4. As of March 31, 2021, there were no Series K Preferred stock issued and outstanding.
Stock Options and Warrants
Stock OptionsWarrants
Stock warrant transactions for the three months ended March 31, 2021:
| | Weighted Average Exercise Price |
Outstanding at December 31, 2020: | 221,041 | $3.40 |
Granted | 5,192,250 | 5.50 |
Forfeited/canceled | - | - |
Exercised | (94,424) | 3.23 |
Outstanding at March 31, 2021 | 5,318,867 | $5.44 |
Exercisable at March 31, 2021 | 5,318,867 | $5.44 |
As of March 31. 2021, all issued and outstanding warrants are fully vested and the intrinsic value of these warrants amounted to $7,415,000.
The following table summarizes stock optionwere transactions forduring the sixthree months ended June 30, 2020:March 31, 2021:
| | Weighted Average Exercise Price |
Outstanding, December 31, 2019 | 40 | $877.50 |
Granted | - | - |
Exercised | - | - |
Expired | - | - |
Outstanding, June 30, 2020 | 40 | $877.50 |
Exercisable, June 30, 2020 | 40 | $877.50 |
Common Stock Warrants
Warrant transactions forOn February 16, 2021, as part of the six months ended June 30, 2020 are as follows:
| | Weighted Average Exercise Price |
Outstanding at December 31, 2019: | 1,813,053 | $0.20 |
Granted | 5,500,000 | $0.20 |
Forfeited/canceled | 480,352 | $0.20 |
Exercised | - | - |
Outstanding at June 30, 2020 | 6,832,701 | $0.20 |
Exercisable at June 30, 2020 | 6,832,701 | $0.20 |
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2020
(UNAUDITED)
Settlement Warrants
Pursuant to the Settlement Agreement,Company’s public offering, the Company issued pre-funded warrants to investors to purchase up to an aggregate of 5,500,0005,192,250 shares of common stock (the “Settlement Warrants”) atstock. The warrants have an exercise price of $0.20$5.50 per share, subject to adjustment in certain circumstances. The Settlement Warrantscircumstances and will expire on June 19, 2025. The aggregate exercise price of the Settlement Warrants was deemed to be pre-funded to the Company in conjunction with exchange of previously issued warrants to purchase 480,352 shares of common stock pursuant to the Settlement Agreement. Exercise of the Settlement Warrant is subject to certain additional terms and conditions, including certain beneficial ownership limitations.
Forbearance Agreements
Pursuant to the Forbearance Agreements,(i) the exercise price of all warrants to purchase common stock held by holders of the Default Notes will be reduced to equal the conversion price of the Default Notes and (ii)the number of shares of common stock underlying such warrants shall be increased so that the total exercise price of all such warrants after the decrease in the exercise price equals the total exercise price of all such warrants prior to the decrease in the exercise price. Further, the expiration date of all such warrants shall be extended for three years following the closing date of any New Financing.five years.
5.
Commitments and Contingencies
Leases
On October 1, 2018,During the Company entered into a three-year lease agreement for its office in Westlake Village, CA. In addition to minimum rent, certain leases require payment of real estate taxes, insurance, common area maintenance charges and other executory costs. The Company recognizes rent expense under such arrangements on a straight-line basis over the effective term of each lease.
The following table summarizes the Company’s future minimum lease commitments as of June 30, 2020:
Year ending December 31: | |
2020 | 36,000 |
2021 | 61,000 |
Total minimum lease payments | $97,000 |
Rent expense for the sixthree months ended June 30, 2020 and 2019 was $35,000 and $35,000, respectively.
Convertible Notes
On July 7, 2020, the Company entered into a securities purchase agreement with certain purchasers pursuant to which March 31, 2021, the Company issued Convertible Notes in an aggregate principal amount of $3,190,000 (the “July 2020 Notes”). The July 2020 Notes are convertible at any time, at the holder’s option, into shares of our common stock at an initial conversion price of $0.20 per share, subject to certain beneficial ownership limitations (with a maximum ownership limit of 9.99%).
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2020
(UNAUDITED)
The July 2020 Notes mature on January 7, 2021, unless earlier converted or repurchased. The terms of the July 2020 Notes are generally the same as the Company’s other Convertible Notes, except that the July 2020 Notes will be subject to mandatory conversion in the event of the completion of a future financing in the amount of at least $15 million at a conversion price equal to the lesser of (i) the conversion price in effect for the July 2020 Notes on the date of completion of such financing or (ii) 75% of the lowest per share price at which common stock may be issued in connection with any conversion rights associated with the financing, in each case, subject to the beneficial ownership limitations described above. See Note 2,Debtunder the caption “Convertible Notes/Debentures” for additional information regarding the terms of the Company’s Convertible Notes.
Common Stock
In July 2020, the Company issued 1,125,00094,424 shares of common stock upon conversionexercise of $225,000 aggregate principal amountwarrants which also resulted cash proceeds of Convertible Notes.$58,000.
WarrantNote 8 – Related Party
On July 28, 2020,During the period ended March 31, 2021, the Company recorded consulting expense of $250,000 for services rendered by a consultant who is also an owner of approximately 10% of the Company’s issued and outstanding common stock. In addition, the Company also issued a warrantnote payable to purchase up to an aggregatethis consultant of 1,000,000 shares$525,000 in exchange for the cancellation of common stockunpaid consulting fees of $525,000 that was recorded as part of accrued expenses at an exercise price of $0.20 per share, subject to adjustment in certain circumstances. The warrant expires on July 28, 2025. The warrantDecember 31, 2020. There was issued as compensation for certain services provided tono similar consulting expense incurred during the Company.period ended March 31, 2020.
Employment AgreementsNote 9 – Equity Compensation to Officers and Board of Directors
Effective August 11, 2020 (the “Effective Date”), the CompanyAs part of employment agreements with its CEO and Anthony J. Cataldo (“Mr. Cataldo”) entered into an employment agreement (the “Cataldo Agreement”) with respectits CFO, these officers were to Mr. Cataldo’s continued employment as Chief Executive Officer of the Company. The term of the Cataldo Agreement is three years (the “Initial Term”) with the option of automatic one-year renewals thereafter. Mr. Cataldo will be paidreceive a cash salary of $30,000 per month, together with customary benefits, expense reimbursement and the possibility of performance bonuses. Mr. Cataldo will receive afully vested stock grant equal to ten percentaggregate of 10% and 1.5% of the fully diluted shares of common stock of the Company (calculated with the inclusion of the current stock holdings of Mr. Cataldo) upon conversion of options, warrants and Convertible Notes in association with a national markets qualified financing as consideration for entering into the Cataldo Agreement (with such stock to vest and be delivered within 30 days after the national markets qualified financing). Mr. Cataldo will be entitledIn addition, the Company also granted similar equity compensation to certain additional severance payments and other benefits in connection with a Change in Control Period Involuntary Termination or a Non Change in Control Period Involuntary Termination (each as defined in the Cataldo Agreement) or his resignation as a result of a Change in Control Period Good Reason or Non Change in Control Period Good Reason (each as defined in the Cataldo Agreement). Following the Effective Date, Mr. Cataldo will also continue to serve as the chairmanmembers of the boardCompany’s Board of the Company.
Effective August 11, 2020, the Company and Steven Weldon (“Mr. Weldon”) entered into an employment agreement (the “Weldon Agreement” and, together with the Cataldo Agreement, the “Employment Agreements”) with respectDirectors wherein these directors were to Mr. Weldon's continued employment as the Chief Financial Officer of the Company. The term of the Weldon Agreement is three years (the “Initial Term”) with the option of automatic one-year renewals thereafter. Mr. Weldon will be paid a cash salary of $25,000 per month, together with customary benefits, expense reimbursement and the possibility of performance bonuses. Mr. Cataldo will receive a stock grant equal to seven percent1% and 1.25% of the fully diluted shares of common stock of the Company. Pursuant to the agreement, approximately 75% of the common stock to be issued vested immediately while the remaining 25% will vest over a period of two years.
On February 16, 2021, the Company (calculatedcompleted its equity offering and listed its shares of common stock on the Nasdaq Capital Markets (see Note 7). As such, 4,379,407 shares of its common stock were granted to these officers and directors which had a fair value of $18,621,000. Pursuant to current accounting guidelines, as the grant of the common stock is subject to milestone or performance condition, the Company measured the fair value of the common stock on the respective date of the agreement, and then such award was recorded as compensation expense as the milestone or performance condition is met and in accordance with its vesting term of the grant.
During the period ended March 31, 2021, the Company recognized stock compensation of $14,296,000 to account equity compensation to officers and directors of the 3,640,816 shares that vested.
As of March 31, 2021, the fair value of the 738,591 unvested shares that will be recognized as compensation in future periods amounted to $4,325,000.
Note 10 – Commitments and Contingencies
We are involved in certain legal proceedings that arise from time to time in the ordinary course of our business. Except for income tax contingencies, we record accruals for contingencies to the extent that our management concludes that the occurrence is probable and that the related amounts of loss can be reasonably estimated. Legal expenses associated with the inclusioncontingency are expensed as incurred. There is no current or pending litigation of any significance with the exception of the current stock holdingsmatters that have arisen under, and are being handled in, the normal course of Mr. Weldon) upon conversionbusiness.
a.
On August 28, 2019, a complaint was filed in the Superior Court of options, warrantsCalifornia, County of Los Angeles, West Judicial District, Santa Monica Courthouse, Unlimited Civil Division by Jeffrey Lion, an individual (“Lion”), and Convertible Notesby Daniel Vallera, an individual (“Vallera”). Lion and Vallera are referred to jointly as the “Plaintiffs”. The complaint was filed against GT Biopharma, Inc. and its subsidiary Oxis Biotech, Inc. (either of them or jointly, the “Company”). The Plaintiffs allege breach of a license agreement between the Plaintiffs and the Company entered into on or about September 3, 2015. Lion alleges breach of a consulting agreement between Lion and the Company entered into on or about September 1, 2015. Vallera alleges breach of a consulting agreement between Vallera and the Company entered into in association with a national markets qualified financing as considerationor around October, 2018. The Complaint seeks actual damages of $1,670,000, for entering into the Weldon Agreement (withfair market value of the number of shares of GT Biopharma, Inc. that at the time of judgment represent 882,353 shares of such stock as of September 1, 2015, and that GT Biopharma, Inc. issue Lion the number of common shares of GT Biopharma, Inc. that at the time of judgment represent 882,353 such shares as of September 1, 2015.The Company filed an answer to vestthe complaint denying many allegations and be delivered within 30 days afterasserting affirmative defenses. Discovery has commenced and trial is scheduled for May, 2022. The Company believes the national markets qualified financing). Mr. Weldoncase is without merit and will be entitled to certain additional severance payments and other benefits in connection withdefend it vigorously.
b.
On March 3, 2021 a Change in Control Period Involuntary Termination or a Non Change in Control Period Involuntary Termination (each as definedcomplaint was filed by Sheffield Properties in the Weldon Agreement)superior Court of California. County of Ventura. The litigation arises from a commercial lease entered into by GT Biopharma for office space in Westlake Village. GT Biopharma has been served but has not yet answered the complaint. Sheffield Properties seeks damages in excess of $250,000. We intend to vigorously defend against these claims. We believe we have made adequate provision in our financial statements to provide for any potential settlement.
2.
Research and Development Agreement:
We are party to an exclusive worldwide license agreement with the Regents of the University of Minnesota, to further develop and commercialize cancer therapies using TriKE technology developed by researchers at the university to target NK cells to cancer. Under the terms of the agreement, we receive exclusive rights to conduct research and to develop, make, use, sell, and import TriKE technology worldwide for the treatment of any disease, state or his registration as a result of a Changecondition in Control Period Good Reasonhumans. We are responsible for obtaining all permits, licenses, authorizations, registrations and regulatory approvals required or Non Change in Control Period Good Reason (each as definedgranted by any governmental authority anywhere in the Weldon Agreement). Followingworld that is responsible for the Effective Date, Mr. Weldon will also continue to serveregulation of products such as the principal accounting officerTriKE technology, including without limitation the FDA in the United States and asthe European Agency for the Evaluation of Medicinal Products in the European Union. We are presently evaluating GTB-3550, our lead TriKE therapeutic product candidate in a directorPhase I/II clinical trial. Under the agreement, the University of Minnesota will receive an upfront license fee, royalty fees ranging from 4% to 6%, minimum annual royalty payments of $0.25 million beginning in 2022, $2.0 million in 2025, and $5.0 million in 2027 and certain milestone payments totaling $3.1 million.
During the Company.
period ended March 31, 2021, the Company recorded research and development expenses of $224,000 pursuant to this agreement.
Note 11- Subsequent Events
Subsequent to March 31, 2021, the Company issued 1,274,096 shares of common stock upon exercise of warrants for cash proceeds of $7,008,000.
Subsequent to March 31, 2021, the Company issued a total of 5,336,191 shares of common stock to noteholders whose notes payable and accrued interest were mandatorily converted to common stock on February 16, 2021 (see Note 4)
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 this Quarterly Report on Form 10-Q are “forward-looking statements” within the meaning of the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. 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 this report 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,” “may,” “guidance,” “estimate,” “potential,” “outlook,” “target,” “forecast,” “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 “Part I. Item 1A: Risk Factors” and “Part II. Item 7: Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the Form 10-K for the year ended December 31, 2019.2020. Any forward-looking statements in the Form 10-Q are made only as of the date hereof and, except as may be required by law, we do not have any obligation to publicly update any forward-looking statements contained in this Form 10-Q to reflect subsequent events or circumstances.
Throughout this Quarterly Report on Form 10-Q, the terms “GTBP,” “we,” “us,” “our,” “the company” and “our company” refer to GT Biopharma, Inc., a Delaware corporation formerly known as Oxis International, Inc., DDI Pharmaceuticals, Inc. and Diagnostic Data, Inc, together with our subsidiaries.
Overview
We are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-therapeuticimmuno-oncology products based onoff our proprietary Tri-specific Killer Engager (TriKE™) and Tetra-specific Killer Engager (TetraKE™) platform technologies.fusion protein immune cell engager technology platform. Our TriKE and TetraKE platformsplatform generate proprietary therapeutic candidates that aretherapeutics designed to harness and enhance the immune responsecancer killing abilities of a patient’s endogenousown natural killer cells, or NK cells. Once bound to an NK cell, our platform moieties are designed to enhance the activity of NK cells, with targeted directioncell, and precisely direct it to one or more specifically-targeted proteins expressed on a specific type of cancer cell or virus infected cell, ultimately resulting in the targeted cellcell’s death. We have constructed our TriKEs and TetraKEs of recombinant fusion proteins thatTriKE can be designed to target a wide arrayany number of tumor antigen that may be locatedantigens on hematologic malignancies, sarcomas or solid tumors. Our TriKEstumors and TetraKEs do not require patient-specific or autologous customization.
We are using our TriKE and TetraKE platformsplatform with the intent to bring to market immuno-oncology products that can treat a range of hematologic malignancies, sarcomas,sarcoma and solid tumors and selected infectious diseases. Our platforms aretumors. The platform is scalable, and in addition to our first clinical indication of our TriKE platform in relapsed or refractory acute myelogenous leukemia, we are preparing investigational new drug applications based onputting processes in place to be able to produce IND-ready moieties in a timely manner after a specific TriKE or TetraKEconceptual design. We intend to continue to advanceAfter conducting market and competitive research, specific moieties can then be advanced into the clinic on our own or through potential collaborations with larger companies, multiple TriKE or TetraKE product candidates.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 TetraKEsTriKE may have the ability, if approved for marketing, to be used as a monotherapy, be dosed concomitantly withaugment the current monoclonal antibody therapeutics, be used in conjunction with more traditional cancer therapy and potentially overcome certain limitations of current chimeric antigen receptor, or CAR-T, therapy.
We are also using our TriKE and TetraKE platformsplatform to develop therapeutics useful for the treatment of infectious diseasesdisease such as for the treatment of patients infected by the human immunodeficiency virus (“HIV”) and COVID-19 infection. For example, while(HIV). While the use of anti-retroviral drugs has substantially improved the morbidityhealth and mortalityincreased the longevity of individuals infected with HIV, these drugs are designed to suppress virus replication and to help modulate progression to AIDS and to limit further transmission of the virus. Despite the use of anti-retroviral drugs, infected individuals retain reservoirs of latent HIV-infected cells that, upon cessation of anti-retroviral drug therapy, can reactivate and reestablishre-establish an active HIV infection. DestructionFor a curative therapy, destruction of these latent HIV infected cells is the primary objective of curative therapy. Ourmust take place. The HIV-TriKE contains the antigen binding fragment (Fab) from a broadly-neutralizing antibody targeting the HIV-Env protein. The HIV-TriKE is designed to target HIV while redirecting NK cell killing specifically to actively replicating HIV infected cells. The HIV-TriKE induced NK cell proliferation, and demonstrated the ability in vitro to reactivate and kill HIV-infected T-cells. These findings indicate a potential role for the HIV-TriKE in the reactivation and elimination of the latently infected HIV reservoir cells by harnessing the NK cell’s ability to mediate the antibody-directed cellular cytotoxicity.cytotoxicity (ADCC).
We have licensedOur initial work has been conducted in collaboration with the exclusive rights fromMasonic Cancer Center at the University of Minnesota under a program led by Dr. Jeffrey Miller, the Deputy Director. Dr. Miller is a recognized leader in the field of NK cell and IL-15 biology and their therapeutic potential. We have exclusive rights to the TriKE platform and TetraKE platforms.are generating additional intellectual prop
Recent Developments
Collaboration Agreement
On March 10, 2020,February 16, 2021, we entered intocompleted a collaboration agreement with Cytovance® Biologics, a USA-based contract development and manufacturing organization and a subsidiarypublic offering of Hepalink, to provide development services for a TriKE therapeutic for the treatment of the coronavirus infection. Under the terms of the collaboration agreement, the companies will focus on preparing sufficient quantities of our coronavirus TriKE drug product for preclinical evaluation using Cytovance’s E. coli-basedKeystone Expression System™ and subsequently, will scale-up production using Cytovance’s GMP microbial manufacturing platform for evaluation of TriKE in humans to treat the coronavirus infection.
Bridge Financing
Between April 20 and July 7, 2020, we entered into securities purchase agreements pursuant to which we issued Convertible Notes (including the July 2020 Notes) in an aggregate principal amount of approximately $5.2 million (collectively, the “Bridge Notes”), which, together with an additional $0.4 million aggregate principal amount of Convertible Notes issued between December 2019 and January 2020, completed our previously announced bridge financing (the “Bridge Financing”) resulting in gross proceeds to us of approximately $5.6 million. The Bridge Notes are convertible at any time, at the holder’s option, into4,945,000 shares of our common stock at an initial conversion pricefor net proceeds of $0.20 per share, subject to certain beneficial ownership limitations (with a maximum ownership limit of 9.99%).
The Bridge Notes each have a term of six months$24,679,000, after deducting underwriting discounts, commissions and mature between August 20, 2020 and January 7, 2021, unless earlier converted or repurchased. The terms of the Bridge Notes are generally the same as the Company’s other Convertible Notes, except that the Bridge Notes will be subject to mandatory conversion in the event of the completion of a future financing in the amount of at least $15 million at a conversion price equal to the lesser of (i) the conversion price in effect for the Bridge Notes on the date of completion of such financing or (ii) 75% of the lowest per share price at which common stock may be issued in connection with any conversion rights associated with the financing, in each case, subject to the beneficial ownership limitations described above.
The additional $0.4 million aggregate principal amount of Convertible Notes issued between December 2019 and January 2020 asdirect offering expenses. As part of the Bridge Financing have the same terms as the Bridge Notes, except that they are not subject to mandatory conversion in connection with a subsequent financing.
See Note 2,Debtunder the caption “Convertible Notes/Debentures” for additional information regarding the terms of the Company’s Convertible Notes.
Forbearance Agreements
Effective as of June 23, 2020,offering, we entered into the Forbearance Agreements with the holders of approximately $13.2 million aggregate principal amount of the Default Notes, which are currently in default. Pursuant to the Forbearance Agreements, the holders of the Default Notes have agreed to forbear from exercising their rights and remedies under the Default Notes (including declaring such Default Notes (together with default amounts and accrued and unpaid interest) immediately due and payable) until the earlier of (i) the date that we complete a New Financing or (ii) the Termination Date.
Pursuant to the Forbearance Agreement, the holders of the Default Notes have also agreed that the Default Notes (together with default amounts and accrued and unpaid interest) will be converted into common stock upon the closing of a New Financing at a conversion price equal to the lesser of (i) the conversion price in effect for the Default Notes on the date of such New Financing or (ii) 75% of the lowest per share price at which common stock is or may be issued in connection with such New Financing, in each case, subject to certain beneficial ownership limitations (with a maximum ownership limit of 9.99%). Shares of our preferred stock, which are convertible into the Company’s common stock, will be issued in lieu of common stock to the extent that conversion of the Default Notes is prohibited by such beneficial ownership limitations.
In addition, to the extent that any holders of the Default Notes also holdgranted these investors warrants to purchase 5,192,250 shares of the Company’s common stock, the exercise price, number of underlying sharesstock. The warrants are fully vested, exercisable at $5.50 per share and expiration date of such warrants will also be subject to adjustment upon closing of a New Financingexpire in accordance with the terms of the Forbearance Agreements.
Settlement with Empery Funds
Settlement Agreement
On June 19, 2020, we entered into the Settlement Agreement with the Empery Funds, Anthony Cataldo and Paul Kessler resolving all remaining disputes between the parties pertaining to the Original Securities. See Part II, Item 1. “Legal Proceedings.”five years.
As a result of the Settlement Agreement,completion of the Company paidpublic offering and the Empery Funds cash payments in an aggregate amountsuccessful listing of $0.2 million. In addition, pursuant to the Settlement Agreement, the Company issued to the Empery Funds, solely in exchange for the outstanding Original Securities, (i) an aggregate of 3.5 millionour shares of common stock (ii) pre-funded warrants to purchase an aggregate of 5.5 million shares of common stock and (iii) Convertible Notes inon the Nasdaq Capital Markets, convertible notes with an aggregate principal amount of $0.45 million.$33,272,000 and accrued interest of $5,534,000 mandatorily converted at its stated conversion rate of $3.40 per share into 11,413,322 shares of our common stock (see Note 4 of the Financial Statements).
Settlement Notes
The Settlement Notes are convertible at any time, at the holder’s option, intoAs part of consulting agreements with certain consultants, we agreed to grant these consultants shares of common stock at an initial conversion priceequal to 1% and 3% of $0.20 per share, subjectthe fully diluted shares of our common stock upon completion of a qualified financing and listing on a national market as consideration for entering into such consulting agreement (with such stock to certain beneficial ownership limitations (withvest and be delivered within 30 days after the national markets qualified financing). Pursuant to the consulting agreement, approximately 75% of the common stock to be issued will vest immediately while the remaining 25% will vest over a maximum ownership limitperiod of 4.99%). The Settlement Notes mature on December 19, 2020.Thetwo years.
On February 16, 2021, we completed a qualified equity offering and listing. As a result, we granted these consultants 2,502,518 shares of common stock. During the period ended March 31, 2021, pursuant to the vesting terms of the Settlement Notes are generallyconsulting agreements, we issued 1,807,374 shares of common stock to these consultants and recorded the same ascorresponding stock compensation expense of $7,239,000. In addition, we also issued 150,000 shares of common stock with a fair value of $1,213,000 to other consultants for services rendered.
During the Company’s other Convertible Notes,except thatthree months ended March 31, 2021, we also issued 189,753 shares of common stock for a research and development agreement valued at $1,355,000. The common shares were valued on the Company is required to make an offer to repurchase,market price at the holder’s option, the Settlement Notes at price in cash equal to 100% of the aggregate principal amount of the Settlement Notes plus accrued and unpaid interest, if any, to, but excluding, the date of repurchase followinggrant.
During the consummation bythree months ended March 31, 2021, we issued 94,824 shares of common stock upon the Companyexercise of a financing transaction, or a series of transactions,warrants resulting in aggregate grosscash proceeds to the Company in excess of $7.5 million.$58,000.
Settlement WarrantsOn February 16, 2021, as a result of the completion of the public offering and the successful listing of our shares of common stock on the Nasdaq Capital Markets, 2,353,548 shares of Series J-1 Preferred Stock mandatorily converted at a conversion rate of $3.40 per share into 692,220 shares of our common stock. (See Note 7 of our Financial Statements)
The Settlement Warrants provide for theOn February 16, 2021, as part of our public offering of common stock and warrants, we issued warrants to investors to purchase of up to an aggregate of 5.5 million5,192,250 shares of common stock atstock. The warrants have an exercise price of $0.20$5.50 per share, subject to adjustment in certain circumstances and will expire on June 19, 2025. Exercisein five years. (See Note 7 of our Financial Statements)
As part of employment agreements with our CEO and CFO, these officers were to receive a fully vested stock grant of shares of common stock equal to aggregate of 10% and 1.5% of the warrant is subjectfully diluted shares of our common stock (calculated with the inclusion of the current stock holdings of Mr. Cataldo) upon conversion of options, warrants and convertible notes in association with a national markets qualified financing as consideration for entering into the Agreement (with such stock to certain additional termsvest and conditions, including certain beneficial ownership limitations (withbe delivered within 30 days after the national markets qualified financing). In addition, we also granted similar equity compensation to members of our Board of Directors wherein these directors were to receive stock grant equal to 1% and 1.25% of the fully diluted shares of our common stock. Pursuant to these agreement, approximately 75% of the common stock to be issued will vest immediately while the remaining 25% will vest over a maximum ownership limitperiod of 4.99%).two years.
On February 16, 2021, as a result of the completion of the public offering and the successful listing of our shares of common stock on the Nasdaq Capital Markets, we granted 4,379,407 shares of common stock to these officers and directors which had a fair value of $18,621,000.
Subsequent to March 31, 2021, we issued 1,274,096 shares of common stock upon exercise of warrants for cash proceeds of $7,008,000.
Subsequent to March 31, 2021, we issued a total of 5,336,191 shares of common stock to noteholders whose notes payable and accrued interest were mandatorily converted to common stock on February 16, 2021 (see Note 4 of the Financial Statements)
On April 23, 2021, our Compensation Committee approved an amendment and restatement of the employment agreements of Anthony Cataldo, the Chief Executive Officer and Michael Handelman, the Chief Financial Officer. (See Part II, Item 5 of this report)
On April 23, 2021, Dr. Gregory Berk resigned as a director and accepted employment as our Chief Medical Officer. In connection with his appointment as Chief Medical Officer, the Compensation Committee approved a four year employment agreement for Dr. Berk. (See Part II, Item 5 of this report)
Results of Operations
Comparison of the Three Months Ended June 30,March 31, 2021 and 2020 and 2019
Research and Development Expenses
During the three months ended June 30,March 31, 2021 and 2020, and 2019, we incurred $12 thousand$1,640,000 and $154 thousand of$324,000 research and development expenses, respectively.an increase of $1,316,000. Research and development costs decreasedincreased due primarily to the reductionissuance of employee, consultant and preclinical expenses.189,753 shares of common stock as payment of a fee valued at $1,355,000. We anticipate our direct clinical costs willto increase in the second halfremainder of 2020 with2021 upon the continuation of our Phase Ia phase one/two clinical trial of our most advanced TriKe product candidate, GTB-3550.OXS-3550.
Selling, general and administrative expenses
During the three months ended June 30,March 31, 2021 and 2020, and 2019, we incurred $1.5 million$27,362,000 and $2.1 million$746,000 of selling, general and administrative expenses, respectively.expenses. The decreaseincrease in selling, general and administrative expenses is primarily attributable the reductionincrease in stock based compensation. In the period ended March 31, 2021 we incurred $21,535,000 of payrollstock based compensation, we incurred no such expenses during 2020.
Change in fair value of derivative liability
Change in fair value of derivative liability was a gain of $21,000 for the three months ended March 31, 2021 and stock compensation expenses.we had no such gain or loss for the same period in 2020.
Interest Expense
Interest expenses were $4.6 millionexpense was $696,000 and $0.5 million$638,000 for the three months ended June 30,March 31, 2021 and 2020 and 2019, respectively. The increase is primarily due to the accrual of default interest under the Default Notes.
Comparison of the Six Months Ended June 30, 2020 and 2019
Research and Development Expenses
During the six months ended June 30, 2020 and 2019, we incurred $336 thousand and $1 million of research and development expenses, respectively. Research and development costs decreased due primarily to the reduction of employee, consultant and preclinical expenses. We anticipate our direct clinical costs will increase in the second halfamount of 2020 upon the continuation of our Phase I clinical trial of our most advanced TriKe product candidate, GTB-3550.
Selling, general and administrative expenses
During the six months ended June 30, 2020 and 2019, we incurred $2.3 million and $5.3 million of selling, general and administrative expenses, respectively. The decrease in selling, general and administrative expenses is primarily attributable the reduction of payroll and stock compensation expenses.
Interest Expense
Interest expenses were $5.3 million and $0.9 million for the six months ended June 30, 2020 and 2019 respectively. The increase is primarily due to the accrual of default interest under the Default Notes..outstanding convertible notes.
Liquidity and Capital Resources
The Company’s current operations have focused on business planning, raising capital, establishing an intellectual property portfolio, hiring, and conducting preclinical studies and clinical trials. The Company does not have any product candidates approved for sale and has not generated any revenue from product sales. The Company has sustained operating losses since inception and expects such losses to continue over the foreseeable future. During the sixthree months ended June 30, 2020,March 31, 2021, the Company raised $4.5the net amount of $24.7 million through issuance of common stock, raised $1.2 million from a series of issuances of Convertible Notes. convertible notes as compared to $0.2 million during the same period in 2020. We anticipate that cash utilized for selling, general and administrative expenses will range between $1 and $2 million in the coming quarters, while research and development expenses will vary depending on clinical activities. The Company is pursuing several alternatives to address this situation, including the raising of additional funding through equity or debt financings. In order to finance existing operations and pay current liabilities over the next 12 months, the Company will need to raise an additional $15 million of capital in 2020.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 $577 million and cash of $851 thousand$27.6 million as of June 30, 2020.March 31, 2021. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales or revenue from out-licensing of its products currently in development. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
Management is currently evaluating different strategies to obtain the required funding for future operations. These strategies may include but are not limited to: public offerings of equity and/or debt securities, payments from potential strategic research and development, licensing and/or marketing arrangements with pharmaceutical companies. Management has also implemented cost saving efforts, including reduction in executive salaries and reduced travel. Management believes that these ongoing and planned financing endeavors, if successful, will provide adequate financial resources to continue as a going concern for at least the next sixnine months from the date the financial statements are issued; however, there can be no assurance in this regard. If the Company is unable to secure adequate additional funding, its business, operating results, financial condition and cash flows may be materially and adversely affected.
Critical Accounting Policies
We consider the following accounting policies to be critical given they involve estimates and judgments made by management and are important for our investors’ understanding of our operating results and financial condition.
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements containedhave been prepared in this reportaccordance with accounting principles generally accepted in the United States of America. The consolidated financial statements include the accounts of GT Biopharma,the Company and its wholly owned subsidiaries, Oxis Biotech, Inc. and its subsidiaries. All intercompanyGeorgetown Translational Pharmaceuticals, Inc. Intercompany transactions and balances and transactions have been eliminated.eliminated in consolidation.
Long-Lived AssetsReverse Stock Split
Our long-livedOn February 10, 2021, the Company completed a 1:17 reverse stock split of the Company's issued and outstanding shares of common stock and all fractional shares were rounded up. All share and per share amounts in the accompanying financial statements have been adjusted retroactively to reflect the reverse stock split as if it had occurred at the beginning of the earliest period presented.
Accounting Estimates
The preparation of financial statements in conformity with Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include property, plantaccruals for potential liabilities, valuation of notes payable, assumptions used in deriving the fair value of derivative liabilities, share-based compensation and equipment, capitalized costsbeneficial conversion feature of filing patent applicationsnotes payable, and goodwillvaluation of deferred tax assets. Actual results could differ from those estimates.
Stock-Based Compensation
The Company accounts for share-based awards to employees and other assets. We evaluate our long-lived assets for impairmentnonemployees and consultants in accordance with the provisions of ASC 360, whenever events or changes in circumstances indicate718, Compensation-Stock Compensation. Stock-based compensation cost is measured at fair value on the grant date and 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 befair value is recognized is the excess of the carrying amount of the assets over its fair value.
Applicable long-lived assets are amortized or depreciatedas expense over the shorter of their estimated useful lives, the estimated period that the assets will generate revenue,requisite service, 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.vesting, period.
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, 2020.March 31, 2021.
Item 3. Quantitative Qauantitative andnd Qualitative Disclosures About Market Risk
This company qualifies as a smaller reporting company, as defined in 17 C.F.R. §229.10(f)(1) and is not required to provide information by this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our principal executive officer and principal financial officer evaluated the effectiveness of our “disclosure controls and procedures” (as such term is defined in Rules 13a-15(e) and 15d-15(e) of the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”)), as of June 30, 2020.March 31, 2021. Based on that evaluation we have concluded that our disclosure controls and procedures were not effective as of June 30, 2020March 31, 2021 as a result of material weaknesses in internal control over financial reporting due to (i) inadequate segregation of duties, (ii) risks of executive override and (iii) insufficient written policies and procedures for accounting and financial reporting with respect to the requirements and application of both U.S. GAAP and SEC regulation, in each case, as described in "Item“Item 9A. Controls and Procedures"Procedures” in the Company'sCompany’s Form 10-K for the year ended December 31, 2019.2020.
The Company is taking steps, and intends to take additional steps, to mitigate the issues identified and implement a functional system of internal control over financial reporting. Such measures will include, but not be limited to: hiring of additional employees in our finance and accounting department; preparation of risk-control matrices to identify key risks and develop and document policies to mitigate those risks; and identification and documentation of standard operating procedures for key financial and SEC reporting activities.
Changes in Internal Control over Financial Reporting
Except for the ongoing remediation of the material weaknesses in internal controls over financial reporting noted above, no changes in our internal control over financial reporting were made during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal LPegal Proceedings On December 24, 2018, the Empery Funds filed in the N.Y. Supreme Court, Index No. 656408/2018, alleging causes of action against the Company for Breach of Contract, Liquidated Damages, Damages, and Indemnification. The claims arose out of a securities purchase agreement entered into between the Empery Funds and the Company pursuant to which the Company issued the Original Securities to the Empery Funds in or around January 2018. On June 19, 2020, the Company and the Empery Funds, among others, entered into the Settlement Agreement resolving all remaining disputes between the parties pertaining to the Original Securities. See “ Part I, Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations—“under the caption”Recent Developments—Settlement with Empery Funds.”roceedings
On August 28, 2019, a complaint was filed in the Superior Court of California, County of Los Angeles, West Judicial District, Santa Monica Courthouse, Unlimited Civil Division by Jeffrey Lion, an individual (“Lion”), and by Daniel Vallera.Vallera, an individual (“Vallera”). Lion and Vallera are referred to jointly as the “Plaintiffs.”“Plaintiffs”. The complaint was filed against the CompanyGT Biopharma, Inc. and its subsidiary Oxis Biotech, Inc. (either of them or jointly, the “Defendant”“Company”). The Plaintiffs allege breach of a license agreement between the Plaintiffs and the DefendantCompany entered into on or about September 3, 2015. Lion alleges breach of a consulting agreement between Lion and the DefendantCompany entered into on or about September 1, 2015. Vallera alleges breach of a consulting agreement between Vallera and the DefendantCompany entered into in or around October, 2018. The complaintComplaint seeks actual damages of $1,670,000, for the fair market value of the number of shares of the Company’s common stockGT Biopharma, Inc. that at the time of judgment represent 15,000,000882,353 shares of such stock as of September 1, 2015, and that the CompanyGT Biopharma, Inc. issue Lion the number of common shares the Company’s common stockof GT Biopharma, Inc. that at the time of judgment represent 15,000,000882,353 such shares as of September 1, 2015.2015.The Company filed an answer to the complaint denying many allegations and asserting affirmative defenses. Discovery has commenced and trial is scheduled for May, 2022. The Company believes the case is without merit and will defend it vigorously.
On March 3, 2021 a complaint was filed by Sheffield Properties in the superior Court of California. County of Ventura. The litigation arises from a commercial lease entered into by GT Biopharma for office space in Westlake Village. GT Biopharma has been served but has not yet answered the complaint. Sheffield Properties seeks damages in excess of $250,000. We intend to vigorously defend against these claims. We believe we have made adequate provision in our financial statements to provide for potential settlement.
Item 1A. RiskRisk Factors
Information regarding risk factors appears under “Risk Factors” included in Part I. Item 1A. Risk Factors.Factors of our Annual Report on Form 10-K for the year ended December 31, 2019.2020. There have been no material changes from the risk factors previously disclosed in the above-mentioned periodic report.
Item 2. UnregisteredUnregistered Sales of Securities and Use of Proceeds
The Company made the following issuances of its unregistered equity securities pursuant exemptions contained in Section 4(a)(2) or 3(a)(9) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Rule 506 of Regulation D promulgated thereunder that have not previously been reported:
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On May 1, 2020,In January 2021, the Company issued 1,086,429entered into securities purchase agreements with certain purchasers pursuant to which the Company issues convertible notes in an aggregate principal amount of $2,450,000, which notes are convertible into the Company’s common stock at an initial conversion price of $0.20 per share.
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11,413,322 shares of common stock for consulting services.on or after February 16, 2021, in connection with (i) the conversion of the Company’s convertible notes or debentures upon completion of the listing on Nasdaq and (ii) payments of interest in lieu of cash with respect to the Company’s convertible notes or debentures.
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In July 2020,83,824 shares of common stock in connection with the Company issued 1,125,000exercise of certain settlement warrants on or after February 16, 2021.
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692,220 shares of common stock in connection with the conversion of all outstanding shares of Series J-1 Preferred Stock on February 23 and March 17, 2021.
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5,491,638 shares of common stock to certain of the Company’s directors, executive officers and consultants as compensatory bonuses after completion of the successful listing on the Nasdaq Capital Markets on February 11, 2021.
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1,368,520 shares of common stock upon conversionexercise of $225,000 aggregate principal amount of Convertible Notes.warrants for cash subsequent to December 31, 2020.
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On July 28, 2020, the Company issued a warrant to purchase up to an aggregate of 1,000,000 shares of common stock at an exercise price of $0.20 per share, subject to adjustment in certain circumstances. The warrant was issued as compensation for certain services provided to the Company.
Item 3. DefaultsDefaults Upon Senior Securities. As of June 30, 2020, convertible notes totaling approximately $13.2 million are in default.
Item 4. Mine Safety Disclosures
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other OIther Information.nformation.
Effective August 11, 2020, On April 23, 2021, Dr. Gregory Berk resigned as a member of the CompanyBoard of Directors (the “Board”).
On April 23, 2021, the Compensation Committee of the Board (the “Compensation Committee”) approved an amendment and Mr. Cataldo entered intorestatement of the CataldoEmployment Agreement with respect to Mr. Cataldo’s continued employment asAnthony Cataldo, the Chief Executive Officer, increasing his annual base salary to $500,000, setting his target bonus at 50% of his annual base salary, and extending the Company. The Initial Termterm of his agreement to four years. Upon the Cataldo Agreement is three years with the optiontermination of automatic one-year renewals thereafter. Mr. Cataldo will be paid a cash salary of $30,000 per month, together with customary benefits, expense reimbursement and the possibility of performance bonuses.Cataldo’s employment for any reason, Mr. Cataldo will receive a stock grant equalhis accrued but unpaid salary and vacation pay through the date of termination and any other benefits accrued to ten percenthim under any benefit plans outstanding at such time, and the reimbursement of documented, unreimbursed expenses incurred prior to such date. Upon the fully diluted shares of common stock of the Company (calculated with the inclusion of the current stock holdingstermination of Mr. Cataldo) upon conversion of options, warrants and Convertible Notes in association with a national markets qualified financing as consideration for entering into the Cataldo Agreement (with such stock to vest and be delivered within 30 days after the national markets qualified financing). Mr. Cataldo will be entitled to certain additional severance payments and other benefits in connection with a Change in Control Period Involuntary Termination or a Non Change in Control Period Involuntary Termination (each asemployment without cause (as defined in the Cataldohis Amended and Restated Employment Agreement) or upon Mr. Cataldo’s termination of his resignation as a result of a Change in Control Period Good Reason or Non Change in Control Period Good Reason (each asemployment for good reason (as defined in his Amended and Restated Employment Agreement) prior to the end of the term of his Amended and Restated Employment Agreement, Mr. Cataldo Agreement). Followingshall also receive (i) a lump sum payment equal to the Effective Date,greater of the amount of his annual base salary (at the then-current rate) that he would have earned through the end of the term of the agreement, and 50% of his annual base salary, plus (ii) a lump sum payment equal to the greater of the bonus paid or payable to Mr. Cataldo for the immediately preceding year, and the target bonus under the performance bonus plan, if any, in effect during the immediately preceding year, plus (iii) monthly reimbursement for the cost of medical, life and disability insurance coverage at a level equivalent to that provided by the for a period of the earlier of (a) one year and (b) the time Mr. Cataldo begins alternative employment wherein said insurance coverage is available and offered to Mr. Cataldo. All payments to Mr. Cataldo under his Amended and Restated Employment Agreement are subject to withholding of applicable taxes. Mr. Cataldo will also continuebe designated for election to serve as the chairmanBoard during the term of his Amended and Restated Employment Agreement.
On April 23, 2021, the Compensation Committee also approved an amendment and restatement of the board of the Company.
Effective August 11, 2020, the Company and Mr. Weldon entered into the WeldonEmployment Agreement with respect to Mr. Weldon's continued employment asMichael Handelman, the Chief Financial Officer, increasing his annual base salary to $375,000, setting his target bonus at 40% of his annual base salary and extending the Company. The Initial Termterm of the Weldonhis agreement to four years. Mr. Handelman entered into an Amended and Restated Employment Agreement is three years with the option of automatic one-year renewals thereafter.memorializing the foregoing amendments, on terms substantially similar to those set forth in Mr. WeldonCataldo’s Amended and Restated Employment Agreement, other than the obligation to designate Mr. Handelman for election to the Board.
On April 23, 2021, the Compensation Committee also approved the entry into an Employment Agreement with Dr. Gregory Berk pursuant to which Dr. Berk will be paid a cash salary of $25,000 per month, together with customary benefits, expense reimbursement and the possibility of performance bonuses. Mr. Cataldo will receive a stock grant equal to seven percent of the fully diluted shares of common stock of the Company (calculated with the inclusion of the current stock holdings of Mr. Weldon) upon conversion of options, warrants and Convertible Notes in association with a national markets qualified financing as consideration for entering into the Weldon Agreement (with such stock to vest and be delivered within 30 days after the national markets qualified financing). Mr. Weldon will be entitled to certain additional severance payments and other benefits in connection with a Change in Control Period Involuntary Termination or a Non Change in Control Period Involuntary Termination (each as defined in the Weldon Agreement) or his registration as a result of a Changein Control Period Good Reason or Non Change in Control Period Good Reason (each as defined in the Weldon Agreement). Following the Effective Date, Mr. Weldon will also continue to serve as the principal accounting officerChief Medical Officer for a term of four years. Dr. Berk will receive an annual base salary of $425,000 and is eligible to participate in the performance bonus plan or as otherwise determined by the Compensation Committee, with a directortarget annual bonus of 40% of his annual base salary. Concurrent with his employment the granted Dr. Berk 208,543 shares of the Company.
The summary descriptioncommon stock, vesting 25% on each of the first four annual anniversaries of the date of grant, subject to Dr. Berk’s continued service on each such vesting date, provided, that in the event of a change of control transaction, such shares shall immediately accelerate and vest. Such share award is contingent upon shareholder approval. The terms of Dr. Berk’s Employment AgreementsAgreement are otherwise substantially similar to those set forth above does not purportin Mr. Cataldo’s Amended and Restated Employment Agreement, other than the obligation to be complete and is qualified in its entirety bydesignate Dr. Berk for election to the Employment Agreements, which are filed with this Quarterly Report on Form 10-Q.Board.
| | | | | | Incorporated by Reference | | | | | | | Incorporated by Reference |
Exhibit | | Description | | Herewith | | Form | Number | SEC File No. | | Filing Date | Exhibit | | Description | | Filed Herewith | | Form | Number | SEC File No. | | Filing Date |
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| | | | Restated Certificate of Incorporation as filed in Delaware September 10, 1996 and as thereafter amended through March 1, 2002 | | | | 10-KSB | 3.A | 000-08092 | | 04/01/2002 |
| | | | Certificate of Amendment to the Restated Certificate of Incorporation of GT Biopharma, Inc., dated February 9, 2011 | | | | 10-K | 3.2 | 000-08092 | | 03/31/2011 |
| | | | Certificate of Amendment to the Restated Certificate of Incorporation of GT Biopharma, Inc., effective as of July 19, 2017 | | | | 8-K/A | 3.1 | 000-08092 | | 03/15/2018 |
| | | | Certificate of Amendment to the Restated Certificate of Incorporation of GT Biopharma, Inc., effective as of February 10, 2021 | | | | 8-K | 3.1 | 001-40023 | | 02/11/2021 |
| | | | Bylaws, as restated effective September 7, 1994 and as amended through April 29, 2003 | | | | 10-QSB | 3 | 000-08092 | | 08/14/2003 |
| | | | Certificate of Designation of Preferences, Rights and Limitations of Series J-1 Preferred Stock of GT Biopharma, Inc., dated April 3, 2019 | | | | 8-K | 3.1 | 000-08092 | | 04/05/2019 |
4.2 | | 4.2 | | Certificate of Designation of Preferences, Rights and Limitations of Series K Preferred Stock of GT Biopharma, Inc., dated April 3, 2019 | | | | 10-K | 4.2 | 001-40023 | | 04/16/2021 |
| | Form Securities Purchase Agreement among GT Biopharma, Inc. and the purchaser named therein (executed in April/May 2020) | | | | 10-Q | 10.4 | 000-08092 | | 05/15/20 | | | Amended and Restated Employment Agreement with Anthony Cataldo, dated April 23, 2021 | | X | | | | | |
| | | | Amended and Restated Employment Agreement with Michael Handelman, dated April 23, 2021 | | X | | | | | |
| | | | Amended and Restated Employment Agreement with Dr. Gregory Berk, dated April 23, 2021 | | X | | | | | |
31.1 | | 31.1 | | Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d-14(a), promulgated under the Securities and Exchange Act of 1934, as amended. | | X | | | | | | |
32.1* | | 32.1* | | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer and Chief Financial Officer). | | X | | | | | | |
101.INS | | 101.INS | | Inline XBRL Instance Document. | | X | | | | | | |
101.SCH | | 101.SCH | | Inline XBRL Taxonomy Extension Schema Document. | | X | | | | | | |
101.CAL | | 101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | | X | | | | | | |
101.DEF | | 101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document. | | X | | | | | | |
101.LAB | | 101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase Document. | | X | | | | | | |
101.PRE | | 101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | | X | | | | | | |
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| | Form of Registration Rights Agreement among GT Biopharma, Inc. and the purchaser named therein (executed in April/May 2020) | | | | 10-Q | 10.5 | 000-08092 | | 05/15/20 | |
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| | Form of Convertible Note (related to Securities Purchase Agreement executed in April/May 2020) | | | | 10-Q | 10.6 | 000-08092 | | 05/15/20 | |
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| | Securities Purchase Agreement, dated July 7, 2020, among GT Biopharma, Inc. and the purchaser named therein | | | | 8-K | 10.1 | 000-08092 �� | | 07/09/20 | |
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| | Registration Rights Agreement, dated July 7, 2020, among GT Biopharma, Inc. and the purchaser named therein | | | | 8-K | 10.3 | 000-08092 | | 07/09/20 | |
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| | Form of Convertible Note (related to Securities Purchase Agreement, dated July 7, 2020) | | | | 8-K | 4.1 | 000-08092 | | 07/09/20 | |
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| | Form of Standstill and Forbearance Agreement, dated June 23, 2020, between the Company and certain holders of Convertible Notes | | | | 8-K | 10.1 | 000-08092 | | 06/23/20 | |
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| | Settlement Agreement, dated June 19, 2020, among GT Biopharma, Inc., Empery Asset Master Ltd., Empery Tax Efficient, LP and Empery Tax Efficient II, LP, Anthony Cataldo and Paul Kessler | | | | 8-K | 10.1 | 000-08092 | | 06/19/20 | |
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| | Form of Convertible Note, dated June 19, 2020 (related to Settlement Agreement, dated June 19, 2020) | | | | 8-K | 10.2 | 000-08092 | | 06/19/20 | |
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| | Form of Pre-Funded Warrant to Purchase Common Stock, dated June 19, 2020 (related to Settlement Agreement, dated June 19, 2020) | | | | 8-K | 10.3 | 000-08092 | | 06/19/20 | |
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| | Employment agreement with Anthony Cataldo | | X | | | | | | | |
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| | Employment agreement with Steven Weldon | | X | | | | | | | |
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| | Certification of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a), promulgated under the Securities and Exchange Act of 1934, as amended. | | X | | | | | | | |
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| | Certification of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d 14(a), promulgated under the Securities and Exchange Act of 1934, as amended. | | X | | | | | | | |
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| | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer). | | X | | | | | | | |
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| | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Financial Officer). | | X | | | | | | | |
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101.INS | | Inline XBRL Instance Document. | | X | | | | | | | |
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101.SCH | | Inline XBRL Taxonomy Extension Schema Document. | | X | | | | | | | |
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101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | | X | | | | | | | |
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101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document. | | X | | | | | | | |
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101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase Document. | | X | | | | | | | |
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101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | | X | | | | | | | |
* | | This certification shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, 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 or the Exchange Act. |
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| This certification shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, 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 or the Exchange Act. |
Pursuant to the requirements 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: August 17, 2020
| GT Biopharma, Inc. | |
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Dated: May 17, 2021 | By: /s/ | /s/ Anthony Cataldo | |
| | Anthony Cataldo | |
| | Chief Executive Officer, Chief Financial Officer and Chairman of the Board |
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Dated: August 17, 2020 | By: /s/ Steven Weldon
Steven Weldon
Chief Financial Officer
|