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].

PART I FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's financial statements reflect a significant net loss, a widening stockholders' deficit, and substantial doubt about its ability to continue as a going concern [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet shows a widening stockholders' deficit to ($29.78) million, driven by a substantial increase in total liabilities to $30.69 million Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2020 (Unaudited) | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $350 | $28 | | Total Current Assets | $833 | $274 | | **Total Assets** | **$917** | **$396** | | **Liabilities & Stockholders' Deficit** | | | | Convertible notes | $23,000 | $13,207 | | Total Current Liabilities | $30,694 | $19,706 | | **Total Liabilities** | **$30,694** | **$19,706** | | Accumulated deficit | ($580,695) | ($567,332) | | **Total Stockholders' Deficit** | **($29,777)** | **($19,310)** | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported a significantly reduced net loss of ($2.9) million for the third quarter of 2020 compared to ($29.9) million in the prior year Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Research and development | ($84) | $671 | $252 | $1,659 | | Selling, general and administrative | $2,029 | $3,585 | $4,321 | $8,932 | | Loss from operations | ($1,945) | ($8,855) | ($4,573) | ($15,190) | | Interest expense | ($931) | ($560) | ($6,227) | ($1,493) | | **Net loss** | **($2,876)** | **($29,878)** | **($13,363)** | **($31,177)** | | **Net loss per common share** | **($0.04)** | **($0.51)** | **($0.18)** | **($0.69)** | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased, while financing activities provided $5.7 million, resulting in a net cash increase of $0.32 million for the nine-month period Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,335) | ($3,174) | | Net cash used by investing activities | $0 | $200 | | Net cash provided by financing activities | $5,657 | $3,227 | | **Net increase in cash** | **$322** | **$253** | | **Cash at end of period** | **$350** | **$313** | [Condensed Notes to Consolidated Financial Statements](index=8&type=section&id=Condensed%20Notes%20to%20Consolidated%20Financial%20Statements) Notes highlight a significant 'Going Concern' issue, an accumulated deficit of $580 million, and details on convertible notes and subsequent management changes - The company is a clinical-stage biopharmaceutical company focused on developing immuno-oncology products based on its proprietary Tri-specific Killer Engager (TriKE™) platform[21](index=21&type=chunk) - There is **substantial doubt about the company's ability to continue as a going concern** due to substantial losses, an accumulated deficit of **$580 million**, and cash of only **$350 thousand** as of September 30, 2020[24](index=24&type=chunk) - As of September 30, 2020, the company had approximately **$23 million in convertible notes outstanding**, with about **$13.2 million in default**[56](index=56&type=chunk)[62](index=62&type=chunk)[66](index=66&type=chunk) - Subsequent to the quarter end, the company issued additional convertible notes, entered into a settlement agreement, appointed two new directors, and experienced the **resignation of its CFO**[103](index=103&type=chunk)[108](index=108&type=chunk)[112](index=112&type=chunk)[118](index=118&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its focus on the TriKE™ platform, recent financing activities, and reiterates the substantial doubt about its ability to continue as a going concern - The company is focused on developing its proprietary TriKE™ and Dual Targeting TriKE™ platforms for hematologic malignancies, solid tumors, and infectious diseases[129](index=129&type=chunk)[131](index=131&type=chunk) - Entered into a GMP manufacturing services agreement with Cytovance® Biologics for three TriKE™ product candidates[133](index=133&type=chunk) Operating Expense Comparison (in thousands) | Expense Category | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $252 | $1,700 | Decreased due to reduced employee, consultant, and preclinical expenses | | Selling, General & Administrative | $4,300 | $8,900 | Decreased due to reduction in payroll and stock compensation | | Interest Expense | $6,200 | $1,500 | Increased due to accrual of default interest on notes | - The company has an accumulated deficit of **$580 million** and cash of **$350 thousand**, and will need to raise an additional **$18 million** to fund operations over the next 12 months, reinforcing the going concern risk[168](index=168&type=chunk)[170](index=170&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, this disclosure is not required - As a smaller reporting company, GT Biopharma is **not required to provide** quantitative and qualitative disclosures about market risk[179](index=179&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective due to material weaknesses in internal control - Disclosure controls and procedures were concluded to be **ineffective** as of September 30, 2020[180](index=180&type=chunk) - Identified **material weaknesses** include: (i) inadequate segregation of duties, (ii) risks of executive override, and (iii) insufficient written policies for accounting and financial reporting[180](index=180&type=chunk) - The company is implementing **remediation measures**, including hiring additional finance staff and documenting policies and procedures[181](index=181&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is a defendant in a lawsuit alleging breach of agreements and seeking damages of $1,670,000 plus stock issuance - A complaint was filed against the company and its subsidiary on August 28, 2019, by Jeffrey Lion and Daniel Vallera, alleging **breach of license and consulting agreements**[183](index=183&type=chunk) - The plaintiffs are seeking damages of **$1,670,000** and the issuance of common stock equivalent to **15,000,000 shares** as of September 1, 2015[183](index=183&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have been reported since the last Annual Report on Form 10-K - **No material changes** have occurred in the company's risk factors since the filing of its Form 10-K for the year ended December 31, 2019[184](index=184&type=chunk) [Item 2. Unregistered Sales of Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Securities%20and%20Use%20of%20Proceeds) The company issued various unregistered securities for note conversions, consulting services, and settlement agreements - During the nine months ended September 30, 2020, the company issued unregistered securities, including: - **3,147,486 shares** of common stock upon conversion of convertible notes - **1,086,429 shares** of common stock for consulting services - **3,500,000 shares** of common stock pursuant to a settlement agreement - A warrant to purchase **1,000,000 shares** of common stock as compensation[186](index=186&type=chunk)[190](index=190&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company was in default on convertible notes with a principal amount of approximately $13.2 million - As of September 30, 2020, convertible notes totaling approximately **$13.2 million are in default**[186](index=186&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[187](index=187&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) Subsequent events include a significant settlement agreement, the resignation of the CFO, and the appointment of new directors - On November 9, 2020, the company entered into a **settlement agreement** with Theorem Group and other claimants, resolving disputes by agreeing to issue new convertible notes[188](index=188&type=chunk)[189](index=189&type=chunk) - Steven Weldon **resigned as Chief Financial Officer** on November 11, 2020[192](index=192&type=chunk) - Michael Handelman was appointed as the new interim Chief Financial Officer, and Bruce Wendel and Greg Berk were appointed as **new directors** to the Board of Directors[193](index=193&type=chunk)[197](index=197&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including agreements and certifications

U. S. SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q 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 incorporation or organization) 94-1620407 (I.R.S. employer identification number) 9350 Wilshire Blvd. Suite 203 Beverly Hills, CA 90212 (Address of principal executive offices and zip code) (800) 304-9888 (Registrant's telephone number, includi ...

U. S. SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☑ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2020. ☐ For the transition period from to . Commission File Number 0-8092 GT BIOPHARMA, INC. (Exact name of small business issuer as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 94-1620407 (I.R.S. employer identification number) 9350 Wilshire Blvd. Suite 2 ...

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].

U. S. SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☑ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2019. ☐ For the transition period from to . Commission File Number 0-8092 GT BIOPHARMA, INC. (Exact name of small business issuer as specified in its charter) Delaware 94-1620407 (State or other jurisdiction of incorporation or organization) (I.R.S. employer identification number) 9350 Wilshire Blvd. Sui ...

U. S. SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☑ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2019. ☐ For the transition period from to . Commission File Number 0-8092 GT BIOPHARMA, INC. (Exact name of small business issuer as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 94-1620407 (I.R.S. employer identification number) 9350 Wilshire Blvd. Suite 20 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 Commission File Number: 000-08092 GT BIOPHARMA, INC. (Exact name of Registrant as specified in its charter) (State of incorporation or organization) (I.R.S. Employer Identification No.) Delaware 94-1620407 310 N. Westlake Blvd. Suite 206 Westlake Village, CA 91362 (Address of principal executive offi ...