INTERNATIONAL ISOTOPES (INIS) Company Report

International Isotopes Inc. reported revenue from product sales of $3,277,816 for the third quarter of 2025, a 16% decrease compared to the prior year, and $10,172,036 for the nine months ended September 30, 2025, a 2% increase.
The company posted a net loss of $203,601 for Q3 2025 and a net loss of $477,080 for the first nine months of 2025, representing a decrease from net profit in Q3 2024 and an increased loss for the nine-month period compared to the prior year.
Non-GAAP EBITDA decreased significantly to $14,985 for the first nine months of 2025, down from $210,590 in the same period last year.
The decline in Q3 revenue and overall profitability was primarily attributed to raw material outages for Theranostics Products and Calibration & Reference Products, estimated to have reduced Q3 2025 revenues by more than $400,000 and nine-month revenues by more than $750,000.
Despite these challenges, the company achieved operational efficiencies, driving down SG&A costs by 24% for the quarter and 11% for the year, and added Dr. Duke Fu to its board of directors.

Nov 14, 2025, 4:05 PM

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

INIS

New Projects/Investments

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.
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).
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).

Oct 18, 2025, 9:15 AM

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

INIS

Executive Compensation

Board Change

Product Launch

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.
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.
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.
The company also appointed Dr. Fu as a director, compensating him with 250,000 RSUs for each annual term.
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.

Oct 17, 2025, 6:10 PM

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

INIS

Executive Compensation

Board Change

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. 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.
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.
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.
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.

Oct 17, 2025, 6:09 PM

ITM Announces Positive Dosimetry Data from Phase 3 COMPETE Trial

INIS

Product Launch

New Projects/Investments

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).
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.
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.
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.
Renal adverse events (Grade ≥1) occurred less frequently with 177Lu-edotreotide (14.7%) compared to everolimus (21.2%).

Oct 8, 2025, 10:01 AM

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