U. S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
 
FORM 10-Q
 
☑  
Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended June 30, 2018.March 31, 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
94-1620407
(State or other jurisdiction of
incorporation or organization)
94-1620407
(I.R.S. employer
identification number)
100 South Ashley Street, Suite 600
Tampa, FL 33602
310 N. Westlake Blvd, Suite 206
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 August 14, 2018,May 11, 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 Six MonthsQuarter Ended June 30, 2018March 31, 2019
Table of Contents
 
PART I  FINANCIAL INFORMATION Page
Item 1. Financial Statements 
   
Consolidated Balance Sheets as of June 30, 2018 (Unaudited) and December 31, 20171
   
 2
 
 3
 
4
 
13
 
18
 
18
 
PART II  OTHER INFORMATION
 
20
 
Item 1A. Risk Factors20
20
 
21
 
21
 
21
 
21
 
 22
 
 
 
 
GT Biopharma, Inc. and Subsidiaries
as of June 30, 2018 and December 31, 2017
Consolidated Balance Sheets
 
GT Biopharma, Inc. and Subsidiaries
 
 
as of March 31,2019 and December 31, 2018
 
 
Consolidated Balance Sheets
 
 
(in Thousands, Except Par Value and Share Data)
 
 
 
 
 
 
 
 
 
 
March 31,
2019
 
 
December 31,
2018
 
ASSETS
 
(unaudited)
 
 
 
 
Current Assets:
 
 
 
 
 
 
Cash and cash equivalents
 $51 
 $60 
Prepaid expenses
  27 
  30 
Total Current Assets
  78 
  90 
 
    
    
Intangible assets
  25,262 
  25,262 
Deposits
  12 
  12 
Operating lease right-to-use asset
  153 
  - 
Fixed assets, net
  34 
  35 
Total Other Assets
  25,461 
  25,309 
TOTAL ASSETS
 $25,539 
 $25,399 
LIABILITIES AND STOCKHOLDERS’ EQUITY
    
    
Current Liabilities:
    
    
Accounts payable
 $1,898 
 $1,762 
Accrued expenses
  2,136 
  1,455 
Deferred rent
  - 
  8 
Operating lease liability
  161 
  - 
Note payable to related party
  - 
  100 
Line of credit
  31 
  31 
Convertible debentures
  11,297 
  10,673 
Total Current Liabilities
  15,523 
  14,029 
 
    
    
Total liabilities
  15,523 
  14,029 
 
    
    
Stockholders’ Equity:
    
    
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, 2019 and December 31, 2018, respectively
  1 
  1 
Series J – 1,163,548 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively
  1 
  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 
  51 
Additional paid-in capital
  543,327 
  540,171 
Accumulated deficit
  (533,195)
  (528,685)
Noncontrolling interest
  (169)
  (169)
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.
 
 
 
 
June 30,
2018
 
 
December 31,
2017
 
ASSETS
 
(unaudited)
 
 
 
 
Current Assets:
 
 
 
 
 
 
Cash and cash equivalents
 $1,096,000 
 $576,000 
Prepaid expenses
  - 
  - 
Total Current Assets
  1,096,000 
  576,000 
 
    
    
Intangible assets
  253,777,000 
  253,777,000 
Loan costs
  126,000 
  - 
Deposits
  9,000 
  9,000 
Fixed assets, net
  6,000 
  6,000 
Total Other Assets
  253,918,000 
  253,792,000 
TOTAL ASSETS
 $255,014,000 
 $254,368,000 
LIABILITIES AND STOCKHOLDERS’ EQUITY
    
    
Current Liabilities:
    
    
Accounts payable
 $1,887,000 
 $2,546,000 
Accrued expenses
  178,000 
  102,000 
Line of credit
  31,000 
  31,000 
Convertible debentures, net of discount of $905,000
  6,856,000 
  - 
Total Current Liabilities
  8,952,000 
  2,679,000 
 
    
    
Total liabilities
  8,952,000 
  2,679,000 
 
    
    
Stockholders’ Equity:
    
    
Convertible preferred stock - $0.001 par value; 15,000,000 shares authorized:
    
    
Series C - 96,230 and 96,230 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively
  1,000 
  1,000 
Series J – 1,163,548 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively
  1,000 
  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 June 30, 2018 and December 31, 2017, respectively
  50,000 
  50,000 
Additional paid-in capital
  534,849,000 
  521,305,000 
Accumulated deficit
  (288,670,000)
  (269,499,000)
Noncontrolling interest
  (169,000)
  (169,000)
Total Stockholders’ Equity
  246,062,000 
  251,689,000 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
 $255,014,000 
 $254,368,000 
The accompanying notes are an integral part of these consolidated financial statements.
 

 
GT
 
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
 
 
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.
 

GT BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of OperationsCONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the Three Months Ended June 30, 2018 and 2017MARCH 31, 2019
 
 
 
Three Months Ended June 30,
 
 
Six Months Ended June 30,
 
 
 
2018
 
 
2017
 
 
2018
 
 
2017
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Product revenues
 $- 
 $- 
 $- 
 $- 
License revenue
  -  
  -  
  -  
  -  
Total revenue
  - 
  - 
  - 
  - 
Cost of product revenue
  -  
  -  
  -  
  -  
Gross profit
  -  
  -  
  -  
  -  
Operating expenses
    
    
    
    
Research and development
  3,251,000 
  241,000 
  6,724,000 
  385,000 
Selling, general and administrative expenses
  1,906,000  
  1,044,000  
  5,593,000  
  2,438,000  
Total operating expenses
  5,157,000  
  1,285,000  
  12,317,000  
  2,823,000  
Loss from operations
  (5,157,000)
  (1,285,000)
  (12,317,000)
  (2,823,000)
Other income (expense)
    
    
    
    
Interest expense
  (3,924,000)
  (1,178,000)
  (6,855,000)
  (4,698,000)
Total other income (expense)
  (3,924,000)
  (1,178,000)
  (6,855,000)
  (4,698,000)
Loss before minority interest and provision for income taxes
  (9,081,000)
  (2,463,000)
  (19,172,000)
  (7,521,000)
Plus: net (income) loss attributable to the noncontrolling interest
  -  
  -  
  -  
  -  
Loss before provision for income taxes
  (9,081,000)
  (2,463,000)
  (19,172,000)
  (7,521,000)
Provision for income tax
  -  
  -  
  -  
  -  
Net loss
  (9,081,000)
  (2,463,000)
  (19,172,000)
  (7,521,000)
Weighted average common shares outstanding – basis and diluted
    
    
    
    
Basic
  50,117,977 
  479,053 
  50,117,977 
  335,450 
Diluted
  50,117,977 
  479,053 
  50,117,977 
  335,450 
Net loss per share
    
    
    
    
Basic
 $(0.18)
 $(5.14)
 $(0.38)
 $(22.42)
Diluted
 $(0.18)
 $(5.14)
 $(0.38)
 $(22.42)
The accompanying condensed notes are an integral part of these consolidated financial statements.

GT Biopharma, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
For the Six Months Ended June 30, 2018 and 2017
 
 
2018
 
 
2017
 
 
 
(unaudited)
 
 
(unaudited)
 
CASH FLOWS FROM OPERATING ACTIVITIES:
 
 
 
 
 
 
Net loss
 $(19,172,000)
 $(7,521,000)
Adjustments to reconcile net loss to net cash used in operating activities:
    
    
Depreciation
  2,000 
  1,000 
Stock compensation expense for options and warrants issued to employees and non-employees
  6,489,000 
  1,524,000 
Amortization of debt discounts
  6,855,000 
  1,376,000 
Note Allonge
    
  100,000 
Non-cash interest expense
  - 
  2,197,000 
Amortization of loan costs
  407,000 
  - 
Changes in operating assets and liabilities:
    
    
Other assets
  - 
  - 
Accounts payable and accrued liabilities
  (581,000)
  1,282,000 
Net cash used in operating activities
  (6,000,000)
  (1,041,000)
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 
  1,061,000 
Loan costs
  (533,000)
  - 
Repayment of note payable
  - 
  - 
Net cash provided by financing activities
  6,522,000 
  1,061,000 
Minority interest
  - 
  - 
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
  520,000 
  20,000 
CASH AND CASH EQUIVALENTS - Beginning of period
  576,000 
  19,000 
CASH AND CASH EQUIVALENTS - End of period
 $1,096,000 
 $39,000 
 
    
    
Supplemental disclosures:
    
    
Interest paid
 $- 
 $- 
Income taxes paid
 $- 
 $- 
 
    
    
Supplemental disclosures:
    
    
Issuance of common stock upon conversion of convertible notes
 $- 
 $2,025,000 
Issuance of common stock upon conversion of accrued interest
 $- 
 $486,000 
The accompanying condensed notes are an integral part of these consolidated financial statements.

(UNAUDITED)
 
1.            
The Company and Summary of Significant Accounting Policies
  
We are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno­oncology products based off our proprietary Tri­specific Killer Engager (TriKE), Tetra­specific Killer Engager (TetraKE) and bi­specific Antibody Drug Conjugate (ADC) technology platforms. Constructs include bispecific and trispecific scFv constructs, proprietary drug payloads, bispecific targeted antibody­drug conjugates, as well as tri­ and tetra­specific antibody­directed cellular cytotoxicity, or ADCC. Our proprietary tri­ and tetra­specific 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. 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 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 $289$533.3 million and cash of $1.1 million$51 thousand as of June 30, 2018.March 31, 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 implementingimplemented 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.

 
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 $845,000 ofno balances in excess of this limit at June 30, 2018.March 31, 2019.
 

GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 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 six monthsquarters ended June 30,March 31, 2019 and 2018, and 2017, respectively
 

Impairment of Long LivedLong-Lived Assets
 
The Company'sOur long-lived assets currently consistinclude property, plant and equipment, capitalized costs of capitalized patentsfiling patent applications and other indefinite lived intangible assets. The Company evaluates itsWe 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'sour 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 anymore significant estimates and assumptions inherent in this approach include: the amount and timing of the indefinite lived intangibles duringprojected net cash flows, which includes the six months ended June 30, 2018expected 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 1,695,68622,731,781 and 1,030,9514,553,668 as of June 30,March 31, 2019 and 2018, and 2017, respectively.
 
Patents
 
Acquired patents are capitalized at their acquisition cost or fair value. The legal costs, patent registration fees and models and drawings required for filing patent applications are capitalized if they relate to commercially viable technologies. Commercially viable technologies are those technologies that are projected to generate future positive cash flows in the near term. Legal costs associated with patent applications that are not determined to be commercially viable are expensed as incurred. All research and development costs incurred in developing the patentable idea are expensed as incurred. Legal fees from the costs incurred in successful defense to the extent of an evident increase in the value of the patents are capitalized.
 
Capitalized cost for pending patents are amortized on a straight-line basis over the remaining twenty year legal life of each patent after the costs have been incurred. Once each patent is issued, capitalized costs are amortized on a straight-line basis over the shorter of the patent's remaining statutory life, estimated economic life or ten years.
 
Fixed Assets
 
Fixed assets is stated at cost. Depreciation is computed on a straight-line basis over the estimated useful lives of the assets, which are 3 to 10 years for machinery and equipment and the shorter of the lease term or estimated economic life for leasehold improvements.
 
Fair Value
 
The carrying amounts reported in the balance sheets for receivables and current liabilities each qualify as financial instruments and are a reasonable estimate of fair value because of the short period of time between the origination of such instruments and their expected realization and their current market rate of interest.  The three levels are defined as follows:

 
● 
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 June 30, 2018.March 31, 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 $6,724,000$.8 million and $385,000$3.5 million for the six monthsyears ended June 30,March 31, 2019 and 2018, and 2017, 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 June 30, 2018,March 31, 2019, the Company has not generated any licensing revenue.
 
Recent Accounting Pronouncements

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.
2.            
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 representsrepresented 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 werewas allocated to intangible assets consisting of a portfolio of three CNS development candidates, which are classified as IPR&D. 
As 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 key senior management, led by the appointment of 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 limited resources, changes in senior leadership, and favorable market conditions for immuno-oncology development candidates have resulted in the Company choosing to focus on development of its immuno-oncology portfolio. In light of this shift in market strategy, the Company performed a commercial assessment and a valuation of the CNS IPR&D assets, both to assess fair value and support potential future licensing efforts. The valuation indicated an excess carrying value over the fair value of these assets, resulting in the impairment charge noted above.
 

 
As stated in Note 1, Company's long-lived assets currently consist of capitalized patents and other indefinite lived intangible assets.  
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2019
(UNAUDITED)

The Company evaluates its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. If any of the Company's long-lived assets are considered to be impaired, the amount of impairment to be recognized is equal to the excess of the carrying amount of the assets over the fair value of the assets.  ThereCNS IPR&D assets was no impairment of anydetermined using the discounted cash flow method which utilized significant estimates and assumptions surrounding the amount and timing of the indefinite lived intangibles duringprojected net cash flows, which includes the six months ended June 30, 2018.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.
 
3.            
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 arewere 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 (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.

GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 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 June 30, 2018.

March 31, 2019.
 
4.            
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)

5.            
Stock Options and Warrants
 
Stock Options
 
The following table summarizes stock option transactions for the six monthsquarter ended June 30,March 31, 2018:
 
 
 
Number of Options
 
 
Weighted Average Exercise Price
 
Outstanding, December 31, 2017
  1,246 
 $1,428.00 
Granted
  - 
  - 
Exercised
  - 
  - 
Expired
  - 
  - 
Outstanding, June 30, 2018
  1,246 
 $1,428.00 
Exercisable, June 30, 2018
  1,246 
 $1,428.00 

 
 
Number of Options
 
 
Weighted Average Exercise Price
 
Outstanding, December 31, 2018
  1,133 
 $1,320.00 
Granted
  - 
  - 
Exercised
  - 
  - 
Expired
  - 
  - 
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 six monthsquarter ended June 30, 2018March 31, 2019 are as follows:
 
 
Number of Warrants
 
 
Weighted Average Exercise Price
 
 
Number of Warrants
 
 
Weighted Average Exercise Price
 
Outstanding at December 31, 2017:
  - 
 $- 
Outstanding at December 31, 2018:
  1,813,053 
 $2.00 
Granted
  1,694,440 
  4.58 
  - 
Forfeited
  - 
  -
  - 
Exercised
  - 
  - 
Outstanding at June 30, 2018
  1,694,440 
 $4.58 
Exercisable at June 30, 2018
  1,694,440 
 $4.58 
Outstanding at March 31, 2019
  1,813,053 
 $2.00 
Exercisable at March 31, 2019
  1,813,053 
 $2.00 
 
6.            
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.
On September 1, 2017,
We determine if a contractual arrangement is a lease at inception. Our lease arrangements provide the Company has entered intothe right to utilize certain specified tangible assets for a three-yearperiod 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 agreement for its office in Washington, D.C. In addition to minimum rent, certain leases require paymentliability and a right of real estate taxes, insurance, common area maintenance chargesuse 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 other executory costs. The Company recognizes rentinitial direct costs, less incentives received.
We recognize operating lease expense under such arrangements on a straight-line basis over the effective term of each lease. Thisthe lease was terminated as of June 30, 2018.within selling general and administrative expenses.
 
RentOur 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 six monthsquarters ended June 30,March 31, 2019 and 2018 was $17,000 and 2017 was $54,000 and $6,000,$24,000, respectively.
 

GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2019
(UNAUDITED)

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 lastsshall remain in effect until August 31, 2020September 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.
 
On February 15,October 19, 2018, the Company entered into an Executive Employment Agreement with Mr. Cross, pursuant to which Mr. Cross will be employedDr. Urbanski, reflecting his current position as the Company’s Chief Executive Officer.  The termOfficer of the Executive Employment Agreement is three years and is terminable at will by eitherCompany. Under the Company or Mr. Cross and subject to automatic extensions for successive one year periods. Mr. Cross will be paid anterms of this agreement, Dr. Urbanski’s annual salary of $500,000, paid in equal monthly installment. Mr. Crossis 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 anDr. Urbanski a Non-Qualified stock option to purchase 2,000,0002,971,102 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 ofshares 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% of the471,102 shares on FebruaryJanuary 1, 2020. On March 15, 2020. Mr. Cross2019, Dr, Urbanski resigned his position as the Chief Executive Officer, President and from the Board of Directors effective July 2, 2018.

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 endChairman 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.
7.            
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 six months ended June 30, 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
 
 
 
For the Three Months Ended June 30, 2017
 
 
 
Previously
Reported
 
 
 
Revisions
 
 
Revised
Report
 
Change in Warrant Liability
 $(367,000)
 $367,000 
 $- 
Earnings Per Share
 $(5.91)
 $0.77 
 $(5.14)
 
 
Consolidated Statement of Operations
 
 
 
For the Six Months Ended June 30, 2017
 
 
 
Previously
Reported
 
 
 
Revisions
 
 
Revised
Report
 
Change in Warrant Liability
 $2,376,000 
 $(2,376,000)
 $- 
Earnings Per Share
 $(15.34)
 $(7.08)
 $(22.42)

Board.
 
8.            
Subsequent Events
 
 DebenturesPreferred Stock
 
On August 2, 2018, GT Biopharma, Inc.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.
On April 19, 2019, the Companyissued a total of 2,353,548 shares of Series J-1 Preferred Stock (the “Company”"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 Securities Purchase Agreementletter agreement with the purchasers identified on the signature pages thereto (individually, a “Purchaser,” and collectively, the “Purchasers”)two entities, pursuant to which the Company has issuedagreed to include the Purchasers one year 10% Senior Convertible Debentures in an aggregate principal amountshares of $5,140,000 (the “Debentures”), which Debentures shall be convertible into the Company’s common stock par value $0.001 per shareissuable upon full conversion of the Series J-1 Preferred Stock in the next registration statement that the Company files (the “Common Stock”"Piggyback Registration Statement"), at a price of $2 per share.. The Company must file the Piggyback Registration Statement on or before August 30, 2019.
 
Also on August 2, 2018, $3,315,141.74 of notes issued on January 22, 2018 were converted into the Debentures at the same terms as discussed above. Common Stock
In addition,April 2019, the Company utilized a portionissued 656,181 shares of these proceeds to repay $4.411 millioncommon stock upon conversion of the notes issued$393,709 in principal and interest on January 12, 2018.convertible notes.

 

Item
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 area clinical stage biopharmaceutical company predominantly 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 TriKEimmuno-oncology portfolio is based off a proprietary technology platform consisting of single-chain bi-, tri- and TetraKE platforms generatetetra-specific scFv’s, combined with proprietary moieties designed to harnessantibody-drug linkers and enhance the cancer killing abilities of a patient’s owndrug 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. Once bound toNK 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 cell, our moieties are designed to enhance 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 certain tumor antigens on hematologic malignancies, sarcomas or solid tumors andcells do not require patient-specific customization. They are designed to be dosed in a common outpatient setting similar to modern antibody therapeutics and are expected to have reasonably low cost of goods. Our ADC platform can generate product candidates that are bi-specific, ligand-directed single-chain fusion proteins that, we believe, represent the next generation of ADCs.
Our most advanced bi-specific ADC, which targets CD19+ and/or CD22+ hematological malignancies, is in the Phase 2 component of a Phase 1/2 Non-Hodgins Lymphoma (NHL)/Acute Lymphocytic Leukemia (ALL) trial which is an open-label, investigator-led study. We expect to be in a position to begin a First-in-Class, Phase 1 trial in CD33+ hematologic malignancies for our most advanced TriKE product candidate in the second half of 2018. We are initially targeting certain hematologic malignancies as we believe our product candidates may have certain advantages over existing and other in-development products. We are also focused on developing TetraKE product candidates designed to target the larger solid tumor population and are working towards beginning clinical trials in 2019.
Our TriKE product candidates are single-chain, tri-specific scFv recombinant fusion proteins composed of the variable regions of the heavy and light chains (or heavy chain only) of anti-CD16 antibodies, wild-type or a modified form of IL-15 and the variable regions of the heavy and light chains of an antibody designed to precisely target a specific tumor antigen. We utilize the NK stimulating cytokine human IL-15 as a crosslinker between the two scFvs which is designed to provide a self-sustaining signal leading to the proliferation and activation of NK cells thus enhancing their ability to kill cancer cells mediated by antibody-dependent cell-mediated cytotoxicity (ADCC). Our second TriKE product candidate, OXS-C3550, is a next-generation version of OXS-3550 containing a modified CD16 component.

Our TetraKE product candidates are single-chain fusion proteins composed of human single-domain anti-CD16 antibody, wild-type IL-15 and the variable regions of the heavy and light chains of two antibodies that are designed to target two specific tumor antigens expressed on specific types of cancer cells. An example of a TetraKE product candidate is OXS-1615 which is designed to target EpCAM and CD133 positive solid tumors. EpCAM is found on many solid tumor cells of epithelial origin and CD133 is a marker for cancer stem cells. OXS-1615 is designed to enable a patient’s NK cells to kill not only the heterogeneous population of cancer cells found in many solid tumors but also kill the cancer stem cells that can be responsible for recurrences.
Our TriKEs and TetraKEs are designed to act by binding to a patient’s NK cells and a specific tumor antigen enabling an immune synapse between the now IL-15-enhanced NK cell and the targeted cancer cell. The formation of an immune synapse can induce NK cell activation which can lead to the death of the cancer cell. We believe the self-sustaining signal caused by our IL-15 cross-linker may enable prolonged and enhanced proliferation and activation of NK cells similar to the increased proliferation of T-cells caused by 41BB-L or CD28 intracellular domains in CAR-T therapy but without the need to enhance the patient’s NK cells ex vivo.
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.
OXS-3550 is our first TriKE product candidate. The OXS-3550 IND will focus on AML, the most common form of adult leukemia with 21,000 new cases expected in 2018 alone (American Cancer Society). These patients typically receive frontline therapy, usually chemotherapy, including cytarabine and an anthracycline, a therapy that has not changed in over 40 years. About half will have relapses and require alternative therapies. In addition, MDS incidence rates have dramatically increased in the population of the United States from 3.3 per 100,000 individuals from 2001-2004 to 70 per 100,000 annually, MDS is especially prevalent in elderly patients that have a median age of 76 years at diagnosis. The survival of patients with MDS is poor due to decreased eligibility, as a result of advanced age, for allogeneic hematopoietic cell transplantation (Allo-HSCT), the only curative MDS treatment (Cogle CR. Incidence and Burden of the Myelodysplastic Syndromes. Curr Hematol Malig Rep. 2015; 10(3):272-281). We believe that OXS-3550 could serve as a relatively safe, cost-effective, and easy-to-use therapy for resistant/relapsing AML and MDS and could also be combined with chemotherapy as frontline therapy thus targeting the larger patient population.
The IND for OXS-3550 was filed in June 2017 by the University of Minnesota. 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 filed the IND amendment in June 2018 and expect to be in a position to begin a Phase 1 clinical trial in the second half of 2018.
We also believe our bi-specific, ligand-directed single-chain fusion proteins are examples of the next generation of ADCs. We believe OXS-1550 has certain properties that could result in competitive advantages over recently approved ADC products targeting leukemias and lymphomas and/or have utility 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 patient, who had failed multiple previous treatment regimens, has been in remission since early 2015.

OXS-1550 is being evaluated in a Phase 2 component of an investigator-led Phase 1/2 clinical trial in relapsed/refractory NHL/ALL patients. We recently assembled a Bi-Specific ADC Advisory Board to work with us to assess and interpret the OXS-1550 pre-clinical and clinical data, including an interim review of the Phase 1/2 study. Eighteen patients have been enrolled to date, including 12 NHL and six ALL patients. At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients. More than 50% of patients (seven of 13) exhibited a clinical benefit, defined as stable disease, partial remission or complete remission at Day 29. Of the seven patients, one demonstrated a complete remission (CR), one demonstrated a partial remission (PR) and five demonstrated stable disease (SD).
The efficacy signal was more prominent in ALL patients with 75% (three of four) exhibiting clinical benefit including one CR, one PR and one SD. In the NHL population, four of nine patients exhibited SD. Adverse events were mostly grade 1 and 2 and reversible. One patient had a grade 4 low platelet count, two patients had a grade 3 increase in liver function tests, or LFTs, and one patient had a grade 3 capillary leak.
The Company currently expects final data for this trial to be available in the fourth quarter of 2018 or the first quarter of 2019.
Our initial and ongoing work is being conducted in collaboration with the Masonic Cancer Center at the University of Minnesota under research agreements led by Dr. Jeffrey Miller, the Deputy Director and Dr. Daniel Vallera, Director, Section of Molecular Cancer Therapeutics.Through these research agreements we have access to a range of capabilities and resources such as construct design and functional testing, early single-chain fusion protein GMP production, scientific and clinical expertise and experience including early phase human testing. 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.priming.
 
We also have a CNS portfolio consists of three product candidates consisting of what we believe are innovative reformulations and/or repurposing of existing therapies. We believe these therapeutic agents may address certain unmet medical needs that can lead to improved efficacy while addressing tolerability and safety issues that may have limitedtended to limit the usefulness of the original approved drug. Our CNS drug candidates may address disease states such as chronic neuropathic pain, myasthenia gravis and motion sickness.vestibular disorders.
 
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 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 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.
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.
On August 2, 2018, $3,315,141.74 of notes issued on January 22, 2018 were converted into new Debentures and $4,410,748.14 was repaid in cash.
On August 2, 2018,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 has issued to the Purchasers, 10% Senioron February 4, 2019, Secured Convertible DebenturesNotes in an aggregate principal amount of $5,140,000$1,352,224 (the “Debentures”“Notes”), consisting of gross proceeds of $1,052,224 and settlement of existing debt of $300,000, which DebenturesNotes 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 $2$0.60 per share.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.
 
Results of Operations
 
Comparison of the Three Months Ended June 30,March 31, 2019 and 2018 and 2017
 
Research and Development Expenses
 
During the three months ended June 30,March 31, 2019 and 2018, and 2017, we incurred $3,251,000$.8 million and $241,000$3.5 million of research and development expenses. Research and development costs increaseddecreased due primarily to the addition of newreductions employees, consultant costsconsultants and preclinical and clinical expenses and include $2.9 million of the expenses related to non-cash compensation.expenses. We anticipate our direct clinical costs to increase in second half of 20182019 upon the initiation of a Phase 1phase one clinical trial of our most advanced TriKe product candidate, OXS-3550.
 
Selling, general and administrative expenses
 
During the three months ended June 30,March 31, 2019 and 2018, and 2017, we incurred $1,906,000$3.2 million and $1,044,000$3.7 million of selling, general and administrative expenses.  The increasedecrease in selling, general and administrative expenses is primarily attributable to an increase $.4 millionthe reduction of professional fees and $0.5 million of loan costs.salaries.
 
Interest Expense
 
Interest expense was $3,924,000$.5 million and $1,178,000$2.9 million for the three months ended June 30,March 31, 2019 and 2018 and 2017 respectively.  The increasedecrease is primarily due to a decrease related to the amortization of the original issue discount and the value of warrants issued with the January 2018 financing.
 
Comparison of the Six Months Ended June 30, 2018 and 2017
Research and Development Expenses
During the six months ended June 30, 2018 and 2017, we incurred $5,593,000 and $2,438,000 of research and development expenses. Research and development costs increased due primarily to the addition of new employees, consultant costs and preclinical and clinical expenses and include $6.0 million of the expenses related to non-cash compensation. We anticipate our direct clinical costs to increase in second half of 2018 upon the initiation of a Phase 1 clinical trial of our most advanced TriKe product candidate, OXS-3550.
 

Selling, general and administrative expenses
During the six months ended June 31, 2018 and 2017, we incurred $6,724,000 and $385,000 of selling, general and administrative expenses.  The increase in selling, general and administrative expenses is primarily attributable to an increase $1.3 million of professional fees, $1.2 million of public and investor relations expenses and $1.0 million of loan costs.
Interest Expense
Interest expense was $6,855,000 and $4,698,000 for the six months ended June 30, 2018 and 2017 respectively.  The increase is primarily due to the current interest expense relates 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 $289$533.4 million and cash of $1.1 million$51 thousand as of June 30, 2018.March 31, 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 implementingimplemented 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.
 

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 June 30, 2018.March 31, 2019.
 
ItemItem 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.
 
ItemItem 4. Controls and Procedures
 
Evaluation of Disclosure Controls and Procedures
 
Our principal executive officer and principal financial officer evaluated the effectiveness of our “disclosure controls and procedures” (as such term is defined in Rules 13a-15(e) and 15d-15(e) of the United States Securities Exchange Act of 1934, as amended), as of June 30, 2018.March 31, 2019.  Based on that evaluation we have concluded that our disclosure controls and procedures were not effective as of June 30, 2018.March 31, 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 June 30, 2018,March 31, 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 June 30, 2018.March 31, 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 June 30, 2018.March 31, 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
 
ItemItem 1.  Legal Proceedings
 
On June 23, 2016, we were served with a complaintDecember 24, 2018, Empery Asset Master, Empery Tax Efficient, LP, and Empery Tax Efficient II, LP (collectively, “Plaintiffs) filed in the CircuitN.Y. Supreme Court, Index No. 656408/2018, alleging causes of action against the 13th Judicial CircuitCompany 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/Heilshornfailed 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 providedwarrants representing the right of Plaintiffs to us and is seeking paymentacquire an aggregate of $73,898. We have engaged legal counsel to answer480,352 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. 
ItemItem 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.
 
ItemItem 2.  Unregistered Sales of Securities and Use of Proceeds
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 has issued to the Purchasers 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.
 
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 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 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.
 
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 of the SPA, the Registration Rights Agreement, the Notes and the Warrants contained herein are qualified in their entirety by reference to the exhibits filed herewith.
 
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, $3,315,141.74September 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 notes issuedthe 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 January 22, 2018 were converted into new Debentures and $4,410,748.14Form 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 repaid in cash.filed by the Company on February 14, 2019.
Item 3.  Defaults Upon Senior Securities.
None
Item 4.  Mine Safety Disclosures
None.
Item 5. Other Information.
None.
 

 
Item 3.  Defaults Upon Senior Securities.Item 6.  Exhibits
 
None
Item 4.  Mine Safety Disclosures
None.
Item 5. Other Information.
None.
Item 6.  Exhibits
Exhibit Description Herewith Form SEC File No. Filing Date
 
Certificate of Amendment to the Certificate of Incorporation of the Registrant, effective as of July 19, 2017.
   
8-K
000-0809203/15/18
 
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
000-0809201/23/18
 
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
000-0809201/23/18
 
000-08092
02/06/19
10.3
Form of Note.
   
8-K
000-0809201/23/18
 
000-08092
02/06/19
10.4
Form of Warrant.
   
8-K
000-0809201/23/18
 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
000-0809202/21/18
 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
 Consultant Agreement, dated as of February 14, 2018, between the Company and Mr. Cataldo.8-K000-08092
02/21/18
06/19Form of 10% Senior Convertible Debenture 8-K 000-08092 08/03/18 
Security Purchase Agreement
8-K 000-0809208/03/18 
Stock Pledge Agreement
X
 
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
      
 
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
      
 
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
      
 
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
101.SCH
 
XBRL Taxonomy Extension Calculation LinkbaseSchema Document.
        
101.DEF XBRL Taxonomy Extension Definition Linkbase Document.        
101.LAB
101.CAL
 
XBRL Taxonomy Extension LabelCalculation Linkbase Document.
        
101.PRE 
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.
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.
 

 
SIGNATURESSIGNATURES
 
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, 2019
GT Biopharma, Inc.
Dated: August 14, 2018
By: 
/s/ Dr. Raymond UrbanskiAnthony Cataldo                                            
Dr. Raymond Urbanski  
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/ Dr. Raymond UrbanskiAnthony Cataldo
Anthony Cataldo
 Chief Executive Officer and Chairman of the Board August 14, 2018
Dr. Raymond Urbanski
May 15, 2019
/s/ Steven Weldon
Steven Weldon
 Chief Financial Officer (Principal Financial Officer), and Director August 14, 2018
Steven Weldon
/s/ Dr. Kathleen Clarence-Smith
Vice Chairwoman and DirectorAugust 14, 2018
Dr. Kathleen Clarence-Smith
/s/Anthony J. Cataldo
DirectorAugust 14, 2018
Anthony J. Cataldo
/s/ Geoffrey Davis
DirectorAugust 14, 2018
Geoffrey Davis
/s/ Dr. John Bonfiglio
DirectorAugust 14, 2018
Dr. John Bonfiglio
/s/ Dr. Peter Kiener
DirectorAugust 14, 2018
Dr. Peter KienerMay 15, 2019
 
 
 
 
22