and Use of Proceeds		16 18
Item 3.	Defaults Upon Senior Securities		17 20
Item 4.	Mine Safety Disclosures		17 20
Item 5.	Other Information		17 20
Item 6.	Exhibits		18 21
SIGNATURES			19 22

GT Biopharma, Inc. and Subsidiaries
as of March 31,2018 and December 31, 2017
GT Biopharma, Inc. and Subsidiaries			GT Biopharma, Inc. and Subsidiaries
as of March 31,2019 and December 31, 2018			as of March 31,2019 and December 31, 2018
Consolidated Balance Sheets	Consolidated Balance Sheets		Consolidated Balance Sheets
(in Thousands, Except Par Value and Share Data)			(in Thousands, Except Par Value and Share Data)

	March 31, 2018	December 31, 2017	March 31, 2019	December 31, 2018
ASSETS	(unaudited)		(unaudited)
Current Assets:
Cash and cash equivalents	$2,870,000	$576,000	$51	$60
Prepaid expenses	-		27	30
Total Current Assets	2,870,000	576,000	78	90

Intangible assets	253,777,000		25,262
Loan costs	670,000	-
Deposits	9,000		12
Operating lease right-to-use asset			153	-
Fixed assets, net	7,000	6,000	34	35
Total Other Assets	254,463,000	253,792,000	25,461	25,309
TOTAL ASSETS	$257,333,000	$254,368,000	$25,539	$25,399
LIABILITIES AND STOCKHOLDERS’ DEFICIT
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable	$1,830,000	$2,546,000	$1,898	$1,762
Accrued expenses	283,000	102,000	2,136	1,455
Deferred rent			-	8
Operating lease liability			161	-
Note payable to related party			-	100
Line of credit	31,000		31
Convertible debentures, net of discount of $4,829,000	2,932,000	-
Convertible debentures			11,297	10,673
Total Current Liabilities	5,076,000	2,679,000	15,523	14,029

Total liabilities	5,076,000	2,679,000	15,523	14,029

Stockholders’ Deficit:
Stockholders’ Equity:
Convertible preferred stock - $0.001 par value; 15,000,000 shares authorized:	Convertible preferred stock - $0.001 par value; 15,000,000 shares authorized:
Series C - 96,230 and 96,230 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively	1,000
Series J – 1,163,548 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively	1,000
Common stock - $0.001 par value; 750,000,000 shares authorized; and 50,117,977 and 50,117,977 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively	50,000
Series C - 96,230 and 96,230 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively			1
Series J – 1,163,548 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively			1
Common stock - $0.001 par value; 750,000,000 shares authorized; and 51,374,417 and 50,650,478 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively			51
Additional paid-in capital	531,963,000	521,305,000	543,327	540,171
Accumulated deficit	(279,589,000)	(269,499,000)	(533,195)	(528,685)
Noncontrolling interest	(169,000)		(169)
Total Stockholders’ Deficit	252,257,000	251,689,000
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$257,333,000	$254,368,000
Total Stockholders’ Equity			10,016	11,370
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY			$25,539	$25,399

The accompanying notes are an integral part of these consolidated financial statements.			The accompanying notes are an integral part of these consolidated financial statements.

~~The accompanying notes are an integral part of these consolidated financial statements.~~

GT Biopharma, Inc. and Subsidiaries
March 31, 2019 and 2018
Statements of Operations
(in Thousands, Except per Share Data)
	March 31,
	2019	2018
Revenue:	(unaudited)	(unaudited)
License revenues	$-	$-
TOTAL REVENUE	-	-
Cost of License Revenue	-	-
Gross profit	-	-
Operating Expenses:
Research and development	834	3,473
Selling, general and administrative	3,222	3,687
Total operating expenses	4,056	7,160
Loss from Operations	(4,056)	(7,160)
Other income (expense)
Interest expense/income	(454)	(2,931)
Total Other Income (Expense)	(454)	(2,931)
Loss before minority interest and provision for income taxes	(4,510)	(10,091)
Less: Loss attributable to the noncontrolling interests	-	-
Loss before provision for income taxes	(4,510)	(10,091)
Provision for income taxes	-	-
Net loss	(4,510)	(10,091)
Loss per share
Basic	$(0.09)	$(0.20)
Diluted	$(0.09)	$(0.20)

Weighted Average Shares Outstanding – basic and diluted
Basic	51,092,886	50,117,977
Diluted	51,092,886	50,117,977

The accompanying notes are an integral part of these consolidated financial statements.

~~GT Biopharma, Inc. and Subsidiaries~~

~~March 31, 2018 and 2017~~

~~Statements of Operations~~

March 31,

2018

2017

Revenue:

(unaudited)

(unaudited)

License revenues
$-
$-
TOTAL REVENUE
  -
  -
Cost of License Revenue
  -
  -
Gross profit
  -
  -
Operating Expenses:


Research and development
  3,473,000
  144,000
Selling, general and administrative
  3,687,000
  1,394,000
Total operating expenses
  7,160,000
  1,538,000
Loss from Operations
  (7,160,000)
  (1,538,000)
Other income (expense)


Interest expense/income
  (2,931,000)
  (3,520,000)
Total Other Income (Expense)
  (2,931,000)
  (3,520,000)
Loss before minority interest and provision for income taxes
  (10,091,000)
  (5,058,000)
Less: Loss attributable to the noncontrolling interests
  -
  -
Loss before provision for income taxes
  (10,091,000)
  (5,058,000)
Provision for income taxes
  -
  -
Net loss
  (10,091,000)
  (5,058,000)
Loss per share


Basic
$(0.20)
$(26.36)
Diluted
$(0.20)
$(26.36)




Weighted Average Shares Outstanding – basic and diluted

Basic
  50,117,977
  191,847
Diluted
  50,117,977
  191,847

GT Biopharma, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
For the Three Months Ended March 31, 2019 and 2018
(in Thousands)

	2019	2018
	(unaudited)	(unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$(4,510)	$(10,091)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	1	1
Stock compensation expense for options and warrants issued to employees and non-employees	2,565	3,060
Amortization of debt discounts	163	2,665
Non-cash interest expense	-	266
Amortization of loan costs	-	407
Changes in operating assets and liabilities:
Other assets	3	-
Accounts payable and accrued liabilities	817	(534)
Net cash used in operating activities	(961)	(4,226)
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisition of fixed assets	-	(2)
Net cash used by investing activities	0	(2)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from notes payable	1,052	7,055
Loan costs	-	(533)
Repayment of note payable	(100)	-
Net cash provided by financing activities	952	6,522
Minority interest	-	-
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(9)	2,294
CASH AND CASH EQUIVALENTS - Beginning of period	60	576
CASH AND CASH EQUIVALENTS - End of period	$51	$2,870

Supplemental disclosures:
Interest paid	$-	$-
Income taxes paid	$-	$-

Supplemental disclosures:
Issuance of common stock upon conversion of convertible notes	$430	$-
Issuance of common stock upon conversion of accrued interest	$4	$-

The accompanying condensed notes are an integral part of these consolidated financial statements.

~~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, 2018 and 2017~~

2018

2017

(unaudited)

(unaudited)

CASH FLOWS FROM OPERATING ACTIVITIES:

Net loss
$(10,091,000)
$(5,058,000)

Adjustments to reconcile net loss to net cash used in operating activities:


Depreciation
  1,000
  1,000
Stock compensation expense for options and warrants issued to employees and non-employees
  3,060,000
  873,000
Amortization of debt discounts
  2,665,000
  814,000
Non-cash interest expense
  266,000
  2,197,000
Amortization of loan costs
  407,000
  -
Changes in operating assets and liabilities:


Other assets
  -
  -
Accounts payable and accrued liabilities
  (534,000)
  523,000
Net cash used in operating activities
  (4,226,000)
  (650,000)
CASH FLOWS FROM INVESTING ACTIVITIES:


Acquisition of fixed assets
  (2,000)
  -
Net cash used by investing activities
  (2,000)
  0
CASH FLOWS FROM FINANCING ACTIVITIES:


Proceeds from notes payable
  7,055,000
  866,000
Loan costs
  (533,000)
  -
Repayment of note payable
  -
  -
Net cash provided by financing activities
  6,522,000
  866,000
Minority interest
  -
  -
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
  2,294,000
  216,000
CASH AND CASH EQUIVALENTS - Beginning of period
  576,000
  19,000
CASH AND CASH EQUIVALENTS - End of period
$2,870,000
$235,000



Supplemental disclosures:


Interest paid
$-
$-
Income taxes paid
$-
$-



Supplemental disclosures:


Issuance of common stock upon conversion of convertible notes
$-
$1,864,000
Issuance of common stock upon conversion of accrued interest
$-
$442,000

~~The accompanying notes are an integral part of these consolidated financial statements.~~

GTGT BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, ~~2018~~2019

(UNAUDITED)

The Company and Summary of Significant Accounting Policies

~~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 Antibody Drug Conjugate (ADC) technology platforms. Constructs include bispecific and trispecific scFv constructs, proprietary drug payloads, bispecific targeted antibody-drug conjugates, as well as tri- and tetra-specific antibody-directed cellular cytotoxicity, or ADCC. Our proprietary tri- and tetra-specific ADCC platform engages natural killer cells, or NK cells. NK cells are cytotoxic lymphocytes of the innate immune system capable of immune surveillance. NK cells mediate ADCC through the highly potent CD16 activating receptor. Upon activation, NK cells deliver a store of membrane penetrating apoptosis-inducing molecules. Unlike T cells, NK cells do not require antigen priming.

Also, we have a CNS portfolio consisting of innovative reformulations and/or repurposing of existing therapies. We believe these new therapeutic agents address numerous unmet medical needs that can lead to improved efficacy while addressing tolerability and safety issues that tended to limit the usefulness of the original approved drug. These CNS drug candidates address disease states such as chronic neuropathic pain, myasthenia gravis and motion sickness.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;~~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 Natural Killer (NK) cell engager (Tri-specific Killer Engager (TriKE) & Tetra-specific Killer Engager (TetraKE)) and bi-specific Antibody Drug Conjugate (bispecific-ADC) technology platforms. Our TriKE and TetraKE platforms generate proprietary moieties designed to harness and enhance the cancer killing abilities of a patient’s own natural killer, or NK, cells. Once bound to a NK cell, our moieties are designed to stimulate the NK cell and precisely direct it to one or more specifically-targeted proteins (tumor antigens) expressed on a specific type of cancer, ultimately resulting in the cancer cell’s death. TriKEs and TetraKEs are made up of recombinant fusion proteins, can be designed to target tumor antigens on hematologic malignancies, sarcomas or solid tumors and do not require patient-specific customization. They are designed to be dosed in an outpatient setting and are expected to have reasonably low cost of goods. Our bispecific-ADC platform can generate product candidates that are ligand-directed single-chain fusion proteins that simultaneously target two tumor antigens. We believe our bispecific-ADC moieties represents the next generation of ADCs.

Going Concern

The financial statements of the Company have been prepared on a ~~going-concern~~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 ~~$280~~$533.3 million and cash of ~~$2.8 million~~$51 thousand as of March 31, ~~2018.~~2019. 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.

GT BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2019

(UNAUDITED)

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. Management ishas also ~~implementing~~implemented cost saving efforts, including reduction in executive ~~salaries.~~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;~~issued. however, there can be no assurance in this regard. If the Company is unable to secure adequate additional funding, ~~in 2018,~~ its business, operating results, financial condition and cash flows may be materially and adversely affected.

~~GT BIOPHARMA, INC. AND SUBSIDIARIES~~

~~CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS~~

~~MARCH 31, 2018~~

~~(UNAUDITED)~~

Use of Estimates

The financial statements and notes are representations of the Company's management, which is responsible for their integrity and objectivity. These accounting policies conform to accounting principles generally accepted in the United States of America, and have been consistently applied in the preparation of the financial statements. The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities revenues and expenses and disclosures of contingent assets and liabilities at the date of the financial statements. Actual results could differ from those estimates.

Basis of Consolidation and Comprehensive Income

The accompanying consolidated financial statements include the accounts of GT Biopharma, Inc. and its subsidiaries. All intercompany balances and transactions have been eliminated. The Company's financial statements are prepared using the accrual method of accounting.

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, ~~2017.~~2018. 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 ~~$2,617,000 of~~no balances in excess of this limit at March 31, ~~2018.~~2019.

GT BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, ~~2018~~2019

(UNAUDITED)

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, ~~2018~~2019 and ~~2017,~~2018, respectively

~~Impairment of Long Lived~~Long-Lived Assets

~~The Company's~~Our long-lived assets ~~currently consist~~include property, plant and equipment, capitalized costs of ~~capitalized patents~~filing patent applications and other indefinite lived intangible assets. ~~The Company evaluates its~~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 ~~the Company's~~our intangible or long-lived assets are considered to be impaired, the amount of impairment to be recognized is ~~equal to~~ the excess of the carrying amount of the assets over 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.

Impairment of Long-Lived Assets

The Company's long-lived assets currently consist of indefinite lived intangible assets associated with IPR&D (“In-Process Research & Development”) projects and related capitalized patents acquired in the acquisition of Georgetown Translational Pharmaceuticals, Inc. as described in Note 2 below. Intangible assets associated with IPR&D projects are not amortized until approval by the Food and Drug Administration (FDA) is obtained in a major market subject to certain specified conditions and management judgment. The useful life of an amortizing asset generally is determined by identifying the period in which substantially all of the cash flows are expected to be generated.

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 ~~assets. There was no impairment of any~~more significant estimates and assumptions inherent in this approach include: the amount and timing of the ~~indefinite lived intangibles during~~projected net cash flows, which includes the ~~quarter ended March 31, 2018.~~

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.

GT BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2019

(UNAUDITED)

Income Taxes

The Company accounts for income taxes using the asset and liability approach, whereby deferred income tax assets and liabilities are recognized for the estimated future tax effects, based on current enacted tax laws, of temporary differences between financial and tax reporting for current and prior periods. Deferred tax assets are reduced, if necessary, by a valuation allowance if the corresponding future tax benefits may not be realized.

Net Income (Loss) per Share

Basic net income (loss) per share is computed by dividing the net loss for the period by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net loss for the period by the weighted average number of common shares outstanding during the period, plus the potential dilutive effect of common shares issuable upon exercise or conversion of outstanding stock options and warrants during the period. The weighted average number of potentially dilutive common shares excluded from the calculation of net income (loss) per share totaled in ~~1,695,686~~22,731,781 and ~~848,115~~4,553,668 as of March 31, ~~2018~~2019 and ~~2017,~~2018, respectively.

Patents

Acquired patents are capitalized at their acquisition cost or fair value. The legal costs, patent registration fees and models and drawings required for filing patent applications are capitalized if they relate to commercially viable technologies. Commercially viable technologies are those technologies that are projected to generate future positive cash flows in the near term. Legal costs associated with patent applications that are not determined to be commercially viable are expensed as incurred. All research and development costs incurred in developing the patentable idea are expensed as incurred. Legal fees from the costs incurred in successful defense to the extent of an evident increase in the value of the patents are capitalized.

Capitalized cost for pending patents are amortized on a straight-line basis over the remaining twenty year legal life of each patent after the costs have been incurred. Once each patent is issued, capitalized costs are amortized on a straight-line basis over the shorter of the patent's remaining statutory life, estimated economic life or ten years.

Fixed Assets

Fixed assets is stated at cost. Depreciation is computed on a straight-line basis over the estimated useful lives of the assets, which are 3 to 10 years for machinery and equipment and the shorter of the lease term or estimated economic life for leasehold improvements.

~~GT BIOPHARMA, INC. AND SUBSIDIARIES~~

~~CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS~~

~~MARCH 31, 2018~~

~~(UNAUDITED)~~

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, ~~2018.~~2019.

●

Level 3 inputs to the valuation methodology are unobservable and significant to the fair value measurement.

GT BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2019

(UNAUDITED)

Research and Development

Research and development costs are expensed as incurred and reported as research and development expense. Research and development costs totaling ~~$3,473,000~~$.8 million and ~~$144,000~~$3.5 million for the years ended March 31, ~~2018~~2019 and ~~2017,~~2018, respectively.

Revenue Recognition

License Revenue

License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments. Some of these arrangements are multiple element arrangements.

Non-refundable, up-front fees that are not contingent on any future performance by us, and require no consequential continuing involvement on our part, are recognized as revenue when the license term commences and the licensed data, technology and/or compound is delivered. We defer recognition of non-refundable upfront fees if we have continuing performance obligations without which the technology, right, product or service conveyed in conjunction with the non-refundable fee has no utility to the licensee that is separate and independent of our performance under the other elements of the arrangement. In addition, if we have continuing involvement through research and development services that are required because our know-how and expertise related to the technology is proprietary to us, or can only be performed by us, then such up-front fees are deferred and recognized over the period of continuing involvement.

Payments related to substantive, performance-based milestones in a research and development arrangement are recognized as revenue upon the achievement of the milestones as specified in the underlying agreements when they represent the culmination of the earnings process. As of March 31, ~~2018,~~2019, the Company has not generated any licensing revenue.

Recent Accounting Pronouncements

~~GT BIOPHARMA, INC. AND SUBSIDIARIES~~

~~CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS~~

~~MARCH 31, 2018~~

~~(UNAUDITED)~~

In February 2016, the Financial Accounting Standards Board (“FASB”) issued new guidance related to accounting for leases, Accounting Standards codification Topic 842 (ASC 842). We adopted the new guidance on January 1, 2019 using the modified retrospective approach and the optional transition method. Under this adoption method, comparative prior periods were not adjusted and continue to be reported with our historical accounting policy. The primary impact of adopting this standard was the recognition of $173 thousand in operating lease liabilities and $165 thousand in right of use assets.

Intangibles

On September 1, 2017, the Company entered into an Agreement and Plan of Merger whereby it acquired 100% of the issued and outstanding capital stock of Georgetown Translational Pharmaceuticals, Inc. (GTP). In exchange for the ownership of GTP, the Company issued a total of 16,927,878 shares of its common stock, having a share price of $15.00on the date of the transaction,, to the three prior owners of GTP which ~~represents~~represented 33% of the issued and outstanding capital stock of the Company on a fully diluted basis. ~~$253,777,000~~ $253.8 million of the value of shares issued ~~were~~was allocated to intangible assets. consisting of a portfolio of three CNS development candidates, which are classified as IPR&D.

As ~~stated~~of September 30, 2018, the Company recorded an intangible asset impairment charge of $228.5 million related to the portfolio of CNS IPR&D assets within Operating Expenses, which represents the excess carrying value compared to fair value. The impairment charge was the result of both internal and external factors. In the 3rdquarter of 2018, the Company experienced changes in ~~Note 1, Company's long-lived assets currently consist~~key senior management, led by the appointment of ~~capitalized patents and other indefinite lived intangible~~a new CEO with extensive experience in oncology drug development. These changes resulted in the prioritization of immuno-oncology development candidates relative to CNS development candidates. In conjunction with these strategic changes, limited internal resources have delayed the development of the CNS IPR&D assets. The ~~Company evaluates its long-lived assets for impairment whenever events or~~limited resources, changes in ~~circumstances indicate that~~senior leadership, and favorable market conditions for immuno-oncology development candidates have resulted in the ~~carrying amount~~Company choosing to focus on development of ~~such assets may not be recoverable. If any~~its immuno-oncology portfolio. In light of this shift in market strategy, the Company performed a commercial assessment and a valuation of the ~~Company's long-lived~~CNS IPR&D assets, ~~are considered~~both to ~~be impaired, the amount of impairment to be recognized is equal to the~~assess fair value and support potential future licensing efforts. The valuation indicated an excess ~~of the~~ carrying ~~amount of the assets~~value over the fair value of these assets, resulting in the ~~assets. There was no~~ impairment ~~of any~~charge noted above.

GT BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2019

(UNAUDITED)

The fair value of the ~~indefinite lived intangibles during~~CNS IPR&D assets was determined using the ~~quarter ended March 31, 2018~~discounted cash flow method which utilized significant estimates and assumptions surrounding the amount and timing of the projected net cash flows, which includes the probability of commercialization, the assumption that the assets would be out-licensed to third-parties for continued development for upfront licensing fees and downstream royalty payments based on net sales, and expected impact of competitive, legal and/or regulatory forces on the projections, 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.

Debt

Convertible Notes

On January 22, 2018, the Company entered into a Securities Purchase Agreement (“SPA”) with ~~the~~ fourteen accredited investors (individually, a “Buyer” and collectively, the “Buyers”) pursuant to which the Company ~~has~~ 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 ~~are~~were subject to an original issue discount of 10% resulting in proceeds to the Company of $7,055,000 from the transaction. The Notes are due on July 22, 2018. The Notes are convertible, at the option of the Buyers, at any time prior to payment in full, into shares of common stock of the Company at a price of $4.58 per share (“Conversion Price”). According to the terms of the note agreement, the Notes 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.~~

Upon the purchase of the Notes, the Buyers received Warrants to purchase 1,694,440 shares of Common Stock. Such Warrants are exercisable for ~~five~~(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. ~~All descriptions~~

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 ~~SPA,~~notes issued on January 22, 2018. Additionally, the ~~Registration Rights Agreement,~~remaining $3.3 million of the ~~Notes and~~notes issued on January 22, 2018 were converted into the ~~Warrants contained herein are qualified in their entirety by reference to~~Debentures at the ~~exhibits filed herewith.~~same terms discussed above.

GT BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, ~~2018~~2019

(UNAUDITED)

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 a price of $2 per share.

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 a 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 a 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, 2019

(UNAUDITED)

Financing Agreement

On November 8, 2010, the Company entered into a financing arrangement with Gemini Pharmaceuticals, Inc., a product development and manufacturing partner of the Company, pursuant to which Gemini Pharmaceuticals made a $250,000 strategic equity investment in the Company and agreed to make a $750,000 purchase order line of credit facility available to the Company. The outstanding principal of all Advances under the Line of Credit will bear interest at the rate of interest of prime plus 2 percent per annum. There is $31,000 due on this credit line at March 31, ~~2018.~~2019.

Stockholders' Equity

Common Stock

In the first quarter of 2019, the Company issued 723,940 shares of common stock upon conversion of $434,271 in principal and interest on senior convertible notes.

Preferred Stock

On September 1, 2017, the Company authorized 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 September 1, 2017 the Company issued a total of 208,224 shares of Series J Preferred Stock in exchange for the conversion of debt in the total amount of $250,000.

On September 1, 2017 the Company issued a total of 700,278 shares of Series J Preferred Stock in exchange for the cancellation of debt in the total amount of $840,000.

On September 1, 2017 the Company issued 5,046 shares of Series J Preferred Stock upon the exercise of warrants on a cashless basis.

On September 1, 2017 the Company also issued 600,000 shares of Series J Preferred Stock to one entity as payment for $720,000 of consulting services provided to the Company.

In December 2017, the Company converted 350,000 Series J shares of preferred stock into 350,000 shares of common stock.

GT BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2019

(UNAUDITED)

Stock Options and Warrants

Stock Options

The following table summarizes stock option transactions for the quarter ended March 31, 2018:

	Number of Options	Weighted Average Exercise Price	Number of Options	Weighted Average Exercise Price
Outstanding, December 31, 2017	1,246	$1,428.00
Outstanding, December 31, 2018			1,133	$1,320.00
Granted	-		-
Exercised	-		-
Expired	-	-	-
Outstanding, March 31, 2018	1,246	$1,428.00
Exercisable, March 31, 2018	1,246	$1,428.00
Outstanding, March 31, 2019			1,133	$1,320.00
Exercisable, March 31, 2019			1,133	$1,320.00

Common Stock Warrants

Warrant transactions for the quarter ended March 31, 2019 are as follows:

	Number of Warrants	Weighted Average Exercise Price
Outstanding at December 31, 2018:	1,813,053	$2.00
Granted	-	-
Forfeited	-	-
Exercised	-	-
Outstanding at March 31, 2019	1,813,053	$2.00
Exercisable at March 31, 2019	1,813,053	$2.00

Commitments and Contingencies

Leases

As described in Note 1. Nature of Operations and Summary of Significant Accounting Policies, we adopted new lease accounting guidance effective January 1, 2019.

We determine if a contractual arrangement is a lease at inception. Our lease arrangements provide the Company the right to utilize certain specified tangible assets for a period of time in exchange for consideration. Our leases primarily relate to building office space. Our leases currently consist solely of operating leases. Leases with an initial term of 12 months or less are not recorded on the balance sheet.

We recognize a lease liability and a right of use asset at the lease commencement date based on the present value of the future lease payments over the lease term discounted using our incremental borrowing rate. Implicit interest rates within our lease arrangements are rarely determinable. Right of use assets also include, if applicable, prepaid lease payments and initial direct costs, less incentives received.

We recognize operating lease expense on a straight-line basis over the term of the lease within selling general and administrative expenses.

Our leases do not contain any material residual value guarantees or material restrictive covenants. Some of our leases include optional renewal periods or termination provisions which we assess at inception to determine the term of the lease, subject to reassessment in certain circumstances.

The following table summarizes the Company’s future minimumpayments under operating leases as of December 31, 2018:

Year ending December 31:
2019	69,000
2020	71,000
2021	61,000
Total minimum lease payments	$201,000

Lease expense for the quarters ended March 31, 2019 and 2018 was $17,000 and $24,000, respectively.

GT BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, ~~2018~~2019

(UNAUDITED)

~~Common Stock Warrants~~

~~Warrant transactions for the quarter ended March 31, 2018 are as follows:~~

Number of
Warrants

Weighted Average Exercise Price

Outstanding at December 31, 2017:
  -
$-
Granted
  1,694,440
  4.58
Forfeited
  -
  -
Exercised
  -
  -
Outstanding at March 31, 2018
  1,694,440
$4.58
Exercisable at March 31, 2018
  1,694,440
$4.58

~~Commitments and Contingencies~~

~~Leases~~

On September 1, 2017, the Company has entered into a three-year lease agreement for its office in Washington, D.C. In addition to minimum rent, certain leases require payment of real estate taxes, insurance, common area maintenance charges and other executory costs. These executory costs are not included in the table below. 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, 2018 :~~

Year ending December 31:

     2018
  81,000
     2019
  108,000
     2020
  81,000
Total minimum lease payments
$270,000

~~Rent expense for the quarters ended March 31, 2018 and 2017 was $27,000 and $3,000, respectively.~~

Employment Agreements

On February 14, 2018, the Company entered into the First Amendment to the Employment Agreement with Dr. Clarence-Smith, amending the Employment Agreement, dated September 1, 2017, between the Company and Dr. Clarence-Smith. Under the First Amendment, Dr. Clarence-Smith’s title has been revised to reflect her new position and she will be paid an annual salary of $500,000, paid in equal monthly installment. All other terms of her original Employment Agreement remain unchanged.

~~On February 14,~~October 18, 2018, the Company entered into a Consultant Agreement with ~~Mr.~~Anthony Cataldo. The term of the Consultant Agreement ~~lasts~~shall remain in effect until ~~August 31, 2020~~September 30, 2019. This Agreement supersedes the Consultant Agreement dated February 14, 2018 and ~~is terminable at~~ will ~~and is subject to automatic extension for successive one-year periods.~~pay Mr. Cataldo ~~will be paid $41,666.67~~$25,000 per month during the term of the ~~Consultant Agreement and will be entitled to participate in the Company’s bonus plans.~~Agreement.

~~GT BIOPHARMA, INC. AND SUBSIDIARIES~~

~~CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS~~

~~MARCH 31, 2018~~

~~(UNAUDITED)~~

On ~~February 15,~~October 19, 2018, the Company entered into an Executive Employment Agreement with ~~Mr. Cross, pursuant to which Mr. Cross will be employed~~Dr. Urbanski, reflecting his current position as ~~the Company’s~~ Chief Executive ~~Officer. The term~~Officer of the ~~Executive Employment Agreement is three years and is terminable at will by either~~Company. Under the ~~Company or Mr. Cross and subject to automatic extensions for successive one year periods.~~ ~~Mr. Cross~~ ~~will be paid an~~terms of this agreement, Dr. Urbanski’s annual salary ~~of $500,000, paid in equal monthly installment. Mr. Cross~~is essentially unchanged from his previous positions. Dr. Urbanski is also entitled to participate in the Company’s bonus plans. Under the Executive Employment Agreement, the Company has agreed that itupon shareholder approval of a Stock Option Plan, it will recommend to the Board that the Company grant ~~Mr. Cross an~~Dr. Urbanski a Non-Qualified stock option to purchase ~~2,000,000~~2,971,102 shares of the Company’s common stock athaving an exercise ~~price~~ equal to the fair market value of ~~each share as determined by~~ the ~~Board as of~~shares on the date of the ~~grant.~~Agreement. The stock option grant would vest according to the following schedule: (i) ~~34%~~1,250,000 fully vested shares upon signing of the agreement, (ii) 1,250,000 shares on ~~February 15, 2018, (ii) 33% of the shares on February 15,~~January 1, 2019, and (iii) ~~33%~~471,102 shares on January 1, 2020. On March 15, 2019, Dr, Urbanski resigned his position as Chief Executive Officer, President and Chairman of the ~~shares on February 15, 2020.~~

If any of our executive officers’ employment with us is terminated involuntarily, or any executive resigns with good reason as a result of a change in control, the executive will receive (i) all compensation and benefits earned through the date of termination of employment; (ii) a lump-sum payment equal to the greater of (a) the bonus paid or payable to the executive for the year immediately prior to the year in which the change in control occurred and (b) the target bonus under the performance bonus plan in effect immediately prior to the year in which the change in control occurs; (iii) a lump-sum payment equivalent to the remaining base salary (as it was in effect immediately prior to the change in control) due to the executive from the date of involuntary termination to the end of the term of the employment agreement or one half of the executive’s base salary then in effect, whichever is the greater; and (iv) reimbursement for the cost of medical, life, disability insurance coverage at a level equivalent to that provided by us for a period expiring upon the earlier of (a) one year or (b) the time the executive begins alternative employment where said insurance coverage is available and offered to the executive.

~~Change of Accounting Method~~

~~Adoption of ASU 2017-11~~

In connection with the securities purchase agreements and debt transactions during and previous the year ended December 31, 2017, the Company issued warrants, to purchase common stock with a five-year term. Upon issuance of the warrants, the Company evaluated the note agreement to determine if the agreement contained any embedded components that would qualify the agreement as a derivative. The Company identified certain put features embedded in the warrants that potentially could result in a net cash settlement in the event of a fundamental transaction, requiring the Company to classify the warrants as a derivative liability. The Company changed its method of accounting for the debt and warrants through the early adoption of ASU 2017-11 during the three months ended March 31, 2018 on a retrospective basis. Accordingly, the Company recorded the warrant derivative and conversion option derivative liabilities to additional paid in capital upon issuance.

~~The following table provides a summary of the derivative liability activity as a result of the adoption of ASU 2017-11:~~

Consolidated Balance Sheet

December 31, 2017

Previously
Reported

Revisions

Revised
Report

Additional Paid in Capital
$519,702,000
$1,603,000
$521,305,000
Accumulated Deficit
$(267,896,000)
$(1,603,000)
$(269,499,000)

Consolidated Statement of Operations

March 31, 2017

Previously
Reported

Revisions

Revised
Report

Change in Warrant Liability
$2,743,000
$(2,743,000)
$-
Earnings Per Share
$(12.07)
$(14.29)
$(26.36)
Board.

Subsequent Events

The Company evaluated subsequent events from March 31, 2018 through the date of this filing and concluded that no subsequent events have occurred that would require recognition or disclosure in the consolidated financial statements. Preferred Stock

On April 4, 2019, the Company filed a Certificate of Designation with the Office of the Secretary of State of the State of Delaware. The Certificate of Designation designated 3,000,000 shares of preferred stock as Series J-1 Preferred Stock. A copy of the Certificate of Designation detailing the rights and preferences of the stock is attached hereto as Exhibit 3.1. In the State of Delaware, the Certificate of Designation has the effect of amending the Certificate of Incorporation by adding to the Certificate of Incorporation the terms and conditions of the Designation and the stock designated.

~~Item~~On April 19, 2019, the Companyissued a total of 2,353,548 shares of Series J-1 Preferred Stock (the "Shares") to a total of two entities. The Shares are convertible into shares of common stock of the Registrant at the rate of $0.60 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.

In addition, the Company entered into a letter agreement with the two entities, pursuant to which the Company has agreed to include the shares of common stock issuable upon full conversion of the Series J-1 Preferred Stock in the next registration statement that the Company files (the "Piggyback Registration Statement"). The Company must file the Piggyback Registration Statement on or before August 30, 2019.

Common Stock

In April 2019, the Company issued 656,181 shares of common stock upon conversion of $393,709 in principal and interest on convertible notes.

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, ~~2017.~~2018. 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 Antibody Drug Conjugate (ADC) technology platforms. Our immuno-oncology portfolio is based off a proprietary technology platform consisting of single-chain bi-, tri- and tetra-specific scFv’s, combined with proprietary antibody-drug linkers and drug payloads. Constructs include bispecific and trispecific scFv constructs, proprietary drug payloads, bispecific targeted antibody-drug conjugates, or ADCs, as well as tri- and tetra-specific antibody-directed cellular cytotoxicity, or ADCC. Our proprietary tri- and tetra-specific ADCC platform engages natural killer cells, or NK cells. NK cells are cytotoxic lymphocytes of the innate immune system capable of immune surveillance. NK cells mediate ADCC through the highly potent CD16 activating receptor. Upon activation, NK cells deliver a store of membrane penetrating apoptosis-inducing molecules. Unlike T cells, NK cells do not require antigen priming.

We also have a CNS portfolio ~~consisting~~consists of innovative reformulations and/or repurposing of existing therapies. We believe these therapeutic agents address certain unmet medical needs that can lead to improved efficacy while addressing tolerability and safety issues that tended to limit the usefulness of the original approved drug. Our CNS drug candidates address disease states such as chronic neuropathic pain, myasthenia gravis and ~~motion sickness.~~vestibular disorders.

OXS-3550 is our most advanced TriKE product candidate. The IND for OXS-3550 was filed in June 2017 by the University of Minnesota. Before the IND was transferred to us in October 2017, FDA requested that additional preclinical toxicology be conducted prior to initiating clinical trials. The FDA also requested some additional information and clarifications on the manufacturing (CMC) and clinical packages. The requested additional information and clarifications have been completed and are being incorporated by us into the IND in eCTD format. We expect to file the IND in mid 2018 and be a in position begin a Phase 1 clinical trial in the second half of 2018.

Our most advanced bi-specific ADC, OXS-1550, which targets CD19+ and/or CD22+ hematological malignancies is currently in a single site Phase 2 trial being conducted at the University of Minnesota Masonic Cancer Center in patients with relapsed/refractory B-cell leukemias or lymphomas. There are approximately 18 patients enrolled in this trial. Based on the rapidly changing landscape of in-development and available treatment options for this patient population, as well as what we believe are compelling data from the OXS-1550 phase I trial, we recently assembled an ADC Advisory Board to work with us to assess and interpret the OXS-1550 pre-clinical and clinical data, including a snapshot from the Phase 2 study, and evaluate next steps for this program. We expect data from the Phase 2 trial to be available in the second half 2018.

In January 2018, we completed a study in healthy volunteers for GTP-004, our product candidate for the treatment for the symptoms of myasthenia gravis. We also announced the initiation of an investigator led study in healthy volunteers for GTP-011, for the prevention of motion sickness, with data expected in the second half of 2018. We expect to take advantage of our CNS portfolio by generating what we believe to be proof-of-concept data and/or achieving other milestones, making what we believe are cost effective go/no-go decisions, and pursuing strategic transactions with commercialization-oriented pharmaceutical companies.

Recent Developments

Financing

~~In January 22, 2018, the Company~~On February 4, 2019, GT Biopharma, Inc. (the “Company”) entered into a Securities Purchase Agreement ~~(“SPA”~~(the “Purchase Agreement”) with the ~~fourteen accredited investors~~purchasers identified on the signature pages thereto (individually, a ~~“Buyer”~~“Purchaser,” and collectively, the ~~“Buyers”~~“Purchasers”), pursuant to which the Company ~~has agreed to issue~~issued to the ~~Buyers senior convertible notes~~Purchasers, on February 4, 2019, Secured Convertible Notes in an aggregate principal amount of ~~$7,760,510~~$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 a conversion price of $0.60 per share (the “Conversion Price”).

The Notes accrue interest at the rate of 10% per annum and ~~five-year warrants to purchase~~mature on August 2, 2019. Interest on the ~~Company’s Common Stock representing the right to acquire an aggregate of approximately 1,694,440~~Notes is payable in cash or, at a Purchaser’s option, in shares of Common Stock ~~(the “Warrants”).~~

~~Pursuant~~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 ~~terms of SPA~~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 ~~are subject to an original issue discount of 10% resulting in proceeds to~~with the ~~Company of $7,055,000 from the transaction. The Notes are due on July 22, 2018. The Notes are convertible, at the option~~prior written consent of the Buyers, at any time prior to payment in full, into shares of common stock of the Company at a price of $4.58 per share (“Conversion Price”). According to the terms of the note agreement, the Notes 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.~~

~~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.~~

Contemporaneously with the execution and delivery of the ~~SPA,~~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 ~~Buyers executed~~Purchasers, and ~~delivered~~with the Purchasers, pursuant to which the Purchasers have been granted a ~~Registration Rights~~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.

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 ~~provide certain~~file, within 14 days after February 4, 2019, one or more registration ~~rights with respect~~statements on Form S-3 (or, if Form S-3 is not then available to the ~~Registrable Securities under the 1933 Act and the rules and regulations promulgated thereunder, and applicable state securities laws. All descriptions~~Company, such form of registration that is then available to effect a registration for resale of the ~~SPA,~~subject securities) covering the resale of all Conversion Shares, subject to certain penalties set forth in the Registration Rights ~~Agreement,~~Agreement. The Form S-3 was filed by the ~~Notes and the Warrants contained herein are qualified in their entirety by reference to the exhibits filed herewith.~~Company on February 14, 2019.

Results of Operations

Comparison of the Three Months Ended March 31, ~~2018~~2019 and ~~2017~~2018

Research and Development Expenses

During the three months ended March 31, ~~2018~~2019 and ~~2017,~~2018, we incurred ~~$3,473,000~~$.8 million and ~~$144,000~~$3.5 million of research and development expenses. Research and development costs ~~increased~~decreased due primarily to the ~~addition of new~~reductions employees, consultants ~~costs~~ and preclinical ~~and clinical expenses and includes $2.9 million of expenses related to non-cash compensation.~~expenses. We anticipate our direct clinical costs to increase in second half of ~~2018~~2019 upon the initiation of a ~~Phase 1~~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, ~~2018~~2019 and ~~2017,~~2018, we incurred ~~$3,687,000~~$3.2 million and ~~$1,394,000~~$3.7 million of selling, general and administrative expenses. The ~~increase~~decrease in selling, general and administrative expenses is primarily attributable to an increase $1.3 million of professional fees, $0.8 million of public and investor relations expenses and $0.5 million of loan costs. We anticipate the second quarter of 2018 selling, general and administrative expenses will be lower than the first quarter of 2018 primarily due to the reduction of ~~executive salaries and professional fees.~~salaries.

Interest Expense

Interest expense was ~~$2,931,000~~$.5 million and ~~$3,520,000~~$2.9 million for the three months ended March 31, ~~2018~~2019 and ~~2017~~2018 respectively. The decrease is primarily due to a decrease ~~debt issuance costs associated with the convertible debentures and demand notes payable that were settled in September 2017. The current interest expense relates~~related to the amortization of the original issue discount and the value of warrants issued with the January 2018 financing.

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, 2019, the Company raised $1 million through a series of issuances of convertible debentures in February. 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 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 ~~$280~~$533.4 million and cash of ~~$2.8 million~~$51 thousand as of March 31, ~~2018.~~2019. 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, ~~and~~ licensing and/or marketing arrangements with pharmaceutical companies. Management ishas also ~~implementing~~implemented cost saving efforts, including reduction in executive ~~salaries.~~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, ~~in 2018,~~ 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.

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, ~~2018.~~2019.

~~Item~~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~~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, ~~2018.~~2019. Based on that evaluation we have concluded that our disclosure controls and procedures were not effective as of March 31, ~~2018.~~2019.

Management’s Report on Internal Control over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the supervision of, a company’s principal executive and principal financial officers and effected by a company’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

●

Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;

●

Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and

●

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.

All internal control systems, no matter how well designed, have inherent limitations and can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

As of March 31, ~~2018,~~2019, 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, ~~2018.~~2019. The most significant issues identified were: 1) lack of segregation of duties due to very small staff and significant reliance on outside consultants, and 2) risks of executive override also due to lack of established policies, and small employee staff. Based on the material weaknesses identified above, management has concluded that internal control over financial reporting was not effective as of March 31, ~~2018.~~2019. As the company’s operations increase, the company intends to hire additional employees in its accounting department.

Changes in Internal Control over Financial Reporting

Other than as described above, no changes in our internal control over financial reporting were made during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

~~Item~~Item 1. Legal Proceedings

On ~~June 23, 2016, we were served with a complaint~~December 24, 2018, Empery Asset Master, Empery Tax Efficient, LP, and Empery Tax Efficient II, LP (collectively, “Plaintiffs) filed in the ~~Circuit~~N.Y. Supreme Court, Index No. 656408/2018, alleging causes of action against the ~~13th Judicial Circuit~~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 ~~for Hillsborough County, Florida, Case No. 16-CA-004791, by Lippert/Heilshorn~~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 ~~Associates, Inc. Lippert/Heilshorn and Associates, Inc. is alleging it is owed compensation for consulting services provided~~warrants representing the right of Plaintiffs to ~~us and is seeking payment~~acquire an aggregate of ~~$73,898. We have engaged legal counsel to answer~~480,352 shares of common stock in the ~~complaint.~~Company.

On February 15, 2017, MultiCell Immunotherapeutics, or MultiCell, filed an arbitration proceeding against us with the American Health Lawyers Association, Claim #3821. MultiCell is seeking $207,783 plus interest and costs of arbitration pursuant to alleged contract rights against us under a research agreement between MultiCell and us. Following a hearing held September 1, 2017, the arbitrator awarded MultiCell the payment amount of $207,783 plus interest in the amount of $34,699. We have engaged legal counsel to advise us in connection with this matter.

~~Item~~Item 1A. Risk Factors

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, ~~2017.~~2018. There have been no material changes from the risk factors previously disclosed in the above-mentioned periodic report.

~~Item~~Item 2. Unregistered Sales of Securities and Use of Proceeds

In January 22, 2018, the Company entered into a Securities Purchase Agreement (“SPA”) with the fourteen accredited investors (individually, a “Buyer” and collectively, the “Buyers”) pursuant to which the Company has 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”), 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 are subject to an original issue discount of 10% resulting in proceeds to the Company of $7,055,000 from the transaction. The Notes are due on July 22, 2018. The Notes are convertible, at the option of the Buyers, at any time prior to payment in full, into shares of common stock of the Company at a price of $4.58 per share (“Conversion Price”). According to the terms of the note agreement, the ~~Notes~~notes 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.

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~~notes 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.

~~Item~~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 a price of $2 per share.

Item 3. Defaults Upon Senior Securities.

None

~~Item~~Item 4. Mine Safety Disclosures

None.

~~Item~~Item 5. Other Information.

None.

~~Item~~Item 6. Exhibits


Exhibit	Description	Herewith	Form	SEC File No.	Filing Date

3.1	Certificate of Amendment to the Certificate of Incorporation of the Registrant, effective as of July 19, 2017.		8-K	~~000-08092~~	~~03/15/18~~
~~10.1~~	000-08092	03/15/18
10.1	Securities Purchase Agreement by and among the Company and the Buyers, dated ~~January 22, 2018.~~February 4, 2019.		8-K	~~000-08092~~	~~01/23/18~~
~~10.2~~	000-08092	02/06/19
10.2	Form of Registration Rights Agreement by and among the Company and the Buyers, dated ~~January 22, 2018.~~February 4, 2019.		8-K	~~000-08092~~	~~01/23/18~~
~~10.3~~	000-08092	02/06/19
10.3	Form of Note.		8-K	~~000-08092~~	~~01/23/18~~
~~10.4~~	000-08092	02/06/19
10.4	Form of Warrant.		8-K	~~000-08092~~	~~01/23/18~~
~~10.5~~	~~Executive Employment~~ 000-08092	02/06/19
10.5	Form of Security Agreement ~~dated as of February 15, 2018, between the Company and Cross.~~		8-K	~~000-08092~~	~~02/21/18~~
~~10.6~~	~~First Amendment to the Employment Agreement, dated as of February 14, 2018, between the Company and Dr. Clarence-Smith.~~		~~8-K~~	000-08092	~~02/21/18~~
~~10.7~~	~~Consultant Agreement, dated as of February 14, 2018, between the Company and Mr. Cataldo.~~		~~8-K~~	~~000-08092~~	02/~~21/18~~06/19
31.1	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.	X

31.2	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.	X

32.1*	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).	X
32.2*	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).	X

Exhibit No.	Description
101.INS	XBRL Instance Document.

101.SCH	XBRL Taxonomy Extension Schema Document.

101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF	XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB	XBRL Taxonomy Extension Label Linkbase Document.

101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document.

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.

~~SIGNATURES~~

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: May 15, ~~2018~~2019	GT Biopharma, Inc. By: /s/ ~~Shawn Cross~~Anthony Cataldo ~~Shawn Cross~~Anthony Cataldo Chief Executive Officer and Chairman of the Board

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	Position	Date

/s/ ~~Shawn Cross~~Anthony Cataldo ~~Shawn Cross~~Anthony Cataldo	Chief Executive Officer and Chairman of the Board	May 15, ~~2018~~2019
/s/ Steven Weldon Steven Weldon	Chief Financial Officer (Principal Financial Officer), and Director	May 15, ~~2018~~2019
~~/s/ Dr. Kathleen Clarence-Smith~~ ~~Dr. Kathleen Clarence-Smith~~

~~Vice Chairwoman and DirectorMay 15, 2018~~

~~/s/Anthony J. Cataldo~~

~~Anthony J. Cataldo~~

~~DirectorMay 15, 2018~~

~~/s/ Geoffrey Davis~~

~~Geoffrey Davis~~

~~DirectorMay 15, 2018~~

~~/s/ Federica O’Brien~~

~~Federica O’Brien~~

~~DirectorMay 15, 2018~~

~~/s/ Peter Kiener~~

~~Peter Kiener~~

~~DirectorMay 15, 2018~~

1922

	March 31,
	2018	2017
Revenue:	(unaudited)	(unaudited)
License revenues	$-	$-
TOTAL REVENUE	-	-
Cost of License Revenue	-	-
Gross profit	-	-
Operating Expenses:
Research and development	3,473,000	144,000
Selling, general and administrative	3,687,000	1,394,000
Total operating expenses	7,160,000	1,538,000
Loss from Operations	(7,160,000)	(1,538,000)
Other income (expense)
Interest expense/income	(2,931,000)	(3,520,000)
Total Other Income (Expense)	(2,931,000)	(3,520,000)
Loss before minority interest and provision for income taxes	(10,091,000)	(5,058,000)
Less: Loss attributable to the noncontrolling interests	-	-
Loss before provision for income taxes	(10,091,000)	(5,058,000)
Provision for income taxes	-	-
Net loss	(10,091,000)	(5,058,000)
Loss per share
Basic	$(0.20)	$(26.36)
Diluted	$(0.20)	$(26.36)

Weighted Average Shares Outstanding – basic and diluted
Basic	50,117,977	191,847
Diluted	50,117,977	191,847

	Number of Warrants	Weighted Average Exercise Price
Outstanding at December 31, 2017:	-	$-
Granted	1,694,440	4.58
Forfeited	-	-
Exercised	-	-
Outstanding at March 31, 2018	1,694,440	$4.58
Exercisable at March 31, 2018	1,694,440	$4.58

Year ending December 31:
2018	81,000
2019	108,000
2020	81,000
Total minimum lease payments	$270,000

	Consolidated Balance Sheet
	December 31, 2017
	Previously Reported	Revisions	Revised Report
Additional Paid in Capital	$519,702,000	$1,603,000	$521,305,000
Accumulated Deficit	$(267,896,000)	$(1,603,000)	$(269,499,000)

	Consolidated Statement of Operations
	March 31, 2017
	Previously Reported	Revisions	Revised Report
Change in Warrant Liability	$2,743,000	$(2,743,000)	$-
Earnings Per Share	$(12.07)	$(14.29)	$(26.36)