☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Washington, D.C. 20549 FORM 10-K (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the fiscal year ended: December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number: 001-40023 GT BIOPHARMA, INC. (Exact name of Registrant as specified in its charter) Delaware 94-1620407 (St ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 September 30, 2022. ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to ____________. Commission File Number 001-40023 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 94-1620407 (State or ot ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended June 30, 2022. ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to ____________. Commission File Number 001-40023 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 94-1620407 (State or other jurisdiction of incorporation or organization) Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or ...

Financial Performance - Interest income rose to $8,000 for the three months ended March 31, 2022, compared to $0 in the same period of 2021, indicating improved financial performance [108]. - Interest expense dropped to $0 for the three months ended March 31, 2022, down from $696,000 in the same period of 2021, due to the conversion of notes payable to common shares [109]. - The company reported cash and cash equivalents of $7.3 million and short-term investments of $19.5 million as of March 31, 2022, indicating sufficient liquidity for operations [113]. Expenses - Research and development expenses increased to $2.1 million for the three months ended March 31, 2022, up from $1.6 million in the same period of 2021, reflecting a $500,000 increase primarily due to the addition of employees [106]. - Selling, general and administrative expenses decreased significantly to $3.4 million for the three months ended March 31, 2022, compared to $27.4 million in the same period of 2021, mainly due to reduced stock-based compensation [107]. - The company anticipates cash utilization for selling, general and administrative expenses to range between $5 million and $6 million, and for research and development expenses to range between $14 million and $16 million over the next twelve months [112]. Revenue and Losses - The company has not generated any revenue from product sales and has sustained operating losses since inception, which are expected to continue in the foreseeable future [112]. Legal and Compliance - A settlement of $425,000 was reached on February 7, 2022, regarding a breach of a license agreement, which was fully accrued at December 31, 2021, and paid on March 4, 2022 [125]. - The company has begun implementing measures to address material weaknesses in internal controls over financial reporting, including hiring a Chief Financial Officer and engaging a forensic accountant [122]. Future Strategies - The company is evaluating strategies for future funding, including public offerings of equity and/or debt securities and potential collaborations with pharmaceutical companies [114].

Financial Position - The company incurred an accumulated deficit of $653.6 million through December 31, 2021[173]. - Cash and cash equivalents were $9.0 million and short-term investments were $23.0 million as of December 31, 2021[173]. - The Company reported $32.0 million in cash and short-term investments as of December 31, 2021, which is expected to fund operations for the next 12 months[207]. - The Company has no off-balance sheet arrangements as of December 31, 2021[217]. Revenue and Losses - The Company has not generated any revenue from product sales and has sustained operating losses since inception[207]. - The Company has incurred substantial losses and anticipates additional losses until it can generate significant sales or revenue from out-licensing its products[209]. - The company had no loss from legal settlements in 2021, compared to a loss of $5.4 million in 2020[204]. Expenses - Research and development expenses increased to $9.6 million in 2021 from $485,000 in 2020, driven by stock compensation and the initiation of the Phase 1 clinical trial for GTB-3550[199]. - Selling, general and administrative expenses rose to $47.9 million in 2021 from $6.3 million in 2020, primarily due to stock compensation expenses of $32.6 million[201]. - The Company anticipates cash utilized for selling, general, and administrative expenses will range between $2 million and $4 million in the coming quarters[207]. - The amortization of debt discount was $0.32 million in 2020, a decrease attributed to the adoption of ASU 2020-06[206]. Funding and Capital Raising - The company completed a public offering of 4,945,000 shares of common stock for net proceeds of $24.7 million on February 16, 2021[187]. - The company issued 3,076,017 shares of common stock upon the exercise of warrants, resulting in cash proceeds of $16.4 million during the year ended December 31, 2021[193]. - The Company raised $24.7 million through common stock issuance, $16.4 million from warrant exercises, and $1.2 million from convertible notes in 2021, compared to $12.5 million raised in 2020[207]. - Management is evaluating strategies for obtaining required funding, including public offerings of equity and/or debt securities[210]. Research and Development - The company has entered into a scientific research agreement with the University of Minnesota for a total fixed sum of $2.1 million to support TriKE product development[196]. - The company anticipates direct clinical and preclinical expenses to increase significantly in 2022, totaling approximately $12 million to $14 million[199]. Regulatory and Market Conditions - The Company does not have any product candidates approved for sale as of December 31, 2021[207]. - Inflation has not had a material adverse impact on the Company's business or operating results during the periods presented[216].

For the transition period from _____ to _____. GT BIOPHARMA, INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission File Number 001-40023 For the quarterly period ended September 30, 2021. ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (State or other jurisdiction of incorporation or organization) Delaware 94-1620407 (I.R.S. Employer ...

Financial Performance - The company completed a public offering of 4,945,000 shares of common stock for net proceeds of $24,679,000 on February 16, 2021[112]. - The company raised a net amount of $24.7 million through common stock issuance, $16.3 million through warrant exercises, and $1.2 million from convertible notes during the six months ended June 30, 2021[135]. - The company had cash of $39.5 million as of June 30, 2021, and anticipates incurring additional losses until it can generate significant sales or revenue[137]. Research and Development - Research and development expenses increased to $639,000 for the three months ended June 30, 2021, compared to $12,000 for the same period in 2020, reflecting an increase of $627,000[126]. - The company issued 189,753 shares of common stock for a research and development agreement valued at $1,355,000 during the six months ended June 30, 2021[124]. - The company anticipates an increase in direct clinical costs for the remainder of 2021 due to the continuation of a phase one/two clinical trial of its TriKe product candidate, OXS-3550[130]. Expenses - Selling, general and administrative expenses rose to $3,742,000 for the three months ended June 30, 2021, up from $1,546,000 in 2020, an increase of $2,196,000 primarily due to stock-based compensation[127]. - The company incurred $25,007,000 in stock-based compensation during the six months ended June 30, 2021, compared to no such expenses in 2020[131]. - A total of 2,050,060 shares of common stock were issued to consultants, with a recognized stock compensation expense of $8,779,000 for the period ended June 30, 2021[122]. - The change in fair value of derivative liability was an expense of $480,000 for the three months ended June 30, 2021, with no such gain or loss for the same period in 2020[128]. - The change in fair value of derivative liability was an expense of $459,000 for the six months ended June 30, 2021, with no such gain or loss for the same period in 2020[132]. - Settlement expense was $11,206,000 for the six months ended June 30, 2020, with no such gain or loss for the same period in 2021[133]. - Interest expense decreased to $696,000 for the six months ended June 30, 2021, from $5,296,000 in 2020, primarily due to the conversion of outstanding convertible notes[134]. - Interest expense decreased to $0 for the three months ended June 30, 2021, down from $4,658,000 in 2020, primarily due to the conversion of outstanding convertible notes[129]. Funding and Cost Management - Management is evaluating strategies for obtaining required funding, including public offerings and potential licensing arrangements[137]. - The company has implemented cost-saving measures, including reductions in executive salaries and travel expenses[137]. - The company completed a 1:17 reverse stock split on February 10, 2021, with all share amounts adjusted retroactively[141]. - The company has no off-balance sheet arrangements as of June 30, 2021[146]. Economic Impact - Inflation has not had a material adverse impact on the company's business or operating results during the periods presented[145].

GT Biopharma, Inc. (NASDAQ:GTBP) Q2 2021 Earnings Conference Call August 13, 2021 8:30 AM ET Company Participants David Castaneda - Investor Relations Tony Cataldo - Chairman & Chief Executive Officer Martin Schroeder - Chief Technology Officer Greg Berk - Chief Medical Officer Conference Call Participants Justin Walsh - B. Riley Securities Ram Selvaraju - H.C. Wainwright Tony Butler - ROTH Capital Operator Greetings and welcome to the GT Biopharma Second Quarter 2021 Conference Call. All participants are ...

Financial Performance - The company incurred research and development expenses of $1,640,000 for the three months ended March 31, 2021, compared to $324,000 for the same period in 2020, representing an increase of $1,316,000[120]. - Selling, general and administrative expenses rose to $27,362,000 in Q1 2021 from $746,000 in Q1 2020, primarily due to stock-based compensation of $21,535,000 in 2021[121]. - The company has not generated any revenue from product sales and has sustained operating losses since inception[124]. Funding and Capital - The company raised net proceeds of $24,679,000 from a public offering of 4,945,000 shares of common stock on February 16, 2021[112]. - The company issued 189,753 shares of common stock for a research and development agreement valued at $1,355,000 during the three months ended March 31, 2021[116]. - The company is evaluating strategies for obtaining required funding, including public offerings and licensing arrangements[127]. Cash Flow and Expenses - As of March 31, 2021, the company had cash of $27.6 million and anticipates incurring additional losses until it can generate significant sales or revenue[126]. - The company expects cash utilized for selling, general and administrative expenses to range between $1 million and $2 million in the coming quarters[124]. - The company anticipates direct clinical costs to increase in 2021 due to the continuation of a phase one/two clinical trial of its advanced TriKE product candidate, OXS-3550[120]. Stock and Equity - The company granted 4,379,407 shares of common stock to officers and directors with a fair value of $18,621,000 as part of its public offering[118]. - The company qualifies as a smaller reporting company and is not required to provide information regarding market risk disclosures[135].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 September 30, 2020. ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from _____ to _____. Commission File Number 0000-08092 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of in ...