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 June 30, 2023. ☐ 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 j ...

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 March 31, 2023. ☐ 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 ...

☒ 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 ...

PART I – FINANCIAL INFORMATION Provides detailed financial statements, management's analysis of operations, market risk disclosures, and internal control assessments [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported no revenue, a reduced net loss of $15.3 million, and decreased total assets to $21.1 million for the nine months ended September 30, 2022 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $21.1 million, liabilities to $5.1 million, and stockholders' equity to $16.0 million as of September 30, 2022 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 (Unaudited) | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,465 | $8,968 | | Short-term investments | $18,319 | $23,011 | | Total Current Assets | $20,872 | $32,169 | | **Total Assets** | **$21,071** | **$32,169** | | **Liabilities & Equity** | | | | Accounts payable | $3,325 | $8,220 | | Total Current Liabilities | $5,025 | $10,259 | | **Total Liabilities** | **$5,117** | **$10,259** | | **Total Stockholders' Equity** | **$15,954** | **$21,910** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported no revenue, with a Q3 2022 net loss of $6.9 million and a nine-month net loss of $15.3 million, a significant reduction from the prior year Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2022 (Unaudited) | Q3 2021 (Unaudited) | YTD 2022 (Unaudited) | YTD 2021 (Unaudited) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $ - | $ - | $ - | $ - | | Research and development | $2,743 | $1,008 | $5,969 | $3,287 | | Selling, general and administrative | $4,280 | $4,946 | $9,510 | $36,050 | | Loss from Operations | $7,023 | $5,954 | $15,479 | $39,337 | | **Net Loss** | **$(6,881)** | **$(5,453)** | **$(15,300)** | **$(39,991)** | | Net loss per share | $(0.22) | $(0.17) | $(0.48) | $(1.54) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased to $16.0 million due to a $15.3 million net loss, partially offset by equity compensation and stock issuance for payables - Key changes in stockholders' equity for the nine months ended Sep 30, 2022 include a net loss of **$15.3 million**, equity compensation totaling **$6.3 million** (**$3.85 million** to officers/employees and **$2.46 million** to consultants), and issuance of common stock worth **$3.25 million** to settle vendor payables[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $10.9 million, investing activities provided $4.6 million, resulting in a $6.5 million net cash decrease, ending at $2.5 million Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2022 (Unaudited) | Nine Months Ended Sep 30, 2021 (Unaudited) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(10,919) | $(11,901) | | Net Cash Provided by (Used in) Investing Activities | $4,639 | $(26,031) | | Net Cash (Used in) Provided by Financing Activities | $(223) | $42,317 | | **Net (Decrease) Increase in Cash** | **$(6,503)** | **$4,385** | | Cash at Beginning of Period | $8,968 | $5,297 | | **Cash at End of Period** | **$2,465** | **$9,682** | [Condensed Notes to Consolidated Financial Statements](index=11&type=section&id=Condensed%20Notes%20to%20Consolidated%20Financial%20Statements) Notes detail the company's biopharmaceutical focus, liquidity, significant accounts payable settlement, stock-based compensation, ongoing litigation, and research commitments - The company is a clinical-stage biopharmaceutical company focused on developing its proprietary Tri-specific Killer Engager (TriKE) immuno-oncology platform[23](index=23&type=chunk) - Management anticipates that its cash, cash equivalents, and short-term investments of **$20.8 million** as of September 30, 2022, are adequate to fund operations for at least one year[27](index=27&type=chunk) - On August 24, 2022, the company settled a portion of its payables with a third-party manufacturer by issuing **1,222,281 shares** of common stock valued at **$3.3 million** and making cash payments[59](index=59&type=chunk) - On October 10, 2022, stockholders approved a reduction in the number of authorized shares of common stock from **750,000,000** to **250,000,000**[103](index=103&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's biopharmaceutical focus, increased R&D expenses, decreased SG&A, and confirms sufficient liquidity for over twelve months with projected future spending - The company is a clinical-stage biopharmaceutical company developing immuno-oncology products based on its proprietary Tri-specific Killer Engager (TriKE) platform[106](index=106&type=chunk) - Management believes it has sufficient cash and short-term investments (**$20.8 million** as of Sep 30, 2022) to fund operations for more than twelve months from the filing date[120](index=120&type=chunk) - Anticipated expenses for the next twelve months are projected to be **$13 million to $15 million** for R&D and **$4 million to $5 million** for SG&A[119](index=119&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) R&D expenses increased to $5.9 million due to development costs, while SG&A expenses decreased to $9.5 million primarily from reduced stock-based compensation Operating Expense Comparison (in millions) | Expense Category | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $5.9 | $3.3 | +$2.6 | | Selling, General & Administrative | $9.5 | $36.1 | -$26.6 | - The increase in R&D expense was due to hiring additional employees and costs for developing advanced TriKE® product candidates GTB-3650 and GTB-5550[112](index=112&type=chunk) - The decrease in SG&A expense was primarily due to a significant reduction in stock-based compensation to consultants, officers, and directors compared to the prior year[113](index=113&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risks - As a smaller reporting company, GT Biopharma is not required to provide disclosures about market risk[129](index=129&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were deemed ineffective due to material weaknesses, prompting remediation efforts including new hires and external consultants - Disclosure controls and procedures were concluded to be not effective as of September 30, 2022[129](index=129&type=chunk) - The ineffectiveness is due to material weaknesses in internal control, including: (i) inadequate segregation of duties, (ii) risks of executive override, and (iii) insufficient written accounting policies and procedures[129](index=129&type=chunk) - Remediation measures include hiring an experienced CFO, retaining outside consultants, and actions by a Special Committee of the board to evaluate compliance and operations[130](index=130&type=chunk) PART II – OTHER INFORMATION Presents information on legal proceedings and a list of exhibits filed with the report [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company initiated binding arbitration against its former CFO for misappropriation of funds and stock, seeking $370,000 in damages and share returns - On May 13, 2022, the Company filed a claim against its former CFO, Michael Handelman, for misappropriating funds and stock and failing to file required SEC reports[133](index=133&type=chunk) - The Company is seeking monetary damages estimated at **$370,000**, the return of unauthorized shares, and disgorgement of profits from the sale of those shares[133](index=133&type=chunk) - The dispute is being resolved through binding arbitration with the American Arbitration Association (AAA)[134](index=134&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) The report includes key exhibits such as Sarbanes-Oxley certifications and a Settlement and Investment Agreement with Cytovance Biologics - Key exhibits filed include CEO and CFO certifications pursuant to Sarbanes-Oxley Act rules[135](index=135&type=chunk) - A Settlement and Investment Agreement dated August 24, 2022, between the company and Cytovance Biologics, Inc. was filed as Exhibit 10.1[135](index=135&type=chunk) Signatures Confirms the official signing and authorization of the quarterly report [Signatures](index=33&type=section&id=Signatures) The quarterly report was signed and authorized on October 31, 2022, by Manu Ohri, Chief Financial Officer - The report was signed on October 31, 2022, by Manu Ohri, Chief Financial Officer[139](index=139&type=chunk)[140](index=140&type=chunk)

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].

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].

Financial Data and Key Metrics Changes - The company reported approximately $40 million available to execute business plans for the next couple of years, indicating a strong financial position [12] - The company has seen continued share price appreciation, reflecting positive market sentiment [17] Business Line Data and Key Metrics Changes - The GTB-3550 TriKE clinical trial continues to show safety and clinical results, demonstrating effectiveness in activating patients' NK cells [14][26] - The company is advancing its TriKE platform through a new sponsored research agreement with the University of Minnesota, enhancing its research capabilities [13] Market Data and Key Metrics Changes - The company was added to the Russell 2000 and the Chicago Options Exchange, which may enhance its visibility and market presence [12] Company Strategy and Development Direction - The company focuses on the TriKE platform, which is designed to enhance the cancer-killing abilities of patients' NK cells without the need for supplemental therapies [18][19] - The pipeline includes several TriKE products targeting various solid tumors, indicating a broad approach to cancer treatment [22] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the competitive and rapidly changing environment, emphasizing the importance of adapting to new risks [5] - The management expressed optimism about the ongoing clinical trials and the potential for significant advancements in cancer treatment [27] Other Important Information - The Phase I trial for GTB-3550 is expected to conclude later in the fall, with updated safety and efficacy data to be presented at the ESMO conference in September [27] Q&A Session Summary Question: What to expect at ESMO? - Management indicated that updated safety data will be presented for at least 12 patients, with patient number 13 being dosed shortly [32] Question: Details on CRS case? - The CRS case involved a Grade 1 fever without significant toxicity, which is not considered dose-limiting [33][35] Question: Dr. Miller's involvement post-research agreement? - Dr. Miller's involvement will remain strong, focusing on understanding TriKE's capabilities and its influence on NK cell biology [38] Question: Timing for final top-line data from the 3550 trial? - Final data is expected later in the fall, with potential presentation at a conference in winter or early spring [44] Question: Where in the treatment continuum will 3550 be deployed? - The current study is monotherapy, with plans to pursue accelerated strategies if compelling efficacy signals are observed [46] Question: Additional color on B7H3 targeted TriKE? - The B7H3 TriKE is in preclinical studies, showing good efficacy in targeting various cancers [53] Question: Commentary on second-generation TriKEs? - The second-generation TriKEs are designed to improve potency and activity, with significant advancements in drug candidates [64]

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].

Financial Position - The company has incurred an accumulated deficit of $567,332,000 through December 31, 2019[199]. - As of December 31, 2019, the company had cash and cash equivalents of $28,000[199]. - As of December 31, 2019, the company had cash and cash equivalents of $28,000 and raised $3.5 million through convertible debentures during the year[249]. - The company will need to raise an additional $15 million of capital in 2020 to finance existing operations and pay current liabilities[249]. - The company has no off-balance sheet arrangements as of December 31, 2019[260]. Revenue and Losses - The company has not generated any revenue from product sales and expects operating losses to continue in the foreseeable future[249]. - A loss of $20,463,000 was reported for the sale of GTB-004 in the year ended December 31, 2019[246]. - An additional impairment charge of $4,599,000 was reported for remaining projects during the year ended December 31, 2019, following the loss on the sale of GTB-004[247]. - The company has sustained operating losses since inception and expects such losses to continue over the foreseeable future[249]. Expenses - Research and development expenses for the year ended December 31, 2019, were $1.7 million, a decrease from $9.1 million in 2018, with expectations to increase to approximately $12 to $15 million in 2020 due to ongoing clinical trials[242]. - Selling, general and administrative expenses for the year ended December 31, 2019, were $9.7 million, down from $12.5 million in 2018, with future expenses anticipated to range between $1 and $2 million in the coming quarters[243]. - Interest expense decreased to $2.1 million for the year ended December 31, 2019, from $9.1 million in 2018, attributed to reduced non-cash amortization of debt issuance costs[248]. - The company anticipates cash utilization for selling, general, and administrative expenses to range between $1 million and $2 million in the coming quarters[249]. - Research and development costs totaled $1.7 million for the year ended December 31, 2018, which included non-cash compensation of $6.8 million[257]. Agreements and Collaborations - The company entered into a Securities Purchase Agreement on January 22, 2018, issuing senior convertible notes totaling $7,760,510, convertible at a price of $4.58 per share[211]. - The company received proceeds of $7,055,000 from the Securities Purchase Agreement after a 10% original issue discount[212]. - The company issued 10% Senior Convertible Debentures in an aggregate principal amount of $5,140,000 on August 2, 2018, convertible at a price of $2 per share[216]. - The company executed a clinical trial agreement in September 2019 for the GTB-3550 TriKE™ Phase I/II clinical trial targeting certain types of leukemia[209]. - The company has entered into a collaboration agreement with Cytovance® Biologics to develop a TriKE™ therapeutic for coronavirus treatment[210]. - The company has exclusive rights to develop and commercialize DT2219ARL (GTB-1550) for various human cancers under a license agreement with Dr. Vallera[207]. - The company has a co-development partnership with Altor BioScience Corporation for the clinical development of a novel TriKE fusion protein for cancer therapies[204]. - The company has a Sponsored Research Agreement with the University of Minnesota to determine toxicities and in vivo behavior in its TriKE technology[203]. Impairment and Asset Evaluation - The company recorded an intangible asset impairment charge of $228.5 million for the year ended December 31, 2018, related to CNS IPR&D assets, due to strategic shifts towards immuno-oncology development[244]. - The company evaluates indefinite lived intangible assets for impairment at least annually and records impairment losses when necessary[255]. Market Conditions - Inflation has not had a material adverse impact on the company's business or operating results during the periods presented[259].