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, 2024. ☐ 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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2023 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 ...

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, 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 ot ...

Financial Performance - The company recorded a net loss of $2.0 million for Q2 2023, an improvement compared to a net loss of $3.0 million in Q2 2022, representing a 33.3% reduction in losses[124] - Selling, General and Administrative (SG&A) expenses decreased to $1.5 million for Q2 2023, down from $1.9 million in Q2 2022, a reduction of 21.1%[118] - Interest income rose to $220,000 in Q2 2023 from $36,000 in Q2 2022, marking a significant increase due to higher interest rates[119] Research and Development - Research and Development (R&D) expenses increased to $2.1 million for Q2 2023, up from $1.1 million in Q2 2022, reflecting a 90.9% increase[117] - The company anticipates R&D expenses to range between $10.0 million and $12.0 million over the next twelve months[125] - GTB-3650, a next-generation TriKE product, is expected to file an Investigational New Drug (IND) application in the second half of 2023[113] - GTB-5550, targeting B7-H3 on advanced solid tumors, is advancing through preclinical studies with plans for an IND filing[114] Cash and Investments - Cash and cash equivalents were reported at $2.8 million, with short-term investments totaling $15.2 million as of June 30, 2023[126] - The company raised $6.5 million from an institutional investor by selling 3.6 million shares of common stock in January 2023[125] Future Outlook and Strategies - The company is evaluating strategies for future funding, including public offerings and partnerships with pharmaceutical companies[127] - Inflation has not had a material adverse impact on the company's business or operating results during the periods presented, but future inflationary pressures could increase operating costs and stress working capital resources[133] - The company has no off-balance sheet arrangements as of June 30, 2023[134] - 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 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 ...

PART I [Item 1. Business](index=5&type=section&id=Item%201.%20Business) GT Biopharma is a clinical-stage biopharmaceutical company developing immuno-oncology products via its TriKE platform, targeting hematologic malignancies and solid tumors, with key candidates GTB-3650 and GTB-5550 - The company's core technology is the **Tri-specific Killer Engager (TriKE) platform**, which creates fusion proteins to engage a patient's NK cells and direct them to kill specific cancer or virus-infected cells[14](index=14&type=chunk) - The first-generation product, **GTB-3550**, has completed its Phase 1 trial and is being replaced by a more potent, next-generation camelid nanobody TriKE, **GTB-3650**, for treating **Acute Myeloid Leukemia (AML)** and **Myelodysplastic Syndromes (MDS)**[35](index=35&type=chunk)[39](index=39&type=chunk) - The product pipeline includes **GTB-3650** (targeting CD33 for **AML/MDS**) with an anticipated **IND filing in H1 2023**, and **GTB-5550** (targeting **B7-H3** for **solid tumors**) with an anticipated **IND filing in late H2 2023**[44](index=44&type=chunk)[45](index=45&type=chunk) - The company operates without its own manufacturing facilities, relying on **third-party contract manufacturers** for the production of its product candidates for clinical and potential commercial needs[48](index=48&type=chunk) License Agreements with University of Minnesota (UofMN) | Agreement | Key Terms | | :--- | :--- | | **2016 Exclusive License** | Upfront payment of $200,000, annual maintenance fees of $100,000 (starting 2021), 4% royalties, and up to $9.1 million in milestone payments | | **2021 B7H3 TriKE License** | Upfront fee of $20,000, annual maintenance fees of $5,000 (starting 2022), 2.5%-5% royalties, and up to $9.1 million in milestone payments (non-duplicative of the 2016 agreement) | [Item 1A. Risk Factors](index=14&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including early development stage, substantial operating losses, capital needs, clinical trial uncertainties, regulatory hurdles, and Nasdaq delisting risk - **Financial Risks**: The company has a history of operating losses, reporting a **net loss of $20.9 million** for the year ended December 31, 2022, and an **accumulated deficit of $674.5 million**, expecting to incur future losses and requiring **substantial additional capital**[57](index=57&type=chunk)[60](index=60&type=chunk) - **Operational & Development Risks**: The business is at an **early stage** with **no products in late-stage clinical trials**, relying heavily on **third parties** for manufacturing and conducting clinical trials, which introduces risks of delays and lack of control[56](index=56&type=chunk)[126](index=126&type=chunk)[146](index=146&type=chunk) - **Regulatory Risks**: The company is subject to **extensive, costly, and time-consuming regulation** by the FDA and other authorities, with product candidates potentially causing **undesirable side effects** that could delay or prevent regulatory approval[105](index=105&type=chunk)[121](index=121&type=chunk) - **Intellectual Property Risks**: The business **depends on licenses from third parties**, such as the University of Minnesota, where failure to meet license obligations could result in the **loss of rights to key technologies**[86](index=86&type=chunk) - **Market & Stock Risks**: The company's common stock has a **limited public market** and may be deemed a **'penny stock'**, making it a high-risk investment, and on February 22, 2023, it received a deficiency letter from **Nasdaq** for its stock price falling below the **$1.00 minimum bid requirement**[155](index=155&type=chunk)[159](index=159&type=chunk)[161](index=161&type=chunk) [Item 1B. Unresolved Staff Comments](index=40&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved comments from the SEC staff - The company has no unresolved comments from the SEC staff[168](index=168&type=chunk) [Item 2. Properties](index=40&type=section&id=Item%202.%20Properties) The company subleases 4,500 square feet of office space in Brisbane, CA, with the agreement expiring on June 30, 2024 - The company's principal executive offices are located in **Brisbane, CA**, under a sublease agreement expiring **June 30, 2024**[169](index=169&type=chunk) [Item 3. Legal Proceedings](index=40&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in legal matters including a convertible note holder demand, an arbitration claim against its former CFO, and previously settled disputes - In **March 2023**, the company received a demand letter from a **convertible note holder** alleging failure to deliver shares upon conversion and claiming liquidated damages[170](index=170&type=chunk) - The company has a pending **arbitration claim** against its **former CFO, Michael Handelman**, seeking monetary damages of approximately **$370,000** and the return of shares for alleged misappropriation[171](index=171&type=chunk) - A lawsuit with Jeffrey Lion and Daniel Vallera regarding a 2015 license agreement was settled for **$425,000**, paid on **March 4, 2022**[173](index=173&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[174](index=174&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=40&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under 'GTBP', with 46 stockholders of record as of March 30, 2023, and no history or plans for dividend payments - The company's common stock is listed on the **Nasdaq Capital Market** under the ticker '**GTBP**'[175](index=175&type=chunk) - As of **March 30, 2023**, there were **46 stockholders of record**[177](index=177&type=chunk) - The company has **never paid dividends** and does not intend to pay them in the foreseeable future[179](index=179&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's **net loss decreased to $20.9 million** in 2022 from $58.0 million in 2021, driven by lower SG&A expenses, with management projecting sufficient capital for the next 12 months [Results of Operations](index=47&type=section&id=Results%20of%20Operations) In 2022, R&D expenses decreased to **$8.8 million** and SG&A expenses significantly fell to **$12.4 million**, resulting in a **net loss of $20.9 million** compared to $58.0 million in 2021 Comparison of Operating Results (in millions) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Research and Development Expenses | $8.8 | $9.6 | | Selling, General and Administrative Expenses | $12.4 | $47.9 | | Loss from Operations | ($21.3) | ($57.5) | | Net Loss | ($20.9) | ($58.0) | - The **significant decrease in SG&A expenses** was mainly due to a reduction in payroll and stock compensation expenses of approximately **$27.0 million**, along with lower marketing, legal, and professional fees[212](index=212&type=chunk) [Liquidity and Capital Resources](index=48&type=section&id=Liquidity%20and%20Capital%20Resources) The company had an accumulated deficit of **$674.5 million** as of December 31, 2022, with **$16.5 million** in cash and investments, and raised **$6.5 million** in January 2023, sufficient for the next 12 months - The company had **$5.7 million** in cash and cash equivalents and **$10.8 million** in short-term investments as of December 31, 2022[184](index=184&type=chunk)[216](index=216&type=chunk) - An additional **$6.5 million** was raised on **January 4, 2023**, from an institutional investor through a sale of common stock and warrants[216](index=216&type=chunk)[396](index=396&type=chunk) - Management expects cash needs of approximately **$15.0 million** for the next twelve months and believes current funds are **sufficient to fund operations** for that period[216](index=216&type=chunk) [Significant Agreements](index=46&type=section&id=Significant%20Agreements) Key agreements include a **$2.1 million** research agreement with the University of Minnesota expiring June 2023, and a revised manufacturer agreement involving **$3.2 million** in stock and **$3.3 million** in cash - A scientific research agreement with the University of Minnesota for **$2.1 million** is in place to support TriKE development, with **$1.7 million** incurred as of December 31, 2022, and the agreement expires on **June 30, 2023**[207](index=207&type=chunk) - In **August 2022**, the company revised its agreement with a third-party manufacturer, issuing **1.22 million shares** of common stock (valued at **$3.2 million**) and paying **$3.3 million** in cash as part of a payment arrangement[208](index=208&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, GT Biopharma is exempt from providing this information - The company qualifies as a **smaller reporting company** and is not required to provide this information[228](index=228&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=50&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited consolidated financial statements for 2022 and 2021, showing a **net loss of $20.9 million**, reduced total assets to **$16.7 million**, and total liabilities to **$5.0 million** [Consolidated Balance Sheets](index=62&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2022, total assets were **$16.7 million** (down from $32.2 million), total liabilities were **$5.0 million**, and total stockholders' equity was **$11.7 million** Key Balance Sheet Data (in thousands) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $5,672 | $8,968 | | Short-term investments | $10,836 | $23,011 | | **Total Assets** | **$16,736** | **$32,169** | | Accounts payable | $3,140 | $8,189 | | **Total Liabilities** | **$5,002** | **$10,259** | | **Total Stockholders' Equity** | **$11,734** | **$21,910** | [Consolidated Statements of Operations](index=63&type=section&id=Consolidated%20Statements%20of%20Operations) For 2022, the company reported no revenue and a **net loss of $20.9 million** (or **$0.66 per share**), a significant improvement from the **$58.0 million loss** in 2021 Key Operations Data (in thousands, except per share data) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Research and development | $8,811 | $9,591 | | Selling, general and administrative | $12,446 | $47,924 | | **Net Loss** | **($20,884)** | **($58,013)** | | Net Loss Per Share | ($0.66) | ($2.06) | [Consolidated Statements of Cash Flows](index=66&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2022, net cash used in operating activities was **$15.2 million**, net cash provided by investing activities was **$12.1 million**, leading to a net decrease in cash of **$3.3 million**, ending with **$5.7 million** Key Cash Flow Data (in thousands) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($15,217) | ($15,606) | | Net Cash Provided by (Used in) Investing Activities | $12,145 | ($23,040) | | Net Cash (Used in) Provided by Financing Activities | ($224) | $42,317 | | **Net (Decrease) Increase in Cash** | **($3,296)** | **$3,671** | [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=50&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting or financial disclosure matters - There were no disagreements with accountants on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure[230](index=230&type=chunk) [Item 9A. Controls and Procedures](index=50&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of December 31, 2022, having fully remediated material weaknesses in internal control over financial reporting from 2021 - Based on an evaluation as of December 31, 2022, the company's principal executive officer and principal financial officer concluded that disclosure controls and procedures were **effective**[231](index=231&type=chunk) - **Material weaknesses** in the Control Environment and Risk Assessment components, previously disclosed in the 2021 Form 10-K, were **fully remediated** as of December 31, 2022[232](index=232&type=chunk)[233](index=233&type=chunk) [Item 9B. Other Information](index=52&type=section&id=Item%209B.%20Other%20Information) No other information is reported under this item - There is no information to be reported under this item[240](index=240&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=52&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - This item is not applicable to the company[241](index=241&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=52&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding directors, executive officers, and corporate governance will be filed in the **2023 Proxy Statement**[242](index=242&type=chunk) [Item 11. Executive Compensation](index=52&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding executive compensation will be filed in the **2023 Proxy Statement**[243](index=243&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=52&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding security ownership will be filed in the **2023 Proxy Statement**[244](index=244&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=52&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding related transactions and director independence will be filed in the **2023 Proxy Statement**[245](index=245&type=chunk) [Item 14. Principal Accounting Fees and Services](index=52&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding principal accounting fees and services will be filed in the **2023 Proxy Statement**[246](index=246&type=chunk) PART IV [Item 15. Exhibits and Financial Statement Schedules](index=53&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides an index of all exhibits filed with the Form 10-K, including articles of incorporation, bylaws, material contracts, and certifications - This section contains the **index of all exhibits** filed with the Form 10-K[248](index=248&type=chunk) [Item 16. Form 10-K Summary](index=56&type=section&id=Item%2016.%20Form%2010-K%20Summary) No summary is provided under this item - No summary is provided under this item[253](index=253&type=chunk)

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)

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].