Justin Walsh

Ram Selvaraju

Tony Butler

- **GT Biopharma** has advanced its lead drug candidate, **GTB-3650**, into **Cohort 3** of its Phase 1 clinical trial for relapsed or refractory CD33-expressing blood cancers in August 2025, following successful safety reviews and encouraging early signals of immune system activation.  **[109657_20251015LN98590:0]** 
- Early data from the GTB-3650 trial showed **measurable increases in natural killer cell activity and expansion** in the first four patients, with more detailed Phase 1 results expected later in 2025.  **[109657_20251015LN98590:1]** 
- The company anticipates submitting an application to initiate human testing for its second drug candidate, **GTB-5550**, which targets various solid tumors, during the **fourth quarter of 2025**.  **[109657_20251015LN98590:1]** 
- As of **June 30, 2025**, **GT Biopharma** reported **cash and cash equivalents of approximately $5.3 million**, expected by management to fund operations into the **first quarter of 2026**.  **[109657_20251015LN98590:1]**

GT Biopharma Provides Updates on Clinical Trials and Financial Position

- GT Biopharma announced that enrollment in the dose escalation cohorts of its **GTB-3650 Phase 1 trial** for relapsed or refractory CD33 expressing hematologic malignancies is well on track.  **[109657_ea5ac547692647b4b2386db75656ff76_0]** 
- **Enrollment in Cohorts 1 and 2 was successfully completed**, and both patients in **Cohort 3 have initiated treatment with no evidence of dose-limiting toxicities** or tolerability concerns to date.  **[109657_ea5ac547692647b4b2386db75656ff76_0]** 
- The first patient in Cohort 3 has shown **promising evidence of immune activation**, consistent with levels observed in patients from the previous two lower-dose cohorts.  **[109657_ea5ac547692647b4b2386db75656ff76_0]** 
- The company anticipates an **additional update by year-end** regarding Cohort 3, and **initiation of Cohort 4 dosing is planned by year-end 2025**.  **[109657_ea5ac547692647b4b2386db75656ff76_0]** 
- **Additional data updates are anticipated in Q1 2026**.  **[109657_ea5ac547692647b4b2386db75656ff76_0]**

GT Biopharma (GTBP)