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Core Insights - The FDA's recent approval of the first bispecific antibody combination for second-line blood cancer treatment signifies a major shift from traditional chemotherapy, with engineered cell therapies and bispecific antibodies achieving response rates over 90% in relapsed and refractory hematologic malignancies [1][2] Company Developments - GT Biopharma, Inc. is advancing its Phase 1 clinical trial of GTB-3650 to Cohort 4, with patients receiving a dose of 10 µg/kg/day, focusing on relapsed or refractory blood cancers expressing CD33, particularly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) [3][4][6] - The therapy utilizes the patient's natural killer cells to target cancer cells, with treatment structured in two-week cycles followed by rest intervals, continuing for up to four months based on patient response [5][6] - The current dose in Cohort 4 is seen as a threshold for potential clinical efficacy, supported by positive immunological biomarker trends and no dose-limiting toxicities reported across previous cohorts [6][7] - GT Biopharma is also developing GTB-5550, targeting B7H3 in various solid tumors, with regulatory submission for human trials expected in late December 2025 or January 2026 [8][9] Market Trends - The CAR-T cell therapy market is projected to grow from $3.87 billion in 2024 to $13.25 billion by 2030, driven by its efficacy in treating relapsed and refractory patient populations [2]

Core Insights - Patients with aggressive blood cancers have limited treatment options and uncertain outcomes [1] - There is a growing focus among scientists on utilizing the body's own defenses, specifically developing therapies that enhance natural killer (NK) cells to target and eliminate malignant cells [1] Industry Trends - The development of NK cell therapies represents a significant advancement in the treatment landscape for aggressive blood cancers [1] - This approach highlights a shift towards immunotherapy, leveraging the immune system to combat cancer more effectively [1]

Clinical Development - GTB-3550 showed interim clinical trial results with reduced CD33+ bone marrow blast levels by 33.3%, 61.7%, 63.6%, and 50% across different patient doses[131]. - GTB-3650, a next-generation TriKE®, is anticipated to enhance efficacy in treating relapsed/refractory AML and high-risk MDS, with an IND application filed in December 2023 and cleared by the FDA in June 2024[140]. - GTB-5550 targets B7-H3 on advanced solid tumors, with preclinical studies demonstrating NK-cell targeted activity against various cancers, and an IND application expected by late December 2025 or January 2026[142]. - GTB-7550 is in development for lupus and other autoimmune disorders, effectively targeting CD19+ malignant cell lines and primary CLL[143][144]. - The TriKE® platforms are designed to activate NK cells, potentially offering a safer alternative to T-cell immunotherapy with reduced cytokine release syndrome[125][126]. - The company is focusing on developing second-generation TriKEs utilizing camelid nanobody technology, which may provide greater affinity and potency against target antigens[133][135]. - The IND application for GTB-3650 was filed with the FDA in December 2023, with study enrollment for patients starting on January 21, 2025[140]. - The company has exclusive rights to the TriKE® platform and is generating additional intellectual property for specific moieties[127]. Financial Performance - Research and development expenses decreased by approximately $0.7 million (51%) for the three months and $1.8 million (46%) for the nine months ended September 30, 2025, primarily due to a decrease in production and material costs[152][161]. - Total operating expenses for the three months ended September 30, 2025, were $3.38 million, a decrease of $222,000 (6%) compared to the same period in 2024; for the nine months, total operating expenses were $6.83 million, down $3.77 million (36%) year-over-year[151]. - Net loss for the three months ended September 30, 2025, was $3.11 million, a decrease of $297,000 (9%); for the nine months, net loss was $5.32 million, down $4.06 million (43%) compared to the prior year[161]. - Cash used in operating activities was approximately $8.89 million for the nine months ended September 30, 2025, compared to $10.44 million for the same period in 2024[165][166]. - Current assets increased by $89,000 to $4.32 million as of September 30, 2025, while current liabilities decreased by $4.58 million to $1.32 million, resulting in a working capital improvement of $4.67 million[169]. - Interest income decreased by $60,000 (63%) for the three months and $237,000 (69%) for the nine months ended September 30, 2025, due to lower money market fund and short-term investment balances[156]. - The change in fair value of warrant liability increased by $137,000 (144%) for the three months but decreased by $626,000 (72%) for the nine months ended September 30, 2025, primarily due to stock price fluctuations[157][158]. - The company recorded a gain of $998,000 on the settlement of vendor payable in March 2025, which was classified as other income[159]. - Net cash provided by financing activities was approximately $7.47 million for the nine months ended September 30, 2025, compared to $2.98 million for the same period in 2024[168]. - The company has raised substantial doubt about its ability to continue as a going concern, with a net loss of approximately $5.3 million and cash used in operations of approximately $8.9 million for the nine months ended September 30, 2025[162][164]. Accounting and Financial Reporting - The financial statements preparation involves significant estimates, including accruals for potential liabilities and fair value of warrant liabilities[145][146]. - Stock-based compensation is periodically issued, with expenses recognized based on grant date fair values, affecting future periods' compensation expense[150].

Financial Results - GT Biopharma, Inc. announced its financial results for the fiscal quarter ended September 30, 2025[4]. - The press release detailing the financial results was issued on November 14, 2025[4]. - The financial results include key metrics that will be detailed in Exhibit 99.1[4]. - The financial statements and exhibits are included in the filing[6]. Company Structure - The company became a fully remote organization effective July 1, 2024, and no longer maintains a principal executive office[3]. - The company has not indicated whether it is an emerging growth company[3]. Regulatory Information - The report is not deemed "filed" under the Securities Exchange Act of 1934[5]. - The report was signed by Alan Urban, Chief Financial Officer[11]. Company Identification - The company is listed on The Nasdaq Stock Market under the trading symbol GTBP[2]. - The company’s IRS Employer Identification Number is 94-1620407[1].

Core Insights - GT Biopharma, Inc. is advancing its Phase 1 clinical trial for GTB-3650, targeting relapsed or refractory CD33 expressing hematologic malignancies, with the next update expected in Q1 2026 [1][2][3] - The company plans to submit an IND application for GTB-5550, aimed at B7H3-expressing solid tumors, by late December 2025 or January 2026 [1][3] Clinical Trials - The Phase 1 trial for GTB-3650 involves 14 patients with conditions such as refractory acute myeloid leukemia and high-risk myelodysplastic syndrome, assessing safety and clinical activity [2] - The trial is structured in two-week dosing blocks, with the potential for up to four months of treatment based on clinical benefit [2] - The trial has progressed to Cohort 4 at a dose level of 10 µg/kg/day, with expectations of approaching efficacy levels predicted by preclinical models [3] Financial Summary - As of September 30, 2025, the company reported cash and cash equivalents of approximately $2.6 million, sufficient to fund operations into Q1 2026 [4] - Research and Development (R&D) expenses for Q3 2025 were approximately $0.6 million, a decrease from $1.3 million in Q3 2024, primarily due to reduced production and material costs [5] - Selling, General and Administrative (SG&A) expenses remained relatively flat at approximately $2.4 million compared to $2.3 million in the same quarter of 2024 [6] - The company reported a net loss of approximately $3.1 million for Q3 2025, an improvement from a net loss of $3.4 million in Q3 2024, attributed to decreased R&D expenses [7]

Market Overview - The market has seen significant declines among several companies, including Vantage Corp, ZIVO Bioscience, CCSC Technology, Thunder Power Holdings, and GT Biopharma, influenced by company-specific developments and broader market conditions [1]. Vantage Corp - Vantage Corp's stock price plummeted by 81.09% to $1.21, with a trading volume of 15,522,991, far exceeding its average [2]. - The company is scheduled to present at the 2025 Gateway Conference, which may provide an opportunity to showcase its services and potentially influence future stock performance [2]. CCSC Technology International Holdings - CCSC Technology experienced a 41.45% decrease in its stock price to $1.3701, with a trading volume spike to 11,391,387 [3]. - The company announced a memorandum of understanding with Konstruktor Group to develop a new supply chain management center in Serbia, aiming to enhance its logistics and manufacturing infrastructure in Europe [3]. Thunder Power Holdings - Thunder Power Holdings saw a 35.07% fall in its stock price to $0.19, with minimal trading activity [4]. - The company is focused on expanding its operations in Taiwan and is making strides in the clean energy market, which may impact its future stock performance [4]. GT Biopharma - GT Biopharma's stock decreased by 33.23% to $0.72, with a trading volume of 5,837,946 [5]. - The company is advancing its TriKE® platform for cancer treatment and has reported its financial results for the second quarter of 2025, which may influence investor sentiment and future stock movements [5]. Conclusion - These developments highlight the dynamic nature of the market, with company-specific news and strategic initiatives playing a crucial role in stock performance [6]. Investors are closely monitoring these companies for any updates that could impact their future trajectories [6].

Core Insights - The company is progressing well with Phase 1 enrollment, with both patients in Cohort 3 having initiated treatment without any dose-limiting toxicities or tolerability concerns to date [1][2] - The first patient in Cohort 3 has shown promising immune activation, consistent with previous cohorts, with further updates expected by year-end [1] - Upon successful completion of Cohort 3's safety assessment, the trial will escalate dosing into Cohort 4, planned for year-end 2025, with the potential to expand to 7 cohorts if necessary [1][2] Company Overview - GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutics based on its proprietary TriKE NK cell engager platform [4] - The TriKE platform aims to enhance the cancer-killing abilities of natural killer cells in patients' immune systems [4] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies utilizing TriKE technology [4] Trial Details - The Phase 1 trial protocol allows for the evaluation of GTB-3650 in approximately 14 patients across seven cohorts, with doses ranging from 1.25 µg/kg/day in Cohort 1 to 100 µg/kg/day in Cohort 7 [3] - Dosing will occur in two-week cycles, with treatment blocks lasting up to four months based on clinical benefit [3] - The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous NK cells, and clinical activity [3]

Core Insights - 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 cells [1][3] - Michael Breen, the Executive Chairman and CEO, will participate in the Centurion One Capital 3rd Annual Bahamas Summit on October 28-29, 2025 [1] - The company will be available for one-on-one meetings at the conference, indicating an opportunity for potential investors to engage directly [2] Company Overview - GT Biopharma is dedicated to the development and commercialization of immuno-oncology therapeutic products utilizing the TriKE NK cell engager platform [3] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [3] - For further information, the company directs interested parties to its website [3]

Summary of GT Biopharma Conference Call Company Overview - **Company Name**: GT Biopharma - **Ticker**: GTBP - **Industry**: Biotechnology, specifically focused on oncology and immunotherapy - **Current Stage**: Clinical-stage company conducting Phase 1 trials for blood cancer and acute myeloid leukemia [2][3] Core Technology and Pipeline - **Technology**: Trispecific killer cell engager camelid nanobodies designed to target cancer and HIV - **Pipeline**: Over six candidates in development, with plans to file an IND for solid tumors by the end of the calendar year [3] - **Key Focus**: Solid tumor oncology market, which is significantly larger than the blood cancer market [3] Clinical Trials and Findings - **GTB-3550**: First-generation TriKE® targeting CD33 for myeloid leukemia; well-tolerated with no safety issues reported [9][10] - **NK Cell Expansion**: The therapy demonstrated the ability to increase NK cell counts in patients, which is crucial for effective cancer treatment [10] - **GTB-3650**: Second-generation camelid TriKE® currently in trials, showing early signs of sustained immune activation and no dose-limiting toxicity [13][14] Advantages of Trispecific Engagers - **Unique Mechanism**: Combines IL-15 with NK cell engagement, enhancing the proliferation and activity of NK cells compared to other engagers that do not include IL-15 [19][20] - **Clinical Activity**: Preliminary data indicates potential clinical activity with reductions in leukemia blast cells observed in treated patients [11] Targeting B7H3 - **B7H3 TriKE®**: Developed to target a pan-tumor antigen, showing increased potency in preclinical models compared to first-generation engagers [12][16] - **Solid Tumor Trials**: Plans to conduct outpatient therapy with subcutaneous injections, aiming for a more manageable treatment regimen [18] Future Directions - **Basket Trials**: Seven cohorts planned to identify clinical activity across various diseases, which will inform the FDA approval pathway [19] - **Exploration of CD19 Targeting**: Investigating the potential of CD19 TriKE® for treating autoimmune diseases, with promising preclinical data [21][22] Conclusion - GT Biopharma is positioned to leverage its innovative trispecific engager technology to address significant unmet needs in oncology, with a focus on both blood cancers and solid tumors, while also exploring applications in autoimmune diseases. The company aims to advance its clinical trials and seek FDA approval in the coming years [2][19]