Company Overview - GT Biopharma, Inc. is a clinical stage immuno-oncology company focused on developing therapeutics based on its proprietary TriKE platform, which enhances the cancer-killing abilities of natural killer (NK) cells [2][4] - The company has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE technology [2] Upcoming Events - The company will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City [1] - An on-demand webcast of the company's presentation will be available starting at 7:00 a.m. ET on September 5, 2025 [2] Clinical Trials - The Phase 1 trial for GTBP-3650, aimed at treating relapsed or refractory CD33 expressing hematologic malignancies, is continuing to enroll as expected, with initial results from multiple dose cohorts anticipated later in 2025 [1] - The company is on track for the IND submission of GTB-5550 TriKE for the treatment of B7H3 positive solid tumors in Q4 2025 [1]

Core Viewpoint - GT Biopharma, Inc. reported positive progress in its Phase 1 clinical trial for GTB-3650, with a successful safety review and plans for further data release later in 2025 [2][8]. Financial Summary - As of June 30, 2025, the company had cash and cash equivalents of approximately $5.3 million, expected to fund operations into Q1 2026 [3][8]. - Research and Development (R&D) expenses for Q2 2025 were approximately $400,000, a decrease from $1.8 million in Q2 2024, primarily due to reduced production and scientific research costs [4]. - Selling, General and Administrative (SG&A) expenses for Q2 2025 were approximately $1.1 million, down from $2.0 million in the same quarter of 2024, attributed to lower legal fees and cost reduction measures [5]. - The company reported a net loss of approximately $1.4 million for Q2 2025, compared to a net loss of $3.7 million in Q2 2024, reflecting significant decreases in R&D and SG&A expenses [6]. Clinical Development - The Phase 1 trial for GTB-3650 is evaluating the treatment in 12 patients with relapsed or refractory CD33 expressing hematologic malignancies, with dosing structured in two-week blocks [2]. - The trial has successfully completed Cohort 1 and Cohort 2, advancing into Cohort 3, with initial data expected later in 2025 [8]. - The company anticipates submitting an IND application for GTB-5550, targeting B7H3 positive solid tumors, in Q4 2025 [8]. Company Overview - GT Biopharma is focused on developing immuno-oncology therapeutics based on its proprietary TriKE NK cell engager platform, which enhances the cancer-killing abilities of natural killer cells [9]. - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [9].

PART I FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents GT Biopharma, Inc.'s unaudited condensed financial statements for June 30, 2025, and December 31, 2024, including balance sheets, operations, equity, cash flows, and notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) | ASSETS (in thousands of USD) | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $5,228 | $3,951 | $1,277 | 32.3% | | Restricted cash | $93 | $93 | $0 | 0.0% | | Deferred offering costs | $760 | — | $760 | N/A | | Prepaid expenses and other current assets | $1,043 | $188 | $855 | 454.8% | | **TOTAL ASSETS** | **$7,124** | **$4,232** | **$2,892** | **68.3%** | | LIABILITIES & EQUITY (in thousands of USD) | | | | | | Accounts payable | $1,374 | $3,853 | $(2,479) | (64.3%) | | Accrued expenses | $608 | $1,797 | $(1,189) | (66.2%) | | Dividend payable | $85 | — | $85 | N/A | | Warrant liability | $240 | $252 | $(12) | (4.8%) | | **Total Current Liabilities** | **$2,307** | **$5,902** | **$(3,595)** | **(60.9%)** | | Convertible Preferred stock (Series L) | $1,956 | — | $1,956 | N/A | | Total Stockholders' Equity (Deficit) | $2,861 | $(1,670) | $4,531 | 271.3% | | **TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS' (EQUITY) DEFICIT** | **$7,124** | **$4,232** | **$2,892** | **68.3%** | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) | Metric (in thousands of USD) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Revenues | $— | $— | $0 | 0.0% | $— | $— | $0 | 0.0% | | Research and development | $363 | $1,784 | $(1,421) | (79.6%) | $1,462 | $2,561 | $(1,099) | (42.9%) | | Selling, general and administrative | $1,150 | $2,122 | $(972) | (45.8%) | $1,983 | $4,436 | $(2,453) | (55.3%) | | Loss from Operations | $(1,513) | $(3,906) | $2,393 | 61.3% | $(3,445) | $(6,997) | $3,552 | 50.8% | | Total Other Income (Expense), Net | $80 | $196 | $(116) | (59.2%) | $1,236 | $1,021 | $215 | 21.1% | | Net Loss | $(1,433) | $(3,710) | $2,277 | 61.4% | $(2,209) | $(5,976) | $3,767 | 63.0% | | Dividends on preferred stock | $(85) | $— | $(85) | N/A | $(85) | $— | $(85) | N/A | | Net Loss attributable to common stockholders' | $(1,518) | $(3,710) | $2,192 | 59.1% | $(2,294) | $(5,976) | $3,682 | 61.6% | | Net Loss Per Share - Basic and Diluted | $(0.55) | $(2.17) | $1.62 | 74.7% | $(0.90) | $(3.86) | $2.96 | 76.7% | | Weighted average common shares outstanding | 2,771,765 | 1,711,955 | 1,059,810 | 61.9% | 2,559,604 | 1,546,294 | 1,013,310 | 65.5% | [Condensed Statements of Stockholders' Equity (Deficit) and Mezzanine](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity%20(Deficit)%20and%20Mezzanine) - Total Stockholders' Equity (Deficit) improved significantly from a deficit of **$(1,670,000)** as of December 31, 2024, to an equity of **$2,861,000** as of June 30, 2025, primarily driven by new equity issuances[15](index=15&type=chunk) - The Company issued 6,611 Series L convertible preferred stock for cash, net, contributing **$3,389,000** to additional paid-in capital and **$2,052,000** to mezzanine equity during the six months ended June 30, 2025[15](index=15&type=chunk) - Common shares outstanding increased from **2,234,328** at December 31, 2024, to **3,272,995** at June 30, 2025, due to warrant exercises, Series L preferred stock conversions, and issuances for ELOC fees and services[15](index=15&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (in thousands of USD) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Net Cash Used in Operating Activities | $(5,216) | $(7,699) | $2,483 | 32.2% | | Net Cash Provided by Investing Activities | $— | $12,893 | $(12,893) | (100.0%) | | Net Cash Provided by Financing Activities | $6,493 | $2,976 | $3,517 | 118.2% | | Net Increase in Cash and Cash Equivalents and Restricted Cash | $1,277 | $8,170 | $(6,893) | (84.4%) | | Cash and Cash Equivalents and Restricted Cash at End of Period | $5,321 | $9,249 | $(3,928) | (42.5%) | - Non-cash financing activities for the six months ended June 30, 2025, included **$3,389,000** for vested warrants issued in Series L convertible preferred stock transaction, **$672,000** for prefunded warrants issued for ELOC fee, and **$718,000** for common stock and warrants issued for services[21](index=21&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) [Note 1 – Organization and Going Concern Analysis](index=8&type=section&id=Note%201%20%E2%80%93%20Organization%20and%20Going%20Concern%20Analysis) - GT Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing novel immune-oncology products using its proprietary Tri-specific Killer Engager (TriKE®) and Tetra-specific Killer Engager (Dual Targeting TriKE®) platforms[24](index=24&type=chunk) - The Company has sustained operating losses since inception, recorded a net loss of approximately **$2.2 million** and used **$5.2 million** in cash from operations for the six months ended June 30, 2025, raising substantial doubt about its ability to continue as a going concern[28](index=28&type=chunk) - The Company's ability to continue as a going concern is dependent on securing additional financing, as existing cash resources are not sufficient to fund anticipated operations for the next year[30](index=30&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=9&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) - The financial statements are unaudited and prepared in accordance with GAAP and SEC interim reporting rules, condensing certain information compared to annual reports[31](index=31&type=chunk) - Significant accounting estimates include liquidity, potential liabilities, fair value of derivative liabilities, valuation of equity instruments, and deferred tax assets[33](index=33&type=chunk) - Cash equivalents, primarily money market funds and treasuries, amounted to approximately **$4.9 million** at June 30, 2025, and **$3.8 million** at December 31, 2024[34](index=34&type=chunk) - The Company capitalizes deferred offering costs related to in-process equity financings, totaling **$0.8 million** as of June 30, 2025[36](index=36&type=chunk) - Warrant liabilities are classified as Level 3 fair value measurements, with a carrying amount of **$240,000** at June 30, 2025[40](index=40&type=chunk) - The Company operates as a single reportable segment, with the CEO as the chief operating decision maker evaluating performance on a consolidated basis[51](index=51&type=chunk) [Note 3 – Accounts Payable and Related Party](index=11&type=section&id=Note%203%20%E2%80%93%20Accounts%20Payable%20and%20Related%20Party) | Accounts Payable (in thousands of USD) | June 30, 2025 | % | December 31, 2024 | % | | :------------------------------ | :------------ | :- | :---------------- | :- | | Cytovance (related party) | $598 | 44% | $1,183 | 31% | | University of Minnesota | $432 | 31% | $712 | 18% | | Legal services firm | $— | —% | $1,505 | 39% | | Other accounts payable | $344 | 25% | $453 | 12% | | **Total accounts payable** | **$1,374** | **100%** | **$3,853** | **100%** | - Accounts payable to Cytovance, a related party, decreased from **$1,183,000** at December 31, 2024, to **$598,000** at June 30, 2025. This reduction was partly due to the issuance of pre-funded warrants valued at **$847,000** in March 2025[55](index=55&type=chunk)[56](index=56&type=chunk) - A legal services firm reduced the Company's prior year unpaid fees by approximately **$1 million** in March 2025, which was classified as other income[57](index=57&type=chunk) [Note 4 – Warrant Liability](index=12&type=section&id=Note%204%20%E2%80%93%20Warrant%20Liability) - The 2023 Warrants are classified as a liability due to a provision that introduces leverage, potentially resulting in a value greater than a fixed-for-fixed option on the Company's own equity shares[60](index=60&type=chunk) | 2023 Warrants Valuation Assumptions | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :------------ | :---------------- | | Stock price | $3.58 | $3.05 | | Risk-free interest rate | 3.68% | 4.27% | | Expected volatility | 111% | 114% | | Expected life (in years) | 2.5 – 3.0 | 3.0 – 3.50 | | Expected dividend yield | — | — | | Fair value of warrants (in thousands of USD) | $240,000 | $252,000 | - The warrant liability decreased by **$12,000** for the six months ended June 30, 2025, from a beginning balance of **$252,000** to an ending balance of **$240,000**[62](index=62&type=chunk) [Note 5 – Stockholders' Equity (Deficit)](index=13&type=section&id=Note%205%20%E2%80%93%20Stockholders'%20Equity%20(Deficit)) - The Company entered into a common shares purchase agreement in May 2025, allowing it to sell up to **$20 million** of common stock to investors at 93% of the volume-weighted average price[64](index=64&type=chunk)[66](index=66&type=chunk) - In February 2025, the Company received **$686,000** gross proceeds from a warrant exercise inducement transaction, issuing new inducement warrants for **604,138** shares and placement agent warrants for **21,145** shares[68](index=68&type=chunk)[69](index=69&type=chunk) - A private placement of Series L Convertible Preferred Stock and warrants in May 2025 generated net proceeds of **$5,441,000**, allocated to mezzanine equity (**$2,025,000**) and additional paid-in capital (**$3,389,000**)[72](index=72&type=chunk)[83](index=83&type=chunk) - Series L Convertible Preferred Stock is classified as mezzanine equity because it is conditionally redeemable at the option of holders upon certain events not solely within the Company's control[83](index=83&type=chunk) - Dividends of **$85,000** on Series L Convertible Preferred Stock were declared and unpaid as of June 30, 2025[80](index=80&type=chunk) [Note 6 – Common Stock Warrants and Options](index=15&type=section&id=Note%206%20%E2%80%93%20Common%20Stock%20Warrants%20and%20Options) | Warrant Transactions (Six Months Ended June 30, 2025) | Number of Warrants | Weighted Average Exercise Price (USD) | | :-------------------------------------------------- | :----------------- | :------------------------------ | | Warrants outstanding at December 31, 2024 | 1,120,429 | $18.85 | | Granted | 16,468,308 | $2.04 | | Exercised | (837,069) | $2.11 | | Warrants outstanding at June 30, 2025 | 16,751,668 | $3.07 | | Warrants exercisable at June 30, 2025 | 4,995,263 | $5.49 | - The aggregate intrinsic value of all warrants outstanding at June 30, 2025, was approximately **$25.4 million**, and for exercisable warrants, it was **$7.4 million**[84](index=84&type=chunk) - The Company issued **3,235,978** Common Warrants and **11,576,406** Vesting Warrants in May 2025, both with an initial exercise price of **$2.043** and full ratchet price protection[85](index=85&type=chunk) | Stock Option Transactions (Six Months Ended June 30, 2025) | Number of Options | Weighted Average Exercise Price (USD) | | :------------------------------------------------------- | :---------------- | :------------------------------ | | Options outstanding at December 31, 2024 | 124,600 | $32.69 | | Options outstanding at June 30, 2025 | 124,600 | $32.69 | | Options exercisable at June 30, 2025 | 109,692 | $36.85 | - The total fair value of options that vested during the six months ended June 30, 2025, was **$7,000**, recognized in selling, general and administrative expense[90](index=90&type=chunk) [Note 7 – Commitments and Contingencies](index=17&type=section&id=Note%207%20%E2%80%93%20Commitments%20and%20Contingencies) - The Company is involved in ongoing legal proceedings, including the Ohri Matter (arbitration against former CFO), TWF Global Matter (dispute over convertible notes), and Silberfein, DiPietro, and Werthman Trust Matters (claims for breach of securities purchase agreements and convertible notes)[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - Commitments to Cytovance Biologics, a related party, for unbilled and unaccrued SOWs amounted to approximately **$310,000** as of June 30, 2025[101](index=101&type=chunk) - The 2023 Sponsored Research Agreement with the University of Minnesota was amended to expire on December 31, 2025, with total payments due increasing to approximately **$1.9 million**[103](index=103&type=chunk) - The 2016 Exclusive Patent License Agreement with the University of Minnesota was amended in May 2024, adjusting license maintenance fees and royalty rates, and includes clinical development milestone payments totaling **$3.1 million**[107](index=107&type=chunk) - The Company regained compliance with Nasdaq's Minimum Stockholders' Equity Requirement on June 13, 2025, after submitting a plan of compliance and conducting securities offerings[116](index=116&type=chunk) [Note 8 – Segment Information](index=20&type=section&id=Note%208%20%E2%80%93%20Segment%20Information) - The Company operates as a single reportable and operating segment, focused on developing and commercializing immune-oncology products[118](index=118&type=chunk) | Segment Expenses (in thousands of USD) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $363 | $1,805 | $1,462 | $2,561 | | Salaries | $351 | $287 | $632 | $765 | | Insurance | $61 | $76 | $121 | $152 | | Stock-based compensation | $4 | $120 | $7 | $222 | | Operating expenses | $734 | $1,619 | $1,223 | $3,297 | | Other income | $(80) | $(197) | $(1,236) | $(1,021) | | Net loss | $1,433 | $3,710 | $2,209 | $5,976 | [Note 9 – Subsequent Events](index=20&type=section&id=Note%209%20%E2%80%93%20Subsequent%20Events) - On July 28, 2025, a purchaser exercised Greenshoe Rights for Series L Preferred Stock, purchasing **222.22** shares for **$200,000**, which decreased the conversion price from **$2.043** to **$1.7766**[121](index=121&type=chunk) - From July 1, 2025, through August 10, 2025, holders converted **543,273** shares of Series L Convertible Preferred Stock into **284,507** shares of common stock[122](index=122&type=chunk) [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 the Company's financial condition and results of operations for the three and six months ended June 30, 2025, covering product development, accounting policies, liquidity, and going concern [Organization](index=22&type=section&id=Organization) - GT Biopharma, Inc. was incorporated in California in 1965 as Diagnostic Data, Inc., underwent several name changes and mergers, and adopted its current name on July 17, 2017[124](index=124&type=chunk) [Overview](index=22&type=section&id=Overview) - The Company is a clinical-stage biopharmaceutical company developing novel immuno-oncology products based on its proprietary TriKE® and Dual Targeting TriKE® fusion protein immune cell engager technology platforms[125](index=125&type=chunk) - The TriKE® and Dual Targeting TriKE® platforms are designed to harness and enhance the cancer-killing abilities of a patient's natural killer (NK) cells, targeting various tumor antigens without patient-specific customization[125](index=125&type=chunk) - The product candidate pipeline includes GTB-3650 (Phase 1 for AML, MDS), GTB-5550 (preclinical for solid tumors, IND anticipated Q4 2025), GTB-6550 (preclinical for solid tumors), GTB-7550 (preclinical for B-Cell Malignancies and autoimmune disorders), and GTB-1050 (preclinical for HIV)[129](index=129&type=chunk) - GTB-3550, the first TriKE® product candidate, was replaced by the more potent second-generation camelid nanobody TriKE®, GTB-3650, due to enhanced potency observed in preclinical studies[132](index=132&type=chunk) - GTB-3650, targeting CD33, received FDA IND clearance in late June 2024, and study enrollment for relapsed/refractory AML and high-grade MDS patients began on January 21, 2025[139](index=139&type=chunk) - GTB-5550, a B7-H3 targeted dual camelid TriKE®, is being advanced through preclinical studies with GMP manufacturing initiated, and an IND application is anticipated in the fourth quarter of 2025[147](index=147&type=chunk)[155](index=155&type=chunk) [Critical Accounting Policies and Estimates](index=26&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - The preparation of financial statements requires management to make significant estimates and assumptions, including accruals for potential liabilities, fair value of warrant liabilities, valuation of equity instruments, and deferred tax assets[146](index=146&type=chunk)[148](index=148&type=chunk) - Warrant liabilities are initially recorded at fair value and re-valued each reporting period, with changes reported in the statements of operations[149](index=149&type=chunk) - Stock-based compensation for officers, directors, employees, and consultants is recognized based on grant date fair values, estimated using the Black-Scholes option-pricing model[152](index=152&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) [Operating Expenses](index=27&type=section&id=Operating%20Expenses) | Operating Expenses (in thousands of USD) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $363 | $1,784 | $(1,421) | (80%) | $1,462 | $2,561 | $(1,099) | (43%) | | Selling, general and administrative | $1,146 | $2,002 | $(856) | (43%) | $1,976 | $4,214 | $(2,238) | (53%) | | Stock compensation | $4 | $120 | $(116) | (97%) | $7 | $222 | $(215) | (97%) | | **Total Operating Expenses** | **$1,513** | **$3,906** | **$(2,393)** | **(61%)** | **$3,445** | **$6,997** | **$(3,552)** | **(51%)** | - Research and development expenses decreased by **$1.4 million** and **$1.1 million** for the three and six months ended June 30, 2025, respectively, primarily due to lower production and scientific research costs[154](index=154&type=chunk) - Selling, general, and administrative expenses decreased by **$856,000** and **$2.2 million** for the three and six months ended June 30, 2025, respectively, mainly due to a significant reduction in legal fees and other cost-reduction measures[156](index=156&type=chunk) [Other Income (Expense)](index=28&type=section&id=Other%20Income%20(Expense)) | Other Income (Expense) (in thousands of USD) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :------------------------------------ | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Interest income | $38 | $105 | $(67) | (64%) | $70 | $247 | $(177) | (72%) | | Change in fair value of warrant liability | $(114) | $117 | $(231) | (197%) | $12 | $775 | $(763) | (98%) | | Gain on settlement of vendor payable | $— | $— | $0 | 0% | $998 | $— | $998 | N/A | | Other | $156 | $(27) | $183 | 678% | $156 | $— | $156 | N/A | | **Total Other Income (Expense)** | **$80** | **$196** | **$(116)** | **(59%)** | **$1,236** | **$1,021** | **$215** | **21%** | - Interest income decreased due to lower money market fund and short-term investment balances[158](index=158&type=chunk) - The change in fair value of warrant liability decreased significantly, primarily due to a reduction in the Company's stock price[159](index=159&type=chunk) - A **$1 million** gain on settlement of vendor payable was recorded in March 2025 due to a legal services firm reducing prior year unpaid fees[160](index=160&type=chunk) - Other income for the six months ended June 30, 2025, included **$44,000** from warrants issued for a VRT waiver and **$200,000** from the extinguishment of consulting fees accrual[161](index=161&type=chunk) [Net Loss](index=29&type=section&id=Net%20Loss) | Net Loss (in thousands of USD) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :---------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Net Loss | $(1,433) | $(3,710) | $2,277 | 61% | $(2,209) | $(5,976) | $3,767 | 63% | - Net loss decreased by approximately **$2.3 million** and **$3.8 million** for the three and six months ended June 30, 2025, respectively, primarily due to decreased research and development expenses and legal fees[162](index=162&type=chunk) [Liquidity and Going Concern Analysis](index=29&type=section&id=Liquidity%20and%20Going%20Concern%20Analysis) - The Company has no approved products or revenue from sales, and has sustained operating losses since inception, including a **$2.2 million** net loss and **$5.2 million** cash used in operations for the six months ended June 30, 2025[163](index=163&type=chunk) - These factors, along with the independent auditor's report, raise substantial doubt about the Company's ability to continue as a going concern within one year[163](index=163&type=chunk) - The Company's ability to meet its obligations and continue operations is dependent on securing additional financing, as current cash resources are insufficient for the next year[165](index=165&type=chunk) [Cash Flows](index=29&type=section&id=Cash%20Flows) | Cash Flow Data (in thousands of USD) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :---------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(5,216) | $(7,699) | | Net cash provided by investing activities | $— | $12,893 | | Net cash provided by financing activities | $6,493 | $2,976 | | Net increase in cash and cash equivalents and restricted cash | $1,277 | $8,170 | | Cash and cash equivalents and restricted cash, end of period | $5,321 | $9,249 | - Net cash used in operating activities decreased to **$5.2 million** for the six months ended June 30, 2025, from **$7.7 million** in the prior year, primarily due to a decrease in accounts payable and accrued expenses and a lower net loss[167](index=167&type=chunk) - Net cash provided by financing activities increased to **$6.5 million** for the six months ended June 30, 2025, from **$3.0 million** in the prior year, driven by proceeds from Series L Convertible Preferred Stock and warrant issuances[169](index=169&type=chunk) [Working Capital (Deficit)](index=30&type=section&id=Working%20Capital%20(Deficit)) | Working Capital (in thousands of USD) | June 30, 2025 | December 31, 2024 | Increase/(Decrease) | | :----------------------------- | :------------ | :---------------- | :------------------ | | Current assets | $7,124 | $4,232 | $2,892 | | Current liabilities | $2,307 | $5,902 | $(3,595) | | Working capital (deficit) | $4,817 | $(1,670) | $6,487 | - The Company's working capital significantly improved from a deficit of **$1.67 million** at December 31, 2024, to a positive working capital of **$4.82 million** at June 30, 2025[170](index=170&type=chunk) [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) - The Company had no off-balance sheet arrangements as of June 30, 2025[171](index=171&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, GT Biopharma, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The Company qualifies as a smaller reporting company and is exempt from providing quantitative and qualitative disclosures about market risk[172](index=172&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the Company's disclosure controls and procedures, concluding effectiveness as of June 30, 2025, with no material changes to internal controls - The Principal Executive Officer, Principal Financial Officer, and Principal Accounting Officer concluded that the Company's disclosure controls and procedures were effective as of June 30, 2025[173](index=173&type=chunk) - Management is responsible for establishing and maintaining adequate internal control over financial reporting, designed to provide reasonable assurance regarding financial reporting reliability[174](index=174&type=chunk) - No changes in internal controls over financial reporting were made during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[177](index=177&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) This section updates the Company's ongoing legal proceedings, including arbitration with a former CFO, a dispute over convertible notes, and new claims for breach of securities purchase agreements - The AAA Arbitration Demand against former CFO Manu Ohri for breach of fiduciary duties and contract is ongoing, with the final hearing postponed indefinitely for mediation[179](index=179&type=chunk) - Z-One, LLC filed a new complaint on June 25, 2025, alleging breach of a Convertible Note and seeking damages exceeding **$500,000**, which the Company intends to dismiss[180](index=180&type=chunk) - Three separate summonses with notice were filed in July 2025 by Coby Silberfein, Justin DiPietro, and Phillip Werthman Trust, each seeking damages for breach of securities purchase agreements and convertible notes, which the Company believes are without merit[181](index=181&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred in the risk factors since the Annual Report on Form 10-K for December 31, 2024, and the Quarterly Report on Form 10-Q for March 31, 2025 - No material changes have occurred in the risk factors since the Annual Report on Form 10-K for December 31, 2024, and the Quarterly Report on Form 10-Q for March 31, 2025[182](index=182&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details unregistered equity sales during Q2 2025, including common stock and warrants for services, pre-funded warrants for an equity facility, and warrants for a VRT waiver - In May and June 2025, the Company issued **50,000** shares of common stock and warrants for **200,000** shares, with an aggregate fair value of approximately **$718,000**, to vendors as compensation for services[183](index=183&type=chunk) - On May 14, 2025, pre-funded warrants to purchase **300,000** shares of common stock, with a fair market value of **$672,000**, were issued as consideration for an irrevocable commitment under an equity facility[184](index=184&type=chunk) - On May 15, 2025, warrants for **24,390** shares of common stock, with a fair market value of **$44,000**, were issued to investors in exchange for a waiver of a variable rate transaction[185](index=185&type=chunk) [Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[187](index=187&type=chunk) [Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The Company reported no mine safety disclosures - There were no mine safety disclosures[8](index=8&type=chunk) [Other Information](index=31&type=section&id=Item%205.%20Other%20Information) This section includes an amendment to the 2023 Sponsored Research Agreement and confirms no Rule 10b5-1 trading plans were adopted, amended, or terminated by directors or officers - The 2023 Sponsored Research Agreement with the University of Minnesota was amended on June 18, 2025, to expire on December 31, 2025, with an additional **$216,000** in payments, bringing the total to approximately **$1.9 million**[189](index=189&type=chunk) - No directors or officers adopted, amended, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the six months ended June 30, 2025[190](index=190&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including certificates of incorporation, preferred stock designations, warrant forms, securities purchase agreements, and certifications - The exhibits include amendments to the Restated Certificate of Incorporation, Certificates of Designation for Series J-1, K, and L Preferred Stock, and various forms of warrants (Series A, Series B Inducement, Prefunded Common Stock Purchase, Common, and Vesting Warrants)[191](index=191&type=chunk) - Key agreements filed as exhibits include the Securities Purchase Agreement and Registration Rights Agreement dated May 12, 2025, and their amendments, related to the Series L Convertible Preferred Stock and warrants[191](index=191&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to the Securities Exchange Act of 1934 and the Sarbanes-Oxley Act of 2002 are also included[191](index=191&type=chunk) SIGNATURES - The report was signed on August 14, 2025, by Michael Breen, Chief Executive Officer and Executive Chairman of the Board, and Alan Urban, Chief Financial Officer & Secretary[194](index=194&type=chunk)

Core Insights - GT Biopharma has initiated dosing in Cohort 3 of its Phase 1 dose escalation trial for GTB-3650, targeting relapsed or refractory CD33 expressing hematologic malignancies [1][2] - The first patient in Cohort 3 has completed the first week of cycle 1, following successful safety reviews of previous cohorts with no safety or tolerability issues reported [1][2] - Encouraging early results from Cohorts 1 and 2 indicate GTB-3650's potential to activate endogenous NK cells and induce NK cell expansion, with heightened immune activity observed in multiple blood biomarker assays [3] Trial Details - The Phase 1 trial will evaluate GTB-3650 in approximately 14 patients across seven cohorts, with dosing occurring in two-week blocks for up to four months based on clinical benefit [4] - The trial aims to assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous NK cells, and clinical activity [4] - Initial Phase 1 results are expected to be released later in 2025 after the completion of additional dose cohorts [3] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutics based on its proprietary TriKE NK cell engager platform [5] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies utilizing TriKE technology [5]

TriKE® Technology and Pipeline - GT Biopharma's TriKE® platform utilizes camelid nanobodies to target NK cells to tumor cells, activating them via CD16A and IL-15 [5, 13] - The company has 6+ pipeline assets in preclinical development, targeting both solid tumors and hematological malignancies [5] - GTB-3650, a 2nd generation TriKE® targeting CD33, has an IND accepted in June 2024, with the first patient dosed on January 21, 2025 [5, 7] - GTB-7550 TriKE® is in development for the treatment of lupus and other autoimmune disorders [5, 37] - GTB-3550, the first generation TriKE® targeting CD33, showed proof of concept in Phase 1 in AML patients, reducing CD33+ bone marrow blast levels by 333%-636% in some patients [5, 26] Financial Status - As of March 31, 2025, GT Biopharma had $25 million in cash and short-term investments, with a debt-free balance sheet [5] - An additional $54 million in cash was raised on May 12, 2025 [5]

Core Insights - GT Biopharma, Inc. has successfully completed dosing in Cohort 1 and has initiated dosing in Cohort 2 of its Phase 1 trial for GTB-3650, targeting relapsed or refractory CD33 expressing hematologic malignancies [2][3] - No safety or tolerability issues were observed in Cohort 1, allowing the company to proceed with further dosing [1][3] - Early evidence of increased immunologic activity has been observed in patients from Cohort 1, indicating the potential effectiveness of GTB-3650 in activating natural killer (NK) cells [4] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company focused on immuno-oncology therapeutics, utilizing its proprietary TriKE NK cell engager platform [6] - The company has an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [6] Trial Details - The Phase 1 trial plans to evaluate GTB-3650 in approximately 14 patients across seven cohorts, with dosing occurring in two-week blocks [5] - The trial will assess various parameters including safety, pharmacokinetics, pharmacodynamics, and clinical activity [5]

Clinical Development - GT Biopharma is advancing its TriKE® platform, with GTB-3650 targeting CD33 in relapsed/refractory AML and high-risk MDS, having initiated Phase 1 trials on January 21, 2025 [118]. - Interim clinical trial results for GTB-3550 showed a reduction in CD33+ bone marrow blast levels by 33.3% to 63.6% across various patient doses [120]. - GTB-3650 has shown enhanced potency compared to GTB-3550, leading to the decision to focus on the next-generation camelid nanobody platform [121]. - GTB-5550 targets B7-H3 on advanced solid tumors and is currently in preclinical studies, with a pre-IND packet submitted to the FDA in October 2023 [131]. - GTB-7550 is being developed for lupus and other autoimmune disorders, effectively targeting CD19+ malignant cell lines [132]. - The FDA cleared the IND application for GTB-3650 in June 2024, allowing for clinical study enrollment [129]. - The TriKE® platform is designed to enhance the cancer-killing abilities of NK cells, potentially offering a safer alternative to T-cell immunotherapy [115]. - GT Biopharma's strategy includes introducing next-generation camelid nanobody technology to improve therapeutic efficacy [122]. - The company is implementing processes to produce IND-ready moieties in a timely manner after TriKE® conceptual design [116]. Financial Performance - Total operating expenses decreased by 37% to $1,932,000 for the three months ended March 31, 2025, compared to $3,091,000 in the same period of 2024 [140]. - Research and development expenses increased by 41% to $1,099,000 for the three months ended March 31, 2025, primarily due to increased scientific research costs [140][141]. - Selling, general, and administrative expenses decreased by approximately $1.4 million, or 62%, to $830,000 for the three months ended March 31, 2025 [143]. - Net loss decreased by 66% to $776,000 for the three months ended March 31, 2025, compared to a net loss of $2,266,000 in the same period of 2024 [149]. - Cash used in operating activities was approximately $2.2 million for the three months ended March 31, 2025, down from $4.2 million in the same period of 2024 [154][155]. - Current assets decreased by $1,574,000 to $2,658,000 as of March 31, 2025, compared to $4,232,000 as of December 31, 2024 [159]. - Current liabilities decreased by $2,264,000 to $3,638,000 as of March 31, 2025, compared to $5,902,000 as of December 31, 2024 [159]. - The company recorded a gain of $998,000 on the settlement of vendor payable in March 2025 [148]. - Interest income decreased by 77% to $32,000 for the three months ended March 31, 2025, compared to $142,000 in the same period of 2024 [145][146]. - The company has no off-balance sheet arrangements as of March 31, 2025 [160].

Core Insights - GT Biopharma, Inc. has appointed Hilary Kramer to its Board of Directors, replacing Bruce Wendel who is resigning [1][2] - The company is focused on developing innovative therapeutics based on its proprietary TriKE natural killer (NK) cell engager platform [1][4] - Hilary Kramer brings extensive experience in investment and strategic operations, having previously managed a $12 billion family office portfolio and served on multiple public company boards [2][3] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company specializing in immuno-oncology therapeutic products [4] - The TriKE platform is designed to enhance the cancer-killing abilities of a patient's immune system's natural killer cells [4] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [4]

Core Insights - GT Biopharma, Inc. is a clinical stage immuno-oncology company focused on developing therapeutics based on its proprietary TriKE NK cell engager platform [1][4] - Dr. Jeffrey Miller from the University of Minnesota will present at the 10th Anniversary of the Innate Killer Summit, discussing the advantages of tri-specific engagers in enhancing NK cell activity [2] Company Developments - GTB-3650, a second-generation TriKE, is currently in a Phase 1 dose escalation study for patients with hematological malignancies, with enrollment proceeding as expected [3] - The study will evaluate GTB-3650 in approximately 14 patients with relapsed or refractory CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome [3] - Initial data from the GTB-3650 study is anticipated to be shared in 2025 [3] Technology and Collaboration - The TriKE platform is designed to enhance the cancer-killing abilities of natural killer cells in patients [4] - GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to develop and commercialize therapies using TriKE technology [4]

Core Points - GT Biopharma, Inc. has entered into definitive agreements for the exercise of existing warrants to purchase 302,069 shares of common stock at an exercise price of $4.35 per share, expected to generate approximately $0.7 million in gross proceeds [1] - The company will issue new unregistered warrants to purchase up to 604,138 shares at an exercise price of $2.02 per share in exchange for the immediate exercise of existing warrants at $2.27 per share [3] - The offering is expected to close on or about February 27, 2025, and the net proceeds will be used for working capital and general corporate purposes [4] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutic products based on its proprietary TriKE® NK cell engager platform, which enhances the cancer-killing abilities of natural killer cells [7] - The company has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology [7]