- **ITM Isotope Technologies Munich SE** announced positive results from its Phase 3 COMPETE trial for **n.c.a. 177Lu-edotreotide (ITM-11)** in Grade 1 or Grade 2 GEP-NETs, which met its primary endpoint of statistically significant improvement in median progression-free survival (mPFS) compared to everolimus.  **[1038277_dbed7d7658474615ac96a527b310a678_0]** 
- The trial also achieved a key secondary endpoint, demonstrating a significantly **higher objective response rate (ORR)** for 177Lu-edotreotide, with a central assessment of **21.9%** versus **4.2%** for everolimus (p<0.0001).  **[1038277_dbed7d7658474615ac96a527b310a678_0]** 
- Additionally, the study showed **prolonged mPFS across patient subgroups** and a **lower frequency of treatment-emergent adverse events** leading to premature study discontinuation in the 177Lu-edotreotide arm (**1.8%** compared to **15.2%** for everolimus).  **[1038277_dbed7d7658474615ac96a527b310a678_0]** **[1038277_dbed7d7658474615ac96a527b310a678_1]**

ITM Announces Positive Phase 3 COMPETE Trial Results for GEP-NETs

- **International Isotopes Inc. (INIS)** entered into a new employment agreement with **Shahe Bagerdjian**, continuing his role as President and CEO from **July 18, 2025, to July 18, 2030**.  **[1038277_0001437749-25-031242_ex_871447.htm:0]** **[1038277_0001437749-25-031242_inis20251016_8k.htm:1]** 
- Mr. Bagerdjian's initial annual base salary is **$314,000** as of July 18, 2025, with **5% annual automatic increases** and potential **$50,000 increases** for each quarterly revenue milestone achieved at **$3.75 million, $6.25 million, $12.5 million, $18.75 million, and $25 million**.  **[1038277_0001437749-25-031242_inis20251016_8k.htm:1]** **[1038277_0001437749-25-031242_ex_871447.htm:2]** 
- He will be awarded up to **37,500,000 restricted stock units (RSUs)** under a 2025 Milestone Award, vesting based on company share price milestones ranging from **$0.10 to $0.30**.  **[1038277_0001437749-25-031242_ex_871447.htm:2]** **[1038277_0001437749-25-031242_ex_871447.htm:20]** 
- The company also appointed **Dr. Fu** as a director, compensating him with **250,000 RSUs** for each annual term.  **[1038277_0001437749-25-031242_inis20251016_8k.htm:3]** 
- Key Performance Indicators (KPIs) for the CEO's annual bonus for July 18, 2025, through July 17, 2026, include the successful roll-out of the **Easy-Fil automated Iodine dispenser**, expansion of **iodine sales to U.S. Customers**, and **NASDAQ uplisting**.  **[1038277_0001437749-25-031242_ex_871447.htm:26]**

International Isotopes Inc. Renews CEO Employment Agreement and Appoints New Director

- International Isotopes Inc. entered into a new employment agreement with **Shahe Bagerdjian**, who will continue as President and CEO for an initial term from **July 18, 2025**, to **July 18, 2030**.  **[1038277_0001437749-25-031241_inis20251016_8k.htm:1]**  His initial annual base salary is **$314,000** as of **July 18, 2025**, with annual **5%** automatic increases and potential **$50,000** increases based on quarterly revenue milestones.  **[1038277_0001437749-25-031241_inis20251016_8k.htm:1]** 
- Mr. Bagerdjian was awarded up to **37,500,000** restricted stock units (RSUs) under the 2025 Milestone Award, vesting based on the Company's share price reaching targets from **$0.10** to **$0.30**.  **[1038277_0001437749-25-031241_ex_871447.htm:2]** **[1038277_0001437749-25-031241_inis20251016_8k.htm:2]** **[1038277_0001437749-25-031241_ex_871447.htm:20]** **[1038277_0001437749-25-031241_ex_871447.htm:22]** 
- **Dr. Duke W. Fu** was appointed to the Board of Directors and the audit committee, effective **October 10, 2025**, and will receive **250,000** RSUs for each annual term served.  **[1038277_0001437749-25-031241_inis20251016_8k.htm:2]** **[1038277_0001437749-25-031241_inis20251016_8k.htm:3]** 
- The Company approved amendments to its bylaws on **October 14, 2025**, including changes to special meeting procedures, new advance notice requirements for business and director nominations, permission for advisory directors, and revisions to shareholder written consent, indemnification, and insurance provisions.  **[1038277_0001437749-25-031241_ex_871446.htm:0]** **[1038277_0001437749-25-031241_inis20251016_8k.htm:3]** **[1038277_0001437749-25-031241_inis20251016_8k.htm:4]**

International Isotopes Inc. Announces CEO Employment Agreement, Equity Grants, Board Appointment, and Bylaws Amendments

- ITM Isotope Technologies Munich SE (ITM) announced positive dosimetry data from its Phase 3 COMPETE trial for **n.c.a. 177Lu-edotreotide (ITM-11)**, a targeted radiotherapeutic agent for patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** 
- The data, presented on **October 8, 2025**, demonstrated that ITM-11 delivered **targeted radiation to tumors** while minimizing exposure to healthy tissue, supporting its favorable efficacy and safety profile.  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** 
- Key dosimetry findings showed a significantly higher absorbed dose in tumors (**110.0 ± 90.8 Gy**) compared to normal organs, with kidney and red bone marrow doses remaining well below assumed safety thresholds.  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** **[1038277_0eadfb384c9c43968efe29cc433d1dec_1]** 
- The COMPETE trial previously met its primary endpoint in January and March 2025, demonstrating **significantly longer median progression-free survival** for 177Lu-edotreotide compared to everolimus.  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** 
- Renal adverse events (Grade ≥1) occurred less frequently with 177Lu-edotreotide (**14.7%**) compared to everolimus (**21.2%**).  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** **[1038277_0eadfb384c9c43968efe29cc433d1dec_1]**

INTERNATIONAL ISOTOPES (INIS)