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Radnostix, Inc. Reports on Second Quarter FY2026 Results

Radnostix, Inc. (formerly International Isotopes Inc.), a notable player in the production of radioisotope technologies catering to medical, industrial, and research needs, recently disclosed its financial results for the second quarter and the first half of FY2026. This report offers an in-depth look at the company's challenges and achievements during this period, particularly focusing on the impact of recent FDA actions.

Financial Overview

For the quarter ending June 30, 2026, Radnostix reported a total revenue of $2.67 million, a 27% decline compared to the $3.66 million recorded in the same quarter of the previous year. Similarly, revenue for the first half of the fiscal year also fell by the same percentage, amounting to $5.05 million, down from $6.89 million in the first half of FY2025. This downturn is largely attributed to the residual effects of two voluntary product recalls related to Theranostics Products and issues surrounding the shutdown of Cobalt Products.

The company recorded a gross profit of $1.36 million for the quarter, translating to a 51% margin, down from $2.14 million and a 59% margin in Q2 2025. Over the six-month period, gross profit stood at $2.51 million, also reflecting a margin decrease to 50% from 61% in the prior-year period. Notably, the company experienced a significant net loss of $0.88 million in Q2 2026, a stark increase from the $0.16 million loss in Q2 2025; the net loss for the first half of FY2026 reached $2.23 million, drastically higher than $0.27 million in the same period in 2025.

Regulatory Challenges and Strategic Actions

The voluntary recalls significantly impacted Radnostix's operations, but the company successfully restored its capsule inventory entirely by the end of June 2026. Sales began returning to normal in July 2026 following the completion of the recall action. The company released all necessary documentation to the FDA in June and is awaiting closure on the recalls.

Additionally, all corrective actions related to the FDA Form 483 issued back in April 2025 have been accomplished, with the company also submitting a request for a close-out inspection on June 19, 2026. The rehabilitation of the Cobalt-60 hot-cell, finished in Q1, has further improved profit margins and reduced substantial waste disposal costs from the previous year, positioning Radnostix favorably moving forward.

An important acquisition took place on June 25, 2026, when Radnostix procured assets from Lucerno Dynamics, which includes the Lara System technology platform and Ellexa Explorer Software. This move expands the company's portfolio in the medical devices segment and signifies a strategic leap for their technological capabilities in the market.

Updates on Business Segments

Examining the company's key segments, the Theranostics Products segment earned $1.08 million in revenue during Q2, reflecting a 43% drop year-over-year. The anticipated recovery in this segment is expected as inventory restoration continues. The Cobalt Products segment reported $0.50 million in Q2, with positive income returning due to cost reductions from the hot-cell rehabilitation.

On the positive side, the Calibration and Reference Products segment showed resilience with a Q2 revenue of $1.06 million, a 4% increase compared to last year. This growth stems from continued product development despite the ongoing global isotope supply constraints.

The newly acquired Medical Devices segment is under development with new products such as EasyFill and RadVent targeted for commercial launch in early 2027.

Future Outlook

Looking ahead, Radnostix's management is committed to achieving a full recovery of the Theranostics volumes now that the recalls and inventory restoration are addressed. They aim to improve operational cleanliness to achieve more predictable manufacturing outputs while minimizing compliance and waste costs. Moreover, the team is focused on advancing the commercialization of newly acquired medical devices and managing costs effectively to return to cash-flow positive results by the end of FY2026.

As Radnostix navigates these challenges, its strategic expansions and operational adjustments reflect a dedicated commitment to its core values and the enhancement of its market position.